Effectiveness of Oral Probiotics (Lactobacillus Rhamnosus Gr1 and Lactobacillus Reuteri RC14) as Adjuvant Therapy in Reproductive Aged Women with Vaginal Discharge

Abstract


 
 Objective: To investigate the efficacy of oral probiotics andprove the high proportion of cure and satisfaction levels ofpost-treatment patients with a combination of antimicrobialprobioticoral Lactobacillus rhamnosus GR-1 and Lactobacillusreuteri RC-14 compared to a combination of antimicrobialplaceboin the treatment of reproductive aged patients withvaginal discharge in the outpatient obstetrics and gynecologicclinic in Dr. Cipto Mangunkusumo Hospital, Jakarta, Indonesiaand Arifin Achmad Regional Hospital Pekanbaru, Riau,Indonesia.
 
 Methods: This was a randomized, double-blind, placebo-controlledtrial involving 50 subjects consisting of reproductive aged women.Data were collected using syndromic approach, probiotics weregiven as an adjuvant for standard antimicrobial therapy versusplacebo as control, response was recorded 4 weeks later, for cureproportion and satisfaction level. Statistical analysis was performedto assess the variables. Interim analysis with conditional powerassesment and futility testing were performed at midway due toinsufficient sample size. Research was approved by Ethics Commiteefor Health Researches Faculty of Medicine University of IndonesiaDr. Cipto Mangunkusumo Hospital in March 2016.
 
 Results: A total of 50 subjects participated in this study andanalyzed (25 subjects in each group), cure proportion 56% (14) ofthe treatment and 60% (15) on the control group, with relativerisk of 1.1, Chi-square test p value 0.77 (95% CI; 0.57 to 2 , 11).High satisfaction level (score 67) was higher in the placebo(52.6%, 10 subjects) compared to probiotic group (47.4%,9 subjects), p value 0.65 (0.05). Conditional power and futilitytesting curve, revealed Z = -0.2865, conditional power 0.11 to0.13, and futility index of 0.87 to 0.88, equals to low possibility ofstatistical significance with full sample size (84).
 
 Conclusion: There was no clinical and statistical difference in theproportion of cure rate and the level of satisfaction in patients ofprobiotics vs placebo groups after treatment for 4 weeks. Theinitial hypothesis of higher proportion of the cure rate in thetreatment group still cannot be excluded, due to insufficientsamples.
 
 Keywords: bacterial vaginosis, lactobacillus reuteri RC-14, lactobacillusrhamnosus GR-1, randomized double blind controlled trial,trichomoniasis, vaginal discharge, vulvovaginal candidiasis