Background
Summary of Council decision:
Seven issues were investigated of which five were Upheld and two were Not upheld.
Ad description
A leaflet, for The Royal London Hospital for Integrated Medicine (RLHIM) was headed "Medical and Clinical Hypnosis" and made a number of claims for the therapy.
Issue
The Nightingale Collaboration challenged whether the following claims were misleading and could be substantiated:
1. "Hypnosis can benefit almost anyone to improve their physical, emotional and mental health";
2. "Research has shown that hypnosis can help regulate various systems of the body, such as the Immune System, Nervous System and Gastro-intestinal System";
3. "The following medical problems have been shown to benefit from the use of medical hypnosis: Gastrointestinal Disorders
Irritable Bowel Syndrome - Chronic Functional Abdominal Pain - Gastro-oesophageal Reflux Disease - Functional Dyspepsia";
4. "[The following medical problems have been shown to benefit from the use of medical hypnosis:] Chronic Pain
Headache - Oral and facial pain - Neuropathic pain - Neuralgia - Fibromyalgia - Rheumatic pain";
5. "[The following medical problems have been shown to benefit from the use of medical hypnosis:] Cancer Pain";
6. "[The following medical problems have been shown to benefit from the use of medical hypnosis:] Skin Conditions
Eczema - Psoriasis - Urticaria - Itching";
7. "[The following medical problems have been shown to benefit from the use of medical hypnosis:] Chronic Fatigue Syndrome (referral through the CFS Service)".
Response
1. The RLHIM said they intended to amend the claim "Hypnosis can benefit almost anyone to improve their physical, emotional and mental health" to "Hypnosis can benefit a variety of physical and emotional health problems", because they believed that it was more accurate and better reflected the use of Medical and Clinical Hypnosis at the RLHIM.
2. - 7. The RLHIM provided the ASA with numerous clinical studies and research papers, which they believed supported the claims in the leaflet.
Assessment
1. Upheld
The ASA has accepted that hypnotherapy could help relieve anxiety, confidence issues and minor skin conditions for example those exacerbated by stress. Although we acknowledged that those conditions were likely to be mental health related, we considered that the claim, as it appeared, would be understood to cover a broader range of mental health conditions and that hypnosis would benefit severe problems. We had, however, not seen evidence to support that interpretation. We noted RLHIM proposed to amend the claim by removing the words "mental health", but we were nonetheless concerned that the intended wording, "Hypnosis can benefit a variety of physical and emotional health problems", exaggerated the potential benefit. We considered that it was still likely to be understood to be a claim that hypnosis would always be of benefit to a variety of physical and emotional health problems, rather than a claim that hypnosis could be of help in some cases.
The claim in the leaflet, "Hypnosis can benefit almost anyone to improve their physical, emotional and mental health", also gave the impression that, even if their physical health was already high, most people were likely to improve it by hypnosis; we saw no evidence to support that interpretation. We also considered that consumers were likely to understand from the claim that hypnosis would improve any existing physical conditions and not just their physical well-being.
We concluded that the claim "Hypnosis can benefit almost anyone to improve their physical, emotional and mental health" exaggerated the potential benefit to patients' mental and physical health and was therefore misleading.
On this point the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products).
2. Upheld
We understood that stress and anxiety could affect the immune system, nervous system and gastrointestinal system, but while we accepted that hypnotherapy could help with anxiety and stress, we had nonetheless not seen evidence to show that it regulated systems of the body. The evidence sent by RLHIM consisted of meta-analytic studies and reviews, but the research analysed in those articles was not provided.
Although hypnotherapy was a benefit to anxiety and stress problems that affected immune, nervous and gastrointestinal systems, the evidence did not support the claim that it helped regulate those systems. We therefore concluded that the claim "Research has shown that hypnosis can help regulate various systems of the body, such as the Immune System, Nervous System and Gastro-intestinal System" was misleading.
On this point, the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products).
3. Upheld
We noted the claim "The following medical problems have been shown to benefit from the use of medical hypnosis", which preceded the claims in Issues 3 to 7, referred to the medical conditions themselves rather than to patients with those problems. We considered that the claim gave the impression that hypnosis would have an impact on the condition itself by treatment or cure, whereas we understood from the evidence provided by RLHIM that hypnosis might have a benefit on the symptoms of the condition by helping patients cope with discomfort or pain, management of the condition or to help avoid a reoccurrence of the condition by using coping mechanisms. We noted from the research that, while some people might indeed benefit from hypnosis to cope with the pain caused by a condition or illness, the medical condition itself was unlikely to be eliminated.
Irritable bowel syndrome (IBS) is one of the most common functional gastrointestinal disorders, with a wide range of symptoms, some of which overlap with other gastrointestinal disorders. We understood that lifestyle changes, such as diet and physical activity, could help in controlling the symptoms. We noted the National Institute for Health and Clinical Excellence (NICE) clinical guidelines on irritable bowel syndrome recommended considering referral for psychological interventions (cognitive behavioural therapy [CBT], hypnotherapy and/or psychological therapy) for people with IBS whose symptoms did not respond to pharmacological treatments after 12 months and who develop a continuing symptom profile (described as refractory IBS).
RLHIM provided the ASA with a review by The Cochrane Collaboration, which evaluated the efficacy of hypnotherapy for the treatment of IBS, by looking at the results of four clinical studies with 147 participants. Hypnotherapy was either compared with standard treatment of IBS, with supportive psychotherapy, or with no treatment. The Cochrane Review concluded that the studies provided some evidence that suggested that hypnotherapy might have a beneficial short-term effect in treating IBS symptoms including abdominal pain, but this had not been convincingly proven and the results of the studies should be interpreted with caution due to poor study quality and small size.
A second study 'Hypnotherapy for Children With Functional Abdominal Pain or Irritable Bowel Syndrome: A Randomized Controlled Trial' (Arine M. Vlieger et al.) compared clinical effectiveness of hypnotherapy with standard medical treatment in 53 children, aged eight to 18 years, with either Functional Abdominal Pain (FAP) or IBS. Pain intensity, pain frequency and associated symptoms were monitored, with the results at the end of the study showing that pain intensity and frequency and symptoms had decreased in both groups, but with a greater reduction in the hypnotherapy group. We noted that only 22 children with IBS and 31 with FAP took part in the study, half of whom received standard medical treatment. We considered the sample size was not large enough to show the effectiveness of hypnotherapy on IBS or FAP.
We noted that we had not seen any evidence to support the claim that medical hypnosis could benefit Gastro-oesophageal Reflux Disease.
We understood that Functional Dyspepsia (FD) was pain in the upper abdomen, the cause of which was unclear. The report provided by RLHIM, 'Long-term Improvement in Functional Dyspepsia Using Hypnotherapy' (Emma Louise Calvert et al.), was a study of 126 FD patients randomised into groups of hypnotherapy, supportive therapy plus placebo medication or medical treatment; 33 patients dropped out of the study. Symptoms such as pain severity and frequency, nausea, poor appetite, early satiety, bloating and belching were recorded, as well as quality of life in regards to psychological and physical well-being and mood. The study concluded that FD symptoms improved, with the exception of nausea, in the long term compared to the other two groups. The quality of life also improved significantly. However, we considered that one clinical study was not sufficient to show the effectiveness of hypnotherapy on FD symptoms.
We noted the quality of the studies varied significantly, but each had shown that hypnotherapy/hypnosis had some effect on helping patients to deal with the pain or discomfort from their conditions. However, we considered that the studies had not supported the claim that medical hypnosis could treat or cure gastrointestinal disorders. We therefore concluded that the claim "The following medical problems have been shown to benefit from the use of medical hypnosis: Gastrointestinal Disorders - Irritable Bowel Syndrome - Chronic Functional Abdominal Pain - Gastro-oesophageal Reflux Disease - Functional Dyspepsia" was misleading.
On this point, the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products).
4. Not upheld
We understood that chronic pain was defined as pain that persists beyond healing time needed to recover from an injury or as pain associated with an ongoing chronic disease or degenerative process. RLHIM provided a number of studies on burn pain control, but we understood that such pain was defined as 'acute pain' associated with a specific injury and expected to be short lived, resolved once the injury has healed. They also provided studies on the use of hypnotherapy in child birth, also defined as acute pain rather than chronic pain. Although we noted the studies showed hypnotherapy helped patients to cope with pain control, we disregarded them in this investigation as the claim referred specifically to chronic pain.
One of the papers RLHIM provided was an analysis of a number of studies into hypnosis and chronic pain, together with some studies. The conclusions of a study on tension headaches that we saw, together with the conclusions of the paper, claimed that changes in perceived pain control were associated with pain reduction. Although we had not seen the other studies mentioned in the paper, we considered on the evidence provided that although hypnotherapy was unlikely to treat or cure the underlying cause of pain, it helped with perceived pain control and perceived pain reduction.
We noted the conclusions of a study on Chronic Orofacial Pain (COFP) patients showed a significant reduction in pain scores, completed by the participants, in the hypnosis group compared to the control group, who had relaxation therapy. During the trance state, attempts were made to improve the hypnosis group's coping methods and stress management.
RLHIM provided a paper on neuropathic pain – pain arising from the sensory system – but we noted it stated that hypnosis in the treatment of neuropathic pain symptoms had not been systematically assessed in controlled clinical trials but in uncontrolled trials and reports. We also noted that we had not seen any evidence to support the claim that medical hypnosis could benefit Neuralgia.
A clinical trial on Fibromyalgia, widespread muscular pain, concluded that hypnotherapy might be useful in relieving symptoms in patients with the condition. Compared with the patients in physical therapy group, the patients in the hypnotherapy group reported a better outcome with respect to their pain experience, fatigue on waking and their sleep pattern, but the report noted that those feelings nonetheless remained abnormally strong in some people.
The study undertaken on patients with rheumatic pain, which RLHIM provided, was conducted on 12 people, which we considered was too limited in size to demonstrate the effects of hypnosis on this condition; the study itself acknowledged that because of the limited number of participants, other studies should be conducted. Nonetheless, we noted the conclusion that hypnosis treatment might have a positive effect on pain and quality of life for patients.
We noted the body of evidence varied in quality and in sample size and did not support the implication that hypnotherapy could treat or cure the conditions listed, but nonetheless considered that, overall, it suggested that a claim that hypnotherapy could help with the management of pain, and therefore the perceived relief of pain, was likely to be acceptable.
We considered that it was clear that the claim "[The following medical problems have been shown to benefit from the use of medical hypnosis:] Chronic Pain … Headache - Oral and facial pain - Neuropathic pain - Neuralgia - Fibromyalgia - Rheumatic pain" was referring specifically to pain caused by the conditions listed rather than implying that hypnosis could treat or cure the underlying condition. We therefore concluded that the body of evidence provided by RLHIM supported the claim that hypnotherapy could help with the management and perceived relief of pain associated with the conditions listed and the claim was not misleading.
On this point, we investigated the leaflet under CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products), but did not find it in breach.
5. Not upheld
RLHIM provided a number of clinical trials involving children and adults with cancer which looked into reducing acute pain, distress and anxiety, and helping pain management by hypnotherapy. The studies covered invasive medical procedures, such as bone marrow aspirations and lumbar punctures, and patients with metastatic breast carcinoma.
Observational and self-reported measures were used in most cases to monitor pain and anxiety before and after procedures, or at regular intervals during the study. The results concluded that hypnotherapy was generally successful in reducing pain and anxiety, particularly in children undergoing invasive medical procedures, but it did not eliminate those symptoms entirely.
We considered that the body of evidence provided by RLHIM supported the claim that hypnotherapy could help with the management and perceived relief of cancer pain, as well as anxiety, associated with painful cancer treatment. It was clear from the claim that it was referring specifically to pain caused by cancer rather than implying that hypnosis could treat or cure the underlying condition.
We therefore concluded that the claim "[The following medical problems have been shown to benefit from the use of medical hypnosis] - Cancer Pain" was not misleading.
On this point, we investigated the leaflet under CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products), but did not find it in breach.
6. Upheld
The ASA has accepted that hypnotherapy can help people with minor skin conditions, for example those exacerbated by stress, but, to date, we have not seen evidence to show that it can help with more serious skin conditions such as psoriasis.
RLHIM provided two studies, one consisting of 11 and the other 18 patients. Both studies stated that further testing on larger sample sizes was needed. We considered that these studies, plus a review of hypnosis in dermatology also provided, were not suitably robust to show that hypnotherapy might help people with Psoriasis or to substantiate the claim that it could treat or cure the condition. We therefore concluded that the claim "[The following medical problems have been shown to benefit from the use of medical hypnosis] - Skin Conditions ... Psoriasis" was misleading.
On this point, the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products).
7. Upheld
We noted the sample size of the two studies provided on the effects of hypnosis on Chronic Fatigue Syndrome were particularly small; one was a study involving one participant and the other involved three patients.
We considered that the studies were not suitably robust and a sample size of only four people was not adequate or large enough to demonstrate the effects of hypnotherapy on Chronic Fatigue Syndrome. We therefore concluded that the claim "[The following medical problems have been shown to benefit from the use of medical hypnosis] - Chronic Fatigue Syndrome" was misleading.
On this point, the leaflet breached CAP Code (Edition 12) rules 3.1 (Misleading advertising), 3.7 (Substantiation) and 12.1 (Medicines, medical devices, health related products and beauty products).
In summary, we considered that the body of evidence provided by RLHIM, as a whole, had supported the notion that hypnotherapy might help people to cope with and manage pain, and with perceived relief of pain. However, we considered that the leaflet had misleadingly implied more: that hypnotherapy could treat or cure the conditions listed, an interpretation for which we had not seen suitably robust evidence.
Action
The leaflet must not appear again in its current form. We told RLHIM to ensure that they held robust evidence to substantiate efficacy claims in the future.
