Background : In view of the high recurrence of kidney stones in patients, the search for less aggressive, preventive treatments has become increasingly essential. Renalof ® offers a phytotherapy alternative. Due to its diuretic and kidney stone demineralisation properties, it has been widely used in this patient population, disintegrating and eliminating calcium oxalate and struvite kidney stones painlessly in the genitourinary system. Methods : A Phase II, randomised, prospective, observational, single-blind study with two treatment arms was conducted in order to determine the efficacy of this alternative therapy: a total of 155 patients were enrolled, 120 were assigned to a Renalof ® treatment group and 35 to the placebo group. All were over 18 years of age, of both genders, diagnosed with kidney stones of under 10 mm in diameter, present along the entire renal-ureteral-vesicular tract, diagnosed by ultrasound and renal CAT scan. Divided into two study arms, 120 were administered a dosage of a single 325 mg capsule of the Renalof ® product half an hour before the two main meals for 3 months. The presence of kidney stones in any part of the renal-ureteral tract was assessed at monthly consultations using one of the above-mentioned diagnostic tools. Results : Study results show a high rate of effectiveness with Renalof ® , finding up to a 65% expulsion rate (78 patients) in the first 8 weeks of treatment, compared to 11.4% (4 patients) in the placebo control group, P < 0.001. It is likely a longer follow-up period would be necessary in patients with kidney stones of 10 mm in diameter or larger than the period applied in the study. Discussion : We strongly recommend the inclusion of this product in kidney stone disease management protocols, especially for patients with kidney stones under 10 mm in diameter, where high response and effectiveness have been observed. Thus, it should be evaluated to reduce surgical treatment costs, as well as those for possible colic episodes and other associated complications.
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