Menopace® Nutrient Therapy
Russell S. Kirby, PhD, MS, FACE
Department of Maternal and Child Health
School of Public Health
University of Alabama at Birmingham
Considerable controversy surrounds the use of hormone replacement therapy [HRT] for treatment of peri-menopausal symptoms. Recent publications from three large, prospective randomized studies call the safety of HRT into question, and leave patients searching for answers.
Nutrient therapy may provide symptomatic relief without increasing risk of chronic disease. In this study, results of a series of uncontrolled prospective studies of peri-menopausal symptom relief using Menopace® nutrient therapy were combined to provide a broad perspective on the safety and effectiveness of this alternative treatment modality.
Data from seven studies with a total of 766 subjects were analyzed. Subjects with specific menopausal symptoms reported improvement after three months of daily use of the therapy, ranging from 87.8% of subjects with hot flashes to 67.5% of subjects with poor concentration reporting
Overall improvement in menopausal symptoms was reported in 93.2% of all subjects. These results provide consistent evidence of the effectiveness of comprehensive, nutritionally balanced nutrient therapy for treatment of menopausal symptoms. While most evidence-based practitioners focus primarily on research results from randomized, controlled clinical trials, other forms of research evidence can also guide clinicians for safe and effective treatment options for their patients. Int J Fertil 51:125-129, 2006.
KEY WORDS: menopause, nutrient therapy, evidence-based practice, and uncontrolled prospective studies
AS LIFE EXPECTANCY INCREASES and the population grows throughout the world, more women not only are reaching the age of menopause and living well beyond it, but are also demanding a higher quality of life during these later life stages. Whereas menopause is not a disease per se in any sense of the word, it does represent a natural biological process in the human female , which is often associated with a range of unpleasant physiological occurrences. In the past, most women put up with the vicissitudes of menopausal changes, believing that there was little that they could do to alleviate them.
With the advent of prototype hormonal replacement therapy in the 1960s, however, many women were initially offered estrogen, and later, combinations of estrogen and progesterone, to alleviate the numerous annoying symptoms of this stage of life. Alone or combined, these two hormonal agents became known to medical professionals and the lay public as hormone replacement therapy [HRT].
Recently, HRT has been called into question, most notably through the initial publication and subsequent interpretations of the American Women’s Health Initiative study [WHI], the Heart and Estrogen/ Progestin Replacement Study (HERS/ HERS II), and the British Million Women Study [2,3,4].
The immediateness of the response of clinicians and gynecological professional societies to published results from these studies was not unexpected. This, coupled with a worldwide medical coverage that was little less than sensationalistic, resulted in a dramatic decline in the use of hormonal therapies for women during and after menopause.
With time for reflection, the appropriateness of this ‘rejection response’ has been called into serious question, not only in the United States, but in the United Kingdom as well [5,6,7]. As this debate continues and secondary analyses and counter analyses of these studies continue to appear, many women are bewildered by this conflict and appropriately ask their health care providers what non-hormonal alternatives might be available to provide relief from the symptoms of menopause. This basic question has resulted in an enormous outpouring of interest in the literature, much of which is related to the discipline of alternative medicine, an area of medicine now so vast that is cannot be addressed in this review.
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 .
This report describes the tolerability, safety, and efficacy of Menopace®, a vitamin and nutrient supplement marketed for peri- and postmenopausal women.
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.
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.
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.
A third study from India compared 60 peri-menopausal women, 30 of whom received placebo and 30 Menopace®, and found greater improvements in menopausal symptomatology among women in the Menopace® group; unfortunately, this publication did not provide sufficient study design information to determine if the study was a scientifically randomized, controlled clinical trial. Other trials were conducted in Russia, Denmark, and India (Dr. R. Arora, Maulana Azad Medical College, New Delhi) during the early 1990s; however, here also the study designs and methods of analysis were not similar to the majority of trials cited in this report. Despite this, these results were similar to those reported above.