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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So according to environmentalists it would seem that coastal erosion didn’t exist until atmospheric CO2 reached a certain level. That would have come as a surprise to the former inhabitants of Dunwich (now somewhere off the Suffolk coast).
A little further north the BBC used Happisburgh as an example of sea level rise a few monthes ago .Again very soft cliffs and the odd storm take large chunks out of East Anglia every winter.Been going on for centuries .No link to CO2 ever ..More BBC bollocks !!
Those submerged Welsh counties in Cardigan Bay…
They do not teach basic arithmetic in politics, journalism and sociology courses just as the amount of economics on a PPE is small and only Keynsian.
Ah. I had wondered how all those PPE MPs could come out with such rubbish. I know economics has been called the dismal science, but that’s ridiculous.
Isn’t the other key missing piece “Which coastal castles are affected”. I don’t know all the castles in the UK but are any actually by the side of the sea ie within 1 metre of current sea level- if anyone knows….
Caernarfon
https://cadw.gov.wales/visit/places-to-visit/caernarfon-castle
I have paddled past Caernarfon Castle in a sea kayak, splendid site but it appeared quite safe and sound and under no great threat from the sea.
Hundreds of years old too. Like those irrigation channels to make gardens in the desert. Better uses of money than inevitably futile attempts to engineer a more profitable climate (which in reality are attempts to produce a greater role for the United Nations).
I have read David Craig’s book and highly recommend it. From my own observations (and I am sure many others make similar observations) the amount of sea rise level where I live is negligible. For 30 years I have been watching the tides in the Severn Estuary, and there has been no change in the height of the highest tides, which one would expect if alarmist predictions were correct. As is usual, some years the tides are good (exciting and high) some years indifferent – important if you are one of these hardy souls who likes surfing the Severn Bore!
Exactly.
Currently in Campania, Italy, specifically the towns of Amalfi, Atrani, Praiano, Positano. Sea levels are obviously quite unchanged for at least hundreds of years.
I seem to remember a report about subduction in (I think) Tuvalu leading to a perception of sea level rise. Anyhow, I have long felt that putting money into flood defences, irrigation and reversing desertification would be a better use of resources than any net zero carbon nonsense and related rubbish such as importing American wood to Drax instead of using locally available coal.
The BBC is a left-wing political campaign organisation pretending to be a broadcaster.
Always have been apparently. I know they were taking a partisan view on issues back in the 1960s.
Which is exactly why they shouldn’t be funded by a tax on TV users.
Not sure it’s even so much the left they pander to any more. They’re as much stooges for the establishment as they’ve always been, which is neither right nor left but entirely self-serving.
In this respect, nothing much has changed bar the fact this establishment enjoy total control of and protection from the media, who also act in feedback to enhance the reality distortion field in which they exist. Free of scrutiny, it is entirely lacking in honesty or integrity.
Towards the end of the UK’s summer of 1976, BBC2’s Horizon – a reasonably serious science-based series – caved in to the lunatic doom-monger fringe and broadcast a silly episode warning us of an imminent threat of the UK turning to desert. I sensed then that a milestone had been reached and soon lost interest in watching what had turned into a junk entertainment programme. Even the recent summer, 46 years later, was a mere shadow of the 100 day Mediterranean one of 76.
I remember the late, great Christopher Booker reporting on how Owen Paterson MP endeavoured to find the real causes of the flooding on the Somerset levels some years back and took effective action to do something about it. It seems they came for him alright. I rather suspect that the BBC (who have decided that it’s alright for them to be biased on the climate scare) told a different story to Mr. Booker.
Can we stop confusing coastal erosion with inundation.
Gravity sort of ensures that a dense liquid like water maintains the same relative level around the planet (or across the flatness if you are a Green). Unless the same relative rise is noted around the world, local variations are obviously due to the land moving, not the water.
President Obama on crisis of rising sea levels. 2013
https://twitter.com/barackobama/status/362595604385370113?lang=en
President Obama purchases multi million dollar Martha’s Vinyard island home 2021
https://www.townandcountrymag.com/leisure/real-estate/a30169311/barack-michelle-obama-buy-marthas-vineyard-house/