This multi-centre, randomized, double-blind, placebo-controlled clinical trial evaluated the efficacy and safety of Huaiqihuang Granule (HQH) in 216 children with chronic immune thrombocytopenia (CITP) across 13 hospitals in China. Participants were randomized to receive either HQH or placebo for a 24-week double-blind period, followed by a 24-week open-label period where placebo recipients switched to HQH. The primary endpoint was the clinical effectiveness rate, defined by a decrease in bleeding grade and platelet response. HQH demonstrated a significantly higher clinical effectiveness rate of 71.74% compared to 45.65% in the placebo group (p=0.0013). This result remained consistent even when patients requiring rescue treatment were considered ineffective or excluded. Secondary endpoints included safety assessments, where adverse events (AEs) and serious AEs were comparable between groups. Notable severe AEs were thrombocytopenia (6.9%), respiratory tract infection (5.1%), and hemorrhagic episodes (2.8%). The study concludes that HQH is effective in improving bleeding outcomes in children with CITP and maintains a favorable safety profile over long-term use. These findings suggest HQH as a viable treatment option for pediatric CITP, warranting consideration in clinical practice.
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· Auto-published
This study focuses on chronic immune thrombocytopenia (CITP), a condition where the body doesn't make enough platelets, leading to easy bleeding and bruising. Researchers tested a traditional Chinese medicine called Huaiqihuang Granule (HQH) in 216 children with CITP over 96 weeks. They compared the effects of HQH to a placebo, which is a treatment that looks like the real medicine but has no active ingredients. The results showed that children taking HQH had better outcomes, including less bleeding and improved platelet counts, compared to those on the placebo. This suggests that HQH could be a helpful option for managing CITP in children. However, while the treatment was generally safe, some children experienced side effects like low platelet counts and infections. It's important for families to discuss all treatment options with their healthcare providers to find the best approach for their child's health.
What this means for you: Huaiqihuang Granule may help reduce bleeding in children with chronic immune thrombocytopenia.
View Original Abstract ↓
ETHNOPHARMACOLOGICAL RELEVANCE: Chronic immune thrombocytopenia (CITP) seriously affects the patients' quality of life. In the real world, a traditional Chinese medicine, Huaiqihuang Granule (HQH) shows certain value in ITP treatment.It primarily comprises Huai'er (Trametes robiniophia Murr), Gouqizi (Lycium chinense Mill), Huangjing (Polygonatum sibiricum F. Delaroche).
AIM OF THE STUDY: This study aims to investigate the clinical efficacy and safety of HQH in children with CITP.
MATERIALS AND METHODS: A multi-centre, randomized, double-blind, placebo-controlled clinical trial was conducted among 216 children with CITP from June 27, 2017 to October 14, 2023, at 13 hospitals in China. Patients were followed up for 96 weeks. Patients with CITP were treated with HQH or with matching placebo in a randomized, double-blind, 24-week treatment period. Patients who received placebo and completed 24 weeks of treatment switched to receive HQH, and patients treated with HQH in the double-blind period continued HQH during the following open-label 24-week treatment.
RESULTS: HQH was superior to placebo in decreasing the bleeding grade and achieving a platelet response. The total clinical effectiveness rate of HQH group (71.74 % in 24-week) was higher than that of the placebo group (45.65 % in 24-week, p = 0.0013). The result was similarly seen when the data of patients with rescue treatment was analyzed as ineffectiveness or excluded. AEs and serious AE was comparable between the two groups. The severe AEs included thrombocytopenia (6.9 %), respiratory tract infection (5.1 %) and hemorrhagic episodes (2.8 %).
CONCLUSIONS: In CITP children, HQH can improve the clinical effectiveness especially the degree of bleeding, and shows good safety even with long-term treatment.