Efficacy and safety of motherwort injection add-on therapy to carboprost tromethamine for prevention of post-partum blood loss: A meta-analysis of randomized controlled trials.

Motherwort (YiMuCao), a traditional Chinese herb, has been shown beneficial effects for women's diseases. This meta-analysis aimed to evaluate the efficacy and safety of motherwort injection add-on therapy to carboprost tromethamine for prevention of post-partum blood loss. A systematic literature search was conducted in PubMed, Embase, Cochrane Library, CNKI, VIP and Wanfang from their inception to December 2017. Randomized controlled trials that determined the add-on effects of motherwort injection to carboprost for prevention of post-partum blood loss were eligible. Pooled risk ratio (RR) and mean difference (MD) with 95% confidence interval (CI) were used to summarize the effect sizes. Eight trials including 1276 pregnant women fulfilled the inclusion criteria. Prophylactic use of motherwort injection add-on therapy significantly reduced the post-partum 2 h (MD -127.5 mL; 95% CI -149.13 to -105.88) and 24 h (MD -146.85 mL; 95% CI -179.77 to -113.94) blood loss and incidence of post-partum hemorrhage (RR 0.28; 95% CI 0.17-0.45) than carboprost. Moreover, adjunctive treatment with motherwort injection significantly decreased the length of the third stage of labor (MD -3.41 min; 95% CI -4.33 to -2.49) and duration of lochia (MD -7.13 days; 95% CI -8.49 to -5.76). There was no statistical significant difference in the incidence of adverse events (RR 0.76; 95% CI 0.50-1.16). Prophylactic use of motherwort injection add-on therapy to carboprost tromethamine could reduce post-partum blood loss. However, more well-designed trials are necessary to confirm the findings of this study due to the methodological flaws of the included trials.

Effects of Motherwort Injection Versus Intramuscular Oxytocin for Preventing Postpartum Hemorrhage Among Women Who Underwent Cesarean Section.

Objectives: Subject to ethical constraints, real-world data are an important resource for evaluating treatment effects of medication use during pregnancy and the postpartum period. This study investigated whether motherwort injection, a traditional Chinese medicine preparation, was more effective than intramuscular (IM) oxytocin for preventing postpartum hemorrhage (PPH) in a real-world setting when intravenous (IV) oxytocin is administered. Methods: We conducted an active-controlled, propensity-score matched cohort study using an established pregnancy registry database. Women who underwent cesarean section and received IV oxytocin at the third stage of labor were included. We used an active-comparator design to minimize indication bias, in which we compared IM motherwort injection in the uterus versus IM oxytocin, both on top of IV oxytocin use. We applied 1:1 propensity-score matching (PSM) to balance patient baseline characteristics and used a logistic regression model to estimate treatment effect (i.e., risk difference (RD) and odds ratio (OR)) by using the counterfactual framework. The outcomes of interest were blood loss over 500 ml within 2 h after delivery (PPH, primary) and blood loss over 1,000 ml (severe PPH, secondary). We conducted four sensitivity analyses to examine the robustness of the results. Results: A total of 22,519 pregnant women underwent cesarean sections, among which 4,081 (18.12%) PPH and 480 (2.13%) severe PPH occurred. Among included women, 586 (2.60%) were administrated with IM motherwort injection, and 21,933 (97.40%) used IM oxytocin. After PSM, patient baseline characteristics were well balanced. Compared with IM oxytocin, the use of IM motherwort injection was associated with significantly lower risk of PPH (RD -25.26%, 95% CI -30.04% to -20.47%, p < 0.001; OR 0.25, 95% CI 0.18 to 0.32, p < 0.001) and severe PPH (RD -3.58%, 95% CI -5.87% to -1.30%, p < 0.001; OR 0.39, 95% CI 0.20 to 0.71, p < 0.002). Sensitivity analyses showed that the results were similar. Conclusion: With the use of data from a real-world setting, the findings consistently showed that among women undergoing cesarean section who had received IV oxytocin, the additional use of IM motherwort injection could achieve a lower risk of PPH as compared to the additional use of IM oxytocin. Our study suggested a paradigm for investigating the treatment effect of Chinese herbal medicine in the real-world practice setting.

Motherwort Injection for Preventing Uterine Hemorrhage in Women With Induced Abortion: A Systematic Review and Meta-Analysis of Randomized Evidence.

Objective: Motherwort injection (MI) is a modern patented injection extracted from motherwort (Leonurus japonicus Hoult). Empirical studies and systematic reviews have shown the benefits of motherwort injection for preventing postpartum hemorrhage after vaginal delivery and cesarean section. This study was conducted to explore the efficacy and safety of motherwort injection for women with the prevention of post-abortion uterine hemorrhage. Methods: A comprehensive literature search was conducted to identify RCTs regarding the effect of the use of motherwort injection in women after abortion. Data from trials were pooled by meta-analysis and a random-effects model was used to calculate the summarized relative risks (RRs) and their 95% confidence intervals (CIs). The grading of recommendations assessment, development, and evaluation (GRADE) methodology was used to access the quality of the evidence. Results: Nine trials with a total of 1,675 participants were identified. Overall, motherwort injection combined with oxytocin compared to oxytocin had a significantly lower blood loss within 2 hours (MD = -50.00, 95% CI -62.92 to -37.08, very low quality); lower blood loss within 24 h (MD = -50.00, 95% CI -62.92 to -37.08, very low quality); however, there was no significant difference between motherwort injection and oxytocin (24 h: MD: 0.72, 95% CI -7.76 to 9.20; 48 h: MD: -0.01, 95% CI -11.35 to 11.33; 72 h: MD: -1.12, 95% CI -14.39 to 12.15, very low quality). Compared with oxytocin or no intervention, both motherwort injection and motherwort injection combined with oxytocin had a significantly decreased duration of blood loss (MI vs. O: MD -2.59, 95% CI -4.59 to -0.60, very low quality; MI + O vs. O: MD -2.62, 95% CI -3.02 to -2.22, very low quality; MI + O vs. No intervention: MD: -1.80, 95% CI -2.28 to -1.33, low quality). Seven of nine included trials reported adverse event outcomes. Three cases were found in the motherwort injection group, and five induced abortion syndromes were found in the motherwort injection plus oxytocin group. 29 adverse events were reported in the oxytocin group instead. The recovery time of normal menstruation after abortion was significantly earlier in the group using motherwort injection compared with oxytocin (MDs -3.77, 95% CI -6.29 to -1.25, very low quality), and the endometrial thickness in the motherwort injection group was significantly different from that in the oxytocin group (MD: 2.24, 95% CI 1.58 to 2.90, very low quality). Conclusion: The results of this meta-analysis indicate prophylactic use of motherwort injection may reduce the risk of uterine hemorrhage in women after abortion, and more high-quality research is needed to confirm the efficacy and safety of motherwort injection in preventing uterine hemorrhage after abortion. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=274153, identifier CRD42021274153.

Motherwort injection in preventing post-abortion hemorrhage after induced abortion: A multi-center, prospective, randomized controlled trial.

OBJECTIVE: The aim of this study was to evaluate the efficacy and safety of motherwort injection (MI, Yi mu cao) in preventing post-abortion hemorrhage and promoting uterine retraction after induced abortion surgery. METHODS: In this multi-center randomized controlled trial undertaken between September 2014 and August 2016, 408 child-bearing age women who underwent induced abortion surgery and randomly assigned to two groups: MI group who received intramuscular MI treatment (n = 207) and no-treatment group (n = 201). The volume of vaginal bleeding and its duration were used as primary end points; and uterine size and dimension were measured as secondary end points. Blood coagulation indices, routine blood and adverse events were recorded to evaluate the safety. RESULTS: The efficacy analysis was based on 366 patients. No significant difference were found in baseline characteristics between the two groups (P > 0.05). The amount of vaginal bleeding and duration of bleeding were significantly reduced in MI group compared with on-treatment group in Full Analysis Set (FAS) and Per Protocol Set (PPS) populations (P < 0.001). The volume and perimeter of the uterine dimensions in MI group were smaller than no-treatment group (P < 0.001). No significant abnormal vital signs were observed. Only 1 case of mild, transient erythema was found in MI group. CONCLUSIONS: MI could reduce post-abortion hemorrhage and improve uterine retraction in women undergoing surgical induced abortion, without serious adverse events. It was a safe and effective treatment in preventing post-abortion hemorrhage after induced abortion.

Motherwort injection for preventing postpartum hemorrhage in pregnant women with cesarean section: A systematic review and meta-analysis.

OBJECTIVE: To assess the impact of motherwort injection alone or combined with oxytocin for preventing postpartum hemorrhage in pregnant women with caesarean section. METHODS: A systematic review and meta-analysis of randomized trials were performed. PubMed, EMbase, The Cochrane Central Register of Controlled Trials (CENTRAL), Chinese database Sino-Med, Chinese National Knowledge Infrastructure Database (CNKI), VIP Chinese Science and Technique Journals Database, WanFang, and ClinicalTrials.gov were searched. Randomized controlled trials (RCTs) that compared motherwort injection alone or motherwort injection combined with oxytocin in pregnant women receiving cesarean section were included. Paired reviewers independently screened abstracts and full texts for eligibility, assessed risk of bias, and extracted data. We performed random-effects meta-analyses of RCTs along with a limited number of prespecified subgroup hypotheses, and sensitivity analyses were carried out with other statistical approaches. RESULTS: Forty-six RCTs (n = 7359) proved eligible. Compared with oxytocin, both motherwort injection and motherwort injection combined with oxytocin had a significantly lower blood loss within 2 hours (MD = -21.81, 95% CI -37.05 to -6.58 and MD = -53.04, 95% CI -61.68 to -44.39); lower blood loss within 24 hours (MD = -25.44, 95% CI -39.38 to -11.51 and MD = -67.81, 95% CI -78.02 to -57.60); and lower the risk of adverse events (ORPeto 0.40, 95% CI 0.16 to 0.96 and ORPeto 0.50, 95% CI 0.35 to 0.71). Motherwort injection combined with oxytocin also decreased the risk of postpartum hemorrhage (OR 0.22, 95% CI 0.14 to 0.35.) CONCLUSIONS: In pregnant women with cesarean section, motherwort injection suggests an obvious benefit and less adverse event.

Post-marketing safety surveillance and reevaluation of Motherwort injection: A clinical study of 10 094 cases.

OBJECTIVE: To investigate the safety profiles of Motherwort injection (MI). METHODS: A multi-center, prospective and drug- derived hospital intensive monitoring method was conducted to assess the safety of MI in real world applications. This study was based on a very large population after the injection was approved and marketed in China. All patients using the injection in participating hospitals were monitored to determine the incidence, pattern, severity and outcome of associated adverse events. RESULTS: The post-marketing surveillance was performed in 10 094 female patients from April to December, 2015. The incidence of adverse drug reactions (ADRs) was 0.79¡ë(8/10 094). Among the 8 patients, the reported adverse events mainly included systemic abnormalities, such as fever, chills and eyelid edema; skin and appendages disorders, such as pruritus and rash; gastrointestinal disorders, such as nausea, abdominal distension and pain; heart rate and rhythm disorders, such as palpitation and increased heart rate. All of these ADRs were mild in severity. CONCLUSION: In this study the ADRs incidence rate of MI is very low, which supports that it is generally safe for use in obstetric and gynecological diseases. However, the total number of 8 ADRs recorded over a relatively short time span seems limited, and the low number of reports could not represent an absolute guarantee of safety.