Sunday 30 August 2015

The End of Tamsulosin (and Nifedipine) for Ureteral Colic

The evidence for offering tamsulosin to patients with ureteral colic was never very robust. It was comprised mostly small single centre studies of dubious quality. Nevertheless, tamsulosin seemed to be embraced by the urologists who then demanded that we give it to our patients being discharged from the ED. I was always a bit uneasy that this would be of any benefit and often thought of it as a stalling tactic by my consulting colleagues. I also knew that patients would bear the expense of the prescription not covered by insurance (Australian PBS).

We now have the most definitive evidence to show that tamsulosin does not work as medical expulsive therapy for ureteral colic. We can officially stop the silliness.

This multicenter, randomized trial randomized 1167 patients in the UK to either tamsulosin, nifedipine or placebo. The primary outcome was the proportion of patients who did not need further intervention for stone clearance within 4 weeks of randomization.

Say what you will about the primary outcome measure but at least it is pragmatic and does not mandate further radiation by serial imaging.

The bottom line? In all treatment groups, 80% needed no further intervention at 4 weeks. There were no real trends of any benefit anywhere. Tamsulosin and nifedipine did nothing to facilitate stone passage.

Of course one could get picky about the study design, secondary outcome measures, safety measures, external validity and other details. But the message is pretty darn clear. Medical expulsive therapy is now dead.

I believe the authors summarize best:

“Seekers of evidence often have to decide whether to base treatment decisions on a meta-analysis of several small low-quality trials typically showing larger treatment differences, or one large high quality trial with a smaller effect size or finding no effect... Our judgment is that the results of our trial provide conclusive evidence that the effect of both tamsulosin and nifedipine in increasing the likelihood of stone passage as measured by the need for intervention is close to zero. “

“...further trials involving these agents for increasing spontaneous stone passage rates will be futile.”

This is about as good as it gets.

Pickard R, Starr K, MacLennan G, et al. Medical expulsive therapy in adults with ureteral colic: a multicentre, randomised, placebo-controlled trial. Lancet 2015;386:341-349.

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