OBJECTIVE: To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN: Randomised clinical trial. SETTING: 30 general practices in the Netherlands. PATIENTS: 125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES: Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS: Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS:Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication.
RCT Entities:
OBJECTIVE: To compare the effect of lactic acid locally, metronidazole orally and placebo in women with bacterial vaginosis. DESIGN: Randomised clinical trial. SETTING: 30 general practices in the Netherlands. PATIENTS: 125 women consulting the general practitioner for symptomatic bacterial vaginosis. MAIN OUTCOME MEASURES: Duration of subjective symptoms, recurrence of symptoms, clinically diagnosed cure, adverse events. RESULTS: Survival analysis showed a significantly faster disappearance of symptoms in the metronidazole category compared with both lactic acid and placebo (p = 0.0005 metronidazole v placebo, p = 0.0002 metronidazole v lactic acid p = 0.6521 lactic acid v placebo [The stratified Mantel Cox test]). The median duration until absence of symptoms was 21 days for metronidazole and 80 days for placebo. Disappearance of symptoms did not occur in 50% of the lactic acid group in 90 days. Recurrence rates of symptoms were similar over the treatment categories (p = 0.13 metronidazole v placebo and p = 0.12 lactic acid v placebo). After 2 weeks cure rates (cure defined as less than three of four clinical criteria present) were 83%, 49% and 47% for metronidazole, lactic acid and placebo category respectively. At that time cure rates (cure defined as none of three clinical criteria present) were 10%, 0% and 3%. After four weeks and three months these figures were: 55%, 20%, 20% and 64%, 28%, 28%. No differences in adverse events were found between the three interventions. CONCLUSIONS:Lactic acid suppositories are ineffective, metronidazole capsules are effective on signs and symptoms in bacterial vaginosis. A considerable proportion of the patients recover without active medication.
Authors: Jose A Simoes; Luis G Bahamondes; Rodrigo P S Camargo; Valeria M N Alves; Lourens J D Zaneveld; Donald P Waller; Jill Schwartz; Marianne M Callahan; Christine K Mauck Journal: Br J Clin Pharmacol Date: 2006-02 Impact factor: 4.335
Authors: C van der Veer; S M Bruisten; R van Houdt; A A Matser; G Tachedjian; J H H M van de Wijgert; H J C de Vries; J J van der Helm Journal: BMC Microbiol Date: 2019-07-25 Impact factor: 3.605
Authors: Lindsay Armstrong-Buisseret; Clare Brittain; Miruna David; Gillian Dean; Frances Griffiths; Trish Hepburn; Louise Jackson; Joe Kai; Alan Montgomery; Tracy Roberts; Sukhwinder Thandi; Jonathan D C Ross Journal: Trials Date: 2019-11-27 Impact factor: 2.279
Authors: J D Sobel; W Chaim; J Thomason; C Livengood; R Sweet; J A McGregor; D Eschenbach; S Hillier; R Galask; S Faro; E Shangle; D Baker Journal: Infect Dis Obstet Gynecol Date: 1996