Continuous versus interrupted use of vaginal probiotics plus vaginal clindamycin cream for bacterial vaginosis: a randomized controlled study. 2021

Ibrahim Elsharkawy, and Elsayed Noureldin, and Ekramy Mohamed, and Ali Mohamed, and Hussein Abdeldayem, and Shymaa Abdelazim Mansour Mansour
Faculty of Human Medicine, Zagazig University, Zagazig, Egypt.

Purpose: To compare between continuous and interrupted use of vaginal probiotic after vaginal clindamycin cream for treatment and prevention of recurrence of bacterial vaginosis.Methods: A double-blinded randomized controlled clinical trial, 273 women were randomly allocated to use clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed after 1 week by continuous probiotics vaginal capsule once daily for 6 weeks (n = 129) or clindamycin 2% vaginal cream 5 g at bedtime for 7 days followed by one probiotic vaginal capsule twice a week for 6 weeks (n = 144). The initial evaluation was at 1 week after cessation of probiotics treatment to estimate the cure rates, the follow-up visits were at 1, 3, 6, and 9 months from the initial visit. The primary outcome of this study was cure rate; the secondary outcomes were the frequency of recurrence, the presence of vaginal discharge, pH > 4.5, positive whiff test and detection of clue cells.Results: At the initial visit there was no significant difference in cure rate between continuous probiotics group and interrupted probiotics group (87.4 versus 82.5%; p = .81). There was no significant difference between the two groups in the recurrence rate at one, three, six and 9 months follow up visits (p = .16, p = .42, p = .59, p = .66). There was no significant difference between both groups regarding vaginal discharge reduction, pH dropping, the presence of positive whiff test and detection of clue cells at one, three, six and 9 months follow up visits. Except at 9-month visits, the differences in vaginal discharge reduction and positive whiff test were statically significant.Conclusions: After initial treatment of bacterial vaginosis with vaginal clindamycin cream, the continuous use of vaginal probiotics is equally effective to short repetitive courses in terms of cure rates and prevention of relapse.

UI MeSH Term Description Entries
D009364 Neoplasm Recurrence, Local The local recurrence of a neoplasm following treatment. It arises from microscopic cells of the original neoplasm that have escaped therapeutic intervention and later become clinically visible at the original site. Local Neoplasm Recurrence,Local Neoplasm Recurrences,Locoregional Neoplasm Recurrence,Neoplasm Recurrence, Locoregional,Neoplasm Recurrences, Local,Recurrence, Local Neoplasm,Recurrence, Locoregional Neoplasm,Recurrences, Local Neoplasm,Locoregional Neoplasm Recurrences,Neoplasm Recurrences, Locoregional,Recurrences, Locoregional Neoplasm
D002981 Clindamycin An antibacterial agent that is a semisynthetic analog of LINCOMYCIN. 7-Chloro-7-deoxylincomycin,Chlolincocin,Chlorlincocin,Cleocin,Clindamycin Hydrochloride,Clindamycin Monohydrochloride,Clindamycin Monohydrochloride, Monohydrate,Dalacin C,7 Chloro 7 deoxylincomycin,Hydrochloride, Clindamycin,Monohydrate Clindamycin Monohydrochloride,Monohydrochloride, Clindamycin,Monohydrochloride, Monohydrate Clindamycin
D004311 Double-Blind Method A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment. Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked
D005260 Female Females
D006801 Humans Members of the species Homo sapiens. Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D000282 Administration, Intravaginal The insertion of drugs into the vagina to treat local infections, neoplasms, or to induce labor. The dosage forms may include medicated pessaries, irrigation fluids, and suppositories. Administration, Vaginal,Drug Administration, Vaginal,Instillation, Vaginal,Intravaginal Administration,Vaginal Drug Administration,Vaginal Administration,Administration, Vaginal Drug,Administrations, Intravaginal,Administrations, Vaginal,Administrations, Vaginal Drug,Drug Administrations, Vaginal,Instillations, Vaginal,Intravaginal Administrations,Vaginal Administrations,Vaginal Drug Administrations,Vaginal Instillation,Vaginal Instillations
D000900 Anti-Bacterial Agents Substances that inhibit the growth or reproduction of BACTERIA. Anti-Bacterial Agent,Anti-Bacterial Compound,Anti-Mycobacterial Agent,Antibacterial Agent,Antibiotics,Antimycobacterial Agent,Bacteriocidal Agent,Bacteriocide,Anti-Bacterial Compounds,Anti-Mycobacterial Agents,Antibacterial Agents,Antibiotic,Antimycobacterial Agents,Bacteriocidal Agents,Bacteriocides,Agent, Anti-Bacterial,Agent, Anti-Mycobacterial,Agent, Antibacterial,Agent, Antimycobacterial,Agent, Bacteriocidal,Agents, Anti-Bacterial,Agents, Anti-Mycobacterial,Agents, Antibacterial,Agents, Antimycobacterial,Agents, Bacteriocidal,Anti Bacterial Agent,Anti Bacterial Agents,Anti Bacterial Compound,Anti Bacterial Compounds,Anti Mycobacterial Agent,Anti Mycobacterial Agents,Compound, Anti-Bacterial,Compounds, Anti-Bacterial
D014622 Vaginal Creams, Foams, and Jellies Medicated dosage forms for topical application in the vagina. A cream is a semisolid emulsion containing suspended or dissolved medication; a foam is a dispersion of a gas in a medicated liquid resulting in a light, frothy mass; a jelly is a colloidal semisolid mass of a water soluble medicated material, usually translucent. Vaginal Creams, Foams and Jellies,Vaginal Cream,Vaginal Creams,Vaginal Foam,Vaginal Foams,Vaginal Gel,Vaginal Jellies,Vaginal Jelly,Vaginal Tablet,Vaginal Tablets,Cream, Vaginal,Creams, Vaginal,Foam, Vaginal,Foams, Vaginal,Gel, Vaginal,Gels, Vaginal,Jellies, Vaginal,Jelly, Vaginal,Tablet, Vaginal,Tablets, Vaginal,Vaginal Gels
D016585 Vaginosis, Bacterial Polymicrobial, nonspecific vaginitis associated with positive cultures of Gardnerella vaginalis and other anaerobic organisms and a decrease in lactobacilli. It remains unclear whether the initial pathogenic event is caused by the growth of anaerobes or a primary decrease in lactobacilli. Bacterial Vaginosis,Vaginitis, Bacterial,Vaginitis, Nonspecific,Bacterial Vaginitides,Bacterial Vaginitis,Bacterial Vaginoses,Vaginitides, Bacterial,Vaginoses, Bacterial,Nonspecific Vaginitis
D016896 Treatment Outcome Evaluation undertaken to assess the results or consequences of management and procedures used in combating disease in order to determine the efficacy, effectiveness, safety, and practicability of these interventions in individual cases or series. Rehabilitation Outcome,Treatment Effectiveness,Clinical Effectiveness,Clinical Efficacy,Patient-Relevant Outcome,Treatment Efficacy,Effectiveness, Clinical,Effectiveness, Treatment,Efficacy, Clinical,Efficacy, Treatment,Outcome, Patient-Relevant,Outcome, Rehabilitation,Outcome, Treatment,Outcomes, Patient-Relevant,Patient Relevant Outcome,Patient-Relevant Outcomes

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