An Adjunct Role Of Potassium Rich Vegetarian Diet And A Novel Potassium Food Supplement To Improve Pain In Chronic Rheumatoid Arthritis On Supervised Standard Care: A Randomized Controlled Study

Abstract

Objective: Evaluate potassium for reducing joint pain in rheumatoid arthritis (RA) Methods: 172 consenting patients with painful RA (median duration 6.5 years) on standard treatment with conventional DMARD (median duration 22 months) were randomized into an assessor-blind multi-arm study (80% power) of 16 weeks duration; potassium-rich vegetarian diet (Arm A) and with additional potassium food supplement (Arm B) or regular diet (control, Arm C). Efficacy (American College Rheumatology), safety and food consumption (three-day retrospective recall) were assessed at four-weekly intervals. Potassium and diet were analyzed according to India recommendations. Standard statistic tests were used (significance at p <0.05, two sided). Study arms were matched at baseline. Background medication remained stable except reduced analgesics. Results: 155 patients (90.1%) completed study. Patients improved several measures with good safety and tolerance (potassium). Adverse events were mild; none caused withdrawal. The mean change in pain visual analogue scale/VAS (-2.23, 95% confidence interval -2.99 to -1.48) at week 16 (primary efficacy) in Arm B was significantly superior by study arms as per protocol analysis; better improvement in function and quality of life. High potassium intake (≥ 5 gm daily) showed significant association with low pain (< 4ms VAS) on study completion; Odds Ratio 2.5 univariate analysis, Likelihood Ratio 2.9 stepwise forward logistic regression adjusted for several clinical and diet variables. Compliance and food record were an important concern. Conclusion: High potassium intake using diet and a novel food supplement reduced joint pain in RA and seemed a safe adjunct. Further validation is required.