School of Medicine, Chung Shan Medical University, Taichung, Taiwan.
Institute of Medicine, Chung Shan Medical University, Taichung, Taiwan.
Int J Rheum Dis. 2024 Jan;27(1):e14986. doi: 10.1111/1756-185X.14986. Epub 2023 Nov 28.
Studies have demonstrated the association of hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease, and chronic renal disease. Although Western medicine presents promising effects for treating hyperuricemia and gout, identifying a safe and effective alternative to traditional Chinese medicine (TCM) for treating hyperuricemia is essential.
To evaluate the efficacy and safety of TCM formulas, "Wu-Ling San" and "Yin Chen Wu-Ling San," in patients with hyperuricemia.
A randomized, double-blinded, placebo-controlled clinical trial in adults with hyperuricemia was conducted. Sixty patients with serum urate level higher than 8 mg/dL were enrolled in the study. Patients were then randomized into three arms: "Wu-Ling San," "Yin Chen Wu-Ling San," and placebo for 4 weeks. Efficacy and safety were evaluated at weeks 2, 4, and 8. Primary and secondary endpoints were set to evaluate the serum urate concentration and related indicators at weeks 2, 4, and 8.
No significant differences were observed among the three arms in terms of the serum urate level (<6 mg/dL) at week 4. The serum urate level was lower in the "Yin Chen Wi-Ling" arm at week 8 (8.1 mg/dL vs. 9.1 mg/dL, p = .034). The serum urate levels were significantly different in both the "Wu-Ling San" and "Yin Chen Wu-Ling San" arms from those at the baseline (p < .05).
Two TCM formulas were found to be relatively safe for the short-term treatment of the patients with hyperuricemia. No statistically significant difference was observed in reaching the target-serum urate level <6 mg/dL.
研究表明，高尿酸血症与高血压、代谢综合征、心血管疾病和慢性肾病有关。虽然西医在治疗高尿酸血症和痛风方面有很好的效果，但寻找一种安全有效的中药（TCM）替代方案治疗高尿酸血症是非常重要的。
评价中药方剂“五苓散”和“茵陈五苓散”治疗高尿酸血症的疗效和安全性。
采用随机、双盲、安慰剂对照的临床试验方法，纳入 60 例血清尿酸水平高于 8mg/dL 的成人高尿酸血症患者。将患者随机分为三组：五苓散组、茵陈五苓散组和安慰剂组，治疗 4 周。分别在第 2、4、8 周评估疗效和安全性。主要和次要终点分别设定为评估第 2、4、8 周时血清尿酸浓度及相关指标。
第 4 周时，三组间血清尿酸水平（<6mg/dL）无显著差异。第 8 周时，“茵陈五苓散”组的血清尿酸水平较低（8.1mg/dL 比 9.1mg/dL，p=0.034）。第 2 周和第 4 周时，“五苓散”和“茵陈五苓散”组的血清尿酸水平均明显低于基线水平（p<0.05）。
两种中药方剂在治疗高尿酸血症患者的短期治疗中相对安全。但在达到<6mg/dL 的目标血清尿酸水平方面，两组之间没有观察到统计学上的显著差异。
