Prospective randomized clinical trial comparing phytotherapy with potassium citrate in management of minimal burden (≤8 mm) nephrolithiasis

AIM: To compare efficacy and tolerability of phytotherapy (PT) vs. potassium citrate (KC) in patients with minimal nephrolithiasis. To compare and assess changes in value of certain serum (Ca(2)+, PO(4)(3-), uric acid [UA]) and urinary (24-hr Ca(2+), PO(4)(3-), UA, citrate, oxalate, and urine pH) parameters in patients being treated with PT or KC. MATERIALS AND METHODS: After clearance by the local institutional ethics committee, 60 patients of nephrolithiasis who had consented for the study, were enrolled (as per entry criteria) and randomized into citrate therapy (group-I) or PT (group-II). PT was administered as a nutritional supplement, using a lupeol-based extract (Tablet Calcury™, two tablets twice a day). They were monitored for the changes in the serum and urinary biochemical, radiological, and clinical parameters (efficacy and tolerability) as per protocol. RESULTS: Group-I patients demonstrated favorable changes in certain biochemical parameters (decreased serum calcium, urinary UA/oxalate, increased urinary citrate and pH) along with significant symptomatic improvement (decrease in visual analogue pain score with increased stone clearance/reduction in stone size). Four (13.3%) patients of group-I had mild upper gastrointestinal discomfort which was controlled with antacids. Group-II patients had favorable changes in biochemical parameters (decreased serum UA and increased urinary citrate) along with significant symptomatic improvement (reduction/clearance in the stone size), but without any noticeable side effects. CONCLUSIONS: Medical therapies with both KC and PT (with lupeol extract using Calcury™) were effective in reducing the stone size and symptoms of nephrolithiasis. It appeared that KC was biochemically efficacious in producing some favorable biochemical changes with some side effects, whereas PT was probably clinically efficacious in hastening stone expulsion (<8 mm) without any observed adverse events. Although both the medical therapies were not effective in all aspects, we believe that PT using lupeol-based extract (Calcury™) may be used as an alternative form of medical therapy in select patients with minimal nephrolithiasis. Long-term randomized placebo-controlled trials are needed to better define the precise role of lupeol-based PT vs. citrate therapy in minimal nephrolithiasis.