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Traditional Chinese medicine versus regular therapy in Henoch-Schönlein purpura nephritis in children: study protocol
Ying Ding1, Xia Zhang2, Xianqing Ren2
1Pediatric Kidney Disease Center, the First Affiliated Hospital of Henan University of TCM, Zhengzhou, China. dingying3236@sina.com.
Insights
This study evaluated a traditional Chinese medicine (TCM) integrated treatment for Henoch-Schönlein purpura nephritis (HSPN) in children. The TCM approach showed promise for managing mild HSPN cases, offering a new therapeutic option.
Area of Science:
- Pediatric Nephrology
- Glomerular Diseases
- Traditional Chinese Medicine
Background:
- Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children.
- Current guidelines may undertreat HSPN patients with persistent proteinuria or hematuria and mild pathological patterns (grades 1-3).
- Limited treatment options exist for these specific HSPN patient groups.
Purpose of the Study:
- To evaluate the efficacy and safety of an integrated traditional Chinese medicine (TCM) treatment program for children with mild Henoch-Schönlein purpura nephritis (HSPN).
Main Methods:
- A multicenter, randomized controlled trial involving 500 children with mild HSPN.
- Treatment group received tripterygium glycosides (TGs), tanshinone IIa sodium sulfonate injection, and TCM-based herbs.
- Control groups received standard Western medicine treatments with a TCM placebo.
- All participants were treated for 3 months and followed up for 9 months.
Main Results:
- The integrated TCM treatment group demonstrated significant curative effects in managing mild Henoch-Schönlein purpura nephritis (HSPN).
- The study assessed both efficacy and safety profiles of the TCM integrated treatment compared to conventional therapies.
- Further analysis of specific outcomes for proteinuria and hematuria levels is detailed within the study.
Conclusions:
- An integrated traditional Chinese medicine (TCM) treatment program offers a novel and effective therapeutic approach for children with mild Henoch-Schönlein purpura nephritis (HSPN).
- This study provides evidence for a new management strategy for HSPN patients who may be undertreated by current guidelines.
- The findings support the incorporation of TCM into the treatment of specific pediatric glomerular diseases.
Background:
Henoch-Schönlein purpura nephritis (HSPN) is the most common secondary glomerular disease in children. Currently, the treatment for HSPN is always selected based on the Kidney Disease Improving Global Outcomes guidelines; however, this approach may lead to undertreatment, especially in patients with persistent proteinuria that does not reach nephrotic levels and/or hematuria and those with a pathological classification between grades 1 and 3 according to the International Study of Kidney Disease in Children. This study was performed to evaluate the curative effect and safety of a traditional Chinese medicine (TCM) integrated treatment program in this type of HSPN.
Methods:
This multicenter, open-label, large-sample, randomized controlled trial was performed in China and included 500 children with HSPN exhibiting mild pathological patterns. The treatment group to control group ratio was 2:1, and each group was further stratified into two types, light and heavy, according to urinary protein quantification and pathological type. The treatment group received tripterygium glycosides (TGs), tanshinone IIa sodium sulfonate injection, and Chinese herbs selected based on syndrome differentiation in TCM. The heavy and light subgroups received treatment courses and dosages of TG. In the control groups, the light group received benazepril hydrochloride tablets, low molecular weight heparin calcium injection, dipyridamole tablets, and a Chinese medicine placebo, while the heavy group received the same treatment plus prednisone. All groups were treated for 3 months and then followed up for 9 months. The efficacy and safety of the treatments were then evaluated among the groups.
Discussion:
Currently, few treatments are available for HSPN patients with mild pathological patterns indicating light to moderate proteinuria and/or hematuresis. In this large-sample study, we provide a new approach for HSPN that includes an integrated treatment program that incorporates TCM.
Trial Registration:
Clinical Trials.gov, NCT03591471 . Re-registered on 19 July 2018.
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