A Soviet-era pill from Bulgaria, used for smoking-cessation, may be the cheapest and most effective method to help cigarette smokers quit their unhealthy habit, according to the first large study of the remedy.
The tablets, called Tabex, have been shown to more than triple a smoker´s chances of quitting. The research could aid in the in the lead to a rush of Internet orders from smokers who are hooked on nicotine.
Tabex uses the drug Cytisine, which is an extract from the laburnum seeds of the Golden Rain acacia that was first marketed in Bulgaria in 1964.
Dr. Robert West, a professor at the University College London whom led the recent study on cytisine, told The Associated Press (AP) that it was discovered by the Soviet Union when it expanded its drug research to Bulgaria. Russian soldiers referred to it as “fake tobacco.”
It is believed the drug could become a new weapon to combat smoking in poor countries, but it remains unclear whether it will ever make it to US or Western European markets.
“It is possible that extensive bureaucracy and overcautious regulations will prevent its use in the U.S. and Europe,” Peter Hajek, director of the Tobacco Dependence Research Unit at Queen Mary University Hospital in London, told AP reporter Maria Cheng.
Currently, Cytisine is only used in Eastern Europe, where smokers usually take the pill for three to four weeks. Generic versions cost anywhere from $5 to $17 per month, compared with about $100 for a two-month supply of nicotine patches or about $300 for a three-month supply of Pfizer´s Chantix pill.
The study, published in the New England Journal of Medicine, tested 740 volunteers from Poland. It found that 8.4 percent of those who were given cytisine for 25 days quit smoking for one year, compared to 2.4 percent in the placebo group.
That success rate is comparable to treatment with nicotine patches and other anti-smoking drugs like Chantix and Zyban, West told Reuters Health.
Cytisine “is so cheap that even in developing countries, if you can afford to smoke, you can afford to stop,” he said.
Although, if a big drugmaker got involved, the price would probably jump, said Hajek.
About 95 percent of smokers who try to quit without a smoking-cessation aid fail to do so within six months, and more than two-thirds of the world´s 1 billion smokers live in developing countries.
Nearly 14 percent of people taking cytisine in the study reported stomach problems such as nausea, compared to 8 percent in the placebo group. Two deaths had occurred in the cytisine group, one from lung cancer and one from cardiac arrest. There were three deaths in the placebo group; one from lung cancer, one from stroke and the third from respiratory illness. Cytisine users also reported more dizziness and sleep problems.
There have been no signs of any serious side effects in the more than 7 million people who have used cytisine in the past 40 years, according to data taken from health agencies in countries where the drug is licensed.
Experts expect Tabex to prove as effective as many existing smoking-cessations aids on the market today and could ultimately save the National Health Service (NHS) tens of millions of dollars annually because the drug is so cheap.
A spokesman with the Department of Health the Guardian: “This drug sounds promising, especially as a lower cost alternative to help smokers to quit in developing countries. We will look at whether the medicine has prospects for use in the UK.”
“We recognize that stopping smoking can be extremely difficult and we hope that by using cytisine as a substitute for nicotine, the results of this trial could transform the health of nations around the globe by offering a practical option, even for the poorest smokers,” West added.
“We need some bigger trials first, but this pill may yet offer a low-cost treatment to help people break this harmful habit,” Doireann Maddock, a senior cardiac nurse at the British Heart Foundation told the Guardian.
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.”
The study was paid for by Britain’s Medical Research Council, while the cytisine and the placebo pills were provided by Sopharma AD.
Cytisine “looks promising, but the jury is still out,” said Dr. Michael Fiore, director of the Center for Tobacco Research and Interventions at the University of Wisconsin, Madison, who had no role in the study. Fiore said that more studies are needed to confirm the findings, but that an inexpensive anti-smoking drug would be useful anywhere.
The World Health Organization reports most of the six million people who die from tobacco each year are located in poor countries. The organization reports that tobacco will likely lead to the premature deaths of about half of the estimated one billion people who currently smoke cigarettes.
Extab, a Sopharma subsidiary, has purchased the worldwide rights to market cytisine in developing nations such as China and India.
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