Effect of eryngo (Eryngium caucasicum Trautv) on primary dysmenorrhea: A randomized,double-blind,placebo-controlled study

ObjectiveThis study strove to investigate the safety and effectiveness of Eryngo in the treatment of primary dysmenorrhea.Materials and methodsThe researchers conducted a blinded, randomized, trial design on 169 women, 15–30 years of age, who had been diagnosed with primary dysmenorrhea at Babol University of Medical Sciences. Subjects were randomly assigned to receive 5 ml syrup of Eryngo, placebo, or Ibuprofen (200 mg) three times a day (15 ml/day), from one day prior to the onset of bleeding for five days. The degree of dysmenorrhea was reported by two measures; Visual analogue scale (VAS), as a primary outcome, and the assessment of dysmenorrhea severity (VMS), as a secondary outcome at 4 menstrual cycles: at pretreatment phase, at the first menstrual cycle, at the second menstrual cycle, and the third menstrual cycle without drug.ResultsThe reduced peak-pain differed by the treatment length in women treated for two menstrual cycles: 4.2 (1.0) cm in the Eryngo group, 4.3 (0.0) cm in the Ibuprofen group, and 0.9 (0.1) cm in the placebo group (P < 0.0001). No serious side effects were reported in all groups under study. According to the results, minor side effects did not increase in the Eryngo group when compared with the placebo group.ConclusionEryngo relieved dysmenorrhea as effectively as Ibuprofen did. Thus, Eryngo could be regarded as a new herbal remedy for the treatment of dysmenorrhea. However, in order to prescribe Eryngo as herbal remedy, rigorous research studies are required to establish its efficacy by investigating its chemical, pharmacologic, and therapeutic properties.     

The use of the leukotriene receptor antagonist montelukast (Singulair) in the management of dysmenorrhea in adolescents

PURPOSE: Previous studies have shown an increase in leukotrienes in the uterine tissue as well as in the menstrual flow of adult women with dysmenorrhea. An increase in leukotriene-E4, the major urinary leukotriene, was also reported in adolescent girls with dysmenorrhea, further suggesting a possible involvement of these potent vasoconstrictors and inflammatory mediators in generating dysmenorrhea symptoms. In the present study we examined whether blocking leukotrienes might alleviate symptoms of dysmenorrhea in adolescents. METHODS: Twenty-five adolescents (age 16 +/- 1 years, 4 +/- 1 years post menarche, body mass index 23 +/- 1) with dysmenorrhea participated in a randomized, double blind, crossover study. Thirteen girls received one tablet of montelukast (Singulair, Merck, West Point, PA) 10 mg daily starting on day 21 of the cycle until the last day of the menstrual period for two menstrual cycles, followed by one tablet of placebo (Merck, West Point, PA) daily starting on day 21 of the cycle until the last day of the menstrual period for two additional menstrual cycles. The other 12 girls had a reverse schedule starting with placebo. Participants were instructed to use one or two 200-mg tablets of ibuprofen every 6 h in the event of continuing menstrual symptoms. The Cox Menstrual Symptom Scale was used to assess response to treatment. An intent-to-treat approach was used for data analysis. RESULTS: Twenty-two girls completed the study. Two girls were noncompliant with the study protocol, and one was withdrawn because of Helicobacter pylori infection. Compared with Cox menstrual score (mean +/- SE) before study (46 +/- 6), there was no significant change in menstrual symptoms during treatment with placebo (Cox score 42 +/- 7) or during treatment with montelukast (Cox score 39 +/- 7), and there was no significant difference between montelukast and placebo treatments as well. Likewise, there was no significant difference between the amount of ibuprofen tablets consumed during the menstrual periods before study (4 +/- 1), while on placebo (3 +/- 1), and while on montelukast (4 +/- 1). CONCLUSIONS: This study does not support the use of montelukast, in the current FDA-approved dose (for asthma) and commencing immediately before the menstrual period, for treatment of dysmenorrhea. It remains to be determined in further studies whether a higher dose or a prolonged daily use of montelukast may alleviate symptoms of dysmenorrhea in adolescents.     

The effect of vitamin D on primary dysmenorrhea with vitamin D deficiency: a randomized double-blind controlled clinical trial

Dysmenorrhea is common among women of reproductive age. This study aim was to investigate the effect of vitamin D (vit D) supplementation in treatment of primary dysmenorrhea with vit D deficiency. A randomized double-blind placebo-controlled clinical trial was conducted on 60 women with primary dysmenorrhea and vit D deficiency referred to our clinic at Arash Women’s Hospital from September 2013 to December 2014. Eligible women were randomly assigned into treatment and control groups (30 in each group). Individuals in the treatment group received 50?000?IU oral vit D and the control group received placebo weekly for eight weeks. After two months of treatment, there was a significant difference in serum vit D concentration between the two groups (p?<?0.001). Pain severity decreased significantly in treatment group after eight weeks of treatment. There was a significant difference in pain intensity between the two groups after eight weeks of treatment and one month after the end of treatment (p?<?0.001 for both). A weekly high dose (50 000?IU) oral vit D supplementation for eight weeks in patients with primary dysmenorrhea and vit D deficiency could improve pain intensity.     

Efficacy of intravenous tranexamic acid in reducing blood loss after elective cesarean section: a prospective, randomized, double-blind, placebo-controlled study

We sought to determine the efficacy and safety of tranexamic acid (TA) in reducing blood loss during elective cesarean section (CS). We performed a randomized, double-blind, placebo-controlled study of 660 women who underwent elective CS. The patients were randomly selected to receive an intravenous infusion of either TA (1 g/10 mL in 20 mL of 5% glucose; N = 330) or 30 mL 5% glucose prior to surgery. The primary outcome was the estimated blood loss following CS. No demographic difference was observed between groups. The mean estimated blood loss was significantly lower in women treated with TA compared with women in the placebo group (499.9 ± 206.4 mL versus 600.7 ± 215.7 mL, respectively; P < 0.001), and the proportion of women in the TA group who had an estimated blood loss >1000 mL was significantly lower than in the placebo group (7 [2.1%] versus 19 [5.8%], respectively; relative risk [RR] 2.7; 95% confidence interval [CI] 1.1 to 6.3; P < 0.03). Furthermore, more women in the placebo group than in the TA group required additional uterotonic agents (48 [14.5%] versus 28 [8.5%], respectively; RR 1.7; 95% CI 1.1 to 2.6; P = 0.02). Maternal and neonatal outcomes did not differ significantly. TA significantly reduced bleeding during CS, the percentage of patients with blood loss >1000 mL, and the need for additional uterotonic agents. Furthermore, the incidence of thromboembolic events did not increase. Our results suggest that TA can be used safely and effectively to reduce CS bleeding.     

A multicenter,double-blind,randomized, placebo-controlled study of rifaximin for the treatment of bacterial vaginosis

ObjectiveTo compare efficacy and tolerability between different regimens of rifaximin vaginal tablets and a placebo for treatment of bacterial vaginosis.MethodsIn a prospective study carried out at 13 sites in 3 European countries between August 2009 and October 2010, White, non-pregnant, premenopausal women with bacterial vaginosis were randomly assigned to receive rifaximin at 100 mg for 5 days (100 mg/5 days), 25 mg/5 days, or 100 mg/2 days, or placebo. Women were assessed at 7–10 and 28–35 days. Diagnosis and cure were based on Amsel criteria and Nugent score. Fisher exact test was used to compare cure rates.ResultsAmong 114 women recruited, 103 were evaluable for drug efficacy. Therapeutic cure rate at first follow-up was higher in the rifaximin 25 mg/5 days (48%, P = 0.04), 100 mg/2 days (36.0%), and 100 mg/5 days (25.9%) groups than in the placebo group (19.0%). At second follow-up, therapeutic cure rate was 28.0%, 14.8%, and 4.0% in the respective groups versus 7.7% in the placebo group. No difference in adverse events was observed.ConclusionRifaximin at 25 mg/5 days showed better therapeutic cure rates and maintenance of therapeutic cure after 1 month versus placebo. All treatment regimens were well tolerated.EudraCT number: 2009-011826-32.     

Endometrial effects of long-term treatment with phytoestrogens: a randomized, double-blind, placebo-controlled study

Objective

To determine the effects of 5 years of treatment with soy phytoestrogens on histological characteristics of endometrium in postmenopausal women.

Design

Randomized, double-blind, placebo-controlled study.

Setting

Centre of Perinatal and Reproductive Medicine, Department of Gynecological, Obstetrical, and Pediatric Sciences, University of Perugia, Italy.

Patient(s)

Three hundred seventy-six postmenopausal healthy women, all with intact uterus.

Intervention(s)

Women were distributed in two different groups using randomized criteria: group A (n = 179) patients received soy tablets (150 mg of isoflavones per day) for 5 years; group B (n = 197) patients received identical appearing placebo tablets for 5 years.

Main outcome measure(s)

Results of endometrial histology from biopsies obtained at baseline, 30 months, and 5 years after the beginning of the treatment.

Result(s)

Two hundred ninety-eight women completed the 5-year treatment. No cases of malignancy were detected during biopsy. Seventy percent of women undergoing treatment with soy phytoestrogens had an endometrium classified as atrophic or nonassessable versus 81% receiving placebo. The occurrence of endometrial hyperplasia was significantly higher in group A (3.37% vs. 0%).

Conclusion(s)

Long-term treatment (up to 5 years) with soy phytoestrogens was associated with an increased occurrence of endometrial hyperplasia. These findings call into question the long-term safety of phytoestrogens with regard to the endometrium.     

An oxytocin receptor antagonist (atosiban) in the treatment of preterm labor: a randomized, double-blind, placebo-controlled trial with tocolytic rescue

OBJECTIVES: This study was designed to evaluate the efficacy and safety of the oxytocin receptor antagonist atosiban in the treatment of preterm labor. STUDY DESIGN: A multicenter, double-blind, placebo-controlled trial with tocolytic rescue was designed. Five hundred thirty-one patients were randomized to receive, and 501 received, either intravenous atosiban (n = 246) or placebo (n = 255), followed by subcutaneous maintenance with the assigned agent. Standard tocolytics as rescue tocolysis were permitted after 1 hour of either placebo or atosiban if preterm labor continued. The primary end point was the time from the start of study drug to delivery or therapeutic failure. Secondary end points were the proportion of patients who remained undelivered and did not receive an alternate tocolytic at 24 hours, 48 hours, and 7 days. RESULTS: No significant difference was found in the time from start of treatment to delivery or therapeutic failure between atosiban and placebo (median, 25.6 days vs 21.0 days, respectively; P =.6). The percentages of patients remaining undelivered and not requiring an alternate tocolytic at 24 hours, 48 hours, and 7 days were significantly higher in the atosiban group than in the control group (all P < or =.008). A significant treatment-by-gestational age interaction existed for the 48-hour and 7-day end points. Atosiban was consistently superior to placebo at a gestational age of > or =28 weeks. Fourteen atosiban-treated patients and 5 placebo-treated patients were randomized at <24 weeks; the incidence of fetal-infant deaths was higher for the atosiban group at <24 weeks. Maternal-fetal adverse events were similar except for injection-site reactions, which occurred more often with atosiban. CONCLUSIONS: In this trial the treatment of patients in preterm labor with atosiban resulted in prolongation of pregnancy for up to 7 days for those at a gestational age > or =28 weeks, and this occurred with a low rate of maternal-fetal adverse effects. In addition, at a gestational age > or =28 weeks, the infant morbidity and mortality of atosiban-initiated standard care were similar to those with placebo-initiated standard care. Given that all patients in this study were eligible for tocolysis and that, in practice, nearly all patients who are eligible for a tocolytic receive one, the benefit of using atosiban is the placebo-like maternal-fetal side effect profile. These observations support the use of this oxytocin receptor antagonist in the treatment of patients in preterm labor with intact membranes. Efficacy and infant outcome data at <28 weeks are inconclusive.     

French maritime pine bark extract significantly lowers the requirement for analgesic medication in dysmenorrhea: a multicenter, randomized, double-blind, placebo-controlled study

OBJECTIVE: A previous open study demonstrated that French maritime pine bark extract (Pycnogenol) may soothe menstrual pain in dysmenorrhea. We thus investigated the effects of Pycnogenol on menstrual pain in a double-blind study. STUDY DESIGN: Subjects were 116 women aged 18-48 years. The first 2 menstrual cycles served as a control period; during the subsequent 2 menstrual cycles women received either a Pycnogenol supplement (60 mg/day) or a placebo in identical capsule form. One further cycle was monitored after cessation of capsule administration. Women were assigned to either a group with low menstrual pain or a group with dysmenorrhea. The criterion for assignment to the first group was absence of analgesic medication. RESULTS: In women with low menstrual pain, no significant difference for lowering of pain scores was found. In contrast, women with dysmenorrhea had a significantly lower pain score and required statistically significantly less analgesic medication during supplementation with Pycnogenol. The number of days women required analgesic medication was likewise found to be statistically significantly lowered in the Pycnogenol group. Even after discontinuation of Pycnogenol supplementation, the required analgesic medication remained significantly decreased. CONCLUSION: The analgesic-sparing effect of Pycnogenol increases with duration of supplementation and benefits persist even after discontinuation.     

Pentoxifylline therapy after laparoscopic surgery for different stages of endometriosis: a prospective, double-blind, randomized, placebo-controlled study

STUDY OBJECTIVE: To evaluate the effects of pentoxifylline administration on patients with different stages of endometriosis on whom laparoscopy was performed. DESIGN: Prospective, double-blind, randomized, placebo-controlled clinical (Canadian Task Force classification I). SETTING: University and private hospitals. PATIENTS: Eighty-eight women, all with infertility, some with dysmenorrhea, dyspareunia, or pelvic pain, on whom a laparoscopic diagnosis of endometriosis was made. INTERVENTIONS: The treatment group received 800 mg pentoxifylline daily for 6 months immediately after surgery. The control group received placebo capsules. All patients were followed-up for 1 year thereafter. MEASUREMENTS AND MAIN RESULTS: A comparison of pregnancy rate and recurrence of signs and symptoms in the 2 groups was performed. Forty-three patients were studied in the pentoxifylline group and 45 in the placebo group. The cumulative pregnancy rate was 39.5% and 35.6% in the treatment and control groups, respectively. The overall recurrence of signs and symptoms was 14% in the former group and 15.6% in the latter. There were no statistically significant differences between the 2 groups in rates of pregnancy and recurrence (p = .700 and .832, respectively). Nor was there any significant statistical difference between the same stages in the 2 groups regarding immunomodulation. CONCLUSIONS: According to the results of this study, and while keeping in mind that appropriate surgery is the main aspect of endometriosis treatment, there is no evidence that immunomodulation with pentoxifylline aids fertility or lessens recurrence of signs and symptoms in women with different stages of endometriosis (i.e., minimal, mild, moderate, or severe).     

A randomized, placebo-controlled, double-blind study evaluating leuprolide acetate depot treatment before myomectomy

Eighteen premenopausal women with symptomatic leiomyomata uteri were enrolled in a stratified, randomized, double-blind, placebo-controlled study evaluating the efficacy of leuprolide acetate (LA) depot treatment before myomectomy. Stratification was based on pretreatment uterine volume (less than 600 cm3 versus greater than or equal to 600 cm3). Nine women received intramuscular (IM) depot LA 3.75 mg every 4 weeks for 12 weeks (group A); nine women received IM placebo with the same injection schedule (group B). All women underwent myomectomy within 4 weeks of their last injection. Mean total intraoperative blood loss was 213 +/- 44 mL (mean +/- standard error of the mean [SEM]) in group A and 302 +/- 43 mL in group B. When data from patients with large uteri (pretreatment uterine volumes of 600 cm3 or greater) were analyzed, mean total blood loss was 189 +/- 44 mL in group A and 390 +/- 20 mL in group B. These data suggest that leuprolide depot treatment before myomectomy may decrease intraoperative blood loss in women with large leiomyomata uteri.