Improving Stone Clearance After Extracorporeal Shock Wave Lithotripsy in Urolithiasis Patients by a Special Terpene Combination (Rowatinex®): Results of a Placebo-Controlled, Randomized Trial

BackgroundExtracorporeal shockwave lithotripsy (ESWL) is the first-choice treatment for most renal stones. Rowatinex®, a special terpene combination, has been used therapeutically in the supportive treatment of urolithiasis and for assistance in the expulsion of stones of the renal system for many years.ObjectiveThe aim of the study was to investigate the safety and efficacy of Rowatinex® in the treatment of patients with urolithiasis after ESWL.Design, setting, and participantsIn a randomized, double-blinded, placebo-controlled, multicenter trial, 222 patients with clinically unapparent kidney or ureter stones who had undergone complication-free ESWL were included between June 2003 and December 2006. The study consisted of a 12-wk active treatment phase and a 2-wk follow-up phase. All patients underwent physical examination, and diagnosis of kidney stones was made by x-ray, intravenous pyelogram (IVP), or ultrasound at weeks 1, 4, 8, and 12 as well as after 2 wk of follow-up.InterventionPatients were randomized to receive either 3 × 2 Rowatinex® capsules per day or placebo.MeasurementsThe primary end point was the rate of stone-free patients (without any fragments) after 12 wk of treatment.Results and limitationsSignificantly more patients treated with the terpene combination were stone free at the end of the study compared to placebo (intention-to-treat [ITT]—verum vs placebo: 72 patients [67.9%] vs 49 patients [50.0%]; p = 0.0009; per-protocol [PP]—verum vs placebo: 69 patients [78.4%] vs 48 patients [52.2%]; p = 0.0004). The treatment was even more effective when analyzed with respect to the size of the treated stone. In addition, the terpene combination treatment significantly reduced the median time to stone-free status (ITT—placebo vs verum: 85.0 d vs 56.0 d; p = 0.0061; PP—placebo vs verum: 85.0 d vs. 49.5 d; p = 0.0028). Tolerability was excellent.ConclusionsThe terpene combination Rowatinex® was found to be an efficacious, well-tolerated, and safe treatment for eliminating calculi fragments generated by ESWL compared to placebo.