FROM:
Clinical Chiropractic 2012 (Mar); 15 (1): 23–30 ~ FULL TEXT
Joel Alcantara, Joey D. Alcantara, Junjoe Alcantara
International Chiropractic Pediatric Association,
327 N Middletown Rd,
Media, PA 19063, USA
Introduction Estimates place some 300 million people worldwide suffer from asthma with 180,000 deaths attributed to the disease. The financial burden from Asthma in Western countries ranges from $300 to $1,300 per patient per year. In the United States, asthma medication costs between $1 billion and $6.2 billion per annum. With an increasing prevalence of 50% every decade, there is no question that the burden of asthma is tremendous. The prevalence of complementary and alternative medicine (CAM) use amongst adult asthmatics ranges from 4% to 79% whilst, in children, it ranges from 33% to 89%. Of the various practitioner-based CAM therapies, chiropractic stands as the most popular for both children and adults. As with other chiropractors, the authors aspire to the principles of evidence-based practice in the care of asthma sufferers. Recent systematic reviews of the literature places into question the effectiveness of chiropractic. To assuage the discord between our clinical experience and those of our patients with the dissonant literature, we performed a systematic review of the literature on the chiropractic care of patients with asthma.
Methods Our systematic review utilized the following databases for the years indicated: MANTIS [1965–2010]; Pubmed [1966–2010]; ICL [1984–2010]; EMBASE [1974–2010], AMED [1967–2010], CINAHL [1964–2010], Index to Chiropractic Literature [1984–2010], Alt-Health Watch [1965–2010] and PsychINFO [1965–2010]. Inclusion criteria for manuscript review were manuscripts of primary investigation/report published in peer-reviewed journals in the English language involving the care of asthmatic patients.
Results The studies found span of research designs from non-experimental to true experimental studies consisting of 3 randomized controlled clinical trials (RCTs), 10 case reports, 3 case series, 7 cohort studies, 3 survey studies, 5 commentaries8 and 6 systematic reviews. The lower level design studies provide some measure of evidence on the effectiveness of chiropractic care for patients with asthma while a critical appraisal of 3 RCTs revealed questionable validity of the sham SMTs involved and hence the conclusions and interpretations derived from them. The RCTs on chiropractic and asthma are arguably comparison trials rather than controlled clinical trials per se.
Conclusion Chiropractic may offer an alternative care approach for asthmatic patients. Future investigations of this conservative care approach for patients with asthma should pave the way for higher-level design studies such as randomized controlled clinical trials.
From the FULL TEXT Article:
Introduction
The burden of asthma is tremendous. Prevalence estimates of asthma range from 7% in France and Germany to 11% in the United States and as high as 15–18% in the United Kingdom. [1] In Britain, asthma is the commonest chronic childhood disease. [1] [2] In the United States, approximately 6.7 million children (or 9.1% of the pediatric population) have asthma. Some 10.6 million office visits to medical physicians are attributed to the symptoms of asthma. Deaths as a result of asthma have been estimated at approximately 1.2 deaths per 100,000 population. [3] Asthma medications alone have been placed at costing $1 billion per year in the United States. In 1985, the burden of asthma was placed at almost $4.5 billion and extrapolated to $6.2 billion in 1990 in the United States. Given the ever increasing prevalence of asthma since the 1990s, the cost to society undoubtedly enormous. [4]
An examination of the prevalence of complementary and alternative medicine (CAM) use for asthma sufferers found that adult CAM use ranged from 4% to 79% whilst, for children, CAM use ranged from 33% to 89%. [5] Of the various practitioner-based CAM therapies, chiropractic stands as the most popular for both children and adults. [6] Given the popularity of chiropractic, it stands to reason that individuals with asthma would consider a trial of chiropractic care; indeed, the chiropractic clinical experience is such that asthmatics benefit from chiropractic care (i.e., improved symptoms of dyspnea and decrease medication use) (unpublished observations). Recent systematic reviews of the literature on chiropractic, however, spinal manipulative therapy (SMT) and asthma [7, 8] place into question the effectiveness of chiropractic for this patient population. As stated above, this is dissonant with the chiropractic clinical experience and the reported benefits experienced by chiropractic patients. In keeping with evidence-based practice and to reconcile the “conscientious, explicit, and judicious use of current best evidence” with that of empirical clinical experience, a systematic review of the literature on the chiropractic care of patients with asthma was performed.
Discussion
In keeping with evidence-based practice (EBP), clinicians have grown to rely heavily on systematic reviews incorporating some evidence-based assessment protocol. The comprehensiveness, reproducibility and objectivity of these types of systematic reviews have made them attractive and the method of choice to address questions for making clinical and policy-level healthcare decisions. As alluded to earlier, the clinician is challenged to critically appraise (i.e., a careful and systematic examination of the research to judge its trustworthiness, its value and relevance to clinical practice) the systematic reviews particular to their field in the context of their unique individual clinical expertise/experience and the needs and wants of their patients.
This systematic review found 2 previous reviews that concluded that chiropractic care provided benefit to asthmatic patients, [41] and [42] one review was neutral [40] while 3 reviews [7], [39] and [43] concluded that the addition of chiropractic care to usual medical care provided no benefit to asthmatic patients. From a chiropractic perspective, the dissenting reviews challenge the veracity of the chiropractic clinical experience. The sweeping conclusion by Ernst [7] that spinal manipulation is not effective in the treatment of asthma reflected his disinclination to critically and objectively appraise such studies. Alcantara et al. [56] challenged the veracity of Ernst's review by pointing out the same issues that Kaminskyj et al. [42] failed to consider in their systematic review. Even more ironic, and indicative of Ernst's lack of objectivity, was our finding that he was keenly aware that even in studies employing a true sham SMT, [57–61] the level of success achieved in these studies has been minimal. As Ernst noted with his co-author [62], even the small number of trials using a placebo maneuver precludes making definitive conclusions. How much more so when the placebo maneuver employed is questionable?
The design of an appropriate sham SMT that resembles the active SMT as much as possible in terms of procedure, visit frequency and duration, and doctor contact and support to create similar expectations in both groups has been found to be challenging. [63], [64] and [65] For example, in their design of an adequate sham SMT for flexion-distraction technique, Hawk et al. [58] and [59] found it impossible and instead utilized a hand-held adjusting instrument set to deliver no pressure, and applied only to soft tissues adjacent to the spine. To date, Vernon et al. [66] may have developed a sham SMT procedure for the cervical spine that is perceived by the subjects to be a real manipulation, but does not produce any important change in cervical status.
Previous systematic reviews focused on the higher-level design studies (i.e., RCTs) as per the evidence hierarchy. [67] Our systematic review was more inclusive and wished to point out that uncontrolled studies have value. As it stands, questions about the most appropriate SMT technique or combinations thereof for asthmatic patients remain unanswered. What are appropriate treatment frequencies? What is an appropriate placebo or sham treatment? These too remain unanswered. Uncontrolled studies can inform higher-level research designs with respect to these variables.
In the 3 clinical trials on asthma, the patients reported subjective improvements (i.e., quality of life, symptom severity, etc.) as well as decrease in medication use (i.e., ß-agonist). In this era of integrative care (i.e., the integration of complementary and alternative medicine with conventional medicine in the care of patients), the benefits conferred by chiropractic SMT to this patient population support chiropractic as a viable alternative. Consider that inhaled corticosteroids are said to be the most effective class of controller medication available today and is evidence-based guideline-recommended first-line treatment for controlling asthma. [68] Yet many asthmatic patients continue to experience symptoms despite appropriate clinical and guideline based treatment. [69] Furthermore, corticosteroids are not without side effects and include suppression of the hypothalamic–pituitary–adrenal axis, growth retardation, osteoporosis, cataract formation, blood count and immunoglobulin changes, oropharyngeal candidiasis and dysphonia. [70–72] Current standard asthma therapies today do not directly address the immunoglobulin (IgE)-mediated component of the inflammatory cascade and may explain, in part, the continued persistent symptoms of medicated asthmatics. Ali and colleagues50 examined the effects of chiropractic treatments on the neuroendoimmunology of asthmatic patients. Asthmatic subjects were randomly allocated into 4 groups: a chiropractic treatment at centers group, a no treatment at centers group, a no treatment at home group, and a control group of non-asthmatic patients with no treatment at home. The trial consisted of a 14-week program of a 2-week pretreatment, 6-week treatment, and 6-week post-treatment protocol with numerous quality of life (QoL) and biochemical outcomes but no lung function measures. The authors reported their preliminary results on 110 subjects that demonstrated clinically important changes in QoL (decrease symptoms, increased physical activity, decreased medication use) in the treated group. Additionally, salivary Ig A increased and cortisol levels decreased overall in the treated group and not the controls. As the investigators noted, stress is associated with an increase in circulating cortisol which causes a reduction in immunity and increases smooth muscle contractibility. Immunoglobulin A is associated with the respiratory epithelial lining and its reduction confers susceptibility of an individual to spasms of the respiratory smooth muscle due to pathogenic invasion. According to Ali et al. [50] these neurophysiological changes were responsible for the decrease in severity and frequency of asthmatic attacks experienced by the subjects.
Conclusion
This systematic review of the literature examined the trials and tribulations of designing a randomized controlled clinical trial with chiropractic SMT and asthma and the important contribution of uncontrolled studies. Chiropractic may offer an alternative care approach for asthmatic patients in an integrative healthcare setting. Further investigations of the chiropractic intervention in the care of patients with asthma should pave the way for higher-level design studies such as randomized controlled clinical trials.