Talk:Prostate steam treatment

Medical uses update

I added information from a 2020 Cochrane review comparing prostate steam treatment with a placebo procedure to improve the quality of information about the potential outcomes of the procedure. I also updated the date for the lack of reviews comparing prostate steam treatment with transurethral resection of the prostate. --Gsom12812 (talk) 17:43, 15 February 2021 (UTC)

Rearranged the page to have a Benefits and Harms section for clarity of reading. Eliminated conflicting information about the effectiveness of treatment. Added information about the certainty of evidence regarding the benefits and harms of prostate steam treatment and the number of participants used in the review paper. --Gsom12812 (talk) 02:15, 17 February 2021 (UTC)

Source not appropriate

The following text has been been moved here for a discussion of its problems:

A systematic review from 2020 comparing prostate steam treatment to a sham procedure (a placebo) found with moderate certainty that this procedure may improve quality of life for men with moderate urinary symptoms. This review was conducted from a single trial with 197 men whose average age was 63 years and had moderately bothersome urinary symptoms. Prostate steam treatment has not been compared to transurethral resection of the prostate in randomised controlled trials as of 2020.

The source is not regarded as appropriate, because

• (1) sham operations of the prostate are per se controversial and are rejected by most researchers. Further, in this particular case the patients cannot be kept blind to their status - placebo or not placebo - because the effects of the treatment become obvious to them after 3 to 4 weeks. Therefore the design of a 3-months-placebo-controlled study is bound to fail,
• and (2) the results of this controversial study with a 3-months follow-up are in conflict with several observational studies with much longer follow-ups, up to four years.

Therefore this source should not be used. It is of little scientific value and it is misleading. --Saidmann (talk) 11:57, 16 April 2021 (UTC)

This source of evidence is not misleading since sham-controlled studies are necessary for drug approval and to inform patients and doctors what the true effect of the intervention is. Furthermore, I've mentioned on your talk page that this edit deleting this source is inappropriate and I reversed it while at the same time maintaining your source with the sentence on observational studies. There is no good reason to think that a Cochrane review is unreliable when you added another systematic review with severe conflicts of interests (which I have not deleted!). I would suggest keeping both sources and let the users define which one they should use. If necessary elaborate a little bit more on the findings of observational data, considering its limitations and not just saying it works, otherwise it violates neutrality and it seems that Wikipedia is promoting this treatment, which might be good for all I know, but we need to be neutral and present the facts Jvaf85 (talk) 16:52, 16 April 2021 (UTC)

This article is not about drugs. It is about an operation. Sham operations are common in preclinical animal studies, but not in human patients. In this particular case sham operations are considered by most researchers as unethical. Further, the study design could only lead to inconclusive results, because blinding of the subjects broke down after one third of the observation period.

You are mistaken to assume that your source is in conflict with only one other source. It is in conflict with many others.

On your user page you declared yourself "as contact editor of the Cochrane Urology Review Group". Well, this means you are in a conflict of interest here. Your are apparently trying to defend a low-quality paper that you were involved with as an editor. Therefore, I strongly suggest that you do not further participate in editing this WP-article here. --Saidmann (talk) 19:35, 16 April 2021 (UTC)

@Saidmann: The sham-controlled trial was approved by an institutional review board and it followed international ethical standards. Nevertheless, the review itself highlights that the certainty of the evidence is low (the review analysed only the blinded period). I'm worried that the observational data is misleading too. It's important to get a balanced view of the issue. I'm not for or against the procedure. Of course, as my profile states, this is part of the Cochrane-Wikipedia Project (as your profile states too, which I find unsettling in this debate), but I'm not the author nor the editor of that review. Besides the original edit was not done by me, but by a science student and this was reverted by you. I don't understand why we should "hide" this trial when its evidence the same as the observational studies. Perhaps more information can be added to the observational data to get a more balanced view, but I don't see the need for deleting the evidence from randomised controlled trials. Hopefully, we can settle this in peace and with science Jvaf85 (talk) 21:08, 16 April 2021 (UTC)

OK, if you were not involved in the publication of this source, we can perhaps reach a kind of agreement on its value.

• "We included a single, industry-sponsored RCT, with 197 randomised men, that compared convective radiofrequency water vapour thermal therapy to a sham procedure. [.....] We only found short-term data, measured up to three months." This means that all other studies - with long-term data up to 4 years - were treated as if they did not exist. Is this science?

• "The men were reported to have been blinded for three months." This is counterfactual. The literature is full of reports that the effects of the treatment are commonly noticed by the patients after 3-4 weeks. There was no status of blindness after these 3-4 weeks for most of the participants of the study. Is this science?

• The follow-up data after the 3 months - and up to 4 years - of this single study were published in several reports, but they were not used by the Cochrane paper, because they could not be compared to sham-treated patients. There were no sham treated patients after 3 months (as stated, but actually not after 3-4 weeks). How could one keep sham-treated patients blinded over a period of 4 years? Is this selective treatment of data science?

--Saidmann (talk) 16:08, 17 April 2021 (UTC)

@Saidmann: The trial has the limitations you mentioned: we fully agree. Furthermore, the Cochrane review is very critical of this trial (this is why Wikipedia formed the alliance with Cochrane because it is a good source of critically appraised science). But that does not mean that the evidence from randomised controlled trials should be ignored. Cochrane reviews usually restrict to RCTs because they are the best study design to determine the true effect of an intervention. If you look at the methods of the review they did intend to include evidence from comparative observational studies (cohort studies or case-control studies), but the evidence was limited. I fully support adding more information on the observational trials as you suggested, perhaps adding more detail as to what the subsequent studies added and their limitations (single-arm observational studies are prone to serious bias). See my current edit, perhaps we can reach a middle ground.Jvaf85 (talk) 18:21, 18 April 2021 (UTC)

Well, once the authors of the Cochrane review had seen that - in their view - they had almost nothing in their hands, they should have given up the project to write this review and done something else instead. By proceeding with this "hopeless" case they did a disservice to the Cochrane project. Anyhow, I followed your suggestion to include this paper - in a way that I hope is as neutral as possible. --Saidmann (talk) 14:43, 21 April 2021 (UTC)

@Saidmann: I really liked you new edits! I merged the data on observational studies because you mentioned "trials" (which could lead to confusion that they were RCTs). I don't think that adding the cite from the review from McVary (the lead author of the trial) is neutral.Jvaf85 (talk) 00:34, 25 April 2021 (UTC)

OK, I agree. Fine that things are done now. --Saidmann (talk) 11:43, 25 April 2021 (UTC)