Clinical Studies

Adverse Outcomes - miscarriage

StudyDesignAdverse effects and toxicityIntervention failureAdverse pregnancy outcomesAdverse perinatal outcomes
Zhao et al. 2010 RCT-Inevitable abortion Preterm labourNo
Yue et al. 2009 RCT--NoNo
Teng & Wu et al. 2008 RCTNo---
Zhao et al. 2008 RCT--StillbirthLateral ventriculomeqaly
He & Che et al. 2007 RCT--Preterm labourNo
Li L et al. 2006 RCT--Diabetes, Preterm No
Zhang et al. 2005RCTGI symptoms ---
Zhang et al. 2000 RCT---No
Yang CL et al. 1992 RCT---Neurodevelopmental morbidity
Song & Zhu et al. 2007 Quasi-RCTNo--No
Zhou Y et al. 2006 Controlled Trial--Preterm labourNeonatal death
Gong & Chen et al. 1993 Controlled Trial----
For clinical trials of miscarriage, the adverse outcomes of Chinese herbal medicines can be classified into the following four groups: adverse effects and toxicity; intervention failure; adverse pregnancy outcomes; and adverse perinatal outcomes (Table 4). For adverse effects and toxicity, slight gastrointestinal symptoms were recorded in one study (Zhang, et al. 2005). Inevitable abortion was recorded in Zhao’ study (Zhao, et al. 2010), but the exact prevalence was unclear. Some severe adverse pregnancy outcomes such as stillbirth occurred, but no obvious causes for these outcomes were recorded (Zhao, et al. 2008). Other adverse pregnancy outcomes reported were preterm labor (He and Che 2007, Zhao, et al. 2010, Zhao, et al. 2008) and diabetes (Li, et al. 2006). Drug side effects may affect the development of embryos and may have an influence on the neonates. Lateral ventriculomegaly, neurodevelopmental morbidity and neonatal death were found in some cases (Yang 1992, Zhao, et al. 2008, Zhou 2006). Whether the adverse outcomes were directly associated with the use of Chinese herbal medicines is unknown. References: Yang CL. 1992. Study on intellectual development of children with maternal exposure to treatments of threatened miscarriage. Chin. J. Integr. Trad. West. Med. 3: 175. Gong L, Chen D. 1993. Integrative treatment of threatened miscarriage and study of birth health - analysis of 62 cases. Chin. J. Birth. Health. Heredity 2: 75-76. 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. Li L, Zhou Z, Liu J. 2006. Clinical studies of Bu Shen Gu Tai Decoction for threatened miscarriage. Guangxi Chin. Med. 29: 17-18. 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. 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. 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. Teng J, Wu X. 2008. Bu Shen Yi Qi formula and Progesterone for threatened miscarriage. Master thesis. Master thesis. Hubei Chin. Med. Coll. 27: 1-10. Zhao W, Chen X, Zhang L. 2008. Clinical study of serum CA125 Zi Shen Rou Gan formula for early threatened abortion. Sichuan J. Trad. Chin. Med. 26: 88-89. Yue P, Chen Z, Jie F. 2009. Combined Chinese medicines and western medicines for threatened miscarriage. Gansu J. Trad. Chin. Med. 22: 44-45. Zhao W, Chen X, Shen W, Zhang L. 2010. Zi Shen Rou Gan formula for early threatened abortion - preliminary study of serum CA125. Liaoning J. Trad. Chin. Med. 37: 1282-1283.