Clindamycin versus metronidazole in the treatment of bacterial vaginosis. Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial. A new approach for the treatment of bacterial vaginosis: use of polyhexamethylene biguanide. A prospective, randomized study. Bacterial vaginosis: treatment with topical intravaginal clindamycin phosphate. Bacterial vaginosis: treatment with clindamycin cream versus oral metronidazole. Efficacy of clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis. Placebo-controlled trial of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis. A double-blind treatment study of bacterial vaginosis with normal vaginal lactobacilli after an open treatment with vaginal clindamycin ovules. Augmentation of antimicrobial metronidazole therapy of bacterial vaginosis with oral probiotic Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14: randomized, double-blind, placebo controlled trial. Low-dose secnidazole in the treatment of bacterial vaginosis. Antimicrobial resistance associated with the treatment of bacterial vaginosis. Asymptomatic bacterial vaginosis: response to therapy. A randomized trial of the duration of therapy with metronidazole plus or minus azithromycin for treatment of symptomatic bacterial vaginosis. Local treatment of bacterial vaginosis with a bioadhesive metronidazole tablet. A placebo-controlled, double-blind comparison of tinidazole and triple sulfonamide cream for the treatment of nonspecific vaginitis. Cefadroxil as an alternative to metronidazole in the treatment of bacterial vaginosis. Comparison of clindamycin phosphate vaginal cream with triple sulfonamide vaginal cream in the treatment of bacterial vaginosis. Clinical study comparing probiotic Lactobacillus GR-1 and RC-14 with metronidazole vaginal gel to treat symptomatic bacterial vaginosis. Seven day metronidazole versus single dose tinidazole as therapy for nonspecific vaginitis. Clindamycin vaginal cream versus oral metronidazole in the treatment of bacterial vaginosis: a prospective double-blind clinical trial.
One hundred forty-three women with complaints of vaginitis were assigned to receive either 500 mg of metronidazole twice daily for 7 days or clindamycin 300 mg twice daily for 7 days. There was no significant difference in the failure rate between patients treated with clindamycin (6.1%) and those treated with metronidazole (4%). Adverse reactions were infrequent and mild in both treatment groups. Three patients who received clindamycin developed non-bloody diarrhea, which was mild and did not necessitate discontinuing therapy. We conclude that clindamycin may be a safe and effective alternative to metronidazole for treating women with bacterial vaginosis. To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis.
                Women with bacterial vaginosis received either 100-mg ovules of clindamycin (intravaginally for 3 consecutive days) plus placebo capsules (orally twice daily for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice daily for 7 days) plus placebo ovules (intravaginally for 3 consecutive days). The sample was determined prospectively to provide a probability of.84 of correctly concluding that the rate of success for clindamycin is not more than 15% less than the expected 75% success rate for metronidazole. Clinical outcome was determined on the basis of vaginal fluid amine odor and clue cells.
                Of the 399 patients enrolled, 233 could be evaluated for efficacy. Of those, 77 (68.1%) of 113 patients were cured with clindamycin, compared with 80 (66. 7%) of 120 who were cured with metronidazole (95% confidence interval -10.6%, 13.4%; P =.810). Treatment-related adverse events were reported more frequently in the metronidazole treatment group. Systemic symptoms, such as nausea and taste perversion, accounted for most of the difference between groups.
                A 3-day regimen of clindamycin, given as intravaginal ovules, was as effective as and better tolerated than a 7-day regimen of oral metronidazole 500 mg, given twice daily, for treatment of bacterial vaginosis. Bacterial vaginosis (BV) is the most common vulvovaginal infection and represents the 35% of all the infections occurring in women in the reproductive age. It is well recognised that serious forms of BV can induce several complications among women undergoing gynaecologic or obstetric surgery, having pelvic inflammatory diseases, temporary or absolute infertility, miscarriage and abortion. At present, the clinical treatment of choice of BV is the use of systemic or local (gel or cream) metronidazole and clindamycin, though systemic use has some limitations due to side-effects and contraindications. Polyhexamethylene biguanide (PHMB) is a new bi-biguanide compound having a broad spectrum activity and low toxicity, that have been successfully utilized in ophthalmology and dentistry. Aim of this study was to evaluate the efficacy and tolerability of a single-dose vaginal administration of a PHMB vaginal gel in the treatment of BV in comparison to clindamycin vaginal cream.
                One-hundred and ten patients affected by BV were treated with PHMB vaginal gel in single administration or clindamycin vaginal cream 1 daily administration for 7 days.
                We demonstrated the therapeutic efficacy of mono-dose administration of a vaginal solution containing PHMB in BV treatment; this efficacy is similar to the one shown in antibiotic therapy. Furthermore, this product was well tolerated by all treated patients.
                Mono-dose PHMB treatment should be regarded as the therapy of choice for BV, using clindamycin and metronidazole only for relapses treatment. We tested topical intravaginal clindamycin phosphate at concentrations of 0.1, 1.0, and 2.0% in the treatment of 62 women with symptomatic bacterial vaginosis in a prospective, randomized, double-blind, placebo-controlled trial, and offered open-label treatment with 1.0% clindamycin to patients with persistent disease after blinded treatment. Blinded intravaginal clindamycin phosphate treatment cured bacterial vaginosis in 93.5% (43 of 46) of patients 4-7 days after therapy, compared with 25.0% (four of 16) of patients receiving placebo (P less than .001). One month later, 89.7% (35 of 39) of those who initially responded to clindamycin treatment showed persistent cure. There were no significant side effects. In a randomized, double-blind study, 48 women with symptomatic bacterial vaginosis were assigned to receive either 5 g of 2% clindamycin vaginal cream daily or 500 mg metronidazole oral tablets twice a day for 7 days. After completion of therapy, there was no significant difference in cure rates (clindamycin 72% versus metronidazole 87%). One month later, 61% of the patients in each group were still cured. Adverse reactions were mild in both groups. We conclude that clindamycin cream is a safe, well tolerated, and effective alternative to oral metronidazole for treatment of bacterial vaginosis. To compare the efficacy and tolerance with 2% clindamycin vaginal cream versus oral metronidazole for the treatment of bacterial vaginosis.
                This was a multicenter, randomized, double-blind study in which patients were randomly assigned to one of the following two regimens in a 1:1 ratio: clindamycin phosphate vaginal cream 2% (5 g intravaginally at bedtime for 7 days) plus two placebo capsules (twice a day for 7 days) or metronidazole 500 mg (two 250-mg capsules orally twice a day for 7 days) plus placebo vaginal cream (5 g intravaginally at bedtime for 7 days). The patients were seen for follow-up at 5-10 days and 25-39 days after completion of therapy.
                Seven investigators, four in Germany, two in Austria, and one in Switzerland, enrolled 407 patients. Four patients never received either protocol drug, leaving 403 evaluable for safety. Two hundred thirty-four patients were evaluable for efficacy. The analysis for all evaluable patients showed no significant difference between treatment groups. The cure or improvement rate at 1 month after therapy was 83% in the clindamycin group versus 78% in the metronidazole group. The incidence of drug-related adverse medical events was approximately 12% in both groups.
                Oral metronidazole and intravaginal clindamycin cream had a similar efficacy of 78 to 83%. Both drugs were tolerated, with vaginal candidiasis developing in 8.5 and 4.7% of the patients in the clindamycin and metronidazole groups, respectively. To compare the safety and efficacy of intravaginal clindamycin 2% cream with placebo in nonpregnant women with bacterial vaginosis.
                A randomized, double-blind, placebo-controlled clinical trial.
                Ambulatory patients in the general community.
                Two hundred fifteen nonpregnant outpatients with a diagnosis of bacterial vaginosis were entered into this study. Of the 134 evaluable patients, 65 received clindamycin and 69 placebo. Demographic parameters were comparable between the two treatment groups.
                Study subjects were equally randomized to receive either 5 g of clindamycin 2% vaginal cream or placebo cream for seven nights.
                Clinical and microbiologic follow-up evaluations were scheduled for 5-10 days and 25-39 days posttreatment. Patients were interviewed about signs and symptoms, adverse events, and compliance. Diagnostic examinations were performed.
                Clinical success rates (cure and improvement) occurred in 50 of 65 patients who received clindamycin (77 percent) and 17 of 69 patients who received placebo (25 percent) by the first posttreatment visit (p < 0.001). Microbiologic cures or improvement were observed in 59 of the 65 patients treated with clindamycin (91 percent) compared with 20 of 69 placebo-treated patients (29 percent) (p < 0.001). At the end of the study, clinical and microbiologic cures or improvement were evident in 45 of 57 (79 percent) and 37 of 57 clindamycin-treated patients (65 percent), respectively, and 18 of 51 (35 percent) and 14 of 51 (28 percent) of the placebo-treated patients, respectively. The success rates with clindamycin 2% cream were statistically higher than those with placebo. The adverse-effect profiles in the two groups were similar and no serious adverse effects were reported. Patients who received clindamycin had a statistically higher incidence of nonbacterial vaginitis/cervicitis (18.5 vs. 7.5 percent, p = 0.003).
                Intravaginal clindamycin 2% cream appears to be an effective and safe treatment of symptomatic bacterial vaginosis in nonpregnant women. The expected 4-week cure rate after conventional treatment of bacterial vaginosis are only 65-70%. In an attempt to improve the cure rate by adding probiotic lactobacilli we performed a double-blind placebo-controlled study of adjuvant lactobacilli treatment after an open treatment with vaginal clindamycin ovules. Women with bacterial vaginosis as defined by Amsel's criteria were treated with clindamycin ovules. Vaginal smears were collected and analysed according to Nugent's criteria. During the following menstruation period the women used, as an adjuvant treatment, either lactobacilli-prepared tampons or placebo tampons. The lactobacilli tampons were loaded with a mixture of freeze-dried L. fermentum, L. casei var. rhamnosus and L. gasseri. The cure rate was recorded after the second menstruation period. There was no improvement in the cure rate after treatment with lactobacilli-containing tampons compared to placebo tampons; the cure rates as defined by Amsel's criteria were 56% and 62%, respectively, and 55% and 63%, as defined by Nugent's criteria. This is the first study to report cure rates for women with 'intermediate' wet smear ratings according to Nugent's classification and this group had an overall cure rate of 44%. The cure rate of treatment of bacterial vaginosis was not improved by using lactobacilli-prepared tampons for one menstruation. This study enrolled 125 premenopausal women diagnosed with bacterial vaginosis (BV) by presence of vaginal irritation, discharge and 'fishy' odor, and Nugent criteria and detection of sialidase enzyme. The subjects were treated with oral metronidazole (500 mg) twice daily from days 1 to 7, and randomized to receive oral Lactobacillus rhamnosus GR-1 (1 x 10(9)) and Lactobacillus reuteri RC-14 (1 x 10(9)) or placebo twice daily from days 1 to 30. Primary outcome was cure of BV as determined by normal Nugent score, negative sialidase test and no symptoms or signs of BV at day 30. A total of 106 subjects returned for 30-day follow-up, of which 88% were cured in the antibiotic/probiotic group compared to 40% in the antibiotic/placebo group (p<0.001). Of the remaining subjects, 30% subjects in the placebo group and none in the probiotic group had BV, while 30% in the placebo and 12% in the probiotic group fell into the intermediate category based upon Nugent score, sialidase result and clinical findings. High counts of Lactobacillus sp. (>10(5) CFU/ml) were recovered from the vagina of 96% probiotic-treated subjects compared to 53% controls at day 30. In summary, this study showed efficacious use of lactobacilli and antibiotic in the eradication of BV in black African women. To determine whether bacterial vaginosis could be cured with a single 1-g oral dose of secnidazole.
                A total of 80 women were recruited at the outpatient gynecologic clinic of Manuel Noriega Hospital, Maracaibo, Venezuela. Diagnosis and patient enrollment were based on the Amsel criteria. The participants were randomized to 2 groups. In group 1 (n=44) participants received a single 1-g oral dose and in group 2 (n=32) participants received a single 2-g oral dose of secnidazole. Clinical cure was defined as the absence of the characteristic symptoms (a bad odor and a grossly abnormal discharge) and at least 2 of the following: vaginal pH less than 4.5, no fish odor on addition of KOH, and no Gardnerella vaginalis or clue cells on wet-mount examination. Cytologic cure was defined as an absence of G. vaginalis on a Papanicolaou (Pap) smear.
                Clinical cure was experienced by 95.5% of the women who received the 1-g oral dose and by 97.4% of the women who received the 2-g oral dose of secnidazole. There was no significant difference between the groups in the clinical resolution of bacterial vaginosis. Following treatment, results were negative for G. vaginalis in 94.7% of the women. In group 1, 41 women (93.2%), and in group 2, 31 women (96.9%) had cytologic cure. The Pap smear revealed G. vaginalis in 3 of the women in group 1 and 1 of the women in group 2 (P=0.47). Twenty-seven women (35.5%) reported mild side effects. More women had adverse effects in group 1 (n=16) than in group 2 (n=11) but this difference was not statistically significant.
                This clinical study showed that a single 1-g oral dose of secnidazole is effective to cure bacterial vaginosis associated with G. vaginalis. This study was undertaken to evaluate antimicrobial susceptibility of vaginal anaerobic bacteria before and after treatment of bacterial vaginosis.
                A randomized clinical trial of 119 nonpregnant women with bacterial vaginosis receiving either intravaginal metronidazole for 5 days or clindamycin for 3 days was performed. Women had 1 baseline and 3 follow-up visits at which quantitative vaginal cultures were performed. Anaerobic isolates underwent antimicrobial susceptibility testing.
                Complete susceptibility data was available on 95 women (47 metronidazole and 48 clindamycin). Of 1059 anaerobic bacterial isolates, less than 1% demonstrated resistance to metronidazole. In contrast, 17% demonstrated baseline clindamycin resistance, and 53% demonstrated resistance to clindamycin after therapy. Women exposed to clindamycin (but not metronidazole) had high frequencies (80%) of clindamycin-resistant anaerobic bacteria that persisted for 90 days after treatment.
                Treatment of bacterial vaginosis with clindamycin is associated with marked evidence of antimicrobial resistance among vaginal anaerobic bacteria. This may increase the vaginal reservoir of macrolide-resistant bacteria. Bacterial vaginosis causes symptomatic vaginal discharge and has been associated with preterm birth and with the acquisition of human immunodeficiency virus. Half of all women with bacterial vaginosis are free of symptoms, and treatment of these women is controversial. The objective of this study was to determine the extent of poor symptom recognition in this group of women.
                Seventy-five women attending a sexually transmitted disease clinic who had asymptomatic bacterial vaginosis were entered into a randomized, double-blind, placebo-controlled trial comparing metronidazole gel with placebo. Subjects' perceptions about changes in vaginal discharge and odor were determined, and treatment and placebo groups were compared by means of standard statistical analysis.
                When subjects were stratified by treatment group, there were no differences in their retrospective assessments of vaginal discharge and odor. A subset of women who had normalization of clinical parameters or of Gram stain scores did admit retrospectively to improvement; however, the difference between this group and the group without normalization was not statistically significant. Twenty-one percent of treated women subsequently had vaginal candidiasis.
                A greater percentage of women with resolution of bacterial vaginosis did retrospectively notice improvement in vaginal discharge and odor in comparison with those women without resolution; however, this was not statistically significant. These findings do not support routine treatment of women with asymptomatic bacterial vaginosis. Bacterial vaginosis (BV) is the most common cause of vaginitis worldwide. Currently recommended treatments have poor efficacy and are associated with high rates of BV recurrence. We examined whether a longer duration of treatment with metronidazole or combination therapy with metronidazole and azithromycin would enhance the cure rates for BV. In addition, we examined factors other than drug therapy associated with cure.
                Women with symptomatic BV (defined by a modified Amsel criteria) were enrolled in a 4-arm study that compared metronidazole for 7 days versus 14 days, plus or minus azithromycin on days 1 and 3. Data regarding interim behaviors were also obtained, as were vaginal specimens for Gram staining.
                At the first follow-up visit (7 days after the completion of therapy), there was a significant difference in cure rates among patients who received 7 days of metronidazole therapy, compared with those who received 14 days of therapy, combined across azithromycin therapy (P=.0003). There was no effect associated with azithromycin therapy. There were no differences in cure rates between any of the treatment groups at 21 days after completion of therapy. Abstinence or protected sex, refraining from douching, and a lower baseline Nugent score for the vaginal Gram stain were all significantly associated with cure.
                Cure rates for BV were significantly improved by 14 days of metronidazole treatment (compared with 7 days of treatment), but the effects were not sustained, suggesting that relapse or reinfection occurred. Combination therapy with the addition of azithromycin had no benefit. Lower baseline Nugent scores--presumably reflecting less complex vaginal flora--were significantly associated with cure, as was refraining from unprotected sex and from douching. Oral metronidazole is still the drug of choice in the treatment of bacterial vaginosis. Yet, side effects have been reported, and dosage as well as duration of therapy are still controversial. This study presents a possible alternative treatment using a single dose of metronidazole administered in a vaginal bioadhesive tablet.
                Double blind, randomised, placebo-controlled trial.
                The 116 patients were allocated to placebo; metronidazole 100; 250; 500mg in a 1:1:1:1 ratio.
                A cure rate of 64% was obtained with a single 100mg dose of metronidazole formulated in a bioadhesive vaginal tablet compared to a cure rate of 29% in the placebo group. The cure rates with the higher doses were similar 61.5% for 250mg dose and 68% for the 500mg dose. No side effects were reported.
                Treatment of bacterial vaginosis with a single application of 100mg metronidazole in a bioadhesive vaginal tablet was found to be a valid alternative. Further research in relation to tablet shaping and optimal dose finding might increase the cure rate. Oral tinidazole, 500 mg twice daily for 5 days, was compared to triple sulfonamide cream inserted into the vagina twice daily for 7 days for the treatment of nonspecific vaginitis in a placebo-controlled, double-blind trial. At 1 and 3 weeks after treatment, 29 of 30 and 18 of 19 patients, respectively, who had been given tinidazole were cured, as compared to 16 of 27 and 6 of 14 patients, respectively, who had been given oral placebo together with a vaginal cream with or without sulfonamides (p less than 0.01 and p = 0.0015, respectively). At 3 weeks, five of nine women who had received vaginal sulfonamide cream and oral placebo had persistent nonspecific vaginitis, thus suggesting that it was not more effective than a vaginal placebo cream. Untreated nonspecific vaginitis and persistence of this syndrome were significantly associated with Gardnerella vaginalis, anaerobic gram-negative rods, clue cells, a vaginal pH of greater than or equal to 5.0, a succinate/lactate peak heights ratio of greater than or equal to 0.3, and the absence of lactobacilli on a vaginal smear. A randomized single-blind study was performed to compare the efficacy of cefadroxil to that of metronidazole in the treatment of bacterial vaginosis. 22 women completed the study with follow-ups after 1 and 4 weeks. After completion of treatment 2/11 women receiving metronidazole still had bacterial vaginosis compared with 1/11 women receiving cefadroxil. At follow-up after 4 weeks 3/10 women treated with cefadroxil had recurrent bacterial vaginosis while the corresponding figures for metronidazole were 2/9. Triple sulfonamide vaginal cream has been used to treat bacterial vaginosis for many years. There are few studies in which triple sulfonamide cream has been compared with newer regimens.
                To compare the efficacy and safety of clindamycin phosphate vaginal cream with that of triple sulfonamide vaginal cream in the treatment of bacterial vaginosis.
                In this double-blind, randomized multicenter study, nonpregnant women 16 years of age or older with symptomatic bacterial vaginosis were assigned to receive either 2% clindamycin phosphate vaginal cream or triple sulfonamide vaginal cream for 7 days. Follow-up visits were conducted 5 to 10 days and 25 to 39 days after completion of treatment.
                Clinical cure or improvement at 25 to 39 days was noted in 55 (69.6%) of 79 assessable participants who received clindamycin vaginal cream and in 33 (41.8%) of 79 women who received triple sulfonamide vaginal cream (P < 0.0001). Most of the difference between the treatment groups was noted in women with a history of bacterial vaginosis. Among women without a history of bacterial vaginosis, clindamycin and triple sulfonamide creams had similar efficacy. Evaluation of Gram-stained vaginal smears correlated with clinical outcome. Most patients in both treatment groups reported an improvement in symptoms. No significant difference was observed between the treatment groups in the incidence of adverse events.
                Clindamycin 2% vaginal cream is more effective than triple sulfonamide vaginal cream in the treatment of bacterial vaginosis. Bacterial vaginosis (BV) is particularly common in black women, and in Nigeria it is often caused by Mycoplasma, as well as Atopobium, Prevotella and Gardnerella sp. Antimicrobial metronidazole oral therapy is poorly effective in eradicating the condition and restoring the Lactobacillus microbiota in the vagina. In this study, 40 women diagnosed with BV by discharge, fishy odor, sialidase positive test and Nugent Gram stain scoring, were randomized to receive either two dried capsules containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each night for 5 days, or 0.75% metronidazole gel, applied vaginally twice a day (in the morning and evening). Follow-up at day 6, 15 and 30 showed cure of BV in significantly more probiotic treated subjects (16, 17 and 18/20, respectively) compared to metronidazole treatment (9, 9 and 11/20: P=0.016 at day 6, P=0.002 at day 15 and P=0.056 at day 30). This is the first report of an effective (90%) cure of BV using probiotic lactobacilli. Given the correlation between BV and HIV, and the high risk of the latter in Nigeria, intravaginal use of lactobacilli could provide women with a self-use therapy, similar to over-the-counter anti-yeast medication, for treatment of urogenital infections. 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. Bacterial vaginosis is common among patients seen by gynecologists. Several types of therapy have been proposed. The purpose of this prospective, randomized, double-blind clinical trial was to examine the efficacy of clindamycin vaginal cream for the treatment of bacterial vaginosis. Sixty patients with symptoms of bacterial vaginosis were randomized into the study, and 46 completed the protocol. Twenty-three patients received 2% clindamycin vaginal cream (5 g applied intravaginally at bedtime for 7 days), with placebo oral tablets twice daily for 7 days. The other 23 patients received oral metronidazole tablets (500 mg twice a day for 7 days) and placebo vaginal cream (5 g intravaginally for 7 days). The cure rates for the two regimens were comparable. Twenty-two (97%) of the patients treated with clindamycin vaginal cream had improvement or cure at the first follow-up visit versus 19 (83%) of those taking metronidazole. There was no statistically significant difference between the two results. Side effects for both regimens were comparable. We conclude that 2% clindamycin vaginal cream offers similar efficacy and safety to standard oral metronidazole therapy for bacterial vaginosis.
Clindamycin preparations, oral metronidazole, and oral and intravaginal tablets of lactobacillus were effective for bacterial vaginosis. Hydrogen peroxide douche and triple sulphonamide cream were ineffective. Metronidazole caused metallic taste, nausea and vomiting. We need better-designed trials with larger sample sizes to test the effectiveness of promising drugs.