The “nosebo effect” may explain many cases of statin intolerance: SAMSON

According to the results of the SAMSON trial, patients who developed symptoms within 2 weeks of starting statins reported similar side effects while taking placebo, suggesting most of the burden of the nosebo effect. ..

When this nosebo effect was first revealed in these patients who were discontinued, according to a study published in a science session of the Virtual American Heart Association. Statin therapy Due to side effects, half were open to resuming treatment.

“We often see patients who stop taking statins because of side effects. Still, actual studies show that more than half of the patients completely abandoned statins within two years of starting statins. Still, in placebo-controlled trials, few people stopped statins more than those who stopped placebo. ” Dr. James P. Howard, Wellcome Trust PhD Fellow and Cardiovascular Registrar at Imperial College London, said in his presentation. “So, patients suffering from the side effects of statin tablets cannot get help from the experience of thousands of other people in placebo-controlled trials, so we designed a study to resolve this contradiction. The important question is, “Why is this happening? Me?”

The study was published at the same time The· NHe is england JMedical journal..

In this double-blind, 3-group, n-of-1 study, 60 patients (mean age 66 years, 58% male, Caucasian) who had previously discontinued statins due to side effects that occurred within 2 weeks. 90%) has been registered. Treatment of initiation of treatment to determine whether the symptoms resulting from discontinuation were caused by statins or placebo.

Participants were given four bottles of atorvastatin 20 mg, four bottles of placebo, and four empty bottles, each of which was taken in a random order for one month.

Participants reported daily symptom scores ranging from 0 or no symptoms to 100 via the smartphone app. This is the worst possible symptom.

“If the side effects were caused by the statin molecule, the placebo moon would have been reduced at the level of the empty moon. But if the side effects were caused by the nosebo effect, the placebo would be as bad as the statin.” Howard said during the presentation. “I also wanted to see if participating in SAMSON could help patients directly, so I believed that six months after completing this trial, I had previously had to give up forever. I asked each of them if they were able to return to their clinical condition. “

Severity of symptoms

Overall, the average severity scores for reported symptoms are:

• 8 without treatment (95% CI, 4.7-11.3);
• 15.4 (95% CI, 12.1-18.7) for placebo; and
• 16.3 (95% CI, 13-19.6) for statin therapy.

Researchers found that the difference in symptom severity reported for placebo compared to statin therapy was not clinically significant (P <.388); However, the severity of side effects was significant with both staining and placebo compared to untreated (.P Both <.001).

According to the results, the calculated nosebo ratio was 0.9.

“What does Samsung teach us? SAMSON has no doubt that patients rarely have side effects from statin tablets. [but] 90% of this burden is also caused by placebo tablets, “Howard said in a presentation. “Therefore, the most important message from SAMSON is that the side effects of statin tablets are very realistic, but they are mainly The act of taking tablets It is not the statin contained in it. “

Understand Nosebo and resume treatment

In addition, six months after the end of the study, half of the participants resumed statin therapy.

“What changes SAMSON will change? First, when patients report side effects, they need to be taken seriously,” Howard said. “Secondly, this n-of-1 design incorporates a tablet-free period so participants can see as clearly as possible the magnitude of the surprisingly powerful nosebo effect, which allows them to participate. Half of them were happy to resume statins. Finally, we hope that this new study will help patients and other researchers answer questions about medicines in their respective fields. SAMSON is truly original. I believe it will be a typical trial design. “

Debater Francine K. Welty, MD, PhDAn associate professor at Harvard Medical School and a cardiologist at the Beth Israel Dikones Medical Center, said at a press conference: It will restart normally. In reality, many patients develop symptoms after two weeks, so these findings cannot be generalized. For example, in the SEARCH trial, 85% to 90% develop muscle soreness after the first month of treatment.

“There was no washout period between each one-month treatment group,” Welty said. “If a subject develops symptoms during atorvastatin and then goes to placebo, the symptoms may have been carried over to the placebo group.”

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Kim Alan Williams Sr., MD, MACC, FAHA, MASNC, FESC

Samsung was very encouraging to me in working with statin intolerant people to find a fairly good dose to tolerate it. One of the techniques I use is to point the computer screen at the patient and let Google see the two words statin and mortality. Hit the image to see all these Kaplan-Meier plots. I explain to them what the Kaplan-Meier plot is, and they see this big difference. Some have developed familial hyperlipidemia, using 12-year results to show high mortality when not taking statins, and good survival when taking statins. Then there’s another small graph showing how people who stopped statins died. How if you are taking high doses of statins, you are better than medium doses, it is better than low doses. All of this is in a place where the patient can see it.

Over the last few years, Medicare’s data showed that it would go bankrupt in 2026, so I couldn’t predict a reduction in death, so I actually told patients that one of the main causes was statins. ..

After seeing these two things, people always try to administer the next statin. What I didn’t know until now was that I was unknowingly reducing the nosebo effect. I was changing their attitude.

Attitude is important and it really proves to us that whenever there is a problem with medication compliance, especially statins, we should think about it.
At Samsung, they were okay when the patients were given an empty bottle. If they were statin intolerant when they were given statins, they had a problem. However, if you receive a placebopill that looks like a statin, 90% of them will have about the same problem. It’s amazing knowledge that it’s a pill, not a medicine. You need to change it from the inside. We need to make people feel that this medicine saves lives.

Kim Alan Williams Sr., MD, MACC, FAHA, MASNC, FESC

Today’s editorial board of cardiology

Rush University Medical Center

Former President of the American College of Cardiology

Disclosure: Williams has not reported disclosure of relevant financial information.

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