Opher Caspi

Alternative Medicine or "Alternative" Patients: A Qualitative Study of Patient-Oriented Decision- Making Processes with Respect to Complementary and Alternative Medicine

Background. Theory and clinical practice suggest that complementary and alternative medicine (CAM) decisionmaking processesmaydiffer from those used in conventional medicine. If so, understanding the differences could improve patient-provider communication around treatment options. Objectives. To examine patient-oriented decision-making processes relative to CAM use. Population. Adults with chronic rheumatological disorders who utilize allopathic medicine only, CAM only, or both. Method. An exploratory, cross-sectional naturalistic design with thematic and content analyses. Results. Three distinct decision paths were developed, differing substantially on the importance of provider trust, disease severity/prognosis, willingness to experiment, intuitive/spiritual factors, and outcomes evidence. Conclusions. These divergent decision paths indicate the possibility of “alternative patients,” not just “alternative therapies.” Since informed decisions, tailored to the patient, would likely lead to sustainable improvements in health care outcomes, the findings may facilitate providers’ capacity to effectively advise patients about treatment alternatives and CAM use.

Evaluating how placebos produce change: Logical and causal traps and understanding cognitive explanatory mechanisms

The renewed interest in placebo effects from psychological and methodological angles is manifested in two complementary facets: the causal relationship between placebo effects inside and outside of clinical trials and the continual effort to understand how the under-lying mechanisms relate to notions of efficacy and effectiveness. The article challenges the premise that placebo effects can be measured precisely enough that variance attributed to “nonspecific” placebo effects can be hierarchically partitioned from variance attributed to other “more specific” elements of therapy and discusses some of the most important recent developments in the understanding of how placebos produce change through cognitive explanatory mechanisms, including efficacy, outcome, and response expectancies; reverse placebo effects; schemas; and biased-information processing. Although much is already known about the complexity of explanatory mechanisms in placebo and expectancy effects, there is still much to do before establishing causal relationships and developing valid treatments based on this knowledge.

Evidence-based medicine: discrepancy between perceived competence and actual performance among graduating medical students.

Since at the time of graduation from medical school physicians are expected to demonstrate adequate professional competence including mastery of critical appraisal skills, we conducted a preliminary, cross-sectional, web-based study to examine the extent to which fourth year medical students in the US are competent in core areas of evidence-based medicine (EBM). Using self-assessment instruments, subjects (n = 150) were asked to demonstrate their ability to understand the practical meaning of key methodological and data analysis constructs as they relate to patient care, to rate their perceived competence in core areas of EBM and to disclose their attitudes toward critical appraisal of the literature and EBM. The mean score in our cohort was 55% suggesting that students may have knowledge gaps that interfere with their ability to critically appraise the medical literature. There was an apparent chasm between subjects’ perceived competence and their actual performance on the assessment instrument. These findings, if corroborated in larger studies, (1) suggest that better education in EBM is needed so as to avoid the possibility that patient care may inadvertently be jeopardized; and (2) cast doubt on the use of self-assessed knowledge as a proxy for actual skills with respect to EBM and medical decision-making.

Electroencephalographic cordance patterns distinguish exceptional clinical responders with fibromyalgia to individualized homeopathic medicines.

OBJECTIVES To characterize initial central nervous system responses to olfactory administration of homeopathic remedies as biomarkers for subsequently exceptional, simillimum-like clinical outcomes at a systemic level (i.e., both locally and globally). DESIGN Double-blinded, randomized, placebo-controlled clinical trial. SETTING A private homeopathic clinic in Phoenix, AZ, and a university laboratory in Tucson, AZ. PATIENTS Sixty-two (62) persons with physician-confirmed fibromyalgia (FM) (mean age, 49 years; 94% women) enrolled; 53 completed the 3-month assessment visit. Exceptional responders (n = 6, 23% of active treatment group; none on placebo) were those with improvements in the top one-third for both tender point pain and global health ratings after 3 months. INTERVENTION Patients took daily oral doses of treatment solution in LM (1/50,000 dilution) potency (active group received individualized remedy; placebo group received plain solvent). Dependent measures: Baseline and 3-month difference scores for initial prefrontal electroencephalographic alpha frequency cordance (EEG-C, a correlate of functional brain activity) during 16 pairs of randomized, double-blinded bottle sniffs (treatment minus control solutions). RESULTS Exceptional responders versus other patients exhibited significantly more negative initial EEG-C difference scores at prefrontal sites. Right prefrontal cordance findings correlated with subsequently reduced pain (r = 0.85, p = 0.03), better global health (r =-0.73, p = 0.10), and trait absorption (genetically determined ability to focus attention selectively and fully) (r = 0.91, p = 0.012). CONCLUSIONS These observations suggest prefrontal EEG-C as an early biomarker of individualized homeopathic medicine effects in patients with FM who later exhibit exceptional outcomes. Prefrontal cortex controls executive function, including ability to redirect attention. Interactions between executive function, absorption, and the simillimum remedy could facilitate exceptional responses.

Individual Differences in Response to Randomly Assigned Active Individualized Homeopathic and Placebo Treatment in Fibromyalgia: Implications of a Double-Blinded Optional Crossover Design

OBJECTIVE To assess individual difference characteristics of subgroups of patients with fibromyalgia (FM) patients with respect to the decision to stay in or switch from randomly-assigned verum or placebo treatment during an optional crossover phase of a double-blinded homeopathy study. DESIGN Double-blinded, randomized, placebo-controlled, optional crossover clinical trial. PARTICIPANTS Fifty-three (53) community-recruited patients with FM entered the optional crossover phase. INTERVENTION Two homeopaths jointly selected an individualized homeopathic remedy for all patients. The pharmacy dispensed either verum LM remedy or indistinguishable placebo in accord with randomized assignment for 4 months and the patients optional crossover decision for an additional 2 months. OUTCOME MEASURES Patients completed a battery of baseline state/trait questionnaires, including mood, childhood neglect and abuse, and trait absorption. They rated global health (whole person-centered) and tender point pain on physical examination (disease-specific) at baseline, 3 months, and 6 months. RESULTS Rates of optional crossover from verum to placebo or placebo to verum were comparable (p = 0.6; 31%, and 41%, respectively). The switch subgroups had greater baseline psychologic issues (emotional neglect in placebo-switch; depression and anger in verum-switch). The verum-stay subgroup scored highest on treatment helpfulness and included all six exceptional responders who fell, prior to crossover, into the top terciles for improvement in both global health and pain. Patients staying in their randomly assigned groups, active or placebo (n = 34), scored significantly higher in trait absorption than did those who switched groups (n = 19). CONCLUSION Individual difference factors may predict better and poorer responders with FM to specific and nonspecific effects of homeopathic and placebo treatment.

Effect of Acupuncture on the Brain in Children With Spastic Cerebral Palsy Using Functional Neuroimaging (fMRI)

We study the effect of acupuncture on brain activation patterns in children with cerebral palsy using functional magnetic resonance imaging (fMRI). fMRI of the whole brain was performed in 11 children with cerebral palsy and 10 healthy children during stimulation of a common acupoint in Traditional Medicine [Liv3 (Taichong)] on the left foot. We use both twisting and nontwisting methods with a blocked paradigm on a 2.0 Tesla MRI scanner. Functional data were analyzed by using Statistical Parametric Mapping software (SPM 99). Both signal increase and decrease in various regions of the brain were found in both groups of children. However, the pattern was different for the 2 groups, especially with decreases in signal regions. We suggest that the observed differences between children with cerebral palsy and healthy children with the stimulation of acupoint Liv3 might be due to blockage of the liver meridian in children with cerebral palsy.

Evaluating Intense Rehabilitative Therapies With and Without Acupuncture for Children With Cerebral Palsy: A Randomized Controlled Trial

OBJECTIVE To compare the outcomes of conventional therapies (physical, occupational, and hydrotherapies) plus acupuncture with those without acupuncture when administered intensely in the management of children with spastic cerebral palsy (CP). DESIGN Evaluation-blind, prospective randomized controlled trial. SETTING Therapies and video-recorded assessments at a childrens hospital in Beijing, China, and blind scoring and data analyses at a university in the United States. PARTICIPANTS Children (N=75), 12 to 72 months of age, with spastic CP. INTERVENTIONS Intensely administered (5 times per week for 12wk) physical therapy, occupational therapy, and hydrotherapy either with acupuncture (group 1) or without acupuncture (group 2). To satisfy standard of care, group 2 subsequently received acupuncture (weeks 16-28). MAIN OUTCOME MEASURES The Gross Motor Function Measure (GMFM)-66 and the Pediatric Evaluation of Disability Inventory (PEDI) assessments at 0, 4, 8, 12, 16, and 28 weeks. RESULTS At the end of 12 weeks, there was no statistically significant difference between the 2 groups, but when group 2 received acupuncture (16-28wk) there was a shift toward improvement in the GMFM-66 and the PEDI-Functional Skills Self-Care and Mobility domain. When groups were combined, statistically significant improvements after intense therapies occurred from baseline to 12 weeks for each outcome measure at each Gross Motor Function Classification System (GMFCS) level. After adjusting for expected normative maturational gains based on age, the GMFM gains for children with GMFCS II level was statistically significant (P<.05) with a mean gain of 6.5 versus a predicted gain of 3.4. CONCLUSIONS Intense early administered rehabilitation improves function in children with spastic CP. The contribution from acupuncture was unclear. Childrens response varied widely, suggesting the importance of defining clinical profiles that identify which children might benefit most. Further research should explore how this approach might apply in the U.S.

Functional Magnetic Resonance Imaging Activation of the Brain in Children: Real Acupoint Versus Sham Acupoint

The purpose was to examine the brain activation patterns with acupuncture using real acupoint (Liv3) versus sham acupoint in healthy, sedated children using functional magnetic resonance imaging (fMRI). Functional magnetic resonance imaging scans of the brain for 10 healthy, sedated children were taken during stimulation of real acupoint (Liv3 [Taichong]) and a nearby sham acupoint in a randomized order, employing twisting and nontwisting methods using a blocked paradigm using a 2.0-T scanner. The functional data were analyzed by using SPM 99. Various regions of the brain were activated in 2 acupoints. However, the pattern was different for the 2 acupoints. We suggest specific cerebral activation patterns with acupuncture might explain some of its therapeutic effect.

Participatory medicine and patient empowerment towards personalized healthcare in multiple sclerosis.

The current understanding that the key for successful healthcare is an integrated approach, involving predictive, preventive, personalized and participatory medicine, is leading major changes. These are: a shift from medical decisions based on ‘trial and error’ to informed therapeutics based on diagnostics (theranostics); a shift from a ‘disease-centered’ to a ‘patient-centered’ approach; and a shift from a ‘reactive’ to ‘proactive’ medical approach. It is essential that not only the physician, but also the patient, becomes proactive. Therefore, beyond the integration of genomic medicine and predictive biomarkers into practice, patient empowerment and participatory medicine are gaining increasing attention. This requires, besides appropriate sharing of information between patients and healthcare providers, new insights in patient involvement, such as patient-reported outcomes, both at the clinical trial stage of drug development and during post-marketing follow-up assessments. Patient empowerment and participatory medicine, as part of predictive, preventive, personalized and participatory medicine, are especially crucial in paving the way towards optimized healthcare in complex and chronic neurological diseases, such as multiple sclerosis.

Whole Systems Research Becomes Real: New Results and Next Steps

Cheryl Ritenbaugh: The term “whole-systems research” was coined in 2002 on the basis of systems such as Chinese medicine and homeopathy, whose traditions not only included particular treatment modalities such as acupuncture or homeopathic remedies, but also diagnosis and patient–practitioner interactions, techniques for changing patient behavior, and other complementary and alternative approaches to healing. It grew from the realization that the conventional randomized controlled trial (RCT) was probably insufficient for obtaining a more holistic idea of the magnitude of impact of these interventions and how they worked.