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

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      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.

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      Most cited references 41

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      Epidemiology and risk factors in urolithiasis.

      Stone formation in the urinary tract affects about 5-10% of the population in industrialized countries, although it is very rare in other countries such as Greenland or Japan. The high incidence and recurrence rate contribute to making the urolithiasis a serious social problem. Nowadays, urolithiasis must be considered a 'disease in evolution' for several reasons, such as epidemiological changes, evolution of the methods used for diagnosis, and the treatment and prophylaxis of the population considered 'at risk' of stone disease. Some features of stone disease have changed over the last few years due to many social, economical and cultural factors that are described here. The increased prevalence of small urinary calculi has brought about a change in clinical symptoms, with frequent episodes of renal-ureteral colic, persistent pain and hydronephrosis. Similarly, the presence of residual fragments after extracorporeal shock wave lithotripsy has induced a radical change in the management of small calculi through the use of mini-invasive surgical techniques. Copyright 2007 S. Karger AG, Basel.
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        Randomized double-blind study of potassium citrate in idiopathic hypocitraturic calcium nephrolithiasis.

        In an attempt to document the efficacy of potassium citrate in stone formation, 57 patients with active lithiasis (2 or more stones during the preceding 2 years) and hypocitraturia were randomly allocated into 2 groups, with 1 group taking 30 to 60 mEq. potassium citrate daily in wax matrix tablet formation and the other group receiving placebo. In 18 patients receiving potassium citrate for 3 years stone formation significantly declined after treatment from 1.2 +/- 0.6 to 0.1 +/- 0.2 per patient year (p < 0.0001), in 13 patients (72%) the disease was in remission and all patients showed a reduced stone formation rate individually. In contrast, 20 patients taking placebo medication for 3 years showed no significant change in stone formation rate (1.1 +/- 0.4 to 1.1 +/- 0.3 per patient year) and in only 4 patients (20%) was the disease in remission. The stone formation rate during potassium citrate treatment was significantly lower than during the placebo treatment (0.1 +/- 0.2 versus 1.1 +/- 0.3 per patient year, p < 0.001). Potassium citrate therapy caused a significant increase in urinary citrate, pH and potassium, whereas placebo did not. Adverse reactions to potassium citrate were mild causing only 2 patients in the potassium citrate group and 1 in the placebo group to withdraw from the study. In summary, our randomized trial showed the efficacy of potassium citrate in preventing new stone formation in idiopathic hypocitraturic calcium nephrolithiasis.
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          Pathophysiology and management of calcium stones.

          Nephrolithiasis is a common disorder that accounts for significant cost, morbidity, and loss of work. There is a one in eight lifetime chance of being diagnosed with urinary stones. Calcium is the most common component of renal stones in individuals in industrialized nations. Calcium stones form as a result of a variety of environmental and metabolic abnormalities that change the urinary environment and increase supersaturation of stone-forming salts. Understanding the pathophysiology of stone disease can help direct treatment toward correction of the underlying abnormalities. Current medical and dietary therapeutic regimens have been shown to significantly reduce the risk of recurrent stone formation.
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            Author and article information

            Affiliations
            Department of Surgery, University College of Medical Sciences (University of Delhi) and GTB Hospital, Delhi, India
            [1]Department of Urology, University College of Medical Sciences (University of Delhi) and GTB Hospital, Delhi, India
            [2]Department of Radiodiagnosis, University College of Medical Sciences (University of Delhi) and GTB Hospital, Delhi, India
            Author notes
            Address for correspondence: Dr.(Prof.) Iqbal Singh, F-14 NDSE-2, New Delhi - 110 049, India. E-mail: iqbalsinghp@123456yahoo.co.uk
            Journal
            Urol Ann
            UA
            Urology Annals
            Medknow Publications (India)
            0974-7796
            0974-7834
            May-Aug 2011
            : 3
            : 2
            : 75-81
            3130482
            21747596
            UA-3-75
            10.4103/0974-7796.82172
            Copyright: © Urology Annals

            This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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