Dear Editors,

I would like to draw the authors' attention to an eligible systematic review which was not included in their critical overview. Our systematic review of homeopathy for ADHD has been published in the Cochrane Library for some years and is indexed on Medline: Cochrane Database Syst Rev. 2007 Oct 17;(4):CD005648. Homeopathy for attention deficit/hyperactivity disorder or hyperkinetic disorder.

This is important because it raises questions about the sensitivity of the searches, and in this case of this particular review, emphasises the importance of observational and theoretical work prior to conducting expensive RCTs that may not be able to answer clinically relevant questions.

With kind regards

Morag Heirs (ne Coulter)

Conflict of Interest:

None declared

We read with great interest the article by Hunt and Ernst (1) on their critical overview of the systematic reviews of various complementary and alternative medicine (CAM) therapies for children. While Hunt and Ernst are to be lauded for their contribution to the pediatric CAM literature, we wish to address issues raised by the authors. Similar to other chiropractors, other CAM providers and orthodox medical practitioners, we aspire to care for children following the principles of evidence-base medicine (EBM). That is, integrating our individual clinical expertise with the best available external clinical evidence such as systematic research while at all times respecting the needs and wants of patients (or parents in the case of children) (2). It is from this point of view that we wish to address their critical overview of the literature on chiropractic and their comments regarding the recommendation of a trial of chiropractic care (or other types of CAM therapies) for children. Of the various practitioner-based CAM therapies, chiropractic has been found to be the most popular for children (3).

With respect to the chiropractic care of patients with asthma, our review of the literature on the subject revealed 6 review articles (4-9). Three of the reviews support a trial of chiropractic care for patients with asthma (4,6-7) while two do not (8,9) with one neither supporting or refuting its use (5). A closer examination of the involved clinical trials on chiropractic SMT and asthma reveal a failure on the part of Hunt and Ernst (1) to critically appraise the literature. As we pointed out in response to a systematic review by Ernst (1), the clinical trials on asthma and subsequent reviews failed to consider the challenges and pitfalls of designing a randomized controlled clinical trials (RCT) with chiropractic SMT (10). In the clinical trials on chiropractic SMT and asthma (11-13), the investigators failed to ensure the veracity of the sham therapies employed and therefore all subsequent interpretations from these studies are questionable. Consider the clinical trial by Balon and colleagues (12), touted by Ernst and other reviews as the study of highest methodological quality. The design of the simulated treatment incorporated massage and various maneuvers reminiscent of both chiropractic and osteopathic manipulative techniques. Massage has been demonstrated to benefit asthmatic patients (14-16). Furthermore, the assumption on the part of Balon and colleagues (12) that regardless of the maneuver employed, a high velocity, low amplitude thrust type SMT devoid of joint cavitation or audible release has no therapeutic effect could not be further from the truth (17). A number of mechanically assisted SMT instruments are used by chiropractors with reported benefits by patients (18-19). Their use do not result in joint cavitation or audible release. The clinical trials on asthma are arguably comparison trials of chiropractic SMT versus another type of SMT technique (10). The use of spirometry as the objective outcome measure for these studies is also questionable given that their utility as diagnostic instruments for asthma have been found inadequate (10,20).

On the literature examining chiropractic SMT and infantile colic, again Hunt and Ernst (1) failed to critically appraise the literature. Our review found 4 review articles on the subject (21-24). Talmage and Resnick (21) addressed the definition, etiology, prevalence and management strategies utilized by MDs and DCs and advised that proper management should focus on making the correct diagnosis, reassuring the parents, and in addition to medical care, a conservative approach with chiropractic SMT. As with their findings on asthma, Hawk and colleagues (22) concluded that evidence from controlled studies and usual practice supports chiropractic care (i.e., the entire clinical encounter) as providing benefit for patients with infantile colic. Bronfort et. al. (23) concluded that chiropractic SMT for colic is not effective when compared to sham SMT. Ernst (24) reviewed the randomized clinical trials on colic and chiropractic SMT (25-27) and concluded that the evidence for chiropractic SMT for colic is not based on rigorous clinical trials and therefore fails to demonstrate effectiveness. A critical appraisal of these reviews again require a closer examination of the clinical trials on colic. Wiberg et.al. (25) compared chiropractic SMT versus the established medical treatment using dimethicone. Chiropractic was demonstrated to be superior to dimethicone in decreasing hours of crying in colicky infants. Olafsdottir et.al. (26) compared a poorly characterized and unproven chiropractic technique versus no care. Olafsdottir et.al. (26) found the subjects in both groups responded similarly and therefore concluded that chiropractic SMT is no more effective than placebo. No study has ever been published (i.e., not even a case report) to demonstrate some semblance of effectiveness with this unproven technique. Browning and colleague (27) examined the effects of two manual techniques (i.e., chiropractic SMT and occipito-sacral decompression) on infantile colic. Both manual techniques were capable of decreasing the hours of crying in infants when compared to baseline measures. Based on our summary of the clinical trials on colic, Bronfort et.al. failed to recognize the study designs involved and their interpretation must be examined with caution.

In terms of the research on the chiropractic care of patients with nocturnal enuresis, otitis media or any other childhood conditions for that matter, what becomes painfully obvious is the supremacy of practice empiricism over research. One can argue that this is not unique to chiropractic but it is also the case for other CAM therapies or orthodox medicine. Hunt and Ernst (1) admonish that rigorous testing of CAM therapies for their effectiveness and safety are a requisite prior to their recommendation. If this applies to all therapies (CAM of orthodox medicine), we would argue that a large part of pediatric care would cease. Off-label use in pediatric care comes to mind (28-29). We concur that more research is needed on the safety and effectiveness of pediatric care (CAM or orthodox medicine), both in quantity and quality. However, the decision to recommend or pursue a trial of care is not so simple as Hunt and Ernst would want us to believe. Safety and effectiveness are of the utmost consideration as well following the principles of biomedical ethics. In defining EBM, Sackett and colleagues leave no doubt about the integration of research in the clinical decision making process. According to Sackett and colleagues (2), "external clinical evidence can inform, but can never replace, individual clinical expertise, and it is this expertise that decides whether the external evidence applies to the individual patient at all and, if so, how it should be integrated into a clinical decision." Sackett and colleagues (2) further commented that, "evidence based medicine is not restricted to randomised trials and meta-analyses. It involves tracking down the best external evidence with which to answer our clinical questions." Hunt and Ernst (1) failed to consider these very important aspects of EBM in their myopic examination of the evidence base. As an example, consider the chiropractic perspective on the care of infants with infantile colic. The literature demonstrated that chiropractic SMT is superior to dimethicone (25), there is benefit to patients receiving chiropractic SMT and occipito-sacral decompression26 while using light finger tip pressure SMT as Olafsdottir and colleague performed is not effective for infantile colic (27). From the parent's perspective, mothers of infants with colic have multidimensional psychological distress resulting in more bodily dysfunctions, fears, disordered thinking, depression, anxiety, fatigue, hostility, impulsive thoughts and actions, and stronger feelings of personal inadequacy or inferiority (30). A colicky infant adversely affects the family dynamics and inter-relationships (31-32) and may place the infant at risk for abuse. Thoughts and fantasies of aggression and infanticide have been reported by mothers (33). Our experience with parents of infants with colic has been a demand for chiropractic care. Typically, their child has been attended to by a medical doctor but the parents are at their wits end. Medical care for infantile colic has not been proven effective (34). Two clinical trials comparing semithicone (a surfactant to facilitate passage of gas in the gastrointestinal tract) to placebo demonstrated no benefit (35). Anticholinergic drugs (given to infants with colic to relax the smooth muscles of the gut to prevent spasms) have reported adverse events such as drowsiness, diarrhea and constipation, apnea, seizures and coma (35). Methylscopolamine, a muscle relaxant to treat gastric or intestinal hypersensitivity or secretions, has been found to exacerbate colic and may be unsafe (35). In terms of safety, we acknowledge that adverse events associated with pediatric chiropractic SMT may be under-reported. However, based on the available evidence, adverse events are rare and when they do occur, they are minor, self-limiting and does not require the attention of a medical doctor (36-37). A trial of chiropractic care for the infant with colic is therefore warranted in light of the principles of EBM and the principles of biomedical ethics that respects the right of the parent to choose the care for their child, placing their interest above all others, avoiding harm and providing them access to all therapies available. Hunt and Ernst missed these important principles of patient care in their critical appraisal of the literature on CAM therapies.

References

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Conflict of Interest: None declared