A Randomized Three-Arm Double-Blind Placebo-Controlled Study of Homeopathic Treatment of Children and Youth with Attention-Deficit/Hyperactivity Disorder.

Objectives: Approximately 30% of children diagnosed with attention-deficit/hyperactivity disorder (ADHD), the most prevalent mental health disorder in children worldwide, do not respond to conventional pharmaceutical treatments. Previous studies of homeopathic treatment for ADHD have been inconclusive. The objectives of this study were to determine if there (a) is an overall effect of homeopathic treatment (homeopathic medicines plus consultation) in the treatment of ADHD; (b) are any specific effects the homeopathic consultation alone in the treatment of ADHD; and (c) are any specific effects of homeopathic medicines in the treatment of ADHD. Design: The design was a randomized double-blind placebo-controlled clinical trial. Setting/Location: Toronto, Canada. Subjects: Children aged 6-16 years diagnosed with ADHD. Interventions: Participants were randomized to one of three arms: Arm 1 (Remedy and Consultation); Arm 2 (Placebo and Consultation); or Arm 3 (Usual Care). Outcome Measures: Primary Outcome was the change of CGI-P T score between baseline and 28 weeks. Results: There was an improvement in ADHD symptoms as measured by the Conner 3 Global Index-Parent T-score in the two groups (Arms 1 and 2) that received consultations with a homeopathic practitioner when compared with the usual care control group (Arm 3). Parents of the children in the study who received homeopathic consultations (Arms 1 and 2) also reported greater coping efficacy compared with those receiving usual care (Arm 3). There was no difference in adverse events among the three study arms. Conclusions: In this study, homeopathic consultations provided over 8 months with the use of homeopathic remedy was associated with a decrease in ADHD symptoms in children aging 6-16 years when compared with usual treatment alone. Children treated with homeopathic consultations and placebo experienced a similar decrease in ADHD symptoms; however, this finding did not reach statistical significance when correcting for multiple comparisons. Homeopathic remedies in and of themselves were not associated with any change in ADHD symptoms. Clinical Trial Registration: This trial was registered on ClinicalTrials.gov; NCT02086864.

A cross-sectional workforce survey of three traditional and complementary medicine professions in Ontario, Canada.

BACKGROUND: Workforce studies about traditional and complementary medicine (T&CM) occupations in industrialized countries are scant; and, these occupations' position within the broader occupational workforce remains unclear. This study aims to address these gaps using a comparative approach. METHODS: Naturopaths, traditional Chinese medicine (TCM) / acupuncture practitioners, and homeopaths in Ontario, Canada were surveyed regarding their demographics, practice characteristics and self-reported income. Results were compared with parallel data from within and outside of Ontario. RESULTS: Study response rate: 23.3% (n = 1205). While predominantly female (57.9%), Ontario's TCM/acupuncture profession was less feminized than the naturopathic (77.1%) and homeopathic (78.3%) groups. Naturopaths were significantly younger than, and reported fewer years of clinical experience than, the other two groups. About half of TCM/acupuncture practitioners, and almost one-third of homeopaths had trained outside of Canada, predominantly in East and South Asia, respectively. More TCM/acupuncture practitioners (58.9%) and homeopaths (57.6%) had multilingual clinical practices than naturopaths (19.1%). Homeopaths worked fewer hours and saw fewer patients per week than the other occupations. Self-reported mean incomes varied across groups, with naturopaths earning more on average ($63,834, SD $57,101) than did TCM/acupuncture practitioners ($45,624, SD $44,081) or homeopaths ($29,230, SD $41,645). Holding other variables constant, internationally-trained practitioners reported earning one-third less than their Canadian-trained counterparts. DISCUSSION & CONCLUSIONS: Study findings echo occupationally-specific data from other industrialized jurisdictions; and, affirm that different T&CM occupations have distinctive demographic and practice characteristics. The demographic makeup of Ontario's TCM/acupuncture and homeopathy occupations suggests a role for these groups in delivering culturally-responsive care within Asian ethnic communities. T&CM practitioner incomes, in particular for internationally-trained practitioners, fell below the provincial population income median, and in many cases below the poverty line. T&CM occupations' relative socio-political marginality may be impacting clinicians' ability to earn a viable living.

An N-of-1 Feasibility Study of Homeopathic Treatment for Fatigue in Patients Receiving Chemotherapy.

BACKGROUND: Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Homeopathy has been widely used to treat side effects of chemotherapy. The n-of-1 design is a single-patient trial method to study a clinical condition that is either short lived and reversible or is chronic and stable. The n-of-1 design requires a washout/reset period. The feasibility of performing an n-of-1 study in homeopathy has not previously been tested. METHODS: A feasibility n-of-1 trial of individualized homeopathic treatment for fatigue in a single adult undergoing chemotherapy administered periodically was performed. For each matched pair of treatments, the participant was randomly allocated either placebo or verum for the period between treatments. For the subsequent treatment period, the opposite allocation was given. Participant and practitioner were blinded to the allocation. Ongoing conventional treatments were permitted. The ability to recruit and retain was monitored and changes in fatigue and quality of life were measured using two validated outcome measures. RESULTS: Sixty-eight patients were assessed between February 2014 and February 2015. Four patients were eligible for the study and one consented to participate. The participant enrolled in the study for six cycles of chemotherapy and completed all treatment and outcome measures. There was no improvement under homeopathic treatment compared to placebo. There were multiple confounding events such as conventional medication changes and an adverse event unrelated to therapy. CONCLUSION: Adequate recruitment was not feasible in this setting. The n-of-1 study design is feasible in this population from the perspective of the ability to complete the trial. No conclusion on the efficacy of homeopathy for this individual can be made. It is unclear as to whether multiple treatments of chemotherapy would be an appropriate clinical situation in which to apply the n-of-1 trial methodology. Future studies should pilot adaptations to this study design.

A Feasibility Pilot Trial of Individualized Homeopathic Treatment of Fatigue in Children Receiving Chemotherapy.

BACKGROUND: Fatigue is a major problem in children with cancer. The objective was to examine the feasibility of performing a clinical trial of homeopathic treatment for fatigue in children receiving chemotherapy. MATERIALS: This was a single-institution, open-label, pilot study. Children 2 to 18 years old, diagnosed with cancer, and receiving chemotherapy were eligible. Participants were given individualized homeopathic treatment for a maximum of 14 days. In-home or clinic assessments were conducted up to 3 times weekly. Feasibility was defined as the ability to recruit and administer homeopathy to 10 participants within 1 year. Fatigue was measured using the Symptom Distress Scale daily and the PedsQL Multidimensional Fatigue Module weekly. RESULTS: Between April 2012 and April 2014, 155 potential participants were identified. There were 45 eligible and contacted patients; 36 declined participation, 30 because they were not interested; 9 agreed to participate, but 1 participant withdrew prior to treatment initiation. Median length of homeopathic treatment was 10.5 (range = 6 to 14) days. All parents found homeopathic treatment to be easy or very easy to follow. CONCLUSIONS: Trials of individualized homeopathy for fatigue reduction in pediatric cancer are not feasible in this context; lack of interest was a primary reason. Alternative approaches to evaluating homeopathy efficacy are needed.

An open-label pilot study of homeopathic treatment of attention deficit hyperactivity disorder in children and youth.

BACKGROUND: An open-label pilot study of individualized homeopathy for attention deficit hyperactivity disorder (ADHD) was conducted to assess the potential for future studies with a focus on the feasibility of the recruitment plan and outcome measure schedules; identification of any group characteristics of participants who respond significantly to the therapy; and establishing the length of time required for an improvement in ADHD symptoms. PATIENTS AND METHODS: Participants (aged 6-16) were recruited through community advertisement and outreach. Participants completed 1 screening and 9 individualized homeopathic follow-up consultations. ADHD symptoms were assessed using the Conners 3 - Parent Questionnaire administered at each consultation. The pre- and post-study difference in Conners Global Index - Parent (CGI-P) T-score was evaluated for each participant. Baseline data of those who showed a statistically significant improvement (responders) were compared to those who did not (non-responders). RESULTS: 35 participants were enrolled over 11 months. 80% completed all 10 consultations in a median of 12.1 months. 63% had a statistically significant improvement in the primary outcome, first occurring after a mean of 4.5 visits. Overall scores for participants completing at least 2 data points decreased from a baseline median of 85.5 to 74.0 (p < 0.001, CI 95%). There were no significant baseline differences between responders and non-responders. No serious adverse events related to the therapy were reported. CONCLUSION: The change in the median CGI-P T-score from baseline to the end of this open-label pilot study was statistically significant. The research methods are feasible. Future studies are warranted. TRIAL REGISTRATION: NCT01141634.

State-space grid analysis: applications for clinical whole systems complementary and alternative medicine research.

This paper presents state space grids (SSGs) as a mathematically less intensive methodology for process-oriented research beyond traditional qualitative and quantitative approaches in whole systems of complementary and alternative medicine (WS-CAM). SSGs, originally applied in developmental psychology research, offer a logical, flexible, and accessible tool for capturing emergent changes in the temporal dynamics of patient behaviors, manifestations of resilience, and outcomes. The SSG method generates a two-dimensional visualization and quantification of the inter-relationships between variables on a moment-to-moment basis. SSGs can describe dyadic interactive behavior in real time and, followed longitudinally, allow evaluation of how change occurs over extended time periods. Practice theories of WS-CAM encompass the holistic health concept of whole-person outcomes, including nonlinear pathways to complex, multidimensional changes. Understanding how the patient as a living system arrives at these outcomes requires studying the process of healing, e.g., sudden abrupt worsening and/or improvements, 'healing crises', and 'unstuckness', from which the multiple inter-personal and intra-personal outcomes emerge. SSGs can document the indirect, emergent dynamic effects of interventions, transitional phases, and the mutual interaction of patient and environment that underlie the healing process. Two WS-CAM research exemplars are provided to demonstrate the feasibility of using SSGs in both dyadic and within-patient contexts, and to illustrate the possibilities for clinically relevant, process-focused hypotheses. This type of research has the potential to help clinicians select, modify and optimize treatment plans earlier in the course of care and produce more successful outcomes for more patients.