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David Brulé, BA, DHMS (Can.), Homeopath
Canadian Homeopathic Conference, Toronto, Canada - February 5, 2016
What is research and evidence
Research areas explored in Canada◦ Provings
◦ Social sciences
◦ Animal studies
◦ Clinical research
My experience with clinical research
Opportunities and ways forward
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
What
homeopaths do!
What we are
doing
today!
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Writing up cases
in a formalized
manner.
Publication in
journals and
books – with
pertinent
information.
So far we are
hypothesis
generating…
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
A snapshot
in time.
Hypothesis
generating
and
hypothesis
testing!
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
You may have participated in this study!
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Retrospective -
Compare two
groups by
looking back in
time.
Studies such as
comparing
outcomes of
conventional vs.
homeopathic
treatment of the
1918 Flu
epidemic
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Prospective –
sets
parameters
prior to
enrolling
participants.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Patients who seek homeopathic treatment are likely to
improve considerably. These effects persist for as long as 8
years.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Reduces
various
biases
implicit in
other
designs.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Highly
dependent on
defining terms of
the review.
It’s position
at the top of
the pyramid
may mean it
is highly
political and
not driven
by science
and truth.
Practitioner case reports
Provings
Social sciences: studies on practitioner groups, physicians, pharmacists attitudes towards homeopathy and homeopathy regulation
Animal studies: One mouse model study conducted at University of Manitoba
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Research in:◦ History of homeopathy
◦ Homeopathic philosophy
◦ Dispensing methods
◦ Homeopathy best practices
◦ Homeopathy use concurrent with conventional medications
◦ Homeopathy in infectious diseases
◦ Clinical homeopathy
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
4 clinical trials conducted or ongoing
Exploring:
Homeopathic treatment of ADHD
Homeopathic treatment of side effects of chemotherapy
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Set out to explore a rigorous study design which will factor classical homeopathic methods within the context of the RCT design◦ Need to use best practices (classical homeopathy)
◦ Need to have model validity (typical of current homeopathic practice)
◦ Need to base design on consistent practitioners
Sample size estimates generated from experience and not guesswork
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Frei, et al showed that it can take up to one year to get the right remedy when treating ADHD
Possible explanation for mixed results in prior studies
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
36 participants
Designed to see if a larger study was feasible, warranted and to calculate a sample size for future study
Results:◦ 63% had a significant decrease in ADHD symptoms
◦ Future study justified
◦ Sample size calculated based on 28 weeks of homeopathic treatment
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Outcome scale Baseline
Group
Median
Final Group
Median
p-
value
% of
participants
with a
statistically
significant
change
Conners Global Index (CGI-P) T-score 85.5 74 0.001 63%
Conners ADHD Index Probability score 99 91 0.001 N/A *
Conners Content scale T-score for Inattention 85 75 0.001 34%
Conners Content scale T-score for
Hyperactivity/Impulsivity
84 78 0.001 51%
Conners DSM-IV-TR Symptom scale T-score
for the ADHD Inattentive sub-type
84 72.5 0.001 34%
Conners DSM-IV-TR Symptom scale T-score
for the ADHD Hyperactive-Impulsive sub-
type
81.5 74 0.001 51%
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Attempt to maximize model validity – to emulate clinical practice as much as possible.◦ Appointments on a monthly basis
◦ Change remedies and potencies as needed clinically
◦ Total of 10 consultations
Primary restriction was remedy availability; study was limited to use of remedies carrying a DIN-HM # (medicines regulated for over the counter use in Canada).
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Currently ongoing
Used data from pilot study to determine:◦ Sample size
◦ Length of study
◦ Optimal recruitment strategies
◦ All based on similar model as the pilot study including same practitioners, same treatment style, same primary outcome measure
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Collaboration with team at SickKids Hospital
Novel environment – homeopathy has never been used in this setting (children undergoing chemotherapy in hospital setting in Canada)
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
To determine the feasibility of recruiting patients for a study of individualized homeopathy in paediatric patients receiving chemotherapy for cancer.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
1. To determine the feasibility of administering individualized homeopathy in paediatric cancer patients receiving chemotherapy for cancer
by describing the proportion of participants who complete at least 10 days of treatment
2. To assess the acceptability of individualized homeopathy in paediatric cancer patients receiving chemotherapy for cancer.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
3. Describe changes in fatigue scores according to:
Symptom Distress Scale
PedsQL Multidimensional Fatigue Scale
PedsQL Generic Core Scales and Acute Cancer Module.
4. Describe any adverse events possibly, probably or definitely related to the therapy.
5. Describe the clinical experience.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Study conducted from June 2012 to April 2014
Children (ages 2 to 18), diagnosed with any type of cancer who were receiving chemotherapy administered discontinuously in courses or cycles
A full case-taking (classical homeopathy) was performed at the home of the participant
Homeopathic medicines were lactose/sucrose pellet form or in 30% alcohol.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Participants were followed daily for 14 days.
Remedies and dosages could be changed on a daily basis.
Recruitment rates, adverse events and remedy selection were monitored
Changes in fatigue were measured using the Symptom Distress Scale (daily), the PedsQL Multidimensional Fatigue Scale and the PedsQL Generic Core Scales and Acute Cancer Module. (weekly)
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Study clinician identified, through a review of case notes, patterns in homeopathic remedy prescribing as well as any adverse events.
Study clinician identified adverse events which could be considered homeopathic aggravations (clinically expected adverse event following the administration of a homeopathic remedy).
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
155 potential patients who fulfilled the inclusion/exclusion criteria were assessed.◦ Identified by the study team at the Hospital for Sick
Children
45 patients were eligible and 9 consented to participate.
8 participants received homeopathic treatment and one withdrew prior to treatment. All eight participants completed the 14 days of assessment.
We determined that provision of individualized homeopathy in this research setting (pediatric out-patient hospital in Toronto, Canada) was not feasible primarily due to difficulty in recruitment.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
ScreenedN=155
Eligiblen=45
Refused n=36
Not interested (n=30)Too busy (n=3)Too sick (n=2)Fatigue not a problem (n=1)
Consentedn=9
Completed n=8
Withdrew n=1
Ineligible or Not Approached
n=110
Completion of chemotherapy (n=27)Health care team did not permit research team contact (n=23)Palliative (n=12)Too young (n=11)Living too far away (n=6)No fatigue (n=10)Ineligible protocol (n=7)Did not speak English (n=5)No discharge plan (n=4)Other (developmental delay, gastric tube) (n=5)
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
The proxy-report fatigue scores showed a significant improvement in general fatigue (β=1.7, SE=0.8; P=0.038) and sleep/rest fatigue (β=2.4, SE=0.7; P=0.004) over time. There was no change in cognitive fatigue with time (P=0.611).
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Symptom Distress Scale scores significantly improved during the observation time frame (β=-0.08, standard error (SE)=0.02; P=0.0005).
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
At the initial consultation all of the study participants “fit” the homeopathic remedy picture of Cadmium Sulfuricum and that remedy was prescribed in either 6CH or 15CH potency at the beginning of each case.
The following homeopathic medicines were used:◦ Cadmium Sulphuricum (n=8)
◦ Lycopodium Clavatum (n=2)
◦ Calcarea Phosphorica (n=1)
◦ Nux Vomica (n=1)
◦ Phosphorus (n=1)
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Clinically observed homeopathic aggravation◦ Occurred when given a “constitutional” remedy
based on the overall symptom picture of the patient and not on specific symptoms related to the chemotherapy.
◦ The remedy, Calcarea Phosphorica 6CH, was given as a single dose in pellet form.
◦ The remedy was given based on symptoms that emerged on days 5-6 of the treatment
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
1
2
3
4
5
SD
S S
core
Time
SDS score by Time
Calcarea
Phosphorica 6CH
administered here
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Classical homeopathy selects individualized remedies based on the patient’s symptom picture
In some conditions, where there is a lack of individualized symptom picture, a condition specific “therapeutic” remedy may be considered
In this scenario, we found that Cadmium Sulphuricum in a low potency was an effective remedy and yielded significant results.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
In a vulnerable population, it is important to mitigate as much as possible the occurrence of adverse events and/or aggravations
Elements that may have been a factor in this adverse event:◦ 1. Administration of the remedy in dry dose (pellet
form)
◦ 2. Administration of a constitutional remedy when the patient is undergoing chemotherapy treatment
◦ 3. Clinician error (not gauging patient sensitivity)
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Homeopathic treatment may help children with chemotherapy related fatigue. (Just not seemingly feasible in a Canadian hospital).
Future study may consider a routine use of Cadmium Sulfuricum as part of the protocol.
To mitigate unwanted homeopathic aggravation, future study may discourage constitutional prescribing or may suggest the use of techniques such as liquid dosing or water dosing.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Collaboration with a team at the Canadian College of Naturopathic Medicine and the Ottawa Integrative Cancer Centre
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Randomly assigned Randomly assigned Randomly assigned
chemo Verum/p
lacebo
chemo Placebo/
verum
chemo Placebo/v
erum
chemo Verum/
placebo
chemo Placebo/verum
chemo Verum/placebo
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
The n-of-1 design requires a “washout” period which returns the trial
participant to baseline before every intervention.
In this study, regular rounds of chemotherapy act as the “washout” period.
Rigorous scientifically
Inexpensive
Homogeneity - able to follow single participant and draw robust conclusions
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Requires a condition that can be “washed out”.
Questionable generalizability (unsure whether the results of this study are typical of the population in general)
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Is a study of this nature feasible in terms of:
◦ the ability of the participant to stay with the study and to fill out all of the questionnaires,
◦ the time it takes to recruit a single eligible patient and number of screens to find this patient,
◦ possible clinical effect size via changes in scores according to the Multi-dimensional Fatigue Inventory (MFI) and the EORTC-QLQ-C30
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
1 participant recruited at time of initial chemotherapy with scheduled 6 rounds of chemotherapy forthcoming
Homeopath followed the participant with in-person and telephone consultations (contact 2 times per week).
Able to prescribe and change remedy and potency at any time through the treatment period.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Study staff performed “coin-toss” randomization.
Clinician and participant blinded to randomization.
Remedy and instructions sent to participant immediately following prescription.
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
We recruited 1 participant after study recruitment period of 1 year
Participant completed full study (4 months of data collection)
Data analysis of effects of homeopathic treatment ongoing
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Trial design is feasible
Need to explore other recruitment strategies
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Know the literature
Design your study to answer your research question
As clinicians you can design with maximum model validity ◦ Questions that come up during clinical practice
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Research networks - Collaboration is key!◦ IN-CAM
◦ Homeopathy Research Network
◦ ISCMR
Centre for Integrative Medicine (University of Toronto/Scarborough Hospital)
Funding ◦ SickKids Foundation
◦ Lotte and John Hecht Memorial Foundation
◦ Canadian CAM Research Fund
◦ CIHR
◦ otherCanadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
UCLAN
Canadian Universities◦ University of Toronto
◦ University of Alberta
◦ University of Lethbridge
◦ University of Calgary
◦ Université de Montréal
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016
Canadian Homeopathic Conference,
Toronto, Canada - February 5, 2016