Improvement in specific symptoms varied, however. The Daily Mirror study sample contributed the poorest outcomes of any of the studies for each of the specific symptoms reported in Table I. Overall improvement was better in the three observational studies from the United Kingdom than in the four Indian observational studies. Very few side effects were reported in any of the studies, and none of these was significant.

Additional observational studies of the efficacy of Menopace® were also conducted. An uncontrolled clinical trial conducted by Prof. V. I.

Krasnopolsky at the Moscow Regional Obstetrics and Gynecology Research and Development Institute [Russia] compared menopausal symptoms in peri-menopausal women treated with Menopace® (N = 30) and HRT (N = 28) with six months of follow-up. Because these results were reported using different clinical outcomes, this study was not included in the summary analysis. However, by six months, the proportion with severe climacteric manifestations in the Menopace® arm of the study had declined from 50% at baseline to 10%, similar to that observed among those women receiving HRT.

In another study, 120 women with mean age of 50.7 years were followed for three months in gynecology clinics in five Lithuanian cities in 1999 (V. Riauba, Entapharma). Although the results were presented in a manner difficult to include in the summary analysis, almost all patients had at least some overall symptom improvement with three months of daily Menopace®, and results for individual symptoms were in the mid-range of those from the combined analysis.