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dc.contributor.authorPickard, Robert
dc.contributor.authorStarr, Kathryn
dc.contributor.authorMacLennan, Graeme
dc.contributor.authorLam, Thomas
dc.contributor.authorThomas, Ruth
dc.contributor.authorBurr, Jennifer
dc.contributor.authorMcPherson, Gladys
dc.contributor.authorMcDonald, Alison
dc.contributor.authorAnson, Kenneth
dc.contributor.authorN'Dow, James
dc.contributor.authorBurgess, Neil
dc.contributor.authorClark, Terry
dc.contributor.authorKilonzo, Mary
dc.contributor.authorGillies, Katie
dc.contributor.authorShearer, Kirsty
dc.contributor.authorBoachie, Charles
dc.contributor.authorCameron, Sarah
dc.contributor.authorNorrie, John
dc.contributor.authorMcClinton, Samuel
dc.date.accessioned2015-05-19T15:01:01Z
dc.date.available2015-05-19T15:01:01Z
dc.date.issued2015-07-25
dc.identifier.citationPickard , R , Starr , K , MacLennan , G , Lam , T , Thomas , R , Burr , J , McPherson , G , McDonald , A , Anson , K , N'Dow , J , Burgess , N , Clark , T , Kilonzo , M , Gillies , K , Shearer , K , Boachie , C , Cameron , S , Norrie , J & McClinton , S 2015 , ' Medical expulsive therapy in adults with ureteric colic : a multicentre, randomised, placebo-controlled trial ' , Lancet , vol. 386 , no. 9991 , pp. 341-349 . https://doi.org/10.1016/S0140-6736(15)60933-3en
dc.identifier.issn0140-6736
dc.identifier.otherPURE: 188739548
dc.identifier.otherPURE UUID: caa9ecca-55ce-454d-ad2b-2d8195bb5864
dc.identifier.otherScopus: 84937966127
dc.identifier.otherORCID: /0000-0002-9478-738X/work/60196196
dc.identifier.otherWOS: 000358448400023
dc.identifier.urihttp://hdl.handle.net/10023/6669
dc.descriptionRP, KS, KSt, GMa, RT, JB, GMc, AM, MK, KG, and SM report grants from National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme during the conduct of the study.en
dc.description.abstractBackground Meta-analyses of previous randomised controlled trials concluded that the smooth muscle relaxant drugs tamsulosin and nifedipine assisted stone passage for people managed expectantly for ureteric colic, but emphasised the need for high-quality trials with wide inclusion criteria. We aimed to fulfil this need by testing effectiveness of these drugs in a standard clinical care setting. Methods For this multicentre, randomised, placebo-controlled trial, we recruited adults (aged 18–65 years) undergoing expectant management for a single ureteric stone identified by CT at 24 UK hospitals. Participants were randomly assigned by a remote randomisation system to tamsulosin 400 μg, nifedipine 30 mg, or placebo taken daily for up to 4 weeks, using an algorithm with centre, stone size (≤5 mm or >5 mm), and stone location (upper, mid, or lower ureter) as minimisation covariates. Participants, clinicians, and trial personnel were masked to treatment assignment. The primary outcome was the proportion of participants who did not need further intervention for stone clearance within 4 weeks of randomisation, analysed in a modified intention-to-treat population defined as all eligible patients for whom we had primary outcome data. This trial is registered with the European Clinical Trials Database, EudraCT number 2010-019469-26, and as an International Standard Randomised Controlled Trial, number 69423238. Findings Between Jan 11, 2011, and Dec 20, 2013, we randomly assigned 1167 participants, 1136 (97%) of whom were included in the primary analysis (17 were excluded because of ineligibility and 14 participants were lost to follow-up). 303 (80%) of 379 participants in the placebo group did not need further intervention by 4 weeks, compared with 307 (81%) of 378 in the tamsulosin group (adjusted risk difference 1·3% [95% CI −5·7 to 8·3]; p=0·73) and 304 (80%) of 379 in the nifedipine group (0·5% [–5·6 to 6·5]; p=0·88). No difference was noted between active treatment and placebo (p=0·78), or between tamsulosin and nifedipine (p=0·77). Serious adverse events were reported in three participants in the nifedipine group (one had right loin pain, diarrhoea, and vomiting; one had malaise, headache, and chest pain; and one had severe chest pain, difficulty breathing, and left arm pain) and in one participant in the placebo group (headache, dizziness, lightheadedness, and chronic abdominal pain). Interpretation Tamsulosin 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.
dc.format.extent9
dc.language.isoeng
dc.relation.ispartofLanceten
dc.rightsCopyright © 2015 Pickard et al. Open Access article distributed under the terms of CC BY (http://creativecommons.org/licenses/by/4.0/).en
dc.subjectR Medicine (General)en
dc.subjectRA0421 Public health. Hygiene. Preventive Medicineen
dc.subjectNDASen
dc.subjectBDCen
dc.subjectR2Cen
dc.subject~DC~en
dc.subject.lccR1en
dc.subject.lccRA0421en
dc.titleMedical expulsive therapy in adults with ureteric colic : a multicentre, randomised, placebo-controlled trialen
dc.typeJournal articleen
dc.description.versionPublisher PDFen
dc.contributor.institutionUniversity of St Andrews.School of Medicineen
dc.identifier.doihttps://doi.org/10.1016/S0140-6736(15)60933-3
dc.description.statusPeer revieweden


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