Most side effects from this type of medicine only in the mind

By Mark Waghorn via SWNS

Most side effects from statins are in the mind, according to new research.

Up to 70 percent of symptoms are due to a psychological phenomenon known as the nocebo or drucebo effect, say scientists.

It is caused by perceptions that they could be harmful - rather than the actual drugs.

The cholesterol-busting pills have been linked to muscle pain, headaches, dizziness, nausea, tiredness and digestive problems.

Now, for the first time, an international group of experts has issued recommendations to doctors about how to identify true problems.

Professor Maciej Banach, of the Medical University of Lodz, Poland, who originated the advice, said: "There is an enormous worldwide problem with diagnosing statin intolerance correctly.

"In addition, we know that most diagnosed statin side effects should not, in fact, be attributed to statin therapy.

"As much as 70% of symptoms may be due to a psychological phenomenon called the 'nocebo' or 'drucebo' effect."

Last month the same team found statin intolerance is "over-estimated and over-diagnosed."

Data pooled from around the world showed less than one in ten patients suffer side effects. Up to half stop taking them or reduce the dose.

Prof Banach said: "The 'nocebo/drucebo' effect is when patients' expectations that they will experience side effects from the statins result in them actually experiencing these symptoms.

"Their knowledge is gained from the internet, leaflets, friends and family and other sources, and the most common side effects are muscle pain and liver complaints.

"It can result in them discontinuing their therapy and, therefore, increasing their risk of heart problems, stroke and death."

Prof Banach is president of the International Lipid Expert Panel (ILEP) which has over 70 members who have contributed evidence and suggestions.

The recommendations provide a step-by-step approach to diagnosing and managing symptoms such as muscle aches, so as many patients as possible continue to take statins.

They are among the most commonly prescribed drugs. There is strong and unambiguous evidence they reduce the risk of developing cardiovascular disease - or dying from it.

First author Dr. Peter Penson, of Liverpool John Moores University, said: "This is the first paper to deal explicitly with nocebo/drucebo effect.

"It offers practical and evidence-based suggestions which we hope will be of use to physicians in improving patient-centred care in individuals who are at risk of cardiovascular disease, but who experience adverse effects attributable to their medicines."

The recommendations include:

*Healthcare professionals consider the nocebo/drucebo effect when they first prescribe statins and provide information to patients about the rationale and benefits of the therapy.

*The Personalized Lipid Intervention Plan (PLIP) should be used to help this process. It estimates the patient's 10-year risk of cardiovascular disease with and without statin therapy, as well as providing clear information on adverse side effects, including that muscle symptoms are common but rarely caused by statins.

*Routine follow-up to check the safety and efficacy of the therapy

*How to effectively diagnose statin intolerance and exclude nocebo/drucebo effect.

*How to manage patients with no biomarkers that indicate abnormalities and with tolerable statin-associated muscle symptoms (SAMS).

*How to manage patients with biomarker abnormalities and/or intolerable SAMS.

*Strategies for managing patients with complete statin intolerance.

Dr. Penson said: "The benefits of statins are not seen immediately by patients, whilst the associated adverse effects are more tangible, and so many patients stop taking statins, thereby putting themselves at risk of serious illness or death.

"The Personalized Lipid Intervention Plan (PLIP) proposed in our paper helps the patient to understand the reason for their treatment, the large benefits, including that statins may prolong their lives, and the potential harms.

"This allows the patient to make a fully informed decision about commencing and continuing therapy. The PLIP also summarises important lifestyle advice to help them reduce their risk of heart attacks and strokes."

He added: "We hope this document will facilitate shared decision-making between patients and prescribers.

"The recommendations recognize that the vast majority of patients can take statins safely, and that the benefits greatly outweigh the potential risk of side effects.

"They provide advice about improving adherence to statin therapy, whilst making suggestions for the identification and management of the relatively small number of patients who have true statin intolerance."

The study in the Journal of Cachexia, Sarcopenia and Muscle also looks at non-statin drugs that can be used to lower cholesterol.

Dr. Penson added: "It is important that physicians apply their own judgement in the context of the healthcare system in which they work and their knowledge of their individual patients when deciding whether to implement particular recommendations.

"However, if prescribers find the advice helpful, we encourage them to share it with colleagues."