Background: Extracorporeal 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. Objective: The 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 participants: In 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. Intervention: Patients were randomized to receive either 3×2 Rowatinex® capsules per day or placebo. Measurements: The primary end point was the rate of stone-free patients (without any fragments) after 12 wk of treatment. Results and limitations: Significantly 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. Conclusions: The terpene combination Rowatinex® was found to be an efficacious, well-tolerated, and safe treatment for eliminating calculi fragments generated by ESWL compared to placebo. The terpene combination Rowatinex®, when compared with placebo, was found to be an efficacious, well-tolerated, and safe treatment for eliminating calculi fragments generated by extracorporeal shock wave lithotripsy.
- Extracorporeal shock wave lithotripsy
- Kidney stones
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