Finished herbal product as an alternative treatment for menopausal symptoms in climacteric women.
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.


METHODS
A multicenter, prospective, observational follow-up study was conducted from July 2003 to December 2004 in four hospitals in Taiwan.


METHODS
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).


METHODS
Every participant received TMN-1 treatment 4 g, 3 times per day, for 12 weeks.


METHODS
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.
Lai
Jung-Nein
JN
Department of Obstetrics and Gynecology; Department of Chinese Medicine, Taipei Municipal Yang Ming Hospital, Taipei, Taiwan.
Hwang
Jing-Shiang
JS
Chen
Huey-Jeng
HJ
Wang
Jung-Der
JD
D004334:Drug Administration Schedule; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005260:Female; D005500:Follow-Up Studies; D019584:Hot Flashes / Q000188:drug therapy* / Q000517:prevention & control; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D016017:Odds Ratio; D017060:Patient Satisfaction / Q000706:statistics & numerical data; D008517:Phytotherapy; D010936:Plant Extracts / Q000008:administration & dosage; D011446:Prospective Studies; D011788:Quality of Life; D011795:Surveys and Questionnaires; D013624:Taiwan; D016387:Women's Health
D004365:Drugs, Chinese Herbal; D010936:Plant Extracts; C510684:herbal product TMN-1