The effects of antimicrobial therapy on bacterial vaginosis in non-pregnant women

 

Abstract

Background

Bacterial vaginosis (BV) is a very common cause of vaginitis that has been associated with a high incidence of obstetric and gynaecologic complications and increased risk of HIV-1 transmission. This has led to renewed research interest in its treatment.

Objectives

To assess the effects of antimicrobial agents on BV in non-pregnant women.

Search methods

We searched the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library), MEDLINE, EMBASE, LILACS, and African Healthline (December 2007); and proceedings of relevant international conferences (from 1981 to date).

Selection criteria

Randomised controlled trials comparing any two or more antimicrobial agents, or antimicrobial agents with placebo or no treatment, in women with clinical or Gram-stain criteria of BV.

Data collection and analysis

Two authors independently assessed trial quality and extracted data from the original publications while the third author cross checked the data.

Main results

Twenty-four trials involving 4422 participants were reviewed. Most examined symptomatic women only. Only seven trials analysed results by intention to treat; we re-analysed the remainder.

Compared with placebo, clindamycin showed a lower rate of treatment failure (relative risk (RR) 0.25, 95% confidence interval (CI) 0.16 to 0.37). Clindamycin and metronidazole showed identical rates of treatment failure, irrespective of regimen type, at two and four-week follow up (RR 1.01, 95% CI 0.69 to 1.46; RR 0.91, 95% CI 0.70 to 1.18, respectively). Clindamycin tended to cause a lower rate of adverse events (RR 0.75, 95% CI 0.56 to 1.02); metallic taste, and nausea and vomiting were more common in the metronidazole group (RR 0.08, 95% CI 0.1 to 0.59; RR 0.23, 95% CI 0.10 to 0.51, respectively). Given intravaginally as gelatin tablets, lactobacillus was more effective than oral metronidazole  (RR 0.20, 95% CI 0.05 to 0.08). Similarly, oral lactobacillus combined with metronidazole was more effective than metronidazole alone (RR 0.33, 95% CI 0.14 to 0.77). Clindamycin showed a lower rate of clinical failure than triple sulfonamide cream (RR 0.46, 95% CI 0.29 to 0.72). Hydrogen peroxide douche showed a higher rate of clinical failure (RR 1.75, 95% CI 1.02 to 3.00) and adverse events (RR 2.33, 95% CI 1.21 to 4.52) than a single 2 g dose of metronidazole.

Authors' conclusions

Clindamycin preparations, oral metronidazole, and oral and intravaginal tablets of lactobacillus were effective for bacterial vaginosis. Hydrogen peroxide douche and triple sulphonamide cream were ineffective. Metronidazole caused metallic taste, nausea and vomiting. We need better-designed trials with larger sample sizes to test the effectiveness of promising drugs.

 

Plain language summary

The effects of antimicrobial treatment on bacterial vaginosis in non-pregnant women  

Bacterial vaginosis (BV) is a very common cause of symptomatic and asymptomatic vaginal infection. It has been associated with a high incidence of obstetric and gynaecologic complications and an increased risk of transmission of HIV (human immunodeficiency virus). This review evaluated the effectiveness and adverse effects of antimicrobial agents used to treat BV in non-pregnant women. Twenty-four trials involving 4422 women were reviewed. With regard to less treatment failure, clindamycin was superior to placebo but comparable to metronidazole, irrespective of the dose regimen. Metronidazole tended to cause a higher rate of adverse events, such as metallic taste and nausea and vomiting, than did clindamycin. Oral lactobacillus combined with metronidazole was more effective than metronidazole alone. Administered in an intravaginal gelatin tablet, lactobacillus was also more effective than oral metronidazole. Triple sulfonamide cream was less effective compared with clindamycin. Hydrogen peroxide douche was not as effective as a single 2 g dose of metronidazole yet caused more harms. Only one trial involved asymptomatic women and the result was not conclusive. There was insufficient evidence to reach a conclusion on the effectiveness of other promising drugs. Drugs effective for bacterial vaginosis include clindamycin preparations, oral metronidazole, and oral and intravaginal tablets of lactobacillus. Adverse effects of metronidazole include metallic taste, and nausea and vomiting. Information on possible side effects of lactobacillus preparations is required.

 

摘要

背景

抗生素治療非懷孕婦女細菌性陰道炎的療效

細菌性陰道炎(BV)是陰道炎非常常見的原因,且伴有高比例的產科及婦科併發症的及增加HIV1傳染的風險.這些因素引起人們重新研究BV治療的興趣.

目標

評估抗生素治療非懷孕婦女BV的療效

搜尋策略

我們搜尋Cochrane Central Register of Controlled Trials(CENTRAL)(The Cochrane Library), MEDLINE, EMBASE, LILACS, 及 African Healthline(2007年12月);相關國際會議的會議紀錄(1981年至今).

選擇標準

隨機對照試驗在符合臨床表現或葛蘭式染色準則的細菌性陰道炎的婦女,比較任兩種或兩種以上的抗菌藥物,或比較抗菌藥物與安慰劑或不給予治療.

資料收集與分析

兩位作者獨立評估試驗的品質,並且從原始文獻中摘錄資料,而這資料也由第三作者交叉檢驗.

主要結論

共回顧包含4422個參與者的24個試驗.大多數試驗只檢視有症狀的婦女. 只有7個試驗依照治療意向(intention to treat)的原則分析結果;我們重新分析其餘的試驗.與安慰劑比較, clindamycin能降低治療失敗率(相對危險(RR)0.25,95%CI0.16至0.37). Clindamycin及metronidazole不管藥劑型式為何,在第二週及第四週追蹤時都表現一樣的治療失敗率(分別為RR 1.01,95% CI 0.69 至 1.46;RR 0.91, 95% CI 0.70 至 1.18). Clindamycin副作用率較低(RR 0.75, 95% CI 0.56 至1.02);金屬味覺,噁心嘔吐在metronidazole組更常見(分別為RR 0.08, 95% CI 0.1 至 0.59;RR 0.23, 95% CI 0.10 to 0.51).經陰道給予的乳酸菌凝膠錠(gelatin tablets)比口服metronidazole有效(RR 0.20, 95% CI 0.05 to 0.08). 同樣地, 口服乳酸菌合併metronidazole比單獨使用metronidazole治療有效(RR 0.33, 95% CI 0.14 to0.77). Clindamycin比三合一磺胺乳膏臨床失敗率較低(RR 0.46, 95% CI 0.29 to 0.72). 雙氧水灌洗的臨床失敗率(RR 1.75, 95% CI 1.02 to 3.00)及副作用率(RR 2.33, 95% CI 1.21 to 4.52)都比一次性2克的metronidazole高

作者結論

各種Clindamycin製劑,口服metronidazole及口服與經陰道給予的乳酸菌錠劑,治療BV均有效. 雙氧水灌洗及三合一磺胺乳霜則無效. Metronidazole會引起金屬味覺,噁心及嘔吐.我們需要更良好的試驗設計,更大的樣本數去檢驗有潛力的藥物.

翻譯人

本摘要由慈濟醫院朱培元翻譯。

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

總結

無論有無症狀的陰道感染BV都是非常常見的原因. 它會伴隨高的產科及婦科併發症和提高HIV(人類免疫缺乏病毒)傳染風險。這篇回顧評估用抗微生物製劑治療非懷孕婦女的BV之效益及副作用。共回顧包含4422個參與者的24個試驗. 不論藥物的劑量為何, clindamycin治療失敗率低於安慰劑但與metronidazole相當. Metronidazole比clindamycin較高的副作用率, 像是金屬味覺及噁心嘔吐。口服乳酸菌合併metronidazole比單獨使用metronidazole有效. 乳酸菌的陰道凝膠錠也比口服metronidazole有效. 三合一磺胺乳霜效果不如clindamycin. 雙氧水灌洗不如2克單一劑的metronidazole有效卻會引起更多的傷害. 只有一個納入的試驗研究無症狀婦女，但結果不確定. 沒有足夠的證據對其他有潛力的藥物的效益做結論. 對於BV有效的藥物包含clindamycin製劑, 口服metronidazole, 口服及經陰道給予的乳酸菌錠劑. Metronidazole的副作用包括金屬味覺,噁心及嘔吐. 需要收集乳酸菌製劑可能副作用的相關資訊.