Use of a multibotanical (Nutrafem) for the relief of menopausal vasomotor symptoms: a double-blind, placebo-controlled study.

OBJECTIVE: This study aimed to compare the efficacy and safety of a multibotanical (Nutrafem) with those of placebo for the treatment of menopausal vasomotor symptoms. METHODS: In this phase III, double-blind, randomized, placebo-controlled study, 159 postmenopausal women experiencing at least 21 vasomotor symptoms per week were treated with Nutrafem (Bionutra Pte Ltd, Singapore) or a matched placebo for 12 weeks. Treatment outcome was evaluated by the change from baseline in the average weekly number of vasomotor symptoms. RESULTS: At the end of the study, Nutrafem reduced the number of vasomotor symptoms by 46% from baseline, and this is significantly superior to placebo (26% from baseline; P = 0.020). Forty-three percent of women taking Nutrafem experienced an at least 50% reduction in the number of symptoms compared with 6% of women taking placebo (P = 0.021; number needed to treat = 2.7). There were no group differences in adverse events, laboratory values, and gynecological data. CONCLUSIONS: Nutrafem is an effective botanical treatment for vasomotor symptoms in postmenopausal women.

Ovulatory response after ovarian cystectomy

Objective: To determine the ovulatory response of a cystectomized ovary sonographically in the first three cycles post-op in terms of the number and diameter of pre-ovulatory follicles, development of 18 mm follicle, development of corpus luteum, and their correlation to the type of operation, use of cautery, type of ovarian pathology, and use of ovulatory drugs. Design: Prospective study Methods: Thirty (30) patients who underwent ovarian cystectomy either by laparoscopy of laparotomy from February to May 1998 were included in the study. These patients had follicular monitoring for three cycles post-op at days 14, 16 and 18. The number of pre-ovulatory follicles (/- 12 mm), the diameter (mm) of the largest follicle, onset of development of 18 mm follicle, and onset of development of corpus luteum were noted. The onset of development of 18 mm follicle was correlated to the type of operation (laparoscopy versus laparotomy), use of cautery, type of ovarian pathology (endometrial versus dermoid), and use of ovulatory drugs post-op. Statistical analysis used was student t-test. Results: The mean number of pre-ovulatory follicles (/- 12 mm) during the first three cycles was 1-2 follicles. The mean diameter of the largest follicle during the first cycle post-op was 12-16 mm and increased to 14-18 mm during the second and third cycles. The earliest 18 mm follicle was observed on day 14 of the first cycle but 75.1 percent of patients had an 18 mm follicle by day 18 of the first cycle. The type of operation, use of cautery, type of ovarian pathology, and use of ovulatory drugs post-op did not significantly alter the onset of development of an 18 mm folicle. The earliest corpus luteum was noted on day 18 of the first cycle. Conclusion: There is an adequate ovulatory response after ovarian cystectomy in the first three cycles post-op.

Efficacy and safety of raloxifene 60 milligrams/day in postmenopausal Asian women.

In healthy Caucasian postmenopausal women, raloxifene increases bone mineral density (BMD), decreases biochemical markers of bone turnover, and lowers low-density lipoprotein (LDL) cholesterol, without effects on high-density lipoprotein (HDL) cholesterol and triglycerides. This randomized, double-blind study examines the effects of raloxifene 60 mg/d (n = 483) or placebo (n = 485) in healthy postmenopausal Asian women (mean age 57 yr) from Australia, Hong Kong, India, Indonesia, Malaysia, Pakistan, Philippines, Singapore, Taiwan, and Thailand. Serum osteocalcin, serum N-telopeptide, total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were assessed at baseline and 6 months. Lumbar spine BMD was measured at baseline and 1 yr in 309 women from 4 countries. Clinical adverse events were recorded at each interim visit. At 6 months, raloxifene 60 mg/d significantly decreased osteocalcin, N-telopeptide, total cholesterol, and LDL cholesterol by medians of 15.9%, 14.6%, 5.3%, and 7.7%, respectively, from placebo. Changes in HDL cholesterol and triglycerides were similar between raloxifene and placebo. Raloxifene 60 mg/d increased mean lumbar spine BMD (1.9%) from placebo at 1 yr (P = 0.0003). The incidences of hot flashes (placebo 3.5%, raloxifene 5.6%, P = 0.12), and leg cramps (placebo 2.7%, raloxifene 4.3%, P = 0.16) were not different between groups. No case of venous thromboembolism was reported. The effects of raloxifene 60 mg/d on bone turnover, BMD, and serum lipids in healthy postmenopausal Asian women were similar to that previously reported in Caucasian women.