Comparison efficacy of oral Peganum harmala seed versus tamsulosin on pain relief and expulsion of renal and ureteral stones; a randomized clinical tria

Abstract

Introduction: Kidney stones are glycoproteins sediments that are formed inside kidney tubules and collecting ducts and are made of acid crystals and minerals. Objectives: This study aimed to compare the effects of Peganum harmala seed and tamsulosin on pain relief and expulsion of renal and ureteral stones in patients candidate for medical therapy. Patients and Methods: in this randomized clinical trial 80 patients older than 18 years with kidney and ureteral stones sized 4 to 10 mm were randomly allocated to one of two groups by simple sampling method. In group one, after performing ultrasonography and confirming the presence of 4 to 10 mm stone one capsule of tamsulosin 0.4 mg was prescribed per night for two weeks. In group two, harmala seed preparing in form of capsule with dose of 50 mg/kg/d, was prescribed after meal as the same of first group. Two weeks later patients were re-visited and urinary tract ultrasonography was conducted and the change in size of stones and presence of residual stones evaluated and recorded. The severity of pain in the patients was checked using VAS (visual analogue scale). Then the data was collected and analyzed at the end of the study. Results: Mean size of stones after treatment were 4.07±3.66 and 5.15 ± 3.63 mm respectively (P= 0.21). Mean numbers of stones before and after treatment were 0.59±1.38 and 1.18±0.94 (P=0.052). Pain score decreased significantly in both groups which was more significant in P. harmala group (P=0.002). Efficacy of treatment (sum of complete and partial response) in the two groups was 77.5 % and 77.8 % respectively and no significant differences between the two groups were seen (P=0.06). There was no significant side effect in the two groups. Conclusion: This study showed that both P. harmala seed and tamsulosin decrease urinary stone size and numbers without significant difference, but pain score decreased significantly by P. harmala.