No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
A Comparative Study of Oral Seven Day of Metronidazole Versus Tinidazole in Bacterial Vaginosis
Abstract
Background: Metronidazole has been the mainstay of treatment of BV. However, its drawback is the necessity to administer multiple doses of drug, thereby diminishing the compliance which results in risk of incomplete cure and recurrence of BV. Tinidazole, having a longer half life than metronidazole makes it suitable for a single dose therapy. Objective: To compare the efficacy of single dose of tinidazole with 7 days metronidazole for treatment of bacterial vaginosis and compare side effects of the drugs. Study design: This was a prospective, comparative, randomized clinical trial on 200 Indian women who attended a gynecology outpatient department with complaint of abnormal vaginal discharge or who had abnormal vaginal discharge on Gynecological examination but they did not complaint of it. For diagnosis and cure rate of bacterial vaginosis, Amsel's criteria were used. Result: There were no significant differences between the treatment arms. Overall cure rates at 14 days were 72.1% in the metronidazole group whereas 78.1% in the tinidazole group. There were no significant differences in adverse events across treatment arms. Conclusions: There were no significant differences in cure rates of metronidazole and the tinidazole dosing regimens studied. In addition, there were no important differences in the side effect profiles of metronidazole and tinidazole. © 2015, Indian Journal of Public Health Research and Development. All Rights Reserved.
... Despite several studies, the efficacy of tinidazole compared to metronidazole remains unclear [7][8][9][10][11][12]. Individual trials lack sufficient power to detect significant differences in cure outcomes and adverse events. ...
... After removal of duplicate records and ineligible studies, 12 remained and were fully reviewed based on inclusion criteria. Of these, a total of 6 studies were included, comprising 1036 patients from 5 randomized controlled trials (RCTs) [7,[9][10][11][12], and 1 non-randomized study [8]. A total of 511 (49%) patients received tinidazole and 525 (51%) received metronidazole. ...
... RCTs were assessed using Rob2 [14]. Five studies lost points in domains related to lack of information or loss to follow-up [7,[9][10][11][12]. A non-randomized study was evaluated using Robins-I and was considered to have a serious risk of bias due to the important confounding bias due to the inclusion of patients with trichomoniasis, along with bacterial vaginosis [8]. ...
Introduction
Tinidazole shows potential as a first-line treatment for bacterial vaginosis (BV). However, its superiority to metronidazole remains uncertain. Therefore, this meta-analysis compares tinidazole versus metronidazole in patients with BV.
Methods
We systematically searched PubMed, Embase and Cochrane for studies comparing tinidazole and metronidazole in patients with BV. Statistical analyses were performed using R Studio 4.3.2. Heterogeneity was examined with the Cochran Q test and I² statistics. Risk ratios (RR) with 95% confidence intervals (CI) were pooled across trials. Outcomes of interest were BV cure at the first and the second follow-up appointment, and adverse events such as nausea and bad or metallic taste.
Results
Five randomized controlled trials and 1 prospective observational study, reporting data on 1,036 patients were included in this meta-analysis. Among them, 511 (49%) received tinidazole and 525 (51%) received metronidazole. Follow-up ranged from 1 to 6 weeks. There was no significant difference between groups for BV cure at the first follow-up appointment (RR 1.03; 95% CI 0.92 to 1.14; I² = 76%), cure at the second follow-up appointment (RR 1.05; 95% CI 0.80–1.38; I² = 88%), nausea (RR 0.89; 95% CI 0.39–2.04; I² = 83%), and bad or metallic taste (RR 0.74; 95% CI 0.12–4.45; I² = 89%).
Conclusion
In patients with BV, tinidazole and metronidazole exhibit similar efficacy and safety, with equivalent cure rates and incidence of adverse events.
A comparative study of the treatment of nonspecific vaginitis was carried out in 171 reproductive-aged women. The patients were randomly treated with either metronidazole or tinidazole (Ninety-three patients in Group I, received oral metronidazole 1 g daily for 7 days. Another 78 patients in Group II, received oral tinidazole 2 g single dose. The patients were advised to return for follow-up examinations 1-2 weeks after treatment in their nonmenstrual period. Of these, 50 patients in each group were subject to complete study. The cure rates were 92 per cent in Group I and 86 per cent in Group II. The difference was not significant statistically. The adverse drug reactions among the two groups were 22 and 8 per cent respectively. Tinidazole is another effective drug for the treatment of nonspecific vaginitis.
Anaerobic infections of the upper genital tract are common. Antibiotic regimens designed to inhibit anaerobes markedly reduce
morbidity. A vaginal infection associated with an increased concentration of anaerobic bacteria (bacterial vaginosis) has
been recently linked to a wide variety of upper genital tract infections. Bacterial vaginosis has an important role in the
development of clinical chorioamnionitis, postpartum endometritis, posthysterectomy vaginal-cuff cellulitis, postabortion
pelvic inflammatory disease, and upper genital tract infections such as amniotic fluid infection and chorioamnion infection
associated with premature delivery.
A prospective cohort study was conducted to examine the relationship between vaginal colonization with lactobacilli, bacterial
vaginosis (BV), and acquisition of human immunodeficiency virus type 1 (HIV-1) and sexually transmitted diseases in a population
of sex workers in Mombasa, Kenya. In total, 657 HIV-1—seronegative women were enrolled and followed at monthly intervals.
At baseline, only 26% of women were colonized with Lactobacillus species. During follow-up, absence of vaginal lactobacilli on culture was associated with an increased risk of acquiring
HIV-1 infection (hazard ratio [HR], 2.0; 95% confidence interval [CI], 1.2–3.5) and gonorrhea (HR, 1.7; 95% CI, 1.1–2.6),
after controlling for other identified risk factors in separate multivariate models. Presence of abnormal vaginal flora on
Gram's stain was associated with increased risk of both HIV-1 acquisition (HR, 1.9; 95% CI, 1.1–3.1) and Trichomonas infection (HR, 1.8; 95% CI, 1.3–2.4). Treatment of BV and promotion of vaginal colonization with lactobacilli should be evaluated
as potential interventions to reduce a woman's risk of acquiring HIV-1, gonorrhea, and trichomoniasis.
To assess the effectiveness at 21-30 days after treatment of tinidazole administered orally at 1 g once daily for 5 days and 2 g once daily for 2 days, compared with placebo, in the treatment of bacterial vaginosis, using rigorous U.S. Food and Drug Administration (FDA)-recommended criteria to define cure.
A total of 235 women at 10 U.S. centers participated in this prospective, randomized, double-blinded, placebo-controlled trial. Presence or absence of all five following criteria was required to define diagnosis or cure of bacterial vaginosis: 1) clue cells were at least 20% of squamous cells in microscopic examination of vaginal fluid; 2) positive potassium hydroxide whiff test; 3) a homogeneous, thin, white-gray vaginal discharge; 4) vaginal pH greater than 4.5; and 5) Nugent score greater than or equal to 4 on Gram-stained vaginal fluid. Compliance, tolerability, and safety were assessed using patient diaries and interviews at 8-10 days and 21-30 days after treatment. Cochran-Mantel-Haenszel statistical analysis with Bonferroni adjustment was used to compare outcomes.
Superior efficacy was demonstrated by tinidazole for the 1 g once daily for 5 days regimen (36.8% cured, P<.001, number needed to treat 3.2) and for the 2 g once daily for 2 days regimen (27.4% cured, P<.001, number needed to treat 4.5), when compared with placebo (5.1% cured) in the primary endpoint analysis. Using more traditional criteria for cure, efficacy was greater. Compliance with study therapy and tolerability were comparable in the three treatment groups.
Both tinidazole regimens studied provided effective treatment for bacterial vaginosis.
ClinicalTrials.gov, www.clinicaltrials.gov, NCT00229216
I.