Eighteen studies were included in the review. The number of patients in one study was not stated; the remaining 17 studies involved 1,295 patients.
Four trials examined the effectiveness of black cohosh given as the brand Remifemin. Two studies compared Remifemin, conjugated estrogen and diazepam over 12 weeks. The data for one study (n=60) were not reported, although it was stated that the Remifemin group experienced greatest improvement on a number of outcome measures. The second study (n=80) found significant reductions from baseline in the Kupperman Index and the HAMA Scale (P<0.001 in both cases) in the Remifemin group. A study involving women with hysterectomies and one intact ovary (n=60) compared Remifemin, estriol, conjugated estrogens and estrogen-progesterone therapy. All groups showed significant improvement (P=0.01) on the Kupperman Index with no difference between the groups. Finally, a study of breast cancer patients (n=85), of whom 69% were being treated with tamoxifen, compared Remifemin and placebo over 60 days. Hot-flash diaries showed improvements in both groups, with no differences between the groups.
Four trials examined the effectiveness of red clover given as the brand Promensil. A crossover study (n=51) administered Promensil or placebo for 12 weeks, with a 1-month washout, followed by 14 weeks of the alternate treatment. There were no significant differences between the groups on any of the outcome measures. A trial (n=37) compared two different doses of Promensil with placebo over 12 weeks. There were no significant differences between the groups on either of the outcome measures. A third study (n=30) administered single blind placebo tablets for 4 weeks, followed by randomisation to placebo or Promensil for 12 weeks. A significantly larger decrease in hot flush frequency occurred in the treatment group (P<0.01) during the randomised stage. The final study (n=30) compared Promensil and placebo over 16 weeks. Significant reductions in frequency and severity of hot flushes were seen in the treatment group compared with placebo (P<0.001).
Three trials examined the effectiveness of kava. One study (n=40) compared kava extract with placebo over 12 weeks. For all the measures used (Kupperman Index, Anxiety-State Index and symptom diary), the kava group showed significant improvements on all measures (P<0.001) while the placebo group showed no changes. The drop-out rates prevented analysis at subsequent intervals. A second study (n=40) compared Kava WS 1490 with placebo over 8 weeks. A number of health-related quality of life measures were used, including the Kupperman Index, HAMA and the Depression Status Index. Significant improvements were seen in the first two indices in the kava group at 1, 4 and 8 weeks, and in the Depression Status Index at 4 and 8 weeks. A final study (n=40) compared kava in combination with hormone replacement therapy (HRT) with HRT and placebo over 6 months. Both groups showed improvement on the HAMA compared with baseline, but improvement was greatest in the group given kava (P<0.05). The groups were not compared directly.
One trial (n=71) examined the effectiveness of dong quai compared with placebo over 24 weeks. The outcome measures used were the Kupperman Index and a daily flush diary. There were no differences between the groups, although both groups showed improvements on both measures.
One trial (n=56) examined the effectiveness of evening primrose oil compared with placebo over 24 weeks. There was no benefit of treatment on any outcome measure, but there was a significant reduction from baseline in the maximum number of night-time flushes (P<0.05).
One trial (n=384) examined the effectiveness of ginseng compared with placebo over 16 weeks. Of several quality of life questionnaires employed, only the Psychological General Well-being Index showed a significant benefit for ginseng (P<0.01), as did its depression, well-being and health subscales (P<0.05).
Four trials examined the effectiveness of herbal combinations. One (n=179) looked at black cohosh and St. John's Wort (Remifemin Plus) compared with placebo for 6 weeks. There was a greater reduction in the Kupperman Index in the treatment group, but this was not clinically significant. A small study (n=13) compared a combination of burdock, licorice root, motherwort, dong quai and Mexican wild yam with placebo over 12 weeks. The outcomes were patient symptom records of occurrence and severity. More women in the treatment group experienced reductions in these measures, but statistical tests were not reported. A defined Chinese herbal formula with 12 active constituents was also compared with placebo (n=55). There were no significant differences between the groups in either frequency of vasomotor events or Menopause Specific Quality of Life Score. Finally, a crossover study (n=50) compared a BioGest cream containing four active ingredients with placebo over 3 months. A symptom diary showed no differences between the groups.