ANOTHER MEDICAL FIX NOT SUPPORTED BY EVIDENCE – NICOTINE REPLACEMENT THERAPY (NRT) AND MEDICATIONS TO STOP TOBACCO USE
by Clark Miller
Published September 20, 2018
Updated April 6, 2021; September 17, 2021
Business- and Medical-model industries controlling public healthcare funds send patients wanting to stop smoking to medical visits for prescription medications and nicotine replacement therapy (NRT), like nicotine patches, to reduce urges to smoke, but neither are supported by research as significantly effective and both encourage patient belief in the invalidated medical model of addiction, that belief a key predictor of continued problem substance use.
Health costs of smoking eclipse those of almost all other recognized (the possible exception being compulsive use of food with associated obesity and related health problems) compulsive substance use problems, and worse, include direct links to the opioid crisis. Response to the national opioid crisis generally gets it backwards. Marijuana use, often disallowed by healthcare providers for patients with chronic pain and/or prescription opioid use , is supported by research as providing benefit in managing chronic pain and reducing dependence on opioid medications; in contrast tobacco use, long ignored or enabled by medically-managed programs, is established by research as contributing to development of chronic pain syndromes and as worsening perception of chronic pain.
That research and its importance are not shaping and improving healthcare policy and use of public healthcare funds generally and in some areas most hard-hit by problem opioid and tobacco use.
What does the research say about tobacco use, chronic pain as related to the opioid crisis, and how public healthcare funds should be effectively used to support tobacco cessation ?
Extensive research supports the role of tobacco use in etiology (cause) of chronic pain conditions including fibromyalgia, lower back pain, rheumatoid arthritis and in exacerbated perception of chronic pain(1)
Additional research points to increasing risk of continued or return to problem use of substances including opioids due to tobacco use – acting as a “gateway drug” for opioids (2-4)
Recognition of the research-based links among tobacco use, chronic pain, and problem opioid use has led progressive, evidence-based programs to begin making tobacco cessation services a key component of addressing the opioid crisis (2,4)
2. Pakhale S, Kaur T, Charron C, et al. Management and Point-of-Care for Tobacco Dependence (PROMPT): a feasibility mixed methods community-based participatory action research project in Ottawa, Canada BMJ Open 2018;8
There are many ways that research – especially when interpreted by professionals and writers out of scope of competence to analyze and think critically about research results, that is, without training or experience as researchers – can be distorted, invalid, with illegitimately drawn conclusions and potentially lethal consequences One of those ways is related to the distinction between statistical significance and clinical significance.
Statistical significance refers to the method – essentially the purpose and value of statistical testing – by which a probability value (for example P=.02) represents the confidence of drawing the conclusion of a true (not due to chance in the experiment) benefit, or difference between treatment and no treatment as indicated by the chosen measure for a difference. A probability value of P=.02, for example, would indicate the likelihood of the measured difference not being “real” as only 2%, so we would have relatively high confidence in it being a real difference. It does not tell us about the magnitude of the difference or whether the difference can reasonable be expected to be gained by smokers under realistic natural conditions in their natural settings (“external validity”).
Those magnitudes, or size of benefit, for Nicotine Replacement Therapy (NRT) when treatment results in a statistically significant difference, and for the other medications, are quite small, for example in this study a benefit to 3%, or 3 of every 100 people treated with NRT. Clinical significance typically in these studies is ignored, masked by focus on the statistical measures like odds ratios, confidence intervals, probability (P) values.
If a statistically significant clinical trial outcome established benefit from a type of chemotherapy for cancer for 3% or 5% of treated patients, would or should the treatment be strongly recommended and encouraged and provided to patients? And paid for using public healthcare funds? Or instead would recommendations be to use other treatments with greater clinical significance and to factor quality of life and negative side effects of the treatment into decision-making and recommendations? That is, would there be for each patient a thorough and accurate provision by the medical provider of informed consent ? Informed consent, for example, for smoking cessation that would need to convey to the patient that talk therapy, independently, provides quit rates of at least 7 to 12% and does not involve use of nicotine, and that recent, highly publicized claims for effectiveness of NRT and use of e-cigarettes for smoking cessation are invalidated based on fundamental flaws in experimental design and interpretation.
Apart from the cost in public funds to provide “treatments” for smoking cessation with benefit to only 3 – 5% of patients treated, are there additional costs that would outweigh the very small probability of benefit from the medical-model treatment?
Response to the national opioid crisis generally gets it backwards. Marijuana use, often disallowed for patients with chronic pain and/or prescription opioid use by healthcare providers, is supported by research as providing benefit in managing chronic pain and reducing dependence on opioid medications; in contrast tobacco use, long ignored or enabled by medically-managed programs, is established by research as contributing to development of chronic pain syndromes and as worsening perception of chronic pain.
The research related to effectiveness of NRT and other medications for smoking is extensive
and can be summarized by main points:
– Effects sizes (clinical significance, or number of patients benefitting from the treatment) have always been small. For example in this study 3% of patients reporting cessation of smoking with NRT.
– Additional studies (5-7) provide evidence of no benefit for smoking cessation from NRT.
5. Stanley, T.D. et al. (2016) Evidence of nicotine replacement’s effectiveness dissolves when meta-regression accommodates multiple sources of bias. Journal of Clinical Epidemiology , Volume 79 , 41 – 45.
7. Herd, N., Borland, R. and Hyland, A. (2009), Predictors of smoking relapse by duration of abstinence: findings from the International Tobacco Control (ITC) Four Country Survey. Addiction, 104: 2088–2099
– Because effects sizes (clinical significance) of outcomes for smoking cessation for medications like Chantix and Wellbutrin are generally found to be not significantly larger than those for NRT, their benefit is also insignificantly small.
– Studies routinely combine medication in treatment groups with counseling, the combination typically resulting in more positive outcomes than for the medication alone, and disallowing conclusions about benefit due to the medication alone.
– Individual counseling is effective for smoking cessation, with no indications of lack of benefit, and greater clinical significance than for NRT and medications, one review attributing an increase from 7% success with brief counseling support to 10 – 12% with individual counseling. Those results are for standard counseling for substance use, established as generally ineffective. Use of therapies supported by research and theory as effective would predict larger positive outcomes.
Lack of clinically significant benefit from NRT and medications for smoking cessation was predictable based on evidence available related to compulsive substance use and its treatment.
Compulsive substance use is not a disease or medial condition of any type, instead the behavioral symptom of attempts to manage inner distress. We would not expect medical treatments for entirely non-medical problems to be effective.
More specifically, the presumed effect providing benefit for NRT and the medications is moderation or elimination of urges, or cravings, in the weeks after quitting. But research on course of abstinence and relapse after stopping compulsive use of substances establishes that urges per se are not significant in predicting relapse, instead other factors.
Decades of research establish that the course, triggers for, and pattern of relapse is nothing like that.
I. Part of that research establishes that two primary predictors of relapse are not urges or cravings at all, but instead:
Lack of skills for coping with stress
Belief in the disease model of addiction
II. Additional study of the natural history and correlates of relapse provide evidence inconsistent with predictions of a diseased brain model:
In this survey relapsers to alcohol, tobacco, other substances reported on their experience of antecedents, or “triggers” to use again
“Inner states”, not urges or cravings per say, were reported by 58%. Of those: negative emotions accounted for 37%; urges for 7%
Interpersonal stressors were reported by 42%. Of those: 15% reported conflict; 24% reported social pressure
There were no reports of a sense of “loss of control” or of a brain with baseline urges or compulsions untied to inner or environmental stressors
In summary, results of these surveys highlighted the importance of mood states versus impulses with lack of control, and of situational, environmental stressors especially social stressors.
III. A large survey of individuals who had stopped compulsive use of tobacco, by smoking, provides further evidence inconsistent with the diseased brain fiction. This was a four-country survey of relapsers to smoking from a general, non-clinical population in Australia, Canada, United Kingdom and United States.
There were no effects of urges or severity of smoking (HSI) on relapse risk over days 1 – 30 after stopping “during which nicotine dependence would be most likely to influence quitting success”
Self-efficacy (= self-confidence) had a strong effect (statistically significant), through duration of study, day 1 to 3 years
There was a negative correlation, statistically significant, between self-efficacy and frequency of urges – the stronger a participant’s beliefs about being empowered and competent in making changes, the fewer urges were experienced
In summary, results of this survey disconfirmed urges or impulsivity as a factor, even over the first 30 days after stopping, when the diseased or “hijacked” brain would be most vulnerable to those factors, instead confirmed deficiency in self-confidence, or belief in one’s ability to stop smoking as a strong factor, consistent with other findings that establish belief in having a chronic, relapsing disease as a factor predicting relapse.
These results establish the importance of two key factors in predictions of long-term effectiveness versus harm to smokers receiving treatment for compulsive tobacco use – the effects on sense of self-efficacy, a predictor of success in stopping substance use, and effects on belief in the fictional disease model of compulsive substance use, predicting relapse.
Takeaways: visits to a medical office and provider to be prescribed a medical treatment for smoking cessation predicts harm due to
– clinically insignificant or lack of benefit from the treatments
– introduction or reinforcement of belief in the fictional disease model of substance use, a predictor of relapse
– and diminished self-efficacy, treatment consisting of a passive medication intervention as a substitute for focus on patient investment, collaboration, and active changes in behaviors and self-management of internal stressors and environmental stressors
Counseling or psychotherapy interventions predict long-term benefit due to
+ small but clinically significant benefit from treatment, no evidence for lack of benefit
+ gains in self-efficacy inherent in patient-centered treatment and cognitive and behavioral therapy interventions
+ avoidance of pathologizing of behaviors or patient, no reinforcement of disease model
Americans have been trained
to accept as important, valid and crucial to their health the advice of medical professionals, trained by mass media and culture to believe in the false promises of pills or other medical cures for all ailments, from compulsive smoking, to sadness, to chronic pain , and continue to be trained as the associated lethal epidemics worsen.
They do not likely realize that some 70% of complaints in primary care settings are idiopathic, that is, with no identifiable physical or biomedical cause or treatment.
They may not realize that the assurances of medical fixes for “addiction” are based on invalidated, fictional medical models and are without support.
Or that the false assurances of effectiveness of and safety of opioid pain medications for chronic pain were never supported by evidence, were pure fiction from the beginning.
The effectiveness, value and ethical use of a treatment and its individual and public health benefit or harm are determined by its profile of effects, not by selected, context-free, misleading statistical values from cherry-picked studies.
Public betrayal by misuse of “research” gave us the opioid crisis.
Medical encounters with medical professionals by trusting patients
for the potentially lethal condition of compulsive tobacco use, in medical settings, for help to stop smoking predictably reinforce in them false hope and self-defeating beliefs:
that compulsive substance use is a medical condition or disease state
that there are effective medical treatments for substance use
decreasing their motivation to accept and make the behavioral and social changes required to overcome compulsive substance use
increasing risk of return to problem substance use (“relapse”) based on belief in the invalidated disease model of substance use
decreasing their motivation and inclination to access evidence-based psychotherapies for substance use and mental health problems
increasing risk of using ineffective or harmful biomedical interventions for entirely non-medical problems: from smoking and other substance use problems, to depressed or anxious mood, to chronic pain – generating an opioid crisis
Despite the evidence, a triumphant medical-media collusion with the cultural capital to arbitrarily create “knowledge” and public messaging and understanding about healthcare, is highly successful in ensuring that Americans will be misled to continue to access ineffective medical treatments for non-medical problems and that profits and power will be protected.
Costs of harm to public health include not only direct costs of ineffective treatments, but costs tied to the links among tobacco use, chronic pain, opioid misuse, and the associated costs of problem opioid use.
Talking about and challenging these lethal fictions and scams, these threats to public health, requires taking back control of language, of understanding, and of cultural capital to support and protect public health, to begin to use language that constructs true and accurate pictures of American healthcare. Language that penetrates the false sheen of decency, expertise and authority that perpetuates harm.
Words to take the power back.
“Crisis is a necessary condition for a questioning of doxa, but is not in itself a sufficient condition for the production of a critical discourse.”
– Pierre Bourdieu Outline of a Theory of Practice (1972)
In Bourdieu’s Theory of Practice, heterodoxy is dissent, challenge to what “goes without saying” – the accepted, constructed doxa, “knowledge”, reality, that goes without saying precisely because it “comes without saying”, without real scrutiny, untested, unquestioned. The function of doxa is not knowledge or truth or promotion of the collective good, but to protect and serve the interests of those with the power, the cultural capital, to create it.