Safety, efficacy and tolerability of a combination micronutrient and polyherbal preparation (GoutFighter TM) for gout: a single-arm open-label pilot study

Abstract

Abstract Background To evaluate the safety, efficacy and tolerability of a combination micronutrient and polyherbal preparation (GoutFighter TM) for gout management. Methods A single arm, open-label pilot study was conducted at the National Hospital for Traditional Medicine in Vietnam. Participants (n=35 recruited) diagnosed with chronic gout received four tablets of GoutFighter TM daily over a 45-day period. Efficacy was assessed by changes in pain, swelling and blood uric acid levels, with concurrent safety and tolerability assessments. Results A total of 27 (85.2% male) participants (mean ± SD age, 54.2 ± 12.5 years; BMI, 24.2 ± 3.6 kg/m2) with gout (median [IQR], years since diagnosis 4.0 [3.0–8.0]) completed intervention. In relation to safety, there were no significant changes in vital signs, blood biochemistry or cell counts. In regard to efficacy, the degree of perceived pain and frequency of joint swelling significantly declined after 15 and 30 days of treatment, respectively, and remained so until the end of trial. Mean blood uric acid levels also declined by 25.8 μmol/L (95% CI, 3.7 to 48.0, p=0.024). Overall, the predominance of participants (96.3%) responded favorably to treatment (p<0.0001) and GoutFighter TM was well tolerated, with no serious adverse events. Conclusion Clinically relevant doses of GoutFighter TM were found to be generally safe, well-tolerated and effective for the short-term, symptomatic relief of chronic gout. GoutFighter TM appears to be suitable as an adjunctive treatment in lifestyle programs for gout management, and further investigation in placebo-controlled trials is therefore warranted.