Prof Sir Nilesh Samani, the medical director at the British Heart Foundation, which co-funded the study, said the findings should bring an end to decades of debate.
“This research should help millions more people around the world feel confident in talking to their doctors about taking statins to reduce their risk of deadly heart attacks and strokes,” he said.
“This is the definitive study. This is really gold standard evidence. The size of the study gives us enormous confidence.”
Experts said that in future, GPs should place less emphasis on muscle pain and be able to reassure patients that there is little increased risk.
The study found that more than a quarter of patients taking the tablets did report muscle symptoms – but similar findings were found in those who were put on a dummy pill.
For every 1,000 people who start taking statins, only 11 developed muscle aches or weakness as a result, the study found. Overall, the drugs were found to be to blame for just one in 15 cases of muscle pain and even this extra risk disappeared after a year on them.
Scientists said the symptoms were not in people’s minds but were a case of ordinary aches, often caused by old age, being wrongly attributed to the daily medication.
Because patients are often told that statins may cause muscle pain, it creates a “nocebo” effect which meant they are wrongly blamed for unrelated ills, researchers said.
They obtained findings from 23 randomised controlled trials, in which all those involved did not know whether they had been put on a statin or on a placebo pill.
Some 27.1 per cent of those on statins reported muscle aches or weakness – a “tiny” increase on the 26.6 per cent found in the group given dummy pills.
With most people middle-aged or older by the time they were put on the drugs, many were mistaking aches and pains that come with age, and with conditions that are common in the elderly, for a side-effect of the drugs, experts said.
‘Monumental’ study of 30 years of data
Prof Colin Baigent, director of the Medical Research Council Population Health Research Unit at the University of Oxford, said: “There’s no doubt that aging does increase your risk of experiencing pain and other conditions which are known to cause pain… thyroid disease, arthritis, even something simple like exercise when you’re not particularly fit.”
He said scientists had embarked on a “monumental” study of 30 years of data in order to settle the matter.
Until now, the debate had been skewed by non-randomised studies that did not include placebos or random allocation, resulting in “quite extreme” estimates that have misled the public.
“This has put patients off starting statins or made them stop treatment when they develop muscle pain,” he added. “Over 90 per cent of the time, when a patient taking a statin gets muscle pain it isn’t the statin that’s causing it.
“If we could get people to be better informed about the real risks of muscle pain we can get people to stay on therapy for longer.”
The scientist also said there was a need to revise the information placed in drug packs to clarify that most muscle pain experienced during statin therapy is not because of the pills. The current inserts in drug packets were often “incredibly misleading”, he said.
‘Reassuring to clinicians and patients’
Researchers said GPs needed to be extremely careful about the way such risks were discussed, instead of putting such an emphasis on side-effects.
Prof Baigent said: “Up until now they thought that keeping patients safe was best served by having these warnings about the possibility of muscle pain.
“What we’ve shown that is not the best way to serve patients because patients take that information and, the moment they develop muscle pain, they suspect the statin. That causes many of them to stop the statin, which actually puts them in harm’s way.”
Prof Martin Marshall, the chairman of the Royal College of GPs, said: “This study should be reassuring to clinicians and to patients taking or considering taking statins.
“GPs are highly trained to prescribe and will do so based on the circumstances of individual patients.
“We will take into account a patient’s health needs and their medical history, as well as clinical guidance, and we will consider the various treatment options, not just drug therapies, in conversation with the patient about the risks and benefits of each.”