A nicotine substitute which can be bought online for just 12p can more than triple a smoker’s chances of quitting for at least a year, new research has shown.
Tabex, which contains the active ingredient cytisine, is obtained from laburnum seeds.
Experts believe the drug is as effective as conventional stop-smoking treatments and could save the NHS millions of pounds a year.
But despite four decades of use in eastern Europe, the pills are unlikely to be available on prescription in the UK for another two to three years.
The British scientist who led the new trial spoke of the “Alice in Wonderland” regulatory system responsible for the delay.
Professor Robert West, from the Cancer Research UK Health Behaviour Research Centre at University College London, said he expected to see a flood of internet orders for Tabex once news about the drug got out.
“It’s been available in central and eastern Europe for more than 40 years, we have safety data on millions of people, and we know it’s effective, but it’s not licensed in Britain,” he said.
“People can make their own choices. A licence is not a licence to buy, it’s a licence to market. There’s nothing illegal about buying this drug online, but there’s always the risk that you might not get what you expect.”
The Medicines and Healthcare products Regulatory Agency (MHRA), which licences drugs for sale in the UK, warned of the risks of buying unregulated drugs over the internet, however.
A spokesman said: “People are advised that they should take prescription-only medicines after an appropriate consultation with their GP.
“Only healthcare professionals can take into account risks and benefits associated with every medicine.
“Anyone who self medicates and buys their medicines from internet sites could be in danger of receiving counterfeit or substandard medicines.
“At best these will be a waste of money, at worst they can kill. You don’t know what these products contain and you don’t know in what conditions they have been made.”
The trial, involving 740 patients, showed that people who wanted to stop smoking were 3.4 times more likely to succeed with Tabex than with a “dummy” placebo tablet.
Participants took between two and six pills per day for 25 days. After treatment, 8.4% of those given Tabex were able to avoid smoking for a year compared with 2.4% of the placebo group.
The low overall success rates reflected how hard it was even for motivated smokers to quit, said the researchers.
NEWS UPDATE:
(Reuters Health) – Cytisine, an extract from the seeds of the Golden Rain acacia that was first marketed in Bulgaria in 1964, can give smokers an inexpensive assist in kicking the habit, according to the first large modern study of the drug.
In the test on 740 volunteers, published in the New England Journal of Medicine, 8.4 percent of those who were given cytisine for 25 days stayed off cigarettes for one year, compared with 2.4 percent in the placebo group. http://www.nejm.org/doi/full/10.1056/NEJMoa1102035
That success rate is comparable to treatment with nicotine patches and other anti-smoking drugs like varenicline (Chantix) and bupropion (Zyban), chief author Robert West of the University College London told Reuters Health.
Chantix is sold by Pfizer Inc and Zyban is a GlaxoSmithKline product.
It also costs much less — a month of cytisine pills, sold in Central and Eastern Europe under the brand name Tabex, costs about $15 in Poland and $6 in Russia. Nicotine patches and pills to stop smoking typically sell for more than $100 per treatment, depending on the country.
“This is off-patent. In theory, anyone can grow this stuff. The pills can be made for practically nothing,” West said.
The drug is not approved in the United States, Japan or Western Europe.
Smoking kills an estimated five million people worldwide each year, and 95 percent of people who try to quit without help fail to stay off tobacco for six months or longer. Most can’t afford some of the drugs found to be effective in improving the quit rate.
Although some previous studies have suggested that cytisine can help smokers quit, they have not been definitive.
“Cytisine has been lurking in the background in tobacco control for quite a while,” said Thomas Glynn, director of international cancer control for the American Cancer Society, who was not connected with the new research.
“There has never been a large well-conducted study done before. This isn’t definitive, but it’s a breakout study for cytisine.”
Because the price is so much lower than other treatments “this will be huge in low-income countries where the tobacco companies are focusing a lot of their effort now,” he told Reuters Health in a phone interview. “With replication, this can make a real difference in public health.”
HALF A PACK, DAILY
The new study was done on volunteers who smoked 10 or more cigarettes per day. At the smoking-cessation clinic of the Maria Sklodowska-Curie Memorial Cancer Center in Warsaw, the patients were given information about the medicine and tips on how to deal with nicotine withdrawal and cravings.
During the first three days, they were told to take six 1.5 milligram tablets per day, and then begin to taper off cigarettes, with the goal of stopping smoking on the fifth day. Participants continued to take the pills for about three more weeks.
The manufacturer, Sopharma AD in Bulgaria, provided the drugs for the trial.
The patients were judged to have stayed off cigarettes if they reported they had smoked fewer than five cigarettes per month during the year after they stopped taking the pills.
A carbon monoxide breath test, which can detect smoking during the previous day, was used at the six- and 12-month marks to check for abstinence.
The sustained abstinence rate at the one-year mark was three and a half times higher among those getting cytisine than placebo. When the researchers just looked at whether the volunteers were not smoking, the rate was 13.2 percent with cytisine treatment compared to 7.3 percent among placebo patients.
The risks of death, hospitalization and other serious side effects were small and comparable in the two groups. However, complaints of upset stomach, dry mouth and nausea were more common. Nonetheless, a comparable number of people in both groups discontinued treatment.
The researchers cautioned that the study was not large enough to identify uncommon side effects for the drug, which has already been used by more than seven million people.
“There have been reports of neuropsychiatric adverse events, including suicidal ideation, with varenicline, which is a similar class of drug,” they said. “Although the incidence is not higher than would be expected by chance, it seems appropriate to continue to undertake surveillance for such rare events among persons taking cytisine.”
West and Glynn said taking cytisine for more than four weeks might be even more effective.
“We used a dosing schedule over four weeks that is licensed in Poland which, nowadays, would be considered very short,” said West. “So the question is whether moving on to see if you can get better success with 12 weeks, or with the addition of behavioral support, which we know adds quite a bit to the overall effectiveness,” he said.
“But this “is a very useful starting point.”
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