Basri C et al, 2013: The effect of tamsulosin on pain and clearance according to ureteral stone location after shock wave lithotripsy
Basri Cakıroglu, Sinanoglu O, Mahmure Uraz.
Urology Clinic, Hisar Intercontinental Hospital, Umraniye/Istanbul, Turkey
Department of Urology, Maltepe University School of Medicine, Maltepe/Istanbul, Turkey
Department of Emergency Medicine, Maltepe University School of Medicine, Maltepe/Istanbul, Turkey
BACKGROUND: Medical expulsion therapy has shown encouraging results in facilitating spontaneous clearance of ureteral stones after extracorporeal shock wave lithotripsy. However, no other study has yet determined the benefit of medical expulsion therapy for stones in different ureteral locations.
OBJECTIVE: The aim of the study was to evaluate tamsulosin as adjunctive therapy to extracorporeal shock wave lithotripsy (SWL) in terms of pain clearance of stones in the upper, middle, and lower ureter.
METHODS: Between June 2008 and July 2011, patients with a solitary ureteral stone that was ≥6 mm up to 15 mm and located in the upper, middle, or lower ureter undergoing SWL were evaluated. The patients were randomly allocated to a conservative treatment (group 1) and a tamsulosin treatment group (group 2). Administration of the drug was started immediately after SWL and was continued for a maximum of 28 days. Patients were evaluated for stone clearance, time to stone clearance, and number of SWL sessions. The pain intensity was evaluated by visual analog scale.
RESULTS: There were 64 patients in the control group and 59 in the tamsulosin group. The average stone sizes were 10.70 (3.20) mm and 11.40 (3.01) mm (P = 0.24). Group 1 and group 2 received 2507 (984) and 2759 (775) shock waves (P = 0.86), 1.53 (0.8) and 1.49 (0.75) sessions (P = 0.85), respectively. Mean visual analog scale scores and times to clearance were 3.81 (2.74) and 2.73 (2.28) (P = 0.00) and 12.59 (8.63) days and 8.34 (7.60) days (P = 0.00), respectively, for all stones in groups 1 and 2. Only the clearance time of upper ureteral stones between groups showed statistical significance (13.54 [8.32] days vs 7.10 [6.40] days; P = 0.00).
CONCLUSIONS: Tamsulosin may help in the treatment of all ureteral stones after SWL, particularly stones in the upper ureter, with a shorter time to clearance and less need for analgesic drugs.
Curr Ther Res Clin Exp. 2013 Jun;74:33-5. doi: 10.1016/j.curtheres.2012.12.003.
PMID:24385155 [PubMed]. PMCID:PMC3862193. FREE ARTICLE
It says: " Drug administration was started immediately after SWL and was continued for a maximum of 28 days or until an alternative treatment was started. The patients who were not stone free at this examination were excluded from the study and underwent additional treatment. A total of 123 patients met these requirements." The authors do not state how many patients were excluded and consequently would have to be counted as failures in the respective group.
It says: Group 2 " ... our standard medical therapy in association with 0.4 mg tamsulosin once daily." Group 1 "Our standard medical therapy after SWL was 75 mg diclofenac injected intra- muscularly on demand."
How could this be done with all patients being discharged after SWL?
It says: "After discharge, all patients ... were asked to complete a diary about post- discharge pain, stone expulsion, use of analgesic drugs, and side effects of medical therapy."
There are no data on the use of pain medication after discharge in either group.
How informative is the mean of a several days pain diary?
The mean pain scores according to ureteral stone location were not significantly different.
The comparison of stone clearance times according to ureteral locations show the shortest passage time for the longest distance e.g. upper ureteral stones in the tamsulosin Group.
I guess the numbers were good enough for statistics but too small for reliable conclusions.