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

Abstract

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 (Ca2+, PO43-, uric acid [UA]) and urinary (24-hr Ca2+, PO43-, 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.

Hypouricemic effect of the methanol extract fromPrunus mumefruit in mice

“…uric acid in hyperuricemia-like rats and nephrolithiasis patients (Sudharsan et al, 2006;Singh et al, 2011), oleanolic acid and ursolic acid possessed XO inhibition activity in vitro (Yin & Chan, 2007). Therefore, we speculated that the hypouricemic effect of MPMF could be attributed to triterpenoids.…”

Herbal medicines for urinary stone treatment. A systematic review

“…Three independent reviewers selected 25 articles, which were considered of interest to the present review on the basis of title and abstract content. Nine articles were excluded after fulltext screening and 16 study reports were finally included in the present review (13)(14)(15)(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)(28). Among these reports, three lacked efficacy data of interest for the present review (15,16,21), and were only evaluated with respect to the risk of bias and adverse effects of treatment.…”

“…Six trial reports disclosed the randomization strategy. In five cases the ROB was low, as adequate randomization techniques were adopted (15,16,20,24,26). One study adopted block randomization, allowing foreknowledge of the allocation in a fraction of patients (high ROB; 21).…”

Pathogenesis of nephrolithiasis

“…The others are magnesium, p y r o p h o s p h a t e , p r o t e a s e i n h i b i t o r s a n d glycosaminoglycan. Indigenous herbal products may help in expulsion of small stones or may prevent stone formation by contributing to the fluid intake if taken regularly [28,29]. The possible urinary tract factors that cause renal stone formation include infections with ureaseproducing organisms leading to alkaline urine, urinary stasis due to obstruction and foreign bodies lodged in the urinary tract.…”