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.
Covering:
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.