scholarly journals Vaginal Tablets of Metronidazole (750 mg) plus Miconazole Nitrate (200 mg) versus Oral Metronidazole (2 g) for Bacterial Vaginosis: A Randomized Controlled Trial

2021 ◽  
Vol 73 (10) ◽  
Author(s):  
Manopchai Thamkhantho ◽  
Chenchit Chayachinda ◽  
Chanita Lertaroonchai
Keyword(s):  
Side Effects ◽  
Bacterial Vaginosis ◽  
Controlled Trial ◽  
Statistical Significance ◽  
Group Versus ◽  
Comparable Efficacy ◽  
Cure Rate ◽  
Symptom Resolution ◽  
Miconazole Nitrate ◽  
Oral Metronidazole

Objective: To compare the cure rates, side effects, satisfaction, and recurrence rates of bacterial vaginosis (BV) in women having vaginal tablets of metronidazole (750 mg) plus miconazole (200 mg)—the “NPF group”—versus oral metronidazole (2 g)—the “MET group.” Materials and methods: This September 2019–March 2020 trial enrolled symptomatic women aged 18–45 years diagnosed with BV based on Amsel’s criteria. Excluded were women who were immunocompromised; allergic to metronidazole or miconazole; had BV episodes during the preceding 3 months; or had abnormal vaginal bleeding. After randomization with a ratio 1:1, another vaginal swab was done for Nugent scoring. Two weeks later, the evaluation using Amsel’s criteria and Nugent scores was repeated. Also, symptom resolution, side effects and satisfaction were evaluated. Symptomatic resolution referred to 75% improvement in discharge, irritation, itching, odor, and coital pain. At one and three months, subjective symptomatic recurrence was assessed by telephone. Results: Data on 70 participants were analyzed (NPF, N=34; MET, N=36). Their average age was 32.3±7.9 years (NPF, 34.1±8.1; MET, 30.6±7.3). Without statistical significance, NPF had higher symptom resolution (67.7% vs 58.3%; P=0.420), cure rate by Amsel criteria (82.4% vs 77.8%; P=0.632), and cure rate by Nugent scoring (35.3% vs 16.9%; P=0.075). Both groups reported high satisfaction (NPF, 8.5±1.4; MET, 7.9±2.0; P=0.125). Side effects were comparable, including appetite loss, metallic taste, nausea, and dizziness. Conclusion: For BV treatment, both vaginal ovules containing metronidazole (750 mg) plus miconazole nitrate (200 mg) and oral metronidazole (2 g) show comparable efficacy and side effects.

scholarly journals Comparison of efficacy of buccal versus vaginal misoprostol in first trimester induced abortion

2019 ◽  
Vol 8 (8) ◽  
pp. 3368
Author(s):  
Nida Khan ◽  
Anita M. Kant ◽  
Pooja C. Thukral ◽  
Mohammad Saquib
Keyword(s):  
Side Effects ◽  
Group Versus ◽  
First Trimester ◽  
Comparable Efficacy ◽  
P Value ◽  
Vaginal Route ◽  
Trimester Abortion ◽  
Group A ◽  
Vaginal Misoprostol ◽  
Group B

Background: To compare the effectiveness, side effects, and patient satisfaction of buccal versus vaginal misoprostol administration in first trimester abortions.Methods: Women opting for first trimester abortion received oral Mifepristone followed 48 hours latermisoprostol. Group A received Misoprostol via buccal route whereas group B received Misoprostol vaginally. A comparative analysis using SPSS was done.Results: Giving 800µg Misoprostol by either buccal or vaginal route after oral Mifepristone have comparable efficacy in terms of complete abortion rate (96% in buccal group versus 98% in vaginal group; p value = 0.495), failure rate being statistically similar (4% versus 2%). Drug abortion interval was comparable in the two groups. (11.16 hour in buccal group and 12.32 hours in vaginal group). Few side effects like nausea and vomiting, shivering, diarrohea was significantly higher with vaginal Misoprostol while abdominal cramps, altered taste were found more with the buccal group.Conclusions: Buccal Misoprostol is comfortable and easier to administer when compared to other routes and it has potential to be developed as a self-administered regimen. Buccal Misoprostol is as efficacious as vaginal Misoprostol with significantly lesser side effects up to 7 weeks of period of gestation.

scholarly journals Treating male partners of women with bacterial vaginosis (StepUp): a protocol for a randomised controlled trial to assess the clinical effectiveness of male partner treatment for reducing the risk of BV recurrence

2020 ◽  
Vol 20 (1) ◽  
Author(s):  
Lenka A. Vodstrcil ◽  
◽  
Erica L. Plummer ◽  
Michelle Doyle ◽  
Christopher K. Fairley ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Bacterial Vaginosis ◽  
Controlled Trial ◽  
Male Partner ◽  
Standard Of Care ◽  
Trial Registration ◽  
Current Standard ◽  
Randomised Controlled ◽  
Oral Metronidazole ◽  
Amsel Criteria

Abstract Background Bacterial vaginosis (BV) is estimated to affect 1 in 3 women globally and is associated with obstetric and gynaecological sequelae. Current recommended therapies have good short-term efficacy but 1 in 2 women experience BV recurrence within 6 months of treatment. Evidence of male carriage of BV-organisms suggests that male partners may be reinfecting women with BV-associated bacteria (henceforth referred to as BV-organisms) and impacting on the efficacy of treatment approaches solely directed to women. This trial aims to determine the effect of concurrent male partner treatment for preventing BV recurrence compared to current standard of care. Methods StepUp is an open-label, multicentre, parallel group randomised controlled trial for women diagnosed with BV and their male partner. Women with clinical-BV defined using current gold standard diagnosis methods (≥3 Amsel criteria and Nugent score (NS) = 4–10) and with a regular male partner will be assessed for eligibility, and couples will then be consented. All women will be prescribed oral metronidazole 400 mg twice daily (BID) for 7 days, or if contraindicated, a 7-day regimen of topical vaginal 2% clindamycin. Couples will be randomised 1:1 to either current standard of care (female treatment only), or female treatment and concurrent male partner treatment (7 days of combined antibiotics - oral metronidazole tablets 400 mg BID and 2% clindamycin cream applied topically to the glans penis and upper shaft [under the foreskin if uncircumcised] BID). Couples will be followed for up to 12 weeks to assess BV status in women, and assess the adherence, tolerability and acceptability of male partner treatment. The primary outcome is BV recurrence defined as ≥3 Amsel criteria and NS = 4–10 within 12 weeks of enrolment. The estimated sample size is 342 couples, to detect a 40% reduction in BV recurrence rates from 40% in the control group to 24% in the intervention group within 12 weeks. Discussion Current treatments directed solely to women result in unacceptably high rates of BV recurrence. If proven to be effective the findings from this trial will directly inform the development of new treatment strategies to impact on BV recurrence. Trial registration The trial was prospectively registered on 12 February 2019 on the Australian and New Zealand Clinical Trial Registry (ACTRN12619000196145, Universal Trial Number: U1111–1228-0106, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=376883&isReview=true).

The evaluation of flaxseed for hot flashes: Results of a randomized, controlled trial, NCCTG study N08C7.

2011 ◽  
Vol 29 (18_suppl) ◽  
pp. CRA9015-CRA9015 ◽  
Author(s):  
S. Pruthi ◽  
R. Qin ◽  
S. A. Terstriep ◽  
H. Liu ◽  
C. L. Loprinzi ◽  
...  
Keyword(s):  
Placebo Group ◽  
Side Effects ◽  
Controlled Trial ◽  
Hot Flashes ◽  
Group Versus ◽  
Abdominal Distension ◽  
Self Report ◽  
Phase Iii ◽  
Common Symptom ◽  
Hot Flash

CRA9015 Background: Hot flashes are a common symptom during the menopause transition or following breast cancer treatment that can negatively impact the quality of life for many women. Preliminary data have suggested that flaxseed, a rich source of dietary lignans, may be a potentially effective treatment for hot flashes. Methods: A phase III randomized, placebo controlled trial was conducted to evaluate the efficacy of flaxseed in reducing hot flashes. Postmenopausal women were randomly assigned to a flaxseed bar (providing 410 mg of lignans) for 6 weeks vs a placebo bar. Participants completed daily prospective, self report hot flash diaries during the baseline week and then began eating one study bar per day for 6 weeks, while continuing to record their daily hot flashes. The intra-patient difference in hot flash activity between baseline and the last treatment week was the primary endpoint. Side effects of the bars were evaluated through self report and CTC assessment. Results: Between October and December 2009, 188 women were enrolled onto this trial. Mean hot flash scores were reduced by 4.9 units in the flaxseed group and 3.5 in the placebo group (p=0.29). In both groups, a little over a third of the women received a 50% reduction in their hot flash scores. Only one side effect was significantly different between groups, that being grade 1 pruritis, which was more common (7%) in the placebo group versus 1% in the flaxseed group. Both groups reported increased abdominal distension, flatulence, diarrhea and nausea. Adherence and ability to detect treatment assignment did not differ between groups. Conclusions: The results of this trial do not support the use of 410 mg of flaxseed lignans for the reduction of hot flashes. The gastrointestinal side effects seen in both groups were likely due to the fiber content in the flaxseed and placebo bars.

Cefazolin plus Ceftazidime versus Imipenem / Cilastatin Monotherapy for Treatment of Capd Peritonitis — a Randomized Controlled Trial

2004 ◽  
Vol 24 (5) ◽  
pp. 440-446 ◽  
Author(s):  
Chi-Bon Leung ◽  
Cheuk-Chun Szeto ◽  
Kai-Ming Chow ◽  
Bonnie Ching-Ha Kwan ◽  
Angela Yee-Moon Wang ◽  
...  
Keyword(s):  
Treatment Group ◽  
Response Rate ◽  
Controlled Trial ◽  
Group Versus ◽  
Similar Efficacy ◽  
Primary Response ◽  
Control Group ◽  
Cure Rate ◽  
Open Label ◽  
Complete Cure

Background Peritonitis is a serious complication of peritoneal dialysis (PD). We studied the efficacy of imipenem / cilastatin monotherapy in the treatment of PD-related peritonitis. Methods We performed an open-label, randomized control study comparing imipenem / cilastatin monotherapy (treatment group) versus cefazolin plus ceftazidime (control group) in the treatment of PD peritonitis. The result was further compared to a historic group treated with cefazolin plus netilmycin. Outcome measures were primary response rate at day 10 and complete cure rate. Results We enrolled 51 patients in the treatment group, 51 in the control group, and identified 96 in the historic group. The primary response rate to the assigned antibiotics was 49.0%, 51.0%, and 49.0% for the treatment, control, and historic groups, respectively ( p = 0.97). The primary response rate allowing for change in antibiotic was 82.4%, 90.2%, and 82.3%, respectively, for the three groups ( p = 0.41). The complete cure rate was 72.5%, 80.4%, and 82.3%, respectively ( p = 0.60). Tenckhoff catheter removal was needed in 6 cases in the treatment group, 6 cases in the control group, and 13 cases in the historic group ( p = 0.90). Conclusions We concluded that monotherapy of imipenem / cilastatin has similar efficacy compared to the two standard regimens of cefazolin plus ceftazidime or netilmycin in the treatment of PD peritonitis.

Cognitive effects of brief and ultrabrief pulse bitemporal electroconvulsive therapy: a randomised controlled proof-of-concept trial

2019 ◽  
Vol 50 (7) ◽  
pp. 1121-1128 ◽  
Author(s):  
Donel Martin ◽  
Natalie Katalinic ◽  
Dusan Hadzi-Pavlovic ◽  
Anna Ingram ◽  
Nicholas Ingram ◽  
...  
Keyword(s):  
Side Effects ◽  
Visual Memory ◽  
Controlled Trial ◽  
Similar Efficacy ◽  
Seizure Threshold ◽  
Comparable Efficacy ◽  
Proof Of Concept ◽  
Double Blind ◽  
Randomised Controlled ◽  
Cognitive Side Effects

AbstractBackgroundReduction of the pulse width has been reported to improve ECT outcomes with unilateral ECT (similar efficacy, fewer cognitive side effects), but has been minimally studied for bitemporal ECT. The only study comparing brief and ultrabrief pulse bitemporal ECT found reduced efficacy for bitemporal ultrabrief compared to bitemporal brief pulse stimulation. This randomised controlled trial (RCT) aimed to test if ultrabrief pulse bitemporal ECT results in fewer cognitive side effects than brief pulse bitemporal ECT, when given at doses adjusted with the aim of achieving comparable efficacy.MethodsThirty-six participants were randomly assigned to receive ultrabrief (at 3 times seizure threshold) or brief (at 1.5 times seizure threshold) pulse bitemporal ECT given 3 times a week in a double-blind, controlled proof-of-concept trial. Blinded raters assessed mood and cognitive functioning over the ECT course.ResultsEfficacy and cognitive outcomes did not differ significantly between the two treatment groups over the ECT course. The ultrabrief pulse group performed better on a test of visual memory assessed acutely after an ECT treatment.ConclusionsThis study suggests there may be a small cognitive advantage in giving bitemporal ECT with an ultrabrief pulse when dosage is increased to match the efficacy of brief pulse bitemporal ECT, but the study was underpowered to fully examine this issue.Clinical Trials Registration: www.clinicaltrials.gov, NCT00870805.

scholarly journals Probiotic Lacticaseibacillus rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 as an Adjunctive Treatment for Bacterial Vaginosis Do Not Increase the Cure Rate in a Chinese Cohort: A Prospective, Parallel‐Group, Randomized, Controlled Study

2021 ◽  
Vol 11 ◽  
Author(s):  
Yongke Zhang ◽  
Jinli Lyu ◽  
Lan Ge ◽  
Liting Huang ◽  
Zhuobing Peng ◽  
...  
Keyword(s):  
Bacterial Vaginosis ◽  
Clinical Symptoms ◽  
Chinese Women ◽  
Controlled Trial ◽  
Adjunctive Treatment ◽  
Controlled Study ◽  
Cure Rate ◽  
Probiotic Group ◽  
Significant Difference ◽  
Chinese Cohort

The purpose of this study was to evaluate the effectiveness of metronidazole and oral probiotics adjunct to metronidazole in the treatment of bacterial vaginosis (BV). One hundred and twenty-six Chinese women with BV were enrolled in this parallel, controlled trial, and were randomly assigned into two study arms: the metronidazole group, which was prescribed metronidazole vaginal suppositories for 7 days, and the adjunctive probiotic group, which received Lacticaseibacillus rhamnosus GR-1 and Limosilactobacillus reuteri RC-14 orally for 30 days as an adjunct to metronidazole. Clinical symptoms and Nugent scores at the initial visit, 30 days and 90 days were compared. There was no significant difference of the 30-day total cure rate between the adjunctive probiotic group (57.69%) and the metronidazole group (59.57%), with an odds ratio (OR) of 0.97 (95% confidence interval (CI), 0.70 to 1.35, p-value = 0.04), or of the 90-day total cure rate (36.54% vs. 48.94%, OR, 0.75; 95% CI, 0.47 to 1.19; p-value = 0.213). Also, no significant difference of the vaginal and faecal microbial diversity and structure between the two groups at 0, 30 or 90 days were shown based on 16S rRNA sequences. The probiotic species were rarely detected in either the vaginal microbiota or the faecal microbiota after administration which may revealed the cause of noneffective of oral probiotics. No serious adverse effects were reported in the trial. The study indicated that oral probiotic adjunctive treatment did not increase the cure rate of Chinese BV patients compared to metronidazole.

scholarly journals The Efficacy of Lactobacillus plantarum as Adjunctive Therapy of Bacterial Vaginosis: A Double-blind, Randomized, Placebo-controlled Trial

2020 ◽  
Vol 32 (3) ◽  
pp. 214
Author(s):  
Ridha Ramadina Widiatma ◽  
Muhammad Yulianto Listiawan ◽  
Dwi Murtiastutik ◽  
Cita Rosita Sigit Prakoeswa ◽  
Sawitri Sawitri ◽  
...  
Keyword(s):  
Placebo Group ◽  
Bacterial Vaginosis ◽  
Lactobacillus Plantarum ◽  
Adjunctive Therapy ◽  
Controlled Trial ◽  
Vaginal Flora ◽  
Control Group ◽  
Therapeutic Effects ◽  
Cure Rate ◽  
Double Blind

Background: Bacterial vaginosis (BV) is a clinical syndrome caused by the changing of Lactobacillus spp., a producer of hydrogen peroxide, in the normal vagina with a high concentration of anaerobic bacteria, Gardnerella vaginalis and Mycoplasma hominis. This study reports a resistance of BV therapy regimens, high recurrence rates, and side effects of an antibiotic. Therefore, adjunctive therapy for BV management is needed. Research has reported the therapeutic effects of probiotic in BV; however, the results are inconsistent. Purpose: To evaluate the efficacy of standard therapy using metronidazole and Lactobacillus plantarum for BV measured by the cure rate and vaginal flora balance. Methods: A randomized, double-blind, placebo-controlled trial, 30 subjects were randomized to take metronidazole 500 mg twice a day for seven days with weekly evaluation. The Lactobacillus plantarum or placebo group was evaluated every 4 weeks. The cure rate and vaginal flora balance were evaluated using the Amsel criteria and Nugent score before and after the intervention. Result: A total of 30 subjects returned for 28-day follow-up, of which 60% subjects of the antibiotic/probiotic group were cured compared to 40% in the antibiotic/placebo group (p>0.05). Conclusion: There was no difference in the increase of cure rate and vaginal flora balance between the treatment group and significant control group.

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