NEW YORK (Reuters Health) – Tamsulosin facilitates the passage of larger distal ureteral stones and relieves renal colic, researchers from China report.
Medical expulsive therapy aims to accelerate ureteral stone passage and relieve pain, but several recent studies have questioned the effectiveness of alpha-blockers like tamsulosin for managing ureteral stones.
Dr. Hua Xu from Tongji Medical College, in Wuhan, and colleagues from 30 centers in China evaluated the efficacy and safety of tamsulosin as medical expulsive therapy in their randomized, placebo-controlled trial of 3,450 patients (about two-thirds women).
The stone expulsion rate was modestly though significantly greater with tamsulosin than with placebo (86% vs. 79%), the researchers report in European Urology, online November 11.
In subgroup analyses, tamsulosin was twice as effective as placebo for distal ureteral stones >5 mm, but not effective for smaller stones.
Compared with placebo, tamsulosin was associated with a shorter time to expulsion, less recurrent colic, and fewer analgesics.
Adverse events occurred with similar frequency in the tamsulosin (5.6%) and placebo (5.1%) groups.
“Our findings add to the evidence of tamsulosin as a promising and useful treatment for large distal ureteral stones,” the authors conclude.
Dr. Jason Lee from the University of Toronto, Canada, who recently reviewed evidence for medical expulsive therapy, told Reuters Health by email, “Despite several randomized controlled trials, the jury is still out. There is likely no role for smaller stones (<5 mm), but there might be a benefit in those with larger stones.”
His conclusion: “Tamsulosin should not be given for all patients with distal stones, but perhaps only those with larger stones. Patient selection is important.”
Dr. Oliver J. Wiseman from Cambridge University Hospitals NHS Trust, in Cambridge, UK, who earlier made the case for discontinuing the use of alpha-blockers in this clinical setting, said, “I thought the debate regarding the use of medical expulsive therapy (MET; tamsulosin) for ureteric stones was all over. There were meta-analyses of small randomized studies subject to publication bias recommending the use of MET, and then we published a large study in the UK, SUSPEND, the ‘large randomized study’ which previous meta-analyses had been calling for. However, people didn’t believe SUSPEND, but then we had two further corroborative studies showing that MET was not of benefit in ureteric stones.”
“There are some problems with the current study, which will mean that I won’t be changing my practice away from not using MET for ureteric stones,” he told Reuters Health by email. “For me the issues with this study include the narrow inclusion criteria of stones between 4 and 7 mm, which is very precise and makes we wonder why such tight criteria were chosen, or whether the data underwent some ‘post-study’ analysis and retrospective decision of inclusion criteria. Why would you set out to decide to include stones between 4 and 7 mm?”
Dr. Wiseman also noted, “The exclusion of ‘severe hydronephrosis’ in the current study is difficult to interpret and use in clinical practice. Furthermore, we do need to know about compliance in the study, and this is not mentioned.”
“I don’t want to sound disbelieving about such a large, well-conducted study, a little like people were of SUSPEND, but I won’t be switching back to prescribing alpha-blockers for colic, as there are just too many unanswered questions with this current study,” he concluded.
Astellas Pharma, a maker of tamsulosin, sponsored the study. Dr. Xu did not respond to a request for comment.
SOURCE: http://bit.ly/2jutqGk
Eur Urol 2017.
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