Aromatherapy for dementia

  • Review
  • Intervention

Authors


Abstract

Background

Complementary therapy has received great interest within the field of dementia treatment and the use of aromatherapy and essential oils is increasing. In a growing population where the majority of patients are treated by US Food and Drug Administration (FDA)-approved drugs, the efficacy of treatment is short term and accompanied by negative side effects. Utilisation of complimentary therapies in dementia care settings presents as one of few options that are attractive to practitioners and families as patients often have reduced insight and ability to verbally communicate adverse reactions. Amongst the most distressing features of dementia are the behavioural and psychological symptoms. Addressing this facet has received particular interest in aromatherapy trials, with a shift in focus from reducing cognitive dysfunction to the reduction of behavioural and psychological symptoms in dementia.

Objectives

To assess the efficacy of aromatherapy as an intervention for people with dementia.

Search methods

ALOIS, the Cochrane Dementia and Cognitive Improvement Group Specialized Register, was searched on 26 November 2012 and 20 January 2013 using the terms: aromatherapy, lemon, lavender, rose, aroma, alternative therapies, complementary therapies, essential oils.

Selection criteria

All relevant randomised controlled trials were considered. A minimum length of a trial and requirements for follow-up were not included, and participants in included studies had a diagnosis of dementia of any type and severity. The review considered all trials using fragrance from plants defined as aromatherapy as an intervention with people with dementia and all relevant outcomes were considered.

Data collection and analysis

Titles and abstracts extracted by the searches were screened for their eligibility for potential inclusion in the review. For Burns 2011, continuous outcomes were estimated as the mean difference between groups and its 95% confidence interval using a fixed-effect model. For Ballard 2002, analysis of co-variance was used for all outcomes, with the nursing home being treated as a random effect.

Main results

Seven studies with 428 participants were included in this review; only two of these had published usable results. Individual patient data were obtained from one trial (Ballard 2002) and additional analyses performed. The additional analyses conducted using individual patient data from Ballard 2002 revealed a statistically significant treatment effect in favour of the aromatherapy intervention on measures of agitation (n = 71, MD -11.1, 95% CI -19.9 to -2.2) and behavioural symptoms (n = 71, MD -15.8, 95% CI -24.4 to -7.2). Burns 2011, however, found no difference in agitation (n = 63, MD 0.00, 95% CI -1.36 to 1.36), behavioural symptoms (n = 63, MD 2.80, 95% CI -5.84 to 11.44), activities of daily living (n = 63, MD -0.50, 95% CI -1.79 to 0.79) and quality of life (n = 63, MD 19.00, 95% CI -23.12 to 61.12). Burns 2011 and Fu 2013 found no difference in adverse effects (n = 124, RR 0.97, 95% CI 0.15 to 6.46) when aromatherapy was compared to placebo.

Authors' conclusions

The benefits of aromatherapy for people with dementia are equivocal from the seven trials included in this review. It is important to note there were several methodological difficulties with the included studies. More well-designed, large-scale randomised controlled trials are needed before clear conclusions can be drawn regarding the effectiveness of aromatherapy for dementia. Additionally, several issues need to be addressed, such as whether different aromatherapy interventions are comparable and the possibility that outcomes may vary for different types of dementia.

Résumé scientifique

L'aromathérapie dans la démence

Contexte

Les thérapies complémentaires ont suscité beaucoup d'intérêt dans le domaine du traitement de la démence et l'utilisation de l'aromathérapie et des huiles essentielles est en augmentation. Dans une population croissante dans laquelle la majorité des patients sont soignés par des médicaments approuvés par l'agence américaine des produits alimentaires et médicamenteux (FDA), l'efficacité du traitement est de courte durée et s'accompagne d'effets secondaires négatifs. L'utilisation des thérapies complémentaires dans le contexte des soins de la démence se présente comme l'une des rares options intéressantes pour les praticiens et les familles, les patients ayant souvent des capacités réduites de compréhension et de communication verbale sur les réactions indésirables. Parmi les caractéristiques les plus éprouvantes de la démence se trouvent les symptômes comportementaux et psychologiques. Cette facette a particulièrement attiré l'attention dans les essais sur l'aromathérapie, et l'accent est mis aujourd'hui sur la diminution des symptômes comportementaux et psychologiques de la démence plutôt que sur la réduction du dysfonctionnement cognitif.

Objectifs

Évaluer l'efficacité de l'aromathérapie en tant qu'intervention pour les personnes atteintes de démence.

Stratégie de recherche documentaire

Des recherches ont été effectuées le 26 novembre 2012 et le 20 janvier 2013 dans ALOIS, le registre spécialisé du groupe Cochrane sur la démence et les autres troubles cognitifs, en utilisant les termes : aromathérapie, citron, lavande, rose, arôme, thérapies alternatives, thérapies complémentaires, huiles essentielles.

Critères de sélection

Tous les essais contrôlés randomisés pertinents ont été pris en compte. Aucune durée minimale de l'essai ni exigence de suivi n'a été imposée, et les participants dans les études incluses présentaient un diagnostic de démence de tout type et gravité. La revue a considéré tous les essais utilisant des parfums de plantes au titre d'aromathérapie comme une intervention chez les personnes atteintes de démence et tous les critères de jugement pertinents ont été pris en compte.

Recueil et analyse des données

L'éligibilité des titres et résumés identifiés par les recherches a été examinée pour leur inclusion éventuelle dans la revue. Pour Burns 2011, les résultats continus ont été estimés comme la différence moyenne entre les groupes avec intervalle de confiance à 95 % en utilisant un modèle à effets fixes. Pour Ballard 2002, l'analyse de covariance a été utilisée pour tous les critères de jugement, et la maison de soins a été traitée comme un effet aléatoire.

Résultats principaux

Sept études totalisant 428 participants ont été incluses dans cette revue ; seules deux d'entre elles publiaient des résultats utilisables. Les données individuelles des patients ont été obtenues pour un essai (Ballard 2002) et d'autres analyses réalisées. Les analyses supplémentaires réalisées à l'aide des données individuelles des patients provenant de Ballard 2002 ont révélé un effet thérapeutique statistiquement significatif en faveur de l'intervention d'aromathérapie sur les mesures de l'agitation (n = 71, DM de -11,1, IC à 95 % -19,9 à -2,2) et des symptômes comportementaux (n = 71, DM de -15,8, IC à 95 % -24,4 à -7,2). Cependant, Burns 2011 n'a trouvé aucune différence dans l'agitation (n = 63, DM de 0,00, IC à 95 % -1,36 à 1,36), les symptômes comportementaux (n = 63, DM de 2,80, IC à 95 % -5,84 à 11,44), les activités de la vie quotidienne (n = 63, DM de -0,50, IC à 95 % -1,79 à 0,79) et la qualité de vie (n = 63, DM de 19,00, IC à 95 % -23,12 à 61,12). Burns 2011 et Fu 2013 n'ont trouvé aucune différence concernant les effets indésirables (n = 124, RR 0,97, IC à 95 % 0,15 à 6,46) lorsque l'aromathérapie était comparée à un placebo.

Conclusions des auteurs

Les bénéfices de l'aromathérapie pour les personnes atteintes de démence sont équivoques sur la base des sept essais inclus dans cette revue. Il est important de noter qu'il y a eu plusieurs difficultés méthodologiques dans les études incluses. D'autres essais contrôlés randomisés, bien conçus et à grande échelle, sont nécessaires avant de pouvoir tirer des conclusions claires concernant l'efficacité de l'aromathérapie dans la démence. Par ailleurs, plusieurs questions doivent être abordées, comme la comparabilité éventuelle de différentes interventions d'aromathérapie et la possibilité que les résultats puissent varier pour les différents types de démence.

Resumo

Aromaterapia para demência

Introdução

Terapia complementar tem recebido grande interesse no campo do tratamento de demência e a utilização de aromaterapia e óleos essenciais está aumentando. Em uma população em crescimento, na qual a maioria dos pacientes são tratados pelo FDA (EUA Food and Drug Administration)-drogas aprovadas, a eficácia do tratamento é de curto prazo e acompanhado de efeitos colaterais negativos. A utilização de terapias complementares em ambientes de cuidados para pacientes com demência apresenta-se como uma das poucas opções que são atraentes para profissionais e famílias, já que os pacientes muitas vezes têm redução de discernimento e da capacidade de comunicar verbalmente as reações adversas. Entre as características mais angustiantes da demência são os sintomas comportamentais e psicológicos. Enfrentar esta faceta tem recebido especial interesse nos estudos da aromaterapia, com uma mudança de foco de reduzir a disfunção cognitiva para a redução dos sintomas comportamentais e psicológicos da demência.

Objetivos

Avaliar a eficácia da aromaterapia como intervenção para pessoas com demência.

Métodos de busca

ALOISe a base de dados Cochrane Dementia and Cognitive Improvement Group Specialized Register, foram pesquisadas em 26 de Novembro 2012 e 20 de Janeiro de 2013 utilizando os termos: aromaterapia, limão, lavanda, rosa, aroma, terapias alternativas, terapias complementares, óleos essenciais.

Critério de seleção

Todos os ensaios clínicos randomizados relevantes foram considerados. A duração mínima de um ensaio clínico e os requisitos para o acompanhamento não foram incluídos, e os participantes dos estudos incluídos apresentaram qualquer tipo e gravidade de diagnóstico de demência. A revisão considerou todos os ensaios clínicos usando fragrância de plantas definidas como aromaterapia como intervenção em pessoas com demência e todos os resultados relevantes foram considerados.

Coleta dos dados e análises

Os títulos e resumos extraídos pelas pesquisas foram selecionados pela sua elegibilidade para potencial inclusão na revisão. Para Burns 2011, os resultados contínuos foram estimados como a diferença de média entre os grupos com seu intervalo de confiança de 95% usando um modelo de efeito fixo. Para Ballard 2002, a análise de co-variância foi utilizada para todos os resultados, com a casa de repouso sendo tratado como um efeito aleatório.

Principais resultados

Sete estudos com 428 participantes foram incluídos nesta revisão; apenas dois deles haviam publicado resultados utéis. Os dados individuais dos pacientes foram obtidos a partir de um ensaio clínico (Ballard 2002) e análises adicionais realizadas. As análises adicionais conduzidas utilizando dados de pacientes individuais de Ballard 2002 revelou um efeito de tratamento estatisticamente significante a favor da aromaterapia nas medidas de desfecho de agitação (n = 71, DM -11.1, IC 95% -19,9 á -2,2) e sintomas comportamentais (n = 71, DM -15.8, IC 95% -24,4 á -7,2). Burns 2011, no entanto, não encontrou diferença estatisticamente significante na agitação (n = 63, DM 0.00, 95% CI -1.36 á 1.36), sintomas comportamentais (n = 63, DM 2,80, IC 95% -5,84 á 11,44), atividades da vida diária (n = 63, DM -0,50, IC 95% - 1,79 á -0,79) e qualidade de vida (n = 63, DM 19,00, 95% IC -23,12 á 61,12). Burns 2011 e Fu 2013 não encontraram diferença no efeitos adversos (n = 124, RR 0.97, 95% IC 0,15 á 6,46), quando compararam aromaterapia ao placebo.

Conclusão dos autores

Os benefícios da aromaterapia para pessoas com demência são questionáveis dos sete estudos incluídos nesta revisão. É importante notar que houve diversas dificuldades metodológicas nos estudos incluídos. São necessários mais ensaios clínicos randomizados bem desenhados, em larga escala, antes que conclusões claras podem ser tiradas a respeito da eficácia da aromaterapia para a demência. Além disso, várias questões precisam ser abordadas, como por exemplo se diferentes intervenções de aromaterapia são comparáveis entre si e a possibilidade de que os resultados podem variar para diferentes tipos de demência.

Notas de tradução

Traduzido por: Raíssa Pierri Carvalho, Unidade de Medicina Baseada em Evidências da Unesp, Brasil. Contato:portuguese.ebm.unit@gmail.com

アブストラクト

認知症に対する芳香療法

背景

認知症の治療分野では補完療法が大きく注目されており、芳香療法やエッセンシャルオイルの使用が増加している。認知症が増加するなかで、多数の患者が米国食品医薬品局(FDA)認可の医薬品による治療を受けているが、その効果は短く、有害な副作用を伴う。認知症患者は、しばしば副作用について言葉でコミュニケーションを図る能力や洞察力が低下するため、認知症治療現場における補完療法の利用は、数少ない選択肢の1つとして開業医や患者の家族にとって関心の高い治療法となっている。認知症の最も深刻な特徴は、行動・心理症状である。芳香療法の試験では、これらの症状への対処法が特に注目されており、認知症における認知機能障害から行動・心理症状の軽減へと関心が移りつつある。

目的

認知症患者を対象とした介入試験を実施し、芳香療法の有効性を評価すること。

検索戦略

2012年11月26日および2013年1月20日に、次の用語を用いてアロイス(Cochrane Dementia and Cognitive Improvement Group Specialized Register)にて検索した:芳香療法、レモン、ラベンダー、ローズ、アロマ、代替療法、補完療法、エッセンシャルオイル。

選択基準

関連のあるすべてのランダム化比較試験を対象とした。最短試験期間および追跡調査の条件は設定せず、試験参加者の認知症診断結果は種々の型および重症度に及んだ。本レビューでは、芳香療法と定義される植物由来芳香成分の使用に関するすべての試験を認知症患者に対する介入試験とみなし、関連するすべてのアウトカムについて考察した。

データ収集と分析

検索で抽出されたタイトルおよびアブストラクトが本レビューの選択基準を満たしているかどうかをスクリーニングした。Burns(2011)については、固定効果モデルを用いて、連続値をとるアウトカムを群間の平均差および95%信頼区間として推定した。Ballard(2002)については、すべてのアウトカムに対して共分散分析を用い、治療を受けた介護施設を変量効果とした。

主な結果

本レビューでは、参加者428例を対象とした7件の試験を採用した。このうち2件の試験結果のみが学術誌に掲載された利用可能なデータであった。個々の患者データは、1件の試験(Ballard、2002)から入手し、追加分析を実施した。Ballard(2002)の個々の患者データを用いて実施した追加分析の結果、興奮(n = 71, MD -11.1, 95% CI -19.9〜-2.2)および行動症状(n = 71, MD -15.8, 95% CI -24.4〜-7.2)の指標に対して芳香療法の治療介入効果に統計学的有意性が認められた。しかし、Burns(2011)の結果では、興奮(n = 63, MD 0.00, 95% CI -1.36〜1.36)、行動症状(n = 63, MD 2.80, 95% CI -5.84〜11.44)、日常生活動作(n = 63, MD -0.50, 95% CI -1.79〜0.79)およびQOL(n = 63, MD 19.00, 95% CI -23.12〜61.12)に有意差は認められなかった。Burns(2011)およびFu(2013)では、芳香療法およびプラセボ間で有害作用に有意差(n = 124, RR 0.97, 95% CI 0.15〜6.46)は認められなかった。

著者の結論

本レビューで対象とした7件の試験では、認知症患者に対する芳香療法の有益性は明確ではなかった。今回対象とした試験では、方法論上の問題点がいくつか認められたことは留意すべきである。認知症に対する芳香療法の有効性に関する明確な結論を導くためには、より適切にデザインされた大規模ランダム化比較試験を実施する必要がある。さらに、それぞれの芳香療法介入が比較可能であるのか、認知症の型によってアウトカムが異なる可能性など、解決すべき問題点がいくつかある。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.28]《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Plain language summary

Aromatherapy for promotion of relaxation and sleep, relief of pain, and reduction of depressive symptoms in dementia

Aromatherapy is the use of pure essential oils from fragrant plants (such as peppermint, sweet marjoram, and rose) to help relieve health problems and improve the quality of life in general. The healing properties of aromatherapy are claimed to include promotion of relaxation and sleep, relief of pain, and reduction of depressive symptoms. Hence, aromatherapy has been used to reduce disturbed behaviour, to promote sleep, and to stimulate motivational behaviour of people with dementia. Of the seven randomised controlled trials that we found, only two trials including 186 people had useable data. The analysis of these two small trials showed inconsistent effects of aromatherapy on measures of agitation, behavioural symptoms and quality of life. More large-scale randomised controlled trials are needed before firm conclusions can be reached about the effectiveness of aromatherapy for dementia.

Résumé simplifié

L'aromathérapie pour favoriser la relaxation et le sommeil, le soulagement de la douleur et la réduction des symptômes dépressifs dans la démence

L'aromathérapie est l'utilisation d'huiles essentielles pures de plantes parfumées (telles que la menthe poivrée, la marjolaine ou la rose) pour aider à soulager les problèmes de santé et améliorer la qualité de vie en général. Les propriétés guérissantes prétendues de l'aromathérapie comprennent la favorisation de la relaxation et du sommeil, le soulagement de la douleur et la réduction des symptômes dépressifs. Par conséquent, l'aromathérapie a été utilisée pour réduire les comportements perturbateurs, faciliter le sommeil et stimuler le comportement motivationnel chez les personnes atteintes de démence. Sur les sept essais contrôlés randomisés que nous avons trouvés, seuls deux essais portant sur 186 personnes avaient des données utilisables. L'analyse de ces deux essais de petite taille a mis en évidence des effets incohérents de l'aromathérapie sur les mesures de l'agitation, des symptômes comportementaux et de la qualité de vie. D'autres essais contrôlés randomisés à grande échelle sont nécessaires avant de pouvoir tirer des conclusions définitives concernant l'efficacité de l'aromathérapie dans la démence.

Notes de traduction

Traduit par: French Cochrane Centre 29th June, 2014
Traduction financée par: Financeurs pour le Canada : Instituts de Recherche en Santé du Canada, Ministère de la Santé et des Services Sociaux du Québec, Fonds de recherche du Québec-Santé et Institut National d'Excellence en Santé et en Services Sociaux; pour la France : Ministère en charge de la Santé

Resumo para leigos

Aromaterapia para a promoção de relaxamento e sono, alívio da dor e redução de sintomas depressivos em demência

Aromaterapia é a utilização de óleos essenciais puros de plantas aromáticas (como hortelã-pimenta, manjerona e rosa) para ajudar a aliviar problemas de saúde e melhorar a qualidade de vida em geral. As propriedades curativas da aromaterapia são ditas: incluir a promoção de relaxamento e sono, alívio da dor e redução de sintomas depressivos. Por isso, a aromaterapia tem sido usado para reduzir comportamentos perturbados, promover o sono e estimular o comportamento motivacional de pessoas com demência. Dos sete ensaios clínicos randomizados que encontramos, apenas dois ensaios clínicos, incluindo 186 pessoas apresentaram dados úteis. A análise destes dois pequenos estudos mostraram efeitos inconsistentes da aromaterapia em medidas de agitação, sintomas comportamentais e qualidade de vida. Mais ensaios clínicos randomizados de larga escala são necessários antes que conclusões definitivas podem ser alcançadas em relação à eficácia da aromaterapia para a demência.

Notas de tradução

Traduzido por: Raíssa Pierri Carvalho, Unidade de Medicina Baseada em Evidências da Unesp, Brasil. Contato:portuguese.ebm.unit@gmail.com

Laički sažetak

Aromaterapija za opuštanje i san, olakšanje boli, i smanjenje depresivnih simptoma kod demencije

Aromaterapija podrazumijeva korištenje čistih eteričnih ulja iz mirisnih biljki (kao što je paprena metvica, slatki mažuran, i ruža) za ublažavanje zdravstvenih problema i poboljšanje kvalitete života općenito. Kao ljekovita svojstva aromaterapije navodi se mogućnost poticanja opuštanja i boljeg sna, olakšanje boli i smanjenje depresivnih simptoma. Stoga se aromaterapija koristi za ublažavanje poremećaja u ponašanju, za bolji san i da potakne motivacijsko ponašanje osoba s demencijom. Od sedam nasumičnih kontroliranih ispitivanja koji su pronađeni u ovom Cochrane sustavnom pregledu, samo dva ispitivanja koja uključuju 186 osoba su imala upotrebljive podatke. Analiza ova dva mala ispitivanja pokazuje proturječne učinke aromaterapije na mjere uzrujanosti, poremećaje ponašanja i kvalitete života. Potrebno je provesti više velikih nasumičnih kontroliranih ispitivanja da bi se mogli donijeti čvrsti zaključci o učinkovitosti aromaterapije na demenciju.

Bilješke prijevoda

Cochrane Hrvatska
Prevela: Božena Armanda
Ovaj sažetak preveden je u okviru volonterskog projekta prevođenja Cochrane sažetaka. Uključite se u projekt i pomozite nam u prevođenju brojnih preostalih Cochrane sažetaka koji su još uvijek dostupni samo na engleskom jeziku. Kontakt: cochrane_croatia@mefst.hr

Laienverständliche Zusammenfassung

Aromatherapie zur Förderung der Entspannung und des Schlafes, Schmerzlinderung und Reduktion von depressiven Symptomen bei Menschen mit Demenz

Unter Aromatherapie wird der Gebrauch von reinen ätherischen Ölen von wohlriechenden Pflanzen (wie zum Beispiel Pfefferminze, Majoran oder Rose) zur Linderung von Gesundheitsproblemen und zur Verbesserung der allgemeinen Lebensqualität verstanden. Die heilenden Eigenschaften der Aromatherapie erheben den Anspruch, Entspannung und Schlaf zu fördern, Schmerzen zu lindern und depressive Symptome zu reduzieren. Daher wurde Aromatherapie verwendet, um bei Menschen mit Demenz Verhaltensstörungen zu reduzieren, den Schlaf zu fördern und motivierendes Verhalten anzuregen. Von den sieben randomisiert kontrollierten Studien, die wir gefunden haben, hatten nur zwei Studien mit insgesamt 186 Teilnehmenden verwendbare Daten. Die Analyse dieser beiden kleinen Studien zeigte keine eindeutige Wirkung der Aromatherapie auf die Messung der Agitation, Verhaltenssymptome und Lebensqualität. Es bedarf mehr groß angelegter randomisierter kontrollierter Studien um fundierte Schlussfolgerungen zur Alltagswirksamkeit von Aromatherapie bei Menschen mit Demenz ziehen zu können.

Anmerkungen zur Übersetzung

A. Kobleder und C. Schiess, Koordination durch Cochrane Schweiz.

平易な要約

認知症に対するリラクゼーションの促進や睡眠の改善、痛みや抑うつ症状の軽減を目的とした芳香療法の使用

芳香療法は、芳香植物(ペパーミント、スイートマジョラム、ローズなど)から精製されたエッセンシャルオイルを用いて健康上の問題を取り除き、全般的なQOLを向上させる。芳香療法の治療効果には、リラクゼーションの促進や睡眠の改善、痛みや抑うつ症状の軽減などがあると言われている。このため、芳香療法は認知症患者の精神行動異常の軽減、睡眠の改善、動機づけ行動の刺激に用いられる。レビューの対象とした7件のランダム化比較試験のうち、利用可能なデータは186例を含む2件の試験データのみであった。この2件の小規模試験を分析した結果、興奮、行動症状およびQOLの指標について芳香療法の効果に一貫性が認められないことが示された。認知症に対する芳香療法の有効性について確実な結論を得るためには、さらに大規模なランダム化比較試験を実施する必要がある。

訳注

《実施組織》厚生労働省「「統合医療」に係る情報発信等推進事業」(eJIM:http://www.ejim.ncgg.go.jp/)[2015.12.28]《注意》この日本語訳は、臨床医、疫学研究者などによる翻訳のチェックを受けて公開していますが、訳語の間違いなどお気づきの点がございましたら、eJIM事務局までご連絡ください。なお、2013年6月からコクラン・ライブラリーのNew review, Updated reviewとも日単位で更新されています。eJIMでは最新版の日本語訳を掲載するよう努めておりますが、タイム・ラグが生じている場合もあります。ご利用に際しては、最新版(英語版)の内容をご確認ください。

Streszczenie prostym językiem

Stosowanie aromaterapii w celu ułatwienia wypoczynku i zasypiania, łagodzenia natężenia bólu oraz zmniejszenia nasilenia objawów depresji u osób z otępieniem

Aromaterapia wykorzystuje czyste olejki eteryczne z roślin pachnących (takich jak: mięta, majeranek i róża), aby zmniejszyć problemy zdrowotne i poprawić ogólną jakość życia. Uważa się, że lecznicze właściwości aromaterapii obejmują ułatwienie wypoczynku i zasypiania, łagodzenie natężenia bólu i zmniejszenie nasilenia objawów depresji. Dlatego aromaterapię stosuje się w celu zmniejszenia nasilenia objawów zaburzeń zachowania, ułatwienia zasypiania oraz zachęcania do podejmowania zachowań motywacyjnych u osób z otępieniem. Spośród 7 badań z randomizacją, które odnaleźliśmy, jedynie 2 badania, obejmujące łącznie 186 uczestników, dostarczyły użytecznych danych. Analiza tych 2 małych badań wykazała sprzeczne wyniki dotyczące skuteczności aromaterapii pod względem wpływu na pobudzenie, objawy behawioralne i jakość życia. Potrzebne jest przeprowadzenie dużych badań z randomizacją, aby móc sformułować jednoznaczne wnioski dotyczące skuteczności stosowania aromaterapii u osób z otępieniem.

Uwagi do tłumaczenia

Tłumaczenie Magdalena Koperny Redakcja Karolina Moćko

Summary of findings(Explanation)

Summary of findings for the main comparison. Aromatherapy versus placebo for dementia
  1. 1 All studies had an unclear risk of bias for allocation concealment, Burns 2011 also had an unclear risk of bias for incomplete outcome data and Lin 2007 was also unclear for risk of bias for sequence generation and blinding. Data could not be pooled for this outcome - see footnote 4.
    2 There were relatively few included patients and few events.
    3 Only four studies reported data for this outcome.
    4 Data could not be pooled as Lin 2007 was a cross-over trial that did not report the results of the first phase, and the data for Ballard 2002 and Burns 2011 was highly heterogeneous. Ballard 2002 found significant differences in agitation in favour of aromatherapy on the CMAI and NPI subscales agitation or aggression and aberrant motor behaviour. Burns 2011 found no difference in agitation on PAS. Lin 2007 reports that lavender resulted in a significant improvement in agitation of dementias. Cameron 2011 and Fu 2013 did not report any actual data but both found no significant difference in agitation.
    5 Both studies had an unclear risk of bias for allocation concealment, Burns 2011 also had an unclear risk of bias for incomplete outcome data and Ballard 2002 for other biases.
    6 The data could not be pooled for this outcome as it was highly heterogeneous.
    7 Only 2 studies reported data for this outcome.
    8 Ballard 2002 showed a statistically significant treatment effect in favour of the aromatherapy, Burns 2011, however, found no significant difference in behavioural symptoms.
    9 Burns 2011 had an unclear risk of bias for allocation concealment and incomplete outcome data.
    10 Only one study reported data for this outcome.
    11 Fu 2013 had an unclear risk of bias for blinding of participants and personnel.

Aromatherapy versus placebo for dementia
Patient or population: patients with dementia
Settings: specialist care homes and hospital wards
Intervention: aromatherapy versus placebo
OutcomesIllustrative comparative risks* (95% CI)Relative effect
(95% CI)
No of Participants
(studies)
Quality of the evidence
(GRADE)
Comments
Assumed riskCorresponding risk
Control Aromatherapy versus placebo
Agitation
CMAI, PAS and NPI subscales
Follow-up: 4 to 12 weeks
See commentSee commentNot estimable218
(5 studies)
⊕⊝⊝⊝
very low 1,2,3
Agitation was measured by 5 trials on 3 scales, results were equivocal. Data could not be pooled for this outcome - see footnote.4
Behavioural symptoms
NPI
Follow-up: 4 to 12 weeks
See commentSee commentNot estimable63
(2 studies)
⊕⊝⊝⊝
very low 2,5,6,7
Data could not be pooled for this outcome as it was highly heterogeneous - see footnote.8
Adverse effects
Follow-up: 6 to 12 weeks
39 per 1000 38 per 1000
(6 to 253)
RR 0.97
(0.15 to 6.46)
124
(2 studies)
⊕⊝⊝⊝
very low 2,7,9,11
 
Quality of life
Blau QOL Scale
Follow-up: 12 weeks
 The mean quality of life in the intervention groups was
19 higher
(23.12 lower to 61.12 higher)
 63
(1 study)
⊕⊝⊝⊝
very low 2,9,10
 
Activities of daily living
Barthel Scale of Activities of Daily Living
Follow-up: 12 weeks
 The mean activities of daily living in the intervention groups was
0.5 lower
(1.79 lower to 0.79 higher)
 63
(1 study)
⊕⊝⊝⊝
very low 2,9,10
 
Mood - not reportedSee commentSee commentNot estimable-See commentNo studies reported data for this outcome
*The basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI).
CI: Confidence interval; RR: Risk ratio
GRADE Working Group grades of evidence
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.

Background

Description of the condition

Dementia presents as a major healthcare challenge with over 24 million people suffering from the condition and with a projected estimate of the numbers to double every 20 years (Qui 2007). The pathogenesis of dementia remains unclear despite the growing evidence base for attributing factors and their role in the characteristic neurodegeneration that occurs in this condition (for example Iadecola 2010). Dementia is a disabling human affliction with devastating consequences to the person and those known to them, creating inherent challenges for the personal and professional systems that are in place to provide support and best meet their needs (Nolan 2007). With limited capacity to delay the decline of cognitive function in patients with dementia, the field of aromatherapy attempts to alleviate the distress that manifests through challenging and complex behavioural and psychological expressions of confusion (Nguyen 2008; Walker 2000). Although deterioration of explicit memory is a defining characteristic of dementia there is evidence to suggest that implicit memory can remain intact in patients with the disease (Fleischman 2005). The suggestion has been made that the olfactory sense may link in with an implicit odour memory (Degel 2001). It is reported that people with dementia have, as a population, a greater prevalence of degrees of anosmia (the inability to perceive odours) and that differing forms of dementia may be associated with slightly different aspects of anosmia (Luzzi 2007), although people with Alzheimer's disease are not significantly more likely to be anosmic than controls (McShane 2001).

Description of the intervention

Complementary (or alternative) therapies have become more commonly used over the last decade and have been applied to a wide range of health problems, including in care for people with dementia. Therapies have included massage (for example Suzuki 2010), aromatherapy (for example Nguyen 2008), acupuncture (for example Chen 2004), and herbal medicine (for example Perry 2011). Evidence exists that complementary medicine use is a substantial and growing part of healthcare behaviour in Europe, Australia and North America (Harris 2000), and aromatherapy is one of the main complementary therapies to be practised by nurses and other healthcare professionals in hospital, hospice, and community settings (Buckle 2003). It tends to be seen as a relatively non-invasive procedure and is probably the complementary therapy most familiar to consumers.

Aromatherapy is a part of the discipline of phytotherapy (the use of whole plants or parts of plants for medicinal purposes) and uses pure essential oils from fragrant plants (such as peppermint, sweet marjoram, and rose) to help relieve health problems and improve quality of life in general (OnHealth 2000). Essential oils have been defined as "highly fragrant essences extracted from plants by distillation, which evaporate readily" (Tisserand 1988) and have been used by doctors in France for their antibiotic and antiviral properties for many years (Tisserand 1988).

Essential oils are many and varied, with presumed different potential effects. These are claimed to include promotion of relaxation and sleep, relief of pain, and reduction of depressive symptoms (for example Halycon 2000), the rationale being that the essential oils have a calming and de-stressing effect. As such, aromatherapy might be of use as an intervention for people who have little or no preserved language function, are confused, or for whom verbal interaction is difficult and current conventional medicine is seen as of only marginal benefit. Aromatherapy has, therefore, been used to address behavioural and psychological symptoms in dementia such as to reduce disturbed behaviour (Brooker 1997; Lin 2007; Nguyen 2008), promote sleep (for example Wolfe 1996), and stimulate motivational behaviour (for example MacMahon 1998).

Essential oils selected for aromatherapy have very low toxicity profiles and, if administered by qualified practitioners, present as a safer option than conventional pharmacological medications (Perry 2006). Whilst there is little doubt that properly administered aromatherapy is free of any of the side effects that can be associated with pharmacological drugs, the properties of essential oils are unlike the precisely formulated pharmacological medications as standardisation of extraction techniques for complimentary therapies are highly variable across manufacturers (Barnes 2003). However, there are well established systems of quality control (Shinde 2009; Turek 2013) and some manufacturers produce standardised extracts to achieve a within manufacturer consistency, similar to pharmaceutical quality (Barnes 2003).

How the intervention might work

The essential oils used in aromatherapy are most commonly delivered through electric diffusers and vaporizers or massaged into the skin, thus the aroma of the essential oil evaporates and stimulates the olfactory sense (Kong 2009). This is often then linked with a psychological response as past experience may affect the person's response in accordance with connotations of the aroma (Holmes 2004). The emotional significance of an odour is provided by the role of the amygdala in the cerebral analysis of this (Zald 1997). Thus there is increasing interest in any pharmacological action of aroma therapeutics and the terpenes found in aromatherapy essential oils, for example there have been results relating to the ability of essential oils to improve neurotransmission by inhibiting acetylcholinesterase and increasing acetylcholine in cholinergic neurons to delay the neurological degeneration and cognitive decline that is characteristic in dementia (Arruda 2012). In addition, the use of complementary therapy as a co-adjuvant to pharmacological medicines would potentially be well received as the elderly population are frequent users of complementary and alternative therapies to compensate for aspects they perceive to be absent in conventional medicine (Moses 2005).

The modes of delivery of essential oils are varied and the quantity delivered to each person through means such as vaporising or skin massage is dependent upon the volume of oil, temperature, room size and air flow, and the quality is dependent upon factors that can influence the content and concentration of constituents, such as agriculture, storage and processing factors (Barnes 2003). Evidence suggests that isolating and investigating in vivo qualities of oils is required to understand the oil's pharmacokinetic properties (Tariku 2010) and further investigation to identify the bioactivities of oils is becoming increasingly important and a growing area of research (Shaaban 2010).

Why it is important to do this review

Despite an increase in popularity and regular use, the rationale for aromatherapy is based on limited scientific research, with the majority of evidence from case studies as opposed to controlled clinical trials. Additionally, despite the implementation of regulatory processes such as the European (EU) Traditional Herbal Medicinal Products Directive, the absence of a regulatory body to approve the manufacturing practice of unlicensed products makes it impossible to identify those that reach acceptable standards, and the safety around their use remains unclear. As such, the need remains for the effects of aromatherapy to be adequately documented.

Objectives

The aim of this review is to assess the efficacy of aromatherapy for people with dementia.

Methods

Criteria for considering studies for this review

Types of studies

We considered all relevant randomised controlled trials (RCTs). Owing to the nature of aromatherapy, double-blinding may not be possible when combined with informed consent. A minimum length of trial and requirements for a follow-up were not inclusion criteria.

Types of participants

Participants in the included studies were to have a diagnosis of dementia of any type and severity, based on diagnostic criteria such as the International Classification of Diseases-10 (ICD-10) (WHO 1993) and Diagnostic and Statistical Manual of Mental Disorders fourth Edition (DSM-IV) (APA 1994), or well validated assessment scales for cognitive function, such as the Mini-Mental State Examination (MMSE) (Folstein 1975) and the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) (Rosen 1994).

Types of interventions

We considered trials using fragrance from plants in an intervention defined as aromatherapy for people with dementia. We considered all doses, frequencies, and fragrances.

The comparator group was placebo aromatherapy.

Types of outcome measures

Primary outcomes
  1. Agitation

  2. Behavioural symptoms

  3. Adverse effects

Secondary outcomes
  1. Quality of life

  2. Mood

  3. Sleep

  4. Cognition

  5. Activities of daily living

  6. Caregiver burden or distress, or both

Summary of findings table

We used the GRADE approach to interpret findings (Schünemann 2008) and used the GRADE profiler to import data from Review Manager (RevMan) to create 'Summary of findings' tables. These tables provide outcome-specific information concerning the overall quality of evidence from each included study in the comparison, the magnitude of effect of the intervention examined, and the sum of available data on all outcomes that we rated as important to patient care. We selected the following outcomes for inclusion in the summary of findings tables.

  1. Agitation.

  2. Behavioural symptoms.

  3. Adverse effects.

  4. Quality of life.

  5. Activities of daily living.

  6. Mood.

Search methods for identification of studies

Electronic searches

ALOIS (www.medicine.ox.ac.uk/alois), the Cochrane Dementia and Cognitive Improvement Group Specialized Register, was searched on 26 November 2012 and 20 January 2014. The search terms used were: aromatherapy, lemon, lavender, rose, aroma, alternative therapies, complementary therapies, essential oils.

ALOIS is maintained by the Trials Search Co-ordinator of the Cochrane Dementia and Cognitive Improvement Group and contains studies in the areas of dementia prevention, dementia treatment, and cognitive enhancement in healthy individuals. The studies are identified from:  

  1. monthly searches of a number of major healthcare databases: MEDLINE, EMBASE, CINAHL, PsycINFO, and LILACS;

  2. monthly searches of a number of trial registers: International Standard Randomised Controlled Trial Number (ISRCTN); UMIN (Japan's Trial Register); the World Health Organization (WHO) portal (which covers ClinicalTrials.gov; ISRCTN; the Chinese Clinical Trials Register; the German Clinical Trials Register; the Iranian Registry of Clinical Trials; and the Netherlands National Trials Register; plus others);

  3. quarterly search of the Central Register of Controlled Trials (CENTRAL) in The Cochrane Library;

  4. six-monthly searches of a number of grey literature sources: ISI Web of Knowledge Conference Proceedings; Index to Theses; Australasian Digital Theses.

To view a list of all sources searched for ALOIS see About ALOIS on the ALOIS website.

Details of the search strategies used for the retrieval of reports of trials from the healthcare databases, CENTRAL and conference proceedings can be viewed in the ‘methods used in reviews’ section within the editorial information about the Dementia and Cognitive Improvement Group.

Additional searches were performed in many of the sources listed above to cover the timeframe from the last searches performed for ALOIS to ensure that the search for the review was as up-to-date and as comprehensive as possible. The search strategies used can be seen Appendix 1.

Electronic searches carried out in the previous versions of the review can be viewed in Appendix 2 and Appendix 3.

Searching other resources

For the previous version of this review, experts in the field of complementary therapies were contacted to identify ongoing and unpublished research, as well as the Aromatherapy Organisations Council.

Data collection and analysis

Selection of studies

For the original review, LTF and AS independently screened the titles and abstracts extracted by the searches for their eligibility for potential inclusion in the review based on the above criteria, which were discussed with MO.

For the September 2008 update, FEH and TPHB assessed the new study found by the March 2008 search using the same criteria as previously used.

For the current 2014 update, NM and KSW independently screened 28 studies, again using the same criteria as previously used.

Data extraction and management

We extracted the data from the published reports and unpublished company reports.

Assessment of risk of bias in included studies

NM undertook assessment of the risk of bias of all the included trials according to the methods in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011) and KSW checked these.

The risk of bias tool examines five key domains for bias: selection bias, performance bias, attrition bias, detection bias, and reporting bias. Each domain was assessed and classified as either a low or a high risk of bias, and where insufficient detail was reported in a study to assess the risk this was reported as 'unclear'. In addition, we reported any other form of bias noted in the study.

We used the Cochrane 'Risk of bias' tool in RevMan 5.1 (RevMan 2011).

Measures of treatment effect

For binary outcomes we calculated a standard estimation of the risk ratio (RR) and its 95% confidence interval (CI). For continuous outcomes we estimated the mean difference (MD) between groups and its 95% confidence interval (CI).

Unit of analysis issues

Where studies used a cross-over method, we used only data from the first phase of the trial. If they did not report the results separately for each phase we did not add the data to the meta-analysis.

There was one included cluster-RCT (Ballard 2002) where eight homes were matched in pairs and within each pair the homes were randomised to treatment or control. Thus, the unit of randomisation was the home. Since the residents within homes were not the units of randomisation, the mean assessments of all residents within a home were the outcomes values for each home. Analysis of co-variance was used for all outcomes, with the home being treated as a random effect. The change from baseline was analysed for all outcomes. The treatment effect for an outcome was the difference between the overall means of the four homes on treatment and the four homes on placebo. The contribution from each home was weighted and this weight depended on the precision of the mean value for each home. The PROC MIXED procedure in SAS® was used for all analyses.

Dealing with missing data

For any particular outcome where more than 50% of data were unaccounted for, we did not reproduce these data or use them within analyses. We extracted data to allow an intention-to-treat analysis in which all randomised participants were analysed in the groups to which they were originally assigned. For continuous outcomes, we calculated missing standard deviations from other available data such as CIs, standard errors, P, T or F values as detailed in Deeks 2009.

Assessment of heterogeneity

We explored heterogeneity by examining factors that may be influential, such as the care setting and duration of follow-up. In the absence of clinical heterogeneity we assessed heterogeneity using the I2 statistic and Chi2 test.

Assessment of reporting biases

Had there been more than 10 included studies, we would have assessed reporting bias by constructing a funnel plot.

Data synthesis

We used a fixed-effect model unless there was heterogeneity (see Assessment of heterogeneity). If the I2 statistic indicated substantial heterogeneity (values of 50% or greater), we presented the results using a random-effects model meta-analysis.

Subgroup analysis and investigation of heterogeneity

We did not plan to undertake any subgroup analyses.

Sensitivity analysis

There were not sufficient studies reporting data for each outcome to allow a meaningful sensitivity analysis to be carried out.

Results

Description of studies

See Characteristics of included studies and Characteristics of excluded studies for details of the studies considered for this review.

Results of the search

The search identified 1437 records, after duplicates were removed 1068 records remained. After title and abstract screening, 39 full-texts were examined 31 of which were excluded (see Characteristics of excluded studies), one was ongoing (see Characteristics of ongoing studies), and seven were included in the review (see Characteristics of included studies). The process of the screening is summarised in Figure 1.

Figure 1.

Study flow diagram.

Included studies

We included seven studies in this review (Ballard 2002; Burns 2011; Cameron 2011; Fu 2013; Lin 2007; O'Connor 2013; Smallwood 2001) with 428 participants.

1. Study design

All trials were RCTs, six randomised individuals and Ballard 2002 was a cluster-RCT with the nursing home as the unit of randomisation. Cameron 2011, Lin 2007, and O'Connor 2013 used a cross-over design.

2. Duration

Trial durations ranged from three weeks to 12 weeks. The cross-over trial of O'Connor 2013 had two treatment phases of one week each, with a four-day washout period. The two other cross-over trials both had two treatment phases of three-weeks duration. Cameron 2011 had a washout period of one week between treatment phases and Lin 2007 had a two-week washout period. Cameron 2011 also repeated the trial after one year using the same participants.

3. Setting

Lin 2007 was conducted in Hong Kong, China; Fu 2013 and O'Connor 2013 were both based in Australia; and the remaining four studies were based in the UK. Ballard 2002 and Burns 2011 included residents in specialist nursing homes, Fu 2013 included participants from long term care facilities, Lin 2007 was conducted in a 'care and attention home', O'Connor 2013 recruited participants from eight specialist psychogeriatric nursing homes and three private nursing homes, Smallwood 2001 included inpatients in a district general hospital ward, and Cameron 2011 included inpatients but did not report the setting.

4. Participants

Ballard 2002 included 72 people with severe dementia, diagnosed with the Clinical Dementia Rating scale (Hughes 1982), and clinically significant agitation. Burns 2011 included 114 participants with a National Institute of Neurological and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) diagnosis of probable or possible Alzheimer’s disease and agitation. In Cameron 2011 the 18 participants had moderate to severe dementia and 'behavioural and psychological symptoms in dementia' (BPSD); they did not report the diagnostic criteria. Fu 2013 included 67 participants with cognitive functional impairment indicative of a dementia condition and features of Alzheimer’s disease according to the American Psychiatric Association DSM-IV-TR, with a documented history of agitation or aggression. In Lin 2007, the participants were 70 Chinese older persons with dementia (diagnosed according to the DSM-IV) and with clinically significant agitation (Chinese CMAI). The causes of dementia were reported as Alzheimer's disease, vascular and other unstated dementias, but diagnostic criteria were not given. O'Connor 2013 included 66 participants with at least mild dementia on the Clinical Dementia Rating scale and physically agitated behaviour not due primarily to pain, physical illness, depression, or psychosis. The sample used in Smallwood 2001 consisted of 21 patients with a prior diagnosis of dementia.

The mean age of participants ranged from 66.8 years (Smallwood 2001) to 85 years (Burns 2011) and the percentage of female participants was approximately 60%, although Cameron 2011 did not report the mean age or sex of participants.

5. Interventions

Ballard 2002 used 10% melissa and base lotion applied topically to the arms and face twice daily for one to two minutes for four weeks as their intervention. The control condition was sunflower oil applied in the same way.

Burns 2011 compared the effects of melissa oil aromatherapy with two control groups: active medication (donepezil) and placebo aromatherapy (sunflower oil); and placebo medication and placebo aromatherapy. The oil was administered twice a day by gentle massage of the hands and upper arms for one to two minutes.

Cameron 2011 used < 2% lemon balm oil aromatherapy as their intervention and the placebo treatment was 1% geranium and 0.5% lemon oil. There were two treatment phases of three weeks and a one-week washout period between phases, and the trial was repeated after one year with the same participants. The oils were applied by "gentle rubbing" for one minute to the patient's forearm twice a day.

Fu 2013 had two aromatherapy intervention groups, both used 3% lavender mist aromatherapy, one group with and another without hand massage. The control group received water mist. Three sprays of mist were applied twice daily to the participants’ upper chest within a 30 cm distance.

In Lin 2007, for the first three-week period one group received the active treatment, lavender oil, and the other received control placebo treatment, odourless sunflower oil. A two-week washout followed before the next three-week period in which the groups’ treatments were swapped. The active treatment involved unblinded carers placing two drops of oil onto each of two pieces of cosmetic cotton and placing one into each aroma diffuser either side of the participant’s pillow for at least an hour during sleep.

O'Connor 2013 used 30% lavender (Lavandula angustifolia) in jojoba oil as the aromatherapy intervention and jojoba oil as the placebo. The oils were massaged into both forearms for one minute each, 1 ml per arm giving a total of 2 ml per session.

Smallwood 2001 used two aromatherapy groups: lavender applied topically through massage and lavender in a diffuser accompanied by conversation. The control condition was massage only.

6. Outcomes
Outcome scales

i) Cohen-Mansfield Agitation Inventory (CMAI) (Cohen-Mansfield 1989): in Ballard 2002; Cameron 2011; O'Connor 2013; Fu 2013, which used the short version; and Lin 2007, which used the Chinese version of this scale.
This is a seven-point rating scale that assesses the frequency of agitated behaviour. A higher score indicates more agitation.

ii) Pittsburgh Agitation Scale (PAS) (Rosen 1994): in Burns 2011 and Cameron 2011.
This scale measures agitation using four behaviour groups of aberrant vocalisation, motor agitation, aggressiveness, and resisting care. A higher score indicates more agitation.

iii) Neuropsychiatric Inventory (NPI) (Cummings 1994): in Ballard 2002; Burns 2011; Cameron 2011; and Lin 2007, using the Chinese version of this scale.
This scale assesses either 10 or 12 behavioural disturbances common in dementia: delusions, hallucinations, dysphoria, anxiety, agitation or aggression, euphoria, disinhibition, irritability or lability, apathy, and aberrant motor activity. A higher score indicates greater severity of these behaviours.

iv) Blau Quality of Life (Blau 1977) - in Burns 2011.
This scale measures subjective quality of life in a mental health setting using 10 items. A higher score indicates better quality of life.

v) Barthel scale of Activities of Daily Living (Mahoney 1965): in Ballard 2002 and Burns 2011.
This scale measures performance in activities of daily living. A higher score indicates better functioning.

Other outcomes

Compliance was assessed by a tablet count and the weighing of aromatherapy bottles in Burns 2011. O'Connor 2013 measured agitation by recording whether the behaviour was absent or present over three 30-minute observation periods. Smallwood 2001 used video records to assess behaviour at baseline and immediately after treatment.

7. Additional data obtained from study authors

Professor Ballard allowed us access to the individual patient data from his cluster-randomised study (Ballard 2002), and we were able to perform analyses additional to those that had been published. Analysis of co-variance was used for all outcomes, with the home being treated as a random effect. The PROC MIXED procedure in SAS® was used for all analyses. There were several participant level covariates that could be included in the model, such as age, sex, baseline outcomes, and those describing the medication being taken (Table 1). When tested in the model for each outcome the only medication variable that had a significant effect was whether the patient was taking atypical neuroleptics. Sex and the baseline value of the outcome measure also had significant effects. Therefore, the estimate of the treatment effect was adjusted for sex, baseline measure of the outcome, and use of atypical neuroleptic medication.

Table 1. Baseline characteristics for each group (Ballard 2002)
  1. CMAITOT - Cohen Mansfield Agitation Inventory Total score
    NPITOT - Neuropsychiatric Inventory Total score

VARIABLECONTROLTREATMENT
Age79.7 (8.5)77.2 (7.6)
CMAITOT60.6 (16.6)68.3 (15.0)
NPITOT34.9 (15.0)37.6 (17.6)
Number taking atypical neuroleptic medication12/3616/36
Number taking benzodiazepine19/3616/36
Number taking antidepressant medication7/3619/36
Number taking neuroleptic medication18/3623/36
Number taking other psychotropic medication12/3614/36
Number taking any psychotropic medication33/3633/36
Number taking cognitive enhancer0/361/36

Excluded studies

Thirty-one studies were excluded: two were systematic reviews and one was a literature review; two studies were in vitro studies and one was an animal study; thirteen were not randomised; seven studies did not have aromatherapy as the intervention; and in three studies the participants did not have dementia. Snow 2004 was a very small study (n = 7) that attempted a cross-over design of three treatments but the treatment was not blinded, there was no randomisation, and the order was the same for all people. Mitchell 1993 did not include enough details about how the study was conducted to be included.

Ongoing studies

There was one ongoing study (Myers 2005). There were no data available on this completed trial despite repeated efforts to contact the study author. See Ongoing studies for further details.

Risk of bias in included studies

See also Characteristics of included studies, Figure 2, and Figure 3.

Figure 2.

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

Figure 3.

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

Allocation

Five studies were rated low risk of bias for sequence generation and two studies were rated as unclear. The risk of bias for allocation concealment was low in one trial and unclear in all remaining trials.

Blinding

Three trials had a low risk of bias for blinding of participants and personnel and five were low risk for blinding of outcome assessors. The remaining risks of bias for blinding were unclear.

Incomplete outcome data

Four studies were rated as low risk of bias for incomplete data and the risk of bias was unclear in the other three trials.

Selective reporting

Five studies had a high risk of bias for selective reporting as no useable data were reported (Cameron 2011; Fu 2013; Lin 2007; O'Connor 2013; Smallwood 2001), the other two studies had a low risk of bias.

Other potential sources of bias

Cameron 2011 was rated as high risk of bias for other sources of bias as they ran the trial twice, a year apart, using the same participants. In Ballard 2002 the risk of bias was unclear as the published data were not adjusted for clustering, but we were able to analyse the individual patient data provided by the authors. The other five trials had no additional biases.

Effects of interventions

See: Summary of findings for the main comparison Aromatherapy versus placebo for dementia

It was not possible to use the results from Cameron 2011, Fu 2013, O'Connor 2013, Smallwood 2001, and Lin 2007 in the meta-analyses, see 'Narrative results' below. The only studies that were included in the analysis were Ballard 2002 and Burns 2011, although Fu 2013 provided data for adverse effects.

Aromatherapy versus placebo

Primary outcomes
1. Agitation

Ballard 2002 and Burns 2011 measured total agitation scores on two different scales. It would have been possible to calculate the standardised mean difference, however the results were highly heterogeneous (I2 = 83%), so we chose not to pool the data and instead present them here separately.

1.1 Cohen Mansfield Agitation Inventory (CMAI)

Ballard 2002, Cameron 2011, and Lin 2007 measured agitation on this scale, but analysis was only possible for Ballard 2002 (see 'Narrative results' below).

The additional analysis conducted on the data obtained from Ballard 2002 revealed a statistically significant treatment effect in favour of the aromatherapy after 4 weeks of treatment (n = 71, MD -11.1, 95% CI -19.9 to -2.2; Analysis 1.1; see Table 2 for results on subscales).

Table 2. Effect of aromatherapy compared with placebo (Ballard 2002)
  1. CMAI - Cohen Mansfield Agitation Inventory
    NPI - Neuropsychiatric Inventory

OUTCOMEEFFECT (S.E.)T VALUEP VALUE95% CONFIDENCE LIMITFAVOURS
CMAI total (change from baseline at 4 weeks)-11.08 (3.62)-3.060.022-19.95 TO -2.21Aromatherapy
CMAI physical aggression (change from baseline at 4 weeks)-3.27 (1.78)-1.840.115-7.62 TO 1.80-
CMAI physical non-aggressive (change from baseline at 4 weeks)-5.36 (1.42)-3.770.009-8.84 TO -1.88Aromatherapy
CMAI verbal aggression (change from baseline at 4 weeks)-0.39 (0.49)-0.800.456-1.58 TO 0.81-
CMAI verbal non-aggressive (change from baseline at 4 weeks)-2.92 (0.91)-3.220.018-5.14 TO -0.70Aromatherapy
NPI total (change from baseline at 4 weeks)-15.80 (3.50)-4.510.004-24.37 TO -7.22Aromatherapy
NPI agitation (change from baseline at 4 weeks)-2.31 (0.89)-2.590.041-4.50 TO -0.12Aromatherapy
NPI aberrant motor behaviour (change from baseline at 4 weeks)-3.01 (1.23)-2.450.050-6.02 TO 0.00Aromatherapy
1.2 Pittsburgh Agitation Scale (PAS)

Burns 2011 measured agitation on the PAS and found no significant difference in treatment effect between groups after 12 weeks (n = 63, MD 0.00, 95% CI -1.36 to 1.36; Analysis 1.2). Cameron 2011 also used this scale but did not report any data.

1.3 Neuropsychiatric Inventory (NPI) - agitation or aggression

Ballard 2002 found a significant improvement in agitation in favour of aromatherapy after 4 weeks when this outcome was measured on the agitation or aggression subscale of the NPI (n = 71, MD -2.31, 95% CI -4.05 to -0.57; Analysis 1.3; see also Table 2).

1.4 Neuropsychiatric Inventory (NPI) - aberrant motor behaviour

When agitation was measured on the aberrant motor behaviour subscale of the NPI after 4 weeks, Ballard 2002 again found results favouring aromatherapy (n = 71, MD -3.01, 95% CI -5.42 to -0.60; Analysis 1.4; see also Table 2).

2. Behavioural symptoms
2.1 Neuropsychiatric Inventory (NPI)

Ballard 2002 and Burns 2011 both measured total scores on the NPI. When the data were pooled the results were highly heterogeneous (I2 = 89%) so we chose not to pool the data. Again, the additional analysis of Ballard 2002 showed a statistically significant treatment effect in favour of the aromatherapy after 4-weeks treatment (n = 71, MD -15.8, 95% CI -24.4 to -7.2; Analysis 1.5; see Table 2). Burns 2011, however, found no significant difference in behavioural symptoms between those treated with aromatherapy and those treated with placebo after 12 weeks (n = 63, MD 2.80, 95% CI -5.84 to 11.44; Analysis 1.6). Cameron 2011 and Lin 2007 also used this scale but analysis was not possible (see 'Narrative results').

3. Adverse effects

Burns 2011 and Fu 2013 found no difference in adverse events between aromatherapy and placebo (n = 124, RR 0.97, 95% CI 0.15 to 6.46; Analysis 1.7).

Secondary outcomes
1. Quality of life

Quality of life was measured after 12 weeks using the Blau QOL Scale in Burns 2011. There was no statistically significant difference in quality of life between the participants receiving aromatherapy and those receiving placebo (n = 63, MD 19.00, 95% CI -23.12 to 61.12; Analysis 1.8).

2. Activities of daily living

Burns 2011 found no significant difference after 12 weeks of treatment in functional performance measured using the Barthel scale of Activities of Daily Living (n = 63, MD -0.50, 95% CI -1.79 to 0.79; Analysis 1.9).

Narrative results

Cameron 2011 was a cross-over RCT comparing lemon balm oil aromatherapy with placebo treatment for reducing aggression and agitation. The trial was repeated after one year with the same participants. The researchers measured outcomes on the CMAI, PAS and NPI, but did not report any data. They reported a gradual, but not statistically significant, reduction in scores in all outcome measures for both treatment groups. They also reported that there was a temporary rise in the combined scores for both groups in all outcome measures (except an NPI subscale) during the washout week, but these were only statistically significant (P < 0.05) in the CMAl total and CMAI physical non-aggression subscales.

Fu 2013 was a parallel group randomised trial that compared the effects of lavender oil aromatherapy spray with aromatherapy spray plus hand massage and placebo water spray over six weeks. Cogntition was measured using the MMSE at baseline and at the end of the trial, however only baseline data were reported. Agitation was measured using the CMAI-Short Form (CMAI-SF) at baseline; weeks two, four, and six; and six weeks after the intervention. The trial reports that participants in both aromatherapy groups and the placebo treatment group showed less aggressive behaviours at six weeks (P < 0.05) and that there were no significant differences in participants' mean scores for the CMAI across all periods (P < 0.05).

Lin 2007 was a randomised cross-over trial to investigate the effects of lavender oil on clinically significant agitated behaviours. The effect of treatment was evaluated using the Chinese CMAI and the Chinese NPI at weeks 0, 3, 5, and 8 of the trial. There were no dropouts or adverse effects reported. Although concurrent psychotropic medication was permitted, there were no changes in dosage, number and type of psychotropic medication during the study. The trial reported that lavender resulted in a significant improvement in agitation of dementias. However, the data for each phase of the trial were not presented separately.

O'Connor 2013 was a cross-over RCT that compared the effects of lavender oil aromatherapy with jojoba oil placebo aromatherapy. Behaviour was observed by a research assistant who recorded whether agitated behaviour was present or absent each minute of a 30-minute period, with three observation periods. They found that agitated behaviour counts were lower in the aromatherapy treatment group than the placebo group, but baseline counts were also lower. Behaviour counts reduced statistically significantly in both groups. However, the data for each phase of the trial were not presented separately.

Smallwood 2001 reported an RCT of the effects of lavender applied topically through massage and lavender in a diffuser accompanied by conversation, and the control condition was massage only. Assessments consisted of using a video camera to record behaviour for 15-minute periods over a day in a specified sequence and frequency. The video records were sampled and coded into six behaviour categories developed by two blinded raters. Inter-rater reliability was found to be 86% for a randomly chosen sample consisting of 20% of ratings. The outcome used was the mean of several measurements of the frequency of these defined behaviours, and analyses were conducted on the changes from baseline. Smallwood 2001 found no statistically significant difference between groups. The investigators found a significant interaction of treatment with time of day in the massage with aromatherapy condition (P < 0.01), with the greatest improvement relative to the other conditions at between 15.00 and 16.00 hours (P < 0.05).

Missing outcomes

No data were found for mood, sleep, and caregiver burden or distress.

Discussion

Summary of main results

See Summary of findings for the main comparison.

Five trials measured agitation on three scales. Participants were less agitated in the aromatherapy group in two studies, Ballard 2002 and Lin 2007; the latter was a cross-over study only reporting overall data. Three other studies (Burns 2011; Cameron 2011; Fu 2013) found no difference in participants' levels of agitation, although Cameron 2011 did not report any actual data and Fu 2013 did not report data separately for each treatment group. The results from two studies that measured behavioural symptoms were highly heterogeneous, with Ballard 2002 showing an effect in favour of aromatherapy and Burns 2011 finding no treatment effect. O'Connor 2013 also found no difference in observed behaviour between aromatherapy and placebo. Two studies (Burns 2011; Fu 2013) showed no difference in adverse effects, and a single study (Burns 2011) showed no difference in quality of life and activities of daily living of participants treated with aromatherapy compared to those treated with placebo.

Overall completeness and applicability of evidence

Although seven studies are included in this review, we were very limited in the data we could use in analyses. Only two studies (Ballard 2002; Burns 2011) reported data on agitation and behaviour that could be used. Furthermore, in Ballard 2002 the participants that were included were taking a range of medication, including antipsychotics and neuroleptics; any of these could have been altered during the trial, which may have had a confounding effect on the results. In Burns 2011 participants were free of psychotropic medication (antipsychotics or cholinesterase inhibitors, or both) for at least two weeks before the study began, so any confounding effects of medication were less likely.

The length of follow-up was short in these two studies, only four to 12 weeks, and both were conducted in nursing homes in the UK, limiting the applicability of the results to other countries and settings.

It is unfortunate that we were unable to include data from the other five trials in the analysis. Cameron 2011 and Smallwood 2001 did not report any useable data, Fu 2013 only reported useable data for adverse events, and Lin 2007 and O'Connor 2013 were cross-over trials that only reported results from the two phases of the trial combined. The results of a cross-over trial are not usually considered suitable when studying an intervention for a progressive disease. Treatment effect is estimated from the within patient changes for the two periods and assumes that the patient's baseline assessment is the same at the start of each of the two phases. This assumption is difficult to justify for a progressive disease. Although Lin 2007 states there was no deterioration between the two phases, the data for each group are not presented separately. We would prefer to rely on the data from the first phase only, but these were not reported and have not been forthcoming from the author. Therefore this study did not contribute to the meta-analyses.

There are several essential oils currently being used that may not be comparable. Furthermore, the mode of administration differed between trials, although the two trials that had useable data both applied melissa oil topically. There is also great variation in assessment procedures and outcomes reported, and some have not controlled for other variables such as medication use. There is also the possibility that, as with antidementia drugs, aromatherapy might have different effects on people with different types or severity of dementia.

Quality of the evidence

The overall quality of the evidence, based on GRADE, is very low. Four out of the seven studies did not report any data that we could use in the analysis, and the three studies that did report data were small with short follow-ups. Ballard 2002 was a cluster-randomised trial and there might have been variation between the eight nursing homes included in the study that was not accounted for in the adjusted analysis, which could have confounded the results from this trial.

Potential biases in the review process

We tried to identify all relevant trials through our search, however it is possible that we may have failed to identify some studies.

Agreements and disagreements with other studies or reviews

Fung 2012 is a systematic review on the use of aromatherapy in treating behavioural problems in dementia. Fung 2012 reports that there is some evidence that aromatherapy has a positive effect on cognitive functioning and reducing BPSDs. However, although the review stated that they included only RCTs, six of the 11 included studies were not randomised and one was not testing aromatherapy, and so we have not included these studies in our review; accounting for the differences in our results.

The great majority of reported research on aromatherapy for people with dementia is of scientifically inadequate quality. In view of the possibility of a host of biases, no conclusions can be drawn from these studies. The reports can, however, give indications to inform researchers in the design of studies investigating aromatherapy. It is beyond the scope of this systematic review to give an account of all these studies, however, a representative selection that includes different study methodologies follows below.

Burleigh 1997 used an ABAB design to assess the effects of lavender, Roman chamomile, rosemary, and marjoram on the Behaviour Assessment Scale of Later Life (Brooker 1993) of seven participants with dementia. They found a significant reduction of challenging behaviour for four of the five female participants, but an increase of challenging behaviour for the two male participants. Six of the participants additionally showed a decreased need for assistance with activities of daily living. Curiously this is one of very few trials that adhere to one of the main principles of aromatherapy, the selection of oils based upon characteristics of each patient. Via this process different oils are often given for the same problems in different patients. West 1994 reported a single-case study of the effects of 'aromatic oils' on the sleeping pattern of a person with dementia. Their results showed an improvement of sleep patterns and a decrease of agitation. Wolfe 1996 assessed the effects of lavender and Roman chamomile on sleep patterns in two people with severe dementia who acted as their own controls. There was a mean increase of peaceful sleep for one participant, but a mean decrease of peaceful sleep for the other participant.

Kilstoff 1998 used the action research method, which is a qualitative method encouraging participants to design, implement, and evaluate an intervention, to assess the effects of lavender, mandarin, and geranium with hand massage on 16 recipients of day-care who had dementia. The findings indicated a perceived strengthening of the relationship between the people with dementia and their carers, and an improvement in feelings of health and well-being for both recipients and carers.

MacMahon 1998 reported a single-participant AB design study of the effects of an aromatherapy intervention, 'Zeal', on the motivational behaviour of one person with dementia. The results show a significant improvement on the rating scale employed. Vetrivanathan (reference unavailable) used The Brief Agitation Scale (Finkel 1993) and The Relaxation Checklist (Luiselli 1982) to evaluate the effects of lavender and massage on seven participants with dementia on an acute assessment ward. The results from this study showed some short term decrease of agitation, an increase in relaxation one hour after the intervention, but a decrease in relaxation before and immediately after the intervention.

Henry 1993 used a cross-over design with nine patients with dementia in a hospital ward to investigate the effects of lavender, using sleep charts as outcome measure. The results showed a significant increase in duration of sleep (P < 0.05).

Gray 2002 studied 13 older people with dementia living in residential care. All participants were described as being consistently resistive to medication administration, and had displayed an ability to perceive aromas. Each participant was exposed to three different aromas by means of a cotton ball taped to their clothing 20 minutes before medication was administered. The essential oils used were lavender, sweet orange, and tea tree, with no aroma as the control condition. Duration of medication administration and frequency and duration of resistive behaviour during this was used as the outcome, but no significant differences were found.

Bowles 2002 used a cross-over design to investigate the effects of lavender, sweet marjoram, patchouli, and vetiver on resistance to nursing care procedures and the frequency and duration of 'dementia-related behaviours' (aggression etc.). The participants were 56 (36 after attrition) aged care facility residents with moderate to severe dementia. The essential oils were blended into an aqueous cream and massaged onto the bodies and limbs of the residents five times a day, and behaviour was recorded throughout the eight weeks of the trial. The control condition was cream only. They found a significant decrease in 'dementia-related behaviours' occurring at times other than during nursing care, while resistance to nursing care increased for half of the participants. A significant improvement was also found on the Mini-Mental State Evaluation (Folstein 1975) for some participants.

Brooker 1997 reported on the effects of massage and lavender, separately and in conjunction with each other, on the disturbed behaviour of four people with dementia on a continuing care ward. The researchers developed individualized disturbed behaviour scales, which they tested for inter-rater reliability (P < 0.001). The results from this study showed a significant difference following the aromatherapy for one participant. For two participants, the massage and aromatherapy was associated with an increase of agitated behaviour.

Holmes 2002 investigated the effects of lavender on agitated behaviour in 15 patients with severe dementia on a long-stay psychogeriatric ward. This was a placebo-controlled trial with blinded ratings, with the participants acting as their own controls. The outcome measure used was the Pittsburgh Agitation Scale (Rosen 1994). The results show a significant mean improvement of the aromatherapy group, but five of the participants showed no change and one a worsening of agitated behaviour.

In finding some support for a beneficial effect of aromatherapy for people with dementia, the literature indicates that further, more adequate research is needed. Of equal importance are the findings of some adverse effects following aromatherapy, questioning the widespread assumption that it at least does no harm.

Authors' conclusions

Implications for practice

There is plenty of non-randomised evidence of both benefit and harm for aromatherapy for dementia. The seven randomised trials included in this review show equivocal evidence for the benefits of aromatherapy, and further evidence for its effectiveness is needed.

Implications for research

A promising start has been made in systematically investigating the effect of aromatherapy on the experience of dementia, however more well-designed, large-scale RCTs that fully report the data are needed before conclusions can be drawn as to its effectiveness. Many methodological issues need to be addressed such as the comparability of different interventions, the quality of the blinding, and the placebo effect. Treatment effects for the different types and severity of dementia, as well as other variables including sex and age, also need to be investigated. The various types of aromatherapy interventions, including lavender, Roman chamomile, mandarin, geranium, marjoram, melissa, patchouli, vetiver, sweet orange, and tea tree, and combinations, should be considered when designing future trials as well as the level of training of those administering the aromatherapy intervention, from completely untrained members of care staff teams to trained aromatherapists, with different modes of application, frequencies and dosages. Trials should use standardised, well validated instruments and more long term follow-up assessments. See Table 3 for the recommended design of future trials.

Table 3. Design of future trials
MethodsAllocation: randomised, with sequence generation and concealment of allocation clearly described
Blindness: double, or at least raters blinded
Duration: at least 6 months
ParticipantsPeople with dementia of any type and severity
N = 300*
Interventions1. Aromatherapy. All doses, frequencies, and fragrances. N = 150
2. Placebo: N = 150
OutcomesAgitation
Behavioural symptoms
Adverse effects
Quality of life
Mood
Sleep
Cognition
Activities of daily living
Caregiver burden or distress, or both
Notes* The number of participants needed to gain sufficient power to highlight about a 10% difference between groups for primary outcome depends on the primary outcome used and the prevalence or magnitude of this outcome.

Acknowledgements

Margaret Butterworth for her contributions as consumer editor, and Professor Ballard for allowing us access to the data from his study.

Data and analyses

Download statistical data

Comparison 1. Aromatherapy versus placebo - changes from editor
Outcome or subgroup titleNo. of studiesNo. of participantsStatistical methodEffect size
1 Agitation, mean change (CMAI, high score=bad)  Other dataNo numeric data
2 Agitation, mean change (NPI aberrant motor behaviour, high score=bad)  Other dataNo numeric data
3 Agitation, mean change (PAS, high score=bad)  Other dataNo numeric data
4 Agitation, mean change (NPI agitation/aggression, high score=bad)  Other dataNo numeric data
5 Behavioural symptoms, mean change (NPI, high score=bad)  Other dataNo numeric data
6 Behavioural symptoms, mean change (NPI, high score=bad)  Other dataNo numeric data
7 Adverse effects  Other dataNo numeric data
8 Quality of life, mean change (Blau QOL Scale, high score=good)  Other dataNo numeric data
9 Activities of daily living, mean change (Barthel Scale of Activities of Daily Living, high score=good)  Other dataNo numeric data

Analysis 1.1.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 1 Agitation, mean change (CMAI, high score=bad).

Agitation, mean change (CMAI, high score=bad)
StudyMean differenceSEAromatherapy NPlacebo NMean difference (95%CI)
Ballard 2002-11.14.54093536-11.10 [-20.00, -2.20]

Analysis 1.2.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 2 Agitation, mean change (NPI aberrant motor behaviour, high score=bad).

Agitation, mean change (NPI aberrant motor behaviour, high score=bad)
StudyMean differenceSEAromatherapy NPlacebo NMean difference (95%CI)
Ballard 2002-3.011.233536-3.01 [-5.42, -0.60]

Analysis 1.3.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 3 Agitation, mean change (PAS, high score=bad).

Agitation, mean change (PAS, high score=bad)
StudyAromatherapy meanAromatherapy SDAromatherapy NPlacebo meanPlacebo SDPlacebo NMean difference (95%CI)
Burns 2011-0.72.773632-0.72.7263310.00 [-1.36, 1.36]

Analysis 1.4.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 4 Agitation, mean change (NPI agitation/aggression, high score=bad).

Agitation, mean change (NPI agitation/aggression, high score=bad)
StudyMean differenceSEAromatherapy NPlacebo NMean difference (95%CI)
Ballard 2002-2.310.893536-2.31 [-4.05, -0.57]

Analysis 1.5.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 5 Behavioural symptoms, mean change (NPI, high score=bad).

Behavioural symptoms, mean change (NPI, high score=bad)
StudyMean differenceSEAromatherapy NPlacebo NMean difference (95%CI)
Ballard 2002-15.84.38783536-15.80 [-24.40, -7.20]

Analysis 1.6.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 6 Behavioural symptoms, mean change (NPI, high score=bad).

Behavioural symptoms, mean change (NPI, high score=bad)
StudyAromatherapy meanAromatherapy SDAromatherapy NPlacebo meanPlacebo SDPlacebo NMean difference (95%CI)
Burns 2011-7.214.977632-10.019.6291312.80 [-5.84, 11.44]

Analysis 1.7.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 7 Adverse effects.

Adverse effects
StudyAromatherapy eventsAromatherapy totalPlacebo eventsPlacebo totalRisk ratio (95%CI)
Burns 20112322310.97 [0.15, 6.46]
Fu 2013041020Not estimable

Analysis 1.8.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 8 Quality of life, mean change (Blau QOL Scale, high score=good).

Quality of life, mean change (Blau QOL Scale, high score=good)
StudyAromatherapy meanAromatherapy SDAromatherapy NPlacebo meanPlacebo SDPlacebo NMean difference (95%CI)
Burns 201117.083.208932-2.087.24033119.00 [-23.12, 61.12]

Analysis 1.9.

Comparison 1 Aromatherapy versus placebo - changes from editor, Outcome 9 Activities of daily living, mean change (Barthel Scale of Activities of Daily Living, high score=good).

Activities of daily living, mean change (Barthel Scale of Activities of Daily Living, high score=good)
StudyAromatherapy meanAromatherapy SDAromatherapy NPlacebo meanPlacebo SDPlacebo NMean difference (95%CI)
Burns 2011-0.82.773632-0.32.453631-0.50 [-1.79, 0.79]

Appendices

Appendix 1. Update search: January 2012

Source

 

Search strategyHits retrieved
1. ALOIS (www.medicine.ox.ac.uk/alois) (searched: 17/01/12)Keyword search: aroma OR aromatherapy OR lemon OR rose OR lavender OR smell OR “essential oils” OR “essential oil”48 (all dates)
2. MEDLINE In-Process and other non-indexed citations and MEDLINE 1950-present (OvidSP)

1. exp Dementia/

2. Delirium/

3. Wernicke Encephalopathy/

4. Delirium, Dementia, Amnestic, Cognitive Disorders/

5. dement*.mp.

6. alzheimer*.mp.

7. (lewy* adj2 bod*).mp.

8. deliri*.mp.

9. (chronic adj2 cerebrovascular).mp.

10. ("organic brain disease" or "organic brain syndrome").mp.

11. ("normal pressure hydrocephalus" and "shunt*").mp.

12. "benign senescent forgetfulness".mp.

13. (cerebr* adj2 deteriorat*).mp.

14. (cerebral* adj2 insufficient*).mp.

15. (pick* adj2 disease).mp.

16. (creutzfeldt or jcd or cjd).mp.

17. huntington*.mp.

18. binswanger*.mp.

19. korsako*.mp.

20. ((cognit* or memory* or mental*) adj3 (declin* or impair* or los* or deteriorat*)).mp.

21. or/1-20

22. "aroma therap*".mp.

23. exp *Aromatherapy/

24. aromatherapy.mp.

25. "complementary therap*".mp.

26. exp Complementary Therapies/

27. "alternative therap*".mp.

28. exp Complementary Therapies/

29. "essential oil*".mp.

30. aroma*.ti,ab.

31. ("lemon balm" or "rose* oil*" or "lavender oil*").mp.

32. or/22-31

33. 21 and 32

34. randomized controlled trial.pt.

35. controlled clinical trial.pt.

36. placebo.ab.

37. random*.ab.

38. trial.ab.

39. groups.ab.

40. or/34-39

41. (animals not (humans and animals)).sh.

42. 40 not 41

43. 42 and 33

44. (2010* or 2011* or 2012*).ed.

45. 43 and 44

 

 

120

3. EMBASE

1980-2012 week 2 (OvidSP)

1. exp dementia/

2. Lewy body/

3. delirium/

4. Wernicke encephalopathy/

5. cognitive defect/

6. dement*.mp.

7. alzheimer*.mp.

8. (lewy* adj2 bod*).mp.

9. deliri*.mp.

10. (chronic adj2 cerebrovascular).mp.

11. ("organic brain disease" or "organic brain syndrome").mp.

12. "supranuclear palsy".mp.

13. ("normal pressure hydrocephalus" and "shunt*").mp.

14. "benign senescent forgetfulness".mp.

15. (cerebr* adj2 deteriorat*).mp.

16. (cerebral* adj2 insufficient*).mp.

17. (pick* adj2 disease).mp.

18. (creutzfeldt or jcd or cjd).mp.

19. huntington*.mp.

20. binswanger*.mp.

21. korsako*.mp.

22. CADASIL.mp.

23. ((cognit* or memory* or mental*) adj3 (declin* or impair* or los* or deteriorat*)).mp.

24. or/1-23

25. "aroma therap*".mp.

26. exp aromatherapy/

27. aromatherapy.mp.

28. "complementary therap*".mp.

29. exp alternative medicine/

30. "alternative therap*".mp.

31. alternative medicine/

32. "essential oil*".mp.

33. aroma*.ti,ab.

34. ("lemon balm" or "rose* oil*" or "lavender oil*").mp.

35. or/25-34

36. 35 and 24

37. randomized controlled trial/

38. controlled clinical trial/

39. placebo.ab.

40. random*.ab.

41. trial.ab.

42. groups.ab.

43. or/37-42

44. 36 and 43

45. (2010* or 2011* or 2012*).em.

46. 44 and 45

 

55

4. PsycINFO

1806-January week 2 2012 (OvidSP)

1. exp Dementia/

2. exp Delirium/

3. exp Huntingtons Disease/

4. exp Kluver Bucy Syndrome/

5. exp Wernickes Syndrome/

6. exp Cognitive Impairment/

7. dement*.mp.

8. alzheimer*.mp.

9. (lewy* adj2 bod*).mp.

10. deliri*.mp.

11. (chronic adj2 cerebrovascular).mp.

12. ("organic brain disease" or "organic brain syndrome").mp.

13. "supranuclear palsy".mp.

14. ("normal pressure hydrocephalus" and "shunt*").mp.

15. "benign senescent forgetfulness".mp.

16. (cerebr* adj2 deteriorat*).mp.

17. (cerebral* adj2 insufficient*).mp.

18. (pick* adj2 disease).mp.

19. (creutzfeldt or jcd or cjd).mp.

20. huntington*.mp.

21. binswanger*.mp.

22. korsako*.mp.

23. ("parkinson* disease dementia" or PDD or "parkinson* dementia").mp.

24. ((cognit* or memory* or mental*) adj3 (declin* or impair* or los* or deteriorat*)).mp.

25. or/1-24

26. "aroma therap*".mp.

27. exp Aromatherapy/

28. aromatherapy.mp.

29. "complementary therap*".mp.

30. exp Alternative Medicine/

31. "alternative therap*".mp.

32. "essential oil*".mp.

33. aroma*.ti,ab.

34. ("lemon balm" or "rose* oil*" or "lavender oil*").mp.

35. or/26-34

36. exp Clinical Trials/

37. random*.ti,ab.

38. placebo.mp.

39. trial*.ti,ab.

40. groups.ab.

41. or/36-40

42. 25 and 35 and 41

43. (2010* or 2011* or 2012*).up.

44. 42 and 43

 

14
5. CINAHL (EBSCOhost)

S1 (MH "Dementia+") 

S2 (MH "Delirium") or (MH "Delirium, Dementia, Amnestic, Cognitive Disorders") 

S3 (MH "Wernicke's Encephalopathy") 

S4 TX dement*

S5 TX alzheimer*

S6 TX lewy* N2 bod* 

S7 TX deliri*

S8 TX chronic N2 cerebrovascular 

S9 TX "organic brain disease" or "organic brain syndrome"

S10 TX "normal pressure hydrocephalus" and "shunt*" 

S11 TX "benign senescent forgetfulness"

S12 TX cerebr* N2 deteriorat*

S13 TX cerebral* N2 insufficient*

S14 TX pick* N2 disease 

S15 TX creutzfeldt or jcd or cjd 

S16 TX huntington*

S17 TX binswanger*

S18 TX korsako*

S19 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11 or S12 or S13 or S14 or S15 or S16 or S17 or S18 

S20 TX "aroma therap*" 

S21 ("Aromatherapy") or (MH "Aromatherapy") 

S22 TX "complementary therap*"

S23 (MH "Alternative Therapies") 

S24 TX "alternative therap*" 

S25 TX "essential oil*" 

S26 AB aroma*

S27 AB "lemon balm" OR "rose* oil*" OR "lavender oil*" 

S28 S20 or S21 or S22 or S23 or S24 or S25 or S26 or S27 

S29 S19 and S28 

S30 AB random*

S31 AB placebo 

S32 (MH "Clinical Trials+") 

S33 AB groups 

S34 TX trial*

S35 S30 or S31 or S32 or S33 or S34 

S36 S29 and S35 

S37 EM 2010 

S38 EM 2011 

S39 EM 2012 

S40 S37 or S38 or S39 

S41 S36 and S40 

24
6. Web of Knowledge – all databases

Topic=("lemon balm" OR "rose* oil*" OR "lavender oil*" OR aroma* OR aromatherapy OR "essential oil*") AND Topic=(dementia* OR alzheimer* OR BPSD OR lewy OR "cognit* impair*" OR MCI OR VCI OR AD) AND Topic=(randomly OR placebo OR groups OR trial OR RCT OR randomized OR randomised OR "double-blind*" OR "single-blind*" OR CCT OR "cross-over" OR crossover) AND Year Published=(2010-2012)

Timespan=All Years.

Search language=English   Lemmatization=On  

 

77
7. LILACS (BIREME)aroma OR aromatherapy OR lemon OR limão OR limón OR lavender OR lavanda OR alfazema OR "essential oil$" [Words] and dementia OR alzheimer OR demência OR demencia OR cognición OR cognição OR cognition OR cognitive OR MCI [Words]1
8. CENTRAL (The Cochrane Library) (Issue 4 of 4, Dec 2011)

#1 MeSH descriptor Dementia explode all trees

#2 MeSH descriptor Delirium, this term only

#3 MeSH descriptor Wernicke Encephalopathy, this term only

#4 MeSH descriptor Delirium, Dementia, Amnestic, Cognitive Disorders, this term only

#5 dement*

#6 alzheimer*

#7 "lewy* bod*"

#8 deliri*

#9 "chronic cerebrovascular"

#10 "organic brain disease" or "organic brain syndrome"

#11 "normal pressure hydrocephalus" and "shunt*"

#12 "benign senescent forgetfulness"

#13 "cerebr* deteriorat*"

#14 "cerebral* insufficient*"

#15 "pick* disease"

#16 creutzfeldt or jcd or cjd

#17 huntington*

#18 binswanger*

#19 korsako*

#20 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19)

#21 "aroma therap*"

#22 aromatherapy

#23 "alternative therap*"

#24 "essential oil*"

#25 aroma*

#26 "lemon balm" or "rose* oil*" or "lavender oil*"

#27 MeSH descriptor Aromatherapy explode all trees

#28 MeSH descriptor Complementary Therapies explode all trees

#29 (#21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28)

#30 (#29 AND #20), from 2010 to 2012

 

34
9. Clinicaltrials.gov (www.clinicaltrials.gov)Interventional Studies | dementia OR alzheimers OR AD OR alzheimer's OR alzheimer OR lewy OR FTLD OR FLD OR MCI OR cognitive OR cognition | aroma OR aromatherapy OR lavender OR lemon OR rose OR essential oils | Adult, Senior | received from 05/01/2010 to 01/17/20122
10. ICTRP Search Portal (http://apps.who.int/trialsearch) [includes: Australian New Zealand Clinical Trials Registry; ClinicalTrilas.gov; ISRCTN; Chinese Clinical Trial Registry; Clinical Trials Registry – India; Clinical Research Information Service – Republic of Korea; German Clinical Trials Register; Iranian Registry of Clinical Trials; Japan Primary Registries Network; Pan African Clinical Trial Registry; Sri Lanka Clinical Trials Registry; The Netherlands National Trial Register](Interventional Studies | dementia OR alzheimers OR AD OR alzheimer's OR alzheimer OR lewy OR FTLD OR FLD OR MCI OR cognitive OR cognition | aroma OR aromatherapy OR lavender OR lemon OR rose OR essential oils | Adult, Senior | received from 01/05/2010 to 17/01/2012) AND recruitment status = ALL27
TOTAL before de-duplication402
TOTAL after de-dupe7

Appendix 2. Update search: May 2010

SourceSearch strategyHits
MEDLINE In-Process and other non-indexed citations and MEDLINE 1950-present (OvidSP)

1. exp Dementia/

2. Delirium/

3. Wernicke Encephalopathy/

4. Delirium, Dementia, Amnestic, Cognitive Disorders/

5. dement*.mp.

6. alzheimer*.mp.

7. (lewy* adj2 bod*).mp.

8. deliri*.mp.

9. (chronic adj2 cerebrovascular).mp.

10. ("organic brain disease" or "organic brain syndrome").mp.

11. ("normal pressure hydrocephalus" and "shunt*").mp.

12. "benign senescent forgetfulness".mp.

13. (cerebr* adj2 deteriorat*).mp.

14. (cerebral* adj2 insufficient*).mp.

15. (pick* adj2 disease).mp.

16. (creutzfeldt or jcd or cjd).mp.

17. huntington*.mp.

18. binswanger*.mp.

19. korsako*.mp.

20. ((cognit* or memory* or mental*) adj3 (declin* or impair* or los* or deteriorat*)).mp.

21. or/1-20

22. "aroma therap*".mp.

23. exp *Aromatherapy/

24. aromatherapy.mp.

25. "complementary therap*".mp.

26. exp Complementary Therapies/

27. "alternative therap*".mp.

28. exp Complementary Therapies/

29. "essential oil*".mp.

30. aroma*.ti,ab.

31. ("lemon balm" or "rose* oil*" or "lavender oil*").mp.

32. or/22-31

33. 21 and 32

34. randomized controlled trial.pt.

35. controlled clinical trial.pt.

36. placebo.ab.

37. random*.ab.

38. trial.ab.

39. groups.ab.

40. or/34-39

41. (animals not (humans and animals)).sh.

42. 40 not 41

43. 42 and 33

44. (2008* or 2009* or 2010*).ed.

45. 43 and 44

134

EMBASE

1980-2010 week 19 (OvidSP)

1. exp dementia/

2. Lewy body/

3. delirium/

4. Wernicke encephalopathy/

5. cognitive defect/

6. dement*.mp.

7. alzheimer*.mp.

8. (lewy* adj2 bod*).mp.

9. deliri*.mp.

10. (chronic adj2 cerebrovascular).mp.

11. ("organic brain disease" or "organic brain syndrome").mp.

12. "supranuclear palsy".mp.

13. ("normal pressure hydrocephalus" and "shunt*").mp.

14. "benign senescent forgetfulness".mp.

15. (cerebr* adj2 deteriorat*).mp.

16. (cerebral* adj2 insufficient*).mp.

17. (pick* adj2 disease).mp.

18. (creutzfeldt or jcd or cjd).mp.

19. huntington*.mp.

20. binswanger*.mp.

21. korsako*.mp.

22. CADASIL.mp.

23. ((cognit* or memory* or mental*) adj3 (declin* or impair* or los* or deteriorat*)).mp.

24. or/1-23

25. "aroma therap*".mp.

26. exp aromatherapy/

27. aromatherapy.mp.

28. "complementary therap*".mp.

29. exp alternative medicine/

30. "alternative therap*".mp.

31. alternative medicine/

32. "essential oil*".mp.

33. aroma*.ti,ab.

34. ("lemon balm" or "rose* oil*" or "lavender oil*").mp.

35. or/25-34

36. 35 and 24

37. randomized controlled trial/

38. controlled clinical trial/

39. placebo.ab.

40. random*.ab.

41. trial.ab.

42. groups.ab.

43. or/37-42

44. 36 and 43

45. (2008* or 2009* or 2010*).em.

46. 44 and 45

39

PsycINFO

1806-May week 2 2010 (OvidSP)

1. exp Dementia/

2. exp Delirium/

3. exp HuntingtonsDisease/

4. exp Kluver Bucy Syndrome/

5. exp Wernickes Syndrome/

6. exp Cognitive Impairment/

7. dement*.mp.

8. alzheimer*.mp.

9. (lewy* adj2 bod*).mp.

10. deliri*.mp.

11. (chronic adj2 cerebrovascular).mp.

12. ("organic brain disease" or "organic brain syndrome").mp.

13. "supranuclear palsy".mp.

14. ("normal pressure hydrocephalus" and "shunt*").mp.

15. "benign senescent forgetfulness".mp.

16. (cerebr* adj2 deteriorat*).mp.

17. (cerebral* adj2 insufficient*).mp.

18. (pick* adj2 disease).mp.

19. (creutzfeldt or jcd or cjd).mp.

20. huntington*.mp.

21. binswanger*.mp.

22. korsako*.mp.

23. ("parkinson* disease dementia" or PDD or "parkinson* dementia").mp.

24. ((cognit* or memory* or mental*) adj3 (declin* or impair* or los* or deteriorat*)).mp.

25. or/1-24

26. "aroma therap*".mp.

27. exp Aromatherapy/

28. aromatherapy.mp.

29. "complementary therap*".mp.

30. exp Alternative Medicine/

31. "alternative therap*".mp.

32. "essential oil*".mp.

33. aroma*.ti,ab.

34. ("lemon balm" or "rose* oil*" or "lavender oil*").mp.

35. or/26-34

36. exp Clinical Trials/

37. random*.ti,ab.

38. placebo.mp.

39. trial*.ti,ab.

40. groups.ab.

41. or/36-40

42. 25 and 35 and 41

43. (2008* or 2009* or 2010*).up.

44. 42 and 43

13
CINAHL (EBSCOhost)

S1 (MH "Dementia+")

S2 (MH "Delirium") or (MH "Delirium, Dementia, Amnestic, Cognitive Disorders")  

S3 (MH "Wernicke's Encephalopathy")  

S4 TX dement*

S5 TX alzheimer*

S6 TX lewy* N2 bod* 

S7 TX deliri*

S8 TX chronic N2 cerebrovascular  

S9 TX "organic brain disease" or "organic brain syndrome"

S10 TX "normal pressure hydrocephalus" and "shunt*"

S11 TX "benign senescent forgetfulness"

S12 TX cerebr* N2 deteriorat* 

S13 TX cerebral* N2 insufficient* 

S14 TX pick* N2 disease  

S15 TX creutzfeldt or jcd or cjd  

S16 TX huntington*  

S17 TX binswanger* 

S18 TX korsako*

S19 S1 or S2 or S3 or S4 or S5 or S6 or S7 or S8 or S9 or S10 or S11 or S12 or S13 or S14 or S15 or S16 or S17 or S18  

S20 TX "aroma therap*"  

S21 ("Aromatherapy") or (MH "Aromatherapy")  

S22 (MH "Alternative Therapies")  

S23 (MH "Alternative Therapies")  

S24 TX "alternative therap*"  

S25 TX "essential oil*"  

S26 AB aroma* 

S27 AB "lemon balm" OR "rose* oil*" OR "lavender oil*"  

S28 S20 or S21 or S22 or S23 or S24 or S25 or S26 or S27  

S29 S19 and S28  

S30 AB random*

S31 AB placebo  

S32 (MH "Clinical Trials+")  

S33 AB groups  

S34 TX trial*

S35 S30 or S31 or S32 or S33 or S34  

S36 S29 and S35  

S37 EM 2008  

S38 EM 2009  

S39 EM 2010  

S40 S37 or S38 or S39  

S41 S36 and S40  

37
Web of Science with Conference Proceedings (1945 to present)

Topic=(dement* OR alzheimer* OR lewy OR deliri* OR cerebro* OR creutzfeldt OR huntington* OR korsako* OR binswanger*) AND Topic=(aroma* OR "complementary therap*" OR "essential oil*" OR "lemon" OR "rose oil*" OR lavender) AND Topic=(trial OR random* OR placebo OR groups)

Timespan=Latest 5 years

112
LILACS (South and Central American coverage)aroma$ [Words] and demen$ OR alzheimer$ [Words]1
ALOIS (for a list of what ALOIS covers: http://www.medicine.ox.ac.uk/alois/content/about-alois)aromatherapy OR lemon OR lavender OR rose OR aroma OR alternative therapies OR complementary therapies12
Umin (Clinical Trial register of Japan)aromatherapy OR lemon OR lavender OR rose OR aroma0
CENTRAL (The Cochrane Library)

#1 MeSH descriptor Dementia explode all trees

#2 MeSH descriptor Delirium, this term only

#3 MeSH descriptor Wernicke Encephalopathy, this term only

#4 MeSH descriptor Delirium, Dementia, Amnestic, Cognitive Disorders, this term only

#5 dement*

#6 alzheimer*

#7 "lewy* bod*"

#8 deliri*

#9 "chronic cerebrovascular"

#10 "organic brain disease" or "organic brain syndrome"

#11 "normal pressure hydrocephalus" and "shunt*"

#12 "benign senescent forgetfulness"

#13 "cerebr* deteriorat*"

#14 "cerebral* insufficient*"

#15 "pick* disease"

#16 creutzfeldt or jcd or cjd

#17 huntington*

#18 binswanger*

#19 korsako*

#20 (#1 OR #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12 OR #13 OR #14 OR #15 OR #16 OR #17 OR #18 OR #19)

#21 "aroma therap*"

#22 aromatherapy

#23  "alternative therap*"

#24 "essential oil*"

#25 aroma*

#26 "lemon balm" or "rose* oil*" or "lavender oil*"

#27 MeSH descriptor Aromatherapy explode all trees

#28                MeSH descriptor Complementary Therapies explode all trees

#29 (#21 OR #22 OR #23 OR #24 OR #25 OR #26 OR #27 OR #28)

#30 (#29 AND #20), from 2008 to 2010

60
Clinicaltrials.govInterventional Studies | aromatherapy OR lemon OR lavender OR rose OR aroma | received from 01/01/2008 to 05/17/201019
ICTRP Search Portal which covers: ANZCTR; ClinicalTrials.gov; ISRCTN; Chinese ClinicalTrial Registry; India Clinical Trials Registry; German Clinical Trials Register and more.ADVANCED SEARCH: (dementia OR alzheimers OR lewy OR cognitive OR cerebrovascular) AND (aromatherapy OR lemon OR lavender OR rose OR aroma) AND (Recruitment status: ALL) AND (date registered: 01/01/2008-17/05/2010)4
Total438
Total after first-assess and de-duplication by TSC8

Appendix 3. Update search: March 2008

SourceSearch strategyHits
CDCIG SR“aroma therap*” OR “complementary therap*” OR “alternative therap*” OR “essential oil*”1
PubMed (June 2006-March 2008)

“aroma therap*” OR “complementary therap*” OR “alternative therap*” OR “essential oil*”

AND

Phases 1-3 of the Highly sensitive search strategies for identifying reports of randomized controlled trials in Medline (APPENDIX 5b, Cochrane Handbook, 2006), all terms searched as Title, abstract, keyword, Publication type.

33

EMBASE (2008 week 12)

PsycINFO (March week 3 2008)

CINHAL  (March week 2 2008)

CENTRAL Issue 1 2008

(all via OvidSP)

“aroma therap*” OR “complementary therap*” OR “alternative therap*” OR “essential oil*”

AND

Phases 1-3 of the Highly sensitive search strategies for identifying reports of randomized controlled trials in Medline (APPENDIX 5b, Cochrane Handbook, 2006), all terms searched as Title, abstract, keyword, Publication type.

49
LILACS (BIREME)

“aroma therap*” OR “complementary therap*” OR “alternative therap*” OR “essential oil*”

 

AND

LILACS terms for trials

0
Total83
Total after first-assess and de-duplication by TSC2

Appendix 4. Previous version of the methods

Methods  

Criteria for considering studies for this review  

Types of studies  

This review considered all relevant randomized controlled trials (RCTs). Owing to the nature of aroma therapy double-blinding may not be possible when combined with informed consent. A minimum length of trial and requirements for a follow-up were not inclusion criteria.

Types of participants  

Participants in included studies were to have a diagnosis of dementia of any type and severity, based on diagnostic criteria such as ICD-10 (WHO 1993) and DSM-IV (APA 1994), or well validated assessment scales for cognitive function, such as the MMSE (Folstein 1975) and ADAS-Cog (Rosen 1994).

Types of interventions  

This review considered trials using fragrance from plants, in an intervention defined as aroma therapy, for people with dementia. All doses, frequencies, and fragrances were considered.

Types of outcome measures  

The outcomes considered in this review were:
1. cognitive function
2. functional performance
3. behaviour
4. quality of life
5. relaxation
6. wandering
7. sleep
8. mood

Search methods for identification of studies  

Electronic searches  

We searched ALOIS (www.medicine.ox.ac.uk/alois) - the Cochrane Dementia and Cognitive Improvement Group’s Specialized Register on 26 November 2012. The search terms used were: aromatherapy, lemon, lavender, rose, aroma, alternative therapies, complementary therapies, essential oils.

ALOIS is maintained by the Trials Search Co-ordinator of the Cochrane Dementia and Cognitive Improvement Group and contains studies in the areas of dementia prevention, dementia treatment and cognitive enhancement in healthy. The studies are identified from:  

  1. Monthly searches of a number of major healthcare databases: Medline, Embase, Cinahl, Psycinfo and Lilacs

  2. Monthly searches of a number of trial registers: ISRCTN; UMIN (Japan's Trial Register); the WHO portal (which covers ClinicalTrials.gov; ISRCTN; the Chinese Clinical Trials Register; the German Clinical Trials Register; the Iranian Registry of Clinical Trials and the Netherlands National Trials Register, plus others)

  3. Quarterly search of The Cochrane Library’s Central Register of Controlled Trials (CENTRAL)

  4. Six-monthly searches of a number of grey literature sources: ISI Web of Knowledge Conference Proceedings; Index to Theses; Australasian Digital Theses

To view a list of all sources searched for ALOIS see About ALOIS on the ALOIS website.

Details of the search strategies used for the retrieval of reports of trials from the healthcare databases, CENTRAL and conference proceedings can be viewed in the ‘methods used in reviews’ section within the editorial information about the Dementia and Cognitive Improvement Group.

Additional searches were performed in many of the sources listed above to cover the timeframe from the last searches performed for ALOIS to ensure that the search for the review was as up-to-date and as comprehensive as possible. The search strategies used can be seen Appendix 1.

Electronic searches carried out in the previous version(s) of the review can be viewed in Appendix 2 and Appendix 3.

In addition the following online journals were searched: 'Complementary Therapies in Medicine', and 'Complementary Therapies in Nursing and Midwifery'.

Searching other resources  

'Experts' in the field of complementary therapies were contacted to identify ongoing and unpublished research as well as the Aroma Therapy Organisations Council.

Selection of trials

LMT and AS independently screened the titles and abstracts extracted by the searches for their eligibility for potential inclusion in the review based on the above criteria, which were discussed with MO.

Update Sept. 2008: FEH and TPHB assessed the new study found by the March 2008 search using the same criteria as that previously used.

Data collection

Data were extracted from the published reports and unpublished company reports. The summary statistics required for each trial and each outcome for continuous data are the mean change from baseline, the standard error of the mean change, and the number of patients for each treatment group at each assessment. Where changes from baseline were not reported, the mean, standard deviation and the number of patients for each treatment group at each time point were extracted if available. For binary data the numbers in each treatment group and the numbers experiencing the outcome of interest were sought. The baseline assessment is defined as the latest available assessment prior to randomization, but no longer than two months prior. For each outcome measure, data were sought on every patient assessed. To allow an intention-to-treat analysis (ITT), the data were sought irrespective of compliance, whether or not the patient was subsequently deemed ineligible, or otherwise excluded from treatment or follow-up. If ITT data were not available an analysis of patients who completed treatment was conducted. For continuous or ordinal variables which can be approximated to continuous variables, the main outcomes of interest were the assessment score at the time point being considered and the change from the baseline (i.e. pre-randomization or at randomization) at this time point. For some binary and ordinal outcomes the endpoint category relative to baseline category was the outcome of interest. For other categorical outcomes, such as the Clinical Global Impression of Change (CIBIC-Plus), the endpoint itself was of clinical relevance as all patients had begun, by definition, at the same baseline score. The baseline assessment score was the latest available score, no longer than two months prior to the randomization. Studies may have included a titration period prior to the randomization phase of the study. The data from these non-randomized titration periods were not used to assess safety or efficacy since patients were not randomized, nor was treatment or dose allocation concealed. Data from any open follow-on phase, after the randomized phase, were not used to assess safety or efficacy for the same reasons.

Quality assessment

A checklist for assessing the quality of all studies identified was developed, as presented below.

Checklist for assessing methodological quality.
Does the paper include:
1) A thorough review of the literature?
2) Hypothesis formulation/aims/power analysis?
3) Details of informed consent?
4) Description/justification of sampling procedure?
5) Description/justification of design (for non RCTs)?
6) Justification of lack of controls (for non RCTs)?
7) Details of randomization method(s) (selection bias)?
8) Number/details of drop-outs (attrition bias)?
9) Description/justification/standardization of outcome measures?
10) Blind assessment/details of assessor(s) (detection bias)?
11) Clearly presented results (appropriate statistics)?
12) A description of limitations of study/design (for non RCTs)?
13) Intention to treat analysis?
14) Suggestions for future research?

Data analysis

Summary statistics (n, mean and standard deviation) were required for each rating scale at each assessment time for each treatment group in each trial for change from baseline.

When change from baseline results are not reported, the required summary statistics were calculated from the baseline and assessment time treatment group means and standard deviations. In this case a zero correlation between the measurements at baseline and assessment time was assumed. This method overestimates the standard deviation of the change from baseline, but this conservative approach is considered to be preferable in a meta-analysis.

For binary outcomes, such as clinical improvement or no clinical improvement, the odds ratio was used to measure treatment effect.

For continuous or ordinal variables, such as psychometric test scores, clinical global impression scales, functional and quality of life scales, there are two possible approaches. If ordinal scale data appear to be approximately normally distributed or if the analysis that the investigators perform suggests parametric tests were appropriate, then the outcome measures were treated as continuous data. The second approach, which may not have excluded the first, was to concatenate into 2 categories which best represent the contrasting states of interest, and to treat the variable as binary. For binary outcomes such as institutionalization and death, the endpoint itself was of interest and the Peto method of the typical odds ratio was used.

A weighted estimate of the typical treatment effect across trials was calculated. Overall estimates of the treatment difference are presented. In all cases the overall estimate from a fixed-effect model is presented and a test for heterogeneity using I2 statistic performed. Where there is evidence of heterogeneity of the treatment effect between trials then either only homogeneous results are pooled, or a random-effects model is used (in which case the confidence intervals would be broader than those of a fixed-effect model).

Feedback

Abstract, 16 March 2008

Summary

Please can you edit the abstract of the review?

In the abstract, it is not clear what outcomes you looked for, how many studies you found, how many studies are included and what the results are. The Plain Language Summary provides more information than the abstract.

Reply

We have edited the abstract.

Contributors

Vasiliy Vlassov, Occupational Physician.

What's new

Last assessed as up-to-date: 20 January 2014.

DateEventDescription
24 February 2014New citation required but conclusions have not changedNew citation; conclusions unchanged
3 February 2014New search has been performedA pre-publication search was performed on 20 January 2014. Updated with two new studies

History

Protocol first published: Issue 3, 2001
Review first published: Issue 3, 2003

DateEventDescription
10 March 2013New search has been performedUpdated with one new study
26 November 2012New search has been performedA pre-publication search was performed for this review on 26 November 2012
17 January 2012New search has been performedAn update search was performed for this review on 17 January 2012.
8 June 2010New search has been performedAn update search was performed for this review on 17 May 2010. The authors were left with 8 records to assess for possible relevance within the review
10 November 2008New search has been performed

An update search was run in March 2008 that retrieved one study (Lin 2007) which has been included in the review. No data from this trial has been included as data from the first phase of this crossover trial was not reported in the study report and has not been forthcoming from the study author.

This update has been conducted by Theo Birks and Francesca Holt and approved by Martin Orrell.

8 July 2008Feedback has been incorporatedFeedback added
3 April 2008AmendedConverted to new review format.
8 May 2006New search has been performedMay 2006
Four new papers were identified in the search of April 2006. Three were of new trials, two were excluded and one is ongoing (Myers 2005). The fourth paper is a commentary on an existing included trial (Lee 2003 b attached to Smallwood 2001). This update was performed by the CDCIG editorial base and approved by Martin Orrell and the Contact Editor as the first author (Lene Thorgrimsen) could not be contacted.
15 May 2003New citation required and conclusions have changedSubstantive amendment

Contributions of authors

LTF: design of protocol, co-ordination with The Cochrane Collaboration, updating protocol, drafting of review versions, search for trials, obtaining copies of trial reports, selection of trials for inclusion and exclusion, extraction of data, entry of data, and interpretation of data analyses for the first version of the review, and write up of review.
NM: data extraction and analysis, risk of bias assessment, write up of results (2014 update).
MO: drafting of review versions, selection of trials for inclusion and exclusion, interpretation of data analyses, and updating of review.
AS: drafting of review versions, search for trials, selection of trials for inclusion and exclusion, extraction of data, and interpretation of data analyses.
KSW: data extraction and analysis, risk of bias assessment, write up of results (2014 update).
LB: Redraft of introduction (2014 update)

Francesca E Holt: corresponding author for 2008 review update.
Theodore PH Birks: author for 2008 update.
Anne Wiles: search for trials and obtaining copies of trial reports for previous review version.

Searches: Dymphna Hermans and Vittoria Lutje (2008 search).

Margaret Butterworth: consumer editor.
Lon Schneider: contact editor.

This review was peer reviewed anonymously in July 2003 and for the 2014 update.

Declarations of interest

None known

Sources of support

Internal sources

  • University College London (UCL), UK.

External sources

  • The Mental Health Foundation, UK.

Differences between protocol and review

The methods section has been updated to the current methods in the Cochrane Handbook for Systematic Reviews of Interventions (Higgins 2011), the previous version of the methods can be found in Appendix 4.

Characteristics of studies

Characteristics of included studies [ordered by study ID]

Ballard 2002

MethodsCluster-randomised controlled trial
Double-blind
Parallel-group
4-week duration
ParticipantsCountry: UK
8 specialist nursing homes were randomised
Mean age of occupants 78.4 years
72 participants
60% females
Inclusion criteria:
Occupants of nursing homes were people with severe dementia (CDR=3) and clinically significant agitation (defined as occurring on a daily basis and causing moderate to severe management problems)
There were no other restrictions other than meeting the inclusion criteria. Medication was allowed, but changes in psychotropic prescriptions were monitored and recorded
Interventions1. 10% melissa essential oil and base oil (200mg/day divided into two doses), applied topically to the face and both arms twice a day by a care assistant. N=36.
2. 10% sunflower oil and base oil (200mg/day divided into two doses), applied topically to the face and both arms twice a day by a care assistant. N=36.
Outcomes

Agitation: CMAI, NPI agitation or aggression and NPI aberrant motor behaviour
Behavioural symptoms: total NPI
Not used in review:

Dementia Care Mapping

Barthel scale of Activities of Daily Living

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"The facilities were matched in pairs (according to number of residents) and then assigned randomly (using the toss of a coin), to active treatment or placebo"
Allocation concealment (selection bias)Unclear riskNo details reported
Blinding of participants and personnel (performance bias)
All outcomes
Low risk"In each facility only one of the aromatherapy substances was used, preventing comparisons between agents by staff. For the same reason staff were not informed of the nature of either the active treatment or placebo oils"
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"The assessments were repeated at weekly intervals for 4 weeks, by raters blind to treatment assignment"
Incomplete outcome data (attrition bias)
All outcomes
Low risk"Seventy-one (99%) participants completed the 4 week trial, one participant receiving active treatment died over the course of the study (unrelated to the study treatment)"
Selective reporting (reporting bias)Low riskAll outcomes reported
Other biasUnclear riskThe published data were not adjusted for clustering, however, unpublished individual patient data were provided and we adjusted the data used in the analysis

Burns 2011

MethodsRandomised controlled trial
Double-blind
Parallel-group
12-week duration
Participants

Country: UK
114 participants

Mean age: 85 years
60% females
Inclusion criteria:
Agitation for at least 4 weeks and score >39 on the CMAI, NINCDS-ADRDA diagnosis of probable or possible Alzheimer’s disease, clinical dementia rating of 3, resident in a specialist nursing home or NHS continuing care facility, age > 60 years and free of psychotropic medication (antipsychotics and/or cholinesterase inhibitors) for at least 2 weeks

Interventions

1. Placebo medication and active aromatherapy (melissa oil)

2. Active medication (donepezil) and placebo aromatherapy (sunflower oil). 5 mg of donepezil a day increasing to 10 mg after 1 month

3. Placebo medication and placebo aromatherapy

The oil was administered twice a day by gently massage of the hands and upper arms for 1-2 minutes

Outcomes

Agitation: PAS

Behavioural symptoms: total NPI

Adverse effects

Quality of life: Blau QOL scale

Activities of Daily Living: Barthel scale of Activities of Daily Living

Unable to use:

NPI agitation/aggression and NPI aberrant motor behaviour (no SDs)

Not used in review:

Compliance assessed by a tablet count and the weighing of aromatherapy bottles

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Participants were randomised to 1 of the 3 groups by computer-generated blocks of size 6 stratified by centre"
Allocation concealment (selection bias)Unclear riskNo details reported
Blinding of participants and personnel (performance bias)
All outcomes
Low risk"Labelling of tablet bottles and oils was carried out by an external organization, and thus researchers and patients were blinded to the treatment allocation." The aromatherapy "was dispensed in opaque plastic dispensers"
Blinding of outcome assessment (detection bias)
All outcomes
Low risk

"Assessments were carried out at baseline, week 4 and week 12 by the research nurse who was blind to treatment group."

"raters were required to wear nose clips to ensure that full blinding was maintained"

Incomplete outcome data (attrition bias)
All outcomes
Unclear risk"Eight subjects withdrew from the study at baseline, and an additional 12 subjects withdrew before the first follow-up assessment at week 4. Of the remaining 94, 13 had no assessment data in week 12."
Selective reporting (reporting bias)Low riskAll outcomes reported
Other biasLow riskNo additional biases

Cameron 2011

MethodsRandomised controlled trial
Double-blind
Cross-over
7-week duration (Treatment 1: 3 weeks, washout 1 week, Treatment 2: 3 weeks), trial was run twice a year apart
Participants

Country: UK
18 participants

Mean age: not reported
% females not reported
Inclusion criteria:
Not reported, "all inpatients were deemed eligible for inclusion in the study ... final study group consisted of 18 patients, all with moderate to severe dementia and significant BPSD"

Interventions

1. Aromatherapy <2% lemon balm oil

2. Placebo treatment 1% geranium and 0.5% lemon oil

Outcomes

Unable to use:

CMAI, PAS, NPI, adverse effects (no data reported)

Notes 
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"randomly allocated to two groups by means of· an anonymous computer-generated programme."
Allocation concealment (selection bias)Unclear riskNo details reported
Blinding of participants and personnel (performance bias)
All outcomes
Low risk

"Double-blind"

"The two groups of oils appeared very similar in terms of smell, viscosity and texture. In a test prior to starting the trial, no member of the team was able to detect reliably which of the oils was either treatment or placebo."

Blinding of outcome assessment (detection bias)
All outcomes
Unclear risk

"Double-blind"

"the PAS assessments were completed twice per day by nursing staff, and the NPI and CMAl assessments weekly by a consultant psychiatrist and a trained nurse."

Incomplete outcome data (attrition bias)
All outcomes
Unclear riskNot reported how many participants completed the trial
Selective reporting (reporting bias)High riskNo data reported
Other biasHigh riskThe trial was run twice a year apart using the same participants

Fu 2013

MethodsRandomised controlled trial
Single-blind
Parallel design
6-weeks duration
ParticipantsCountry: Australia
67 participants
Mean age: 84 years, SD = 6.36
59% females
Inclusion criteria:
Aged 60 or over; living in a participating nursing home for at least three months; cognitive functional impairment indicative of a dementia condition; MMSE score of 24 out of 30 or less; and features of Alzheimer’s disease according to American Psychiatric Association DSM-IV-TR; a documented history of a minimum of two weeks of agitation or aggression in total (consecutively or 14 single days), within the past three months; a documented history of physical and/or chemical restraint for agitation and aggression, including PRN (as required) medication
Interventions

1. 3% lavender mist

2. 3% lavender mist plus and massage twice a day for 10 days; each hand massaged for 2.5 minutes

3. Water mist applied to the participants’ chest within a 30cm distance.

The lavender mist consisted of 75 drops of pure 100% lavender oil mixed with 4 ml essential oil solubiliser and 125 cc purified water. Three sprays of lavender mist applied to the participants’ chest within a 30cm distance. All treatments were given twice a day, at two time periods, 9 am to 11 am and 2 pm to 4 pm, seven days a week for six weeks

Outcomes

Adverse events

Unable to use:
Agitation: CMAI-SF (data not reported separately for each treatment group)
MMSE (no data reported)

NotesParticipants from long term care facilities
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Randomisation assignments were given to participants following baseline testing; these were generated using a random number table"
Allocation concealment (selection bias)Low risk"A person not involved in the study randomised participants into three groups in each residential care facility."
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskParticipants were not blinded
"Participants received treatments in a quiet and private environment, such as the participant’s room in an attempt to keep staff and family blind to the intervention type. If necessary, curtains and folding screens were used to screen participants from the view of the nursing staff."
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"All primary outcome measures were assessed by facility staff blind to treatment assignment."
Incomplete outcome data (attrition bias)
All outcomes
Low risk"One male resident died in the first week of the study, and as no data were collected he was excluded. Five participants or their relatives withdrew consent for participation and data during the six weeks of the intervention stage of the study. Withdrawal of consent was related to family wanting reassurance their family member was in the intervention rather than control group and the team being unable to reassure the family. The data for these individuals was also excluded"
Selective reporting (reporting bias)High riskMMSE was measured but data not reported
Other biasLow riskNo additional biases

Lin 2007

MethodsRandomised controlled trial
Single-blind
Cross-over design
8-week duration (treatment 1: 3 weeks; washout: 2 weeks; treatment 2: 3 weeks)
Participants

Country: Hong Kong, China
70 participants
Mean age: 78.29 years
58.6% females
Inclusion criteria:
Diagnosis of dementia according to DSM-IV; APA 1994, 'Clinically significant agitation' as determined by research team psychiatrist using Chinese version of CMAI

Concurrent psychotropic medication was allowed. 51.4% of subjects were receiving psychotropic medication. Their medication was not altered during the course of the trial

Interventions

1. 100% Lavandula angustifolia essential oil
2. Sunflower preparation essential oil

Two drops of the oil assigned to the patient were dropped onto cosmetic cotton. This was then placed into an aroma diffuser. Two diffusers were then placed one on each side of the subject's pillow for at least an hour a night whilst they slept

Outcomes

Unable to use:

Chinese CMAI, Chinese NPI (data not reported for first phase of the trial)

Notes

Data for first period of cross-over has not been received for reanalysis

Residents of care and attention homes

Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Participants were randomly assigned to group A or B by blocked randomisation", no additional information provided
Allocation concealment (selection bias)Unclear riskNo details reported
Blinding of participants and personnel (performance bias)
All outcomes
Unclear riskNo details reported
Blinding of outcome assessment (detection bias)
All outcomes
Unclear riskNo details reported
Incomplete outcome data (attrition bias)
All outcomes
Low riskNo dropouts reported
Selective reporting (reporting bias)High riskData were not reported separately for each phase of the trial
Other biasLow riskNo additional biases

O'Connor 2013

MethodsRandomised controlled trial
Single-blind
Cross-over design
3-week duration (treatment 1: 1 week; washout: 4 days; treatment 2: 1 week)
Participants

Country: Australia
66 participants
Mean age: 77.6 years, SD 9.4
59% females
Inclusion criteria:
At least mild dementia on the Clinical Dementia Rating scale; physically agitated behaviour; behaviour was not due primarily to pain, physical illness, depression or psychosis; residence in the facility for at least three months

Nursing and medical staff were asked not to alter participants’ psychotropic medications if possible

Interventions

1. 30% lavender (Lavandula angustifolia) in jojoba oil
2. Jojoba oil

A nursing staff member then massaged 1 ml of either the lavender or control oil into both forearms for one minute each, giving a total of 2 ml per session. Treatments were administered at times when nursing staff reported that the selected physically agitated behaviour was most likely to be present

OutcomesUnable to use:
Observation of behaviour, MMSE, CMAI, Philadelphia Geriatric Center Affect Rating Scale (PGCARS), adverse effects (data not reported for first phase of the trial)
NotesParticipants recruited from eight specialist psychogeriatric nursing homes and three private nursing
homes
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Low risk"Participants were allocated randomly by the project manager using an Excel random number generator to either a lavender or control study condition with no pre-set blocking"
Allocation concealment (selection bias)Unclear risk"Only a single researcher, who had no other involvement in the study, was aware of the allocation.", further details not reported
Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk"The lavender and control oils were stored in identical vials, marked as A or B."
"It was not considered practicable or desirable to attempt to blind participants, all of whom had marked cognitive impairment, to the treatment condition."
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"To maintain observer blinding, nurses applying the oil wore a nose clip and research assistants, who completed the observations, applied a mixture of essential oils to their upper lip to disguise lavender’s fragrance."
Incomplete outcome data (attrition bias)
All outcomes
Unclear riskTwo participants did not complete the trial, reasons not reported
Selective reporting (reporting bias)High riskData were not reported separately for each phase of the trial
Other biasUnclear riskNo additional biases

Smallwood 2001

  1. a

    BPSD - behavioural and psychological symptoms in dementia
    CDR - Clinical Dementia Rating Scale
    CMAI - Cohen Mansfield Agitation Inventory
    PAS - Pittsburgh Agitation Scale
    NINCDS-ADRDA - National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association 
    NPI - Neuropsychiatric Inventory
    SD - standard deviation
    QOL - quality of life

MethodsRandomised controlled trial
Single-blind
Parallel-group
Unknown duration
ParticipantsCountry: UK
21 patients in a district general hospital ward (12 female, 9 male)
mean age 66.8 (11.5)
Diagnosis of severe dementia made by psychiatrist
Interventions1. Lavender in diffuser with conversation twice a week
2. Lavender with massage twice a week
3. Plain oil massage twice a week
OutcomesVideo record to assess behaviour at baseline and immediately after treatment
NotesSignificant interaction with time
Risk of bias
BiasAuthors' judgementSupport for judgement
Random sequence generation (selection bias)Unclear risk"Seven patients were randomly allocated to each of three conditions", no additional information provided
Allocation concealment (selection bias)Unclear risk"Random allocation of patients was made by two authors (EI and FC), neither of whom was involved in either data collection or data analysis"
Blinding of participants and personnel (performance bias)
All outcomes
Unclear risk"The same aromatherapist administered each condition and was blind to condition but not hypothesis", no blinding of staff to allocation was reported
Blinding of outcome assessment (detection bias)
All outcomes
Low risk"Video records were rated by two individuals, both blind to condition, and one who was blind to hypothesis"
Incomplete outcome data (attrition bias)
All outcomes
Low risk"One subject was excluded following deterioration in health preceding the completion of the study period"
Selective reporting (reporting bias)High riskOnly reports P values, no useable data
Other biasLow riskNo additional biases

Characteristics of excluded studies [ordered by study ID]

StudyReason for exclusion
Akhondzadeh 2003Intervention was drops of melissa extract, route of administration not reported, no mention of aromatherapy in the study
Bowles 2002Not randomised
Brooker 1997Not randomised
Burleigh 1997Not randomised
Chiayana 2012In vitro study
Cohen-Mansfield 2012Not aromatherapy intervention
Cohen-Mansfield 2012aNot aromatherapy intervention
Cooper 2012Systematic review
Fung 2012Systematic review
Gray 2002Not randomised
Guendling 2010Not randomised
Henry 1993Not randomised
Holmes 2002Not randomised
Jimbo 2009Not randomised
Kaufmann 2011In vitro study
Kilstoff 1998Not randomised
Kimura 2013Not randomised
Klages 2011Not aromatherapy intervention
Korn 2012Not aromatherapy intervention
Lucian 2012Animal study
MacMahon 1998Not randomised
Mitchell 1993Cross-over RCT comparing 3% lemon balm (melissa) in grape seed oil and 100% lavender. Did not include enough details about how the study was conducted to be included: no details of how the assessments were carried out, how results were analysed, and there is no definition of 'mean satisfaction rating' which appears in the histogram of results
Moss 2003The participants were all healthy volunteers
Opie 1999Literature review
Pengelly 2012Not aromatherapy intervention
Sakamoto 2012The participants did not have dementia
Snow 2004This very small study (n=7) attempted a cross-over design of three treatments, but the treatment was not blinded and the order was the same for all people, not randomised
Watanabe 2010The participants had temporal lobe epilepsy
West 1994Not randomised
Wolfe 1996Not randomised
Woods 1996Not aromatherapy intervention

Characteristics of ongoing studies [ordered by study ID]

Myers 2005

  1. a

    CDCIG - Cochrane Dementia and Cognitive Impairment Group
    CMAI - Cohen Mansfield Agitation Inventory
    MMSE - Mini-Mental State Examination
    NOSGER - Nurses' Observation Scale for Geriatric Patients

Trial name or titleInvestigating cognitive effects of aromatherapy on people with dementia living in residential care facilities
Methods

Randomised controlled trial

12-weeks duration

Participants

Country: Australia

Inclusion criteria:

People with dementia (MMSE 10-26) or mild cognitive impairment; age > 65 years; have been living in the nursing home for more than 3 months

Interventions1. The 'active' treatment will contain 1 ml each of cypress (Cupressus sempervirens), lime (Citrus latifolia) and eucalyptus (Eucalyptus globulus) essential oils, diluted in a non-fragranced aqueous cream lotion
2. The 'inactive' preparation will contain 1 ml each of ginger (Zingiber officinalis), lemongrass (Cymbopogon citratus) and mandarin (Citrus recticulata) essential oils, diluted in a non-fragranced aqueous cream lotion
3. The placebo preparation will contain only non-fragranced aqueous cream lotion and will be used during the washout periods. An important purpose of the placebo is to control for the possible effect of touch
OutcomesPrimary: MMSE; Secondary: NOSGER
Starting date01/04/2005
Contact information

Professor Stephen Myers

P.O. Box 157
Lismore

2480

Australia

smyers@scu.edu.au

NotesDespite repeated attempts, CDCIG have been unable to get any reply from the study author Professor Stephen Myers: smyers@scu.edu.au. No data were available from this study

Ancillary