A Special Terpene Combination (Rowatinex®) Improves Stone Clearance after Extracorporeal Shockwave Lithotripsy in Urolithiasis Patients: Results of a Placebo-Controlled Randomised Controlled Trial
| Autor: | Stelios Mavrogenis, József Varga, E. Holman, Ralf Kohnen, György Siller, Imre Romics |
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| Rok vydání: | 2010 |
| Předmět: |
Adult
Male medicine.medical_specialty Adolescent Urology medicine.medical_treatment Analgesic Lithotripsy Placebo law.invention Ureter Double-Blind Method Urolithiasis Randomized controlled trial law medicine Humans Adverse effect Aged Aged 80 and over Terpenes business.industry Middle Aged medicine.disease Combined Modality Therapy Surgery Treatment Outcome medicine.anatomical_structure Pharmacodynamics Female Kidney stones business |
| Zdroj: | Urologia Internationalis. 86:102-109 |
| ISSN: | 1423-0399 0042-1138 |
| DOI: | 10.1159/000320999 |
| Popis: | Objective: To investigate the safety and efficacy of a special terpene combination in the treatment of patients with urolithiasis after extracorporeal shockwave lithotripsy (ESWL). Patients and Methods: 222 patients with clinically stable kidney or ureter stones of 0.3–2.0 cm undergoing complication-free ESWL were randomised to receive a special terpene combination (Rowatinex®; 3 × 2 capsules/day) or placebo. The study consisted of a 12-week active treatment phase and a 2-week follow-up phase. All patients had a physical examination, and diagnosis of kidney stones was made by X-ray, intravenous pyelogram or ultrasound at weeks 1, 4, 8 and 12 as well as after 2 weeks of follow-up. Stone-free status was defined as obviously successful expulsion of calculi/fragments, being without any stone. Results: In all, when compared to placebo, significantly more patients receiving the terpene combination treatment in the intent-to-treat (ITT) group [72 (67.9%) vs. 49 (50.0%); p = 0.0009] and the per-protocol (PP) group [69 (78.4%) vs. 48 (52.2%); p = 0.0004] were stone-free at the end of the study. Treatment with the terpene combination was also more effective when analysed with respect to the size of the treated stone. In addition, treatment with the terpene combination significantly reduced the median time to stone-free status from 85.0 to 56.0 days (p = 0.0061) and from 85.0 to 49.5 days (p = 0.0028) in the ITT and PP populations, respectively. Nine mild-to-moderate adverse events (AE; terpene combination group: 7 AE in 4 patients; placebo group: 2 AE in 2 patients) were assessed as drug-related. Conclusions: Treatment with the terpene combination is well tolerated and safe. The terpene combination was found to be an efficacious treatment in eliminating calculi fragments generated by ESWL as compared to placebo. The pharmacodynamic properties of the terpene combination (antilithogenic, antibacterial, antiinflammatory, spasmolytic and analgesic effects), which have been also confirmed in preclinical studies, represent a valuable alternative to the different drugs used in the treatment of urolithiasis. |
| Databáze: | OpenAIRE |
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