This week, the media reported that “obese NHS patients are being given a gastric weight loss balloon”.
The balloon is placed inside a capsule and swallowed, then filled with water through a thin tube during a 15-minute consultation. An X-ray is conducted to confirm that it is in the correct position in the stomach and filled with water. After four months, a time-activated release valve opens, which allows the water-filled balloon to empty and pass through the gastrointestinal tract.
Two NHS patients have received this treatment at Musgrove Park Hospital. All the hype suggests it’s risk-free and a simple procedure, but can anything go wrong?
NICE says that the “evidence on the safety of the swallowable gastric balloon capsule for weight loss shows infrequent but potentially serious adverse events”. Yet the Guardian and the BBC made no mention of the problems
NICE reports: “The evidence of efficacy is adequate to support the use of this procedure provided that special arrangements are in place for clinical governance, consent and audit.”
Special arrangements mean “there are uncertainties about whether a procedure is safe or effective. NICE also recommend special arrangements if risks of serious harm are known”. Hmm, we didn’t see that either in the news.
The BBC trots out a consultant who says the pill offers “meaningful weight loss”. But no mention of the possible harms.
NICE evidence was updated in April 2020, including a meta-analysis, eight case series, and one case report.
The review included six studies, which were all prospective cohort studies – none were randomised. The meta-analysis reports total body weight loss after treatment (four to six months) of 12.8% (95% CI 11.6 to 13.9). Only two studies of 191 patients reported 12 months of weight loss of 10.9% (95% CI 5.0 to 16.9). Both these effects showed high study heterogeneity and should not have been pooled methodologically.
Serious complications occurred in about one in 200 patients and included gastric perforation and small bowel obstructions. Symptoms such as abdominal pain and nausea or vomiting were frequently reported and required management with medication.
The Daily Mail did make its readers aware of some of the problems:
Some had side-effects – 2.9% couldn’t tolerate it and needed it removed with an endoscope, but the authors said “serious adverse events were very rare”: these included three cases of small bowel obstruction, and one patient had a perforated stomach, all requiring surgery.
Readers of Trust the Evidence will be aware of our Deadly Device series on breast implants, the Essure Implant and transvaginal mesh, amongst others.
As it turns out, gastric balloon insertion has been around for some time as a strategy for managing weight loss. In June 2018, the FDA alerted healthcare providers about five more deaths associated with the use of liquid-filled intragastric balloon devices for obesity. The FDA said it was “carefully tracking adverse events, including a total of 12 deaths over the past two years, that have been reported in patients with two balloon devices used to treat obesity”.
These new capsule balloons avoid the surgery associated with previous devices, and no deaths have been reported.
We have previously written about ‘The Inevitable Harms of Weight Loss Drugs‘, whose history tells us it’s all too predictable. In the absence of randomised trials, a lack of long-term safety data beyond 12 months and serious adverse events in the observational data, we again think it may be all too predictable. However, without journalism criticising the evidence, the public might think balloons are the latest risk-free answer to their dietary woes.
Prof. Carl Heneghan is the Oxford Professor of Evidence Based Medicine and Dr. Tom Jefferson is an epidemiologist based in Rome who works with Professor Heneghan on the Cochrane Collaboration. This article was first published on their Substack, Trust The Evidence, which you can subscribe to here.
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“Give me a child until he is seven and I will show you the man.”
Modern education is all about indoctrination and effectively embedding the future dystopia.
This won’t end well.
Indeed. That is one thing that St. Ignatius of Loyola and Vladimir Lenin both could agree upon. The hand that rocks the cradle rules the world.
It is happening all over the western world, but most certainly in Scotland. Teaching children “what to think” rather “how to think” is part of the “indoctrination” that you speak of.—– Imagine if a 13 year old were to ask a question in school like “How much CO2 is in the atmosphere, and how much of it comes from human activity and what evidence is there that it is causing or will cause dangerous changes to the climate”?———————- First of all the teacher would be totally aghast, and then almost certainly not be able to properly answer that question. The teacher would resort to the Argument from Authority, and likely claim that “All scientists say it is true and therefore who are we to disagree”? ——-So, kids are to be instructed in “Official Science” rather than “Science”.——- And ofcourse no 13-year-old would have the wherewithal to challenge that teacher with “Please Miss, but science is not decided by a show of hands from government funded data adjusters” or all hell would break loose. The fact that Liberal progressives attempt to indoctrinate does not surprise me, but what does surprise me is that parents do not kick up a stink on all manner of woke issues being passed off as education and ultimate truth.
Well I’m sure they’ll be embracing the nonsensical censorship of kids’ favourite books in Scottish schools, as per the Roald Dahl travesty. I hadn’t given much thought to whether the books will continue to be translated into foreign languages using the new woketard version or if countries outside of the UK will be up in arms about all of these changes. This Dutch publisher is none too happy and even Salman Rushdie has complained;
”British publisher Puffin has made the changes so that “everyone can enjoy Dahl’s books.” For example, the character Augustus Gloop in Charlie and the Chocolate Factory is no longer called “fat” but “huge,” the Oompa Loompas in the same book are not “little men” but “little people,” and in the book The Creeps, the main female character is no longer describes as “ugly.”
The director of De Fontein admits in Trouw that there are clichés and exaggerations in Dahl’s books. “But that’s where his humor lies. Children recognize them, and they make children think about right and wrong. That also makes them timeless. If you take all that away, it loses its power.”
https://nltimes.nl/2023/02/19/dutch-publisher-critical-altered-passages-roald-dahl-books-said-offensive
the character Augustus Gloop in Charlie and the Chocolate Factory is no longer called “fat” but “huge
Erasure of small fat people! Somebody sue them!
I wonder when Little Red Riding Hood will be re-written …. with the Big Bad Wolf re-written to become the Large, Misunderstood, Victim of Discrimination?
We have ‘anti racism’ training tomorrow at work so I guess I will find out if it’s the same in England.
You are guilty!
Send ’em down!
Oh dear. Looks like South Park might be next to get the Harry and Meghan Treatment;
”Royal commentator Neil Sean has stated the couple’s legal team is now watching the series closely for any more attacks.
Sean said: “According to sources close to the ex-royals, it appears that, like so many things with Meghan and Harry, this may have legal ramifications attached.
“Their legal team are casting an eye over the episode to see what is wrong, and what could be turned into something more sinister.”
However, Fox News have stated it has not yet been confirmed whether legal action will be taken or not.”
https://www.gbnews.uk/royal/meghan-markle-and-prince-harrys-lawyers-are-looking-into-south-park-after-sussexes-ruthlessly-attacked-in-new-series/444846
Harry and Meghan really have some paper-thin skins, it seems! They can’t seem to take even a tiny fraction of what they dish out.
Everyone is equal, but some are more equal than others.
Well done SNP. You have successfully trashed what was the best educational system in the UK and you don’t even recognise the damage done in your name.
God help us.
I doubt if State “Education” in England is much better.
Go private if you can afford it, or Home School, or emigrate …… if you don’t want your children turned into brain-dead, indoctrinated drones.