Efficacy and Safety of Qinpi Tongfeng Formula Combined with Bloodletting Therapy in the Treatment of Acute Gouty Arthritis: A Study Protocol for a Randomized Controlled Trial

BACKGROUND: Acute gouty arthritis (AGA) is a common arthritis disease, with the characteristics of acute onset, severe condition, and poor prognosis. The conventional treatments have shown certain curative effects but are accompanied with many adverse reactions. The combination of orally taken Qinpi Tongfeng Formula (QPTFF) and bloodletting therapy could effectively alleviate arthralgia and joint swelling in AGA patients. However, there is a lack of high-quality randomized controlled trials (RCTs) to evaluate the clinical efficacy and safety of the combined therapy against AGA. METHODS: This is a prospective, randomized, parallel controlled trial conducted in the First Teaching Hospital of Tianjin University of Traditional Chinese Medicine to explore the efficacy and safety of QPTFF combined with bloodletting therapy in the treatment of AGA. Eighty-six AGA patients meeting the inclusion and exclusion criteria will be randomly divided into the treatment group and control group in a 1 : 1 ratio using a randomization table. The investigators and the patients will not be blinded, while the outcome assessors and statisticians will be blinded to the allocation. Patients in the treatment group will take QPTFF and bloodletting therapy simultaneously, while patients in the control group will be instructed to orally take colchicine tablets. The primary outcome is the total effective rate, and the secondary outcomes are the pain changes after the first treatment, pain scores, complete pain relief time, joint symptom scores, TCM syndrome score, and laboratory test. SPSS22.0 will be used for statistical analysis. Discussion. This study will evaluate the clinical efficacy and safety of QPTFF combined with bloodletting therapy in the treatment of AGA, and the results of this study will provide reliable clinical evidence for the clinical use of QPTFF combined with bloodletting in the treatment of AGA. The trial is registered with ChiCTR2100048836.