was 4%. The corresponding pooled result for nifedipine(nine studies, n = 686) showed that active treatment gave a50% increased likelihood of stone passage, with an absoluterisk reduction of 26%. The incidence of mild adverseeffects was 15%. Both drugs significantly shortened, by between2 and 6 days, the average time to stone expulsion[18]. However, the overall quality of the trials was poor.In both meta-analyses, the majority of studies involvedstones <10 mm located in the lower (distal) ureter. Thesetwo reviews both concluded that a large, high-qualityrandomized controlled trial is required to confirmtheir findings, suggesting that MET with either drugclass can enhance spontaneous stone passage rate. Inaddition, several studies have previously reported thatMET can significantly reduce the pain burden amongpatients in terms of reducing the frequency of pain episodes,pain severity and analgesic requirements.However, more recent results provided by Bensalahand co-workers [19] appear to challenge the notion thatα-blockers enhance spontaneous ureteric stone passage.The study, recently presented as an abstract, was aprospective, multicentre, randomized, double-blind,placebo-controlled trial, which evaluated the efficacyof tamsulosin versus placebo in patients with uretericcolic caused by distal ureteric stones. A total of 129 patientswere treated for 42 days or until stone expulsion.At 42 days, there was no significant difference betweenthe spontaneous expulsion rates between placebo (70.5%)and tamsulosin (77.0%; P = 0.41), nor in the mean stonepassage times (10.1 and 9.6 days, respectively). Nevertheless,the overall mean stone diameter was 3.1 mm, whichis smaller than all of the earlier studies included in themeta-analyses by Hollingsworth [17] and Singh [18]. Thespontaneous stone passage rate in the placebo arm washigh (70.5%) in comparison with other studies included inthe two meta-analyses.There is limited evidence on the cost-effectiveness ofMET; an indirect cost-benefit analysis based on cost datafrom the USA and four European countries suggestedthat the use of tamsulosin could potentially result in acost saving of US$ 1,132 per patient episode over conventional‘watchful waiting’ [20].In summary, the role of MET in reducing the morbidityand economic costs associated with ureteric stone diseaseis promising. The majority of clinical trials conducted todate have been small and of poor to moderate quality interms of trial methodology or design. Furthermore, theyhave lacked a comprehensive economic evaluation. There isthus an urgent need for a definitive randomized controlledtrial, such as that described in this protocol to inform theclinical management of patients with ureteric stone disease.For the purposes of this randomized controlled trial, wehave chosen to compare tamsulosin versus nifedipine. Theweight of available evidence supports the use of tamsulosin
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