Climacteric Symptoms Clinical Trial
Context:Clinical trials demonstrating increased risk of cardiovascular disease and breast
cancer among women randomized to hormone replacement therapy have attracted people's focus
on the alternative therapy for menopausal symptoms. This study drug- a mixture of
CHIA-WEI-HSIAO-YAO-SAN, CHIH-PO-TI-HUANG-WAN, HSIANG-SHA-LIU-CHUN-TZU-TANG (TMN1) is widely
used as an alternative to hormonal therapies for hot flush in Taiwan. However, there is a
paucity of data supporting their efficacy and safety.
Objective:To evaluate the safety and efficacy of TMN1 in the treatment of hot flush.
Design and Setting:A multi-center, prospective, observational follow-up study was conducted
from July 2003 to December 2004 in 4 hospitals.
Participants:In total, 136 eligible subjects entered this study. They were required to take
study drug 3 times a day for 12 weeks and make 9 visits at scheduled time for follow up
efficacy and safety evaluations.
Main Outcome Measures:During the observation period, the investigators and study nurses
actively enquired subjects if there was any adverse event (AEs) occurring to them by using
Traditional Chinese medicine Adverse Events (TCM AE) questionnaire which includes 20 AEs
proposed by experienced CM doctors as most commonly seen in the use of study drug. Every
subject's complaint or abnormal laboratory value were carefully examined for possible
causality and reviewed and decided by the research team. The primary outcome measure was the
mean changes from baseline to week 12 in terms of frequency of hot flush and the severity of
menopausal symptoms measured by the Kupperman Menopause Index. The secondary outcome
measures included changes in quality of life measured by World Health Organization Quality
of Life (WHOQOL) questionnaire, and adverse events monitored actively by a global assessment
of tolerability. During the study period, every subject also received tests on routine
hematology, biochemical function, and gynecologically relevant hormones at baseline visit, 4
weeks and 12 weeks after medication.
n/a
Time Perspective: Prospective
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