Placebo Elicits Same Side Effects As Cholesterol-Lowering Statins

An American Heart Association study recently found that patients taking cholesterol-lowering statin medication and patients taking a placebo reported the same side effects. 

Specifically, researchers found that 90 percent of the symptoms that patients reported when they took a statin were also reported when they unknowingly took placebo tablets. 

Additionally, patients were just as likely to stop placebo tablets because of intolerable side effects as patients taking the statin tablets.

These results could point to a psychological rather than pharmacological effect of statins, researchers stated.

“We know that many patients are not able to take statins because of side effects such as muscle pain, called myalgia,” James Philip Howard, MB, PhD, lead study author and a PhD fellow at Imperial College in London, said in the study.

“Prior placebo-controlled randomized trials have not found evidence of what should be an overwhelmingly obvious difference in side effect symptoms while a person is taking statins rather than taking a placebo. This randomized study allowed us to examine participants’ symptoms when they were off all tablets and compare them with symptoms occurring when on statin therapy vs. placebo therapy,” he continued.

The study, Self-Assessment Method for Statin Side-effects Or Nocebo (SAMSON), enrolled 60 UK adults who had previously taken a statin but stopped taking them due to side effects.

SAMSON measured self-reported symptoms throughout a 12-month period that included alternating statin use (four months), placebo (four months), and no medications (four months).

Participants were given 12 medication jars. Four jars contained statins, four contained placebos, and four contained nothing. They would start a new jar each month at random.

Howard noted that the design of the trial, alternating the different treatment options, can help patients explore their personal symptoms more efficiently. 

Patients tracked the intensity of their symptoms daily on their smartphone and ranked them on a scale from zero (no symptoms) to 100 (worst imaginable), researchers said. Participants had the choice to stop the tablets for the month if their symptoms become intolerable. 

“Patients should be taken seriously when they report side effects, because they are genuinely suffering,” Howard said. “We were surprised how severe some of the symptoms experienced during the study were. Twenty-four patients, on 71 occasions, had symptoms so severe they had to stop taking their tablets temporarily. However, this occurred just as frequently when patients took a placebo as when they took a statin.”

Six months after the trial, half of the trial participants restarted taking a statin medication and were still taking it, researchers added.

Statins lower LDL cholesterol and may reduce their risk of heart attack. But sometimes, individuals experience side effects, such as muscle pain, and stop taking their medication.

In the US, 95 million adults have total cholesterol levels higher than 200 mg/dL, and most are recommended to lower their LDL cholesterol through lifestyle changes and LDL-lowering medications, according to a September JAMA Network Open study. 

The most popular of these drugs are statins, which are currently prescribed to more than 35 million people in the US.