Abstract
BackgroundIntrahepatic cholestasis of pregnancy (ICP) is a pregnancy complication whose range has been calculated to be between 0.01 and 15.6% all around the world. We wanted to systematically evaluate the effect and safety of oral herbal medicine on treatment for ICP.MethodsDetails of the methods could be found in the registered protocol on PROSPERO (CRD42018096013). Trials assessing the effectiveness of herbal medicine for ICP were searched from seven electronic databases from inception to 28th February 2020. RevMan 5.3 software was used to perform all statistical analysis. Meta-analysis, additional analysis, Trial Sequential Analysis (TSA) and Grading of Recommendations Assessment, Development and Evaluation (GRADE) were conducted if data permitted.ResultsTotally 43 randomized controlled trials with 3556 patients were included. Meta-analysis showed potential good adjunctive effect of herbal medicine on decreasing the pruritus scores (MD -0.58, 95% CI − 0.79 to − 0.36), the serum TBA scores (MD − 3.99 μmol/L, 95% CI − 4.24 to − 3.74) on the basis with Ursodesoxycholic acid. Compared to the medicine alone, significantly lower incidence of fetal distress (RR 0.41, 95% CI 0.32 to 0.51), asphyxia neonatorum (RR 0.35, 95%CI 0.25 to 0.49), cesarean section (RR 0.73, 95% CI 0.63 to 0.85), postpartum hemorrhage (RR 0.45, 95% CI 0.28 to 0.72) were observed in the combination group. But the comparison between herbal medicine and medicine showed inconsistent results among trials. Insufficient information could be used to evaluate the safety of herbal medicine for ICP.ConclusionThis review found the current evidence may support the effectiveness of combination of herbal medicine and conventional medicine for decreasing the maternal pruritus scores, the serum TBA, and the number of fetal distress, or asphyxia neonatorum events related to this condition (which was supported by TSA results). Since there were obvious statistical and clinical heterogeneity among trials, and the methodological quality of the included studies was poor, the level of the evidence could only be defined as “very low” according to the GRADE criteria. Further high quality studies are still needed to testify the effectiveness and safety of herbal medicine for ICP.
Highlights
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy complication whose range has been calculated to be between 0.01 and 15.6% all around the world
Three studies reported the number of fetal distress [31, 34, 35], the results showed that there was no significant difference between the herbal medicine group and conventional medicine group (RR 0.77, 95% confidence intervals (CI) 0.43 to 1.39, I2 = 0%, P = 0.36, 3 trials, 218 patients)
Summary of main findings Totally 43 trials with 3556 women were included, all of them were assessed as having high risk of bias. Results from these trials showed potential better effect of herbal medicine when combined with conventional medicine on decreasing pruritus scores, reducing adverse birth events and improving the liver functions according to the serum
Summary
Intrahepatic cholestasis of pregnancy (ICP) is a pregnancy complication whose range has been calculated to be between 0.01 and 15.6% all around the world. Estrogen can decrease the expression of ABCB11 / BSEP gene to inhibit the function of bile salt delivery pump, or decrease the activity of Na+ / K+ ATPase to inhibit the uptake of bile acid by hepatocytes that eventually leads to intrahepatic cholestasis. The mechanism is unknown, studies have shown that the plasma and serum selenium concentrations and glutathione peroxidase activities in ICP patients are lower than those in healthy pregnant women, and the incidence rate is higher in winter. Some environmental factors such as pesticide pollutants, erucic acid in rape and selenium deficiency in food may lead to ICP [12]. Seasonal variations, [17] low selenium intake, erucic acid, increased gut absorption of bacterial endotoxins, pollutants, infections, and medicine are factors suspected as causing the disease [15,16,17,18,19,20]
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