This review is on the recent groundbreaking evidence on medical expulsive therapy (MET). MET using alpha adrenergic blockers (like tamsulosin) are in regular clinical practice. Even though it is an off label prescription, it is well accepted and practised world wide. European Urology Guidelines (2015), British Association of Urology Surgeons guidelines (2012) and American Urological Guidelines (2010) endorsed this practice in spite of the absence of strong evidence. The Cochrane review from the Cochrane Renal Group’s Specialised Register (on meta-analysis of 32 trials involving 5864 participants) and a systematic review by Seitz and colleagues (combining 29 studies involving 2419 participants) supported the role of alpha blockers in MET. A multicentre, randomised, placebo-controlled trial on medical expulsive therapy in adults with ureteric colic (SUSPEND Trial) by Pickard et al. was published online in the Lancet in May 2015. Between 11 January 2011 and 20 December 2013 this study had 1167 participants, randomly assigned to three groups – 391 to tamsulosin, 387 to nifedipine, and 389 to placebo. In all the three groups baseline characteristics were similar. Key entry criteria was identification of one ureteric stone 10mm or smaller by CT KUB. Only patients with a symptomatic ureteric stone were included. Follow-up was four and twelve weeks after randomisation. Eighty percent of patients in all three groups needed no further intervention. There was no difference noted between tamsulosin and nifedipine groups, and no difference between the active treatment and placebo groups. The reasons for this study showing outcomes different to previous studies are: previous studies were from single centres and with small recruited numbers, and meta-analysis of several small low-quality trials typically showed larger differences with methodological minor flaws. The strong points of this study were: level 1b evidence; grade A recommendation; multicentre RCT; centralised robust randomisation; excellent blinding with four and twelve weeks follow-up. Negative aspects of the study were: absence of intervention is the primary outcome, rather than proof of follow-up imaging with possible persistent asymptomatic stones not taken into consideration; aimed at proving (10%) superiority of tamsulosin over nifedipine, but ended up proving both are not useful; stones <5mm (75%) and lower ureteric stones (65%) predominated in the study; women constituted only 20% of study population; not formally powered for size and stone location subgroup analysis; 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; adherence to trial medication not monitored. But as of today this RCT has nailed the coffin for MET practice. This will result in 30-day cost saving of about £13 per patient in the NHS. I’m sure it will be accepted by NICE soon.
