Monday, October 22, 2012

Comprehensive Review of Effectiveness of Intensive Behavioral Intervention and Pharmacotherapy for Smoking Cessation Finds an 87.5% Failure Rate, But Fails to Report or Comment on This Result

In a comprehensive review of the effectiveness of combined pharmacotherapy and intensive behavioral intervention for smoking cessation published as a Cochrane review, the authors report that the combination of nicotine replacement therapy (NRT) or other smoking cessation drugs and behavioral counseling or support is twice as effective for smoking cessation as usual care, in which there is only a brief cessation component but no other behavioral support and no medication.

(See: Stead LF, Lancaster T. Combined pharmacotherapy and behavioural interventions for smoking cessation. The Cochrane Library 2012, Issue 10.)

The methods and results of the study are summarized as follows:

Objectives: "To assess the effect of combining behavioural support and medication to aid smoking cessation, compared to a minimal intervention or usual care, and to identify whether there are different effects depending on characteristics of the treatment setting, intervention, population treated, or take-up of treatment."

Search methods: "We searched the Cochrane Tobacco Addiction Group Specialised Register in July 2012 for records with any mention of pharmacotherapy, including any type of NRT, bupropion, nortriptyline or varenicline."

Selection criteria: "Randomized or quasi-randomized controlled trials evaluating combinations of pharmacotherapy and behavioural support for smoking cessation, compared to a control receiving usual care or brief advice or less intensive behavioural support. We excluded trials recruiting only pregnant women, trials recruiting only adolescents, and trials with less than six months follow-up."

Results: "Forty-one studies with a total of more than 20,000 participants met the inclusion criteria. ... Most studies provided NRT. ... One large study (the Lung Health Study) contributed heterogeneity due to a substantially larger treatment effect than seen in other studies (RR 3.88, 95% CI 3.35 to 4.50). Since this study used a particularly intensive intervention which included extended availability of nicotine gum, multiple group sessions and long term maintenance and recycling contacts, the results may not be comparable with the interventions used in other studies, and hence it was not pooled in other analyses. Based on the remaining 40 studies (15,021 participants) there was good evidence for a benefit of combination pharmacotherapy and behavioural treatment compared to usual care or brief advice or less intensive behavioural support (RR 1.82, 95% CI 1.66 to 2.00) ... ."

The study concludes: "Interventions that combine pharmacotherapy and behavioural support increase smoking cessation success compared to a minimal intervention or usual care. ... clinicians should encourage smokers to use both types of aid."

The Rest of the Story

Despite the length and comprehensiveness of this review, published in the reputable Cochrane Library, there is one piece of critical information that was omitted from the review. In fact, I would argue that it is the single most important piece of information that readers need to know.

What the article fails to reveal to the reader is the answer to the most basic and vital question of all:

What was the average success rate for combined pharmacotherapy and behavioral support?

Believe it or not, the answer is not found in the text of the paper. In fact, to derive the answer, I had to do the calculations myself.

I included only studies in which smoking cessation was biochemically validated because it is widely recognized that smokers over-report true cessation rates in studies like these.

It turns out that if you pool all the studies in which smoking cessation was biochemically validated (27 of the 40 studies), the overall success rate for combined pharmacotherapy and behavioral support (the best of the best of what is currently available and sanctioned by the public health establishment) is only 12.5%.

Put another way, the treatment that this review recommends for all patients and about which the review boasts has a dismal 87.5% failure rate.

It seems to me that any conclusion other than that this treatment was not very effective is a biased one that does not do justice to the scientific integrity of the reporting of the research findings.

And to completely hide the fact that the approach was found to have an 87.5% failure rate seems to me to demonstrate an immense bias in favor of this strategy. Why would the article fail to even mention to the reader that the intervention actually failed for more than 87 of every 100 smokers?

Sure, the fact that the intervention was twice as effective as usual care is technically correct, but it hardly gives the reader and the public an accurate sense of the value of the intervention as a population-based approach to smoking cessation.

This story illustrates the way in which the anti-smoking movement has been systematically distorting the presentation of the science in order to create the false perception that Big Pharma-produced drugs are an effective strategy for smoking cessation. Usually, this deception of the public is associated with researchers or groups that have financial conflicts of interest with Big Pharma. In the present case, these are non-conflicted researchers who apparently have been so brainwashed by the workings of the anti-smoking movement that they can write pages and pages of text without providing the single most important result that is most critical to the review.

The rest of the story is that this review confirms what I have previously argued: the scientific evidence demonstrates that smoking cessation drugs, even when combined with intense behavioral support - are dismally effective for smoking cessation. They fail about 90% of the time. And this is under the most advantageous situation, in which the drugs are being used as part of a closely monitored research study. In "real-life" situations, these drugs are even less effective.

But the anti-smoking movement doesn't want you - the public - to know this fact because it would threaten its huge financial windfall that it receives from the pharmaceutical companies.

Ironically, while the best of the best in terms of NRT and behavioral support is now known to succeed in only about 12.5% of cases, electronic cigarettes were found to result in a six-month cessation rate of 22.5% among unmotivated smokers. Yet NRT continues to be the favored approach by anti-smoking researchers, anti-smoking groups, and federal health agencies including the FDA, while electronic cigarette use is heavily discouraged.

No comments: