ABSTRACT: OBJECTIVE: This study is a phase II clinical trial that aims to investigate the dose-response relationship of a Chinese herbal medicine preparation, Dang Gui Buxue Tang (DBT), with short-term menopausal symptoms and quality of life in local postmenopausal women. METHODS: A randomized, double-blind, multiple-dose escalation trial was performed in 60 postmenopausal women experiencing severe hot flashes and night sweats. The participants were randomized to receive DBT preparations at 1.5, 3.0, or 6.0 g/day for 12 weeks. The primary outcomes were vasomotor symptoms, Greene Climacteric Scale (GCS) score, and Menopause-Specific Quality of Life (MENQOL) score. Secondary outcomes included serum hormones and lipids. RESULTS: There were between-group differences in psychological/psychosocial (P = 0.015, GCS; P = 0.013, MENQOL) and somatic/physical (P = 0.019, GCS; P = 0.037, MENQOL) domains, and improvement was significantly greatest (P < 0.05) in the 6.0 g/day dose group. The frequency and severity of hot flashes and night sweats were significantly reduced in the 3.0 g/day (14.5%-21.2%, P < 0.05, hot flashes; 28.6%-39.6%, P < 0.05, night sweats) and 6.0 g/day (34.9%-37.4.0%, P < 0.01, hot flashes; 10.1%-12.8%, P < 0.01, night sweats) dose groups. The female hormones follicle-stimulating hormone, luteinizing hormone, and 17β-estradiol, as well as the lipids total cholesterol, triglycerides, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol, were not significantly different within groups and between groups. CONCLUSIONS: DBT preparations at 6.0 g/day significantly improve physical and psychological scores and significantly reduce vasomotor symptoms from baseline. The treatment was well tolerated, with no serious adverse events noted during the 12-week intervention period. The changes do not affect hormones and lipid profiles.
Menopause (New York, N.Y.) 09/2012; · 3.08 Impact Factor
ABSTRACT: Threatened miscarriage is very common in early pregnancy. Chinese medicines have been widely used to prevent spontaneous pregnancy loss. However, the safety of Chinese medicines is still unknown. A systematic review was performed to identify and describe adverse events of Chinese medicines used for threatened miscarriage.
Clinical studies of Chinese medicines for threatened miscarriage were selected. Primary outcomes were occurrence of adverse effects or toxicity of Chinese medicines. Secondary outcomes were failure of treatment and adverse pregnancy and perinatal outcomes.
Thirty-two relevant articles included 9 randomized controlled trials, 1 quasi-randomized controlled trial and 2 controlled trials comparing Chinese medicines alone or combined medicines with pharmaceuticals and 20 case series with no controls. Sample sizes of each study were generally small. There was variation in Chinese medicine formulation, dosage and duration of treatment. In the pooled randomized controlled trials, dry mouth, constipation and insomnia (2-10%) and intervention failure (3.1-22.3%), diabetic complications (3%), preterm delivery (5%) and neurodevelopmental morbidity (1.8%) were recorded. Meta-analysis demonstrated that intervention failure was significantly lower in the combined Chinese medicines groups than in the Western medicines controls (relative risk = 0.46; 95% confidence interval: 0.30-0.70, I(2)= 0%). No significant differences were found between these groups for adverse effects and toxicity or for adverse pregnancy and perinatal outcomes.
Studies varied considerably in design, interventions and outcome measures, therefore conclusive results remain elusive. In the absence of placebo-controlled trials, the safety of Chinese medicines for the treatment of threatened miscarriage is unknown. Rigorous scientific and clinical studies to assess the possible risks of Chinese medicines are needed.
Human Reproduction Update 06/2012; 18(5):504-24. · 9.23 Impact Factor
ABSTRACT: It is unclear how safe the use of Chinese herbal medicine is during pregnancy and if the herbal medicines do any harm to pregnancy, embryo-fetal development and prenatal and post-natal growth. A large-scale preclinical study was conducted to detect the adverse effects of Chinese herbal medicines during pregnancy.
Twenty of the most commonly used Chinese herbal medicines prescribed for pregnancy were selected and the crude extract was administered to pregnant mice at clinical doses during five different gestational stages, namely post-implantation, gastrulation, organogenesis, maturation and whole gestation periods. Maternal effects on side effects, weight loss, litter reduction, implantation failure and fetal resorption and perinatal effects on growth restriction, developmental delay, congenital malformations and post-natal mortality were determined.
Adverse pregnancy outcomes were commonly observed after maternal exposure to the herbal medicines, particularly during early pregnancy. Major events included maternal and perinatal mortality were recorded. Maternal weight gain, embryo growth and post-natal weight gain were significantly decreased. Fetal resorption and skeletal malformations were significantly increased.
Reproductive toxicity of Chinese herbal medicines commonly used during pregnancy was identified in mice. Caution should be taken in the clinical use of herbal medicines during pregnancy.
Human Reproduction 05/2012; 27(8):2448-56. · 4.47 Impact Factor
ABSTRACT: Threatened miscarriage occurs in 10% to 15% of all pregnancies. Vaginal spotting or bleeding during early gestation is common, with nearly half of those pregnancies resulting in pregnancy loss. To date, there is no effective preventive treatment for threatened miscarriage. Chinese herbal medicines have been widely used in Asian countries for centuries and have become a popular alternative to Western medicines in recent years. Many studies claim to show that they can prevent miscarriage. However, there has been no systematic evaluation of the effectiveness of Chinese herbal medicines for threatened miscarriage.
To review the therapeutic effects of Chinese herbal medicines for the treatment of threatened miscarriage.
We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 January 2012), Chinese Biomedical Database (1978 to 31 January 2012), China Journal Net (1915 to 31 January 2012), China National Knowledge Infrastructure (1915 to 31 January 2012), WanFang Database (1980 to 31 January 2012), Chinese Clinical Trial Registry (31 January 2012), EMBASE (1980 to 31 January 2012), CINAHL (31 January 2012), PubMed (1980 to 31 January 2012), Wiley InterScience (1966 to 31 January 2012), International Clinical Trials Registry Platform (31 January 2012) and reference lists of retrieved studies. We also contacted organisations, individual experts working in the field, and medicinal herb manufacturers.
Randomised or quasi-randomised controlled trials that compared Chinese herbal medicines (alone or combined with other pharmaceuticals) with placebo, no treatment (including bed rest), or other pharmaceuticals as treatments for threatened miscarriage.
Two review authors independently assessed all the studies for inclusion in the review, assessed risk of bias and extracted the data. Data were checked for accuracy.
In total, we included 44 randomised clinical trials with 5100 participants in the review.We did not identify any trials which used placebo or no treatment (including bed rest) as a control.The rate of effectiveness (continuation of pregnancy after 28 weeks of gestation) was not significantly different between the Chinese herbal medicines alone group compared with the group of women receiving Western medicines alone (average risk ratio (RR) 1.23; 95% confidence interval (CI) 0.96 to 1.57; one trial, 60 women).Chinese herbal medicines combined with Western medicines were more effective than Western medicines alone to continue the pregnancy beyond 28 weeks of gestation (average RR 1.28; 95% CI 1.18 to 1.38; five trials, 550 women).
There was insufficient evidence to assess the effectiveness of Chinese herbal medicines alone for treating threatened miscarriage.A combination of Chinese herbal and Western medicines was more effective than Western medicines alone for treating threatened miscarriage. However, the quality of the included studies was poor. More high quality studies are necessary to further evaluate the effectiveness of Chinese herbal medicines for threatened miscarriage.
Cochrane database of systematic reviews (Online) 01/2012; 5:CD008510. · 5.72 Impact Factor