Focus on Alternative and Complementary Therapies
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Focus Alternat Complement Ther©2005 Pharmaceutical Press
Focus Altern Complement Ther 2004; 9: 12–4
In recent years, CAM use has increased dramatically, and children are not exempt from this use.1–4 In particular, children with serious, chronic or recurrent illness have rates of CAM use that approach (in some cases, even exceed) 70%.5–12 There is a need to examine the safety and efficacy of CAM in children in a systematic unbiased way, with emphasis on the products and practices that are used most commonly or with greatest risk of harm or potential for benefit. As an example of CAM that enjoys widespread use with little systematic data collection regarding safety, let us consider children and chiropractic.
Many children are exposed to chiropractic for a variety of reasons, including health promotion, musculo-skeletal ailments and a wide array of other paediatric concerns, such as infantile colic, asthma, bed-wetting, etc.13–17 Some formal evaluations regarding the efficacy and effectiveness of this intervention have found conflicting results.13,18–21 For example, there is evidence from RCTs both for and against the use of chiropractic in infantile colic.13,18,19 Conflicting results are also reported by systematic reviews of adult chiropractic clinical trials.20,21 While conflicting results are not unique to research involving chiropractic, more work needs to be done to clarify what benefit(s) chiropractic offers children.
Owing to scientific as well as political differences, there has been a historical ‘divide’ between some paediatric and chiropractic organisations. For example, in 1995, the Chairmen of the Departments of Pediatrics of Pediatric Hospitals in Canada issued a joint statement that refuted the role of chiropractic as preventative therapy or treatment for childhood illnesses, and called for suspension of public fiscal support for paediatric chiropractic treatment.22 Unfortunately no references were provided in this article, and in the ‘hierarchy’ of EBM, expert opinion does not fare well. The evidence does support the fact that parents take their children to chiropractors.16,17,23,24 If paediatricians have concerns,25 they need to take an evidence-based approach. In the intervening 8 years there has been little effort to quantify the risks of chiropractic in children. Few case reports of paediatric adverse events related to chiropractic have been published,26–28 and no systematic reviews or prospective studies to quantify harm have yet been done.
In that same time period, case reports of adverse events related to chiropractic have led to more rigorous studies to examine this issue in adults. For example, a review of the literature on complications of spinal manipulation, which evaluated relevant case reports, surveys and review articles, identified 295 complications, yielding estimates of vertebrobasilar accidents from 1 in 20 000 patients to 1 per 1 million cervical manipulations, and cauda equina syndrome to be less than 1 per 1 million treatments.29 A different approach, using a nested case-control study, matched 582 patients who had experienced vertebrobasilar accidents with control subjects (i.e. non-patients) who did not have a history of stroke.30 Patients younger than 45 years who had experienced a vertebrobasilar accident were five times more likely to have had more than three cervical treatments in the preceding month.30 This study also found approximately 1.3 cases of vertebrobasilar accidents within 1 week of treatment for every 100 000 chiropractic patients below the age of 45 years.30 Clearly, if there is no potential for benefit, then it is unreasonable to undertake a potential risk of harm. Most instances are not so clear cut, and the only way to evaluate the risk:benefit ratio is with more data. To date, there have been no such systematic reviews that evaluate adverse events with respect to chiropractic specifically in children. Until such data are collected and synthesised, arguments for or against the safety of chiropractic in children are based on emotion and prejudice, and are inadequate to counsel patients.
Of course, ‘adverse’ events may be interpreted narrowly, such as physical harm, or broadly, such as cost, opportunity cost (time spent when an effective known therapy was also available but not pursued), and effect on overall health (e.g. decision made not to immunise child based on chiropractor’s advice, etc.). Broad interpretation is especially relevant since there is some evidence that some chiropractic care may be inconsistent with medical guidelines,23 and that chiropractors may give advice on diet, immunisations and general health.23,31,32 While a broad interpretation of harm may be clinically relevant, it is much more difficult to quantify. Even a narrow interpretation of harm with respect to chiropractic has yet to be quantified in children.
While the RCT may be the ‘gold’ standard to evaluate the efficacy of some health interventions, it is acknowledged that it is not the ideal tool to collect safety data. Indeed, safety data are rarely even reported in many RCTs or systematic reviews.33,34 Rather, population-based prospective data collection is a much more powerful tool for assessing potential harm. Similar efforts to assess the safety of acupuncture have led to several reassuring reports that rates of serious adverse events are in fact quite low.35,36 Such population-based studies should not be difficult to do, given that many children are seen by chiropractors, and many chiropractors see children.16,17,24 Once the numerator (number of adverse events) and denominator (number of treatments) are known, potential adverse events with chiropractic can be put into context, relative to risks associated with other therapies, such as adverse events due to medications or surgery. The risk:benefit ratio can only be considered if data on both efficacy and harm are collected; at present, in children, neither is substantive. Ultimately, these data are needed so that paediatric patients, their families and their healthcare providers can better evaluate ‘what’s the harm’ with respect to children and chiropractic.