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"There is very little evidence to support claims that probiotic dietary supplements have any health benefits."[edit]

The article this sentence cites cites a 1999 source for the "very little evidence" claim - I could find ten times as many claims of proven effectiveness from more recent studies. Must this statement stay if the original source is 15 years old (WP:MEDDATE)? Most of the subsections below this statement seem to contradict it.

Also: " Through 2012, however, in all cases proposed as health claims to the European Food Safety Authority, the scientific evidence remains insufficient to prove a cause and effect relationship between consumption of probiotic products and any health benefit." The article cited reads like a blog, and the author doesn't cite a single source - it's a rant of his "ideas" regarding probiotics and why every decent-sounding study is apparently wrong. Like above, there's a citation, but it's not a good one (WP:MEDRS). Pcwendland (talk) 16:13, 1 August 2014 (UTC)

You need to be much more specific, @Pcwendland:, in order for anyone editing here to make a change. What good secondary scientific/medical sources are you offering that would allow for a change in the thrust of this conclusion? Le Prof (talk) 13:21, 11 June 2015 (UTC)

How is this for evidence? Willski — Preceding unsigned comment added by (talk) 13:32, 8 November 2015 (UTC) In fact there are dozens of papers including a number of RCTs that show efficacy for specific GI indications, chiefly IBS and the like. This wikipedia article is out-of-touch with current research and is actually quite misleading.

I would like to second the proposed removal of this statement. To echo what has been stated, the footnotes in these sources in some instances are a decade old. The implication that pro-biotics provide little to no health benefits is not in line with current research. Thus, I as well propose its removal. Also, it appears certain sources on this page should be defined as unreliable sources, as per verbiage, is indicative of conspiracy-like bias, ie; dubbing pro-biotics "quackery" in its relation to disease and health.

Attention can be turned to only three of what could be amplified to hundreds of articles discussing health benefits. [1][2][3] Siqa (talk) 19:40, 28 March 2016 (UTC)

The source is from 2012 and is WP:MEDRS. Is there a better source? Alexbrn (talk) 19:50, 28 March 2016 (UTC)

Alexbrn, this is not a matter of which source is 'better' than another. As can be prostrated with current scientific findings, the claim "There is very little evidence to support claims that probiotic dietary supplements have any health benefits," no longer holds true. Your, as well as others, quickness to defend such a claim would lead one to believe that what has been demanded is an uneven burden of proof on behalf of those in favor of its removal.

To defend such pieces of literature that utilize papers from 1992 (World Health Organization (1992) Basic Documents, 39th ed. Geneva: WHO.) and on only begs the question, how does one then come to the conclusion that such literature is deemed a "reliable" source? From a neutral standpoint, this should be labeled an argument by selective observation and incomplete evidence (cherry picking). Thus, consensus should favor the current scientific literature, a few examples amongst a mountain that are far more recent and in line with what is being published virtually daily. You would be hard-pressed to find current literature with references to sources as current as those I myself can provide.

However, before I begin editing and removing such claims, I will gladly await and invite the commentary of others on the replacement of this claim. Siqa (talk) 02:54, 29 March 2016 (UTC)

So what you're saying is that you know better than a high-quality secondary WP:MEDRS source. Well, get your review published in a good journal and then come back. Wikipedia reflects currently accepted published knowledge on this topic, as it should. Alexbrn (talk) 07:11, 29 March 2016 (UTC)
So, let me see if this helps. First, I agree that much of the scientific literature on probiotics is suspect. There IS such a thing as "better" and "worse" sources. When we are talking about biomedical interventions, the standard for evidence is a placebo-controlled, randomized, double-blinded, clinical trial. In writing this or any article, we should be emphasizing studies that meet those requirements, and supplementing with lesser-quality articles only where there are gaps.
Secondly, however, I believe that in the case of probiotics, I believe that we are beyond the stage of "very little evidence to support." Hence, I would favor REMOVING that statement. There HAVE been some well-done RCTs in the world of probiotics. The microbiome, and our medical attempts to modulate it, is within mainstream science, and I think the article should reflect that. The bacterium Lactobacillus reuteri, the one with which I have the most personal experience, does have several double-blinded trials in its support. I'm sure there are at least a few others that do, as well.
This is clearly a far more complicated medical question than a lot of other medicines, treatments, etc. This is inherent in the facts that 1) there are thousands of different probiotics (not just one), some of which ARE probably useless, and all of which are going to have very different effects from each other, and 2) many probiotic species and mixtures are proprietary, and whenever commercial interests become part of the picture people start playing fast and loose with the facts to some extent. It's certainly a messy picture, but that's our job as Wikipedians: to sort out the good evidence from the bad evidence and false claims.
We should neither take the more outlandish claims about some probiotics as fact, nor further the notion that they are useless snake oil. AaronM (talk) 12:17, 30 March 2016 (UTC)
So what you are proposing is to replace a reliably-sourced statement of the current state of knowledge because of your own personal assessment of the primary literature. I'm sorry, but Wikipedia just does not work like that: it is absolutely not our job "to sort out the good evidence from the bad evidence", that is the definition of WP:OR which is prohibited by core policy. Instead we reflect what high quality (in this case WP:MEDRS) sources say about the evidence base. Alexbrn (talk) 13:21, 30 March 2016 (UTC)
I did not mean that to sound like it was my personal assessment that probiotics are very efficacious, and hence the article should be rewritten in that direction. I was trying to emphasize that this is a broad topic with a very complex and confusing primary literature, and that the article should acknowledge that. ANY article about a complex subject has to acknowledge that complexity. And absolutely, the primary sources (and the conclusions THEY reach, not whatever else anyone might want them to reach) should be the sole drivers of that discussion.
To depart from general philosophies of unbiased evidence presentation and give my own opinion, I think most of the claims that people seem to attribute to probiotics (the nebulous "boosted immune system," cure for cancer, weight loss, help your chi flow, whatever) are probably entirely unfounded. And if not, then the article should make it clear which claims are NOT supported by evidence. At the same time, if there are limited areas where probiotics HAVE been tested and shown evidence of efficacy, that should be acknowledged too. To my memory, preventing antibiotic-associated diarrhea might be one such area (which is of course not a reason that many people buy and take probiotics). AaronM (talk) 03:08, 31 March 2016 (UTC)
So long as we use WP:MEDRS, fine. But the primary literature is unreliable and we don't touch it. Alexbrn (talk) 05:56, 31 March 2016 (UTC)

Hello again, to further this discussion i've reached out to the CBER for comment. However, I did stumble upon this [4]. I believe it only to be fair that certain statements such as this, "An example of an LBP, for the purposes of this document, would be one or more strains of lactobacilli administered orally to treat patients with ulcerative colitis, or administered vaginally to prevent bacterial vaginosis." The key-words to be pointed out are "an example," as just one or two out of what can be multiplied into many. As has been repeated, should such the unfounded claim remain, it should reflect the current clinical data being published nigh daily, not the opinions of referenced material nearly a decade old. Siqa (talk) 19:15, 9 April 2016 (UTC)


So long as there are no implications of effectiveness made here on the basis of that guidance document, it would seem a reasonable source. It in no way undermines the statement that there is very little evidence of probiotic supplements being of benefit. Alexbrn (talk) 19:25, 9 April 2016 (UTC)

Based on this discussion I have added some dates into all the "as of right now" claims, to alert the reader to the fact that the well sourced information may be out of date. All the dates have been aligned to the cite date of the sources relating to that section. I've found an "as of 2016", which is unsupported by sources and I've thus removed. Added an out of date banner to "EFSA and FDA scientific reviews", the contens of which, especially in regard to the european institution may be entirely incorrect due to out of date information.

This should be good until someone comes along with any WP:MEDRS sources which give us some more up-to-date information. --DustWolf (talk) 11:43, 9 July 2016 (UTC)

There's no reason to suppose these views have changed with time - the tag isn't needed. Alexbrn (talk) 14:53, 9 July 2016 (UTC)
I have a box of medicine in front of me that has a government-approved certificate that states the opposite, therefore, there is a reason. I am working on researching the issue to provide usable sources, but in the time being I think it would be reasonable if we did edits cooperatively trying to improve the content, rather than making a typical wikipedia edit war where you undo anything anyone who disagrees with your personal perspectives contributes. I have no relationship with the people who provided the previous contributions and you have no reason to angrily undo all my contributions. --DustWolf (talk) 11:21, 10 July 2016 (UTC)
There, added.--DustWolf (talk) 12:11, 10 July 2016 (UTC)
Adding a seven-year-old "Point of View" piece to our article seems a bad idea, particularly when we have two newer, much stronger WP:MEDRS on the topic of IBS and probiotics already here. Such additions tend to betray where the "personal perspectives" are in play. Alexbrn (talk) 15:37, 10 July 2016 (UTC)
Regardless, the contribution is properly sourced and deserves to be here just as much as the existing content, despite the point that it does not align with your personal views of the subject.--DustWolf (talk) 16:11, 10 July 2016 (UTC)
You'd better WP:FOC. The source is weak and fails WP:MEDRS. In particular, it is not acceptable have strong sources undercut with weak ones. Alexbrn (talk) 16:21, 10 July 2016 (UTC)
You know what? Keep your biased article. When you feel your ego is satiated, you can add my contributions back, they'll be waiting right there in the history. I'm done wasting my time here.--DustWolf (talk) 19:40, 10 July 2016 (UTC)

"Strains" heading[edit]

I understand you have some kind of troll war going on here over the content of this article, but the heading "Strains" is in no way "more accurate title, and neutral", as the section has nothing to do with bacterial strains at all, it does not mention a single species. It seems clear that the data on the strains has been moved into a different section. I am therefore undoing this edit. If you wish to have a different kind of heading here be my guest, but "Strains" makes no sense. --DustWolf (talk) 11:12, 10 July 2016 (UTC)

Marginal source; strong claim[edit]

The following ref:

is from a journal published by MDPI, and if you read our article about this publisher you will learn that they are right on the edge of predator and all the bad practices that come with that. And this paper is such a mess. Look at the five papers they included. Look at their conclusions. And yeah, look at the publisher and throw this out the window. Oy. Jytdog (talk) 14:17, 16 September 2016 (UTC)

Wrongness of referencing FDA Warning Letter as lack of evidence[edit]

Text supported by Ref #7 -to an FDA Warning Letter, which by the way, the link no longer functions - misrepresents the nature of such Warning Letters. With rare exceptions, the U.S. FDA does not allow disease prevention or treatment claims on product labels or website content EVEN IF TRUE. The exception is if a dossier is submitted to the FDA, in which case an acceptance of the evidence in the dossier will result in FDA approval of a health claim or qualified health claim (QHC). The latter term does not mean that the claim qualified. Instead, it means that the evidence was not strong, and claims on the label have to use the exact FDA wording based on the quality of the evidence.

Example of a QHC "One small study suggests that chromium picolinate may reduce the risk of insulin resistance, and therefore possibly may reduce the risk of type 2 diabetes. FDA concludes, however, that the existence of such a relationship between chromium picolinate and either insulin resistance or type 2 diabetes is highly uncertain." Companies selling chromium picolinate may chose to make no label claim, use only Structure:Function vocabulary (Chromium picolinate may help maintain healthy blood sugar levels), or use the exact FDA QHC wording. If new stronger evidence is published, the FDA can be petitioned to reconsider, but until it does, only the approved QHC applies.

For this reason I have removed the FDA Warning Letter as a reference in support of probiotics not having government approval, and also the text in two locations depending only on this reference. Please discuss here before deciding to revert my changes. I added text in Labeling to explain how a company can sell a probiotic product in the U.S. even if science evidence is not at consensus. This probably needs a citation to the FDA position on Structure:Function claims. David notMD (talk) 12:25, 9 May 2017 (UTC)

am reviewing what you deleted. Please do not add unsourced content to Wikipedia - there is no "probably" about that. Jytdog (talk) 13:34, 9 May 2017 (UTC)
J - Busy now (day job) but can provide links to FDA descriptions of Structure:Function claim wording. In my opinion, not falsely presenting a FDA Warning Letter as indication of lack of science is a higher priority than my explanation of how 'probiotic' products can be sold in the U.S. if the evidence of efficacy is contested. David notMD (talk) 13:40, 9 May 2017 (UTC)
reverted, fixed ref, tweaked last paragraph slightly. sure we can discuss later. :) Jytdog (talk) 13:47, 9 May 2017 (UTC)
Thanks for rescuing the dead link to the FDA Warning Letter. The use of this ref in the Labeling section is now closer to the reason the FDA issues Warning Letters. However, the text in EFSA and FDA science reviews still misrepresents the intent of Warning Letters. In general, the FDA goes after disease treatment/prevention claims regardless of quality of science; it is the Federal Trade Commission that pursues claims that are false or misleading. Note that the FDA Letter to CocoKefir warns the company of possible FTC action. FTC prevailed in a probiotic action against Nestle in 2010 but lost in court in 2015 in an action against Bayer. David notMD (talk) 14:05, 9 May 2017 (UTC)
Added the FTC-Dannon source as an example of enforcement into the lede and regulatory and labeling sections. I have to disagree with David notMD about the underlying background for an FDA warning letter. The FDA comes to that conclusion because the manufacturer has no or weak scientific evidence for making a claim of health benefit. To me, it is a decisive statement about the historical timeline of science on a potential benefit and the use (or ignorance) of that science for advertising. Interesting from this 2014 warning letter that the current commercial website of a major 'weight loss' retailer still makes exaggerated, scientifically baseless claims, here. --Zefr (talk) 15:24, 9 May 2017 (UTC)
Z - Adding FTC's Dannon example to the article is a good idea, as FTC has been the major constraint on unsupported probiotic health claims. I still disagree with the conclusion that an FDA Warning Letter is citable as evidence for lack of efficacy. A close read of FDA Warning Letters starts with statement that a product claims to prevent or treat a disease. As only drugs can claim to prevent/treat disease, the FDA is treating your product as a (new) drug. "New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA... The FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective." A typical response to a Warning Letter is to remove the disease claims and continue to sell the product with S:F claims, which can be made with much weaker science. The example you linked, Plexus Worldwide, discontinued Fast Relief and revised the claims for ProBio5 and BioCleanse to S:F wording. The FDA and FTC could return to do a number on the weight loss claims made for the other products, as this is the government's favorite topic. David notMD (talk) 17:25, 9 May 2017 (UTC)
This discussion is a waste of time. Your edit was an overreach and was reverted. if you want to start a new discussion about some specific aspect of it, that's fine. I get it that you were probably trying to bang something out before the workday started. nbd Jytdog (talk) 17:33, 9 May 2017 (UTC)

Z - Yes, the Dannon settlement you added was the beginning of realization that class action lawsuits could be profitably brought against dietary supplement companies. Dannon lost not because there was no health benefit, but because the advertisements did not clearly state that the claimed benefits were from a trial in which women consumed two servings a day every day. David notMD (talk) 20:41, 9 May 2017 (UTC)

misleading lead sentence, and common errors in alt med reasoning occur in this article and discussion page[edit]

  • Editors make a leap from a study showing a positive effect of a single specific probiotic, to general statements of efficacy for general probiotics. This is similar to reasoning from the (dubious) finding about a single acupuncture point, to statements that there are studies showing acupuncture (in general) is effective.
  • Starting a medical article with a statement about beliefs, rather than a statement of fact, is misleading in the same way that is similar to the misleading marketing strategies of alt med promoters. — Preceding unsigned comment added by (talk) 15:13, 19 March 2018 (UTC)