Miscarriage or spontaneous abortion is the loss of a pregnancy without medical or mechanical means before completion of the 20th week of gestation. The fetus is not sufficiently developed to have been able to survive outside the mother’s womb. Threatened miscarriage is a very common in early pregnancy. Most threatened miscarriages occur in the first 12 weeks of pregnancy and become evident as vaginal bleeding, abdominal and low back pain that persist for days or weeks. So far, therapies have limited effectiveness in preventing early pregnancy loss due to threatened miscarriage. Chinese herbal medicines are a part of Traditional Chinese Medicines and are made up of products from plants and some animal and mineral substances. They have become very popular and are commonly used as an alternative treatment for threatened miscarriage.
This review compared the therapeutic effects of Chinese herbal medicines with other pharmaceutical agents. Among the 44 included randomised trials involving 5100 participants, all from China, no trial used placebo or bed rest as a control intervention. Twenty trials used a common prescription of Shou Tai Pill as a basic formula, while the other 24 trials used other formulae. The Western medicines included tocolytic drugs such as salbutamol and magnesium sulfate, hormonal supplementation with human chorionic gonadotrophin or progesterone and supportive supplements including vitamin E and folic acid. Five trials followed 550 women until after 28 weeks of gestation and delivery and showed that combined Chinese herbal and Western medicines were more effective than Western medicines alone in the treatment of threatened miscarriage. The remaining studies looked at the immediate effects of treatment. Combined treatment was more effective than Western medicines in preventing inevitable miscarriage so that the pregnancy continued. Many of the trials did not report on side effects during treatment or throughout continuing pregnancy and birth. Chinese medicine practitioners slightly modify the classical prescriptions depending on the individual women’s clinical presentations. All the trials had poor methodological quality. In conclusion, there is a lack of evidence from randomised controlled trials on the effectiveness of Chinese herbal medicines for the treatment of threatened miscarriage and to determine if Chinese herbal medicines alone are more beneficial than Western medicines alone for threatened miscarriage.
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.
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).