Ischaemic heart disease

Statin myalgia is a nocebo effect, crossover study shows

Statins get a bad rap for aches and pains, but new evidence suggests a nocebo effect from taking tablets is to blame.

A UK study involving 60 patients who had discontinued statins due to intolerable side effects found they showed no difference in side effects when they re-started on a statin or placebo tablets.

During three month periods in which they were blinded to their treatment, patients had similar (P = 0.388) mean daily symptom scores while on atorvastatin 20 mg (16.3) and placebo (15.4), and lower scores while on no tablet at all (8.0).

The 12 month study also showed they also experienced similar levels of symptom intensity and relief on treatment initiation and cessation, and stopped taking tablets at comparable rates (P = 0.173).

The study investigators led by Dr James Howard of Imperial College London  said their findings and 0.90 nocebo ratio led them to conclude that the side effects were driven by the act of taking a tablet, rather than the statin itself.

This could be due to the “misfortune of statins commonly being started for primary prevention where there are no symptoms to improve in an age group wherein ill-defined discomfort becomes increasingly common”, the authors wrote.

Additionally, family and friends, media and internet coverage and drug leaflets may “prime” patients to expect side effects.

“A third possibility is unintentional creation of a false association through patients or doctors trying to test causation by starting and stopping tablets as an informal experiment.”

Where the latter option is true, conducting multiple cross-overs with no-tablet periods could help desensitise patients to the nocebo effect, they suggested. Indeed, the study’s drug/placebo/no tablet protocol allowed half the patients with reported side effects to restart statins six months post-trial, the authors wrote in the Journal of the American College of Cardiology.

“The issue of statin intolerance warrants considerable further investigation, because it undermines standard of care for a very large number of patients worldwide and leaves them vulnerable to atherosclerotic cardiovascular disease-related events,” Dr Peter Toth wrote in an accompanying editorial.

Currently, 50% of patients stop statin treatments after six months — a figure the nocebo effect could contribute to — despite their wide-ranging benefits.

Statins can help reduce myocardial infarction (MI), ischaemic stroke, hospitalisation for unstable angina, the need for revascularisation and death risk; conversely, premature discontinuation can increase the risk of MI, stroke and death compared with adherent patients, noted Dr Toth, Director of Preventative Cardiology at CGH Medical Center, Illinois.

“Aches and pains are a fact of life; just because a patient has them does not mean they should be attributed to their statin,” he concluded.

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