Post by Admin on Feb 20, 2021 17:43:36 GMT
A recent methodologically novel study on the nocebo effect sparked discussion in the Journal of the American Medical Association (JAMA) about how patients are adversely affected by negative expectations about their treatment. The greater a patient’s negative perception of treatment or medication, the stronger the nocebo response.
This first of its kind study found that patients’ negative expectations for statin therapy contributed overwhelmingly to intolerable adverse side-effects:
“SAMSON, in fact, found that 90% of adverse effects from statins were explained by this nocebo effect. The nocebo effect is a massive burden; in our 60 patients, side effects were so bad that they had to come off the tablets on 71 occasions.”
New Research Highlights Adverse Impacts of Nocebo Effect in Medicine
The study estimated that nocebo effects can account for 90% of adverse side effects in patients undergoing statin therapy
www.madinamerica.com/2021/02/new-research-highlights-adverse-impacts-nocebo-effect-medicine/
Medical News & Perspectives
February 3, 2021
“Important Conversations” Are Needed to Explain the Nocebo Effect
Anita Slomski, MA
JAMA. Published online February 3, 2021. doi:10.1001/jama.2020.25840
jamanetwork.com/journals/jama/fullarticle/2776228
Roger needed no convincing that taking a statin could prevent his early death. At age 52 years, he had mixed lipidemia, severe peripheral vascular disease, obesity, fatty liver disease, and a previous femoral artery occlusion. But as he explained to the investigators of the SAMSON (Self-Assessment Method of Statin Side Effects or Nocebo) trial, he’d already tried 3 different statins and discontinued each one due to the dreadful muscle pain he felt while taking them.
“He was totally gobsmacked when we unblinded the results of SAMSON and showed him that his worst months—including muscle pain so bad he couldn’t get out of bed—were from placebo,” said cardiologist James P. Howard, MB BChir, clinical research fellow at Imperial College London and co–first author of the SAMSON report published in the New England Journal of Medicine. After discovering that he reported feeling fine during the months of the trial that he received a statin, Roger resumed statin therapy with no symptoms for the 4 years since receiving his personal results.
The novel n-of-1 trial validated what physicians have long observed: patients’ negative expectations for statin therapy rather than the drug’s pharmacological action are often responsible for intolerable adverse effects. SAMSON, in fact, found that 90% of adverse effects from statins were explained by this nocebo effect. “The nocebo effect is a massive burden; in our 60 patients, side effects were so bad that they had to come off the tablets on 71 occasions,” Howard said in an interview.
The 60 study participants, all who had previously discontinued statin therapy because of intolerable adverse effects, received 4 bottles each of 20-mg atorvastatin and placebo, and 4 empty bottles. Each month for a year, participants took pills or nothing in a random sequence and recorded their daily symptom intensity on their smartphones.
“To work out the nocebo effect, it’s imperative that you have a nontreatment arm where the patient takes nothing so you can subtract the background symptoms that are ever-present, such as the aches and pains of getting older or of arthritis, for example,” Howard said. “As far as we know, this is the first time anyone has done such a trial.”
At the end of the trial, patients saw how they rated their symptoms during the 3 treatment sequences, which was compelling enough to convince half of them to resume statin therapy. “Only 18 of the original 60—less than one-third—told us that they weren’t restarting statins because they still believed they caused side effects,” Howard said.
Although trials in other journals including JAMA and The Lancet have reported nocebo effects in statin therapy, SAMSON stood out because the study design demonstrated to patients themselves that the nocebo effect is real.
The study’s participants had first-hand evidence that “just the simple act of taking a pill, where they might have been expecting side effects, explained much of the symptoms,” Donald Lloyd-Jones, MD, ScM, president-elect of the American Heart Association (AHA), told JAMA last fall during the AHA’s virtual Scientific Sessions conference.
However, some experts question the magnitude of the nocebo effect in SAMSON’s results. “It’s easy for me to believe that 50% to 60% of statin side effects are nocebo, but not 90%,” Steven E. Nissen, MD, chief academic officer and Lewis and Patricia Dickey Chair in Cardiovascular Medicine at the Cleveland Clinic, said in an interview. “Some patients who have tried very hard to take statins have a real disorder” that prevents them from taking statins.
Howard agrees that his results shouldn’t be extrapolated to all patients who take statins. “In a larger trial, you might find a 70% or 95% nocebo effect,” he said. What’s important “is that the nocebo effect dominates in a majority of patients on a statin and that real side effects are much rarer than we thought.”
For physicians, that means explaining the nocebo effect. “We have to have very important conversations with our patients rather than just writing a prescription, actually telling them what to expect,” said Lloyd-Jones, also chair of preventive medicine at Northwestern Medicine Feinberg School of Medicine.
This first of its kind study found that patients’ negative expectations for statin therapy contributed overwhelmingly to intolerable adverse side-effects:
“SAMSON, in fact, found that 90% of adverse effects from statins were explained by this nocebo effect. The nocebo effect is a massive burden; in our 60 patients, side effects were so bad that they had to come off the tablets on 71 occasions.”
New Research Highlights Adverse Impacts of Nocebo Effect in Medicine
The study estimated that nocebo effects can account for 90% of adverse side effects in patients undergoing statin therapy
www.madinamerica.com/2021/02/new-research-highlights-adverse-impacts-nocebo-effect-medicine/
Medical News & Perspectives
February 3, 2021
“Important Conversations” Are Needed to Explain the Nocebo Effect
Anita Slomski, MA
JAMA. Published online February 3, 2021. doi:10.1001/jama.2020.25840
jamanetwork.com/journals/jama/fullarticle/2776228
Roger needed no convincing that taking a statin could prevent his early death. At age 52 years, he had mixed lipidemia, severe peripheral vascular disease, obesity, fatty liver disease, and a previous femoral artery occlusion. But as he explained to the investigators of the SAMSON (Self-Assessment Method of Statin Side Effects or Nocebo) trial, he’d already tried 3 different statins and discontinued each one due to the dreadful muscle pain he felt while taking them.
“He was totally gobsmacked when we unblinded the results of SAMSON and showed him that his worst months—including muscle pain so bad he couldn’t get out of bed—were from placebo,” said cardiologist James P. Howard, MB BChir, clinical research fellow at Imperial College London and co–first author of the SAMSON report published in the New England Journal of Medicine. After discovering that he reported feeling fine during the months of the trial that he received a statin, Roger resumed statin therapy with no symptoms for the 4 years since receiving his personal results.
The novel n-of-1 trial validated what physicians have long observed: patients’ negative expectations for statin therapy rather than the drug’s pharmacological action are often responsible for intolerable adverse effects. SAMSON, in fact, found that 90% of adverse effects from statins were explained by this nocebo effect. “The nocebo effect is a massive burden; in our 60 patients, side effects were so bad that they had to come off the tablets on 71 occasions,” Howard said in an interview.
The 60 study participants, all who had previously discontinued statin therapy because of intolerable adverse effects, received 4 bottles each of 20-mg atorvastatin and placebo, and 4 empty bottles. Each month for a year, participants took pills or nothing in a random sequence and recorded their daily symptom intensity on their smartphones.
“To work out the nocebo effect, it’s imperative that you have a nontreatment arm where the patient takes nothing so you can subtract the background symptoms that are ever-present, such as the aches and pains of getting older or of arthritis, for example,” Howard said. “As far as we know, this is the first time anyone has done such a trial.”
At the end of the trial, patients saw how they rated their symptoms during the 3 treatment sequences, which was compelling enough to convince half of them to resume statin therapy. “Only 18 of the original 60—less than one-third—told us that they weren’t restarting statins because they still believed they caused side effects,” Howard said.
Although trials in other journals including JAMA and The Lancet have reported nocebo effects in statin therapy, SAMSON stood out because the study design demonstrated to patients themselves that the nocebo effect is real.
The study’s participants had first-hand evidence that “just the simple act of taking a pill, where they might have been expecting side effects, explained much of the symptoms,” Donald Lloyd-Jones, MD, ScM, president-elect of the American Heart Association (AHA), told JAMA last fall during the AHA’s virtual Scientific Sessions conference.
However, some experts question the magnitude of the nocebo effect in SAMSON’s results. “It’s easy for me to believe that 50% to 60% of statin side effects are nocebo, but not 90%,” Steven E. Nissen, MD, chief academic officer and Lewis and Patricia Dickey Chair in Cardiovascular Medicine at the Cleveland Clinic, said in an interview. “Some patients who have tried very hard to take statins have a real disorder” that prevents them from taking statins.
Howard agrees that his results shouldn’t be extrapolated to all patients who take statins. “In a larger trial, you might find a 70% or 95% nocebo effect,” he said. What’s important “is that the nocebo effect dominates in a majority of patients on a statin and that real side effects are much rarer than we thought.”
For physicians, that means explaining the nocebo effect. “We have to have very important conversations with our patients rather than just writing a prescription, actually telling them what to expect,” said Lloyd-Jones, also chair of preventive medicine at Northwestern Medicine Feinberg School of Medicine.