Statins and placebos cause … the same side effects!

In France, an estimated 6.4 million patients are currently receiving statin therapy. These leading drugs prescribed to fight cholesterol are the main class of lipid-lowering drugs: they inhibit the functioning of HMG Co A reductase, an enzyme that controls the synthesis of cholesterol by liver cells. This inhibition also stimulates the expression of LDL receptors, allowing them to enter the target cell.

In a clinical study published in New England Journal of Medicine involving 60 patients, conducted by Imperial College London and doctors from Imperial College Healthcare NHS Trust (England), the researchers showed that 90% of the symptoms experienced by patients taking statins were present even when they were on placebo.

Effet nocebo

Previous studies have shown that statins reduce the risk of heart attack, stroke, and even death from heart disease by 25 to 35 percent in some people. While the majority of patients tolerate statins well, about one in five patients stop treatment due to side effects. The main ones reported on muscle and joint pain, as well as on fatigue.

For the researchers of this new work, the main culprit of these side effects is what is called the nocebo effect: that is, patients experience side effects not due to a drug effect. real drug, but because they associate a negative image with it.

“Our study suggests that the reported side effects of statins are not caused by the statin itself, but by the effect of taking a tablet. explains Dr. James Howard, who led the work. Some of the side effects could also be due to the typical pains of aging. “ Explaining what the side effects of statins are “minimum”, calls for patient awareness of the nocebo effect to encourage them to take their treatment or continue to do so. “In severe cases, patients could be referred to speech therapy”, he suggests.

90% of the side effects seen with placebo

To reach this conclusion, the researchers recruited 60 patients aged 37 to 79 who were taking statins and had stopped their treatment due to side effects between June 2016 and March 2019. During the study, the patients took received four vials containing a statin, four vials of a placebo and four empty vials to be taken over a period of one year. Patients took identical tablets, not knowing whether they were statins or placebos for eight months, and then took nothing for four months. The patients took the vials in random order and rated the experience time from 0 – no symptoms – to 100 – the worst symptoms imaginable – the daily side effects they experienced. A total of 49 of the 60 patients completed the full 12 months of the study.

The team found that 90% of the symptoms experienced by patients taking statins were present while taking the placebo tablets. They also found that among the 60 patients, the mean symptom intensity score was eight during the pill-free months, 15.4 during the placebo months, and 16.3 during the statin months.

24 of the 49 participants who completed the trial discontinued the tablets early due to intolerable side effects for at least one month of the trial, with 71 total discontinuations. Of these 71 interruptions, 31 occurred during the placebo months and 40 during the statin months.

Per Frances Wood, of the Imperial National Heart and Lung Institute and co-author, “Statins play an essential role in lowering cholesterol levels and reducing the risk of serious diseases related to blood vessels”hence the need to educate patients on the psychosomatic effect of taking pills. “Our study can help physicians manage patient expectations for statins and explain more clearly to patients the possibility that some side effects they experience may be caused by the nocebo effect and provide them with additional support if needed.”