Effects of external application of compound Qingbi granules on acute gouty arthritis with dampness-heat syndrome: A randomized control trial

Abstract

<jats:title>Abstract</jats:title> <jats:p>Background The use of anti-inflammatory and analgesic drugs such as nonsteroidal anti-inflammatory drugs(NSAIDs) for treating acute gout has limitations, such as a high incidence of adverse reactions in the gastrointestinal tract and toxicity in the liver, kidney, and heart. Hence, a new safe and effective treatment approach to reduce the use of anti-inflammatory and analgesic drugs, incidence of adverse reaction, and patients’ burden needs to be explored. This randomized controlled clinical trials investigated the clinical efficacy and safety of external application of compound Qingbi granules (CQBG) in treating acute gouty arthritis, providing evidence for designing a safe and effective optimization protocol of acute gouty arthritis (AGA) comprehensive treatment. Methods A total of 90 patients in line with the diagnostic standard of AGA were recruited and divided randomly into control, T1, and T2 groups (30 in each group). Participators in three groups all received Western–medicine–bastic treatment (low-purine diet, drinking water more than 2000 mL/d, oral loxoprofen, and NAHCO<jats:sub>3</jats:sub>). Besides, the T1 group received an external application of diclofenac diethylamine emulgel, while the T2 group received an external application of CQBG. Participators in control group were treated by single-use Western–medicine–bastic treatment. With a treatment course of 7 days and a follow-up for subsequent 7 days, the three groups were compared in terms of primary outcome indicators including swelling, pain improvement, and change in pain duration and secondary outcome indicators including serum C-reactive protein (CRP), uric acid (UA), and change in thickness of the inflammatory synovium of joints under ultrasound. Meanwhile, the safety of the protocol was evaluated. Results The three groups of patients had no obvious differences in age, body mass index, history of gout, complication, and so on before recruitment. A comparison between pretreatment and post-treatment revealed remarkable reductions in the arthralgia VAS score and the swelling score in the three groups after the treatment and the improvements in the T2 group were more obvious than those in the T1 and control groups (<jats:italic>P</jats:italic> &lt; 0.05). Regarding onset-time of pain improvement and pain duration, the T2 group had more significant efficacy compared with the other two groups (<jats:italic>P</jats:italic> &lt; 0.05). The serum CRP and blood UA levels in the three groups significantly decreased after the treatment, but with no significant inter-group difference. The improvement in thickness of the inflammatory synovium in joints tested by ultrasound was more significant in the T2 group than in the control group (<jats:italic>P</jats:italic> &lt; 0.05). For safety evaluations, no significant difference in the incidence of adverse events was found. Conclusions The external application of CQBG combined with Western–medicine–bastic treatment in patients with AGA improved arthralgia and swelling, shortened the period of taking NSAIDs, and reduced the levels of CRP and serum UA. Its therapeutic effect was significantly better than the effect of single-use Western medicine bastic treatment and additive diclofenac diethylamine emulgel. The study provided evidence for the clinical application of CQBG combined with Western medicine in treating AGA. Trial registration: ChiCTR, ChiCTR1800018020. Registered 27 August 2018, http://www.chictr.org.cn/showproj.aspx?proj=27138</jats:p>