Most statin problems caused by mysterious 'nocebo effect', study suggests

Andy

Andy

Senior Member (Voting rights)
Most of the debilitating effects of statins are not caused by the drug, but by people believing it will make them sick, a UK study suggests.

The phenomenon is known as the "nocebo effect" and may account for 90% of the ill health associated with the cholesterol-lowering drugs.

The British Heart Foundation said the results were undeniable.

The Imperial College London researchers hope the findings will help more people stay on statins.

The drugs are one of the most prescribed in the UK. Nearly eight million people taken them to lower their cholesterol and in turn reduce the risk of heart attacks and stroke.

However, up to a fifth of people stop taking them due to side-effects such as muscle aches, fatigue, feeling sick and joint pain.
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https://www.bbc.co.uk/news/health-54951648

More evidence of how unreliable self-reports can be?
 
considering the majority of patients given statin have other health problems you could only ever gather confounding evidence so many heath conditions naturally fluctuate how the hell is anyone supposed to know whether recent increases in pain discomfort are down to a particular drug . also the under standing of cholesterol and its function is not fully understood just because we can alter certain parts of body chemistry does not mean we should . their was a japanese study on healthy people over retirement age that showed many had higher levels of cholesterol than sick people the same age . there really needs to be honest research into the pros and cons of taking statins for each patient .
 
"Each patient" as you say alktipping. Doesn't that go agains't modern population-based evidence based medicine with the RCT as the gold standard for best evidence? I mean "each patient" implies that "each patient" is important onto themselves and has individual unique characteristics and circumstances, the academics where I live in Hamilton, Ontario Canada where EBM was perhaps born with Dr. David Sackett as founder (RIP Dr Sackett) at McMaster University would surely regard any reference to "each patient" as a bit too touchy feely perhaps. ;)
 
Statins do have some rare but known side effects, like onset of type-2 diabetes and rhabdomyolysis.

I started taking a statin last year and my doctor had me get a couple of blood tests early on to make sure that this kind of thing wasn't happening.
 
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Nothing would ever persuade me to take a statin. Just one of many issues I have with them is ...

If statins reduce heart disease and thus reduce death rates from those heart conditions, then what do people die of instead? If the alternatives to dying of heart disease are to die of cancer or dementia, then I wouldn't be interested. I suspect having a heart attack would be, for many people, a quicker and less distressing death than dying of cancer or dementia.
 
Just to highlight that the link discusses a trial and its results:
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They were given 12 bottles - four contained a month's worth of statins, four a month's worth of dummy pills and four were empty.

Every day for a year they would score, from zero to 100, how bad their symptoms were.

The study showed an average score of:

  • 8 in those taking no tablets
  • 15.4 while taking dummy pills
  • 16.3 while taking statins
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From June 2016 through March 2019, a total of 60 patients underwent randomization. The screening data, the baseline characteristics of the patients, and a diagram showing screening, ran-domization, intervention, and follow-up are pro-vided in Sections S1 through S3 in the Supplemen-tary Appendix. A total of 49 patients completed all 12 months of the trial.
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This appendix is not included in the sci-hub entry unfortunately. It would be important to know where those 60 patients came from.

The 0-100 pain scale seems tricky to interpret and potentially very noisy once you get away from 0 since each person's 'imagination' reference is different and possibly not very consistent. However to me the blinding takes care of a lot of the doubts. I also think testing each individual in three cycles is a convincing methodology.

In patients who had discontinued statin thera-py because of side effects, 90% of the symptom burden elicited by a statin challenge was also elicited by placebo. Half the trial patients were able to successfully restart statins.
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This would be a good result and I would strongly disagree should be written off as BPS garble. As another example we know that, thanks to unfortunate memes, people have very strong beliefs about vaccines which clearly cause them to make quite erroneous interpretations. So I don't see why this would be an unreasonable finding.

It would be helpful to see the full analysis, of course.
 
I know almost nothing about the 'statin wars', but just for this result, I wonder if the reporting of side-effects with placebo would be more common after people have already reported side-effects from the pill?

eg if I've eaten food I really like around the time of having a stomach bug then the thought of having that food again can be pretty unappealing (at least for a while).

To interpret this study as showing that 90% of the side-effects initially reported from statins would also have occurred with placebo seems too strong to me.

It seems like within 'placebo/nocebo' there can be lots of different effects being lumped together.
 
Esther12 said:
I know almost nothing about the 'statin wars', but just for this result, I wonder if the reporting of side-effects with placebo would be more common after people have already reported side-effects from the pill?

eg if I've eaten food I really like around the time of having a stomach bug then the thought of having that food again can be pretty unappealing (at least for a while).

To interpret this study as showing that 90% of the side-effects initially reported from statins would also have occurred with placebo seems too strong to me.

It seems like within 'placebo/nocebo' there can be lots of different effects being lumped together.
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Swallowing a pill isn't exactly the same as chewing food, which has a taste and is much more noticeable in your mouth.

Also I would say that association would be strongest with nausea, vomiting and similar GI effects.

But theoretically you could have a point, but then it would extend not just to this drug, but the after effects of tablets in general, which would be interesting though I suspect if it was as large as the effect seen in this trial, it would be talked about more.

A review of the data could check whether there were order effects like you suggest.
 
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If the different pills were taken at different times could the weather have had an effect? My muscles get very sore when it gets colder. That sort of effect is one of the reasons for having controls rather than self controls.

I remember a letter in the New Scientist years ago by a man complaining that his doctor wanted him to start a trial of vitamin D supplements. He discovered they had been referring patients for some time but it was now Summer when people were getting a high dose of the vitamin from sunshine. He was very scathing about medical trial standards and the lack of imagination in the people running them.
 
Mithriel said:
If the different pills were taken at different times could the weather have had an effect? My muscles get very sore when it gets colder. That sort of effect is one of the reasons for having controls rather than self controls.

I remember a letter in the New Scientist years ago by a man complaining that his doctor wanted him to start a trial of vitamin D supplements. He discovered they had been referring patients for some time but it was now Summer when people were getting a high dose of the vitamin from sunshine. He was very scathing about medical trial standards and the lack of imagination in the people running them.
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Not sure there would be a strong seasonal effect with this drug but looks like that shouldn’t explain the findings:
The patients received four bottles containing atorvastatin at a dose of 20 mg, four bottles containing placebo, and four empty bottles; each bottle was to be used for a 1-month period ac- cording to a random sequence.
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