Effect of Baihu and Guizhi Decoction in acute gouty arthritis: a randomized, double-blind, controlled clinical study

Abstract

Background The prevalence rates of gout worldwide have increased annually. Acute gouty arthritis (AGA) accounts for a large proportion of gout patients and causes severe physical and mental pain in patients. Controlling the occurrence and development of gout inflammation is the first step in the treatment of gout. The main treatment drugs in gout are Non-Steroid Anti-Inflammatory Drugs (NSAIDS), colchicine and glucocorticoids, but these treatments have many adverse reactions which limit their clinical application. Baihu and Guizhi decoction (BHGZ) is one of the classic prescriptions in the Synopsis of the Golden Chamber, and is a good prescription for AGA. Previous clinical studies have shown that BHGZ confers a strong benefit for treating AGA. However, the literature shows a lack of high-quality RCT research on BHGZ with respect to AGA. Therefore, in this study, we use a randomized, double-blind, controlled study with a placebo to evaluate the clinical efficacy and safety of BHGZ on the AGA of moist heat arthralgia spasm syndrome. Methods This study is a randomized, double-blind, controlled clinical trial. A total of 102 adult participants with AGA of moist heat arthralgia spasm syndrome will be enrolled, with balanced treatment allocation (1:1). The experimental intervention will be BHGZ plus the low-dose colchicine and the control intervention will be placebo plus the low-dose colchicine for 10 days. To study the clinical efficacy (including VAS score; joint tenderness, joint swelling, joint movement disorder; TCM evidence efficacy score) and the changes of inflammatory indexes. At the same time, the improvement of joint inflammation in patients with AGA will be observed from musculoskeletal ultrasound imaging, and the safety evaluation will be carried out. Discussion This study will be the first placebo-controlled RCT to assess whether BHGZ plus low-dose colchicine have beneficial effects on changing reducing inflammation of joints for patients with AGA of moist heat arthralgia spasm syndrome. The results of this trial will help to provide evidence-based recommendations for clinicians. Trial registration: Chinese Clinical Trials Register, ChiCTR1900024974. Registered on 5 August 2019.

Treatment of gouty arthritis with traditional Chinese medicine decoction: Meta-analysis, network pharmacology analysis, and molecular docking

“…Fourteen studies reported the score of VAS. [36,38,46,48,49,52,53,57,76,77,83,92,109,111] There were 626 patients in the treatment group and 620 in the control group. Meta-analysis indicated that TCMD treatment had a better effect on reducing the score of VAS than routine treatment (I 2 = 96.39%, random effects model, WMD = −0.98, 95% CI [−1.66, −0.30], P < .001, Fig.…”

“…All studies mentioned randomization and 49 studies described the method of randomization as a random number table. [18,20,23,24,[41][42][43]46,[48][49][50]52,53,55,[58][59][60][61]63,64,[66][67][68]70,72,74,75,[78][79][80][84][85][86][88][89][90][94][95][96][98][99][100][101]104,106,107,109,111] Therefore, in terms of selection bias, the 49 studies were rated as low risk, and the rest were rated as unclear risk or high risk. Overall, the quality of included studies was not high.…”

“…Sixty-seven studies reported the effective rate. [18][19][20][21]24,[36][37][38][40][41][42][43][44][45][46][47][48][49][51][52][53][54][55][58][59][60][61][62][63][64][65][66][67][68]71,[73][74][75][76][77][78][79][80][81][82][83][85][86][87]89,[92][93][94]…”

“…Seventy-three studies reported BUA. [18,[20][21][22][23][24][36][37][38][39][40][41][42][43][44][45][46]48,50-54,56-62,64-66,68-72,74-78,80-82,84-86,88-91, [93][94][95][96][97][98][99][100][101][102][103][104][105][106][107][108][109][110][111][112] There were 3101 patients in the treatment group and 3077 in the control group. Meta-analysis indicated that TCMD therapy had a better effect in lowering the level of BUA compared with routine treatment (I 2 = 98.91%, random effects model, WMD = −45.97, 95% CI [−53.55, −38.38], P < .001, Fig.…”

“…The metaregression failed to identify the possible cause of heterogeneity (see Figure S4, Supplemental Digital Content, http:// links.lww.com/MD/L142). In addition, heterogeneity test revealed that the significant heterogeneity might be caused by 11 studies, [42,44,46,52,54,62,71,78,82,96,103] and it slightly reduced after excluding these studies (I 2 = 84.19%, random effects model, WMD = −45.08, 95% CI [−52.39, −37.77], P < .001) (see Figure S5, Supplemental Digital Content, http://links.lww.com/ MD/L143). Together, these results provide important insights that the level of BUA could be better reduced by TCMD than routine treatment.…”