A website for an acupressure wrist band, www.sea-band.com, stated "Sea-Band Drug Free Nausea, Motion Sickness and Morning Sickness Relief Band ... Using Sea-Band couldn't be simpler: put the acupressure band around your wrist and see your nausea symptoms subside ... Learn more about Sea-Band for relieving your motion sickness, morning sickness or cancer nausea and vomiting".
The complainant, who did not believe that the product could relieve nausea, motion sickness, morning sickness, cancer nausea and vomiting, challenged whether the ad was misleading.
Sea-Band Ltd (Sea-band) submitted over 40 studies and two e-mails from the Medicines and Healthcare products Regulatory Agency (MHRA), which they believed substantiated the claims that the product could relieve nausea, motion sickness, morning sickness, cancer nausea and vomiting. They believed the claims were further supported by the fact that the product was in accordance with Annex X of the Medical Devices Directive 93/42/EEC."
The ASA considered that the claims that the acupressure band could relieve nausea, motion sickness, morning sickness, cancer nausea and vomiting were medical claims that needed to be supported by robust, scientific evidence, consisting of clinical trials conducted on people, in order to substantiate them. The e-mails from the MHRA suggested that the product was in accordance with Annex X of the Medical Devices Directive 93/42/EEC. However, while medical devices were regulated by health regulators such as the MHRA, marketing communications were assessed by the ASA against the Advertising Codes and in light of the response and substantiation provided by the advertiser. We noted the studies submitted and sought expert advice.
The expert believed that there was some evidence of superiority over placebo or no treatment for at least one outcome measure in relation to the claims that the product could relieve and prevent motion sickness and, by inference, travel sickness. He believed that was also true of claims that the product could relieve and prevent morning sickness, relieve cancer nausea and vomiting (or chemotherapy-induced nausea and vomiting) and relieve general nausea. However, he also indicated that due to the nature of the intervention in question, positive outcome judgements could well reflect positive bias and inflation of effectiveness. We noted those trials which the expert indicated were good quality in terms of adequately controlled experiments on humans, or systematic reviews of such studies, and reviewed those to determine whether they met the standards required by the ASA to substantiate health claims.
The expert indicated that the body of evidence supplied to support motion sickness included one adequately controlled experimental human study which used 64 participants. He also said another study not related specifically to motion sickness could be used as strong evidence for P6 acupressure as a superior treatment over placebo. He stated “On balance there is evidence to substantiate the claim that the product can relieve and/or prevent motion sickness and by inference travel sickness”. In both studies, participants were rotated in either an optokinectic drum or a chair, in order to provoke a feeling of sickness. The results indicated that P6 Acupressure reduced nausea and vomiting. However, the adequately controlled study related to manual, rather than band acupressure and indicated that the mechanism of any positive outcome measure was unknown and showed no significant difference in the severity of symptoms between the placebo and control conditions. The other study involved women only who were at high risk of post-operative nausea and vomiting and concluded that no difference could be demonstrated between P6 acupressure and placebo.
We considered that the evidence was insufficient to substantiate claims that the product was effective in relieving or preventing symptoms of motion sickness experienced by general sufferers. We concluded that the claims had not been substantiated and were therefore misleading.
The expert indicated that the body of evidence supplied to support morning sickness included at least one adequately controlled randomised study on 97 women. He stated “On balance there is evidence to substantiate the claim that the product can relieve and/or prevent morning sickness”. The study was carried out on pregnant women who had experienced nausea for at least one week before the trial. The results indicated that 71% of the active group reported that their morning sickness was less intense while using the wristbands, compared to 63% in the placebo group. A reduction in intensity was also measured with 71% in the active group and 59% in the placebo group and the conclusion indicated that the hours of discomfort seemed to be reduced. However, the ad stated that the product could relieve morning sickness, rather than reduce its duration, and the results relating to both were not statistically significant. Furthermore, two women in the active group reported feeling more sick during the study period and discussions indicated that there were possible sources of bias. The conclusion stated that the results could not support claims of a substantial effect of acupressure on morning sickness.
A review of four studies into the effectiveness and safety of all interventions for nausea, vomiting and retching in early pregnancy was also included but the conclusions indicated that evidence regarding the effectiveness of P6 acupressure was inconsistent and limited. Because we had not seen robust evidence demonstrating that the wristbands were effective in relieving morning sickness we considered the claims had not been substantiated and concluded that they were misleading.
Cancer nausea and vomiting
The expert indicated that the body of evidence supplied to support cancer nausea and vomiting included one adequately controlled randomised study that demonstrated that P6 acupressure was superior to transcutaneous electrical stimulation and four studies that P6 acupressure was superior to no treatment. He stated “On balance there is evidence to substantiate the claim that the product can relieve cancer nausea and vomiting (or chemotherapy-induced nausea and vomiting). Generally, the effects on nausea are more consistent than those on vomiting”. We considered the claims that the product could relieve cancer nausea and vomiting implied that the product could relieve symptoms caused by the cancer itself. However, the studies submitted related to nausea and vomiting caused by cancer treatments, while the one referred to by the expert as a good quality trial related to radiation-induced nausea. Whilst we considered that referring to nausea and vomiting caused by cancer treatments as "cancer nausea and vomiting" was misleading, we reviewed the study as we understood they were intended to refer to the nausea and vomiting caused by radiation therapy.
The study was carried out on 88 patients and its objective was to boost the efficacy of acupressure bands by providing positive information to the subjects; a hypothesis that was not successful. Fifty-nine patients received the acupressure bands while 29 did not and tests indicated that those wearing the acupressure bands had a significantly greater reduction in average nausea. The conclusion extended these findings to the population of patients experiencing radiation therapy-induced nausea. However, all ancillary treatments, including antiemetic medications for the control of symptoms caused by the cancer or cancer treatments were allowed for all patients. We were concerned that with the presence of medications that reduced nausea and vomiting, any positive outcome measures were unable to be attributable to the acupressure bands alone. The discussions also indicated that while the acupressure bands were helpful there were limitations to the study, including the possibility that positive findings were inaccurate due to report bias on the patient's part. It also indicated that the study was not adequately controlled, because it was not blinded, and that there was a lack of control for the size, site and dose per fraction of the radiation fields patients received. Various other limitations were further highlighted.
One adequately controlled study and a systematic review of studies looked at the efficacy of acupressure wristbands on chemotherapy-induced nausea and vomiting. However, acupressure showed no benefit for vomiting. The study reported positive outcome measures for both the control and sham group, indicating the presence of a significant placebo effect, and the review highlighted concerns about the contribution of placebo effects, the lack of a sham control in some studies and whether the reduction of acute nausea severity was a true finding or a function of performance bias in unblinded patients.
Because we had not seen robust evidence demonstrating that the wristbands were effective in relieving nausea and vomiting associated with either the cancer disease or cancer treatments, we considered the claims had not be substantiated and concluded that they were misleading.
General nausea and vomiting
The expert indicated that the body of evidence supplied to support the claims about cancer nausea and vomiting included six adequately controlled randomised studies that demonstrated that P6 acupressure was superior to placebo. He stated “On balance, the evidence in the documents substantiate the claim that the product can relieve general nausea and especially post-operative nausea”. We considered that readers would understand from the claims relating to nausea and nausea symptoms that the product could relieve general feelings of nausea and sickness regardless of their causes. However, all six studies related to post-operative nausea and vomiting. We considered that the conditions in which nausea and sickness were experienced were likely to be varied and dependent on the nature of the conditions suffered by the patients, the associated surgical operations and the type and dose of any anaesthetics or medications administered, and were therefore not comparable to nausea and symptoms of nausea as experienced generally by otherwise healthy individuals. Furthermore, all six studies indicated that there was no significant difference found between the reduction of nausea in the P6 acupressure groups and placebo acupressure groups.
Because we had not seen robust evidence demonstrating that the wristbands were effective in relieving general nausea and nausea symptoms, we considered the claims had not been substantiated and concluded that they were misleading.
Although we noted the expert indicated that superiority over placebo or no treatment had been demonstrated on some outcome measures in some studies, the ASA considered that efficacy claims for the product needed to be substantiated by a statistically significant superiority over any placebo effects. We acknowledged that, while the studies indicated some instances of P6 acupressure reducing symptoms of nausea and sickness in some people, these were largely attributable to the placebo effect. We also considered that such evidence should be consistent and noted from the studies submitted that other bodies of evidence existed that contradicted positive outcome measures for the reduction of nausea using P6 acupressure. We concluded that the claims that the product was effective in relieving nausea, motion sickness, morning sickness, cancer nausea and vomiting (or cancer-treatment induced nausea and vomiting) had not been substantiated with sufficiently robust evidence and therefore concluded that they were misleading.
The ad breached CAP Code (Edition 12) rules
Marketing communications must not materially mislead or be likely to do so.
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.
Marketing communications must not mislead consumers by exaggerating the capability or performance of a product.
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. (Medicines, medical devices, health-related products and beauty products).
The ad must not appear again in its current form. We told Sea-Band not to claim that the product could relieve nausea, motion sickness, morning sickness, cancer nausea and vomiting, unless they held robust, clinical evidence to substantiate them.