Objective: To evaluate within the Traditional Chinese Medicine (TCM) setting, the effect of CHM-formulae on menopausal symptoms.
Design: A double-blind and double-dummy randomised placebo-controlled trial.
Method: Between February and June 2002 and June and October 2004, 31 peri- and postmenopausal Dutch women were recruited to complete 12 weeks of treatment with either CHM formulae (n=10), HRT (n=11) or placebo (n=10) medications plus 4 weeks of non-treatment follow-up observation. Hereby a double-dummy setting is applied, i.e. the medications and placebo's taken were both capsules and liquid extracts. Appropriate to the TCM setting, the CHM-prescriptions could be adjusted according to the symptoms and signs of the individuals for that moment.
Main outcome measures: The primary end-point was the reduction in frequency of vasomotor symptoms (hot flushes and night sweats). Secondary end-point were the improvements measured in quality of life questionnaire SF-36 and other symptoms and signs related to the peri- and postmenopausal period.
Results: Placebo had a score of 30%. Compared to Placebo, on average CHM is 29% significantly (p<0.05) more effective in reducing the amount of hot flushes, while HRT is almost 50%. Although quantitatively there was a significant difference in the reduction of hot flushes between groups, qualitatively there was no overall improvement.
Conclusions: This pilot study proved clearly that CHM could help women with their menopausal problems. The chosen trial methodology with its TCM differential diagnosis after orthodox medicine diagnosis is fully compatible with TCM practice and hence acceptable for western and Chinese medical practitioners. For a place in the western health care system, we need to conduct a larger trial with a more menopause specific questionnaire.