Complementary and alternative medicine use and the menopausal transition : the effect of a Chinese herbal formula on vasomotor symptoms and bone turnover

Although Hormone Therapy (HT) is the most effective treatment for alleviating menopausal vasomotor symptoms and reducing bone loss, many women are reluctant to take this treatment due to side effects and concerns about safety. Epidemiological studies suggest that a significant proportion of women use Complementary and Alternative Medicine (CAM) therapies to alleviate vasomotor symptoms and improve quality of life. Anecdotal and clinical evidence indicate a number of CAM therapies, such as herbal medicine, may be effective in alleviating symptoms and modulating bone metabolism. Hence, in the context of concerns over the safety of HT and the extensive history of the clinical use of herbal medicine, this thesis investigated issues pertinent to CAM use and the menopausal transition. The aims of this thesis were to: • Examine the nature and extent of CAM use by women transitioning through menopause • Evaluate the effectiveness of a herbal formula containing Chinese herbs and Cimicifuga racemosa for alleviating vasomotor symptoms, improving quality of life and modulating bone turnover markers. From July 2003 until July 2004 the Women’s Health during Midlife Survey recruited 1,296 women aged 45-65 who were symptomatic when transitioning through menopause or asymptomatic but taking menopause specific treatments. A validated 19-item survey instrument assessed the use of CAM modalities and menopause specific products. The instrument was completed voluntarily and anonymously by women recruited from three strata; menopause clinics, clinics of general practice and government agencies. Approximately 54% of respondents had visited a CAM practitioner and/or used a CAM product during the previous 12 months. The most popular practitioners were the naturopath (7.2%) and acupuncturist (4.8%), while soy (25.4%) and evening primrose oil (EPO, 18.4%) were the most popular products. Massage and chiropractic were considered the most effective therapies, while phytoestrogen tablets and EPO were the most efficacious products. Although 26.4% of respondents indicated their doctor asked about CAM use, 71% of CAM users said they informed their physician about using CAM. Of the 60% of women using pharmaceutical medicines, 62.5% reported using a CAM product during the preceding 12 months. The survey results confirm the continued popularity of CAM use amongst women transitioning through menopause. A number of treatments were perceived to be effective in relieving symptoms. However, communication between medical practitioners and patients about CAM use is inadequate, and given the high use of pharmaceutical medicines this oversight may unnecessarily expose women to drugherb interactions. A randomised, double-blind, placebo controlled clinical trial was conducted to evaluate the effectiveness of a herbal formula derived from two traditional Chinese herbal formulae with the addition of Cimicifuga in alleviating vasomotor symptoms. The trial recruited 93 healthy women who reported at least six vasomotor symptoms per day. After a four week baseline period, women were randomly allocated to receive either herbal treatment or identical looking placebo tablets for 16 weeks. During the trial women recorded the number and severity of their flushes on a Daily Flush Diary, and at each monthly consultation two quality of life scales were completed. Forty nine eligible trial women were entered into a pilot study to assess the effect of the formula on bone turnover markers; bone specific alkaline phosphatase and deoxypyridinoline (corrected for creatinine). The herbal formula was found to be no more effective than placebo in reducing the frequency of flushing and the composite hot flush score or in improving quality of life. The pilot study found the formula had no effect on bone turnover markers after 16 weeks of treatment. Therefore, this formula cannot be recommended as a treatment for vasomotor symptoms and is unlikely to have any long term effect on bone. The use of CAM during the menopausal transition is very popular. Although this thesis found the current herbal formula to be an ineffective treatment, the scientific evaluation of potential CAM therapies is imperative so that health care professionals and consumers can make informed decisions concerning treatment options for the alleviation of symptoms

Traditional Chinese medicine

200

A randomised placebo-controlled trial on the effectiveness of an herbal formula to alleviate menopausal vasomotor symptoms

Objective: To evaluate the effectiveness of a formula containing Chinese herbs and Cimicifuga racemosa in alleviating vasomotor symptoms and improving quality of life. Methods: Between September 2004 and October 2005, 93 healthy women aged 45 to 65 years who reported six or more vasomotor symptoms per 24 hours were recruited into a 20-week randomized, double-blind, placebo-controlled trial. Women were consulted in clinics conducted within the Sydney metropolitan area. After a 4-week baseline period, women were randomly allocated to receive herbal (equivalent to 3,150 mg dry herb) or identical placebo tablets for 16 weeks. Women recorded the number and severity (1 = mild to 4 = very severe) of vasomotor symptoms in a daily hot flash diary and completed the Greene Climacteric and Hot Flash Related Daily Interference scales at each monthly consultation. Results: Intention-to-treat and per-protocol analyses found no statistically significant differences in mean hot flash scores (product of frequency and intensity), Greene Climacteric Scale scores, and Hot Flash Related Daily Interference Scale scores between the placebo and herbal treatment groups after 16 weeks of intervention. Conclusions: This herbal formula containing Chinese herbs and Cimicifuga cannot be recommended to alleviate menopausal vasomotor symptoms or improve quality of life

Women's health during mid-life survey : the use of complementary and alternative medicine by symptomatic women transitioning through menopause in Sydney

Objective: To survey the extent of complementary and alternative medicine (CAM) use among women for the alleviation of menopausal symptoms. Design: A total of 1,296 eligible women aged 45 to 65 years were recruited from three Sydney menopause clinics, general practice clinics, and government agencies between July 2003 and July 2004. Volunteers were invited to complete a 19-item questionnaire covering basic demographics, general health status, use of CAM therapies and products, use of pharmaceuticals, and sources of CAM advice. Results: Of respondents, 53.8% had visited a CAM practitioner and/or used a CAM product during the past year, with 34% using a product only and 5% consulting a practitioner only. The most commonly visited practitioners were naturopaths (7.2%) and acupuncturists (4.8%), whereas the most popular products were soy (25.4%) and evening primrose oil (18.4%). Massage, chiropractic, and nutrition were rated the most effective therapies, and phytoestrogen tablets, evening primrose oil, and black cohosh were deemed the most effective products. Of the 59.9% of respondents currently using prescription or over-the-counter pharmaceuticals, 62.5% reported using CAM products during the past 12 months. Of CAM users 71% had informed their doctor about CAM use, whereas 26.4% of respondents reported their doctor had inquired about CAM use. Conclusions: CAM use by women to alleviate menopausal symptoms is common, with several therapies perceived to be effective. Although a significant proportion of women may use CAM in conjunction with pharmaceuticals, relevant communication between medical practitioners and patients remains inadequate and may expose the patient to potential drug-herb interactions