A large, multicenter study “definitively demonstrates” the treatment’s infectiveness, one expert says.
Medical expulsive therapy is ineffective in the treatment of ureteral stones, according to a large-scale study that was recently published.
“Medical expulsive therapy, particularly the alpha-blocker drug tamsulosin (Flomax), is increasingly prescribed for people with ureteric colic on the basis of summarized evidence from several small clinical trials that suggests it increases the chance of spontaneously passing the stone and not needing intervention to remove the stone,” lead study author Robert Pickard, MD, of the Institute of Cellular Medicine, Newcastle University, United Kingdom, told Urology Times.
“Our large, well powered, placebo-controlled, multicenter study carried [out] in a routine care setting with full masking of patients and clinicians to the treatment received has now found no evidence that medical expulsive therapy with tamsulosin or nifedipine is effective for these patients. Our judgment based on the trial result is that these drugs should no longer be recommended or used for the purpose of reducing the risk of needing intervention to remove stones for people with ureteric colic.”
For the study, which was published online in The Lancet (May 18, 2015), Dr. Pickard and colleagues enrolled 1,136 adults undergoing expectant management for a single ureteral stone, which included patients with symptomatic stones of 10 mm or smaller (at the largest dimension) located at any site in the ureter, according to the study. Participants were randomized to receive once-daily tamsulosin, 0.4 mg; nifedipine, 30 mg; or placebo for up to 4 weeks.
Flexible URS found safe, effective in stones <2 cm
The authors found no evidence that the drugs reduced pain, hastened time to stone passage, or improved health status. About 80% of patients in each group did not require additional interventions to assist with stone passage. Serious adverse events were reported in three participants in the nifedipine group and one in the placebo group.
Commenting about the study in the NEJM Journal Watch, family physician Bruce Soloway, MD, wrote: “This trial, designed to reflect current recommendations and clinical practice, not only definitively demonstrates the ineffectiveness of medical expulsive therapy for ureteral stones but also reaffirms the essential importance of large, well-designed, randomized trials for assessing clinical interventions and formulating treatment guidelines.”
Separately, in commentary also published online in The Lancet (May 18, 2015), Jean de la Rosette, MD, and M. Pilar Laguna, MD, PhD, of AMC University Hospital, Amsterdam, the Netherlands, wrote: “This study… removes, beyond any reasonable doubt, any positive expectations with respect to α blockers in the treatment of ureter stones.”
The paper also generated discussion on social media. Henry Woo, MBBS, of the University of Sydney, Sydney, Australia, and Fardod O’Kelly, MD, of Mater Misericordiae University Hospital, Adelaide and Meath incorporating the National Childrens Hospital, Dublin, Ireland, tweeted about the study’s significance:
- Fardod O'Kelly (@FardodOKelly) May 19, 2015
The paper will also be the subject of discussion on Twitter for the International Urology Journal Club.
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