- In a study of more than 200 patients, pregabalin performed no better than a dummy pill at relieving their agony
- In fact, the pill marketed by Pfizer left users with twice as many side effects
- Worldwide sales have swelled to $5 billion annually since its approval in 2004
Millions of back pain sufferers are being prescribed a drug that does nothing to ease their suffering, according to new research.
In a study of more than 200 patients, pregabalin – originally marketed as Lyrica by pharmaceutical giant Pfizer – performed no better than a dummy pill at 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, follows research just over two years ago that came up with similar results.
In a study of more than 200 patients, pregabalin performed no better than a dummy pill at relieving agony for people with chronic lower back pain
Pregabalin has become the most widely prescribed medicine for ‘neuropathic’, or nerve, pain globally.
Worldwide sales have swelled to $5 billion annually since its approval in 2004.
Pregabalin is commonly used to treat chronic lower back pain syndromes such as lumbar spinal stenosis – the leading reason why elderly people have spinal surgery.
It causes shooting or twinging pains, tingling, and numbness in the lower back, buttocks and legs. These symptoms are often called sciatica.
Professor Christine Lin, of The George Institute for Global Health in Australia, said: ‘We have seen a huge rise in the amount of prescriptions being written each year for patients suffering from sciatica.
‘It’s an incredibly painful and disabling condition so it’s no wonder people are desperate for relief and medicines such as pregabalin have been widely prescribed.
‘But, until now there has been no high quality evidence to help patients and doctors know whether pregabalin works for treating sciatica.
‘Our results have shown pregabalin treatment did not relieve pain – but did cause side effects such as dizziness.’
Other side effects include headaches and feeling sleepy – and even blurred or double vision. Co-ordination and balance problems can also occur – along with weight gain can occur.
Sciatica is caused by irritation of the sciatic nerve – the longest nerve in the body which runs from the back of the pelvis through the buttocks and down each leg to the feet.
It usually happens when one of the shock-absorbing discs that sits between the bones of the spine bulges – or ‘slips’ – and then presses on the nerve.
At any one time around 12 percent of the world’s population has low back pain. It’s estimated up to one-in-ten of these will have sciatica.
The researchers said they carried out the study because they were increasingly concerned about the rise in the use of pregabalin, limited data on its effectiveness and fears over 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 either group. Over one year the amount of days lost from work were also about the same.
Despite the findings almost two thirds of patients on the study reported being very satisfied or satisfied with their drug regimen.
One of the possible serious side effects is suicidal thoughts or actions. Pregabalin is used for a number of painful conditions that include nerve pain.
Despite the findings almost two thirds of participants reported being very satisfied or satisfied with their drug treatment.
Professor Lin said: ‘Over the course of eight weeks the levels of pain patients experienced did decrease but the drop in pain was the same for both those taking the drug and those on placebo.
‘It seems people associate a drop in pain being due to taking a capsule – rather than something which would happen naturally over time.
‘GPs who are prescribing pregabalin should take note of these findings and talk with their patients about other ways of managing and preventing pain.
‘Unfortunately there are no drugs proven to work for people with sciatica and even epidural injections only provide a small benefit in the short term.
‘What we do know is that most people with sciatica do eventually recover with time. It’s also important to avoid bed rest and to stay as active as possible.’
The team found no increase in the risk of self-harm. But the trial was not set up to detect risk of suicide so GPs are advised to exercise caution when prescribing.
Pregabalin is known as ‘bud’ or ‘Budweisers’ by teenage recreational users because it is makes them feel the same high as if they were drunk. It’s been linked to a string of deaths in the UK since 2012.
It’s believed more than three million people a year take it in the UK.
In December 2014 a study by US researchers found there was no significant difference in the levels of back pain experienced by those taking the drug and those who received a placebo while walking on a treadmill.