Probiotics for the treatment of bacterial vaginosis

 

Abstract

Background

The dominance of lactobacilli in healthy vaginal microbiota and its depletion in bacterial vaginosis (BV) has given rise to the concept of oral or vaginal instillation of probiotic Lactobacillus strains for the management of this condition.

Objectives

To ascertain the efficacy of probiotics in the treatment of BV.

Search methods

We searched electronic databases irrespective of publication status or language. These included: Cochrane Central Register of Controlled Trials (CENTRAL), the HIV/AIDS and STD Cochrane Review Groups' specialized registers, the Cochrane Complementary Medicine Field's Register of Controlled Trials, MEDLINE (1966 to 2008), EMBASE (1980 to 2007), ISI science citation index (1955 to 2007), CINAHL (Cumulative Index to Nursing & Allied Health Literature (1982 to 2007).

We handsearched of specialty journals, conference proceedings and publications list on the website of the International Scientific Association of Probiotics and Prebiotics (http://www.isapp.net/default.asp).

For unpublished studies or ongoing trials, we contacted authors from relevant publications, nutraceutical companies and probiotic-related scientific associations. We searched electronic databases on ongoing clinical trials.

Selection criteria

Randomized controlled trials using probiotics for the treatment of women of any age diagnosed with bacterial vaginosis, regardless of diagnostic method used. The probiotic preparation could be single or "cocktail" of strains, any preparation type/dosage/route of administration. Studies comparing probiotics with placebo, probiotics used in conjunction with conventional antibiotics compared with placebo or probiotics alone compared with conventional antibiotics were eligible for inclusion.

Data collection and analysis

We screened titles and abstracts , obtained full reports of relevant trialsand independently appraised them for eligibility. A data extraction form was used to extract data from the four included studies. For dichotomous outcomes, odds ratios (OR) and 95% confidence intervals (CI) were derived for each study using RevMan (versions 4.2 and 5). We did not perform meta-analysis due to significant differences in the probiotic preparations and trial methodologies.

Main results

Analysis suggests beneficial outcome of microbiological cure with the oral metronidazole/probiotic regimen (OR 0.09 (95% CI 0.03 to 0.26)) and the probiotic/estriol preparation (OR 0.02, (95% CI 0.00 to 0.47)). For the probiotic/estriol preparation, the OR and 95% CI for physician-reported resolution of symptoms was OR 0.04 (95% CI 0.00 to 0.56).

Authors' conclusions

The results do not provide sufficient evidence for or against recommending probiotics for the treatment of BV. The metronidazole/probiotic regimen and probiotic/estriol perparation appear promising but well-designed randomized controlled trials with standardized methodologies and larger patient size are needed.

 

Plain language summary

Probiotics for the treatment of bacterial vaginosis

Bacterial vaginosis (BV) is one of the most common causes of genital discomfort in women of reproductive age. This condition occurs when there is an imbalance in the population of normal vaginal micro-organism with depletion of the dominant lactobacilli and overgrowth of other types of bacteria. Treatment of this condition using recommended antibiotics is often associated with failure and high rates of recurrence. This led to the concept of replacing the depleted lactobacilli using probiotic strains as a treatment approach. This review investigated the evidence for the use of probiotic preparations either alone or in conjunction with antibiotics for the treatment of BV. The current research does not provide conclusive evidence that probiotics are superior to or enhance the effectiveness of antibiotics in the treatment of BV. In addition, there is insufficient evidence to recommend the use of probiotics either before, during or after antibiotic treatment as a means of ensuring successful treatment or reduce recurrence. Larger, well-designed randomized controlled trials with standardized methodologies are needed to confirm the benefits of probiotics in the treatment of BV.

 

摘要

背景

以益生菌(Probiotics)治療細菌性陰道炎(bacterial vaginosis)

健康人的陰道內細菌以乳酸菌(lactobacilli)為主，在感染細菌性陰道炎時乳酸菌則幾乎消失不見。因此產生一種以口服、或在陰道內引進乳酸菌種益生菌來處理細菌性陰道炎的想法。

目標

驗證以益生菌治療細菌性陰道炎之效果。

搜尋策略

我們搜尋電子資料庫中無論是否已發表之所有語言的文獻，包括Cochrane Central Register of Controlled Trials (CENTRAL), the HIV/AIDS and STD Cochrane Review Groups'specialized registers, the Cochrane Complementary Medicine Field's Register of Controlled Trials, MEDLINE (1966年至2008年), EMBASE (1980年至2007年), ISI science citation index (1955年至2007年),以及CINAHL (Cumulative Index to Nursing& Allied Health Literature (1982年至2007年). 我們也以人工方式搜尋專科期刊、研討會論文，以及在International Scientific Association of Probiotics and Prebiotics (http://www.isapp.net/default.asp)網站上列舉之論文。對於未發表或正在進行中之研究我們也聯絡作者、業者及相關學會。我們搜尋進行中臨床試驗的電子資料庫。

選擇標準

不論患者之年紀或診斷方法，凡是以益生菌治療細菌性陰道炎之隨機對照試驗(Randomized controlled trials)。使用單一或混和益生菌、劑量或給藥途徑均不拘。比較益生菌與安慰劑、與傳統抗生素並用和安慰劑比較或單獨使用益生菌與傳統抗生素比較者均包括在內。

資料收集與分析

我們過濾標題與摘要，取得相關研究的全文，並獨立評估是否應納入分析。我們以一種資料擷取表格將4個被收錄的研究資料擷取出來。對於二分法(dichotomous)的結果則以Rev Man (4.2 及 5版)計算其odds ratios (OR)和 95% CI。因為益生菌製劑及試驗方法的差異相當大，我們並未進行統合分析(metaanalysis)。

主要結論

口服的metronidazole/probiotic(OR 0.09 (95%CI 0.03 to 0.26)) 或probiotic/estriol (OR 0.02,(95% CI 0.00 to 0.47)治療，有助於清除細菌。以probiotic/estriol治療時，醫師報告症狀消除的OR為 0.04 (95% CI 0.00 to 0.56).

作者結論

結果並未提供足夠的證據至支持或反對以益生菌治療細菌性陰道炎。metronidazole/probiotic 及 probiotic/estriol 似乎會有效，但仍待樣本夠大、設計良好及符合標準方式進行的臨床試驗來證實。

翻譯人

本摘要由慈濟醫院葉日弌翻譯。

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

總結

以益生菌療細菌性陰道炎: 菌療細菌性陰道炎是育齡婦女生殖道不適最常見的原因之ㄧ。這種情況常出現於陰道微生物不平衡時，正常情況下居優勢的乳酸桿菌消失而其他細菌過度射繁殖。使用建議的抗生素治療常失敗且富發率高。因此產生一種以益生菌取代正常乳酸菌來治療的想法。本回顧探討單獨以益生菌或合併抗生素來治療細菌性陰道炎的證據。現有研究並未提供益生菌治療細菌性陰道炎的效果比抗生素好，或能增強抗生素效果的確切證據。此外,也沒有足夠證據建議在抗生素使用前後,或同時使用能提高成功率或減少復發率。需要樣本較大、設計良好及符合標準方式進行的臨床試驗來證實益生菌菌療細菌性陰道炎的好處。