According to new research, millions of back pain sufferers are being prescribed a drug that does nothing to relieve their pain.
In a study of more than 200 patients, pregabalin – originally marketed as Lyrica by pharmaceutical giant Pfizer – did no better than a dummy pill in relieving their agony.
In fact, it left them with almost twice as many side effects.
The findings, published in the New England Journal of Medicine, follow research just over two years ago that found similar results.
In a study of over 200 patients, pregabalin was no more effective than a dummy pill in relieving the agony of people with chronic low back pain.
Pregabalin has become the most widely prescribed medication for “neuropathic,” or nerve, pain in the world.
Global sales have reached $5 billion a year since its approval in 2004.
Pregabalin is commonly used to treat chronic low back pain syndromes such as lumbar spinal stenosis – the main reason elderly people undergo spine surgery.
It causes shooting or pulling pains, tingling, and numbness in the lower back, buttocks, and legs. These symptoms are often called sciatica.
Professor Christine Lin, from the George Institute for Global Health in Australia, said: ‘We have seen a huge increase in the number of prescriptions written each year for patients with sciatica.
“It’s an incredibly painful and debilitating disease, so it’s no wonder people are desperate for relief and drugs such as pregabalin have been widely prescribed.
“But, until now, there was no high-quality evidence to help patients and doctors know whether pregabalin works for the treatment of sciatica.
“Our results showed that pregabalin treatment did not relieve pain, but caused side effects such as dizziness.”
Other side effects include headaches and feeling drowsy – and even blurry or double vision. Coordination and balance problems can also occur, as well as weight gain.
Sciatica is caused by irritation of the sciatic nerve – the longest nerve in the body that runs from the back of the pelvis through the buttocks and down each leg to the feet.
This usually happens when one of the shock-absorbing discs between the bones of the spine bulges out – or “slips” – and then presses on the nerve.
At any one time, approximately 12% of the world’s population suffers from low back pain. It is estimated that up to one in ten will have sciatica.
The researchers said they conducted the study because they were increasingly concerned about the rise in pregabalin use, limited data on its effectiveness and fears about the drug’s safety.
A total of 209 Australian patients with sciatica received either pregabalin or a placebo pill.
After eight weeks, there was no significant difference in pain intensity between the two groups. Over a year, the number of workdays lost was also about the same.
Despite the results, almost two-thirds of patients in the study said they were very satisfied or satisfied with their drug treatment.
One of the possible serious side effects is suicidal thoughts or actions. Pregabalin is used for a number of painful conditions, including nerve pain.
Despite the results, almost two-thirds of the participants said they were very satisfied or satisfied with their drug treatment.
Prof Lin said: ‘Over the course of eight weeks, the pain levels experienced by the patients decreased, but the reduction in pain was the same for those taking the drug and those on the placebo.
“People seem to associate a drop in pain with taking a capsule rather than something that would naturally occur over time.
“GPs who prescribe pregabalin should take note of these findings and discuss with their patients other ways to manage and prevent pain.
“Unfortunately, there is no proven medication for people with sciatica and even epidural injections provide little short-term benefit.”
“What we do know is that most people with sciatica eventually recover over time. It is also important to avoid bed rest and to stay as active as possible.
The team found no increased risk of self-harm. But the trial was not set up to detect suicide risk, so GPs are advised to exercise caution when prescribing.
Pregabalin is known as “bud” or “Budweisers” to teenage recreational users because it makes them feel like they’re drunk. He has been linked to a series of deaths in the UK since 2012.
It is believed that more than three million people take it every year in the UK.
In December 2014, a study by American researchers found that there was no significant difference between the levels of back pain experienced by those taking the drug and those given a placebo while walking on a treadmill. .