Interventions for treating scabies

  • Review
  • Intervention

Authors


Abstract

Background

Scabies is an intensely itchy parasitic infection of the skin caused by the Sarcoptes scabiei mite. It is a common public health problem with an estimated global prevalence of 300 million cases. Serious adverse effects have been reported for some drugs used to treat scabies.

Objectives

To evaluate topical and systemic drugs for treating scabies.

Search methods

In June 2010, we searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2010, Issue 2), MEDLINE, EMBASE, LILACS, and INDMED. In August 2010, we also searched the grey literature and sources for registered trials. We also checked the reference lists of retrieved studies.

Selection criteria

Randomized controlled trials of drug treatments for scabies.

Data collection and analysis

Two authors independently assessed trial quality and extracted data. Results were presented as risk ratios with 95% confidence intervals and data combined where appropriate.

Main results

Twenty-two small trials involving 2676 people were included. One trial was placebo controlled, 18 compared two or more drug treatments, three compared treatment regimens, and one compared different drug vehicles.

Fewer treatment failures occurred by day seven with oral ivermectin compared with placebo in one small trial (55 participants). Topical permethrin appeared more effective than oral ivermectin (140 participants, 2 trials), topical crotamiton (194 participants, 2 trials), and topical lindane (753 participants, 5 trials). Permethrin also appeared more effective in reducing itch persistence than either crotamiton (94 participants, 1 trial) or lindane (490 participants, 2 trials). No difference was detected between permethrin (a synthetic pyrethroid) and a natural pyrethrin-based topical treatment (40 participants, 1 trial), and between permethrin and benzyl benzoate (53 participants, 1 trial), however both these trials were small.

No significant difference was detected in the number of treatment failures between crotamiton and lindane (100 participants, 1 trial), lindane and sulfur (68 participants, 1 trial), benzyl benzoate and sulfur (158 participants, 1 trial), and benzyl benzoate and natural synergized pyrethrins (240 participants, 1 trial); all were topical treatments. No trials of malathion were identified.

No serious adverse events were reported. A number of trials reported skin reactions in participants randomized to topical treatments. There were occasional reports of headache, abdominal pain, diarrhoea, vomiting, and hypotension.

Authors' conclusions

Topical permethrin appears to be the most effective treatment for scabies. Ivermectin appears to be an effective oral treatment. More research is needed on the effectiveness of malathion, particularly when compared to permethrin, and on the management of scabies in an institutional setting and at a community level.

摘要

背景

治療疥瘡的方式

疥瘡是一種極癢的寄生蟲皮膚感染,由一種蝨子(Sarcoptes scabiei)感染。它是常見公共衛生問題而全球盛行率約三億病例。某些治療疥瘡的藥物已被報告具有嚴重的副作用。

目標

去評估治療疥瘡局部性和全身性治療藥物。

搜尋策略

在2007年2月,我們收集了Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2006, Issue 1), MEDLINE, EMBASE, LILACS, INDMED。在2007年3月我們也收尋灰色文獻(grey literature)和已註冊的臨床試驗。我們也查核了這些研究的參考文獻。

選擇標準

疥瘡藥物治療的隨機控制研究試驗。

資料收集與分析

2名作者分別評估試驗品質併摘取資訊。只要適宜資料便會彙集一起分析,最後結果以相對危險及95%信心區間呈現。

主要結論

20個小型試驗共有2392人參與。其中1個試驗是安慰劑的比較,16個試驗比較2種或多種藥物,2個比較不同處方,1篇比較不同藥物載體(vehicles)。在一篇55人參與的小型研究中口服ivermectin治療7天後有少數治療失敗。局部permethrin治療比下列研究有效,包括口服ivermectin(1篇研究85位病人),局部crotamiton(2篇研究194位病人),局部lindane(5篇研究753位病人)。Permethrin在與下列研究比較下也顯示降低皮膚搔癢程度會更有效,包括crotamiton(1篇研究94位病人)或lindane(2篇研究490位病人)。在一篇小型研究(40位病人)中,並不能發現permethrin(合成的pyrethroid)與天然局部的pyrethrin有何差異。在治療失敗數目未有任何臨床意義的差異有crotamiton與lindane(1篇研究100位病人), lindane與sulfur(1篇研究68位病人), benzyl benzoate與sulfur(1篇研究158位病人), benzyl benzoate與natural synergized pyrethrins(1篇研究240位病人),以及所有表面塗劑。沒有人任何關於使用malathion的研究。沒有嚴重副作用被報告。有一些臨床試驗報導在表面塗劑組會發生一些皮膚反應。偶爾有些頭痛,腹痛,腹瀉,嘔吐,低血壓的報導。

作者結論

局部擦抹permethrin顯然對疥瘡治療最有效。口服Ivermectin也是有效的治療。至於malathion則需要更多的研究去評估其療效,特別是與permethrin的比較,以及其在醫療機構內及社區層面治療疥瘡的效益。

翻譯人

本摘要由三軍總醫院宋志建翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

疥瘡的介入治療,疥瘡是一種發生於全世界的寄生蟲皮膚感染,對公共衛生環境差,擁擠,社會秩序不佳等地區尤其困擾。它通常流行於資源缺乏的國家。全球盛行率預估約30億病例但是感染的程度隨著不同城市及社區而有差異。雌性蝨子鑽進皮膚產卵,孵化且繁殖。感染可以在人與人之間經由皮膚接觸而傳染,包括性接觸。它會引起皮膚極癢且破皮。不同的藥物包含草藥以及傳統醫藥已被研發治療疥瘡。本評論嘗試包含所有治療方式。作者們共找到了20個小型試驗共有2392人參與,其中17個試驗在資源缺乏國家完成,局部permethrin治療顯然對疥瘡治療最為有效,口服Ivermectin也很有效。然而Ivermectin在許多國家都沒有合法使用的執照。副作用包含紅疹,嘔吐,腹痛,但是這些試驗都規模太小以致無法適當評估罕見但可能嚴重的副作用。本文沒有包括任何中藥以及傳統治療的臨床試驗。

Résumé scientifique

Interventions pour le traitement de la gale

Contexte

La gale est une infection parasitaire de la peau provoquée par l'acarien Sarcoptes scabei , qui entraîne d'intenses démangeaisons. Il s'agit d'un problème de santé publique courant, dont la prévalence est estimée à 300 millions de cas à l'échelle mondiale. Des effets indésirables graves associés à certains médicaments utilisés dans le traitement de la gale ont été rapportés.

Objectifs

Évaluer les médicaments topiques et systémiques dans le traitement de la gale.

Stratégie de recherche documentaire

En juin 2010, nous avons consulté le registre spécialisé du groupe Cochrane sur les maladies infectieuses, CENTRAL (Bibliothèque Cochrane 2010, numéro 2), MEDLINE, EMBASE, LILACS et INDMED. En août 2010, nous avons également consulté la littérature grise et d'autres sources afin d'identifier des essais enregistrés. Nous avons également examiné les références bibliographiques des études identifiées.

Critères de sélection

Les essais contrôlés randomisés examinant des médicaments utilisés dans le traitement de la gale.

Recueil et analyse des données

Deux auteurs ont évalué la qualité des essais et extrait les données de manière indépendante. Les résultats ont été présentés sous forme de risques relatifs avec des intervalles de confiance à 95 %, et les données ont été combinées lorsque cela était approprié.

Résultats principaux

Vingt-deux petits essais portant sur 2 676 participants ont été inclus. Un essai était contrôlé par placebo, 18 comparaient au moins deux médicaments, trois comparaient différents schémas thérapeutiques et un comparait différentes voies d'administration.

Moins d'échecs du traitement se produisaient dans les sept jours sous ivermectine orale par rapport au placebo dans un petit essai (55 participants). La perméthrine topique semblait plus efficace que l'ivermectine orale (140 participants, 2 essais), le crotamiton topique (194 participants, 2 essais) et le lindane topique (753 participants, 5 essais). La perméthrine semblait également plus efficace pour réduire la persistance des démangeaisons que le crotamiton (94 participants, 1 essai) ou le lindane (490 participants, 2 essais). Aucune différence n'était détectée entre la perméthrine (un pyréthrinoïde de synthèse) et un traitement topique à base de pyréthrine naturelle (40 participants, 1 essai) et entre la perméthrine et le benzoate de benzyle (53 participants, 1 essai), mais ces deux essais étaient de petite taille.

Aucune différence significative n'était détectée concernant le nombre d'échecs du traitement entre le crotamiton et le lindane (100 participants, 1 essai), le lindane et le soufre (68 participants, 1 essai), le benzoate de benzyle et le soufre (158 participants, 1 essai) et le benzoate de benzyle et les pyréthrines naturelles synergisées (240 participants, 1 essai) ; il s'agissait dans chaque cas de traitements topiques. Aucun essai portant sur du malathion n'a été identifié.

Aucun événement indésirable grave n'a été rapporté. Plusieurs essais rapportaient des réactions cutanées chez les participants randomisés pour des traitements topiques. Des céphalées, des douleurs abdominales, des diarrhées, des vomissements et une hypotension étaient occasionnellement rapportés.

Conclusions des auteurs

La perméthrine topique semble constituer le traitement le plus efficace contre la gale. L'ivermectine semble efficace en traitement oral. Des recherches supplémentaires sont nécessaires concernant l'efficacité du malathion, en particulier par rapport à la perméthrine, et concernant la prise en charge de la gale dans un contexte institutionnel et à l'échelle de la communauté.

Abstrak

Intervensi untuk rawatan skabies (kudis buta)

Latar Belakang

Skabies adalah jangkitan parasit yang disebabkan oleh tungau Sarcoptes scabei Ia adalah satu masalah kesihatan awam yang biasa dengan anggaran prevalen global sebanyak 300 juta kes. Kesan buruk yang serius telah dilaporkan untuk beberapa ubat yang digunakan untuk merawat skabies.

Matlamat

Untuk menilai ubat-ubatan topikal dan sistemik untuk merawat skabies.

Kaedah Pencarian

Pada bulan Jun 2010, kami telah meneliti daftar khusus kumpulan penyakit berjangkit Cochrane, CENTRAL (The Cochrane Library 2010, Isu 2), MEDLINE, EMBASE, LILACS dan INDMED. Pada bulan Ogos 2010, kami juga meneliti kesusteraan kelabu dan sumber pendaftaran kajian. Kami juga memeriksa senarai-senarai rujukan dari kajian yang didapati.

Kriteria Pemilihan

Kajian rawak terkawal rawatan ubat untuk skabies.

Pengumpulan Data dan Analisis

Dua penulis menilai secara berasingan kualiti kajian dan data yang diekstrak. Keputusan telah dibentangkan sebagai nisbah ratio dengan selang keyakinan 95 % dan data digabungkan bila mana sesuai.

Keputusan Utama

Dua puluh dua kajian kecil melibatkan 2676 orang telah dirangkumkan. Satu kajian adalah plasebo terkawal, 18 membandingkan dua atau lebih rawatan ubat, tiga membandingkan regimen rawatan, dan satu membandingkan pembawa ubat yang berbeza.

Lebih kurang kegagalan rawatan berlaku dalam hari ke-tujuh dengan ivermectin oral berbanding plasebo dalam satu kajian kecil (55 peserta). Permethrin topikal didapati lebih berkesan berbanding ivermectin oral (140 peserta, 2 kajian), cromatimon topikal (194 peserta, 2 kajian), dan lindane topikal (753 peserta, 5 kajian). Permethrin juga didapati lebih berkesan dalam mengurangkan kegatalan berbanding samada dengan crotamiton (94 peserta, satu kajian) atau lindane (490 peserta, 2 kajian). Tiada perbezaan diperolehi di antara permethrin (pyrethroid sintetik) dan rawatan topikal berdasarkan pyrethrin semulajadi (40 peserta, satu kajian) dan di antara permethrin dan bensyl benzoate (53 peserta, satu kajian), walau bagaimanapun kedua-dua kaijian adalah kecil.

Tiada perbezaan yang ketara diperolehi dalam sejumlah rawatan yang gagal di antara crotamiton dan lindane (100 peserta, satu kajian), lindane dan sulfur (68 peserta, satu kajian), benzyl benzoate dan sulfur (158 peserta, satu kajian) dan benzyl benzoate dan pyrethrins yang disinergi secara semulajadi (240 peserta, satu kajian); kesemuanya adalah rawatan topikal. Tiada kajian dengan malathion telah dikenalpasti.

Tiada kesan buruk yang serius telah dilaporkan. Beberapa kajian telah melaporkan reaksi kulit pada peserta rawak yang menerima rawatan topikal. Terdapat sesekali laporan sakit kepala, sakit perut, cirit-birit, muntah, dan tekanan darah yang rendah (hipotensi).

Kesimpulan Pengarang

Permethrin topikal didapati sebagai rawatan yang paling berkesan untuk skabies. Ivermectin didapati sebagai rawatan oral yang berkesan. Lebih banyak penyelidikan diperlukan untuk mengenalpasti keberkesanan malathion, terutamanya apabila dibandingkan dengan permethrin, dan pengurusan skabies dalam persekitaran institusi dan pada peringkat komuniti.

Catatan terjemahan

Diterjemahkan oleh Rahimah Zakaria (Universiti Sains Malaysia). Untuk sebarang pertanyaan berkaitan terjemahan ini sila hubungi rahimah@usm.my. Disunting oleh Tan May Loong (Penang Medical College; mltan@pmc.edu.my).

Resumo

Intervenções para o tratamento de escabiose

Introdução

A escabiose é uma infecção parasitária com intenso prurido da pele causada pelo ácaro Sarcoptes scabiei . É um problema de saúde pública comum com uma prevalência global estimada de 300 milhões de casos. Efeitos adversos graves têm sido relatados para algumas drogas usadas para tratar sarna.

Objetivos

Avaliar medicações tópicas e sistêmicas para o tratamento de escabiose.

Métodos de busca

Em Junho de 2010, buscamos no Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2010, edição 2), MEDLINE, EMBASE, LILACS, e INDMED. Em Agosto de 2010, também buscamos a literatura e as fontes para os ensaios clínicos registrados. Também verificamos as listas de referência de estudos recuperados.

Critério de seleção

Ensaios clínicos controlados randomizados de tratamentos com drogas para escabiose.

Coleta dos dados e análises

Dois autores avaliaram independentemente a qualidade dos ensaios e os extraíram os dados. Os resultados foram apresentados como razões de risco com intervalo de confiança de 95% e de dados combinados, quando apropriado.

Principais resultados

Vinte e dois pequenos ensaios clínicos envolvendo 2.676 pessoas foram incluídas. Um ensaio clínico foi controlado por placebo, 18 compararam dois ou mais tratamentos de droga, três compararam regimes de tratamento, e um comparou diferentes veículos de drogas.

Ocorreram poucas falhas do tratamento por sete dias com ivermectina oral comparada com placebo em um pequeno ensaio clínico (55 participantes). Permetrina tópica apareceu mais eficaz do que a ivermectina oral (140 participantes, 2 ensaios clínicos), crotamiton tópica (194 participantes, 2 ensaios clínicos), e lindano tópica (753 participantes, 5 ensaios clínicos). A permetrina também apareceu mais eficaz na redução da persistência do prurido do que qualquer crotamiton (94 participantes, um ensaio clínico) ou lindano (490 participantes, 2 ensaios clínicos). Não foi detectada diferença entre permetrina (um piretróide sintético) e um tratamento tópico à base de piretrina natural (40 participantes, um ensaio clínico), e entre permetrina e benzoato de benzilo (53 participantes, um ensaio clínico), porém ambos os ensaios clínicos eram pequenos.

Nenhuma diferença significante foi detectada no número de falhas de tratamento entre crotamiton e lindano (100 participantes, um ensaio clínico), lindano e enxofre (68 participantes, um ensaio clínico), benzoato de benzilo e enxofre (158 participantes, um ensaio clínico) e benzoato de benzilo e piretrinas intensificadas naturais (240 participantes, um ensaio clínico); todos foram tratamentos tópicos. Não foram identificados ensaios clínicos de malathion.

Não foram relatados eventos adversos graves. Um número de ensaios clínicos relatou reações cutâneas em participantes randomizados para tratamentos tópicos. Houve relatos ocasionais de dor de cabeça, dor abdominal, diarreia, vómitos e hipotensão.

Conclusão dos autores

Permetrina tópica parece ser o tratamento mais eficaz para escabiose. Ivermectina parece ser um tratamento oral eficaz. É necessária mais pesquisa sobre a eficácia de malathion, particularmente quando comparado com permetrina, e sobre o manejo da sarna em um ambiente institucional e ao nível da comunidade.

Notas de tradução

Notas de tradução CD000320

Plain language summary

Interventions for treating scabies

Scabies is a parasitic infection of the skin. It occurs throughout the world, but is particularly problematic in areas of poor sanitation, overcrowding, and social disruption, and is endemic in many resource-poor countries. The global prevalence of scabies is estimated at 300 million cases, but the level of infection varies between countries and communities. The female mite burrows into the skin to lay eggs which then hatch out and multiply. The infection can spread from person to person via direct skin contact, including sexual contact. It causes intense itching with eruptions on the skin. Various drugs have been developed to treat scabies, and herbal and traditional medicines are also used. The review of trials attempted to cover all these. The authors identified 22 small trials involving 2676 people, with 19 of the trials taking place in resource-poor countries. Permethrin appeared to be the most effective topical treatment for scabies, and ivermectin appeared to be an effective oral treatment. However, ivermectin is unlicensed for this indication in many countries. Adverse events such as rash, vomiting, and abdominal pain were reported, but the trials were too small to properly assess serious but rare potential adverse effects. No trials of herbal or traditional medicines were identified for inclusion.

Résumé simplifié

Interventions pour le traitement de la gale

La gale est une infection parasitaire de la peau. Elle existe partout dans le monde mais est particulièrement problématique dans les régions présentant des installations sanitaires insuffisantes, une surpopulation et des perturbations sociales, et est endémique dans de nombreux pays aux ressources limitées. La prévalence de la gale est estimée à 300 millions de cas à l'échelle mondiale, mais le niveau d'infection varie d'un pays et d'une communauté à l'autre. La femelle de l'acarien creuse des galeries sous la peau et pond des œufs qui éclosent et se multiplient. L'infection peut se transmettre d'une personne à une autre par contact cutané direct, y compris par contact sexuel. Elle entraîne des démangeaisons intenses accompagnées d'éruptions cutanées. Plusieurs médicaments ont été développés pour traiter la gale, et des remèdes traditionnels et à base de plantes sont également utilisés. Cette revue des essais s'est attachée à examiner l'ensemble de ces traitements. Les auteurs ont identifié 22 petits essais portant sur 2 676 participants, dont 19 avaient été réalisés dans des pays aux ressources limitées. La perméthrine semblait être le traitement topique le plus efficace contre la gale, et l'ivermectine semblait efficace en traitement oral. Néanmoins, l'ivermectine n'est pas homologuée pour cet usage dans de nombreux pays. Des événements indésirables tels que des éruptions cutanées, des vomissements et des douleurs abdominales étaient rapportés, mais les essais étaient trop petits pour évaluer correctement des effets indésirables potentiels rares mais graves. Aucun essai portant sur des remèdes traditionnels ou à base de plantes n'a été identifié.

Notes de traduction

Traduit par: French Cochrane Centre 1st April, 2013
Traduction financée par: Pour la France : Minist�re de la Sant�. Pour le Canada : Instituts de recherche en sant� du Canada, minist�re de la Sant� du Qu�bec, Fonds de recherche de Qu�bec-Sant� et Institut national d'excellence en sant� et en services sociaux.

Ringkasan bahasa mudah

Intervensi untuk rawatan skabies (kudis buta)

Skabies (kudis buta) adalah jangkitan parasit kulit. Ia berlaku di seluruh dunia, terutamanya di kawasan yang tidak mempunyai sistem sanitasi yang baik, kesesakan, dan gangguan sosial, dan ianya endemik di negara-negara yang kekurangan sumber. Prevalen global skabies dianggarkan sebanyak 300 juta kes, tetapi tahap jangkitan berbeza-beza antara negara dan masyarakat. Tungau betina membuat lubang di bawah kulit untuk bertelur, telur tersebut menetas dan bertambah biak. Jangkitan ini boleh merebak dari seorang kepada seorang yang lain melalui sentuhan kulit secara langsung, termasuk hubungan seks. Ia menyebabkan kegatalan yang amat sangat dengan letusan kulit. Pelbagai ubat-ubatan telah dihasilkan untuk merawat skabies, termasuk ubat-ubatan herba dan tradisional. Kajian semula ke atas kajian-kajian sebelum ini bertujuan menjawab kesemua persoalan ini. Penulis mengenal pasti 22 kajian kecil melibatkan 2676 orang, di mana 19 daripada kajian ini dijalankan di negara-negara yang kekurangan sumber. Permethrin merupakan rawatan topikal yang paling berkesan untuk skabies, dan ivermectin merupakan rawatan oral yang berkesan. Walau bagaimanapun, ivermectin tidak dilesenkan untuk indikasi ini di kebanyakan negara. Kesan-kesan buruk seperti ruam, muntah dan sakit perut telah dilaporkan, tetapi kajian-kajian yang telah dilakukan adalah terlalu kecil untuk betul-betul menilai kesan buruk serius tetapi jarang yang mungkin berlaku. Tiada kajian ke atas ubat-ubatan herba atau tradisional telah dikenal pasti untuk dirangkumkan.

Catatan terjemahan

Diterjemahkan oleh Rahimah Zakaria (Universiti Sains Malaysia). Untuk sebarang pertanyaan berkaitan terjemahan ini sila hubungi rahimah@usm.my. Disunting oleh Tan May Loong (Penang Medical College; mltan@pmc.edu.my).

எளியமொழிச் சுருக்கம்

சொறி சிரங்கிற்கான சிகிச்சை தலையீடுகள்

சொறி சிரங்கு, (ஸ்கேபிஸ்) என்பது தோலின் ஒரு ஒட்டுண்ணி தொற்றாகும். அது, உலகம் முழுவதும் ஏற்படக் கூடும், ஆனால், மோசமான சுற்றுப்புற சுகாதாரம், கூட்டநெரிசல், மற்றும் சமூக இடையூறு கொண்ட பகுதிகளில் இது குறிப்பாக பிரச்னைக்குரியதாக உள்ளது மற்றும் இது, அநேக வள-குறைவான நாடுகளில், ஆண்டுத் தோறும் ஏற்படக் கூடியதாக உள்ளது. சொறி சிரங்கின் உலகளவு பரவல் 30 கோடி மக்களில் உள்ளது என்று மதிப்பிடப்பட்டுள்ளது, ஆனால், தொற்றின் மட்டங்கள் நாடுகள் மற்றும் சமூகங்களிடையே வேறுப்படுகிறது. தோலினுடே முட்டைகள் இட பெண் உண்ணி துளையிடும், மற்றும் அவை அதன் பின் குஞ்சு பொரித்து பெருகும். இந்த தொற்று, பாலியல் தொடர்பு உட்பட நேரடி தோல் தொடர்பு மூலம் ஒரு நபரிடம் இருந்து இன்னொரு நபருக்கு பரவக் கூடும். இது, தோலில் வெடிப்பு ஏற்படும் வகையில் தீவிரமான சொரிதலை உண்டாக்கும். சொறி சிரங்கை குணப்படுத்த அநேக வகையான மருந்துகள் உருவாக்கப்பட்டுள்ளன, மற்றும் மூலிகை மற்றும் பாரம்பரிய மருந்துகளும் பயன்படுத்தப்படுகின்றன. இவை அனைத்தையும், சோதனைகளின் இந்த திறனாய்வு உள்ளடக்க முயற்சி செய்தது. வள-குறைவான நாடுகளில் நடைபெற்ற 19 சோதனைகளோடு, 2676 மக்களை சம்மந்தப்படுத்திய 22 சிறிய சோதனைகளை ஆசிரியர்கள் அடையாளம் கண்டனர். சொறி சிரங்கிற்கு, பெர்மெத்ரின் மிக திறன் வாய்ந்த புற மருந்து சிகிச்சையாக, மற்றும் ஐவர்மேக்டின் திறன் வாய்ந்த வாய் வழி மருந்து சிகிச்சையாக காணப்பட்டன. எனினும், அநேக நாடுகளில் ஐவர்மேக்டினை இதற்கு பயன்படுத்துவதற்கு உரிமம் இல்லை. அரிப்பு, வாந்தி, மற்றும் வயிற்று வலி போன்ற பாதகமான நிகழ்வுகள் அறிக்கையிடப்பட்டன, கடுமையான ஆனால், அரிதான சாத்தியமான பாதக நிகழ்வுகளை சரிவர மதிப்பிட சோதனைகள் மிகவும் சிறிதாக இருந்தன. சேர்க்கைக்கு, மூலிகை அல்லது பாரம்பரிய மருந்துகளுக்கான சோதனைகள் அடையாளம் காணப்படவில்லை.

மொழிபெயர்ப்பு குறிப்புகள்

மொழிபெயர்ப்பாளர்கள்: சிந்தியா ஸ்வர்ணலதா ஸ்ரீகேசவன், ப்ளசிங்டா விஜய், தங்கமணி ராமலிங்கம், ஸ்ரீகேசவன் சபாபதி.

Resumo para leigos

Intervenções para o tratamento de escabiose

A escabiose é uma infecção parasitária da pele. Ela ocorre em todo o mundo, mas é particularmente problemática em áreas de saneamento deficiente, com superlotação, e problemas sociais, sendo endêmica em muitos países pobres. A prevalência global de escabiose é estimado em 300 milhões de casos, mas o nível de infecção varia entre países e comunidades. O ácaro feminino forma tocas na pele para botar ovos que eclodem fora e se multiplicam. A infecção pode se espalhar de pessoa para pessoa através do contato direto da pele, incluindo o contato sexual É algo que provoca prurido intenso com erupções na pele. Vários medicamentos têm sido desenvolvidos para o tratamento de escabiose, e os medicamentos fitoterápicos e tradicionais também são utilizados. A revisão de ensaios clínicos tentou cobrir todos estes. Os autores identificaram 22 ensaios clínicos pequenos envolvendo 2.676 pessoas, com 19 dos ensaios clínicos que ocorrem países com poucos recursos. Permetrina pareceu ser o tratamento tópico mais eficaz para escabiose, e ivermectina pareceu ser um tratamento oral eficaz. No entanto, a ivermectina não tem licença para esta indicação em muitos países. Os eventos adversos, tais como erupções cutâneas, vômitos e dor abdominal foram relatados, mas os ensaios clínicos eram pequenos demais para avaliar adequadamente os potenciais efeitos adversos graves, mas raros. Não foram identificados ensaios clínicos de medicamentos fitoterápicos ou tradicionais para a inclusão.

Notas de tradução

Notas de tradução CD000320

Laienverständliche Zusammenfassung

Interventionen zur Behandlung von Skabies (Krätze)

Skabies ist eine parasitäre Infektion der Haut. Sie tritt weltweit auf ist aber besonders problematisch in Gebieten mit mangelnder Hygiene, Überbevölkerung und sozialen Unruhen und ist in vielen ressourcenarmen Ländern endemisch. Die weltweite Prävalenz von Skabies wird auf 300 Millionen Fälle geschätzt, jedoch variiert die Infektionsrate zwischen den Ländern und Gemeinden. Die weibliche Milbe gräbt sich in die Haut ein, um Eier zu legen, die dann schlüpfen und sich vermehren. Die Infektion kann durch Hautkontakt, einschließlich sexuellem Kontakt, von Mensch zu Mensch übertragen werden. Sie verursacht starken Juckreiz mit Eruptionen auf der Haut. Verschiedene Medikamente wurden entwickelt, um Skabies zu behandeln, sowohl pflanzliche Mittel als auch die traditionelle Medizin werden angewendet. Der Review versucht all diese Medikamente abzudecken. Die Autoren identifizierten 22 kleine Studien mit 2676 Personen, davon wurden 19 Studien in ressourcenarmen Ländern durchgeführt. Permethrin scheint die wirksamste topische Behandlung für Skabies zu sein, und Ivermectin scheint eine wirksame orale Behandlung zu sein. Allerdings ist Ivermectin für diese Indikation in vielen Ländern nicht zugelassen. Unerwünschte Ereignisse, wie Hautausschlag, Erbrechen und Bauchschmerzen wurden berichtet, aber die Studien waren zu klein, um adäquat ernste und seltene unerwünschte Wirkungen festzustellen. Es wurden keine Studien, welche sich mit pflanzlicher oder traditioneller Medizin auseinandersetzen identifiziert und eingeschlossen.

Anmerkungen zur Übersetzung

M. Schmidt-Haghiri, freigegeben durch Cochrane Deutschland.

Background

What is scabies?

Scabies is an intensely itchy parasitic infection of the skin that is caused by the Sarcoptes scabiei mite. It occurs throughout the world, but is particularly problematic in areas of poor sanitation, overcrowding, and social disruption. The global prevalence of scabies is estimated at 300 million cases (Alexander 1984), with large variations between countries. In the UK, no up-to-date robust prevalence data exist, but general practitioners recorded approximately 1200 new cases per year in the 1990s (Downs 1999). In resource-rich communities, scabies tends to occur in cyclical epidemics, particularly within institutional-living situations such as nursing homes (Scheinfeld 2004) or the army (Mimouni 1998; Mimouni 2003). There is some seasonal variation with incidence being greater in the winter than the summer, perhaps related to the tendency for more indoor overcrowding in colder weather (Downs 1999). In resource-poor communities, the occurrence pattern is quite different with the disease being endemic in many areas (Chosidow 2000). For example, the prevalence of scabies among the remote Aboriginal communities of Northern Australia is around 50% in children and 25% in adults (Wong 2002). The prevalence of infection in a community is potentially influenced by changes in social attitudes, population movements, wars, misdiagnosis, inadequate treatment, and changes in the immune status of the population. Scabies infestation represents a considerable burden of ill health in many communities, and although the disease is rarely life threatening, it causes widespread debilitation and misery (Green 1989).

The life cycle of S. scabiei begins with the pregnant female laying two to three eggs a day in burrows several millimetres to several centimetres in length in the stratum corneum (outermost layer) of the skin. After about 50 to 72 hours, larvae emerge and make new burrows. They mature, mate, and repeat this 10- to 17-day cycle. Mites usually live for 30 to 60 days (Green 1989).

Humans are the main reservoir for S. scabiei var. hominis (variety of the mite named to reflect the main host species). Scabies is usually spread person to person via direct skin contact, including sexual contact, though transfer via inanimate objects such as clothing or furnishings is also possible (Hay 2004). The mite can burrow beneath the skin within 2.5 minutes, though around 20 minutes is more usual (Alexander 1984). The level of infectiousness of an individual depends in part on the number of mites harboured, which can vary from just a single mite to millions (Chosidow 2000). Humans can also be transiently infected by the genetically distinct animal varieties of S. scabiei (eg var. canis), though cross infectivity is low (Fain 1978; Walton 2004).

Clinical infection with the scabies mite causes discomfort and often intense itching of the skin, particularly at night, with irritating papular or vesicular eruptions. While infestation with the scabies mite is not life threatening, the severe, persistent itch debilitates and depresses people (Green 1989). The classical sites of infestation are between the fingers, the wrists, axillary areas, female breasts (particularly the skin of the nipples), peri-umbilical area, penis, scrotum, and buttocks. Infants are usually affected on the face, scalp, palms, and soles. Much of the itching associated with scabies is as a result of the host immune reaction, and symptoms can take several weeks to appear after initial infection in a person exposed to scabies for the first time. Symptoms appear after a much shorter interval (one to two days) after reinfestation (Arlian 1989).

A more severe or 'crusted' presentation of infestation is associated with extreme incapacity and with disorders of the immune system, such as HIV infection. Clinically this atypical form of scabies presents with a hyperkeratotic dermatosis resembling psoriasis. Lymphadenopathy and eosinophilia can be present, but itching may be unexpectedly mild. Patients with crusted scabies may harbour millions of mites and are highly infectious (Meinking 1995a). The dermatological distribution of mites in such patients is often atypical (eg including the head), and treatment in hospital is often advised (Chosidow 2000).

Complications are few although secondary bacterial infection of the skin lesions by group A Streptococcus pyogenes or Staphylococcus aureus, or both, can occur following repeated scratching, particularly in warmer climates (Meinking 1995a). Secondary infection with group A Streptococcus can lead to acute glomerulonephritis, outbreaks of which have been associated with scabies (Green 1989).

Diagnosis, treatment, and prevention

Diagnosis on clinical grounds is usually made on a history of itching (particularly if contacts are also affected) and the finding of lesions in the classical sites. The diagnosis can in most cases be confirmed by microscopically identifying a mite, egg, or mite faeces in a skin scraping, or by extracting a mite from a burrow (Chosidow 2000).

Various treatments are available for scabies. These include sulfur compounds, which have been used for centuries; benzyl benzoate (first used in 1931); crotamiton (used since the late 1970s); hexachlorocyclohexane, which is also known as gamma benzene hexachloride or the commercial purified form lindane ('lindane' is used in this review) (available since 1948); malathion (used since the mid 1970s); permethrin (first licensed in 1985 by the US Food and Drug Administration); and oral ivermectin (first used in humans in the 1980s). A number of herbal remedies have also been proposed (Oladimeji 2000; Alebiosu 2003; Oladimeji 2005).

Serious adverse effects have been associated with the use of some antiscabietic treatments. Convulsions and aplastic anaemia have been reported with the use of lindane (Rauch 1990; Elgart 1996), and an increased risk of death amongst elderly patients has been reported with the use of ivermectin (Barkwell 1997).

Evidence of cure ideally requires follow up for about one month. This allows time for lesions to heal and for any eggs and mites to reach maturity if treatment fails (ie beyond the longest incubation interval). Patients should be warned that itching may persist for one to two weeks after treatment, even if the mite is successfully eradicated (Buffet 2003). Because of this delay in symptom relief it may sometimes be difficult to distinguish reinfestation from primary treatment failure.

Contacts of cases are usually advised to treat themselves at the same time as the case in order to reduce the risk of reinfestation (Orkin 1976). Prevention is based on principles common to most infectious diseases, that is, limitation of contact with the mite.

Using data from randomized controlled trials, this review examines the existing evidence of effectiveness of treatments for scabies.

Objectives

To evaluate topical and systemic drugs for treating scabies.

Methods

Criteria for considering studies for this review

Types of studies

Randomized controlled trials.

Types of participants

Children or adults with a clinical or parasitological diagnosis of scabies.

Types of interventions

Intervention
  • Drug treatment (systemic or local).

  • Herbal or traditional medicine treatment.

  • Any combination of above.

  • Treatment of contacts in addition to cases.

Control
  • Placebo or no intervention.

  • A different drug intervention, drug intervention vehicle, intervention regimen, or combination of interventions.

  • Different or no treatment of contacts.

Types of outcome measures

Primary
  • Treatment failure in a clinically diagnosed case.

  • Treatment failure in a parasitologically confirmed case.

Treatment failure is defined in both the above cases as the persistence of original lesions, the appearance of new lesions, or confirmation of a live mite.

Secondary
  • Persistence of patient-reported itch.

Adverse events
  • Serious adverse event that leads to death, is life threatening, results in persistent or significant disability or incapacity, or requires hospitalization.

  • Adverse event that requires discontinuation of treatment.

  • Other adverse event.

Search methods for identification of studies

We attempted to identify all relevant trials regardless of language or publication status (published, unpublished, in press, and in progress).

Databases

We searched the following databases using the search terms and strategy described in Appendix 1: Cochrane Infectious Diseases Group Specialized Register (June 2010); Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2010, Issue 2); MEDLINE (1966 to June 2010); EMBASE (1974 to June 2010); LILACS (1982 to June 2010); and INDMED (June 2010).

Grey literature

In August 2010, we searched the following sources for published and unpublished trials using the term 'scabies': British Library Index of Conference Proceedings (catalogue.bl.uk/); British Library for Development Studies (blds.ids.ac.uk/); BRIDGE (www.bridge.ids.ac.uk/); Social Care Online (www.scie-socialcareonline.org.uk/); EconLit; ERIC; Institute for Development Studies (www.ids.ac.uk/ids/particip/information/readrm.html); IIED (www.iied.org/). We searched Science.gov (www.science.gov/) using the terms 'scabies' AND ('trial' OR 'study').

Registered trials

In August 2010, we searched the following sources for registered trials using the term 'scabies': Current Controlled Trials (www.controlled-trials.com/); Thompson CenterWatch Clinical Trials Listing Service (www.centerwatch.com/); US National Institutes of Health ClinicalTrials.gov (www.clinicaltrials.gov/); TrialsCentral (www.trialscentral.org/); and the UK Department of Health National Research Register (www.nihr.ac.uk/).

Reference lists

We checked the reference lists of all retrieved trials.

Data collection and analysis

Selection of studies

All identified trials were entered into a trials register. MS and PJ independently applied the inclusion criteria to the potentially relevant trials. If a trial's eligibility was unclear, we attempted to contact the trial authors for further information. MS reassessed all included and excluded trials cited in the previous review version (Walker 2000). Where the review authors disagreed, the Co-ordinating Editor of the Cochrane Infectious Diseases Group was consulted, and a consensus reached among the three parties; this process was also used for assessing the risk of bias in trials, and extracting data. The trial reports were scrutinized to ensure that multiple publications from the same trial were included only once. We listed the reasons for excluding studies in the 'Characteristics of excluded studies'.

Data extraction and management

We independently extracted data from the newly included trials. Where important data were missing, we attempted to contact the trial authors for further information. MS entered the data into Review Manager 5.0. We extracted the number of patients randomized and the number analysed for each group for each trial. For each dichotomous outcome, we recorded the number of participants experiencing the event in each arm of the trial.

Assessment of risk of bias in included studies

Both authors independently assessed the quality of the newly included trials. We assessed the generation of allocation sequence and allocation concealment as adequate, inadequate, or unclear (Juni 2001). We assessed the inclusion of randomized participants in the analysis to be adequate if greater than 80%. We recorded who was blinded (eg participants or investigators) rather than using potentially ambiguous terms such as double blind or single blind. MS reassessed the included trials from the previous review version (Walker 2000).

Data synthesis

MS analysed the data using Review Manager 5.0. Analyses were stratified by comparison. We undertook an available case analysis, that is, participants were analysed in the group to which they were randomized regardless of treatment received, but only where an outcome was recorded (Higgins 2005).

Results were presented as risk ratios (RRs) with 95% confidence intervals (CIs) around these estimates. RRs less than one were taken to demonstrate a favourable outcome of the intervention of interest, and these are presented to the left of the line of no effect.

For those comparisons in which there were data from more than one trial we assessed heterogeneity by visually inspecting forest plots, calculating an I2 statistic, and carrying out a chi square test for heterogeneity. If heterogeneity was detected we undertook a subgroup analysis, grouping trials according to drug regimen and follow up time (1 week vs 2 weeks vs 3 weeks vs 4 weeks) in order to explore causes of heterogeneity. If heterogeneity was not detected we pooled results from trials in a fixed-effect meta-analysis.

Results

Description of studies

Trial selection

Of the 79 trials identified and included in our trials register, 57 were excluded (see 'Characteristics of excluded studies') and 22 met the inclusion criteria (see 'Characteristics of included studies'). All trials were identified from published literature. One ongoing study, Naeyaert ongoing has also been identified.

Trial location

Nineteen of the 22 included studies were conducted in resource-poor countries, although one, Schultz 1990, was a large multicentre trial involving eight centres (four sexually transmitted disease clinics, two dermatology clinics, and two family practice clinics), with one of the family practice centres in Mexico and the others in the USA. Of the other three trials, one was carried out in the USA (Hansen 1986) and two in Italy (Amerio 2003; Biele 2006).

Participants

Three trials included only adults (Chouela 1999; Amerio 2003; Biele 2006), six included only children (Maggi 1986; Schenone 1986; Taplin 1990; Avila-Romay 1991; Brooks 2002; Singalavanija 2003); and the other 13 included both adults and children. The total number of participants randomized in the 22 trials was 2676; all had a clinical diagnosis of scabies, with a subset of 903 identified as having their diagnosis confirmed parasitologically.

Interventions

The effectiveness of the following drugs was tested: topical benzyl benzoate; crotamiton; decamethrin; lindane; permethrin; synergized natural pyrethrins; sulfur; and oral ivermectin. Eighteen trials compared one drug with at least one other drug, one trial compared ivermectin against placebo, three trials compared different drug treatment regimens, and one trial compared two different vehicles for the same drug. No randomized controlled trials investigating malathion were identified.

Clinicians and drug companies recommended treatment of family members and close contacts at the same time as cases, to improve cure rates and reduce reinfection (Taplin 1986). None of the trials tested this hypothesis. Close and family contacts in both intervention and control groups were treated, however, in all but six trials (Hansen 1986; Maggi 1986; Amer 1992; Macotela-Ruiz 1993; Amerio 2003; Biele 2006).

Five trials stipulated that a bath or shower should be taken before treatment (Gulati 1978; Schenone 1986; Taplin 1990; Avila-Romay 1991; Bachewar 2009); and ten trials stipulated that participants should change and wash their linen after treatment (Avila-Romay 1991; Glaziou 1993; Chouela 1999; Usha 2000; Madan 2001; Nnoruka 2001; Brooks 2002; Singalavanija 2003; Zargari 2006; Ly 2009).

Dosing and regimen

Benzyl benzoate

The strength of the topical benzyl benzoate solution varied with three trials using 10% (Glaziou 1993; Brooks 2002; Biele 2006), one trial using 12.5% (Ly 2009) and three trials using 25% (Gulati 1978; Nnoruka 2001; Bachewar 2009). The treatment regimen was different in each trial: it was applied once and left overnight in Brooks 2002; applied twice, 12 hours apart in Glaziou 1993; applied twice and left overnight on two consecutive nights in Bachewar 2009; applied three times, 12 hours apart in Gulati 1978; applied on five consecutive days in Biele 2006; and a single application was left for 72 hours in Nnoruka 2001. Ly 2009 included two benzyl benzoate intervention groups, one in which the drug was applied once and left for 24 hours, and another in which the drug was applied twice, 24 hours apart, left in each case for 24 hours.

Crotamiton

A 10% topical preparation was used in two trials (Taplin 1990; Amer 1992). It was applied overnight on two consecutive nights in Amer 1992, and was applied once overnight in Taplin 1990.

Decamethrin

Schenone 1986 compared 0.02% decamethrin lotion applied daily for two days repeated on two more days a week later with 0.02% decamethrin lotion applied daily for four consecutive days.

Lindane

Each lindane trial used a 1% topical preparation, except for Singalavanija 2003, which used a 0.3% preparation. The number of applications ranged from one (Hansen 1986; Maggi 1986; Taplin 1986; Schultz 1990; Chouela 1999) to two (Amer 1992; Zargari 2006) to seven (Singalavanija 2003). Maggi 1986 compared a single application of lindane left on for four days, washed off and then repeated after a week with a single one-hour application of lindane, repeated after a week.

Permethrin

A 5% topical preparation was used in each permethrin trial. The number of applications ranged from one (Schultz 1990; Taplin 1990; Usha 2000; Bachewar 2009) to two (Amer 1992; Zargari 2006) to two consecutive overnight applications repeated after 14 days (Amerio 2003).

Synergized natural pyrethrins

A 0.16% topical preparation of natural pyrethrins synergized with pyperonil butoxide was used in Amerio 2003, applied on two successive nights and repeated 14 days later. In Biele 2006, a 0.165% preparation was applied on three consecutive days.

Sulfur

Two of the three sulfur trials used a 10% topical preparation (Avila-Romay 1991; Singalavanija 2003). In the third trial, Gulati 1978, the strength of the preparation was not stated. Avila-Romay 1991 compared sulfur in cold cream with sulfur in pork fat; both medications were applied nightly for three nights and then once three nights later. Singalavanija 2003 applied the sulfur on seven consecutive nights. Gulati 1978 applied sulfur once in the morning, once in the evening, and once again the next morning; treatment was repeated after 10 days if lesions persisted.

Ivermectin

The oral dose of ivermectin varied from a 100 µg/kg bodyweight (Glaziou 1993) to 200 µg/kg bodyweight (Macotela-Ruiz 1993; Usha 2000; Madan 2001; Nnoruka 2001; Brooks 2002; Bachewar 2009). The Chouela 1999 and Ly 2009 trials used an ivermectin dose between 150 µg/kg and 200 µg/kg bodyweight. Each trial gave a single dose.

Length of follow up

Follow up ranged from seven days to one month. In 11 trials it was possible to extract outcome data at 28 to 31 days after treatment (Hansen 1986; Taplin 1986; Schultz 1990; Taplin 1990; Amer 1992; Glaziou 1993; Madan 2001; Nnoruka 2001; Amerio 2003; Singalavanija 2003; Biele 2006). Follow up was at 21 days in two trials (Schenone 1986; Brooks 2002); 14 to 15 days in six trials (Gulati 1978; Maggi 1986; Chouela 1999; Usha 2000; Zargari 2006; Ly 2009); and seven to 10 days in the remaining three trials (Avila-Romay 1991; Macotela-Ruiz 1993; Bachewar 2009).

Outcome measures

The review's primary outcome measure (treatment failure) was reported in 21 of the 22 trials. Six of these 21 trials reported treatment failure in both clinically diagnosed cases and in microscopically confirmed cases (Schultz 1990; Taplin 1990; Amer 1992; Amerio 2003; Singalavanija 2003; Biele 2006); the other 13 trials reported treatment failure in clinically diagnosed cases who may or may not have been confirmed microscopically. Seven trials reported the secondary outcome measure (itch persistence) in addition to treatment failure (Hansen 1986; Schultz 1990; Taplin 1990; Brooks 2002; Amerio 2003; Singalavanija 2003; Biele 2006). Itch persistence alone was reported by Maggi 1986. Adverse events were reported as an outcome in all trials except Gulati 1978 and Maggi 1986.

The seven trials that reported on itch varied in their methods to assess this outcome:

  • Hansen 1986: did not report on the method used.

  • Maggi 1986: participants reported on itch using a three-point scale ("absent", "moderate", and "intense") before and after treatment; numbers in each category were reported.

  • Schultz 1990: participants reported the presence or absence of itch before and after treatment; numbers in each category were reported.

  • Taplin 1990: participants were reported as either having presence or absence of itch; no further details of assessment were given.

  • Brooks 2002: participants described itch severity on a visual analogue scale before and after treatment; mean scores were reported along with the number of participants with absence of night-time itch.

  • Amerio 2003 and Biele 2006: participants reported on itch using a five-point scale (from 0 = "no itch" to 4 = "severe itch") before and after treatment; mean scores were reported along with the number of participants with complete relief from itching.

  • Singalavanija 2003: participants were divided into those who reported a decrease or absence of itch, and those who reported no improvement.

Sources of support

Seven trials stated that funding or support had been provided by drug companies (Taplin 1986; Schultz 1990; Taplin 1990; Glaziou 1993; Usha 2000; Amerio 2003; Zargari 2006).

Background prevalence

Fifteen trial reports did not state the background prevalence of scabies. In the four trials where prevalence was stated, it ranged from 9% in India (Gulati 1978) to 14% among children in a boarding school in Chile (Schenone 1986) to 36% in French Polynesia (Glaziou 1993) to 67% in Panama (Taplin 1990).

Risk of bias in included studies

See Table 1 for a summary assessment and the 'Characteristics of included studies' for details.

Table 1. Quality assessment
  1. aInclusion of randomized participants in analysis.

TrialAllocation sequence generationAllocation concealmentBlindingInclusiona
Amer 1992UnclearUnclearUnclearAdequate
Amerio 2003AdequateAdequateInvestigatorsAdequate
Avila-Romay 1991UnclearUnclearUnclearAdequate
Bachewar 2009AdequateUnclearNoneInadequate
Biele 2006AdequateUnclearInvestigatorsAdequate
Brooks 2002AdequateUnclearInvestigatorsInadequate
Chouela 1999UnclearUnclearDescribed as "double blind"; participants blindedAdequate
Glaziou 1993UnclearUnclearOutcomes assessorAdequate
Gulati 1978UnclearUnclearUnclearAdequate
Hansen 1986UnclearUnclear"Single blind", unclear who was blindedAdequate
Ly 2009AdequateUnclearNoneAdequate
Macotela-Ruiz 1993UnclearUnclearParticipant and outcomes assessorAdequate
Madan 2001UnclearUnclearOutcomes assessorInadequate
Maggi 1986UnclearUnclearUnclearAdequate
Nnoruka 2001AdequateUnclearUnclearAdequate
Schenone 1986UnclearUnclearUnclearAdequate
Schultz 1990UnclearAdequateOutcomes assessorAdequate
Singalavanija 2003AdequateUnclearUnclearInadequate
Taplin 1986UnclearAdequateInvestigatorsAdequate
Taplin 1990UnclearAdequateInvestigatorsAdequate
Usha 2000AdequateAdequateNoneAdequate
Zargari 2006UnclearAdequateInvestigators and participantsAdequate

Generation of allocation sequence

Eight trials described an adequate method of generating a random allocation sequence: by computer in Usha 2000, Brooks 2002, Amerio 2003, Biele 2006 and Bachewar 2009; and by random-number table in Nnoruka 2001, Singalavanija 2003 and Ly 2009. The method was unclear in the other trials.

Allocation concealment

Six trials reported adequate allocation concealment: by phone call to third party-based procedure in Amerio 2003; by use of identical coded medication containers in Taplin 1986, Schultz 1990, Taplin 1990, and Zargari 2006; and the author of Usha 2000 confirmed that the allocation was by a third party, not the investigator. The remaining trials had methods of concealment that were either unclear or not reported.

Blinding

Twelve trials reported blinding. In two of these trials both the investigators or outcome assessors and the participants were described as blinded (Macotela-Ruiz 1993; Zargari 2006), and in eight trials the investigators or outcome assessors alone were described as blinded (Taplin 1986; Schultz 1990; Taplin 1990; Glaziou 1993; Madan 2001; Brooks 2002; Amerio 2003; Biele 2006). Chouela 1999 described the participants as blinded but also reported the trial as "double blind". Hansen 1986 described the trial as "single blind", but it is unclear who was blinded.

Inclusion of randomized participants in the analysis

Ten trials included all randomized participants in the analysis with no mention of losses to follow up. The completeness of follow up was greater than 80% (ie adequate) in eight trials (Hansen 1986; Taplin 1986; Schultz 1990; Taplin 1990; Macotela-Ruiz 1993; Chouela 1999; Zargari 2006; Ly 2009). The remaining four trials reported completeness of follow up less than 80% (Brooks 2002 − 27% lost to follow up, Madan 2001 − 25% lost to follow up, Singalavanija 2003 − 32% lost to follow up; Bachewar 2009 - 22% lost to follow up).

Effects of interventions

1. Ivermectin

Only one trial assessed the effectiveness against placebo, while eight trials compared it with another drug.

1.1. Versus placebo (55 participants, 1 trial)

Macotela-Ruiz 1993 compared 200 µg/kg bodyweight oral ivermectin with placebo.

Treatment failure in clinically diagnosed cases

Macotela-Ruiz 1993 reported fewer treatment failures in the ivermectin group at seven days (RR 0.24, 95% CI 0.12 to 0.51; 55 participants, Analysis 1.1). Figure 1.

Figure 1.

Forest plot of comparison: 1 Ivermectin versus placebo, outcome: 1.1 Treatment failure in clinically diagnosed cases.

Adverse events.

None were reported.

1.2. Versus permethrin (153 participants, 2 trials)

Usha 2000 and Bachewar 2009 both compared 200 µg/kg bodyweight oral ivermectin with 5% topical permethrin cream.

Treatment failure in clinically diagnosed cases

Usha 2000 reported more treatment failures in the ivermectin group at two weeks (RR 13.50, 95% CI 1.84 to 99.26; 85 participants), as did Bachewar 2009 at one week follow up (RR 2.90, 95% CI 1.21 to 6.96; 55 participants, Analysis 2.1). Significant heterogeneity was not detected and the trials' combined estimate showed more treatment failures with ivermectin (RR 4.61, 95% CI 2.07 to 10.26, fixed-effect model; 140 participants). Figure 2.

Figure 2.

Forest plot of comparison: 2 Ivermectin versus permethrin, outcome: 2.1 Treatment failure in clinically diagnosed cases.

Adverse events

Three of 43 participants in the ivermectin group in the Usha 2000 trial reported aggravation of symptoms. No adverse events were reported in Bachewar 2009 (see Table 2).

Table 2. Adverse events
  1. aNo. participants reporting event/total no. participants.

ComparisonTrialAdverse eventInterventionn/NaInterventionn/Na
Ivermectin vs placeboMacotela-Ruiz 1993None recordedIvermectinPlacebo
Ivermectin vs permethrinUsha 2000Aggravation of symptomsIvermectin3/43Permethrin0/45
Bachewar 2009None recordedIvermectinPermethrin
Ivermectin vs lindaneChouela 1999HeadacheIvermectin1/26Lindane6/27
HeadacheIvermectin1/26Lindane0/27
HypotensionIvermectin1/26Lindane0/27
Abdominal painIvermectin1/26Lindane0/27
VomitingIvermectin1/26Lindane0/27
Madan 2001Severe headacheIvermectin1/100Lindane0/100
Ivermectin vs benzyl benzoateGlaziou 1993Mild increase in pruritusIvermectin0/23Benzyl benzoate5/21
Nnoruka 2001Pruritus and irritationIvermectin0/29Benzyl benzoate7/29
Brooks 2002Pustular rashIvermectin3/43Benzyl benzoate0/37
CellulitisIvermectin1/43Benzyl benzoate0/37
Burning or stingingIvermectin0/43Benzyl benzoate6/37
DermatitisIvermectin0/43Benzyl benzoate6/37
Bachewar 2009None recordedIvermectinBenzyl benzoate
Ly 2009Abdominal painIvermectin5/65Benzyl benzoate0/116
Mild diarrhoeaIvermectin2/65Benzyl benzoate0/116
Irritant dermatitisIvermectin0/65Benzyl benzoate30/116
Permethrin vs crotamitonTaplin 1990Worsening of symptomsPermethrin0/48Crotamiton10/48
Amer 1992None recordedPermethrinCrotamiton
Permethrin vs lindaneHansen 1986Mild burning, stinging, or itchingPermethrin5/49Lindane5/50
Taplin 1986None recordedPermethrinLindane
Schultz 1990Burning/stingingPermethrin23/234Lindane12/233
PruritusPermethrin15/234Lindane17/233
ErythemaPermethrin5/234Lindane3/233
TinglingPermethrin4/234Lindane5/233
RashPermethrin2/234Lindane2/233
DiarrhoeaPermethrin1/234Lindane1/233
Persistent excoriationPermethrin1/234Lindane0/233
Contact dermatitisPermethrin0/234Lindane1/233
PhemphigusPermethrin0/234Lindane1/233
Papular rashPermethrin0/234Lindane1/233
Amer 1992None recordedPermethrinLindane
Zargari 2006Skin irritationPermethrin2/59Lindane1/58
Permethrin versus benzyl benzoateBachewar 2009None recordedPermethrinBenzyl benzoate
Permethrin vs synergized natural pyrethrinsAmerio 2003Secondary skin infectionPermethrin10/20Synergized pyrethrins2/20
Crotamiton vs lindaneAmer 1992None recordedLindaneCrotamiton
Lindane vs sulfurSingalavanija 2003Foul odourLindane3/50Sulfur10/50
BurningLindane6/50Sulfur2/50
ErythemaLindane5/50Sulfur2/50
Benzyl benzoate vs sulfurGulati 1978None recordedBenzyl benzoateSulfur
Benzyl benzoate vs synergized natural pyrethrinsBiele 2006Skin irritation and burning sensationsBenzyl benzoate22/120Synergized pyrethrins3/120
Lindane: short vs long applicationMaggi 1986None recordedLindane (short course)Lindane (long course)
Decamethrin: 2-day + 2-day vs 4-day applicationSchenone 1986Moderate skin hotnessDecamethrin (both regimens)15/127
Sulfur: pork fat vehicle vs cold cream vehicleAvila-Romay 1991PruritusSulfur/salicylic acid in pork fat32/53Sulfur in cold cream18/58
XerosisSulfur/salicylic acid in pork fat18/53Sulfur in cold cream14/58
Burning sensationsSulfur/salicylic acid in pork fat9/53Sulfur in cold cream6/58
Keratosis pilarisSulfur/salicylic acid in pork fat8/53Sulfur in cold cream0/58
ErythemaSulfur/salicylic acid in pork fat1/53Sulfur in cold cream6/58
Keratosis follicularis 0/53Sulfur in cold cream1/58
1.3. Versus lindane (253 participants, 2 trials)

Chouela 1999 compared 150 µg/kg bodyweight oral ivermectin with 1% topical lindane, while Madan 2001 compared 200 µg/kg ivermectin with 1% lindane.

Treatment failure in clinically diagnosed cases

Chouela 1999 found no significant difference between the groups at 15 days (43 participants), while at four weeks Madan 2001 found that treatment failures were reduced in the ivermectin group (RR 0.31, 95% CI 0.18 to 0.54; 150 participants, Analysis 3.1). Heterogeneity was not detected and the trials' combined estimate showed a benefit of ivermectin over lindane (RR 0.36, 95% CI 0.23 to 0.58, fixed-effect model; 193 participants). Figure 3.

Figure 3.

Forest plot of comparison: 3 Ivermectin versus lindane, outcome: 3.1 Treatment failure in clinically diagnosed cases.

Adverse events

See Table 2. Chouela 1999 reported adverse events in 4/26 participants in the ivermectin group (headache, hypotension, abdominal pain, and vomiting) and in 6/37 participants in the lindane group (headache). Madan 2001 reported an adverse event in 1/100 participants in the ivermectin group (severe headache); there were none in the lindane group.

1.4. Versus benzyl benzoate (462 participants, 5 trials)

Brooks 2002 compared 200 µg/kg bodyweight oral ivermectin with 10% topical benzyl benzoate. Glaziou 1993 compared 100 µg/kg bodyweight ivermectin with 10% benzyl benzoate. Nnoruka 2001 and Bachewar 2009 compared 200 µg/kg bodyweight ivermectin with 25% benzyl benzoate. Ly 2009 compared 150 to 200 µg/kg bodyweight ivermectin with 12.5% benzyl benzoate.

Treatment failure in clinically diagnosed cases

See Analysis 4.1. No significant difference between the two groups was found in Bachewar 2009 at one week follow up (52 participants). After 14 days Ly 2009 found a significant difference in favour of benzyl benzoate compared with ivermectin (RR 2.00, 95% CI 1.47 to 2.72; 162 participants). No significant difference between the two groups was found in Brooks 2002 at three weeks (80 participants) or by Glaziou 1993 at 30 days (44 participants). At 30 days Nnoruka 2001 found a significant difference in favour of ivermectin (RR 0.13, 95% CI 0.03 to 0.53; 58 participants). Heterogenity was detected between the trials (Chi2 = 27.97, df = 4, P < 0.0001; I2 = 86%; see Figure 4 for forest plot). The differences in drug regimen and length of follow up that exist between the five trials may explain this heterogeneity.

Figure 4.

Forest plot of comparison: 4 Ivermectin versus benzyl benzoate, outcome: 4.1 Treatment failure in clinically diagnosed cases.

Itch persistence

See Analysis 4.2. Brooks 2002 found no significant difference in the number of participants who reported night-time itch at three weeks (58 participants). Figure 5.

Figure 5.

Forest plot of comparison: 4 Ivermectin versus benzyl benzoate, outcome: 4.2 Itch persistence.

Adverse events

See Table 2. Brooks 2002 reported adverse events in 4/43 participants in the ivermectin group (pustular rash, cellulitis) and in 12/37 participants in the benzyl benzoate group (burning or stinging, dermatitis). Glaziou 1993 and Nnoruka 2001 reported adverse events only in the benzyl benzoate group: 5/21 participants (mild increase in pruritus) in Glaziou 1993; and 7/29 participants (pruritus and irritation) in Nnoruka 2001. Ly 2009 reported adverse events in 7/65 participants in the ivermectin group (abdominal pain, diarrhoea) and in 30/116 participants in the benzyl benzoate groups. Bachewar 2009 reported no adverse events.

2. Permethrin

2.1. Versus crotamiton (196 participants, 2 trials)

Two trials compared 5% permethrin with 10% crotamiton (Taplin 1990; Amer 1992). In Taplin 1990 the drugs were applied for 8 to 10 hours, whereas in Amer 1992 the drugs were applied overnight on two consecutive days.

Treatment failure

See Analysis 5.1 and Analysis 5.2. Participants in both trials had their scabies clinically diagnosed and microscopically confirmed. The comparative treatment failure rates described for clinically diagnosed cases therefore apply equally to microscopically diagnosed cases in these trials. Taplin 1990 found that treatment failure was reduced in the permethrin group after 28 days (RR 0.26, 95% CI 0.11 to 0.65; 94 participants, Analysis 5.1.3). Amer 1992 found no significant difference in outcome between the groups after 28 days (100 participants). Heterogeneity was not detected and a combined estimate showed a benefit of permethrin over crotamiton (RR 0.24, 95% CI 0.10 to 0.55, fixed-effect analysis; 194 participants). Figure 6 and Figure 7.

Figure 6.

Forest plot of comparison: 5 Permethrin versus crotamiton, outcome: 5.1 Treatment failure in clinically diagnosed cases.

Figure 7.

Forest plot of comparison: 5 Permethrin versus crotamiton, outcome: 5.2 Treatment failure in microscopically diagnosed cases.

Itch persistence

See Analysis 5.3. Permethrin reduced the number of participants with itch persistence in Taplin 1990 (RR 0.26, 95% CI 0.11 to 0.65; 94 participants). Figure 8.

Figure 8.

Forest plot of comparison: 5 Permethrin versus crotamiton, outcome: 5.3 Itch persistence.

Adverse events

See Table 2. Taplin 1990 reported no adverse events in the permethrin group, but did report adverse events in 10/47 participants in the crotamiton group (worsening of symptoms). Amer 1992 reported no adverse events.

2.2. Versus lindane (835 participants, 5 trials)

Five trials compared 5% topical permethrin with 1% topical lindane (Hansen 1986; Taplin 1986; Schultz 1990; Amer 1992; Zargari 2006).

Treatment failure in clinically diagnosed cases

See Analysis 6.1. Zargari 2006 reported fewer treatment failures in the permethrin group after 14 days (RR 0.15, 95% CI 0.06 to 0.40; 99 participants). At 28 days Amer 1992 found two consecutive overnight applications of permethrin to be superior to two consecutive overnight applications of lindane (RR 0.08, 95% CI 0.01 to 0.57; 100 participants). Three trials compared a single application of permethrin with a single application of lindane, with follow up at 28 days (Hansen 1986, Schultz 1990 and Taplin 1986). No benefit was found for either treatment by Hansen 1986 (28 days, 99 participants) or Schultz 1990 (28 +/- 7 days, 404 participants), whereas Taplin 1986 found permethrin to be superior (RR 0.22, 95% CI 0.05 to 0.95; 51 participants).

Heterogenity was detected between the results of the five studies (Chi2 = 11.83, df = 4, P = 0.02; I2 = 66%; see Figure 9 for forest plot) so the trials were grouped by drug regimen and length of follow up in order to explore causes of heterogeneity. The pooled effect for the three trials sharing the same drug regimen (single application) and length of follow up (four weeks) showed a significant effect in favour of permethrin (RR 0.59, 95% CI 0.37 to 0.95, fixed-effect model; 554 participants). Statistical heterogeneity was not detected in this group of three trials.

Figure 9.

Forest plot of comparison: 6 Permethrin versus lindane, outcome: 6.1 Treatment failure in clinically diagnosed cases.

Treatment failure in microscopically confirmed cases

See Analysis 6.2. Two consecutive overnight applications of permethrin was found to be superior to two consecutive overnight applications of lindane after 28 days in Amer 1992 (RR 0.08, 95% CI 0.01 to 0.57; 100 participants). Taplin 1986 (46 participants) and Schultz 1990 (338 participants) both compared single applications of permethrin and lindane with follow up at 28 days. Neither trial showed a significant difference between the interventions. Figure 10.

Figure 10.

Forest plot of comparison: 6 Permethrin versus lindane, outcome: 6.2 Treatment failure in microscopically diagnosed cases.

Itch persistence

See Analysis 6.3. The two trials that reported on itch persistence found different effects: Hansen 1986 found no significant difference between the two interventions after 28 days (99 participants), whereas Schultz 1990 found permethrin to be superior after 28 +/- 7 days (RR 0.56, 95% CI 0.37 to 0.86; 391 participants). Heterogeneity was not detected and a combined estimate showed permethrin to be superior (RR 0.61, 95% CI 0.44 to 0.86, fixed effects model; 490 participants). Figure 11.

Figure 11.

Forest plot of comparison: 6 Permethrin versus lindane, outcome: 6.3 Itch persistence.

Adverse events

See Table 2. Hansen 1986 recorded mild burning, stinging, or itching in both groups (5/49 participants in the permethrin group, 5/50 participants in the lindane group). Schultz 1990 reported adverse events in 51/234 participants in the permethrin group (burning/stinging, pruritus, erythema, tingling, rash, diarrhoea, persistent excoriation) and in 43/233 participants in the lindane group (burning/stinging, pruritus, tingling, erythema, rash, papular rash, diarrhoea, contact dermatitis, phemphigus). Zargari 2006 reported skin irritation in both groups (2/59 participants in the permethrin group, 1/58 participant in the lindane group). Amer 1992 and Taplin 1986 both reported no adverse events.

2.3 Versus benzyl benzoate (69 participants, 1 trial)
Treatment failure in clinically diagnosed cases

See Analysis 7.1. In Bachewar 2009 there was no significant difference in treatment failure between the two groups after one week (RR 0.74, 95% CI 0.26 to 2.14; 53 participants). Figure 12.

Figure 12.

Forest plot of comparison: 7 Permethrin versus benzyl benzoate, outcome: 7.1 Treatment failure in clinically diagnosed cases.

Adverse events

No adverse events were reported in Bachewar 2009.

2.4. Versus synergized natural pyrethrins (40 participants, 1 trial)

Amerio 2003 compared 5% topical permethrin with topical 0.16% natural pyrethrins synergized with 1.65% pyperonil butoxide.

Treatment failure

All participants had their scabies both clinically diagnosed and microscopically confirmed. There were no treatment failures in either group after 28 days (40 participants).

Itch persistence

See Analysis 8.1.There was no significant difference in itch persistence between the two groups after 28 days (40 participants). Figure 13.

Figure 13.

Forest plot of comparison: 8 Permethrin versus natural synergized pyrethrins, outcome: 8.1 Itch persistence.

Adverse events

See Table 2. Ten of the 20 participants in the permethrin group and two of the 20 participants in the synergized pyrethrin group were reported as having secondary skin infections requiring antibiotic treatment. It was not clear from the trial report whether this was considered an adverse event or rather a baseline characteristic.

3. Other drug comparisons

3.1. Crotamiton versus lindane (100 participants, 1 trial)

Amer 1992 compared 10% topical crotamiton with 1% topical lindane.

Treatment failure

See Analysis 9.1 and Analysis 9.2. All participants in Amer 1992 had their scabies both clinically diagnosed and microscopically confirmed. There was no significant difference in treatment failure between the two groups after 28 days (100 participants). Figure 14 and Figure 15.

Figure 14.

Forest plot of comparison: 9 Crotamiton versus lindane, outcome: 9.1 Treatment failure in clinically diagnosed cases.

Figure 15.

Forest plot of comparison: 9 Crotamiton versus lindane, outcome: 9.2 Treatment failure in microscopically diagnosed cases.

Adverse events

None were reported.

3.2. Lindane versus sulfur (100 participants, 1 trial)

Singalavanija 2003 compared 0.3% topical lindane with 10% topical sulfur.

Treatment failure in clinically diagnosed cases

See Analysis 10.1. There was no significant difference between the two groups after 28 days in Singalavanija 2003 (68 participants). Figure 16.

Figure 16.

Forest plot of comparison: 10 Lindane versus sulfur, outcome: 10.1 Treatment failure in clinically diagnosed cases.

Itch persistence

See Analysis 10.2. There was no significant difference between the groups in the number of participants in whom itch persisted at 28 days (68 participants). Figure 17.

Figure 17.

Forest plot of comparison: 10 Lindane versus sulfur, outcome: 10.2 Itch persistence.

Adverse events

See Table 2. The reported adverse events (foul odour, burning, erythema) occurred in the sulfur group (14/50 participants) and the lindane group (14/50 participants).

3.3. Benzyl benzoate versus sulfur (158 participants, 1 trial)

Gulati 1978 compared 25% topical benzyl benzoate with topical sulfur ointment.

Treatment failure in clinically diagnosed cases

See Analysis 11.1. There was no significant difference between the two groups after 15 days in Gulati 1978 (158 participants). Figure 18.

Figure 18.

Forest plot of comparison: 11 Benzyl benzoate versus sulfur, outcome: 11.1 Treatment failure in clinically diagnosed cases.

Adverse events

None were reported.

3.4. Benzyl benzoate versus synergized natural pyrethrins (240 participants, 1 trial)

Biele 2006 compared 10% topical benzyl benzoate with topical 0.165% natural pyrethrins synergized with 1.65% pyperonil butoxide.

Treatment failure

See Analysis 12.1 and Analysis 12.2. All participants had their scabies both clinically diagnosed and microscopically confirmed. There was no significant difference in treatment failure between the two groups after four weeks in Biele 2006 (240 participants). Figure 19 and Figure 20.

Figure 19.

Forest plot of comparison: 12 Benzyl benzoate versus natural synergized pyrethrins, outcome: 12.1 Treatment failure in clinically diagnosed cases.

Figure 20.

Forest plot of comparison: 12 Benzyl benzoate versus natural synergized pyrethrins, outcome: 12.2 Treatment failure in microscopically diagnosed cases.

Itch persistence

See Analysis 12.3. There was no significant difference in itch persistence between the two groups after four weeks (240 participants). Figure 21.

Figure 21.

Forest plot of comparison: 12 Benzyl benzoate versus natural synergized pyrethrins, outcome: 12.3 Itch persistence.

Adverse events

Twenty-two of the 120 participants in the benzyl benzoate group and three of the 120 participants in the synergized natural pyrethrins group experienced skin irritation and burning sensations after drug application (see Table 2).

4. Length of treatment comparisons

4.1. Benzyl benzoate: one overnight application versus two overnight applications (116 participants, 1 trial)
Treatment failure in clinically diagnosed cases.

There was no significant difference in treatment failure between the two groups after 14 days in Ly 2009 (108 participants, Analysis 13.1). Figure 22.

Figure 22.

Forest plot of comparison: 13 Benzyl benzoate: one application versus two applications, outcome: 13.1 Treatment failure in clinically diagnosed cases.

Adverse events

Irritant dermatitis was reported in 30 out of 116 participants (see Table 2).

4.2. Lindane: short application versus long application (87 participants, 1 trial)
Treatment failure

Maggi 1986 did not assess this outcome measure.

Itch persistence

A short application of lindane reduced itch persistence at 14 days (RR 0.34, 95% CI 0.12 to 0.98; 87 participants, Analysis 14.1). However, the trial authors did suggest that the pruritus experienced by the participants could have been due to a lindane-associated contact dermatitis. Figure 23.

Figure 23.

Forest plot of comparison: 14 Lindane: short application versus long application, outcome: 14.1 Itch persistence.

Adverse events

None other than pruritus (see above) were reported.

4.3. Decamethrin: two-day plus two-day application versus four-day application (127 participants, 1 trial)
Treatment failure in clinically diagnosed cases.

There were no treatment failures in either group in Schenone 1986 after 21 days: 0/53 treatment failures in the two-plus-two-day group; and 0/74 treatment failures in the four-day group. Five participants in each group received a second treatment at seven days due to the presence of active lesions. This second treatment consisted of two applications of 0.02% decamethrin on consecutive days.

Adverse events

Fifteen of 127 participants experienced "moderate skin hotness" after application of decamethrin (see Table 2).

5. Drug vehicle comparisons

5.1. Sulfur: pork fat vehicle versus cold cream vehicle (51 participants, 1 trial)
Treatment failure in clinically diagnosed cases

See Analysis 15.1. There was no significant difference in the number of treatment failures between the two groups after 10 days in Avila-Romay 1991 (51 participants). Figure 24.

Figure 24.

Forest plot of comparison: 15 Sulfur: pork fat vehicle versus cold cream vehicle, outcome: 15.1 Treatment failure in clinically diagnosed cases.

Adverse events

See Table 2. Pruritus, xerosis, burning sensation, and erythema were reported for cases and contacts in both groups. There were adverse events in 68/53 participants in the pork fat vehicle group, including keratosis pilaris. There were adverse events in 45/58 participants in the cold cream vehicle group, including keratosis follicularis.

Discussion

The review's objective was to evaluate the effectiveness of current treatments for scabies in order to inform practice and guide future research. The previous version of this review noted that clinicians faced considerable uncertainty when choosing the best treatment for scabies (Walker 2000). Ten years later the picture is a little clearer, but there are still considerable gaps in our knowledge.

Trial quality

All 22 included trials were designed to test the effectiveness of one or more treatments for scabies. Methodological quality varied between trials. Only two trials described both adequate randomization sequence generation and adequate allocation concealment, and the majority of the reports described neither adequately. The blinding was absent, or the degree of blinding was unclear in ten of the 22 identified trials, and losses to follow up were greater than 20% of the enrolled participants in four of the trials.

Effectiveness

The results of this review suggest that, of the topical treatments for scabies, permethrin is most effective. Permethrin has been tested against topical crotamiton, topical lindane, and oral ivermectin in randomized controlled trials, and it appears to be superior to all three in terms of minimizing treatment failure in participants with a clinical diagnosis of scabies. In the one trial that tested permethrin against topical benzyl benzoate no difference in cure rate was detected, however this trial was small (53 participants) and the data used in the review related only to one week follow up.

In the subgroup of participants with microscopically confirmed scabies, permethrin was again superior to crotamiton, but there is uncertainty as to whether permethrin is superior to lindane. Permethrin also appears to be better at relieving itch than either crotamiton or lindane (itch was not reported as a separate outcome in the ivermectin versus permethrin trial). Unfortunately no trials comparing permethrin with either topical sulfur or topical malathion were identified; permethrin's relative effectiveness against these treatments therefore remains unknown.

In some countries natural pyrethrin-based topical treatments are available as an alternative to permethrin cream (Biele 2006). Pyrethrins are naturally occurring insecticidal compounds found in the Compositae family of plants (Wagner 2000), whereas permethrin is a synthetic pyrethroid analogue. Results from the two Italian trials included in this review suggest that pyrethrin is equivalent in effectiveness to both permethrin and benzyl benzoate.

Trials comparing crotamiton with lindane, lindane with sulfur, and sulfur with benzyl benzoate have all produced equivocal results, suggesting that there is no single most effective treatment out of these four topical options. In most countries the choice is in any case restricted, either due to lack of availability, or the lack of a licence for scabies.

Ivermectin is currently the only oral treatment for scabies that is in routine use. It appears to be more effective than both placebo and lindane, but less effective than permethrin. There was significant heterogeneity in the results of the five trials that compared ivermectin and benzyl benzoate, which may be explained by differences in drug regimen and length of follow up between the trials. After stratifying by drug regimen and length of follow up the relative effectiveness of ivermectin appeared to increase with increasing length of follow up. This may mean that ivermectin is slower in achieving cure than topical benzyl benzoate, however, this conclusion is rather speculative given these data.

An advantage of an oral antiscabietic treatment over a topical one is ease of use, particularly in hot humid climates, when engaging in mass treatment, or when treating children. However, ivermectin is not presently licensed for the treatment of scabies in most countries. Ivermectin's effectiveness, cost effectiveness, and safety in mass treatment in areas of high endemicity (preferably as a sustainable public health intervention) need to be further evaluated in larger trials of sufficient power.

Topical ivermectin has also been suggested to be effective after success in uncontrolled studies (Yeruham 1998; Victoria 2001). At present there is no commercially available topical ivermectin preparation available for the treatment of scabies, and randomized controlled trials are needed to evaluate this potential new treatment option.

There are still no published reports of randomized controlled trials that test the effectiveness of malathion against either placebo or another drug, despite over 30 years passing by since a non-controlled study first suggested that the drug was effective (Hanna 1978). The 2010 British National Formulary recommends malathion as the treatment of choice if permethrin is inappropriate (BNF 2010), despite the lack of evidence from randomized controlled trials. Such a trial comparing malathion with permethrin is needed to test their relative effectiveness.

We found trials of the herbal remedies toto soap (Alebiosu 2003) and lippia oil (Oladimeji 2000; Oladimeji 2005), but these trials did not meet the review's inclusion criteria. Both treatments look promising, but randomized controlled trials making direct comparisons with the existing best treatments are needed to assess their true relative effectiveness.

Treatment regimen was assessed in two trials. Maggi 1986 found that a one-hour application of lindane reduced itch compared with a much longer four-day application; the authors suggested that the itch may, at least in part, have been due to a dermatitis caused by the lindane treatment itself. Schenone 1986 compared two different regimens using decamethrin, a pyrethroid insecticide in the same class as permethrin. All participants were cured in both groups. Decamethrin is not commercially available for the treatment of scabies and we found no trials that tested its effectiveness against other treatments. Decamethrin (as deltamethrin) is usually used as an agricultural insecticide and its safety as an antiscabietic medication has not been established (WHO 1990).

The formulation of a topically applied product may influence its efficacy. For example, a 1% permethrin formulation marketed for the treatment of head lice appears to be less effective than the conventional antiscabietic 5% preparation, according to case reports (Cox 2000). None of the trials included in this review directly compared different strength formulations of the same treatment.

One trial compared different vehicles for the same drug (Avila-Romay 1991). Cold cream as a treatment vehicle for sulfur may be more effective than pork fat, with fewer adverse events. For resource-poor countries this could be a cheap and safe option, which in some circumstances might also be more culturally acceptable.

This review did not seek to assess the relative cost effectiveness of the various treatments for scabies; however, large cost differences are apparent. In the UK, costs are: permethrin £5.51 per 30 g of cream, benzyl benzoate £0.50 per 100 mL, crotamiton £2.99 per 100 mL, and malathion £2.96 per 100 mL (BNF 2010). When lindane was marketed in the UK it was a fifth the cost of permethrin per treatment (BNF 1997).

We did not specifically attempt to assess the effectiveness of treatments for crusted scabies, and none of the included trials selected participants with this diagnosis. Caution should therefore be exercised in generalizing the results of this review to the treatment of patients with atypical severe scabies infection. This is an important area where more research is needed.

Caution should also be exercised in generalizing these results, which were obtained from trials that recruited individual participants (mostly in the outpatient setting), to the management of outbreaks in institutions. Given the burden of disease caused by scabies within institutions, such as long-term healthcare facilities, the inclusion of such patients in randomized controlled trials of effectiveness would be beneficial.

Mass treatment of a community in order to eradicate scabies has been tested in two studies (Dunne 1991; Bockarie 2000), both of which used oral ivermectin. Unfortunately neither of these studies met the review's inclusion criteria (Bockarie 2000 was an uncontrolled trial, and Dunne 1991 recruited participants on the basis of a diagnosis of onchocerciasis). Further research is needed to test the effectiveness, safety, and practicality of this approach to the management of scabies, particularly in areas of high prevalence.

Safety

Serious adverse events leading to death or permanent disability were not reported in any of the included or excluded trials. This review did not seek to systematically review the literature on the safety of antiscabietic treatments, but a number of notable reports of serious adverse events that have been published elsewhere are discussed below.

Convulsions and aplastic anaemia have both been reported with the use of lindane (Rauch 1990; Elgart 1996); in some cases this being thought to be due to the application of the drug to non-intact skin. Lindane was withdrawn by the manufacturer from the UK market in 1996, but this was for commercial and not toxicological reasons. In 1995, the US Food and Drug Administration designated lindane as a second-line treatment due to its potential toxicity; only to be used in those who have failed to respond to, or who are intolerant of, other antiscabietic treatments (WHO 2003).

Ivermectin has been very widely used in the treatment of onchocerciasis (predominantly in adults) and even with repeated doses serious adverse effects have been rare (DeSole 1989; Pacque 1990). However, an increased risk of death among a group of elderly patients with scabies in a long-term care facility has been reported (Barkwell 1997). Whether this was due to ivermectin or to interactions with other scabicides, including lindane and permethrin, or other treatments such as psychoactive drugs was not clear and there was considerable discussion of the validity of this report (Bredal 1997; Coyne 1997; Diazgranados 1997; Reintjes 1997).

Rare adverse reactions have been reported with the use of both permethrin (dystonia, Coleman 2005) and natural pyrethrin (fatal asthma, Wagner 2000).

The relative purity of the active ingredients of certain topical treatments and their isomeric ratios may also affect drug toxicity. In particular, very little is known about the effects of exposure to different isomeric grades of permethrin. Clinical grade material is 25:75 cis isomer:trans isomer and agricultural grade is 40:60. The cis isomer has 10 times the acute toxicity and there could be dangers in people in resource-poor countries using agricultural-grade permethrin for treating human infestations (personal communication from Ian Burgess, Medical Entomology Centre, Cambridge). Similar problems have been reported with the inappropriate use of agricultural grade malathion for treating human infestations (Petros 1990).

A search of the WHO Adverse Drug Reaction Database in 1998 for a previous version of this review found reports of serious adverse drug reactions for convulsions (benzyl benzoate 4, crotamiton 1, lindane 38, malathion 2, permethrin 6) and death (benzyl benzoate 0, crotamiton 1, lindane 1, malathion 0, permethrin 5) (Walker 2000). A search for this update of the review of the UK Medicines and Healthcare Products Regulatory Agency database of suspected drug reactions found reports for convulsions (benzyl benzoate 1, crotamiton 0, lindane 3, malathion 0, permethrin 0, sulfur 0, ivermectin 1) and death (benzyl benzoate 0, crotamiton 0, lindane 1, malathion 0, permethrin 1 (intra uterine death), sulfur 0, ivermectin 3) (MHRA 2006). Extreme caution must be shown in interpreting these reports, as they are clearly influenced by the extent to which the products are used and by the quality of the reporting. Neither can a causal link be assumed for any of the reported events.

Authors' conclusions

Implications for practice

On the basis of the available evidence from randomized controlled trials, topical permethrin appears to be the most effective treatment for scabies. Ivermectin appears to be an effective oral treatment, but in many countries it is not licensed for this indication.

Implications for research

Trials are needed to evaluate the relative effectiveness of malathion against permethrin, and the relative effectiveness of herbal treatments against existing treatments. The effectiveness of topical ivermectin also needs to be explored. The most appropriate treatment for the severe crusted form of scabies has not yet been established in randomized controlled trials.

Researchers should ensure that toxicity and safety outcomes are systematically collected in future trials as well as being notified through routine monitoring of adverse events in clinical practice.

Approaches to the control of outbreaks in institutions and public health programmes to control scabies in populations with high prevalence require evaluation.

Acknowledgements

We are heavily indebted to Dr Godfrey Walker who, with Paul Johnstone, co-authored the previous version (Walker 2000). The editorial base for the Cochrane Infectious Diseases Group is funded by the UK Department for International Development (DFID) for the benefit of low- and middle-income countries.

Data and analyses

Download statistical data

Comparison 1. Ivermectin versus placebo
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 200μg/kg Ivermectin vs placebo. Follow up at 7 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 1.1.

Comparison 1 Ivermectin versus placebo, Outcome 1 Treatment failure in clinically diagnosed cases.

Comparison 2. Ivermectin versus permethrin
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 200μg/kg Ivermectin vs 5% Permethrin overnight.2140Risk Ratio (M-H, Fixed, 95% CI)4.61 [2.07, 10.26]
Analysis 2.1.

Comparison 2 Ivermectin versus permethrin, Outcome 1 Treatment failure in clinically diagnosed cases.

Comparison 3. Ivermectin versus lindane
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 150-200μg/kg Ivermectin vs 1% Lindane.2193Risk Ratio (M-H, Fixed, 95% CI)0.36 [0.23, 0.58]
Analysis 3.1.

Comparison 3 Ivermectin versus lindane, Outcome 1 Treatment failure in clinically diagnosed cases.

Comparison 4. Ivermectin versus benzyl benzoate
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases5 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 200μg/kg Ivermectin vs 25% BB overnight x2. FU at 1 week1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.2 150-200μg/kg Ivermectin vs 12.5% BB 1 or 2 overnights. FU at 14 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.3 200μg/kg Ivermectin vs 10% BB overnight. FU at 3 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.4 100μg/kg Ivermectin vs 10% BB 3 x 12 hrs. FU at 30 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
1.5 200μg/kg Ivermectin vs 25% BB 72 hrs. FU at 30 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Itch persistence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 200μg/kg Ivermectin vs 10% BB overnight. FU at 3 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 4.1.

Comparison 4 Ivermectin versus benzyl benzoate, Outcome 1 Treatment failure in clinically diagnosed cases.

Analysis 4.2.

Comparison 4 Ivermectin versus benzyl benzoate, Outcome 2 Itch persistence.

Comparison 5. Permethrin versus crotamiton
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 5% Permethrin vs 10% Crotamiton. FU at 28 days2194Risk Ratio (M-H, Fixed, 95% CI)0.24 [0.10, 0.55]
2 Treatment failure in microscopically diagnosed cases2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 5% Permethrin vs 10% Crotamiton. FU at 28 days2194Risk Ratio (M-H, Fixed, 95% CI)0.24 [0.10, 0.55]
3 Itch persistence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
3.1 5% Permethrin vs 10% Crotamiton. FU at 28 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 5.1.

Comparison 5 Permethrin versus crotamiton, Outcome 1 Treatment failure in clinically diagnosed cases.

Analysis 5.2.

Comparison 5 Permethrin versus crotamiton, Outcome 2 Treatment failure in microscopically diagnosed cases.

Analysis 5.3.

Comparison 5 Permethrin versus crotamiton, Outcome 3 Itch persistence.

Comparison 6. Permethrin versus lindane
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases5 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
1.1 5% Permethrin vs 1% Lindane single application repeated at 1 week. FU at 14 days199Risk Ratio (M-H, Fixed, 95% CI)0.15 [0.06, 0.40]
1.2 5% Permethrin vs 1% Lindane overnight x2. FU at 28 days1100Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.01, 0.57]
1.3 5% Permethrin vs 1% Lindane single application. FU at 28 days3554Risk Ratio (M-H, Fixed, 95% CI)0.59 [0.37, 0.95]
2 Treatment failure in microscopically diagnosed cases3 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
2.1 5% Permethrin vs 1% Lindane single application. FU at 28 days2384Risk Ratio (M-H, Fixed, 95% CI)0.57 [0.32, 1.02]
2.2 5% Permethrin vs 1% Lindane overnight x2. FU at 28 days1100Risk Ratio (M-H, Fixed, 95% CI)0.08 [0.01, 0.57]
3 Itch persistence2 Risk Ratio (M-H, Fixed, 95% CI)Subtotals only
3.1 5% Permethrin vs 1% Lindane single application. FU at 28 days2490Risk Ratio (M-H, Fixed, 95% CI)0.61 [0.44, 0.86]
Analysis 6.1.

Comparison 6 Permethrin versus lindane, Outcome 1 Treatment failure in clinically diagnosed cases.

Analysis 6.2.

Comparison 6 Permethrin versus lindane, Outcome 2 Treatment failure in microscopically diagnosed cases.

Analysis 6.3.

Comparison 6 Permethrin versus lindane, Outcome 3 Itch persistence.

Comparison 7. Permethrin versus benzyl benzoate
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 5% Permethrin vs 25% BB overnight x2 FU at 1 week1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 7.1.

Comparison 7 Permethrin versus benzyl benzoate, Outcome 1 Treatment failure in clinically diagnosed cases.

Comparison 8. Permethrin versus natural synergized pyrethrins
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Itch persistence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 5% Permethrin vs 0.16% Pyrethrins for 8 hours x2. FU at 4 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 8.1.

Comparison 8 Permethrin versus natural synergized pyrethrins, Outcome 1 Itch persistence.

Comparison 9. Crotamiton versus lindane
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 10% Crotamiton vs 1% Lindane overnight x2. FU at 28 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Treatment failure in microscopically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 10% Crotamiton vs 1% Lindane overnight x2. FU at 28 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 9.1.

Comparison 9 Crotamiton versus lindane, Outcome 1 Treatment failure in clinically diagnosed cases.

Analysis 9.2.

Comparison 9 Crotamiton versus lindane, Outcome 2 Treatment failure in microscopically diagnosed cases.

Comparison 10. Lindane versus sulfur
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 0.3% Lindane gel vs 10% Sulfur overnight x7. FU at 4 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Itch persistence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 0.3% Lindane gel vs 10% Sulfur overnight x7. FU at 4 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 10.1.

Comparison 10 Lindane versus sulfur, Outcome 1 Treatment failure in clinically diagnosed cases.

Analysis 10.2.

Comparison 10 Lindane versus sulfur, Outcome 2 Itch persistence.

Comparison 11. Benzyl benzoate versus sulfur
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 25% BB vs Sulfur ointment 3 applications. FU at 15 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 11.1.

Comparison 11 Benzyl benzoate versus sulfur, Outcome 1 Treatment failure in clinically diagnosed cases.

Comparison 12. Benzyl benzoate versus natural synergized pyrethrins
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 10% BB vs 0.16% Pyrethrins repeated after 2 weeks. FU at 4 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
2 Treatment failure in microscopically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
2.1 10% BB vs 0.16% Pyrethrins repeated after 2 weeks. FU at 4 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
3 Itch persistence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
3.1 10% BB vs 0.16% Pyrethrins repeated after 2 weeks. FU at 4 weeks1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 12.1.

Comparison 12 Benzyl benzoate versus natural synergized pyrethrins, Outcome 1 Treatment failure in clinically diagnosed cases.

Analysis 12.2.

Comparison 12 Benzyl benzoate versus natural synergized pyrethrins, Outcome 2 Treatment failure in microscopically diagnosed cases.

Analysis 12.3.

Comparison 12 Benzyl benzoate versus natural synergized pyrethrins, Outcome 3 Itch persistence.

Comparison 13. Benzyl benzoate: one application versus two applications
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 12.5% BB overnight x1 vs 12.5% BB overnight x2. FU at 14 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 13.1.

Comparison 13 Benzyl benzoate: one application versus two applications, Outcome 1 Treatment failure in clinically diagnosed cases.

Comparison 14. Lindane: short application versus long application
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Itch persistence1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 1% Lindane 2x 1hr applications vs 2x 4 day applications. FU at 14 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 14.1.

Comparison 14 Lindane: short application versus long application, Outcome 1 Itch persistence.

Comparison 15. Sulfur: pork fat vehicle versus cold cream vehicle
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Treatment failure in clinically diagnosed cases1 Risk Ratio (M-H, Fixed, 95% CI)Totals not selected
1.1 10% Sulfur in pork fat vs 10% Sulfur in cold cream. FU at 10 days1 Risk Ratio (M-H, Fixed, 95% CI)0.0 [0.0, 0.0]
Analysis 15.1.

Comparison 15 Sulfur: pork fat vehicle versus cold cream vehicle, Outcome 1 Treatment failure in clinically diagnosed cases.

Appendices

Appendix 1. Search methods: detailed search strategies

Search setCIDG SRaCENTRALMEDLINE/EMBASEbLILACSbINDMED
1scabiesscabiesscabiesscabiesscabies
2Sarcoptes scabieiSCABIEStreatmentSarcoptes scabiei
31 or 21 or 21 and 21 or 2
4treatment
5benzyl benzoate
6crotamiton
7lindane
8malathion
9permethrin
10ivermectin
11sulphur
12hexachlorocyclohexane
13gamma benzene hexachloride
144 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13
153 and 14
16Limit 15 to human

aCochrane Infectious Diseases Group Specialized Register.
bSearch terms used in combination with the search strategy for retrieving trials developed by The Cochrane Collaboration (Higgins 2006); upper case: MeSH or EMTREE heading; lower case: free text term.

What's new

DateEventDescription
11 August 2010New search has been performedTwo new trials Bachewar 2009 and Ly 2009 added. Trials now stratified according to drug regimen and length of follow up if heterogeneity detected. Removal of meta-analyses where heterogeneity detected. Minor changes to conclusion regarding effectiveness of ivermectin compared with benzyl benzoate.

History

Protocol first published: Issue 2, 1996
Review first published: Issue 4, 1997

DateEventDescription
18 August 2008AmendedConverted to new review format with minor editing.
30 April 2007New citation required and conclusions have changed2007, Issue 3: A substantive update with new authors. We included nine new trials and excluded two studies (Dunne 1991 and Macotela-Ruiz 1996) included in Walker 2000 after re-evaluation, as noted in the 'Characteristics of excluded studies'. The review has been rewritten and reformatted throughout, and the conclusions of the review have been updated to reflect the new trial evidence. We used more precise definitions in the 'Types of interventions' and separated the 'Types of outcome measures' into primary, secondary, and adverse events. Treatment failure in those clinically diagnosed and treatment failure in those microscopically confirmed are considered as separate outcome measures, while parasitological cure is no longer an outcome measure. We reformatted the search strategy section, but did not attempt to systematically search literature for adverse events. For data analysis, we used relative risks rather than odds ratios, and used a random-effects model for meta-analysis if significant heterogeneity was present. We used available-case analyses rather than intention-to-treat analyses using imputed data.
1 February 2006New search has been performedNew studies found and included or excluded.
1 January 2000New search has been performed2000, Issue 3: Revised, synopsis added, and updated with new studies (Walker 2000).
1 January 1999New search has been performed1999, Issue 3: Revised and updated with new studies (Walker 1999b).
1 January 1999New search has been performedRevised with new title 'Interventions for treating scabies' (Walker 1999a).

Contributions of authors

Mark Strong and Paul Johnstone jointly authored this review update.

Declarations of interest

None known.

Sources of support

Internal sources

  • No sources of support supplied

External sources

  • Medical Research Council, UK.

    MS is funded by a Medical Research Council Health Services Research / Health of the Public research training fellowship [grant number G0601721].

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Amer 1992

Methods

Design: randomized controlled trial

Generation of allocation sequence: "according to code"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 150 enrolled (all ages; sex not stated)

Inclusion criteria: clinically diagnosed and microbiologically confirmed scabies

Exclusion criteria: significant impetiginization

Interventions

1. 5% permethrin (50 participants)
2. 10% crotamiton (50 participants)
3. 1% lindane (50 participants)

Each medication applied "neck to toe" on 2 successive nights

Outcomes1. Number of participants clinically cured (no new lesions and all original lesions healed) at 28 days
Notes

Location: Egypt

Date: not stated

Colour photographs used for comparison before and after treatment

Amerio 2003

Methods

Design: randomized controlled trial

Generation of allocation sequence: computer generated

Allocation concealment: phone call-based procedure

Blinding: investigators only

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 40 enrolled (mean age 44, standard deviation 17; 19 males, 21 females)

Inclusion criteria: immunocompetent; aged 18 to 75; microscopically confirmed uncomplicated scabies

Exclusion criteria: HIV positive; severe renal failure; liver insufficiency; acute or chronic leukaemia; lymphoma; use of antiscabietic preparations in previous 30 days; pregnancy; breastfeeding

Interventions

1. 5% permethrin cream (20 participants)
2. 0.16% natural pyrethrins synergized with pyperonil butoxide (1.65%) in thermolabile foam ("Milice", Mipharm, Italy) (20 participants)

Both medications applied to entire body surface except head for 8 h overnight on 2 consecutive days, and then same treatment repeated after 14 days

Outcomes

1. Number of participants with clearance of lesions at 4 weeks
2. Number of participants with complete relief of itching at 4 weeks

Not included in this review:
3. Number of participants with clearance of lesions at 2 weeks
4. Number of participants with complete relief of itching at 2 weeks
5. Clinical grading score (semi-quantitative measure of numbers of lesions) at 2 and 4 weeks
6. Itching score at 2 and 4 weeks
7. Numbers of days taking antihistamine drugs
8. Numbers of participants with secondary skin infection

Notes

Location: Italy

Date: March 2001 to October 2001

Trial supported by unrestricted grant from Mipharm SpA

Avila-Romay 1991

Methods

Design: randomized controlled trial

Generation of allocation sequence: "randomly assigned"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 51 cases and 60 contacts enrolled (children 6 to 17 years old; sex not stated)

Inclusion criteria: clinically compatible lesions associated with itching

Exclusion criteria: secondary infection

Interventions

1. 10% sulfur in pork fat with 1% salicylic acid as preservative (25 cases and 28 contacts)
2. 10% sulfur in cold cream (26 cases and 32 contacts)

Both medications applied nightly for 3 nights then once 3 nights later, average dose 7 g

Both medications applied by the patients from shoulders to feet for about 5 minutes, under supervision of a physician

Outcomes

1. Number of participants clinically cured at 10 days (defined as absence of cutaneous lesions and itching)
2. Secondary cutaneous reactions in cases and contacts

Not included in this review:
3. Patient preference (not further defined)

Notes

Location: Mexico; participants from a house for orphan children

Date: not stated

60 contacts also randomly assigned to treatment with sulfur in either pork fat or cold cream

Bachewar 2009

Methods

Design: randomized controlled trial

Generation of allocation sequence: computer generated

Allocation concealment: unclear

Blinding: none

Inclusion of randomized participants in the analysis: 78% (23/103 lost to follow up)

Participants

Number: 103 enrolled (aged over 12; 63 males, 40 females)

Inclusion criteria: clinically diagnosed scabies

Exclusion criteria: pregnancy; lactation; women of child bearing age; abnormal liver or kidney function; thyroid disease; cardiac disorders; nervous system disorders; psychiatric illness; diabetes mellitus; hypertension; chronic infectious disease; any concurrent medication; consuming tobacco, alcohol, or any substance of abuse; any other associated skin disease which could alter the picture of scabies; known/suspected immunocompromised individuals; having scabies with atypical presentations including crusted scabies and scabies incognito; any antiscabetic treatment in the preceding week; noncompliant participants.

Interventions

1. 25% benzyl benzoate lotion applied to whole body below neck and left overnight, on 2 consecutive nights (35 participants)

2. 5% permethrin cream applied to whole body below neck and left overnight (34 participants)

3. Oral ivermectin 200 µg/kg bodyweight single dose (34 participants)

Not included in this review:

4. Second topical application of 25% benzyl benzoate lotion at 1 week for treatment failures in intervention group 1 (benzyl benzoate)

5. Second topical application of 5% permethrin cream at 1 week for treatment failures in intervention group 2 (permethrin)

6. Second dose of oral ivermectin at 1 week for treatment failures in intervention group 3 (ivermectin)

Outcomes

1. Number of participants cured at 1 week (defined as absence of new papules, vesicles or classical burrows)

2. Adverse events

Not included in this review:

3. Number of participants cured at 2 weeks (defined as absence of new papules, vesicles or classical burrows)

4. Itching recorded on visual analogue scale

Notes

Location: Nagpur, India

Date: March to July 2007

All family members and close contacts treated at same time as the participant with 25% benzyl benzoate lotion

Biele 2006

Methods

Design: randomized controlled trial

Generation of allocation sequence: computer generated

Allocation concealment: unclear

Blinding: investigators

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 240 enrolled (aged 18 to 75 years, mean age 31 years (pyrethrin group) and 30 years (benzyl benzoate); males only)
Inclusion criteria: clinically diagnosed and microscopically confirmed scabies

Exclusion criteria: treatment for scabies within previous 15 days; renal failure (plasma creatinine > 2.5 mg/dL); liver insufficiency (alanine aminotransferase or aspartate aminotransferase > 3 upper normal limit); acute or chronic leukaemia or lymphoma

Interventions

1. 10% benzyl benzoate lotion ("SCAB", PentaMedical, Milan, Italy), topical application on 5 consecutive days (120 participants)
2. 0.165% natural pyrethrins synergized with pyperonil butoxide (1.65%) in thermolabile foam ("Milice", Mipharm, Italy), topical application on 3 consecutive days (120 participants)

Both treatments were applied to all skin surfaces from scalp to soles of feet

Treatment was repeated after 2 weeks if participant was not considered clinically cured

Outcomes

1. Number of participants clinically cured at 4 weeks
2. Number of participants with relief of itching at 4 weeks
3. Adverse events

Not included in this review:
4. Number of participants with clearance of lesions at 2 weeks
5. Clinical grading score (semi-quantitative measure of numbers of lesions) at 4 weeks
6. Itching score at 4 weeks

Notes

Location: Italy

Date: October 2003 to July 2004

Brooks 2002

Methods

Design: randomized controlled trial

Generation of allocation sequence: computer generated

Allocation concealment: unclear

Blinding: investigators

Inclusion of randomized participants in the analysis: 73% (30/110 lost to follow up)

Participants

Number: 110 enrolled (children 6 months to 14 years old; sex not stated)

Inclusion criteria: clinically diagnosed scabies

Exclusion criteria: treatment for scabies within previous 2 months; major intercurrent illness; history of meningitis or neurological illness

Interventions1. Oral ivermectin 200 µg/kg bodyweight single dose (55 participants)
2. 10% benzyl benzoate applied neck to toe overnight (55 participants)
Outcomes

1. Number of participants clinically cured at 3 weeks (defined as absence of skin lesions)
2. Number of participants with persistence of night-time itch at 3 weeks
3. Adverse events

Not included in this review
4. Itch severity
5. Numbers of lesions

Notes

Location: Vanuatu

Date: January to April 2001

Family contacts treated with same drug as the participant

Author confirmed equal numbers of participants randomized to each intervention

Chouela 1999

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: unclear

Blinding: participants (study described as double blind)

Inclusion of randomized participants in the analysis: 81% (10/53 participants lost to follow up or withdrew)

Participants

Number: 53 enrolled (aged over 18 years with a mean age of 40.8 years; 19 males, 34 females)

Inclusion criteria: clinical or parasitological signs compatible with scabies

Exclusion criteria: pregnancy; breastfeeding; treatment for scabies within previous 4 weeks; renal dysfunction; hepatic dysfunction; concomitant antidepressant; anxiolytic or antipruritic drug use; severe immunodeficiency; HIV infection; clinically high risk for HIV; neoplasia affecting immunity; immunosuppressive treatment; gastrointestinal dysfunction; history of convulsions

Interventions

1. Single dose of oral ivermectin, 150 to 200 µg/kg in 6 mg tablets plus single topical application of 60 mL placebo solution (26 participants)
2. Single topical application of 60 mL 1% lindane topical solution plus placebo tablets (27 participants)

Both placebo and 1% lindane solutions applied neck to toe and kept on for 8 h

Not included in this review:
3. Second dose of oral ivermectin, 150 to 200 µg/kg in 6 mg tablets plus single topical application of 60 mL placebo solution at 15 days for treatment failures in intervention group 1 (ivermectin)
4. Second topical application of 60 mL 1% lindane topical solution plus placebo tablets at 15 days for treatment failures in intervention group 2 (lindane)

Outcomes

1. Number of participants cured at 15 days (defined as absence of pruritus and clinical lesions or a reduction of signs and symptoms to a score of 1 (mild pruritus and mild lesions))
2. Adverse events

Not included in this review
3. Number of participants receiving second dose at 15 days who were cured at 29 days

Notes

Location: Argentina

Date: April 1996 to February 1997

Members of the same household who were infested but could not be included in the study treated with 1% lindane (adults) or 6% sulfur cream (infants)

Glaziou 1993

Methods

Design: randomized controlled trial

Generation of allocation sequence: "randomly allocated"

Allocation concealment: unclear

Blinding: outcomes assessor

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 44 enrolled (aged 5 to 56 years, mean 17.5 years; 23 males, 21 females)

Inclusion criteria: clinically diagnosed scabies defined as the association of pruritus with at least 1 classical burrow

Exclusion criteria: other disease; pregnancy; abnormal physical examination (except for cutaneous lesions); abnormal laboratory screen; refused consent

Interventions1. Oral ivermectin 100 µg/kg bodyweight single dose (23 participants)
2. 10% benzyl benzoate applied to entire body except head on 3 occasions 12 h apart (21 participants)
Outcomes

1. Number of participants clinically cured at 30 days (defined as complete disappearance of initial lesions and pruritus)
2. Adverse events

Not included in this review:
3. Number of participants clinically cured at 7 days
4. Number of participants clinically cured at 14 days
5. Mean clinical score (based on number and activity of lesions)

Notes

Location: French Polynesia

Date: 1992

All household contacts treated at same time as the participant with 10% benzyl benzoate

Merck Sharp and Dohme supplied the ivermectin tablets at no cost

Gulati 1978

Methods

Design: randomized controlled trial

Generation of allocation sequence: "cases ... divided at random"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 158 enrolled (mean age 16.6 years; 75 males, 83 females)

Inclusion criteria: clinical diagnosis of scabies

Exclusion criteria: none stated

Interventions

1. 25% benzyl benzoate emulsion (89 participants)
2. Sulfur ointment (69 participants)

Both medications "applied all over the body after a thorough scrub bath with soap and water once in the morning, then again at night and again the next morning"

Treatments were repeated in those whose lesions persisted after the 10th day

Outcomes

1. Number of participants with clinically assessed "clearance of lesions" at 15 days

Not included in this review:
2. Numbers of participants with clearance of lesions at 3 to 5, 6 to 8, 9 to 11, and 12 to 14 days
3. Number of days until clearance of lesions

Notes

Location: India

Date: not stated

Family contacts treated concurrently with same drug as the participant

33% of participants had secondarily infected lesions

Prevalence of scabies in this study was 158/1727 (9.1%)

Hansen 1986

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: unclear

Blinding: unclear, "single blind"

Inclusion of randomized participants in the analysis: 95% (5/104 lost to follow up)

Participants

Number: 104 enrolled (aged 2 to 71 years)

Inclusion criteria: clinical and/or microscopic diagnosis of scabies

Exclusion criteria: none stated

Interventions

1. 1% lindane lotion (50 participants)
2. 5% permethrin lotion (49 participants)

Both medications applied as a single application

Outcomes

1. Number of participants with absence of lesions at 28 days
2. Number of participants with persistence of pruritus at 28 days
3. Adverse events

Not included in this review:
4. Number of participants with absence of lesions at 14 days

Notes

Location: not stated

Date: not stated

Data taken from a conference abstract

Ly 2009

Methods

Design: randomized controlled trial

Generation of allocation sequence: random number table

Allocation concealment: unclear

Blinding: none

Inclusion of randomized participants in the analysis: 90% (19/181 lost to follow up)

Participants

Number: 181 enrolled (mean age 16.5 years; 116 males, 65 females)

Inclusion criteria: clinical diagnosis of scabies

Exclusion criteria: pruritus due to insect bites; chickenpox in participant or member of participant's family; treatment for scabies within previous month; under 5 years or over 65 years of age; weight less than 15 kg; pregnancy; breastfeeding; use of bleaching products for cosmetic purposes; crusted scabies; diabetes; hypertension; cardiovascular disease; neurological disease; living outside of Dakar district

Interventions

1. Oral ivermectin 150-200 µg/kg bodyweight single dose (65 participants)

2. 12.5% benzyl benzoate to whole body except head (single application left on for 24 hours, 68 participants; two consecutive 24 hour applications, 48 participants)

Not included in this review

4. Second dose of oral ivermectin at 14 days for treatment failures in intervention group 1 (ivermectin)

5. Second single application of 12.5% benzyl benzoate at 14 days for treatment failures in intervention group 2 (benzyl benzoate single application)

6. Second double application of 12.5% benzyl benzoate at 14 days for treatment failures in intervention group 3 (benzyl benzoate double application)

Outcomes

1. Number of participants cured at 14 days (defined as complete disappearance of visible lesions and itching)

2. Adverse events

Not included in this review

3. Number of participants cured at 28 days

4. Number of participants with bacterial superinfection

5. Compliance with medication regimen

Notes

Location: Dakar, Senegal

Date: July 2003 to September 2004

Macotela-Ruiz 1993

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: unclear

Blinding: participants and outcomes assessor

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 55 enrolled (aged over 5 years;18 males mean age 25 +/- 4 years, 37 females mean age 24 +/- 16 years)

Inclusion criteria: clinical diagnosis of scabies

Exclusion criteria: pregnancy; breastfeeding; impaired renal function; impaired liver function; treatment for scabies within previous 3 weeks

Interventions1. Oral ivermectin 200 µg/kg bodyweight single dose (29 participants)
2. Placebo (26 participants)
Outcomes1. Number of participants clinically cured at 7 days (defined as absence of itching and no dermatologically active lesions)
2. Adverse events
Notes

Location: Mexico

Date: not stated

Trial stopped at 7 days as ivermectin group significantly clinically better

Madan 2001

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: unclear

Blinding: outcomes assessor

Inclusion of randomized participants in the analysis: 75% (50/200 lost to follow up)

Participants

Number: 200 enrolled (aged over 5 years; 132 males, 68 females)

Inclusion criteria: clinical diagnosis of scabies (defined as nocturnal itching and/or family contact with similar complaint and/or typical lesions)

Exclusion criteria: pregnancy; breastfeeding; severe cardiovascular, respiratory, or central nervous system disorders

Interventions1. Oral ivermectin 200 µg/kg bodyweight single dose (100 participants)
2. 1% lindane lotion applied neck to toe and left on overnight (100 participants)
Outcomes

1. Number of participants clinically cured at 4 weeks (defined as no signs or symptoms of scabies)
2. Adverse events

Not included in this review:
3. Number of participants clinically cured at 2 weeks
4. Number of patients with good improvement at 4 weeks

Notes

Location: India

Date: not stated

Microscopic confirmation of diagnosis in 170/200 (85%) of participants

Family contacts treated with 25% benzyl benzoate lotion for 3 days

Maggi 1986

Methods

Design: randomized controlled trial

Generation of allocation sequence: "randomly selected"

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 87 enrolled (children, age range not stated)

Inclusion criteria: scabies, not further explained

Exclusion criteria: pyodermatitis

Interventions1. 1% lindane suspension applied topically from chin to feet; 2 x 1-h applications 7 days apart (45 participants)
2. 1% lindane suspension applied topically from chin to feet; 2 series of 4 daily applications, 7 days apart (42 participants)
Outcomes

1. Number of participants with absence of pruritus at 14 days

Not included in this review:
2. Number of participants with absence of pruritus at 7 days
3. Numbers of participants with excoriations or burrows at days 7 and 14

Notes

Location: Chile

Date: March to November 1985

Nnoruka 2001

Methods

Design: randomized controlled trial

Generation of allocation sequence: random-number table

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%

ParticipantsNumber: 58 enrolled (aged 5 to 63 years, mean 27.9 years; 35 males, 33 females)
Inclusion criteria: clinically diagnosed scabies (microbiologically confirmed in 43/58)
Exclusion criteria: aged < 5 years
Interventions1. Oral ivermectin 200 µg/kg bodyweight single dose (29 participants)
2. 25% benzyl benzoate emulsion applied neck to toe and left for 72 h (29 participants)
Outcomes

1. Number of participants clinically cured at 30 days (defined as complete disappearance of initial lesions and pruritus)
2. Adverse events

Not included in this review:
3. Number of participants clinically cured at 7 days
4. Number of participants clinically cured at 14 days
5. Response of pruritus (graded on subjective scale) at 7, 14, and 30 days
6. Mean clinical score (based on number and activity of lesions)

Notes

Location: Nigeria

Date: June 1998

All household contacts treated at same time as the participant (treatment not stated)

Schenone 1986

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 127 enrolled (aged 4 to 19 years; 53 males, 74 females)

Inclusion criteria: clinical diagnosis of scabies

Exclusion criteria: none stated

Interventions1. 40 mL of 0.02% decamethrin lotion, applied everywhere except skull and face, daily for 2 days, and repeated on 2 more days 1 week later (53 participants)
2. 40 mL of 0.02% decamethrin lotion, applied everywhere except skull and face, daily for 4 days (74 participants)
Outcomes1. Number of participants clinically cured at 21 days (defined as no active lesions)
Notes

Location: Chile (18 boarding schools in Santiago)

Date: 1985

Prevalence amongst boarding school children (aged 4 to 19): 127/868 (14.6%)

Contacts treated with single dose of 0.02% decamethrin

Schultz 1990

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: medication supplied to each trial centre in identical coded boxes

Blinding: outcomes assessor

Inclusion of randomized participants in the analysis: 87% (63/467 participants not analysed (for primary outcome))

Participants

Number: 467 enrolled (aged 2 months to 75 years, mean age 22.1 years; 297 males, 170 females)

Inclusion criteria: clinical diagnosis of scabies

Exclusion criteria: pregnancy; breastfeeding; treatment with ectoparasiticide within previous 3 weeks; renal impairment; hepatic impairment; known allergy to permethrin or lindane

Interventions1. 5% permethrin cream applied to entire body below ears, single application (234 participants)
2. 1% lindane lotion applied from neck down, single application (233 participants)
Outcomes

1. Number of participants clinically cured at 28 +/- 7 days (defined as all original lesions healed and no new lesions)
2. Number of participants with persistence of itch
3. Adverse events

Not included in this review:
4. Number of participants clinically cured at 14 +/- 3 days
5. Number of microbiologically confirmed cases clinically cured

Notes

Location: USA and Mexico (4 sexually transmitted diseases clinics, 2 dermatology clinics, and 2 family practice clinics, 1 of which was in Mexico and all others in USA)

Date: not stated

Personal contacts of 85% of participants provided with 1% lindane for their use

Study supported in part by a grant from Burroughs Wellcome (manufacturers of permethrin) who also provided statistical assistance

Singalavanija 2003

Methods

Design: randomized controlled trial

Generation of allocation sequence: random-number table

Allocation concealment: unclear

Blinding: unclear

Inclusion of randomized participants in the analysis: 68% (32/100 participants lost to follow up)

Participants

Number: 100 enrolled (aged 6 months to 13 years; 60 males, 40 females)

Inclusion criteria: clinically diagnosed and microbiologically confirmed scabies

Exclusion criteria: resident in an orphanage; serious central nervous system illness; malnutrition; immunodeficiency

Interventions

1. 10% sulfur ointment (50 participants)
2. 0.3% lindane gel (50 participants)

Both medications applied neck to toe by parents for 7 consecutive nights

Outcomes

1. Number of participants clinically cured (no new lesions and healing of all old lesions) at 4 weeks
2. Number of participants with decrease or absence of itching at 4 weeks
3. Adverse events

Not included in this review:
4. Number of participants clinically cured at 2 weeks (defined as no new lesions and healing of all old lesions)
5. Number of participants with decrease or absence of itching at 2 weeks
6. Number of participants with absence of parasites on skin scraping at 2 and 4 weeks

Notes

Location: Thailand

Date: December 1999 to May 2000

Contacts treated with either 25% benzyl benzoate (adults) or 10% sulfur (children)

Taplin 1986

Methods

Design: randomized controlled trial

Generation of allocation sequence: "randomized code"

Allocation concealment: identical coded medication tubes; codes held by sponsor

Blinding: investigators

Inclusion of randomized participants in the analysis: 98% (1/52 participant lost to follow up)

Participants

Number: 52 enrolled (aged 2 to 40 years, mean age 9 years; 22 males, 29 females, 1 gender not stated)

Inclusion criteria: clinically diagnosed scabies (confirmed microscopically in 46/52 cases)

Exclusion criteria: unwell; febrile; taking any medication; treatment with pediculicides, scabicides, or other topical agent in previous 3 months

Interventions

1. 5% permethrin cream (27 participants)
2. 1% lindane lotion (25 participants)

Both medications applied as a single application head to toe

Outcomes

1. Number of participants with no new lesions and healing of all original lesions at 1 month
2. Adverse events

Not included in this review:
3. Number of participants with no new lesions and healing of all original lesions at 2 weeks

Notes

Location: Panama

Date: not stated

All family contacts treated with 1% lindane lotion

Photographs taken before and after treatment and distribution of any lesions noted on diagrams

Study supported in part by a grant from Burroughs Wellcome (manufacturers of permethrin)

Taplin 1990

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: "medications supplied in identical ... tubes that were coded and randomized"

Blinding: investigators

Inclusion of randomized participants in the analysis: 98% (2/96 participants lost to follow up)

Participants

Number: 96 enrolled (aged 2 months to 5 years; 42 males, 54 females)

Inclusion criteria: clinical diagnosis and the recovery of at least 1 live mite

Exclusion criteria: none stated

Interventions

1. 10% crotamiton cream (48 participants)
2. 5% permethrin cream (48 participants)

Both medications applied as single application from head to toe and left for 8 to 10 h

Outcomes

1. Number of participants with no new lesions and all original active lesions healed at 28 days
2. Number of participants with persistence of pruritus at 28 days
3. Adverse events

Not included in this review:
4. Number of participants with no new lesions and all original active lesions healed at 14 days
5. Number of participants with persistence of pruritus at 14 days

Notes

Location: Panama

Date: 1985

Household contacts were treated with 5% permethrin cream

65/96 (68%) participants had secondary cutaneous infection

Study supported in part by a grant from Burroughs Wellcome (manufacturers of permethrin)

Usha 2000

Methods

Design: randomized controlled trial

Generation of allocation sequence: computer-generated random-number table

Allocation concealment: investigators did not take part in allocation

Blinding: none

Inclusion of randomized participants in the analysis: 100%

Participants

Number: 88 enrolled (aged over 5 years with a mean age of 21.3 years (ivermectin) and 22.4 years (permethrin); 59 males, 26 females)

Inclusion criteria: clinical diagnosis (3 out of burrow/lesions in classical sites/nocturnal itch/family history) or microscopic diagnosis

Exclusion criteria: pregnancy; breastfeeding; treatment for scabies within previous 1 month; serious central nervous system, hepatic, cardiac, or renal disease

Interventions

1. Oral ivermectin 200 µg/kg bodyweight single dose (43 participants)
2. 5% permethrin cream applied topically overnight (45 participants)

Not included in this review
3. Second dose of oral ivermectin, 200 µg/kg for treatment failures in intervention group 1 (12 participants)
4. Second topical application 5% permethrin cream for treatment failures in intervention group 2 (1 participant)

Outcomes

1. Number of participants clinically cured at 2 weeks (defined as symptom improvement)
2. Adverse events

Not included is this review:
3. Number of participants clinically cured at 1, 4, and 8 weeks

Notes

Location: India

Date: August 1996 to December 1997

Contacts treated with same drug as the index case, except contacts who were children under 5 or pregnant women; these were treated with 12.5% to 25% benzyl benzoate emulsion

Author confirmed randomization method and blinding

3 participants in ivermectin group withdrawn due to using additional treatment

Zargari 2006

Methods

Design: randomized controlled trial

Generation of allocation sequence: unclear

Allocation concealment: "drugs ... packaged in identical appearing tubes and randomized and coded by the manufacturer"

Blinding: participants and investigators

Inclusion of randomized participants in the analysis: 84.6% (18/117 lost to follow up)

Participants

Number: 117 enrolled (aged 6 to 64 years, mean age 30.2 years +/- 15.3; 55 males and 44 females followed up)

Inclusion criteria: clinically diagnosed scabies (defined as burrow or typical lesions at classical sites plus nocturnal pruritus plus similar symptoms in contacts) and/or microscopically diagnosed scabies (demonstration of egg, larvae, mite, or faecal material)

Exclusion criteria: < 5 years of age; treatment with antiscabietic medication or topical steroid in previous 4 weeks; pregnancy; breastfeeding; severe central nervous system, hepatic, or renal problems

Interventions

1. 5% permethrin cream (59 participants)
2. 1% lindane cream (58 participants)

Both medications applied as a single application head to toe, and repeated 1 week later

Outcomes1. Number of participants with no new lesions and improvement in itching at 14 days
2. Adverse events
Notes

Location: Iran

Date: December 2002 to October 2003

Treatment advised for all family members and close contacts

Study supported by Gilaranco Company (manufacturers of permethrin and lindane)

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Abedin 2007Non-randomized study
Alebiosu 2003Allocation method inadequate; expressed preference of participants for different interventions taken into account
Amer 1981Non-randomized study
Bockarie 2000Non-controlled study
Burgess 1986Non-randomized study
Cannon 1948Non-controlled study
Chowdhury 1977Non-controlled study
Cubela 1978Non-randomized study
Curiati 1984Non-randomized study
Damodaran 1979A trial of iron and folic acid supplementation
Daneshpajooh 2000Unclear if randomized
Dika 2006Non-controlled study
Dourmishev 1998Non-controlled study
Dunne 1991Study participants selected on basis of having onchocerciasis rather than scabies
Gallegos 1996Thesis unavailable
Gordon 1944Non-randomized study
Grabner 1970Non-randomized study
Hamm 2006Non-controlled study
Hanna 1978Non-controlled study
Haustein 1989Non-randomized study
Henderson 1991Non-randomized study
Henderson 1992Non-randomized study
Kar 1994Case study
Kaur 1980Non-randomized study
Kenawi 1993Non-randomized study
Khan 2007Non-randomized study
Konstantinov 1979Non-randomized study
Landegren 1979Non-randomized study
López 2003Non-randomized study
Macotela-Ruiz 1996Not truly randomized; unbalanced groups
Mapar 2008Non-randomized study
Meinking 1995bNon-controlled study
Mellanby 1945Non-randomized study
Mozgunov 1978Non-controlled study
Nag 1995Non-randomized study
Neto 1984Non-randomized study
Oberoi 2007Non-randomized study; cure not assessed
Oladimeji 2000Participants randomized to 1 of 3 treatments (lippia oil, benzyl benzoate, or liquid paraffin) but no clear randomization within these groups to 36 separate treatment schedule subgroups
Oladimeji 2005Trial design inadequate with control group consisting of participants excluded from intervention arms
Oyelami 2009Non-controlled study
Paasch 2000Non-randomized study
Paschoal 1985Not a trial of scabies treatment effectiveness
Pierce 1951Non-randomized study
Regis 2003Outcome is reinfestation not treatment failure
Reid 1990Non-controlled study
Sehgal 1972No assessment of any outcomes were reported
Srinivas 1996Randomization unclear; comparison of lindane applied by bath, paint brush, and spray
Srivastava 1980Allocation made on a "random basis and on availability of drugs"
Sule 2007Non-randomized study
Suvanprakorn 1987Non-controlled study
Taplin 1983aNon-randomized study
Taplin 1983bNon-controlled study
Taplin 1991Non-controlled study
Tausch 1999Comparison between 2 different brands of the same drug (10% crotamiton lotion)
Thianprasit 1984Non-controlled study
Woolridge 1948Non-controlled study
Yonkonsky 1990Non-controlled study

Characteristics of ongoing studies [ordered by study ID]

Naeyaert ongoing

Trial name or title"A randomised, double blind, double dummy study to compare the efficacy and safety of a single administration of ivermectin to a single administration of permethrin for the treatment of scabies"
Methods
Participants

Expected enrolment: 160
Minimum age: 5 years
Both genders

Inclusion criteria: at least 1 of scabies tunnels or positive microscopic examination (acarids, faeces, or ova); at least two of non-specific injuries with a typical distribution pattern, serious itching which increases during the night, or family or contacts with similar complaints

Exclusion criteria: treatment for scabies < 4 weeks ago; treatment with corticoids < 1 week ago; pregnancy; breastfeeding; HIV; serious immunodepressive patients; sensitivity or allergy to 1 of the components of the study medication; damage of the central nerve system

InterventionsAdministration of ivermectin or permethrin on day 0
OutcomesPrimary: clinical healing of the skin injuries on day 28
Secondary: decrease of itching on day 28; amelioration of the life quality on day 28; number and gravity of adverse events
Starting dateJuly 2004
Contact informationJean-Marie Naeyaert, Principal Investigator, University Hospital Ghent, Ghent 9000, Belgium
NotesClinicalTrials.gov identifier: NCT00262418

Ancillary