Background
Summary of Council decision:
Two issues were investigated, both of which were Upheld.
Ad description
A website www.lifeprinciples.com for a hypnotherapy and bioresonance practitioner contained claims in relation to treatments for substance abuse, drug addiction, alcoholism, smoking, gambling, weight loss, insomnia and depression.
Issue
The complainant challenged whether:
1. the ad discouraged essential treatment for conditions for which medical supervision should be sought, because they understood that the advertiser was not medically qualified; and
2. the claims relating to the efficacy of the advertiser's treatments for smoking cessation were misleading and could be substantiated.
Response
1. Life Principles Ltd stated that there were many holistic and alternative natural solutions available for those who wished to seek a route to regain health without the need to resort to medication, which would be a personal choice for the individual. They stated that they did not offer diagnosis of clients' conditions; their clients would approach them as a last resort when all other avenues failed them. Life Principles said that they provided clear pre-appointment instructions to their clients, such as not driving, and ensured best possible aftercare.
Life Principles considered that they were suitably qualified to deal with all substance and process addictions. They stated that they were not a doctor and asserted that they did not make claims in their ads that they were a doctor, and did not consider it necessary to hold a general medical qualification to carry out the services that they provided.
Life Principles said that they were a fully certified Neuro-Linguistic Programming (NLP) practitioner and held a Post Graduate Diploma in Clinical Hypnosis from the International Institute of Clinical Hypnosis. Life Principles also provided a list of relevant qualifications and training that they had undertaken, including hypnotherapy, hypnoesitherapy and Timeline technique.
Life Principles further stated that they were a member of the Hypnotherapy Register, an organisation representing over 8,000 hypnotherapists globally, and that they had indemnity insurance for the laser, bioresonance and hypnotherapy treatments that they offered. Life Principles stated that they were formerly a member of the NHS Directory of Complementary and Alternative Practitioners and the General Hypnotherapy Register where they received regular peer reviews of members' skills. They stated that they were willing to rejoin those organisations if required by the ASA.
Life Principles stated that they had 12 years of practical experience in hypnotherapy. They also used other methods, including laser, three bioresonance systems, coMra therapy, miHealth and VisionPro, all of which they had training certificates for. They stated that going forward, they would include a legally binding contract in their pre-appointment documentation that the client would inform their doctor prior to the commencement of the programme and ensure that the doctor would be kept informed of their progress through the 12-month period. They would also include all information the client would need in an emergency, such as the NHS number, the addresses of the nearest A&E and 24-hour walk-in centres.
2. Life Principles explained that they used four different treatment methods for smoking cessation. These were mainly hypnotherapy, backed by low-level laser therapy and two different bioresonance systems, all of which independently enjoyed relatively high success rates. They said that the main focus of the treatment was to identify the circumstances under which clients acted on the habits that they wished to break and to break those patterns; this was carried out under hypnosis. The low-level laser therapy, which they stated was similar to acupuncture where the laser was applied to certain points to stimulate a reaction, acted as a 'safe guard' in circumstances where hypnotherapy failed. They also explained that the two different bioresonance frequency systems complemented the hypnotherapy and laser treatment; one system required a physical substance such as nicotine, to remove the memory of the substance from the body, and consequently cravings, after a couple of sleep cycles, and the other system holistically balanced the body. They stated that the four methods were used together to increase the chances of success, as even if one method failed, another would continue to be effective as demonstrated by their high success rates. Life Principles also said that they did not count a client as being a "success" until they had the client's confirmation that they were no longer smoking three months after the treatment and that they monitored clients' carbon monoxide readings.
Life Principles quoted summaries of a number of published studies in journals that measured a high percentage of success rates for smoking cessation using hypnosis. Some of the summarised studies also found that hypnotherapy patients were twice as likely to remain smoke-free after two years and hypnosis was the most effective for smoking cessation when compared against drug intervention and unaided methods.
Life Principles stated that their low light laser therapy had been approved by NHS Scotland for smoking cessation treatments, and had been found to be more successful than any other drug based method. They said that bioresonance was administered commonly to assist people in quitting cigarettes, cannabis, gambling, alcohol, designer drugs, cocaine, crack cocaine, heroin and methadone. They further stated that bioresonance was a very highly regarded form of therapy in Germany and throughout Europe; it was used in childrens' hospitals in China and also by the Russian military in treating recruits with addiction issues. They also provided extracts of news reports on the use of laser therapy and bioresonance in smoking cessation treatments, two studies involving trials on human subjects that examined the efficacy of laser therapy and bioresonance separately, and links to free online resources for self-hypnosis. They provided a summary of a meta-analysis of trials relating to hypnosis for smoking cessation and an extract from a news programme on the use of low-light laser therapy in Scotland, which stated that over half of those who had undergone treatment at the time had quit smoking.
Life Principles believed that the efficacy of these techniques in assisting smoking cessation were undoubted as they followed similar treatment protocols as other practitioners who had scientific backing. Life Principles also raised examples of other practitioners, some of whom offered treatments based on psychology alone, and some of whom used bioresonance, laser therapy or hypnosis. They stated that given they used all three systems in a unique manner, their results were likely to be greater than using just one method.
They said that they administered the same treatments as those examined in the studies provided and also used NLP, Timeline and Clean Language techniques within deep hypnosis. Life Principles incorporated in-house techniques to guide their clients out of their habits by removing all negative emotions from their past by preventing them from using the habit as an emotional crutch. They explained that once the negative thoughts had been removed, that process could not be undone.
Life Principles stated that they had comprehensive data on the success rates of their techniques on their clients, including testimonials, follow-up interviews and carbon monoxide measurements in cases of smoking cessation treatments. They provided details of their client success rates between January 2014 and March 2015 and client case studies. They also provided 67 clients' video testimonials and pointed out that most of the clients mentioned they had quit after one two-hour session and were genuinely surprised by the results.
Assessment
1. Upheld
The ASA were minded the CAP Code required that marketers must not discourage essential treatment for conditions for which medical supervision should be sought. The Code also required that marketers must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment was conducted under the supervision of a suitably qualified health professional. We considered the following conditions referred to in the ad were conditions for which medical supervision should be sought: alcoholism, substance abuse or addiction to cocaine, crack cocaine, cannabis, recreational drugs or designer drugs, and gambling addiction.
We understood that there were not currently any statutory regulatory bodies for hypnotherapists, NLP practitioners or therapists who offered bioresonance and laser treatments. There were, however, a number of trade bodies and registers for hypnotherapists and NLP practitioners, some of which implemented a code of ethics with a complaints handling procedure with registration systems based on differing standards for training and qualifications. We noted Life Principles' comments that they considered they were suitably qualified for treatments for substance and process addictions for the purposes of CAP Code rule
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
However, we had not seen sufficient documentary evidence which demonstrated that Life Principles were suitably qualified to offer these treatments or that the treatments for these conditions were conducted under the direct supervision of a medical professional.
The ad contained the following text under the title "A Known Fact": "The orthodox method of treating addictions simply does not work for the vast majority of people. This is because the orthodox method involves a huge amount of misery, pain - and even desperation ... You can overcome your addictions, quickly, easily and effortlessly without physical, emotional or financial pain. All you need is the desire to change your life by ... giving a leading-edge scientific method a try. We do the rest". The ad also contained the wording "the reason it can take so long for 'society' to catch on when there are better ways of doing things is our natural tendency to suspect the new and rely on the 'expert' in the 'establishment'". We considered that when this wording was read within the context of the ad, it was likely to be interpreted as meaning that alternative forms of treatments, such as those offered by Life Principles, were preferable and more effective in treating the conditions referenced in the ad than conventional methods, due to the ease of these alternative treatments and the lack of psychological and financial burden.
On the basis that we had not seen evidence that the treatments were conducted by a suitably qualified health professional and the ad contained references which implied that alternative forms of addiction treatments were more effective and less arduous than conventional forms of treatments, we considered that the ad discouraged essential treatment for conditions for which medical supervision should be sought. We therefore concluded the ad breached the Code.
On this point, the ad breached CAP Code (Edition 12) rule
12.2
12.2
Marketers must not discourage essential treatment for conditions for which medical supervision should be sought. For example, they must not offer specific advice on, diagnosis of or treatment for such conditions unless that advice, diagnosis or treatment is conducted under the supervision of a suitably qualified health professional. Accurate and responsible general information about such conditions may, however, be offered (see rule
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
).
Health professionals will be deemed suitably qualified only if they can provide suitable credentials, for example, evidence of: relevant professional expertise or qualifications; systems for regular review of members' skills and competencies and suitable professional indemnity insurance covering all services provided; accreditation by a professional or regulatory body that has systems for dealing with complaints and taking disciplinary action and has registration based on minimum standards for training and qualifications.
((Medicines, medical devices, health-related products and beauty products).
2. Upheld
The ad contained the following claims: "Quit Cigarettes In A Day", "Quit Smoking ... Quit smoking with our proven treatment, literally in hours. No nicotine patches or gum, no inhalers or nasal sprays, no needs or pills", "Using a combination of Hypnotherapy, NLP, Timeline, Laser & Bioresonance and laser therapy, it is entirely possible to overcome any substance or process addiction [...] in a single day. We have been enabling people to quit cigarettes ... in one single day for over 10 years". The ad also described the treatments offered by Life Principles as "proven treatment" and "leading-edge scientific method". We considered that consumers were likely to interpret these claims to mean that they would be able to successfully quit smoking with the advertiser's treatment methods, and that those methods were scientifically proven to work within a short timeframe, such as a few hours or within a day, without the need to use other conventional smoking cessation aids.
The ad also stated "you can overcome your addictions quickly, easily and effortlessly without physical, emotional or financial pain. All you need to do is the desire to change your life by travelling to Birmingham and giving a leading-edge scientific method a try. We do the rest". We considered that, when this wording was read in conjunction with the efficacy claims for smoking cessation, it implied that smoking cessation through the advertiser's treatments would be effortless and that the habit could be broken without self-control on the part of the smoker.
We noted Life Principles quoted summaries of a number of published studies cited on the website for the International Certification Board of Clinical Hypnotherapy, and the success rates of the subjects in quitting smoking and post-treatment abstinence through the use of hypnosis in these studies, and the summary of a meta-analysis of hypnosis trials. Although the cited studies appeared to have measured a high percentage of success rates and some evaluated that hypnosis were more effective than other means of smoking cessation treatments, we had not been provided with the full studies and so were unable to assess whether they were robust enough to support the advertising claims. We noted the claim in the news extract, but a full report of the trial had not been provided; we considered that a television news report in itself did not constitute sufficiently robust evidence.
One study published in the Journal of Chinese Medicine submitted by Life Principles examined the use of low-level laser in smoking cessation by stimulating acupuncture points. There were 417 subjects recruited via an appeal on a local television programme, with the primary inclusion criteria being smokers who wished to give up smoking and had not previously received laser treatments. Twenty-eight were excluded from the study on the basis that they were under 16 years of age, pregnant or had other uncontrolled medical conditions and 47 withdrew partway through the trial or did not attend any of the treatments. The trial appeared to have been double-blinded and randomised, and included a control group. The subjects were asked to attend four treatment sessions with follow-up sessions at three and six months post-treatment, and reply to a questionnaire at 18 months. They were divided into three groups: the first group received laser treatment using an active probe in the first three sessions and a sham probe in the last session; the second group received treatments using the active probe in all four sessions; and the treatments were performed on the last group using a sham probe in all four sessions. Physiological measurements, such as pulse, blood pressure and peak flow, were recorded prior to each treatment. The results suggested that the number of subjects who continued to display non-smoking behaviour in the second group had the least decrease in smoke-free behaviour amongst the subjects over the three- and six-month period, in comparison to the other test groups.
Although the study found that the results from the stages immediately, three months and six months post-treatment were statistically significant, we noted that the measurements of changes in subjects' smoking behaviour were based on them self-reporting; means of biochemical validation of their progress had not been used. Further, the results from the 18-month point post-treatment were deemed insufficient for statistical analysis. The study also commented that because it was a self-selecting sample, notwithstanding its large size, there were doubts as to the applicability of the outcomes of the study on the general population.
The other published study provided by Life Principles was a pilot study which examined the efficacy of MORA bioresonance therapy in smoking cessation. There were 190 subjects, all of whom were smokers who wished to quit. They were divided into a control group who were subjected to simulated bioresonance treatments and a treatment group who received active bioresonance treatments. The study appeared to have been randomised and double blinded, and the results, obtained through the use of questionnaires, were taken at one week, two weeks, one month and one year post-treatment. The study found that the improvements in health and the subjective expectation toward treatment effectiveness were significantly more positive in the treatment group than in the control group. However, we noted that the sample group was self-selected, the findings were self-reported and the carbon monoxide level in participants' blood was not monitored to validate their reported behaviour over the course of the trial. We understood that bioresonance therapy was purported to operate through the use of weak and low frequency electromagnetic oscillations on a biophysical level. However, we had not seen detailed evidence to support the claimed physiological effects of bioresonance therapy.
We also considered Life Principles' own client case studies and testimonials. Life Principles submitted data for all their clients, from January 2014 to March 2015, who had sought smoking cessation treatments, some of whom also had substance addiction. They stated that 56 clients were seen in this period, 55 were followed up on and 43 (73%) had quit smoking after their session and were still non-smokers three months post-treatment.
Although the majority of clients in the case studies reported that they had quit smoking three months after receiving Life Principles' treatments, some of the comments in the case studies suggested that clients had also relied partly on their willpower and their cravings had not been completely eradicated after a single treatment session. Some of the clients also sought the advertiser's treatment for other conditions, such as anxiety, use of cannabis, Class A drugs or anti-depressant medication, whilst also using other medication. We also noted that some clients required more than one treatment session and a small number reverted back to smoking after the three-month follow-up point. Furthermore, we considered that the case studies were not sufficiently robust to demonstrate the long-term effects of Life Principles' treatments, specifically whether their clients maintained abstinence for a long period of time after a single session as suggested by the claims, as there were no indications from the information available of any formal monitoring in place, including detailed measurements of carbon monoxide level, to track continued abstinence post-treatment.
Further, we had not seen any evidence on the efficacy of incorporating Neuro-Linguistic Programming (NLP), Timeline and Clean Language techniques with the other treatment methods used by Life Principles for smoking cessation.
On this basis, we considered that the body of evidence submitted by Life Principles was not sufficiently robust to substantiate the claims that consumers would successfully give up smoking after a single session without much participation or action on their part. Further, we considered the studies were not adequate to support the claims that the advertiser's treatment techniques were "proven methods", due to the weaknesses of the trials considered above. For these reasons, we concluded the claims were misleading.
On this point, the ad breached CAP Code (Edition 12) rules
3.1
3.1
Marketing communications must not materially mislead or be likely to do so.
(Misleading Advertising),
3.7
3.7
Before distributing or submitting a marketing communication for publication, marketers must hold documentary evidence to prove claims that consumers are likely to regard as objective and that are capable of objective substantiation. The ASA may regard claims as misleading in the absence of adequate substantiation.
(Substantiation),
12.1
12.1
Objective claims must be backed by evidence, if relevant consisting of trials conducted on people. Substantiation will be assessed on the basis of the available scientific knowledge.
Medicinal or medical claims and indications may be made for a medicinal product that is licensed by the MHRA, VMD or under the auspices of the EMA, or for a CE-marked medical device. A medicinal claim is a claim that a product or its constituent(s) can be used with a view to making a medical diagnosis or can treat or prevent disease, including an injury, ailment or adverse condition, whether of body or mind, in human beings.
Secondary medicinal claims made for cosmetic products as defined in the appropriate European legislation must be backed by evidence. These are limited to any preventative action of the product and may not include claims to treat disease.
and
12.8
12.8
Marketers must hold proof before claiming or implying that a minor addiction or a bad habit can be treated without effort from those suffering.
(Medicines, Medical Devices, Health-related Products and Beauty Products).
Action
The ad must not appear again in its current form. We told Life Principles Ltd to ensure that future ads did not make efficacy claims that implied guaranteed success for their treatments unless they held robust evidence to substantiate the claims. We also told Life Principles to ensure that their advertising did not offer treatment or discourage essential treatment for conditions for which medical supervision should be sought.
