Headaches Treatment News

2010-10-16 / Headaches / 0 Comments

Ibuprofen May Help Relieve Acute Migraine Headaches

October 12, 2010 — Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of patients, but complete relief in only a few, according to the results of a systematic review reported online October 6 in the Cochrane Database of Systematic Reviews.

“Migraine is a common, disabling condition and a burden for the individual, health services and society,” write Roy Rabbie, from the University of Oxford, United Kingdom, and colleagues from the Cochrane Pain, Palliative, and Supportive Care Group. “Many sufferers do not seek professional help, relying instead on over-the-counter analgesics. Co-therapy with an antiemetic should help to reduce symptoms commonly associated with migraine headaches.”

The goal of this review was to assess the effectiveness and tolerability of ibuprofen, given as monotherapy or together with an antiemetic, vs placebo and other active treatment for relief of acute migraine headaches in adults.

The investigators searched Cochrane CENTRAL, MEDLINE, EMBASE, and the Oxford Pain Relief Database to identify studies published through April 22, 2010. Inclusion criteria were randomized, double-blind trials of self-administered ibuprofen vs placebo or active comparators to treat a migraine headache episode, with outcome data for at least 10 participants per treatment group.

Data were extracted, and methodological trial quality was reviewed independently by 2 investigators. Relative risk and number needed to treat (NNT) or harm vs placebo or other active drug were calculated from numbers of participants achieving each outcome.

The investigators identified 9 studies comparing ibuprofen with placebo or other active drugs, in which a total of 4373 participants were studied during a total of 5223 attacks. None of the identified studies used ibuprofen given together with a self-administered antiemetic. Single doses of medication were used to treat attacks in all identified studies.

Comparing ibuprofen 400 mg with placebo, NNTs were 7.2 for 2 hours pain-free (26% vs 12%), 3.2 for 2 hours of headache relief (57% vs 25%), and 4.0 for 24-hour sustained headache relief (45% vs 19%). Comparing ibuprofen 200 mg vs placebo, NNTs were 9.7 for 2 hours pain-free (20% vs 10%) and 6.3 for 2 hours of headache relief (52% vs. 37%).

The 400-mg dose of ibuprofen offered significantly better 2-hour headache relief than the 200-mg dose. Soluble formulations of ibuprofen 400 mg offered better 1-hour, but not 2-hour, headache relief than standard tablets.

For ibuprofen vs placebo, associated symptoms of nausea, vomiting, photophobia, phonophobia, and functional disability were reduced within 2 hours, and fewer participants used rescue medication. Adverse events were mostly mild and transient and occurred in similar numbers of participants across treatment groups. Two-hour headache relief, 24-hour headache relief, and use of rescue medication were similar for ibuprofen 400 mg vs rofecoxib 25 mg.

Limitations of this review include those inherent in the reviewed studies and that small numbers of events were used to calculate some results.

“Ibuprofen is an effective treatment for acute migraine headaches, providing pain relief in about half of sufferers, but complete relief from pain and associated symptoms for only a minority,” the review authors write. “NNTs for all efficacy outcomes were better with 400 mg than 200 mg in comparisons with placebo, and soluble formulations provided more rapid relief. Adverse events were mostly mild and transient, occurring at the same rate as with placebo.”

Oxford Pain Research Funds, UK, supported this study, along with Pain Research Funds, the National Health Service Cochrane Collaboration Programme Grant Scheme, and National Institute for Health Research Biomedical Research Centre Programme. Some of the study authors report various financial relationships with various pharmaceutical companies, charities, government, and industry sources.

Migraine goldmine for Botox maker

The landscape around the west coast of Ireland is breathtaking enough to wipe years off furrowed brows.

But it is not the rugged Irish scenery that has changed the face of the beauty industry. It is a pristine-looking glass-walled factory set in 12 hectares outside the picturesque town of Westport in County Mayo, which produces the entire world’s supply of Botox.

Kylie Minogue has admitted using it, as have Geri Halliwell, Courteney Cox and Jennifer Aniston, but it is no longer just celebrities looking to iron out the wrinkles in their foreheads.

Since it began production in 1990, the factory has pumped out more than 26m phials of the chemical otherwise known as Botulinum toxin a, generating $500m (£310m) a year for the pharmaceutical firm Allergan. In 2009, at the height of the recession, the company reported 8% earnings growth.

What makes investors “rather ecstatic”, says the chief executive, David Pyott, is that Allergan has grown from a company that relied on “purely reimbursed” business from hospitals and clinics to one that includes a booming cash business of private clients who use Botox and other medical aesthetic treatments under the Allergan umbrella, including dermal-fillers, breast implants and gastric bands. The wealthy always want to look beautiful.

“Even in the depths of the recession, the first half of 2009, the world market [for Botox] only declined 9%,” says Pyott. “In the recession what’s happened is men have spread out their treatments [from every three months to four months] and women have fewer things done.”

The Botulinum toxin, which is produced by the bacterium Clostridium botulinum, works by temporarily paralysing key muscles in the forehead. Pyott, 55, a Scot with a smooth-looking forehead, leads by example and uses it himself.

But it isn’t the beauty treatment that has the company so confident about future growth. It is all its other less sexy applications for Botox – 20 of them in total, including the recently approved application as a preventative medicine for chronic migraine – that opens up another potential goldmine.

There are an estimated 700,000 migraine sufferers in the UK alone reporting chronic head pain – dizziness, nausea and headaches can put someone out of action for up to two days at a time. The chronic form is defined as someone who has 15 headache days a month, of which at least eight are migraine.

Analysts reckon that the migraine breakthrough could generate revenue of between $400m and $1bn by 2015 – almost double the company’s turnover.

Allergan employs 800 staff in Westport but the production of Botox is now so automated that it only requires the direct labour of 80 people. That’s about $625,000 revenue per employee.

“The Botox story is an amazing story and what’s really unusual is that the best may still be to come,” says Pyott, a Glasgow-born lawyer who has been chief executive since 1998.

“Right now our revenues are split 50:50 between cosmetic and therapeutic. But five years from now 70% of our sales may come from therapeutic, and that’s not because the use of Botox will decline.”

Pyott lists off some of the other Botox applications in the pipeline. “It always starts in a severe population,” he says referring to two future therapeutic applications: controlling weak bladders in multiple sclerosis sufferers and crash victims with spinal cord injuries. This is currently in clinical trials as is another weak bladder condition, affecting women over the age of 50.

Many of the discoveries of the use of Botox are by accident. It was discovered that it could erase wrinkles in 1987 after an eye specialist injecting patients to correct crossed eyes reported that a patient’s frown had disappeared.

Another cosmetic application, which was approved in 2008 by the US Food and Drug Administration, was born from an eye-drop product that Allergan makes. Patients reported that one side-effect was longer and fuller eyelashes. Back in the laboratory, Allergan came up with Latisse, which has now been approved in the US and is undergoing clinical trials in Europe.

For Ireland, which is in the throes of one of the worst recessions in the eurozone, the Botox story is important.

One of the reasons that Allergan set up shop in Westport 33 years ago was relocation aid and low corporation tax, which now stands at just 12.5%. Recently the European Union’s European commissioner for economic and financial affairs, Olli Rehn, suggested that this might have to be increased if Ireland was to reduce its gargantuan budget deficit.

But Pyott is unperturbed by the threat of rising taxes: “We have long assumed the rate would go up a couple of points,” he says. Having studied European Union law, he says that Brussels can huff and puff but “at the end of the day, it’s a matter of national sovereignty.”

He is also optimistic about the overall recovery of European markets comparison with those in the US. “Here and there, there are patches of gloom but here in our company we really see no big issues at all,” he says.

“We look at all the statistics very carefully and in fact, looking at the recovery of our markets, particularly those that are cash paid, there is no sign of the infamous ‘double dip’. In fact, I would say most European markets are recovering and growing more quickly than those in the United States.”
The history of Botox

Botox is 21 years old this year, but the bacterium, Clostridium botulinum, from which the product is derived, was discovered as far back as 1895.

By the 1950s scientists discovered the bacteria temporarily relaxed muscles, and so the story of Botox began. Its first medical application was in 1989 to fix crossed eyes and uncontrolled blinking.

The start of its use as a beauty treatment was accidental. An ophthalmologist in Canada treating a woman with crossed eyes noticed that it got rid of the patient’s frowns around the eye area. It was finally unleashed on the market in 2000 and has become a global phenomenon.

But that is only half the story. Botox is also used to alleviate 20 other more serious conditions including foot deformities in children with cerebral palsy; hyper-hydrosis (excessive under-arm sweating) and post-stroke spasticity (twisting of limbs and hands). It is undergoing clinical trials as a treatment for weak bladders in multiple sclerosis sufferers and car-crash victims.

Drug overuse causes headaches

Most people have headaches from time to time. But if you have a long-lasting headache, you may be experiencing a chronic daily headache. Also called “rebound headache,” it is a common disorder related to medication overuse, but it is also the most treatable cause of chronic headaches.

Regardless of the original headache syndrome, overuse of medication is found in approximately one third of patients who develop daily headaches. At general hospitals, 50 to 82 percent of patients suffering chronic daily headaches have experienced drug overuse.

Although the risk could vary depending on the kind of drugs used, any acute headache medication has a potential to lead to rebound headaches. Both prescription and over-the-counter medicines for headaches (such as aspirin and acetaminophen) can cause headaches if you take them too frequently. These medicines should not be consumed on more than two days per week.

Caffeine is an ingredient in some headache medicines. It may relieve your pain for a while but if caffeine or drinks containing it are taken every day, you might suffer headaches more frequently. Even when you stop consuming caffeine, reactive headaches can occur.

It is not clear why rebound headaches occur but scientists suspect that the regular use of medications changes the way in which certain pain pathways and receptors work in the brain. Rebound headaches are not an issue for people who take pain killers on a daily basis for the treatment of other conditions such as arthritis.

Severe rebound headaches occur every day, often waking you up in the early morning. The symptoms can be relieved with analgesics but return as the medication wears off. The location and severity of the headache may change each day. The patients may also have nausea, anxiety, irritability, depression or sleeping problems.

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