Treatment of Hyperuricemia with Thlaspi Bursa Pastoris 6CH: A Randomized, Open-Label, Equivalence Trial

Background: Hyperuricemia (HU) remains a priority research area in every medical science, including complementary and alternative medicine interventions and homeopathy; however, the research evidence is limited. In homeopathy, Thlaspi bursa pastoris (TBP) is considered to be a potential treatment option in HU. Methods: An open-label, randomized, equivalence trial was conducted comparing TBP with individualized homeopathic medicines (IHMs). Serum uric acid (SUA) was the primary outcome; Gout Assessment Questionnaire version 2.0 (GAQ-2) and Measure Yourself Medical Outcome Profile version 2.0 (MYMOP-2) were the secondary outcomes; all measured at baseline and after 6 and 12 weeks. Intention-to-treat analysis was carried out to detect noninferiority and group differences using unpaired t -tests and two-way repeated-measure analysis of variance (ANOVA). Results: There were no differences between the groups at baseline. Reduction in SUA after 6 and 12 weeks was similar between groups ( P = 0.784). Group differences in the secondary outcomes were also nonsignificant (all P > 0.05). TBP revealed noninferiority against IHMs, both after 6 weeks and 12 weeks in SUA and MYMOP-2 profile scores, but not in GAQ2 scores. Sulfur and Calcarea carbonica were the most frequently prescribed medicines in the IHMs group. There were no harms or serious adverse events reported from either of the groups. Conclusion: TBP acted noninferior to IHM in HU and both appeared to be equally effective. Rigorous and larger trials are warranted. Trial Registration: This trial was registered in the Clinical Trials Registry – India (CTRI/2018/10/016174; UTN: U1111-1221-8000).