This release discusses the results of a clinical trial that tested tamsulosin (marketed in the US as Flomax), a drug used to treat enlarged prostate, as an aid in easing the passage of kidney stones in Australian patients, thus avoiding emergency treatment and surgery. The study enrolled 403 patients of whom 316 completed the study and only 77 had stones between 5 and 10 mm in diameter, the ones claimed to benefit from tamsulosin use.
The release didn’t provide any numerical measurement when describing the drug’s benefits or any insights into cost or side effects associated with the drug.
[Editor’s note: The news release links directly to a meta-analysis of several other related trials, instead of the trial described in the release. Reviewers located the correct study and used it as a reference point instead of the meta-analysis.]
As the release points out, “up to 15 per cent of the Australian adult population and 1 in 11 people in the United States suffer from kidney stones,” which “can be excruciating to pass through the urinary tract.” If taking a readily available drug might remedy that situation it would be a real benefit to a vast number of people. But the release paints a rosy picture of the research that isn’t warranted. According to the published study, the majority of patients (76%) had stones less than 5mm in diameter and did not benefit from the drug.
The release gives a brief nod to costs when it quotes the lead author stating “this has potential to improve care and reduce costs,” but it goes no further. There is no mention of the cost of tamsulosin, nor the length of time patients might need to take it to relieve kidney stones.
In the release, the clinical trial leader describes the benefits as:
“Of more than 400 patients in the trial, we found those who received tamsulosin passed their large kidney stones more often than the placebo group.
“This means patients with large stones might not need more complicated treatments including surgeries, and this has potential to improve care and reduce costs. We’re very excited because Tamsulosin treatment may also allow patients to be treated closer to home rather than needing referral to a major centre.”
The release would have been much better had it stated what “more often” actually meant. How many more patients on tamsulosin passed their stones compared to those on placebo?
In addition, the release could have more carefully differentiated which patient group might benefit from the drug intervention. According to the study abstract:
“We found no benefit overall of 0.4 mg of tamsulosin daily for patients with distal ureteric calculi less than or equal to 10 mm in terms of spontaneous passage, time to stone passage, pain, or analgesia requirements. In the subgroup with large stones (5 to 10 mm), tamsulosin did increase passage and should be considered.”
The published study reported that of the 36 patients on the drug with large kidney stones — those between 5 and 10 mm — 30 (83.3%) passed their stones compared with 25 of the 41 (61%) volunteers with large stones who were given placebo. Those would have been good numerical reference points to include in the release.
There are no mentions of potential harms from the use of tamsulosin mentioned in the news release, although a simple web search reveals a host of minor side effects — drowsiness, dizziness, blurred vision, lightheadedness, fainting, back pain, cough, decreased sexual ability, diarrhea, headache, runny or stuffy nose, sinus inflammation, trouble sleeping, or weakness — and possible severe side effects including severe allergic reactions, chest pain or irregular heartbeat, fever or chills, or other conditions.
The release describes the trial only briefly, noting that it involved 400 and was conducted in five Australian hospital emergency departments.
It would have been helpful to note that the trial was randomized with roughly half of the patients getting the drug intervention and half getting placebo.
The release notes that the research was funded by Emergency Medicine Foundation Australasia, and that the quoted researcher has received “more than $270,000” from that group to support his research.
While the study leader states that patients using this drug “might not need more complicated treatments including surgeries,” that doesn’t meet our criteria for comparing alternatives. Are there other drugs similar in function to tamsulosin that might also benefit patients? Alpha blockers which relax the ureter muscles have helped some pass stones with less pain. Some patients with larger stones are treated with lithotripsy which employs sound waves that break stones into smaller pieces.
Tamsulosin is currently prescribed for patients with benign prostatic hyperplasia (BPH), or enlarged prostate and other conditions and is readily available.
The release claims that the researchers “discovered” that this drug has benefits which suggests to readers that this was the first and only study to look at the use of tamsulosin for kidney stones. Previous studies with similar findings have been published over the past few years.
Aside from an over-generalized headline, the release doesn’t engage in unjustifiable language.
Systematic, Criteria-Driven
The tale of two “negative” studies. Or, how spin is applied to make research findings look more impressive. A must read. https://johnmandrola.substack.com/p/the-tale-of-two-negative-studies
The @nytimes chose to interview one of the editors of the @AnnalsofIM (publisher of this paper) who "gushed with extraordinary glee: It’s huge! There are very few things that reduce your mortality by 30%."
Turns out coffee is not one of those few things despite all that glee. https://twitter.com/garyschwitzer/status/1533202075928215558
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