Efficacy and safety of Mahuang Fuzi and Shenzhuo Decoction for treatment of primary membranous nephropathy: a multicenter prospective trial

Abstract

Background

This study aims to undertake a comprehensive assessment of the effectiveness and safety profile of Mahuang Fuzi and Shenzhuo Decoction (MFSD) in the management of primary membranous nephropathy (PMN), within the context of a prospective clinical investigation.

Methods

A multicenter, open-label clinical trial was executed on patients diagnosed with PMN. These individuals were subjected to MFSD therapy for a duration of at least 24 months, with primary outcome of clinical remission rates. The Cox regression analysis was employed to discern the pertinent risk factors exerting influence on the efficacy of MFSD treatment, with scrupulous monitoring of any adverse events.

Results

The study comprised 198 participants in total. Following 24 months of treatment, the remission rate was 58.6% (116/198). Among the subgroup of 130 participants subjected to a 36-month follow-up, the remission rate reached 70% (91/130). Subgroup analysis revealed that neither a history of immunosuppressive therapy (HIST) nor an age threshold of ≥60 years exhibited a statistically significant impact on the remission rate at the 24-month mark (p > .05). Multivariate Cox regression analyses elucidated HIST, nephrotic syndrome, or mass proteinuria, and a high-risk classification as noteworthy risk factors in the context of MFSD treatment. Remarkably, no fatalities resulting from side effects were documented throughout the study’s duration.

Conclusions

This trial establishes the efficacy of MFSD as a treatment modality for membranous nephropathy. MFSD demonstrates a favorable side effect profile, and remission rates are consistent across patients, irrespective of HIST and age categories.

Keywords:

• Primary membranous nephropathy
• traditional Chinese medicine
• Mahuang Fuzi and Shenzhuo Decoction
• efficacy
• safety

Author contributions

BL, HR, and QL were responsible for conception of the study. NZ, SH, QZ, NZ, ZD, YG, XD, YH, and FH are responsible for data analysis and interpretation. NZ was involved in drafting the manuscript. BL, HR, HJ, HD, and WL are responsible for key modifications of important content. BL and HD were responsible for approving the final version to be published and agree to be responsible for all aspects of the work and to ensure that issues relating to the accuracy or completeness of any part of the work are properly investigated and resolved. The authenticity of the original data in this paper has been confirmed by BL and HR, and they are responsible for this.

Disclosure statement

No potential conflict of interest was reported by the author(s).

Data availability statement

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Additional information

Funding

This work was supported by National Key Research and Development Program of China (No. 2019YFC1709402, 2023YFC3503501 to BL), Research and application of clinical characteristic diagnosis and treatment technology in capital (No. Z221100007422092 to BL), Capital’s Funds for Health Improvement and Research (No. 2020-2-2234 to BL) and Beijing Municipal Administration of Hospitals Clinical medicine Development (No. XMLX 201840 to BL).