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Year : 2016  |  Volume : 32  |  Issue : 1  |  Page : 83-84
 

Medical expulsive therapy SUSPENDed


Consultant Urologist, Sandwell and West Birmingham NHS Trust, United Kingdom

Date of Web Publication4-Jan-2016

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DOI: 10.4103/0970-1591.173109

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How to cite this article:
Dhanasekaran AK. Medical expulsive therapy SUSPENDed. Indian J Urol 2016;32:83-4

How to cite this URL:
Dhanasekaran AK. Medical expulsive therapy SUSPENDed. Indian J Urol [serial online] 2016 [cited 2019 Sep 16];32:83-4. Available from: http://www.indianjurol.com/text.asp?2016/32/1/83/173109



   Summary Top


Pickard et al.[1] report a multi-center, randomized, placebo-controlled trial on medical expulsive therapy (MET) in adults with ureteric colic (SUSPEND Trial). Between January 2011, and December 2013, 1167 participants across 24 United Kingdom hospitals were randomly assigned to three groups - 391 to tamsulosin 0.4 mg, 387 to nifedipine 30 mg, and 389 to placebo (1:1:1 ratio). The key entry criterion was one symptomatic ureteric stone 10 mm or smaller detected by computed tomography. The participants received 28 days of unmarked, encapsulated medication by a team not involved in the rest of the study. Follow-up was 4 and 12 weeks after randomization. The study's primary outcome was the need for intervention at 4 weeks. No imaging was utilized to document stone passage. Secondary outcomes assessed via follow-up surveys were analgesic use, pain (measured using visual analog scale and analgesic use), and time to stone passage. In all the three groups, baseline characteristics were similar. 80% of patients in all three groups needed no further intervention. A similar percentage of tamsulosin (7%), nifedipine (6%), and placebo (8%) group participants had interventions planned at 12 weeks.


   Comments Top


MET using alpha adrenergic blockers (such as tamsulosin) is in regular clinical practice. Even though it is an off-label prescription, it is well-accepted and practiced worldwide. European Association Urology Guidelines [2] and American Urological Guidelines [3] endorse this practice despite the absence of strong evidence. A Cochrane review [4] from the Cochrane Renal Group's Specialised Register on a meta-analysis of 32 trials involving 5864 participants and a systematic review by Seitz et al.[5] combining 29 studies involving 2419 participants supported the role of alpha blockers in MET.

The current study, however suggests no better outcomes with MET when compared with placebo. The reasons for this study showing different result could be that previous studies were single centered with small numbers and meta-analysis of several small low-quality trials typically show larger differences with methodological minor flaws. The current study provides level 1b evidence, with a robust centralized randomization, excellent blinding and both a 4 and 12 week follow-up. However, simply the 'absence of intervention' as the primary outcome may not pick up persistent stones in the absence of imaging. Stones <5 mm (75%) and lower ureteric stones (65%) predominated in the study and women constituted only 20% of the study population. The study was not powered for a stone size and location subgroup analysis. However, an analysis of the subgroups suggests that there is a trend towards tamsulosin being effective in women and patients with calculi in the lower ureter or those >5 mm in size. Secondary outcomes such as pain control, time to stone passage, health status, associated disturbance to social and working life, and early discontinuation of trial medication were incomplete, only 62 and 49% if patients completed 4 and 12 weeks questionnaires. Adherence to trial medication was not monitored. It may have been useful if the participants were asked to strain their urine during the study period to look for spontaneous stone passage. At the moment, it seems that this is the best data available for MET today and the SUSPEND trial may have suspended the MET practice.

 
   References Top

1.
Pickard R, Starr K, MacLennan G, Lam T, Thomas R, Burr J, et al. Medical expulsive therapy in adults with ureteric colic: A multicentre, randomised, placebo-controlled trial. Lancet. 2015;386(9991):341-9.  Back to cited text no. 1
    
2.
Türk C, Knoll T, Petrik A, Sarica K, Seitz C, Skolarikos A, et al. European Association of Urology Guidelines on Urolithiasis. Available from: http://www.uroweb.org/guideline/urolithiasis/. [Last accessed on 2015 Jul 10; Last update on 2015 March].  Back to cited text no. 2
    
3.
Fulgham PF, Assimos DG, Pearle MS, Preminger GM. American Urological Association (AUA) Guideline: Clinical Effectiveness Protocols for Imaging in the Management of Ureteral Calculous disease. American Urological Association Technology Assessment; 2012. Available from: https://www.auanet.org/common/pdf/education/clinical-guidance/imaging-assessment.pdf. [Last accessed on 2015 Jul 10].  Back to cited text no. 3
    
4.
Campschroer T, Zhu Y, Duijvesz D, Grobbee DE, Lock MT. Alpha-blockers as medical expulsive therapy for ureteral stones. Cochrane Database Syst Rev 2014;4:CD008509.  Back to cited text no. 4
    
5.
Seitz C, Liatsikos E, Porpiglia F, Tiselius HG, Zwergel U. Medical therapy to facilitate the passage of stones: What is the evidence? Eur Urol 2009;56:455-71.  Back to cited text no. 5
    




 

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