Patients taking statins experience similar side effects from placebo
New research published today has found people taking placebo pills and statins experienced similar side effects.
A clinical trial of 60 patients at Hammersmith Hospital, led by clinicians at Imperial College Healthcare NHS Trust and researchers at Imperial College London, found the intensity of symptoms when taking the placebo was around 90 per cent of the intensity of symptoms experienced when taking statins. All patients involved had previously been on statins and had stopped the treatment.
Statins are one of the most commonly prescribed drugs in the UK, with around seven or eight million adults in the UK taking them. They help lower cholesterol in the blood. Having a high cholesterol level is potentially dangerous as it can cause hardening and narrowing of the arteries, leading to cardiovascular disease.
Previous studies have shown that, in certain people, statins reduce the risk of heart attack, stroke, and even death from heart disease by about 25-35 per cent. Most people tolerate statins but it is estimated that around one fifth of patients stop taking or refuse the drug due to reported side effects such as muscle aches, fatigue or joint pain.
The researchers behind the new study suggest that these side effects are mostly caused by the nocebo effect - where people experience side effects from a therapy because they are subconsciously expecting them – rather than the pharmacological effects of statin tablets. The team suggest that doctors should inform patients of the nocebo effect when prescribing statins and manage their expectations of taking them, to help encourage people to stay on or take the medication.
The study, funded by the British Heart Foundation, is published in the New England Journal of Medicine.
Dr James Howard, cardiologist at Imperial College Healthcare NHS Trust and clinical research fellow at Imperial College London and, said: “Statins are life-saving treatments that can help prevent the risk of heart attacks, strokes and cardiovascular disease. Previous studies have shown that statins are safe and effective at preventing serious health conditions but some patients stop taking or refuse the drug due to reported side effects, potentially increasing their risk of heart attack and stroke in the long-term.
“Our study suggests that the reported side effects of statins are not caused by the statin themselves but by the effect of taking a tablet. Some of the side effects could also be from the typical aches and pains of getting older. Our findings are significant because they are further evidence that side effects from statins are minimal. These drugs play a significant role in keeping patients who are at risk of cardiovascular disease healthy. One way to help encourage patients to take or stay on their medication is for doctors to talk to their patients about the nocebo effect. In more severe cases patients could be referred for talking therapies.”
Francis Wood, from Imperial’s National Heart and Lung Institute and joint first author, added:
“Statins play a vital role in lowering cholesterol levels and decreasing the risk of serious vessel-related diseases. However, some patients are stopping their treatment as a result of perceived side effects. Our study can help doctors manage patients’ expectations of statins and to explain more clearly to patients that any side effects they experience are likely to be caused by the nocebo effect and provide further support if needed.”
The team recruited 60 patients aged between 37-79 who were on statins, and had stopped their treatment due to side effects, from June 2016 – March 2019. During the trial, patients were given four bottles containing a statin, four bottles of a placebo and four empty bottles to take over a course of a year. Patients took identical tablets, blinded to statin or placebo for eight months, and took nothing for four months. The patients took these bottles in a random order and were required to score from 0 - no symptoms - to 100 - worst imaginable symptoms- of any daily side effects they experienced, on a smartphone. Forty-nine of the 60 patients completed the full 12 months of the trial.
The team also found that among the 60 patients, the mean symptom intensity score was eight during no-tablet months, 15.4 during placebo months and 16.3 during statin months. Twenty-four of the 49 participants who completed the trial stopped tablets early due to intolerable side effects for at least one month of the trial, with 71 stoppages in total. Of the 71 stoppages, 31 occurred during placebo months and 40 were during statin months.
Six months after completion of the trial, 30 of the patients had successfully restarted statins and four planned to do so. Twenty-five of the patients were not receiving statins and were not planning to restart their statins.
Professor Sir Nilesh Samani, Medical Director at the British Heart Foundation, said:
“The beauty of this study is that it’s personalised. For the first time, patients were able to see for themselves that statins did not cause their side effects but the physical act of taking a pill did. These results undeniably show that statins are not responsible for many of the side effects attributed to them. Decades of evidence have proven that statins save lives and they should be the first port of call for individuals at high risk of heart attack and stroke.
“This study empowered many of the participants to go back onto statins, which will undoubtedly lower their risk of having a life-threatening heart attack or stroke. We now hope that these findings continue to encourage more people to consider statins with an open mind, and help healthcare professionals to have evidence-based conversations with their patients to ensure they receive the treatment that’s right for them.”
The researchers will now conduct a further study to investigate symptoms caused by beta-blockers, medications that reduce blood pressure, in heart failure.