Statin-induced muscle pain or nocebo effect?: New SAMSON trial explains
M3 India Newsdesk Nov 24, 2020
Dr. Monish Raut provides an elucidation on the SAMSON trial which showed remarkable results proving statin side effects do in fact exist but in most cases are not caused by the drug molecule but by patients expecting to feel worse, which existed even if they were on placebo.
Statin may be the most commonly researched class of any medicine. It has been studied in more than 1 lakh patients in placebo-controlled trials which found a clear 25% relative decrease in potential heart events. However, often patients discontinue the medication due to side effects such as myalgia. In statin users and non-users, observational trials demonstrated a 20 to 50% greater incidence of muscle pain. Persons taking statins had about the same rates of mild side effects in blinded randomised controlled trials as those taking placebo. The difference between the retrospective trials and the RCTs can be explained by non-inclusions of patients with side effects and another reason is - the nocebo effect - a negative belief begetting a negative result.
The SAMSON trial
Recently, the new and exquisite SAMSON research study (self-assessment method for statin side-effects or nocebo) primarily tackles the unresolved problem of statin side effects. The design of the trial is n-of-1 trial design where every patient acts as their own control. The design is similar to what a doctor does in clinical practice i.e. give medication, watch for its result, if not sure, pause the drug, again watch for some time and then recommence it.
The main aspect of SAMSON trial is that the therapy was blinded to patients and clinicians. The study randomly allocated patients who had recently quit statins due to adverse effects to 4 months cycle of no drugs, placebo, and statin over a period of 1 year. On a mobile app, patients reported symptom severity (0 to 100) per day. The primary endpoint of the analysis was the ratio between the placebo-causing excess symptom severity and the statin-causing excess symptom intensity.
For 'no-pill' months, the mean symptom score was 8.0, however it was 15.4 and 16.3 for the placebo months and statin months respectively. The disparity between the placebo and statin months and the no-pill months in symptom scores was extremely important (P <.0001). However, the variation between the placebo and statin months in symptom scores was not important (P = .39). The researchers concluded that people are currently developing complications by taking statin pills. Although most specifically, 90% of these effects are caused by placebo pills as well.
Let us understand these results in reference to other studies. In Anglo-Scandinavian Cardiac Outcomes Trial—Lipid-Lowering Arm (ASCOT-LLA), there were no substantial variations in myalgia complaints in the blinded period of the study, although slightly more patients in the statin arm recorded these symptoms in the open-label phase.
Physicians can use the findings of SAMSON trial to persuade certain patients who were already intolerant to statins to resume a drug that prevents cardiovascular events. Simple perceptions of gain or hurt and social observational learning can significantly affect the outcomes positively or negatively. Appropriate counseling with mindful words and actions can certainly help clinicians to obtain a positive result. Compassion and understanding remains important, though. Patients reporting and actually suffering from statin side effects should not be ignored.
Disclaimer- The views and opinions expressed in this article are those of the author's and do not necessarily reflect the official policy or position of M3 India.
The author, Dr. Monish S Raut is a Consultant in Cardiothoracic Vascular Anaesthesiology. His area of expertise is perioperative management and echocardiography with numerous publications in various national and international indexed journals.
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