Clinical Studies

Meta-analysis - miscarriage

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Adverse outcomes include the adverse effects and toxicity of Chinese medicines, failure and complications of the intervention, adverse pregnancy outcomes and adverse perinatal outcomes. Owing to the substantial diversity of the selected studies with respect to quality, methodology, intervention variations, sample characteristics and outcome reporting, only a few studies meet the requirements for the quantitative data synthesis, comparing the adverse outcomes by meta-analysis. Meta-analysis demonstrated that intervention failure was significantly lower in the combined Chinese medicines groups than in the Western medicines controls. No significant differences were found in adverse effects and toxicity, or in adverse pregnancy and perinatal outcomes. This review identified the adverse maternal and perinatal outcome of Chinese medicines for threatened miscarriage. Preterm premature rupture of membranes (PPROM) was recorded in a study with incidence of 2.1%. Prematurity and associated neonatal mortality were recorded in several studies with an incidence ranging from 0.7 to 6.4%. It is well known that threatened miscarriage is associated with the risk of suboptimal pregnancy outcome (van Oppenraaij et al., 2009; Saraswat et al., 2010). Women with threatened miscarriage have a significantly higher incidence of antepartum haemorrhage (overall 1.2%). They are also more likely to experience PPROM (overall 1.9%), preterm delivery (overall 11.0%) and to have babies with an intrauterine growth restriction (overall 8.3%). First-trimester bleeding is also associated with significantly higher rates of perinatal mortality (overall 1.8%) and low and/or very low birth weight babies (overall 11.0%, odd ratios.2.0). In comparison, after treatment of threatened miscarriage with Chinese medicines, no antepartum haemorrhage, intrauterine growth restriction or low birthweights were recorded and the prematurity rate was relatively lower, but the PPROM rate was slightly higher. The neonatal death rate due to prematurity with respect to first trimester bleeding is 2.6–8.5% (Williams et al., 1991), which is comparable to our current review. These results suggest that Chinese medicines treatment for threatened miscarriage may not be associated with an increased risk of preterm delivery and neonatal mortality. For the adverse effects and toxicity of Chinese medicines, only 2 RCT studies with 130 participants (Zhang et al., 2005; Teng, 2008) reported adverse effects and toxicity of combined Chinese and Western medicines or Chinese medicines alone, but not Western medicines alone. No adverse effects were reported under combined medicines, but minor adverse effects were observed in 2–8% of women with Chinese medicine alone treatment. The effects included dry mouth, constipation and insomnia. No adverse effects and toxicity were identified in the quasi-RCT in either intervention (Song and Zhu, 2007). The controlled trials did not report adverse effects and toxicity after interventions (Gong and Chen, 1993; Zhou, 2006). No meta-analysis was performed. References: van Oppenraaij RH, Jauniaux E, Christiansen OB, Horcajadas JA, Farquharson RG, Exalto N; ESHRE Special Interest Group for Early Pregnancy (SIGEP). 2009. Predicting adverse obstetric outcome after early pregnancy events and complications: a review. Hum Reprod Update 15: 409 –421. Willians MA, Mittendorf R, Lieberman E, Monson RR. 1991. Adverse infant outcomes associated with first-trimester vaginal bleeding. Obstet Gynecol 78: 14 –18. Saraswat L, Bhattacharya S, Maheshwari A, Bhattacharya S. 2010. Maternal and perinatal outcome in women with threatened miscarriage in the first trimester: a systematic review. BJOG 117: 245– 257. Zhang J, Zhang Y, Liu G, Feng Q. 2000. Clinical and Experimental Study on Yun’ an Granule in Treating Threatened Abortion. Chin J Integr Trad West Med 20:251-254. Zhang R, Li G, Chen Z, Ma Y. 2005. Zi Shen Yu Tai Pill for threatened miscarriage. Chin Herb Med 28:1144-1146. Song Y, Zhu L. 2007. The fetus protection of Zhixue Baotai decoction on women of early threatened abortion with dark area surrounding pregnancy sac. Chin J Integr Trad West Med 27:1025-1028. Li L, Zhou Z, Liu J. 2006. Clinical studies of Bu Shen Gu Tai Decoction for threatened miscarriage. Guangxi Chin Med 29:17-18. He Z, Che P. 2007. Clinic curative effects on integrated Chinese and western medicines for threatened miscarriage & the childbearing results. Pract Chin J Integr Trad West Med 7:32-33. Teng J, Wu X. 2008. Bu Shen Yi Qi formula and Progesterone for threatened miscarriage. Master thesis. Master thesis. Hubei Chin Med Col :1-10. Yue P, Chen Z, Jie F. 2009. Combined Chinese medicines and western medicines for threatened miscarriage. Gansu J Trad Chin Med 22:44-45. Zhou Y. 2006. Clinical observation on Shoutai Pill and Shixiao Powder for the treatment of threatened abortion with kidney deficiency and blood stasis. J Guangzhou Univ Trad Chin Med 23:25-29.