Abstract
Objective This study aims to evaluate the efficacy and safety of traditional Chinese medicine (TCM) therapy of tonifying kidney and activating blood circulation (TKABC) based on the theory of “kidney deficiency and blood stasis” for the treatment of immune infertility. Methods Six electronic databases, including the Cochrane Library, PubMed, EMBASE, the China National Knowledge Infrastructure, Wanfang Data, and VIP information database, were searched from inception to January 2021 to identify eligible studies of randomized controlled trials (RCTs). The primary outcome measurements were the total effective rate and pregnancy rate, and the secondary outcome measurements included the negative conversion rate of serum antibodies and the incidence of adverse effects. The quantitative synthesis was performed using the Review Manager 5.3 software. The chi-square statistic and I2 statistic were employed to investigate statistical heterogeneity. The fixed-effects model was used for a low heterogeneity (I2 < 50%), and the random-effects model was applied if heterogeneity was moderate (50% < I2 < 75%). Funnel plots were used to evaluate potential reporting bias when more than ten eligible studies were included. Results Thirteen RCTs involving 1298 patients with immune infertility of kidney deficiency and blood stasis were included. Compared with conventional group, TCM TKABC therapy showed a significant improvement on the total effective rate (RR: 1.38; 95% CI: 1.30,1.47; and I2 = 0%), pregnancy rate (RR: 2.04; 95% CI: 1.73, 2.40; and I2 = 30%), negative conversion rates of AsAb (RR: 1.42; 95% CI: 1.12,1.79; and I2 = 62%), AEmAb rates (RR: 1.21; 95% CI: 1.04,1.41; and I2 = 0%), and AhCGAb with less adverse effects (RR: 0.24; 95% CI: 1.73, 2.40; and I2 = 55%). However, the negative conversion rate of AoAb and ACAb showed no significant statistical difference. Conclusions Our review suggests that TCM TKABC therapy based on the theory of kidney deficiency and blood stasis appears to be an effective and safe approach for patients with immune infertility. However, the methodological quality of included RCTs was unsatisfactory, and it is necessary to verify its effectiveness with more well-designed and high-quality multicenter RCTs.
Highlights
Immune infertility is defined as the presence, in one or both partners, of an antisperm immune reaction capable of impairing fertility variables [1]
Relative risk (RR) with 95% confidence intervals (CIs) was used for binary variables, while the standard mean differences (SMD) with 95% CIs was applied for continuous variables. e chisquare statistic and I2 statistic were employed to investigate statistical heterogeneity. e fixed-effects model was used for a low heterogeneity (I2 < 50%), and the random-effects model was applied if heterogeneity was moderate (50% < I2 < 75%)
Twelve studies reported the total effective rate of traditional Chinese medicine (TCM) tonifying kidney and activating blood circulation (TKABC) therapy in patients with immune infertility [6, 83.4; total effective rate: 18]. e pooled data of meta-analysis showed that the experimental group had a significantly higher total effective rate than that of the control group (RR: 1.38; 95% CI: 1.30, 1.47; and I2 0%) (Figure 3)
Summary
Immune infertility is defined as the presence, in one or both partners, of an antisperm immune reaction capable of impairing fertility variables [1]. E inclusion criteria were prespecified as (1) types of participants: patients diagnosed with immunity infertility using any recognized diagnostic criteria, regardless of age, gender, source of cases, duration of disease, ethnicity, or nationality; (2) types of interventions: TCM therapy of TKABC prescription based on the theory of “kidney deficiency and blood stasis” clearly stated in the trial group either alone or in combination with conventional treatments; no restriction was imposed on the prescription name, administration mode, dosage, and course of treatment; (3) types of comparator(s)/control: patients treated with conventional (the same conventional regimen as intervention group in the same original study), placebo, or no treatment; (4) types of outcome measures: the total effective rate for immune infertility, pregnancy rate, negative conversion rate of antibodies, and adverse effects; and (5) types of study: RCT. Sensitivity analysis was conducted to assess the robustness of the pooled effects of the included studies
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