Q:How safe are the nicotine patches for stopping smoking? Do they really work? J McB, Washington, DC…….

A:As you no doubt know, a number of US and UK companies have nicotine replacement patches on the market to help smokers quit.

These patches, which look a bit like a medium sized square bandage, get placed once a day on a hairless area of your body above the waist or outer upper arm. Depending on the dose you get (from 7 to 44 mg per day of nicotine) the patches provide a continuous drip feed of nicotine “replacement”. The idea is that you stop smoking immediately, but that you are “weaned” off nicotine after six weeks at your starting dose by substituting a lower dose every two weeks. At the 7 mg dose level, you quit the patches.

The short answer is that, yes, these plastic patches can help smokers to quit. The long answer is that we haven’t a clue how well they work, which smokers they best help and how safe they are for individuals. What we do know is that they may be more potentially dangerous than doctors generally make them out to be.

A number of studies have now been completed on the effectiveness of patches, and two recent ones, published in the Journal of the American Medical Association, contradict each other. The first, from the Mayo Foundation, in Rochester, Minnesota, found that standard patch doses (of 15 to 22 mg of nicotine per day) don’t provide the full fix that the average smoker requires. The higher the patch dose, the better the outcome; and smokers who supplement their patch use with nicotine gumdo even better still. Those smokers who substituted an equivalent nicotine replacement with the amount of nicotine they’d inhaled every day as smokers had higher quit rates. According to Dr John Hughes, of the Department of Psychiatry, the University of Vermont at Burlington, who wrote an editorial in the same issue of JAMA, these results accord with what is known about methadone therapy with heroine addicts: the higher the dosage of methadone, the better the outcome.

However, in the second study, from the Center for Tobacco Research and Intervention at the University of Wisconsin Medical School in Madison, Wisconsin, the best clinical trial of higher dose patches to date, says Dr Hughes, there was no difference in long term quit rates between the 22 mg patches or those with double the dosage, except when patients cold turkeyed with the patches and had no other counseling or therapy.

The average quit rate when you use the patch alone (with self help materials) appears to be somewhere in the region of 26 per cent, a respectable number similar to the 29 per cent achieved in earlier studies (JAMA, February 23, 1994). These rates are quoted as being twice those achieved by patients using placebo and three times those who try to cold turkey on their own. However, these results don’t stick, and a high percentage of smokers relapse; according to one study of patients using the patch under their doctor’s instructions, only 12 per cent were still off cigarettes two years later (J Smok Rela Disord, 1992; 3: 241-5)

The Center for Tobacco Research and Intervention found that smokers who were able to completely abstain from smoking during the first two weeks of smoking, particularly week two, were more likely to stay off cigarettes than those who carried on during the initial weeks of therapy (JAMA, February 23, 1994).

Although the Wisconsin study found that quit rates increased another 8 per cent when doctors offered brief advice and follow up about quitting, this study found no increase in quit rates when patients participated in group behaviour therapy.

However, another review of two studies ( Chest, 1994; 105: 524-33) ) and a meta analysis (The Lancet, 1994; 343: 139-42) found higher quit rates when behaviour therapy was added to use of the patch. In the former, patients getting the group counselling achieved a three fold quit rate over those just using the patch.

Although the patch can help, it is not the most effective form of nicotine replacement. According to this meta analysis, which pooled the results of 53 separate studies, people using the transdermal patch were twice as likely to quit smoking as controls, which was better than those using nicotine gum, but not as good as those using a nicotine nasal spray or inhaled nicotine (two systems undergoing testing), who were three times as likely to quit.

It’s important to keep in mind that although all these methods are termed “nicotine replacement therapy”, the patch delivers only about half to three quarters of the nicotine you get from smoking, according to Hughes. It also doesn’t give you the direct hit you get from cigarettes; once you start on patches, according to Dr Jack Henningfield, of the Addiction Research Center, Johns Hopkins University School of Medicine in Baltimore, Maryland, it takes two to three days to achieve the maximum doses of nicotine from the patch, and even then you won’t achieve the high blood concentrations produced by smoking tobacco (New Eng J Med, November 2, 1995).

This means that you will be getting enough nicotine to stop the usual withdrawal symptoms of a heavy smoker anxiety, depression, irritability, sleepiness, inability to concentrate which can last up to four weeks when you quit smoking on your own to levels that might be equivalent to the withdrawal symptoms you’d experience after four to six weeks of stopping. And although they will at least sustain your tolerance level, and so reduce the need for cigarettes, it won’t be nearly as much as you received as a smoker to stop all craving.

With the patch, you don’t get your instant lift that you do with a cigarette (eight seconds, compared to the several hours from the patch).

One of the big worries,says Dr Hughes, is the amount of nicotine released in your blood from a patch. How much you absorb depends a great deal on your individual makeup, particularly how much you weigh; fatter people, naturally, have lower levels of circulating nicotine from the patches than thin people. Dr Hughes says these levels can vary five fold (JAMA, Letters, April 21, 1993).

The biggest danger for healthy patients is nicotine overdose, causing bad headaches, dizziness, upset stomach, diarrhea and vomiting, blurred vision and poor hearing, mental confusion, weakness and even fainting and possibly even fatal heart problems. These symptoms are more likely if you smoke using the patches, and almost half do, according to one study (JAMA, February 23, 1994).

Says the London based market consultants Datamonitor, this practice “turbo charges” cigarettes. A number of Americans have died from heart attacks while having this sort of double dose of nicotine, and in fact there have been at least two reports of deliberately overdosing on the patch as a form of suicide (JAMA, letters, July 21, 1993).

Even without smoking, there is the risk of heart failure or atrial fibrillation (total disorganization of the electrial impulses to the chambers of the heart, causing highly rapid heart beat), even if you don’t have a prior history of heart disease.

In one case, a heart attack occurred in a 39 year old man without a history of heart disease (BMJ, March 11, 1995). One 55 year old woman with no history of heart problems or hypertension developed severe atrial fibrillation requiring hospitalization within five hours of first putting on her patch (JAMA, April 21, 1993).

And of course, these risks multiply if you suffer from a heart problem or hypertension already. This is because nicotine alters blood circulation through your arteries, increases blood pressure and heart rate, increasing the oxygen demands to your heart. Besides a heart attack, it also increases the risk of a blood clot. One study of healthy young volunteers using nicotine gum showed significant short term changes in blood flow pattern and stiffening of the arterial wall soon after the volunteers started chewing similar changes to those caused by smoking.

This study, by the Centre for Biological and Medical Systems at Imperial College, London, puts paid to the argument that it is the carbon monoxide and other gases absorbed during smoking that is responsible alone for heart problems.

Marion Merrell Dow warns that patients should be carefully screened and evaluated before nicotine replacement is prescribed. You should only have, at most, patches of 14 mg per day for six weeks if you have cardiovascular disease, weight less than 100 pounds or smoke less than a half pack a day.

There is also the (admittedly small) risk of becoming addicted to your patch, as has been reported with nicotine gum.

Besides heart problems, up to 9 per cent of patients experience diarrhea, abnormal dreams, muscle pain or lack of strength, back pain, chest pain, constipation, nausea, dizziness, increased cough, sore throat, rash and abnormal menstrual periods.

Twenty nine per cent of patients develop headaches while on the patch, says Dow, and a fifth of patients on 24 hour patches have sleep disturbances, which can be avoided by taking the patch off at night, says Dr Henningfield.

The other worry is the ability of other drugs to alter the amount of nicotine in the blood. Propanolol, the beta blocker, and the contraceptive pill may increase blood concentrations unexpectedly (N Eng J Med, 1988; 319: 1318-30).

Dow also warns that skin reactions, which are common enough in the patch by itself, can increase if you are using more than one patch, such as those for HRT.

If you think these problems are bad enough, beware of unlicensed nicotine patches, which are being sold by mail order.

The National Addiction Centre in London found a wide disparity in the content of these products. None has undergone regulatory scrutiny, and after eight hours some brands delivered no nicotine to the blood whatsoever.

When all is said and done, patches remain the least effective method of stopping. Researchers at the University of Iowa, analyzing results from 600 studies covering 72,000 people from US and Europe the largest ever scientific comparison of stop smoking found that hypnosis was the most effective method of giving up smoking, with an average success rate of 30 per cent. (After 50 plus years of smoking, the 78 year old mother of WDDTY’s editor quit two years ago through hypnosis and has never looked back.)

After hypnosis, exercise and breathing therapy came second, carrying a success rate of 29 per cent, smoke aversion (where smokers have to chain smoke, have their stale smoke blow back at them, and the like) followed next with 25 per cent, and acupuncture after that, at 24 per cent. This suggests that stopping the nicotine addiction is only a small part of kicking the habit.

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Written by What Doctors Don't Tell You

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