Vaginal Clindamycin Research Articles

Changes in the diagnosis and management of bacterial vaginosis following clinical research

It has become common practice to offer patients attending public sexual health clinics participation in research studies. We investigated the premise that clinician involvement in research leads to improvements in clinical practice within a sexual health service in Melbourne, Australia. Retrospective case note reviews were conducted of 100 cases of bacterial vaginosis (BV) during three time periods; 2000, 2002 and 2004. The first and second reviews were conducted 2 years before and immediately prior to a cross-sectional study of BV at Melbourne Sexual Health Centre. The third review was conducted immediately after study completion. Diagnostic criteria and treatment for BV were recorded. Clinicians were divided into high and low recruiters, according to the percentage of eligible patients that they recruited into the cross-sectional study. No audited cases were enrolled in the study. Significant improvements in the use of Amsel's criteria occurred between the second and third audit periods (51 to 65%, P = 0.04) but not between the first and second audits (51% for both, P = 1.0). The improvement was seen in high-recruiting clinicians (P = 0.02) but not low-recruiting clinicians (P = 0.75). Although treatment with 7 days of metronidazole or vaginal clindamycin increased for all clinicians between the first and second audit periods (8 to 18%, P = 0.04), it was greater between the second and third audit periods (18 to 72%, P < 0.01). No difference was observed between high- and low-recruiting clinicians. Introduction of research was temporally associated with improved clinical practice in high-recruiting clinicians only.

Is a change in the vaginal flora associated with an increased risk of preterm birth?

The purpose of this study was to determine if a change in the vaginal flora was associated with an increased risk of preterm birth, and to determine if metronidazole therapy before 32 weeks increased the risk of preterm birth. We compared cultures taken at 23 to 26 weeks of gestation with cultures taken at delivery from women enrolled in the Vaginal Infections and Preterm Birth study to analyze the association of changes in the vaginal flora with preterm birth. Metronidazole therapy before 32 weeks was associated with an increased risk of preterm birth (OR 1.5, 95%CI 1.05-2.1) in an unadjusted model. A change to heavy growth of Escherichia coli or Klebsiella pneumoniae at delivery was found to be associated with preterm birth (OR 2.4, 95%CI 1.6-3.8). After controlling for race, parity, prepregnancy weight <100 pounds, smoking or drinking during pregnancy, Trichomonas vaginalis, bacterial vaginosis, chlamydia, mycoplasmas, group B streptococcus, metronidazole therapy before 32 weeks, vaginal pH >5.0, and an increase in E coli or K pneumoniae , only prepregnancy weight <100 pounds (adjusted odds ratio [AOR] 2.07, 95%CI 1.01-4.21) and increased E coli or K pneumoniae in the vagina at delivery (AOR 2.99, 95%CI 1.37-6.53) were found to be significantly associated with preterm birth. An increase in E coli or K pneumoniae in the vagina is an independent risk factor for preterm birth. Changes in the vaginal flora may explain the increased risk of preterm birth seen with vaginal clindamycin or oral metronidazole therapy.

A Double-blind Treatment Study of Bacterial Vaginosis with Normal Vaginal Lactobacilli after an Open Treatment with Vaginal Clindamycin Ovules

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.

Efficacy of the combination of 2 g oral tinidazole and acidic buffering vaginal gel in comparison with vaginal clindamycin alone in bacterial vaginosis: a randomized, investigator-blinded, controlled trial

Objective: To evaluate the efficacy of tinidazole (T) (Trimonase ®, Mipharm, Italy) and an acidic vaginal gel (Miphil ®) (M) in comparison with vaginal clindamycin (CL) (Cleocin ® Pharmacia Upjohn) in BV. Design: A multicentre, randomised, investigator-blinded, controlled trial. Population and methods: 64 women with BV were enrolled. Thirty-two were allocated to receive oral T 2 g, single dose, and 32 were assigned to CL 2% for 7 consecutive days. After week 1, T group were treated with an acidic vaginal gel, 2 g every 3 days, for additional 3 weeks, whereas CL group did not received any additional treatment. Patients were evaluated at week 1 and 4. Vaginal pH, the BV-blue test (Gryphus Diagnostics, USA) and the whiff test were performed at baseline and at week 4. Main outcomes measures: Clinical cure rate; normalisation of vaginal pH (pH<4.5); and laboratory cure rate (defined as a clinical cure rate and a negative results of BV-blue and whiff test). Results: At baseline, vaginal pH values were (mean±S.D.) 5.4±0.7 and 5.3±0.5 in T and CL groups, respectively. Six patients (2 in T group and 4 in CL group) withdrew from the study due to side effects. At week 1, the clinical cure rates were 84% in both T and CL treated group ( P=N.S.). At week 4, clinical cure rates were 94% in T+M group and 77% in CL group ( P=N.S.). The laboratory cure rates were 81% in T+M group and 59% in CL group ( P<0.04). Vaginal pH normalisation (i.e. pH <4.5) was achieved in 78% and in 38% of T+M and CL groups, respectively ( P<0.0007). Conclusions: In the short term, 2 g single oral dose tinidazole was at least as effective as 7-day of vaginal clindamycin. The sequential treatment of tinidazole and acidic vaginal gel was superior to vaginal clindamycin in lowering vaginal pH and achieving a higher laboratory tests normalization rate at 1-month follow-up.

Vaginal Clindamycin in Preventing Preterm Birth and Peripartal Infections in Asymptomatic Women With Bacterial Vaginosis

In Brief Objective To determine whether treatment of bacterial vaginosis (BV) in early pregnancy decreases the risk of preterm delivery and peripartum infectious morbidity. Methods In this multicenter, randomized, double-masked, placebo-controlled intervention trial, screening for BV was performed by vaginal Gram stain obtained from 5432 healthy women with singleton pregnancies during the first antenatal clinic visit at 10–17 weeks' gestation. Bacterial vaginosis-positive women with no past history of preterm delivery were randomized to a single course of treatment with either 2% vaginal clindamycin cream or identical placebo cream for 7 days. Repeat Gram stains were taken 1 week after treatment and at 30–36 weeks' gestation. Preterm delivery was defined as spontaneous delivery before 37 gestational weeks. Peripartum infectious morbidity was defined as postpartum endometritis, postpartum sepsis, postcesarean wound infection, or episiotomy wound infection, necessitating antimicrobial therapy. According to the power analysis, 180 patients were needed for both treatment arms to show a three-fold difference in the rates of preterm births. Results The overall prevalence of BV was 10.4%. Of all BV-positive women, 375 (66%) were randomized to the treatment arms. The primary cure rate was 66% in the clindamycin group; in the placebo group, 34% spontaneously cleared BV (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.3, 2.8). The rate of preterm deliveries was 5% in the clindamycin group and 4% in the placebo group (OR 1.3, 95% CI 0.5, 3.5). The rate of peripartum infectious morbidity was 11% in the clindamycin group and 18% in the placebo group (OR 1.6, 95% CI 0.9, 2.8). Bacterial vaginosis recurred in 7% of women. The rate of preterm deliveries was 15% in this subgroup compared with 2% among women who remained BV negative (OR 9.3, 95% CI 1.6, 53.5). Conclusion Vaginal clindamycin did not decrease the rate of preterm deliveries or peripartum infections, but recurrent or persistent BV increased the risk for these complications. Vaginal clindamycin in early pregnancy is not effective in the prevention of preterm birth and peripartum infections in low-risk women with bacterial vaginosis.

Vaginal clindamycin in preventing preterm birth and peripartal infections in asymptomatic women with bacterial vaginosis: a randomized, controlled trial

Objective: To determine whether treatment of bacterial vaginosis (BV) in early pregnancy decreases the risk of preterm delivery and peripartum infectious morbidity. Methods: In this multicenter, randomized, double-masked, placebo-controlled intervention trial, screening for BV was performed by vaginal Gram stain obtained from 5432 healthy women with singleton pregnancies during the first antenatal clinic visit at 10–17 weeks’ gestation. Bacterial vaginosis-positive women with no past history of preterm delivery were randomized to a single course of treatment with either 2% vaginal clindamycin cream or identical placebo cream for 7 days. Repeat Gram stains were taken 1 week after treatment and at 30–36 weeks’ gestation. Preterm delivery was defined as spontaneous delivery before 37 gestational weeks. Peripartum infectious morbidity was defined as postpartum endometritis, postpartum sepsis, postcesarean wound infection, or episiotomy wound infection, necessitating antimicrobial therapy. According to the power analysis, 180 patients were needed for both treatment arms to show a three-fold difference in the rates of preterm births. Results: The overall prevalence of BV was 10.4%. Of all BV-positive women, 375 (66%) were randomized to the treatment arms. The primary cure rate was 66% in the clindamycin group; in the placebo group, 34% spontaneously cleared BV (odds ratio [OR] 1.9, 95% confidence interval [CI] 1.3, 2.8). The rate of preterm deliveries was 5% in the clindamycin group and 4% in the placebo group (OR 1.3, 95% CI 0.5, 3.5). The rate of peripartum infectious morbidity was 11% in the clindamycin group and 18% in the placebo group (OR 1.6, 95% CI 0.9, 2.8). Bacterial vaginosis recurred in 7% of women. The rate of preterm deliveries was 15% in this subgroup compared with 2% among women who remained BV negative (OR 9.3, 95% CI 1.6, 53.5). Conclusion: Vaginal clindamycin did not decrease the rate of preterm deliveries or peripartum infections, but recurrent or persistent BV increased the risk for these complications.

Vaginal Clindamycin and Oral Metronidazole for Bacterial Vaginosis: A Randomized Trial

Although metronidazole is an effective therapy for bacterial vaginosis, it can be associated with unpleasant and potentially harmful side effects. This study investigated an alternative therapy, clindamycin vaginal ovules, to determine its efficacy and safety as compared with oral metronidazole. Three hundred ninety-nine women with bacterial vaginosis were recruited from 23 European sites to participate in a randomized comparison of the two treatments. The number of participants in each group was sufficient to ensure statistical accuracy in measuring outcomes. Of the 233 patients who were available for evaluation, 113 were randomly assigned to receive 100-mg ovules of clindamycin administered intravaginally once daily for 3 consecutive days, and 120 were randomly assigned to receive 500 mg of metronidazole taken orally in 250-mg capsules twice each day for 7 days. Each group also received placebo capsules or ovules in doses matching the active therapy. Each group had a similar number of women who discontinued therapy prematurely. Cure was defined as the absence of amine odor and clue cells in the vaginal fluid. At both the first and second follow-up visit, 68 percent of the patients were cured in the clindamycin ovule group, whereas 67 percent of the oral metronidazole group were reported cured. There was no difference in the cure rate for either treatment according to participating site, success or failure at first or second visit, or patient assessment of cure (78 percent in the clindamycin group and 80 percent in the metronidazole group). Similar numbers of patients had symptoms of vaginitis or cervicitis at the first and/or second follow-up visit. At each follow-up visit, patients were asked to report any health problems that had occurred since the last visit. The total number of problems reported by each group was similar, but the metronidazole treatment group had more problems associated with the treatment itself (16.3 percent in the metronidazole group and 10.3 percent in the clindamycin group). Nausea and altered taste were more common among the women taking metronidazole than in those using clindamycin. Moniliasis was seen equally in each group. Two women taking metronidazole discontinued treatment the day after beginning therapy, one because of nausea and one because of vulvovaginal itching and swelling. Even though subjects were asked to abstain from sexual intercourse during the study period, one woman in the clindamycin group became pregnant. She gave birth to a healthy infant. Obstet Gynecol 2000;96:256–260

Vaginal Clindamycin and Oral Metronidazole for Bacterial Vaginosis

In Brief Objective To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis. Methods 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. Results 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. Conclusion 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. Intravaginal clindamycin for 3 days and oral metronidazole for 5 days are similarly effective treatments for bacterial vaginosis, but the former is better tolerated.

Vaginal clindamycin and oral metronidazole for bacterial vaginosis: a randomized trial

Objective: To compare the efficacy and safety of clindamycin vaginal ovules with oral metronidazole for treatment of bacterial vaginosis. Methods: 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. Results: 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. Conclusion: 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.

Vaginal clindamycin is ineffective in preventing preterm birth and peripartum infections in a low risk populaiton with bacterial vaginosis: a doubleblind placebo-controlled multicenter trial

Vaginal clindamycin is ineffective in preventing preterm birth and peripartum infections in a low risk populaiton with bacterial vaginosis: a doubleblind placebo-controlled multicenter trial

Vaginitis: Meeting the clinical challenge

Vaginitis is a common gynecologic disorder that is responsible for 10 million office visits to physicians each Year. Infectious vaginitis is the most common cause of a vaginal discharge, but other important diagnostic considerations include infectious cervicitis, a physiologic discharge, atrophic vaginitis, and allergic or irritant vaginitis. Although the history and gynecologic examination may suggest the diagnosis, laboratory confirmation should be routinely sought by performance of the vaginal pool wet mount examination, the amine whiff test, determination of the vaginal pH, and the Q-tip test. Once a precise diagnosis is made, effective therapy can then be prescribed. For patients with Candida vaginitis, therapeutic options include either the vaginal administration of a number of available imidazole or triazole antifungal agents or the prescription of the oral triazole agent fuconazole. Oral metronidazole remains the only effective treatment for trichomoniasis in the United States. Bacterial vaginosis, which has been linked to a number of obstetric and gynecologic complications, is effectively treated with oral metronidazole, although vaginal metronidazole gel and oral and vaginal clindamycin formulations are available as well.

Treatment of male partners and recurrence of bacterial vaginosis: a randomised trial.

OBJECTIVE: To test the efficacy of treatment with clindamycin of a partner on the recurrence rate of bacterial vaginosis in women within 3 months from diagnosis. SUBJECTS: Eligible for the...

Management of Vaginosis

Although trichomoniasis and bacterial vaginosis represent opposite ends of the clinical spectrum (vaginitis versus vaginosis) and are due to entirely different pathogenic mechanisms, they nevertheless share several characteristics. Common manifestations include a malodorous vaginal discharge, a massive disruption of the normal lactobacillus-dominant flora, elevated pH, and overgrowth of vaginal anaerobes. What these 2 conditions have most in common is an exquisite susceptibility to nitroimidazole agents. For many years, oral multidose metronidazole was the only available nitroimidazole for the indication; however, the recent availability of single dose, long-acting secnidazole offers a useful alternative to conventional therapy. Moreover, although several new options are now available for the treatment of bacterial vaginosis, namely vaginal clindamycin and metronidazole gel, no vaginal regimens are available for the treatment of trichomoniasis. Finally, while clindamycin availability ensures safe treatment of bacterial vaginosis in pregnancy, nitroimidazole therapy is not endorsed for use in the first trimester of pregnancy, and this therapeutic need remains unanswered.

Treatment of bacterial vaginosis.

The purpose of this article is to review the treatment options for bacterial vaginosis, including the newer topical antibiotics, metronidazole gel and clindamycin cream. The article also examines the controversies over whether bacterial vaginosis is a sexually transmitted disease and whether asymptomatic women should be treated. A MEDLINE search was conducted to identify pertinent literature, including review articles. Emphasis was placed on those clinical trials using metronidazole gel or clindamycin cream. Studies addressing the complications of bacterial vaginosis in pregnancy, the risk of treatment in pregnancy, and the method of transmission of the disease also were reviewed. Clinical studies evaluating clindamycin cream and metronidazole gel were scarce; therefore, data from all available trials were reviewed. The objectives, methodology, and results from other studies were reviewed; those addressing complications of the disease and risks and benefits of treatment were included. There is evidence both for and against bacterial vaginosis being a sexually transmitted disease. Potential complications of the disease may warrant treatment of certain asymptomatic women, especially during pregnancy. Treatment options include oral or vaginal metronidazole or clindamycin, all of which provide high cure rates. Vaginal antibiotics result in minimal risk to the fetus in pregnant patients. Complications of bacterial vaginosis may be associated with significant morbidity, especially among pregnant women. Treatment of asymptomatic women with the disease is controversial, but may be justified in certain high-risk populations. The topical agents, clindamycin vaginal cream 2% and metronidazole vaginal gel 0.75% provide a safe, effective, but expensive alternative to oral antibiotic regimens for the treatment of bacterial vaginosis.

Treatments for bacterial vaginosis (or vaginal bacteriosis)

SummaryThis review includes a total of 5316 patients that have been treated with different regimens for bacterial vaginosis (vaginal bacteriosis). After re-calculation, the cure rate with end-point analysis is about 80 per cent in open studies and 65 per cent in blind studies with metronidazole and about the same in blind studies with vaginal clindamycin cream. The expected cure rate after one month is around 65 per cent.