August 8, 2017

Is the 'nocebo effect' costing statin patients their lives?

Daily Briefing

While a new study affirms that people who stop taking prescribed statins are more likely to die from a cardiovascular event than those who stay on the drugs, researchers are divided as to whether statins' actual side effects are deterring adherence—or whether it's the "nocebo effect," Melissa Healy writes for the Los Angeles Times' "Science Now."

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How important are statins?

According to Healy, 19 separate studies have shown that when compared with people who stick to their prescribed statin regime, those who abandon the drugs are between 22 percent and five times more likely to develop a cardiovascular disease and between 25 percent and 2.5 times more likely to die prematurely.

And a new study, published in the Annals of Internal Medicine, further solidifies prior research, Healy writes. For the study, researchers assessed the medical records of more than 28,000 Beth Israel Hospital patients who received statin medication and complained to their doctor about a side effect. According to the researchers, roughly 70 percent of those who registered a complaint stuck with their prescribed regime, while 30 percent stopped taking the drugs.

The researchers compared the health outcomes between the two groups over the course of four years. They found that when compared with those who continued their medication, those who stopped were 14 percent more likely to have a heart attack, a stroke, or to die from a cardiovascular event. According to Healy, the findings suggest that for every 59 patients who stopped taking their statin medication, one would have a stroke, heart attack, or death over the course of the next four years, and one out of every 83 people who abandoned their statin regimen would die.

Why do people stop taking their stain medication?

While the new study—and prior research—affirms cardiologists' general consensus on the benefits of statins for those who need them, research is less clear on why people opt to stop taking the drugs, Healy writes. According to Healy, roughly 56 million Americans are considered candidates for statin drugs, but between 40 and 60 percent of those prescribed abandon them. 

Healy writes that researchers are divided about to what extent people are stopping the drugs because of real side effects, versus the "magnifying effects of patients' expectations, which are often fomented by dramatic online accounts."

It stems from something called the "nocebo effect" —the opposite of the placebo effect—in which the power of suggestion may cause symptoms, Healy writes. She cites research that found when researchers warned people about potential side effects from statins, such as muscle aches, 10 percent of study participants actually prescribed statins reported experiencing muscle aches—as well as 5 percent of participants who were given a placebo statin.

Discussion

In an recent editorial—written in response to the latest study—Steven Nissen, a cardiologist at the Cleveland Clinic, contended, "Statins have developed a bad reputation with the public, a phenomenon driven largely by proliferation on the internet of bizarre and unscientific but seemingly persuasive criticism of these drugs."

He added, "We are losing the battle for the hearts and minds of our patients to websites developed by people with little or no scientific expertise, who often peddle 'natural' or 'drug-free' remedies for elevated cholesterol levels." Nissen pointed out that when someone searches for "statin risks" online, the search terms will pull up about 3.5 million hits, many of which make misleading claims about statins and recommend alternatives that haven't been backed by scientific evidence. In comparison, when someone searches for "statin benefits," search engines turn up only about 655,000 results, he said.

When dealing with patients considering stopping treatment because of side effects, Nissen said physicians "have to trust patients with scientific facts and speak about the science." He said when he cares for his own patients, he'll outline the research on statins, discuss the "nocebo effect," and warn them that stopping treatment could be "a life-threatening mistake." Nissen added, "Passive acceptance of harmful pseudoscience is not an option."

Meanwhile, some cardiologists say the side effects of satins are a valid issue that must be addressed by providers, Healy writes. For instance, Paul Thompson—the chief of cardiology at the Hartford Hospital, who was not involved in the study or editorial—said while Nissen has a point, he might be phrasing it in an unnecessarily provocative way.

Stressing the physicain's role, Thompson said, "I do think there's a lot of poorly documented information on the Internet that confuses people, ... but that is partly our fault: A patient will take mediations if they trust their doctor and think their doctor is doing the best for them."

Thompson said when a patient on statins complains about side effects, a provider should suspend treatment, see if the symptoms fade, and then try again with a lower dose or different type of statin—in addition to stressing the importance of sticking to the regime to the patient (Healy, "Science Now," Los Angeles Times, 7/24).

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