Having said this, among the currently available alternatives to HRT, there is growing international interest in the potential of using nutrient therapy for treatment of the menopause and it symptomatology [8,9].

Indeed, a large number of manufacturers have developed and marketed nutritional or herbal products for relief and control of menopausal symptoms, but few studies exist that describe the safety and efficacy of these products [10].

This report describes the tolerability, safety, and efficacy of Menopace®, a vitamin and nutrient supplement marketed for peri- and postmenopausal women.

METHODS

Menopace® (Vitabiotics Ltd.,London UK.) contains a balanced palatte of 22 nutrients selected based on their published properties to maintain women’s health during menopause.

These nutrients include vitamin B complex, zinc, magnesium, vitamins A, C, D, and E, manganese, chromium, and selenium. For this analysis, study designs and results for all available observational studies of Menoapce®, in uncontrolled as well as randomized studies, were analyzed to determine which might be included in summary analyses.

Specifically, the dosage and recommended frequency of use, the length of follow-up, and the pre- and post-usage symptomatology questionnaires were reviewed for similarities in study design across the studies.

All of these studies are unpublished, and reports provided by their authors to Vitabiotics Ltd. were made available for the purpose of this analysis.

Several placebo-controlled trials were reviewed, including two in India and one in Russia. In none of these studies do the research reports document that study subjects were randomized to treatment groups. Moreover, differences in comparison groups, length of follow-up, and other study design issues made it imprudent to include these trials in the summary analyses.

A total of six out of 7 seven uncontrolled observational studies with a combined 766 subjects were amenable to summary analysis. These studies were:

All studies examined the efficacy of Menopace® in peri- and post-menopausal women, selected as random samples from contacts made by respondents to an appeal for clinical trial volunteers by the health editors of leading magazines or newspapers, with the exception of the Krishna and Virkud studies, which used the same methods but obtained subjects from large outpatient gynecology practices.

Following recruitment, university survey research centers or well-known obstetrician/gynecologists conducted or monitored the investigations. Participants were asked to complete an initial questionnaire and were then provided with a one month supply of Menopace®.

At the month’s end, respondents returned the questionnaire, and received the next month’s supply by mail. Of the seven studies, one followed participants for two months and the other six completed three months of follow-up.

RESULTS

Seven observational studies were conducted from 1992 through 1995, in the United Kingdom and India. Although the study patients ranged in age from 24 to 67, the majority of participants were in their 40s or older. Mean ages were reported for six of the seven studies, and ranged from 44 to 53.

Some attrition occurred in all the studies. A careful statistical analysis of the characteristics of dropouts and those who continued could not be performed with the available data, though some of the studies themselves attempted to do this.

Women who did not continue for the full three months appeared to have had less favorable response from Menopace® in terms of their menopausal symptoms.

For the women completing the three month follow-up, symptomatic improvement is shown in Table I, and overall symptom improvement results are presented in Table II. These data suggest that the vast majority of women participating in these observational studies experienced substantial improvement in their menopausal symptoms using Menopace® daily for three months.