| Summary: | 碩士 === 中山醫學大學 === 醫學研究所 === 103 === Introduction:
The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed by adapting to Western diet and lifestyle. Previous studies have demonstrated the relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular disease and chronic renal disease. While Western medicine shows promising effects in treating hyperuricemia and gout, we are searching for an alternative in traditional Chinese medicine with both safety and efficacy in treating hyperuricemia.
Objective:
To testify the efficacy and safety of traditional Chinese formulae, “Wu-Ling San” and “Yin-Chen Wu-Ling San” for patients with hyperuricemia.
Methods:
We conducted a randomized double-blinded placebo-controlled clinical trial in adults with hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were enrolled. Patients were then randomized into three arms: Traditional Chinese Medicine formulae: “Wu-Ling San”, “Yin-Chen Wu-Ling San” or placebo for 4 weeks. Efficacy and safety were evaluated at Week 2, 4 and 8. Primary endpoint was the serum uric acid<6 mg/dL at Week 4. Secondary endpoints were the differences between groups in serum uric acid at Week 2 and 8, serum SGPT, SGOT, creatinine, total cholesterol, triglycerides, HDL, LDL, fasting blood glucose, body weight, blood pressures and frequency of gouty attack at Week 4.
Results:
There were no significant differences among three arms on serum uric acid levels <6mg/dL at Week 4. The primary endpoint could not be reached in both “Wu-Ling” San and “Ying-Chen Wu-Ling San” groups. The uric acid level was lower in the “Yin-Chen Wi-Ling” arm at Week 8 (8.1 mg/dL vs 9.1 mg/dL, p=0.034). The changes in uric acid from baseline were significant in both “Wu-Ling San” and “Yin-Chen Wu-Ling San” arms (p<0.05). There were also no significant differences in the total cholesterol, triglyceride, liver function profiles, creatinine, blood pressures, body weight and amount of daily uric acid excretion.
Conclusions:
The two formulae in traditional Chinese medicine were relatively safe in treating the patients with hyperuricemia in short-term. There were no significant statistical difference in reaching the target—serum uric acid level <6mg/dL. However, we found that the changes in uric acid from baseline were more significant at Week 8 in both “Wu-Ling San” and “Ying-Chen Wu-Ling San”. Further studies with larger sample size and longer duration should be considered to confirm the safety and efficacy of the two tradition Chinese formulae.
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