Systematic review of randomized trials of treatment of male sexual partners for improved bacteria vaginosis outcomes in women. 2012

Supriya D Mehta
Division of Epidemiology and Biostatistics, University of Illinois at Chicago, Chicago, IL, USA. supriyad@uic.edu

BACKGROUND Bacterial vaginosis (BV) affects 10% to 30% of women and recurs in 15% to 30% within 3 months after treatment. BV is not considered an sexually transmitted infection, and treatment of the male sexual partner is not recommended. This recommendation is based on the results of 6 randomized controlled trials (RCTs) of male partner treatment for reducing BV recurrence, which did not find a uniformly beneficial effect. These results are incongruous with epidemiologic and microbiologic data suggesting a sexually transmissible component of BV. In light of this disconnect, the 6 RCTs of male treatment were reviewed to assess validity. METHODS Trials are summarized according to Consolidated Standards of Reporting Trials guidelines. Absolute differences and risk ratios with binomially obtained 95% confidence intervals were estimated. Post hoc power analyses determined the probability of rejecting the null hypothesis for observed relative effect sizes and for the smallest relative effect size detectable with ≥ 80% power. RESULTS Each of the 6 RCTs had significant flaws: randomization methods were either overtly deficient or insufficiently reported; 5 RCTs used suboptimal treatment regimens in women; adherence to treatment in women was not reported in any trial, and adherence in men was reported in only 2 trials; all 6 trials had limited power. None assessed whether antibiotic treatment affected the penile microbiota. CONCLUSIONS Although the RCT is the gold standard for assessing efficacy, biased results can mislead decision making. By current standards, it is unlikely that the results of any of these trials would be considered conclusive. Specific recommendations are made to examine whether BV-associated bacteria may be sexually transferred.

UI MeSH Term Description Entries
D008297 Male Males
D010413 Penis The external reproductive organ of males. It is composed of a mass of erectile tissue enclosed in three cylindrical fibrous compartments. Two of the three compartments, the corpus cavernosa, are placed side-by-side along the upper part of the organ. The third compartment below, the corpus spongiosum, houses the urethra. Glans Penis,Penis, Glans
D012008 Recurrence The return of a sign, symptom, or disease after a remission. Recrudescence,Relapse,Recrudescences,Recurrences,Relapses
D002944 Circumcision, Male Excision of the prepuce of the penis (FORESKIN) or part of it. Male Circumcision,Circumcisions, Male,Male Circumcisions
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000287 Administration, Topical The application of drug preparations to the surfaces of the body, especially the skin (ADMINISTRATION, CUTANEOUS) or mucous membranes. This method of treatment is used to avoid systemic side effects when high doses are required at a localized area or as an alternative systemic administration route, to avoid hepatic processing for example. Drug Administration, Topical,Administration, Topical Drug,Topical Administration,Topical Drug Administration,Administrations, Topical,Administrations, Topical Drug,Drug Administrations, Topical,Topical Administrations,Topical Drug Administrations
D000891 Anti-Infective Agents, Local Substances used on humans and other animals that destroy harmful microorganisms or inhibit their activity. They are distinguished from DISINFECTANTS, which are used on inanimate objects. Anti-Infective Agents, Topical,Antiseptic,Antiseptics,Microbicides, Local,Microbicides, Topical,Antiinfective Agents, Local,Antiinfective Agents, Topical,Local Anti-Infective Agents,Local Antiinfective Agents,Topical Anti-Infective Agents,Topical Antiinfective Agents,Agents, Local Anti-Infective,Agents, Local Antiinfective,Agents, Topical Anti-Infective,Agents, Topical Antiinfective,Anti Infective Agents, Local,Anti Infective Agents, Topical,Local Anti Infective Agents,Local Microbicides,Topical Anti Infective Agents,Topical Microbicides
D012307 Risk Factors An aspect of personal behavior or lifestyle, environmental exposure, inborn or inherited characteristic, which, based on epidemiological evidence, is known to be associated with a health-related condition considered important to prevent. Health Correlates,Risk Factor Scores,Risk Scores,Social Risk Factors,Population at Risk,Populations at Risk,Correlates, Health,Factor, Risk,Factor, Social Risk,Factors, Social Risk,Risk Factor,Risk Factor Score,Risk Factor, Social,Risk Factors, Social,Risk Score,Score, Risk,Score, Risk Factor,Social Risk Factor
D012725 Sexual Behavior Sexual activities of humans. Anal Sex,Oral Sex,Sexual Activity,Sexual Orientation,Premarital Sex Behavior,Sex Behavior,Sex Orientation,Sexual Activities,Activities, Sexual,Activity, Sexual,Behavior, Premarital Sex,Behavior, Sex,Behavior, Sexual,Orientation, Sexual,Sex, Anal,Sex, Oral

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