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Advertising, expectations and informed consent: the contents and functions of acupuncture leaflets
  1. Felicity L Bishop,
  2. Cathy Salmon
  1. Centre for Applications of Health Psychology, University of Southampton, Southampton, UK
  1. Correspondence to Dr Felicity L Bishop, Centre for Applications of Health Psychology, Faculty of Social and Human Sciences, Building 44 Highfield Campus, University of Southampton, Southampton SO17 1BJ, UK; F.L.Bishop{at}southampton.ac.uk

Abstract

Objective To evaluate the content of patient information leaflets about acupuncture.

Methods 401 patient information leaflets were obtained from practising UK acupuncturists and subjected to content and thematic analysis.

Results 59% of included leaflets were from NHS physiotherapists. Almost all the leaflets defined acupuncture and the majority explained how it might work, described the treatment process and placed it in a historical context. Most described possible benefits and risks of acupuncture and discussed contraindications and safety. Just under a third of leaflets (120, 30%) suggested conditions that might be helped by acupuncture, most commonly musculoskeletal pain, arthritis and injuries. By emphasising differences between individuals in acupuncture treatments and responsiveness, the leaflets fostered hope for positive effects without making any guarantees.

Conclusions Information leaflets are broadly consistent with the evidence for acupuncture, but some claims are inconsistent with official advice from advertising regulators. An ethically sound, scientifically grounded and psychologically effective leaflet should accurately convey both benefits and risks of treatment, optimise patients’ expectations and allay concerns about needling. This study suggests that acupuncture leaflets might achieve these multiple functions but care should be taken to ensure adequate coverage of risks.

  • ACUPUNCTURE

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Introduction

Acupuncture in the UK is a diverse practice which is delivered in multiple settings (eg, National Health Service, private sector), from various theoretical perspectives (eg, traditional Chinese medicine, Western acupuncture) and by different groups of professionals (eg, doctors, physiotherapists, acupuncturists). Patients deciding to try acupuncture are thus faced with choosing from many possible options1 and value advice and recommendations from their social contacts, or lay referral networks.1 ,2 However, use of acupuncture is not so widespread in the UK that everyone knows someone who has tried it—about 1.6% of the general population visited acupuncturists in 19983 and 2001,4 while an estimated 3.9 million acupuncture treatments were delivered in 2009.5 Patients also consult other sources, including information leaflets, to help them choose treatments.1 ,2

Written information about acupuncture, as for any treatment, can inform, educate and enable patients to make informed decisions.6 Accurate information about the benefits and risks of treatment is vital in order to respect patients’ autonomy and facilitate the informed consent process.7 Previous studies have questioned the ethical adequacy of patient information in clinical trials when it obfuscates the nature of sham acupuncture.8 ,9 Information should be based on the highest-quality scientific evidence available, and the quality of the evidence used should be communicated to patients.10 ,11 Written information can shape patients’ expectations and thus influence psychologically mediated components of healing.12 ,13 Finally, written information can function as advertising and claims can be challenged through bodies such as trading standards and the Advertising Standards Authority (ASA).14

We were interested in the extent to which acupuncture information leaflets fulfil ethical and psychological functions and the relationship between information leaflets, the evidence and advertising standards. New, evidence-based and medicolegally appropriate acupuncture informed consent documents have been developed and recommended for use in clinical practice.15 ,16 However, it seems unlikely that such leaflets will have been adopted wholeheartedly by practitioners. We therefore aimed to analyse the content of written leaflets used in everyday clinical practice to inform patients about acupuncture. Our objectives were to establish common and rare features of acupuncture information leaflets; to describe how the leaflets might shape patients’ expectations; and to relate claims made in the leaflets to the extant evidence and advertising standards.

Methods

Data collection

In autumn 2010 advertisements were placed with major professional organisations (Acupuncture Association of Chartered Physiotherapists (AACP); British Acupuncture Council (BAcC); British Medical Acupuncture Society (BMAS)) and journals (Acupuncture in Medicine, The Journal of Chinese Medicine). Acupuncturists were invited to post information leaflets to the researchers for inclusion in a study “to describe the written material that is currently used in clinical practice in the UK to inform potential patients about acupuncture.” Respondents could include contact details for inclusion in a prize draw (10 prizes of £50 gift vouchers). Six hundred and twenty-nine leaflets were received. Two hundred and twenty-eight were excluded (27 arrived after the closing date; 201 duplicated other leaflets already received), leaving 401 for analysis.

Data analysis

Leaflets were assigned unique alphanumeric identifiers to maintain an audit trail. For a macroanalysis of the content of all 401 leaflets, we developed a coding frame based on the nature of acupuncture delivery in the UK and existing literature about patients’ experiences. The coding frame comprised 40 attributes, including physical characteristics of leaflets (eg, length, logos), acupuncture-related content (eg, possible benefits, side effects), acupuncturist-related content (eg, acupuncturist's qualifications) and practical content (eg, travel directions). Four research assistants independently extracted data using the coding frame, rating each item as present or absent for each leaflet. Data were entered into SPSS, checked for reliability, and discrepancies were discussed and resolved with the lead author. Frequency counts were generated to identify typical and atypical attributes of acupuncture leaflets.

A more detailed thematic analysis was then conducted to examine the leaflets’ coverage of three key topics: the treatment process, possible benefits and possible side effects. The corpus of the leaflets was prohibitively large for in-depth analysis; therefore 25% of relevant leaflets were randomly selected. We analysed 61 leaflets for information about the treatment process (25% of the 245 leaflets containing such information), 62 leaflets for the possible benefits of acupuncture (25% of 248) and 22 leaflets for possible side effects of acupuncture (25% of 86). For each topic, descriptions were coded inductively attending to discursive features (eg, vocabulary, voice), similar codes were grouped into categories, cross-cutting themes were identified and a narrative summary was produced incorporating illustrative extracts.17 Quotations below are attributed to leaflets using their unique alphanumeric identifiers. The thematic analysis of possible benefits of acupuncture was supplemented by a content analysis of all the leaflets that suggested conditions which might be helped by acupuncture. Leaflets varied in their specificity (eg, naming a condition such as ‘osteoarthritis of the knee’ vs naming a group of conditions such as ‘gynaecological conditions’). We report the frequency with which groups of conditions were mentioned and give examples of the specific labels included within each group.

To relate claims made in the leaflets to the extant evidence we compared the results of the content analysis with conclusions of relevant Cochrane systematic reviews. When Cochrane reviews were out of date and/or non-existent for particular conditions we consulted systematic reviews published in leading peer-reviewed journals. To relate claims made in the leaflets to advertising standards we reviewed guidance from the Committee of Advertising Practice (CAP), the organisation which is “responsible for writing and maintaining the UK advertising codes.” In general, CAP advises against advertising acupuncture for conditions “unless they (the marketers) have robust evidence to support efficacy”18; specific CAP advice is summarised in table 1.

Table 1

Summary of advice for marketing of acupuncture from the CAP18

Results

Macro-analysis

Most leaflets were received from physiotherapy clinics, either in the NHS (236, 59%) or private practice (117, 29%); others came from private sector Chinese or complementary medicine clinics (45, 11%) or non-physiotherapists working in the NHS (3, 1%). The typical leaflet was two pages long (range 1–9), printed on A4 white paper with back text and organised into six sections (range 1–17). A substantial minority (167, 42%) either included an integrated treatment consent form or were sent with one attached, confirming that one function of the leaflets was to facilitate informed consent.

Acupuncture imagery and institutional logos were used, respectively, to support and legitimise textual messages. Leaflets contained between 0 and 18 images (mean=0.5), including photographs, drawings and symbols depicting acupuncture paraphernalia (in 51 leaflets, 13%), patients (23 leaflets, 6%), Chinese symbols—for example, Yin Yang (22, 5%) and practitioners (19, 5%). Two-thirds of leaflets (255, 64%) contained at least one logo (range 0–8), including NHS Trust logos (138, 34%), AACP or BAcC logos (26, 6%) and individual clinic logos (64, 16%).

Table 2 summarises the content of the leaflets. Almost all leaflets defined acupuncture and most explained how it might work; described the process of having treatment, possible benefits and adverse effects, contraindications, safety and risks; and situated it in a historical context. Just under half mentioned scientific evidence but few cited specific literature. One-third of leaflets suggested particular conditions which might benefit from acupuncture treatment. Few leaflets provided details about the acupuncturist(s) or practicalities of treatment.

Table 2

Proportion and number of leaflets featuring different content (n=401)

Thematic analysis

Shaping outcome expectations: benefits of acupuncture

The leaflets described common benefits of acupuncture and discussed differences in responsiveness. This dual focus arguably enabled leaflets to foster hope without making strong (and potentially misleading) guarantees of effectiveness. One hundred and twenty leaflets (30%) explicitly suggested conditions that might be helped by acupuncture (see table 3). Musculoskeletal pain, arthritis and injuries were commonly mentioned (by at least 60 leaflets). Of all the leaflets which mentioned conditions that might benefit from acupuncture, between one-fifth and one-third mentioned gastrointestinal, gynaecological, immunological, psychological or respiratory problems. Only 13% of these leaflets mentioned that acupuncture might be effective for nausea and/or vomiting. More general benefits were also described (box 1). Some leaflets cited ‘research’ and ‘scientific evidence’ to legitimise their claims: “there is sound research and evidence to show that acupuncture can help to relieve pain” (leaflet ID346).

Table 3

Proportion and number of leaflets claiming that acupuncture can help different conditions (n=120)

Box 1

General benefits of acupuncture claimed in leaflets

▸ Feelings of relaxation, calm and stress relief

▸ Improved mood, energy levels and sense of well-being

▸ Increased mobility

▸ Improved ability to perform activities of daily living

▸ Physiological benefits (eg, improved immune system, increased circulation, tissue healing promoted, reduced inflammation, tight tissue released)

▸ Ability to reduce drugs (typically pain killers)

Differences in response were attributed to three topics: inherent differences between patients: “just as some people are particularly sensitive to tablets, so are some people particularly sensitive to acupuncture” (ID389); health complaints: “chronic conditions often take longer to respond” (ID340); and the acupuncturist's skill “the list of the problems that can be helped by acupuncture is endless and it depends on the level of training of the acupuncturist as to which diseases can be treated” (ID397).

Most leaflets described the mechanisms of acupuncture, which can be viewed as educational and also as persuasive communication to convince patients that acupuncture is credible. Explanations were based on traditional, Chinese acupuncture and/or Western acupuncture theories. Explanations based on Chinese theory typically used concepts of energy, stagnation and flow: “the traditional Chinese view is that Qi (energy) flows freely when the body is in a health state. If there is a problem, energy stagnates. The stimulation of appropriate acupuncture points frees this stagnation.” (ID73). Explanations based on Western theory were more varied. Some focused on neurophysiological mechanisms such as endorphins (‘natural pain-relieving chemicals’ (ID22)) while others focused on localised mechanisms (‘acupuncture allows muscles to relax and enables them to work better’ (ID42)). Popular representations of acupuncture as ‘alternative’ were resisted, supporting representations of acupuncture as a credible treatment with physiological underpinnings: “there is nothing spiritual about it and you don't need to believe in it for it to work” (ID59).

Shaping outcome expectations: risks and side effects of acupuncture

Leaflets described minor side effects and rare, but serious, side effects. Minor side effects were listed as drowsiness, bruising/bleeding/discomfort at the needling site, pain during treatment, temporary symptom exacerbation and fainting/nausea/dizziness/light-headedness. Side effects were described in ways that might reassure patients (table 4).

Table 4

Ways of describing minor side effects that might allay patients’ concerns

Severe side effects were described as manageable by practitioners and included: infection—blood borne diseases and localised infection at the needling site; broken needles; damage to internal organs and premature onset of labour. Leaflets described how reputable acupuncturists would minimise risks of infection and needle breakage by adhering to good standards of professional practice and using high-quality needles: “chartered physiotherapists are trained to use the strictest hygiene, and the needles used are always single use, sterile and disposable” (ID16). Risk of damage to internal organs was described as extremely rare and associated with poorly trained acupuncturists. Risk of premature labour was typically managed by listing pregnancy as a contraindication for acupuncture.

Comparisons with other well-known treatments helped to manage patients’ perception of risk “to put this in perspective, the risk of harm occurring as the result of acupuncture is probably less than the risk of (harm occurring as the result of) taking aspirin or an anti-inflammatory drug for arthritis” (ID231). Occasionally, leaflets used specific details and credible sources, discursive strategies that can help construct information as factual.19 “An extensive worldwide literature search identified only 193 adverse effects (including relatively minor effects such as bruising and dizziness) over 15 years. The more serious effects were usually related to poor practice—for example, cases of hepatitis B infection typically involved bad hygiene practice and unregistered practitioners” (ID8).

Shaping process expectations

Typically, leaflets explained that having acupuncture begins with an interaction with the acupuncturist, who takes a detailed history and/or performs a physical examination involving pulses and tongue inspection. These interactions were presented as informing collaborative treatment decisions: “a chartered physiotherapist will … plan a treatment programme with you” (ID22), and consent which could be withdrawn later: “treatment will always be stopped if you wish” (ID234a). Leaflets described the likely frequency and duration of treatment using cautious language, which furthered the impression that treatment would differ for individual patients: “it is usual to have between 4 and 10 sessions of acupuncture” (ID53).

Objective aspects of the needling process (eg, depth of insertion, location of needles) were described in ways which emphasised the variations in practice: “the needles are left in for anything from 1–2 min to 10–30 min” (ID233). The subjective experience of being needled was often compared to injections and blood tests: “the needles used are much finer than those used in injections and blood tests, and so are less painful to insert” (ID378). The sensation of needle insertion was described as a ‘sharp prick’ (ID49) or a ‘scratch-like sensation’ (ID117). Some leaflets minimised expectations of pain: “you should not experience any significant pain” (ID290a). Others emphasised the important meaning of pain: “(pain) is required for successful treatment” (ID49). In this way leaflets could help patients to expect and make sense of needling sensations.

Comparing leaflets with the extant evidence and advertising standards

The leaflets’ claims that acupuncture provides pain relief are consistent with the comparatively large amount of evidence suggesting that acupuncture can be beneficial for pain,20–22 although some reviewers argue that this benefit might still be due mainly to patient belief.23 Claims about musculoskeletal pain are broadly consistent with CAP's view of the evidence, but the (less common) claims about other types of pain (eg, dental pain) are not.

The leaflets’ claims about the effects of acupuncture on other, non-painful, conditions are fairly consistent with evidence from Cochrane and other systematic reviews. For gastrointestinal conditions, it is stated that acupuncture might help irritable bowel syndrome but the effects might be due to patient expectations.24 For gynaecological conditions, acupuncture might help primary dysmenorrhoea but better quality trials are needed25; there is insufficient evidence testing of acupuncture for polycystic ovary syndrome,26 pain in endometriosis27 and uterine fibroids.28 The Cochrane review of acupuncture for rheumatoid arthritis is based on only two studies involving 84 people and was last updated in 2005.29 For psychological conditions, there was insufficient evidence in 2008 to recommend acupuncture for depression and trials demonstrated a high risk of bias30; more recently a non-Cochrane review concluded that acupuncture is promising for anxiety and depression.31 For respiratory conditions, in 2004 there was insufficient evidence to conclude whether or not acupuncture was effective for chronic asthma32; a non-Cochrane review came to the same conclusion about allergic rhinitis33; since then one large high-quality trial suggests that acupuncture has significant clinical benefit in seasonal allergic rhinitis.34 Most of these non-pain conditions are hardly mentioned in CAP's advice (table 1). However, some of the conditions mentioned by less than 20% of leaflets (eg, addiction, dermatology and sleep concerns) might be deemed problematic by the ASA.

Discussion

Systematic content and thematic analysis of a large quantity of acupuncture leaflets showed common features: definitions of acupuncture; information about its possible benefits, risks, safety and side effects; explanations for how it might work; descriptions of the treatment process. By emphasising individual differences and variability in effects, the leaflets may enable patients to hope for beneficial effects without making unrealistic promises. By presenting information about risks alongside strategies to manage or minimise the risks, the leaflets convey information necessary for informed decision-making while attempting to allay unhelpful concerns. Surprisingly little information about the practicalities of treatment was provided.

The leaflets’ emphasis on painful conditions and pain as a symptom reflects the dominant source of the leaflets (physiotherapy clinics), the strong evidence related to pain and patterns of usage: in 2002, 12% of acupuncture patients attended with back or lower back symptoms.35 Claims made in the leaflets about conditions other than pain were somewhat, but not entirely, consistent with either (a) the extant evidence or (b) official advice from CAP about the advertising of acupuncture. It is important to note that both CAP advice and Cochrane reviews are frequently updated and so the comparisons drawn here reflect the situation at the time of writing.

According to psychological theory and evidence, when communicating information about risk to health it is important to provide patients with efficacious solutions enabling them to manage or reduce the risks.36 Failure to provide such a solution can increase anxiety and avoidance. Consistent with these ideas, when leaflets described the risks of side effects from acupuncture they typically also presented suggestions for managing those risks. Describing risks as manageable through sensible precautions is consistent with evidence from large-scale observational studies that acupuncture is safe with few serious adverse events.15 ,37

This study focused on written information for patients and analysed a large sample of leaflets in use across the UK. Most leaflets were being used by physiotherapists in the NHS, suggesting that our results are most representative of this setting. Using content and thematic analyses enabled us to identify common and rare features of leaflets and to explore the ways in which the leaflets conveyed information and potentially shaped patients’ expectations. We did not examine other formats (eg, web-based) or verbal interactions in patient–practitioner consultations. Studies of acupuncturists’ and patients’ perspectives on information leaflets would supplement our findings.

The findings have some practical implications. Overall, claims in the leaflets were not entirely consistent with official advice from CAP for the advertising of acupuncture. For example, the claims made in up to 15% of leaflets about addiction, dermatology and sleep concerns might be deemed problematic by the ASA. However, the advice from CAP is itself not entirely consistent with evidence from Cochrane reviews. To avoid sanctions and improve consistency of CAP advice and the evidence, acupuncturists might be required to supply evidence to support claims about, for example, irritable bowels syndrome, gynaecological conditions, rheumatoid arthritis, psychological conditions, asthma and allergic rhinitis. Acupuncturists might consider adding more practical details to their leaflets; in particular, references to professional regulatory bodies would seem appropriate. It is concerning that a minority of leaflets did not cover risks or safety concerns: acupuncturists should take care to convey accurate information about risks and risk management to their patients; it might be that these topics were covered in consent forms rather than the information leaflets that we analysed. To be more consistent with evidence-based medicine injunctions, leaflets could comment on the quality of the evidence that supports different claims for effectiveness. However, such information might not be particularly valued by patients themselves,38 disclosing a fundamental tension between the desire to communicate accurate information and ensuring that information leaflets meet the needs of the target audience.

Conclusions

Acupuncture leaflets used in the UK (predominantly by physiotherapists) make claims which appear broadly consistent with the evidence. Although not all claims of effectiveness for specific conditions could be substantiated in Cochrane reviews, this mostly reflects a lack of evidence rather than evidence of a lack of effect. An ethically sound, scientifically grounded and psychologically effective leaflet should accurately convey both benefits and risks of treatment and should do so in such a way as to enhance patients’ expectations and allay patients’ concerns about needling. Future studies should directly test the effects of acupuncture information on patients’ beliefs and subsequent outcomes.

Summary points

  • Printed clinic information leaflets influence patient expectations.

  • We analysed 401 leaflets from members of three UK acupuncture organisations.

  • Leaflets described side effects and risks (sometimes omitted) and outcomes, though rarely the practicalities of treatment.

  • Claims mostly matched evidence, though 15% contained some problematic claims.

Acknowledgments

Sylvie Pinder-White, Alison Tama, Sara Oroz and Richard Deacon, voluntary research assistants in psychology at the University of Southampton, contributed to data extraction. We thank the Acupuncture Association of Chartered Physiotherapists (AACP), the British Medical Acupuncture Society (BMAS) and the British Acupuncture Council (BAcC) for assistance in advertising the study to their members.

References

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Footnotes

  • Contributors FLB conceived and designed the study, led the analysis and interpreted the data, drafted the article, approved the final version to be published and is guarantor for this paper. CS contributed to the interpretation of data, helped to revise the article and gave final approval of the version to be published.

  • Funding FB was supported by Arthritis Research UK (career development fellowship 18099).

  • Competing interests None.

  • Ethics approval Ethical approval was sought and obtained from the host institution's ethics committee (reference SOMSEC061.10).

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data sharing statement Unpublished data may be requested from the corresponding author.

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