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- W2203457772 abstract "A fascinating aspect of clinical research is that it sometimes produces interesting findings that go against the norm. Robert Pickard and colleagues (July 25, p 341),1Pickard R Starr K MacLennan G et al.Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial.Lancet. 2015; 386: 341-349Summary Full Text Full Text PDF PubMed Scopus (234) Google Scholar for instance, published the results of the SUSPEND trial. Contrary to previous data, showing the benefit of medical expulsive therapy (MET) in the management of patients with ureteric colic secondary to ureteral stones smaller than 1 cm,2Campschroer T Zhu Y Duijvesz D Grobbee DE Lock MTWT Alpha blockers as medical expulsive therapy for ureteral stones.Cochrane Database Syst Rev. 2014; 4 (CD008509.)PubMed Google Scholar the authors showed that neither tamsulosin 0·4 mg daily nor nifedipine 30 mg daily are effective at decreasing the need for further treatment at 4 weeks.1Pickard R Starr K MacLennan G et al.Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial.Lancet. 2015; 386: 341-349Summary Full Text Full Text PDF PubMed Scopus (234) Google Scholar Although the methodological rigour of this study is unquestionable, a few aspects regarding the inclusion criteria and outcome measurements might merit thought. First, the status of the excretory axis upstream of the stone was not considered throughout the baseline assessment for patient eligibility.3McClinton S Starr K Thomas R et al.Use of drug therapy in the management of symptomatic ureteric stones in hospitalized adults (SUSPEND), a multicentre, placebo-controlled, randomized trial of a calcium-channel blocker (nifedipine) and an alpha-blocker (tamsulosin): study protocol for a randomized controlled trial.Trials. 2014; 15: 238Crossref PubMed Scopus (16) Google Scholar This consideration might be relevant because the mainstay of conservative management of patients with ureteral stones is to force an increase in fluid intake to increase urine production and mechanically enhance the spontaneous passage of the stone. In the event of severe dilation as a result of a ureteral obstruction, renal function might be temporarily impaired,4Singh I Strandhoy JW Assimos DG Chapter 40. Pathophysiology of urinary tract obstruction.in: Wein A Kavoussi L Novick A Partin A Peters C Campbell's Urology. 10th edn. Elsevier, Amsterdam2012Crossref Google Scholar thus decreasing the likelihood of the spontaneous resolution of this disorder, even with the adjunct of MET. Indeed, previous studies,5Sur RL Shore N L'Esperance J et al.Silodosin to facilitate passage of ureteral stones: a multi-institutional, randomized, double-blinded, placebo-controlled trial.Eur Urol. 2014; 67: 959-964Summary Full Text Full Text PDF PubMed Scopus (66) Google Scholar which have shown the benefit of MET, did actually exclude patients with severe hydronephrosis. Moreover, the extent of hydronephrosis per se has been suggested as an independent predictor of MET effectiveness.6Sahin C Eryildirim B Kafkasli A et al.Predictive parameters for medical expulsive therapy in ureteral stones: a critical evaluation.Urolithiasis. 2015; 43: 271-275Crossref PubMed Scopus (26) Google Scholar Therefore, the status of the excretory axis could be of major clinical importance, and thus, could have biased the results. The study also raises a second potential concern: the primary assessment of drug efficacy judges patients who do not need further treatment at 4 weeks as stone-free patients. Although this endpoint was considered pragmatic in terms of the clinical interest of the patient and health-care costs, stone persistence cannot be ruled out in all patients who do not need further treatment because imaging was deliberately not done because of the inadequate diagnostic accuracy of ultrasound and radiography of the kidneys, ureter, and bladder, the radiation exposure, and the cost of the CT. This situation could explain the surprisingly high proportion of patients (roughly 80%) who were deemed to be stone free at the 4-week assessment compared with previously published reports7Preminger GM Tiselius HG Assimos DG et al.2007 guideline for the management of ureteral calculi.J Urol. 2007; 178: 2418-2434Summary Full Text Full Text PDF PubMed Scopus (625) Google Scholar of about 68% of stones smaller than 5 mm being spontaneously passed, although only 47% of stones exceeding 5 mm were susceptible to spontaneous passage. Moreover, any disorder of unresolved asymptomatic ureteral obstruction might lead to a deterioration of renal function over time, thus questions about the safety of this approach remain. Overall, we believe that further trials with more stringent exclusion criteria, and standardised and objective outcome measurements would help clarify the actual clinical meaning of MET. LV and AS declare no competing interests. FM has received grants from RECORDATI. Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trialTamsulosin 400 μg and nifedipine 30 mg are not effective at decreasing the need for further treatment to achieve stone clearance in 4 weeks for patients with expectantly managed ureteric colic. Full-Text PDF Open Access" @default.
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- W2203457772 title "Ureteric colic and clinical evidence" @default.
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