Abstract
Background Shoutai Pill (STP), a famous classic herbal formula documented in traditional Chinese medicine (TCM), is widely available in China for treating unexplained recurrent spontaneous abortion (URSA). This systematic review and meta-analysis aims at evaluating the efficacy and safety of STP in the first trimester of pregnancy in women with a history of unexplained recurrent spontaneous abortion. Methods The following eight databases were searched from their establishment to Dec 31, 2019, for randomized controlled trials (RCTs): PubMed, Embase, Cochrane Library, Web of Science, China National Knowledge Infrastructure (CNKI), the Chinese BioMedical database (CBM), Chinese Scientific Journal Database (VIP), and the Wanfang database. The quality of evidence was estimated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results A total of 12 studies (916 patients) with URSA were contained in this meta-analysis. The forest plot showed that patients treated with Shoutai Pill and western medicine had a significantly lower incidence of early pregnancy loss (RR: 0.42; 95% CI: 0.34–0.52; P < 0.01, I2 = 0%). Subgroup analysis revealed that different types of TCM syndrome differentiation had the similar results. Also, in the combined group, patients had a lower TCM syndromes and symptoms and serum D-dimer level, while higher incidence of live birth. Conclusions Our findings suggest that cotreatment with STP and western medicine might be superior to western medicine alone in the first trimester of pregnancy to prevent miscarriage in women with unexplained recurrent spontaneous abortion, and there was no adverse event in the experimental group reported. However, the methodological quality of included RCTs was unsatisfactory; it is necessary to verify its effectiveness with further more standardized researches of rigorous design.
Highlights
Recurrent spontaneous abortion (RSA), which is classically defined as the occurrence of two or more clinically consecutive pregnancy losses before 20 gestational weeks in fertile couples [1], is one of the most frustrating and difficult areas in reproductive medicine with complex etiologic factors varying from genetic abnormality, endocrine disorders, abnormal anatomic structures, infectious, to immune factors [2–4] and may affect about 1% to 5% of women in reproductive age BioMed Research International [3, 4]
Approximately 50% of RSA remain unknown and unresolved [5], a condition commonly known as unexplained recurrent spontaneous abortion (URSA) after a diagnosis of exclusion and considered to be early spontaneous abortion when it occurs before 12 weeks [6]
We aim to investigate the efficacy and safety of traditional Chinese medicine (TCM) classical prescription Shoutai Pill combined with western medicine in patients with URSA based on a meta-analysis of the data from the selected studies
Summary
Recurrent spontaneous abortion (RSA), which is classically defined as the occurrence of two or more clinically consecutive pregnancy losses before 20 gestational weeks in fertile couples [1], is one of the most frustrating and difficult areas in reproductive medicine with complex etiologic factors varying from genetic abnormality, endocrine disorders, abnormal anatomic structures, infectious, to immune factors [2–4] and may affect about 1% to 5% of women in reproductive age BioMed Research International [3, 4]. Emerging evidence shows that immunological disturbances and abnormal coagulation and anticoagulation may be involved in this disorder [7, 8] Various therapeutic strategies such as immunologic intervention with allogenic lymphocyte [9] and immunoglobulin [10], anticoagulant therapy using aspirin [11] or lowmolecular weight heparin [12], hormonal supplementation with progesterone or dydrogesterone [13], and microelements supplementation, such as vitamin E, vitamin D [14], and folic acid [15], have been used to improve pregnancy outcomes among these women, but no effective treatment has been identified. Shoutai Pill (STP), a famous classic herbal formula documented in traditional Chinese medicine (TCM), is widely available in China for treating unexplained recurrent spontaneous abortion (URSA). This systematic review and meta-analysis aims at evaluating the efficacy and safety of STP in the first trimester of pregnancy in women with a history of unexplained recurrent spontaneous abortion. The methodological quality of included RCTs was unsatisfactory; it is necessary to verify its effectiveness with further more standardized researches of rigorous design
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