Methods
Objectives
The overall objective is to summarize currently available data (published up to December 31 2010) on the efficacy and tolerability of antiseptics and disinfectants in the treatment of BV, thereby accounting for the quality of the clinical trials identified through a systematic literature search.
Search Strategy
An electronic search was conducted by consulting the following databases: PubMed (1966–2010), CINAHL (1982–2010), International Pharmaceutical Abstracts (IPA) database (1970–2010), and the Cochrane Central Register of Controlled Trials.
Clinical trials were searched for by use of the key words "bacterial vaginosis" and "non-specific vaginitis" in combination with "disinfectant", "antiseptic", and subsequently with all generic names of antiseptics and disinfectants listed in the Anatomical Therapeutic Chemical (ATC) Classification System under the code D08A (Antiseptics and disinfectants), i.e. ethacridine lactate, aminoacridine, euflavine, aluminium agents, dibrompropamidine, chlorhexidine, propamidine, hexamidine, polyhexanide, boric acid, hexachlorophene, policresulen, phenol, triclosan, chloroxylenol, biphenylol, nitrofural, iodine/octylphenoxypolyglycolether, povidone-iodine, iodine, diiodohydroxypropane, dequalinium, chlorquinaldol, oxyquinoline, clioquinol, benzalkonium, cetrimonium, cetylpyridinium, cetrimide, benzoxonium chloride, didecyldimethylammonium chloride, benzethonium chloride, octenidine, benzethonium chloride, dodeclonium bromide, mercuric amidochloride, phenylmercuric borate, mercuric chloride, mercurochrome, mercury, thiomersal, mercuric iodide, phenylmercuric borate, silver nitrate, silver, hydrogen peroxide, eosin, propanol, tosylchloramide sodium, isopropanol, potassium permanganate, sodium hypochlorite, and ethanol.
In addition we accounted for benzydamine which is listed under ATC code G02CC03 for "anti-inflammatory products for vaginal administration", considering benzydamine also has broad antimicrobial activity.
Only English-language studies were considered for review. Additional studies were searched for by checking cross-references cited in the primary studies. No efforts were made to identify unpublished studies.
Types of Studies
Reports were considered eligible if they involved clinical trials in which the efficacy and tolerability of antiseptics and disinfectants in the treatment of BV was assessed in comparison to placebo or in comparison to standard antibiotic treatment with metronidazole or clindamycin.
Studies were considered eligible if at least 40 study participants had been enrolled for comparison between the two treatment arms.
Types of Participants
Women of any age diagnosed with bacterial vaginosis through standardized criteria like Amsel's or Nugent criteria.[5,6] No study was excluded because of (possible) co-infection with sexually transmitted infections.
Types of Intervention
We confined our review to antiseptics and disinfectants for which the dosage and treatment regimen was specified, and which are listed in the Anatomical Therapeutic Chemical (ATC) Classification System under the code D08A ("antiseptics and disinfectants"). In addition we accounted for benzydamine which is listed under ATC code G02CC03 for "anti-inflammatory products for vaginal administration", considering benzydamine also has broad antimicrobial activity. Hence, we excluded any report in which any antiseptic product (e.g. herbal medicines) was used for which the chemical composition and/or substance dose was not verifiable. Treatment with an antiseptic or disinfectant was considered in any preparation type, any dosage regimen, and any route of administration.
Types of Outcome Measures
The primary outcome was cure of bacterial vaginosis as assessed through use of the Amsel criteria or Nugent criteria at least 7 days following treatment initiation. Cure was defined as a Nugent score <7 or the presence of less than 3 Amsel criteria. The secondary outcome was the occurrence of adverse reactions or side effects, with special regard to vaginal symptoms following local administration of antiseptics.
Risk of Bias in Included Studies
As indicated by the PRISMA guidelines no efforts were made to label the quality of studies in a (semi-)quantitative matter.[7] Rather, the Cochrane Collaboration tool for assessing risk of bias was applied to assess the risk of various sources of bias among the included studies.[8]
BMC Infect Dis © 2012 BioMed Central, Ltd.
