Talk:De Simone Formulation
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[edit]Prior content in this draft duplicated one or more previously published sources. The material was copied from: https://cdn.shopify.com/s/files/1/0736/3645/files/ExeGi_Pharma_VSL_White_Paper_Design_FINAL_PAGES.pdf?2990 https://www.businesswire.com/news/home/20181126005445/en/Maryland-Federal-Jury-Unanimously-Finds-Probiotic-Sellers-Liable-for-False-Advertising-and-Awards-Product-Inventor-More-than-18-Million-in-Damages. Copied or closely paraphrased material has been rewritten or removed and must not be restored, unless it is duly released under a compatible license. (For more information, please see "using copyrighted works from others" if you are not the copyright holder of this material, or "donating copyrighted materials" if you are.)
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POV
[edit]This article seems to promote rather inform PROFESSOR De Simone, currently only clinical trials are running with more or less success. Hence, without proper use of reliable sources acc. to WP:MEDRS, this is subject to deletion. --Julius Senegal (talk) 18:36, 22 January 2023 (UTC)
- I am trying to evolve the page entry that I opened while in hospital after losing an organ and was at risk for losing more bowel. Your posts are strangely aggressive and you labeled this a promotion for the professor who invented it, which I find odd every time I see the flag. The page title is the therapy/treatment and I included him because I feel it is relevant to know if a medical doctor developed it. In the IBD space, patients will know that for surgery one pouch surgery option is called a Koch pouch after its doctor inventor. Another is the Parks' pouch after its inventor. Parks also has other surgical treatments named after him including "Parks' painless proctoplasty". Another example is the Hegar dilator which people who have had rectal surgery might be prescribed after surgery named after German doctor Hegar. In my opinion, this is no different. Further, I can't understand why you are so against this entry and come across as an assuming sniper rather than a collaborator who wants to evolve entries for info to help people.(Personal attack removed) WikiEd97531 (talk) 12:57, 9 February 2023 (UTC)
- Please stick to our rules, like WP:PROMO. If De Simone is relevant for this encyclopedia, then you are free to write an own article about him.
- Please take WP:MEDRS into account. What we need are reliable secondary sources.
- Please don't use sources which do not cover statements.
- If you continue with violating WP:PA, this will have consequences. --Julius Senegal (talk) 14:11, 9 February 2023 (UTC)
"high-potency probiotic"
[edit]What does that mean, really? Sounds like marketing speech. Gråbergs Gråa Sång (talk) 08:46, 30 May 2023 (UTC)
- It's not marketing speech. I had originally put this in the first draft I wrote to explain what it is classified as but it was removed by Julius: "The probiotic formulation is classed as a high potency probiotic medical food in the United States. It is intended for the dietary management of dysbiosis (microbiota imbalance) associated with irritable bowel syndrome (IBS), antibiotic-associated diarrhea, ulcerative colitis (UC), pouchitis, hepatic encephalopathy (HE), pregnancy, for babies born by Caesarean Section (C-section), and for babies that are bottle-fed." Then, I tried to explain by using the US FDA guidelines but Julius removed that to: "The probiotic formulation is classed as a probiotic medical food in the United States according to the Food and Drug Administration's Federal Food, Drug, and Cosmetic Act."
- With all that failing, I then found in a Forbes article, because you said to not use primary sources, that it is a 'high potency' probiotic.
- The importance of "medical food" grade or "high potency" is that it I'm trying to explain that it is not your typical store bought probiotic and people should NOT take it!
- If you look at other therapies used for the medical management of ulcerative colitis, for example, they all explain what the 'therapy' is classed as: infliximab classed as biologic:
- http://en.wiki.x.io/wiki/Infliximab
- Mesalazine is classed as 5-ASA: http://en.wiki.x.io/wiki/Mesalazine
- I only used the Forbes link because Julius took the other links out.
- If you look here at a recent guidelines on probiotics 'high potency' is relevant for people using things as a medical therapy (typically requires high potency and medical food status) vs the general public who typically SHOULD NOT use these higher dosage products. It is important - it isn't marketing, I am trying to explain what exactly this is and I'm only getting snipped with sarcastic comments that rip-down instead of work together and evolve into a helpful entry.
- International Scientific Association for Probiotics and Prebiotics (ISAPP)
- https://www.tandfonline.com/doi/full/10.1080/19490976.2023.2185034
- In fact there are a not of news articles about those guidelines when I Google just now including one that looks like it was co-authored by a medical team at Basal hospital and the inventor of the De Simone Formulation:
- Portugal to English: https://www.medscape.com/viewarticle/992453
- https://www.wholefoodsmagazine.com/articles/8758-isapp-defines-postbiotic-stratum-outlines-ingredient-benefits
- https://medicalxpress.com/news/2023-05-resource-gastroenterologists-probiotics-prebiotics-clinical.html
- and
- https://medicalxpress.com/news/2023-05-disrupted-gut-microbiome-involved-depression.html
- I almost bought the other probiotic for disease management when I was in intestinal failure, as I already explained which is why I opened this page. Too many people confused. Snarky comments that don't add value aren't helping. I had found online that there is a big class action lawsuit in the USA because of the mismarketing of the probiotics. I am not involved, thankfully, I figured out the change and didn't buy it but other people say they were harmed in some way. They couldn't find the info. They didn't understand.
- https://www.classaction.org/news/class-action-accuses-pharma-companies-of-secretly-reformulating-vsl3-probiotics-product#:~:text=According%20to%20the%20lawsuit%2C%20De,and%20thereby%20increase%20profit%20margins.
- Now, without the time wasting snipping and sarcastic comments that are unprofessional, what exact sort of source do you need to clarify what level of probiotic product this is?
- I would like to revert to the original language that it is classed as a medical food by the US FDA. What exactly do you need to see in writing? I'm asking for help, not a public mobbing. WikiEd97531 (talk) 20:39, 31 May 2023 (UTC)
Also, can this [1] be considered the official website of the whatever? Gråbergs Gråa Sång (talk) 08:47, 30 May 2023 (UTC)
Reverting POV
[edit]- As Gråbergs mentioned, "high-potency" needs a solid reference, Forbes does not meet WP:MEDRS.
- over 70 trials - not sourced, in-vitro and preclinical trials don't count, sheer numbers don't say anything about efficacy.
- Cochrane "also issued a revision to its guidelines" - blatant lie. Instead we read: The effects of antibiotics, probiotics and other interventions for treating and preventing pouchitis are uncertain. Well designed, adequately powered studies are needed to determine the optimal therapy for the treatment and prevention of pouchitis. This is the polite way to state that there is nothing about DSF. The other review only states: Studies investigating combinations of probiotic species incorporated within the probiotic De Simone Formulation have demonstrated a partial reduction of colitis in animal models. Good for the animals. Nothing about humans (hello "over 70 trials")
- "See also": Just listing several topics "just because" is no valid reason. First please demonstrate that you work acc. to our guidelines and not promoting things. --Julius Senegal (talk) 18:13, 30 May 2023 (UTC)
- As previously requested, please mind your language. Gratuitously aggressive language helps nobody. I would appreciate some professionalism here. It is not a lie! I found that via the U.S. Crohns and Colitis Foundation's website on the page where they help people request insurance coverage. A prior version from a few years ago that I used said that the Cochrane guidelines were revised etc. It was their language. Call the Foundation yourself!
- https://www.crohnscolitisfoundation.org/science-and-professionals/program-materials/appeal-letters
- Googling around I find several guideline and article corrections including those mentioned plus others like Germany's Springer publisher here for the European Journal of Nutrition: https://link.springer.com/content/pdf/10.1007/s00394-021-02592-2.pdf
- The Lancet also updated guidelines to state the formulation change in Strain-specific and outcome-specific efficacy of probiotics for the treatment of irritable bowel syndrome: A systematic review and meta-analysis:
- https://www.thelancet.com/journals/eclinm/article/PIIS2589-5370(21)00434-X/fulltext
- I can keep listing - how many sources do you want??
- As for 'high potency' I already replied above. I have tried to explain it three ways, all of which you delete instead of helping me, in a productive, non-aggressive way, to explain the probiotic formulation as it is!
- And for the last time, stop calling this a promotion. Go back and read when I opened the page while I was in hospital. I clearly wrote that I was a newbie to Wikipedia and asked for help for what sources can be used. I was writing using what I could find online and adjusted as needed. please stick to WP:PA. I am simply trying to put info online that people with health conditions look for. If the info was easy to find, people wouldn't buy and use things they should NOT be using and end up in class action lawsuits!
- Now, suggest useful wording and sources if you have a problem in future otherwise this appears as just a game to you as I have said over and over I am new and trying and I do this while in hospital (frustrated because I had bad care and things were way worse than they ever needed to be...) after that last thing I need (and others) is to buy the wrong therapies. Which is another reason why I believe it is important to understand just what exactly this probiotic is - as the probiotics safety guidelines state is critically important! WikiEd97531 (talk) 20:54, 31 May 2023 (UTC)
- And actually, I would like to ask people on Wikipedia with actual probiotics expertise, as I don't believe Julius has this, to help explain things with the references. Perhaps this ends the game of 'hit me with an insult, delete' then I try again by adjusting to the comments only to 'hit me with another insult - delete' - and it just seems to keep repeating a nasty cycle. I don't have the time or health for games. I am trying to help create a helpful entry. I don't feel like I'm getting any actual HELP from certain Wikipedia people. WikiEd97531 (talk) 21:31, 31 May 2023 (UTC)
- It is not my problem if you feel offended by facts. Please stick to our rules here I have pointed out many times.
- So you are admitting that your first sources (Cochrane reviews) didn't cover what you have claimed. Thank you. Btw, there no thing such a "Cochrane guidelines", there is Cochrane meta reviews.
- The Crohn's & Colitis Foundation is a volunteer-driven NGO, not a medical society, and on your link DSF isn't mentioned. The NGO also doesn't state anything about the efficacy.
- The Lancet paper is not a paper from The Lancet, it is from EClinicalMedicine. Regardless, this review does stress several limitations (patient numbers, heterogeneity). In Figure 3 we can only see borderline advantages, also for the 8 strain formulation. Fig 2 is even "worse". In any case where is the new "guideline" you are talking about? Do you even know what a guideline is?
- As for 'high potency' - where is now the source?
- Instead I read insults against me, so are you running out of arguments? I have deleted those insults as they don't contribute anything useful to this discussion. --Julius Senegal (talk) 17:43, 2 June 2023 (UTC)
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