Background: There is a paucity of scientific evidence supporting the efficacy of herbal medicines in treating menopausal symptoms.
Objective: The aim of this study was to evaluate safety and efficacy of the finished herbal product TMN-1 in the treatment of menopausal symptoms in climacteric women.
Design and setting: A multicenter, prospective, observational follow-up study was conducted from July 2003 to December 2004 in four hospitals in Taiwan.
Participants: Initially, 126 women were included who were between 45 and 55 years of age, were experiencing hot flashes, and were without hormone replacement therapy. Women were excluded if they had any signs of active cancer. Of the participants, 82% completed the study. The reasons for withdrawal included adverse effects (n = 7), failed to return (n = 7), lack of efficacy (n = 6), and from protocol deviation (n = 3).
Intervention: Every participant received TMN-1 treatment 4 g, 3 times per day, for 12 weeks.
Main outcome measure: Primary measures were change in frequency of hot flashes and severity of menopausal symptoms measured by Kupperman Index (KI). Secondary outcomes included changes in quality of life and adverse events.
Results: Significant improvement in scores of hot flashes and KI were found at weeks 4 and 12 in the 50 peri- and 53 postmenopausal women who completed this study (p < 0.001). Logistic regression analyses showed that perimenopausal women with hot flashes had sevenfold (95% confidence interval [CI], 1.8-28.0) odds of improvement in favor of treatment, whereas that of the postmenopausal group was 1.5 (95% CI, 0.5 to 4.2). Further analyses showed that TMN-1 produced superior benefit in women with moderate and severe menopausal symptoms (KI > or = 21), compared to those with mild symptoms. It also improved symptoms of insomnia, nervousness, melancholia, and palpitation in perimenopausal women. Five (5) adverse drug reactions were detected: three single events of nausea, abdominal pain, and abdominal fullness; and two events of diarrhea.
Conclusions: This study provides evidence that 12 weeks of TMN-1 therapy is a viable alternative treatment to consider in perimenopausal women with hot flashes, particularly in those with palpitations, emotional disturbance, and insomnia.