A dummy pill or placebo is an inactive substance, typically a tablet, capsule, or other dosage forms that do not contain an active drug ingredient. On the other hand, Statins are drugs used to lower cholesterol levels in the blood. By reducing the levels, they help prevent heart attacks and stroke.
Past investigations have indicated that, in certain people, statins reduce the danger of heart attack, stroke, and even death from cardiovascular disease by around 25-35 percent. Most people endure statins, yet it is assessed that around one-fifth of patients stop taking or decline the medication because of reported side effects, for example, muscle aches, fatigue, or joint pain.
In a clinical trial of 60 patients aged between 37-79, led by researchers at Imperial College London and clinicians at Imperial College Healthcare NHS Trust, 90 percent of patients’ symptoms while taking statins were all present when they took placebo pills.
During the trial, which took place at Hammersmith Hospital, patients were given four bottles containing a statin, four bottles of a placebo, and four empty bottles to take over 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 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.
90 percent of symptoms experienced by patients on statins were present when they took placebo tablets. They 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.
Scientists suggest that the side effects are caused due to the nocebo effect – where people experience side effects from therapy because of a negative association with it – rather than the drug’s actual pharmacological effect.
It is recommended that doctors inform patients of the nocebo effect when prescribing statins and manage their expectations. Doing this will help encourage people to stay on or take the medication.
Dr. James Howard, Clinical Research Fellow at Imperial College London and Cardiologist at Imperial College Healthcare NHS Trust, 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 severe health conditions. Still, 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.”
Frances 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 the possibility that some side effects they experience may be caused by the nocebo effect and provide further support if needed.”
Professor Sir Nilesh Samani, Medical Director at the British Heart Foundation, said: “The beauty of this study is that it’s personalized. For the first time, patients could 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.”
- James Howard et al. N-of-1 Trial of a Statin, Placebo, or No Treatment to Assess Side Effects. DOI: 10.1056/NEJMc2031173