Many people who take the statin cholesterol lowering drugs report that they cause muscle pain. However, one randomized study suggests that the pain is no different when taking a placebo pill.
In rare cases, statins have been known to cause a serious muscle condition called rhabdomyolysis, which destroys skeletal muscle tissue, leading to serious complications. But much more often, people complain that the drugs simply cause muscle pain.
However, it remains uncertain whether statins are responsible for the muscle pain. Muscle pain has many causes and is common in the older age group using statins. Therefore, it is not easy to determine if statins are causing the pain. Observational study results, as well as many media reports, may have led some to unnecessarily abandon potentially life-saving treatment.
This new study, published in the BMJ, included a series of so-called n-of-1 studies, a method that allows researchers to examine the results of treatment and placebo in individual patients rather than examining them as a group. In fact, each patient serves as their own control.
Recognition…Mike Mergen for the New York Times
The researchers gathered 200 people in England and Wales who had either stopped taking statins because of excruciating muscle pain or were about to stop. For one year, each patient took either a statin or a placebo pill at random over six two-month periods. Half the time they were given 20 milligrams of Lipitor and the other half they were given a similar dummy pill. By the end of the study, neither the researchers nor the patients knew when to take the statin and when to take the placebo.
For the last seven days of each two-month phase, researchers measured each patient’s pain daily using a validated 10-point visual pain scale, with 10 indicating the worst pain. They also tracked other aspects of daily life, including the patient’s general level of activity, mood, walking comfort, ability to engage in normal work activities, social relationships, sleep, and enjoyment of life.
The study found no differences between statin and placebo periods in muscle pain or reports of activities and moods in daily life. Nine percent withdrew because of pain while taking statins, but seven percent who took placebos also withdrew, an insignificant difference.
“These studies are difficult to conduct,” said Dr. Henry N. Ginsberg, professor of medicine at Columbia University who was not involved in the work. “This one is done as well as possible and it’s nice to talk to patients about it. You can tell your patients, “They did studies on people like you, and those people couldn’t tell the difference between placebo and medicine.”
Three months after the last treatment, when the patients were informed of their results, The researchers asked them whether they had started or planned to restart statins and whether they found their own test result helpful in their decision. Most patients said the study was helpful, and more than two-thirds said they intended to start taking statins again.
The lead author, Dr. Liam Smeeth, family doctor and professor of clinical epidemiology at the London School of Hygiene and Tropical Medicine, said that when people stop taking statins for muscle pain, “they miss the tremendous benefits – reducing the risk of a heart attack or stroke by about a third. What we have shown is that among these people who gave up their medicine because of pain – and their pain was real – statins did not make it worse. “