Medical expulsive therapy no help in ureteric colic

Last Updated: 2015-05-29

By David Douglas

NEW YORK (Reuters Health) - Tamsulosin and nifedipine do not assist stone passage in people managed expectantly for ureteric colic, according to a new randomized trial.

As Dr. Samuel McClinton told Reuters Health by email, "The majority of urologists, and other clinicians, believe in evidence-based medicine. The results of the Spontaneous Urinary Stone Passage Enabled by Drugs (SUSPEND) trial should change their practice from today as it clearly shows that medical expulsive therapy (MET) does not work."

In a paper online May 18 in The Lancet, Dr. McClinton of Aberdeen Royal Infirmary and colleagues note that meta-analyses of previous randomized controlled trials suggested that smooth muscle relaxants offered significant benefit in spontaneous stone passage.

Despite the limitations of the trials involved, say the researchers, MET is now recommended and is being adopted as part of routine expectant management of these patients.

To gain more definitive information, the team analyzed data on 1,136 patients in the SUSPEND trial who had been randomized to tamsulosin 400 mcg, nifedipine 30 mg, or placebo taken daily for up to four weeks.

At four weeks, 303 (80%) of 379 participants in the placebo group did not need further intervention, compared with 307 (81%) of 378 in the tamsulosin group and 304 (80%) of 379 in the nifedipine group.

Three of the participants in the nifedipine group reported serious adverse events as did one in the placebo group.

Despite earlier reports of the benefits of these agents, the researchers conclude, "our methodologically sound and large trial offers a strong evidence base for the alternative view that they are unlikely to be useful in the routine clinical care of people with ureteric colic."

Commenting on the findings by email, Dr. Jean de la Rosette, co-author of an accompanying editorial, told Reuters Health that the study and its findings underscore "the important role of quality of evidence and reporting of outcomes. Standardized reporting of outcomes is the first step towards improving scientific knowledge; it forms the basis for comparison between and among studies, and ultimately should allow for meaningful systematic reviews and meta-analysis."

Dr. de la Rosette, of AMC University Hospital in Amsterdam, the Netherlands, notes in the editorial that the study "removes, beyond any reasonable doubt, any positive expectations with respect to alpha blockers in the treatment of ureter stones."

The trial was supported by the UK National Institute for Health Research Health Technology Assessment Programme.

SOURCE: http://bit.ly/1RujZRa and http://bit.ly/1KClP1j

Lancet 2015.