Rheumatology 2004; 43: 666
Rheumatology Vol. 43 No. 5 (c) British Society for Rheumatology 2004; all rights reserved
Letter to the Editor |
Balanced judgements on complementary/alternative medicine. Is informed consent necessary?
Peninsula Medical School, Universities of Exeter and Plymouth, 25 Victoria Park Road, Exeter EX2 4NT, UK.
Correspondence to: E. Ernst. E-mail: Edzard.Ernst{at}pms.ac.uk
SIR, The three main questions around patients’ informed consent for medical treatment are (i) is the patient competent to give consent, (ii) is consent given voluntarily, and (iii) is it based on sufficient information? This letter addresses the last issue in relation to complementary/alternative medicine (CAM).
The prevalence of use of CAM by rheumatological patients is high [1]. The public tend to believe that CAM is not associated with significant risks, but this notion may well be erroneous [2]. Therefore, it seems timely to ask what information a chiropractor, as an example of a fully regulated CAM provider, should provide to patients.
‘Health professionals should try to ensure that the patient is able to make a balanced judgement on whether to give or withhold consent’ [3]. Patients should be informed of any material or significant risks of the proposed treatment, the risks and benefits of any alternative options, and the risks of not having any treatment at all. The Code of the British General Chiropractic Council (GCC) states that ‘before instituting any examination or treatment, a chiropractor shall ensure that informed consent ... has been given. Failure to obtain informed consent may lead to criminal or civil proceedings ... . Informed consent means consent that is given by a persona who has been supplied with all the necessary relevant information’ [4].
Consider a woman consulting a chiropractor for neck pain, which is a common reason for people to seek chiropractic care, and chiropractors claim that it can be effectively treated with spinal manipulation. The relevant facts regarding such a case are as follows:
- Treatment would be elective, i.e. the patient could, without serious risks, postpone her treatment decision.
- Other treatments exist, some of which, like exercise, are virtually risk-free [5].
- The risk of not having any treatment at all is minimal.
- Chiropractic treatment of neck pain has not been demonstrated to be effective or more effective than competing therapies [6].
Manipulation of the upper spine is associated with material and significant risks. About half of all patients will experience transient discomfort or pain, and in a (probably small but essentially unknown) number of cases, it may cause arterial dissection with potentially serious sequelae [7].
‘A significantly more thorough standard of disclosure is needed where the treatment is elective and ... the law may require disclosure of all known risks ...’ [8]. Thus chiropractors must advise patients with neck pain that the risk–benefit balance of upper spinal manipulation is not demonstrably in favour of this approach and that other, less risky and effective treatments (e.g. exercise) exist [9]. Many patients would be alarmed by these facts and decline treatment. As most chiropractors are self-employed, full informed consent is overtly against their own financial interest. Consequently chiropractors might rarely provide such information (to date no data are available). Yet the mere fact that the patient might become upset by hearing the information, or might refuse treatment, is not sufficient to act as a justification for non-disclosure of information [3].
‘Therapeutic privilege’ could be the solution and, in fact, seems to be current clinical practice. It means that chiropractors limit disclosure of risks in the belief that this is in the patient’s best interest. However, therapeutic privilege only applies where ‘treatment is so necessary to maintain the life or health of the patient and the consequences of failing to carry it out are so clearly disadvantageous’ [8].
Another solution would be to apply the principles of evidence-based medicine and use those therapies that are demonstrably associated with the most favourable risk–benefit profile [2]. In our case, this would mean employing exercise rather than spinal manipulation [9]. As ‘the trends in the courts, hospital guidelines and the advice from professional ethicists all point towards more comprehensive disclosure of risk’ [8], it seems both inevitable and desirable that balanced judgements on CAM in general, and chiropractic in particular, should become evidence-based and adhere to generally accepted ethical standards.
The author has declared no conflicts of interest.
References
- Ernst E. Use of complementary therapies in rheumatology: a systematic review. Clin Rheumatol 1998;17:301–5.[CrossRef][Web of Science][Medline]
- Ernst E, Pittler MH, Stevinson C, White AR. The desktop guide to complementary and alternative medicine. Edinburgh: Mosby, 2001.
- Department of Health. Reference guide to consent for examination or treatment, N.5.3. London: Department of Health, 2001;6.
- General Chiropractic Council. Code of practice (internal document), June 1999.
- Aker PD, Gross AR, Goldsmith CH, Peloso P. Conservative management of mechanical neck pain systematic overview and meta-analysis. Br Med J 1996;313:1291–6.
[Abstract/Free Full Text] - Ernst E. Chiropractic spinal manipulation for neck pain—a systematic review. J Pain 2003;4:417–42.[Medline]
- Stevinson C, Ernst E. Risks associated with spinal manipulation. Am J Med 2001;112:566–70.[CrossRef]
- Manning P, Smith D. Informed consent. J Irish Coll Physicians Surg 2002;31:219–21.
- Ylinen J, Takala EP, Nykinen M, et al. Active neck muscle training in the treatment of chronic neck pain in women. J Am Med Assoc 2003;289:2509–16.
[Abstract/Free Full Text]
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