Does laser therapy or acupuncture help smokers quit?

I’m frequently asked about the effectiveness of acupuncture for stopping smoking, and more recently these questions have been about “laser therapy”. “Laser therapy” uses “cold lasers” instead of needles in an acupuncture-like treatment.

Unfortunately the existing evidence does not support the effectiveness of either of these treatments. The conclusion of the most recent Cochrane review was that:
“There is no consistent evidence that acupuncture, acupressure, laser therapy or electrostimulation are effective for smoking cessation”.
If you want to read the details of that review, click on
http://www.cochrane.org/reviews/en/ab000009.html

If you would like to view a Fox news item on this topic click on:
http://www.freedomlasertherapy.com/video/foxnews.htm

Over 10 years ago, when I was running a tobacco treatment clinic at St George’s Hospital Medical School in London, UK, we did a mini evaluation of a local laser therapy clinic. The clinic claimed very high quit rates, but that didn’t turn out to be the case. Basically I’d advise people wanting to quit smoking not to waste their time and money on laser therapy, but rather to make use of treatments that have been demonstrated to increase your chances of quitting smoking (counseling from a trained professional, NRT, Zyban or Chantix).

My report is reproduced below:

Brief Evaluation of the Laser Therapy Stop Smoking Centre (205 St John's Hill, Battersea).

INTRODUCTION

The charity QUIT, which aims to help and encourage smoking cessation provides a Quitline service. As part of this service smokers can phone the Quitline and be informed of smoking cessation treatment services in their local area. However, QUIT quite correctly do not feel it appropriate to direct customers to centres which make excessive and unsubstantiated claims as to their treatment's efficacy. This issue arose when the Battersea Laser Therapy Centre asked to be included on the QUIT register. QUIT was asked to use its good offices to persuade the Department of Health that Laser Therapy should be available in every NHS and Trust Hospital. The Battersea Clinic's Chief Executive, Mr Barry Murphy claimed that their treatment is about 90% successful and that this had been substantiated by a Department of Trade and Industry consultant. In addition he claimed that the treatment is quick, painless and that there are no withdrawal symptoms. Mr Peter McCabe, Director of QUIT, asked me to look into the treatment and decide whether or not these claims are likely to be accurate.

On discussing this with Mr Murphy he was very willing to be of help and suggested that I send along ten smokers with a serious desire to quit, and that I monitor their success. He also confirmed that the treatment is 90% successful, and that by this he meant that 90% of smokers who attend the clinic stop smoking completely and don't have another puff of tobacco for at least the following year. He admitted that they do not have any hard evidence to back up this claim. Although I was aware that ten subjects is not enough to prove anything, there is ample evidence in the scientific and medical literature suggesting that smoking cessation treatments rarely achieve one year success rates above 30% and therefore if even 6 or 7 of the subjects I sent to the clinic succeeded then that might warrant further investigation.

AIM

To evaluate the likelihood that the Battersea Laser Therapy Clinic achieves 90% one-year smoking cessation success rates.

METHOD

10 volunteer smokers with a strong desire to quit and a willingness to attend the Laser Therapy clinic for treatment were recruited by advertisement at St George's Hospital, Tooting. All the subjects were first of all interviewed by Jonathan Foulds in order to check that they were appropriate to refer to the Laser Therapy Clinic (ie highly motivated healthy smokers who would be willing to attend follow-up appointments).

SUBJECTS

A main subject characteristics are presented in the table. All the subjects stated that their desire to stop smoking was "quite strong" or "very strong", and every one of them had tried before. None of them had any serious concurrent medical problems. As indicated by the range of cigarettes per day and expired carbon monoxide, the sample included both light and quite heavy smokers. Generally, they were a fairly typical group of smokers' clinic clients.

Main Subject Characteristics

Number male/ female: 4/6
Mean Age (range): 34 (18-60)
Mean number of cigarettes per day (range): 20 (7-35)
Mean expired carbon monoxide (range): 16 (5-26)
Mean number of years of smoking (range): 17 (3-40)
Strength of desire to quit (0-4, 4=very strong): 3.6 (3-4)
Mean number of previous attempts to quit (range): 5 (1-20)

PROCEDURE

Once the subjects agreed to participate, an appointment was made for them to attend the Laser Therapy Clinic. It was arranged that in addition to attending the clinic they would be contacted by Jonathan Foulds one week after their "quit date" and then again in 2-3 months time in order to monitor progress. Subjects who claimed to be abstinent were asked to validate this by providing a measure of expired carbon-monoxide with a concentration of less than 10 parts per million.

RESULTS

Participation: All of the subjects attended the clinic at least once (range = 1-4 visits).

Smoking Cessation: At one week follow-up 3 of the 10 subjects had stopped smoking and not had a puff during the previous week. All had appropriately low expired carbon monoxide levels (6, 6 and 4 ppm). Of the other seven subjects one managed four days without a cigarette, three managed two days and three only managed to abstain for one day.
At 2-3 month follow-up only two subjects continued to abstain. All of the other subjects were smoking on a daily basis. Interestingly, the two who managed to abstain were by far the lightest smokers in the group. They had been smoking only 7 and 10 cigarettes per day over the past few years, and had expired carbon-monoxide levels of only 5 and 6 ppm at the pre-quit assessment interview.

Withdrawal Symptoms: Several of the subjects reported that they had experienced nicotine withdrawal symptoms and craving during the first week. For example, one subject said "I had a lot of craving, I was in a foul mood, felt miserable and restless. I had poor sleep and dreamt about smoking." Another commented, "They claimed I'd have no craving or irritability. I was disappointed because I was craving for a cigarette as soon as I left the clinic and felt very irritable... no different to previous times".

General Comments by Subjects: The subjects were generally appreciative of the clinic staff's positive attitude and the encouragement they received from the clinic. They did not find the laser treatment uncomfortable and a number commented on how relaxed they felt during the procedure. Three reported headaches after the first session and wondered whether this might have been caused by the laser. Some felt that the clinic made excessive claims about the treatment, eg one commented, "They claimed to be able to help loose weight, stop taking drugs, stress management, depression etc and gave the impression that the laser would take care of it....it can't be true".

DISCUSSION

The success rates found in this small group (30% at one week and 20% at around 10 weeks) are roughly what one would expect to find in a group of smokers who make a serious attempt to stop smoking on their own without any formal help. The fact that only the two lighter smokers stopped smoking suggests that the treatment lacks any ingredient which treats nicotine dependence. This sample is really far too small to come to any conclusions about the clinic's success rates. However, there is no indication or sign that it contains any unusually therapeutic ingredient and it is clear that the claim of 90% success is completely inaccurate. Similarly, the claim that the treatment eradicates craving and withdrawal symptoms would seem to be inaccurate.

One could argue that anything which encourages people to try to stop smoking is not such a bad thing. However, where this involves conning people into parting with large sums of money (eg £100) on the basis of false claims of high success rates this is clearly not in the public interest. Such individuals may consequently fail to obtain effective help to stop smoking, and deserve the right to make decisions about their treatment on the basis of accurate information.

A review of the effectiveness of acupuncture for smoking cessation (Schwartz, 1988) found only one study which attempted to biochemically validate claimed successes. This study found a success rate of 8% at 13 months. The review also commented, "There is no evidence from this review that acupuncture may relieve withdrawal symptoms. It has not been demonstrated that acupuncture is able to promote smoking cessation". Nothing from this small evaluation suggests that laser therapy is able to promote smoking cessation either.

CONCLUSION

This brief evaluation found no evidence to substantiate the claim that Laser Therapy is 90% effective in helping smokers to quit, or in relieving withdrawal symptoms and craving. In fact the short term success rate was only 20%, and a number of subjects experienced strong craving and withdrawal symptoms.

The Laser Therapy Centre and those who are associated with it should immediately cease to make excessive and unsubstantiated claims about the effectiveness of the treatment and should withdraw any material which makes such claims.



Jonathan Foulds
Chartered Clinical Psychologist
Lecturer in Tobacco Addiction, St George's Hospital Medical School
December 1996

Labels: acupuncture, foulds, laser therapy, nicotine nasal spray smoking cessation

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New study of Chantix in comparison with NRT

Recently there has been some concern over side-effects experienced by a minority of people using Chantix (varenicline). Although Chantix had a remarkably good safety and efficacy record in the clinical trials conducted prior to its launch, those trials excluded patients with complex medical or psychiatric problems (normal practice in pre-approval clinical trials). So when a number of patients (albeit a tiny proportion of the millions who have used Chantix) have reported unpleasant and serious mood disturbances or even suicidal thoughts and acts while taking Chantix since it was launched, this has led to a concern that perhaps Chantix may have more serious side-effects in regular patients with complex medical and psychiatric problems.

A new study by John Stapleton and colleagues was published this week in the journal, Addiction, that addressed this issue. The study reports on the clinical outcomes of 412 patients being treated at a tobacco dependence clinic in London, UK. 204 patients were treated with nicotine replacement therapy (NRT) between May and November, 2006 (prior to Chantix being launched in the UK), and 208 patients were treated with Chantix from January to April 2007. Although the two groups were not randomly allocated to treatments, they were very similar on a number of baseline measures - for example 47% of those treated with NRT were men and 50% of those treated with varenicline were men. The daily cigarette consumption of the two groups was 21 and 22 cigarettes per day respectively. The only signs of baseline differences between the groups were that 69% of those treated with NRT were white, compared with 79% of those treated with Chantix. Those treated with Chantix also rated themselves as being slightly more “determined to quit” at baseline. All of the patients were treated in weekly stop-smoking groups for 7 weeks, with the target quit date coming at the third group meeting. Some of the patients using NRT used “combination” NRT (typically the patch plus either nicotine gum, lozenge, nasal spray or inhaler). At the end of group treatment (i.e. four weeks after the target quit date), 66% of those using a single NRT, 75% of those using combination NRT and 80% of those using Chantix were no longer smoking (not a puff in the previous two weeks). So Chantix produced higher quit rates than a single NRT product, but similar to combination NRT.

111 of these patients were receiving treatment for a mental illness, and the pattern of results for those patients was similar to that of the group as whole, with higher quit rates for those using Chantix. In the whole sample, those using Chantix reported significantly lower craving scores, with no differences on ratings of withdrawal symptoms (e.g. irritability, poor concentration, etc).

An analysis of adverse drug reactions found only one that was more commonly reported with NRT than with Chantix (skin irritation related to patch use). However, 12 symptoms were reported more frequently among those using Chantix. Those symptoms were, nausea (38%), disturbed sleep (30%), vivid dreams (13%), drowsiness (12%), constipation (11%), headache (10%), dyspepsia (8%), dry mouth (7%), bad taste (7%), depression/low mood (5%), diarrhoea (5%), and disorientation/confusion (5%). 7 patients reported moderate/severe anxiety/panic while on Chantix, compared with only one on NRT. Two patient had adverse reactions while using Chantix that were of sufficient severity to be reported to the Medicine’s Regulatory Authority in the UK. One of these was for a “severe psychological reaction likened to a bad LSD trip, including anxiety, paranoia, and confusion.”

It should be noted that around 80% of the patients in this study had previous experience trying to quit smoking using NRT. It is possible that those taking the new drug (Chantix) would have a stronger tendency to note side effects than those using an NRT that they were familiar with.

Overall, these results are broadly consistent with the evidence from clinical trials and post-launch clinical experience with Chantix. They are consistent with the ideas that (a) Chantix may result in slightly higher chances of success in quitting smoking than another single medicine/NRT (b) Quitting success rates on Chantix are broadly similar to those with combination NRT, (c) Chantix results in more side effects than NRT, of which some are common (e.g. nausea, disturbed sleep and vivid dreams) and some less common (<5%) – including depressed mood, disorientation and anxiety. The single patient experiencing a severe psychological reaction while using Chantix may be an indication that such reactions can occur but are rare (<1%).

It should be noted that all of the patients in this study were being treated in a specialist tobacco treatment clinic, within the context of support groups facilitated by experienced clinicians. In that context adverse effects of medications can be monitored, and if necessary patients promptly switched to different medications. Many of the psychological side effects were 3-5 times more common among patients using Chantix than among patients using NRT.

The research continues to show that Chantix is an effective drug for smoking cessation, that offers renewed hope for those who have tried and failed with other treatments. However, I think patients who are not planning on maintaining regular contact with an experienced clinician during their quit attempt (i.e. a clinician who can monitor side effects and provide supportive advice on a regular basis) should give serious consideration to using combination NRT (patch plus one other NRT) as a first choice. This treatment has the advantage that the patient is not taking a “new drug” – just the same one (nicotine) they have been taking, but without the 4000 other toxic chemicals.

Labels: Chantix, cigarette smoking, foulds, nicotine, NRT

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Chantix (varenicline) safety being reviewed by FDA

The issue of Chantix safety and particularly its potential psychiatric side effects have been previously discussed on this blog with many informative comments from Chantix users and their family members:
"Chantix: how does this new stop smoking medicine work?” 4/15/07
http://www.healthline.com/blogs/smoking_cessation/2007/04/chantix-how-does-this-new-quit-smoking.html
“Chantix and mental illness: what are the facts?” 08/12/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/chantix-and-mental-illness.html
“Two new studies of Chantix (varenicline)”. 8/19/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/two-new-studies-of-chantix-varenicline.html
"Does Chantix cause mental health problems?" 9/20/07: http://www.healthline.com/blogs/smoking_cessation/2007/09/does-chantix-cause-mental-health.html
Immediate and delayed quitting. 10/14/07: http://www.healthline.com/blogs/smoking_cessation/2007/10/immediate-and-delayed-quitting.html

On November 20th, the US Food and Drug Administration issued an announcement regarding an ongoing safety review of Chantix, focusing on potential effects on suicidal thoughts, aggressive behavior and drowsiness. The full text of yesterday’s announcements by FDA are attached in quotes below.
This will likely get some more headlines in the media and it is important that consumers and patients understand what this announcement means, and don’t over-react.
This “early communication” is simply stating that FDA are analyzing additional data on the potential link between Chantix and these potential side-effects. It has not concluded that there is any causal relationship and FDA is not recommending that doctors stop prescribing Chantix, nor that patients stop taking it, unless they have reason to believe that they are starting to experience potentially dangerous side effects of the medication,. In that case patients should discuss this with their doctor, bearing in mind that irritability and depression are nicotine withdrawal symptoms that commonly occur on stopping smoking without any medication. The FDA announcements are inside the quotation marks below:

“Chantix (Varenicline)
Audience: Healthcare professionals, consumers[Posted 11/20/2007]
FDA informed healthcare professionals of reports of suicidal thoughts and aggressive and erratic behavior in patient who have taken Chantix, a smoking cessation product. There are also reports of patients experiencing drowsiness that affected their ability to drive or operate machinery. FDA is currently reviewing these cases, along with other recent reports. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in the cases had preexisting psychiatric illness and not all had discontinued smoking. Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking this product should report behavior or mood changes to their doctor and use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them. [November 20, 2007 - Ongoing Safety Review: Varenicline (marketed as Chantix) - FDA][November 2007 - Prescribing Information - Pfizer] :”

“This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug products and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.
FDA has received reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix, a smoking cessation product.
Suicidal Thoughts
The manufacturer of Chantix, Pfizer, Inc., recently submitted to FDA postmarketing cases describing suicidal ideation and occasional suicidal behavior. FDA currently is reviewing these cases, along with a number of recent reports in the popular press and internet sites. A preliminary assessment reveals that many of the cases reflect new-onset of depressed mood, suicidal ideation, and changes in emotion and behavior within days to weeks of initiating Chantix treatment. The role of Chantix in these cases is not clear because smoking cessation, with or without treatment, is associated with nicotine withdrawal symptoms and has also been associated with the exacerbation of underlying psychiatric illness. However, not all patients described in these cases had pre-existing psychiatric illness and not all had discontinued smoking.
Aggressive and Erratic Behavior
FDA is aware of a highly-publicized case of erratic behavior leading to the death of a patient using Chantix to attempt to quit smoking. Although other factors, including alcohol consumption, appear to have played a part in this specific case, FDA asked Pfizer for additional cases that might be similar. We are currently evaluating the material Pfizer submitted in response to our request.
Drowsiness
FDA is evaluating reports from Pfizer of drowsiness in patients taking Chantix. Reports described patients who experienced drowsiness that affected their ability to drive or operate machinery.
FDA recommends the following:
Healthcare professionals should monitor patients taking Chantix for behavior and mood changes. Patients taking Chantix should contact their doctors if they experience behavior or mood changes. Patients should use caution when driving or operating machinery until they know how quitting smoking with Chantix may affect them.

This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. FDA is working with Pfizer, Inc., to further evaluate the potential association between Chantix and suicidal thoughts, aggressive and erratic behavior, and impairment that affects one’s ability to drive or operate machinery. FDA is working to complete the analysis of the materials submitted by Pfizer. As soon as this analysis is completed, FDA will communicate its conclusions and recommendations to the public.

The FDA urges both healthcare professionals and patients to report side effects from the use of Chantix to the FDA's MedWatch Adverse Event Reporting program
online at www.fda.gov/medwatch/report.htm
by returning the postage-paid FDA form 3500 available in PDF format at www.fda.gov/medwatch/getforms.htm to 5600 Fishers Lane, Rockville, MD 20852-9787
faxing the form to 1-800-FDA-0178
by phone at 1-800-332-1088 “

Labels: Chantix, cigarette smoking, foulds, varenicline

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Effects of smoke-free workplace legislation on heart attacks

There is no doubt whatsoever that exposure to other people’s tobacco smoke pollution, over a long period of time, can cause various diseases (as summarized in a previous posts):
Health effects of Tobacco Smoke Pollution. 8/6/07 http://www.healthline.com/blogs/smoking_cessation/2007/08/health-effects-of-tobacco-smoke.html
Sidestream cigarette smoke more toxic than mainstream smoke. 8/8/07 http://www.healthline.com/blogs/smoking_cessation/2007/08/sidestream-cigarette-smoke-more-toxic.html
Make yours a smoke-free home. 08/10/07
http://www.healthline.com/blogs/smoking_cessation/2007/08/make-yours-smoke-free-home.html

Since the growing implementation of workplace smoking bans (with bars restaurants etc being workplaces) there have been a number of reports from around the world finding that the rate of hospitalizations for acute myocardial infarction (MI: a “heart attack”) decreases significantly in areas where these smoking bans are implemented.

These studies have sometimes been based on very small geographic regions and a relatively small number of MIs. For example, a widely reported study published in the BMJ in 2004 found that in Helena, Montana, the number of hospitalizations for MI fell from 40 per half-year before the workplace smoking ban to 24 in the six months the law was in effect. The MI hospitalization rate increased slightly in a part of Montana outside Helena, and increased again (to 38) in Helena when the workplace smoking ban was lifted http://www.bmj.com/cgi/content/full/328/7446/977 .

This month a much larger study found that there were 3814 fewer hospital admissions (an 8% drop) for MIs in New York state in 2004 than would have been expected without the smoke-free workplace legislation implemented in 2003 in New York. http://www.ajph.org/cgi/content/abstract/97/11/2035

One question raised by these findings is whether the effects are caused primarily by fewer MIs in smokers who reduce or quit smoking because of the ban on smoking in workplaces, or whether it is primarily caused by fewer MIs in non-smokers who are no longer having to breath air polluted by tobacco smoke.

Another study published this month suggests that the effect is almost exclusively in non-smokers. This study by Drs Seo and Torabi of Indiana University carefully compared the number of hospitalizations in one Indiana county (Monroe) that implemented increasingly strict smoke-free workplace legislation, with another very similar county that did not pass such legislation (Delaware county). They found that in Monroe county the number of non-smoking MI admissions fell from 17 to 5, whereas it fell from 18 to 16 over the same time period in Delaware. The number of smokers admitted with MIs stayed about the same in both counties. This suggests that the reductions in MIs following these smoking bans is due to the reduction in the cardiotoxic effects of inhaling tobacco smoke pollution in non-smokers (For some reason the authors excluded MIs in people with other pre-existing risk factors such as high BP or cholesterol. I’m not sure why, so if you know, please explain it to me).

While none of the studies finding reduced MIs following smoke-free workplace legislation are perfect, and many are based on a very small number of cases, they are telling a fairly consistent story. The only way the data could fall this way by chance (rather than due to a “real” effect) would be if there was a systematic publication bias (i.e. people doing similar studies with different results not publishing them) or a systematic bias in the research process (e.g. researchers “cherry-picking” the time-frames chosen for comparisons to exclude “data blips” that don’t fit with the claimed results). While such biases do sometimes enter into the research process my inclination is to believe the results when they are almost all pointing in the same direction. So if you are aware of any studies of this issue that found different results, please let me know. But in the mean time the main conclusions appear to be:

1. Non smokers exposed to other people’s tobacco smoke pollution have increased risks of suffering a heart attack.

2. Implementing comprehensive smoke-free workplace legislation not only allows people to work in a safer workplace, it results within a year in a reduced number of non-smokers suffering from heart attacks.

3. If making workplaces smoke-free reduces heart attacks, making homes smoke-free will likely have the same effect.

Have a happy and smoke-free Thanksgiving.

Labels: ETS, foulds, myocardial infarction, tobacco smoke pollution

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