Finished herbal product as an alternative treatment for menopausal symptoms in climacteric women
Resource
The Journal of Alternative and Complementary Medicine 11 (6): 1075-1084
Journal
The Journal of Alternative and Complementary Medicine
Pages
1075-1084
Date Issued
2005
Date
2005
Author(s)
Lai, Jung-Nein
Hwang, Jing-Shiang
Chen, Huey-Jeng
Wang, Jung-Der
Abstract
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 ?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. ? Mary Ann Liebert, Inc.
SDGs
Other Subjects
Albus paeoniae extract; Alismatis orientalis extract; Amomum villosum extract; Anemarrhenae asphodeloidis extract; Angelica sinensis extract; Atractylodes macrocephalae extract; Aucklandiae lappa extract; bupleurum chinense extract; cholesterol; Citri reticulatae extract; Cornus officinalis extract; Dioscoreae oppositae extract; Gardenia jasminoides extract; ginger extract; ginseng extract; Glycyrrhiza uralensis extract; hemoglobin; herbaceous agent; Mentha haplocalyx extract; Paeonia suffruticosa extract; Phellodendri extract; Pinellia ternate extract; plant extract; Poria cocos extract; Rehmannia glutinosa extract; tmn 1; unclassified drug; abdominal fullness; abdominal pain; adult; alternative medicine; article; blood pressure; bradycardia; cholesterol blood level; climacterium; clinical trial; coughing; diarrhea; disease severity; drug efficacy; drug safety; drug treatment failure; drug withdrawal; dyspnea; edema; emotional disorder; evidence based medicine; female; fever; gastrointestinal symptom; heart palpitation; hemoglobin blood level; hormone substitution; hot flush; human; hypotension; insomnia; jaundice; logistic regression analysis; major clinical study; melancholia; menopausal syndrome; multicenter study; muscle cramp; nausea; nervousness; observational study; patient compliance; postmenopause; priority journal; pruritus; purpura; quality of life; rash; rhinorrhea; side effect; skin swelling; sore throat; Taiwan; urticaria; vomiting; Drug Administration Schedule; Drugs, Chinese Herbal; Female; Follow-Up Studies; Hot Flashes; Humans; Menopause; Middle Aged; Odds Ratio; Patient Satisfaction; Phytotherapy; Plant Extracts; Prospective Studies; Quality of Life; Questionnaires; Taiwan; Women's Health
Type
journal article
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