David Brulé, BA, DHMS (Can.), Homeopath

Transcription

1 David Brulé, BA, DHMS (Can.), Homeopath

2 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

3 What homeopaths do! What we are doing today!

4 So far we are hypothesis generating Writing up cases in a formalized manner. Publication in journals and books with pertinent information.

5 Hypothesis generating and hypothesis testing! A snapshot in time.

6 You may have participated in this study!

7 Studies such as comparing outcomes of conventional vs. homeopathic treatment of the 1918 Flu epidemic Retrospective - Compare two groups by looking back in time.

8 Prospective sets parameters prior to enrolling participants.

9 Patients who seek homeopathic treatment are likely to improve considerably. These effects persist for as long as 8 years.

10 Reduces various biases implicit in other designs.

11 It s position at the top of the pyramid may mean it is highly political and not driven by science and truth. Highly dependent on defining terms of the review.

12 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

13 Research in: History of homeopathy Homeopathic philosophy Dispensing methods Homeopathy best practices Homeopathy use concurrent with conventional medications Homeopathy in infectious diseases Clinical homeopathy

14 4 clinical trials conducted or ongoing Exploring: Homeopathic treatment of ADHD Homeopathic treatment of side effects of chemotherapy

15 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

16 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

17 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

18 Outcome scale Baseline Group Median Final Group Median p- value Conners Global Index (CGI-P) T-score % Conners ADHD Index Probability score N/A * Conners Content scale T-score for Inattention % Conners Content scale T-score for Hyperactivity/Impulsivity Conners DSM-IV-TR Symptom scale T-score for the ADHD Inattentive sub-type Conners DSM-IV-TR Symptom scale T-score for the ADHD Hyperactive-Impulsive subtype % % % % of participants with a statistically significant change

19 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).

20

21 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

22 Collaboration with team at SickKids Hospital Novel environment homeopathy has never been used in this setting (children undergoing chemotherapy in hospital setting in Canada)

23 To determine the feasibility of recruiting patients for a study of individualized homeopathy in paediatric patients receiving chemotherapy for cancer.

24 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.

25 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.

26 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.

27 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)

28 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).

29 155 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 outpatient hospital in Toronto, Canada) was not feasible primarily due to difficulty in recruitment.

30 Screened N=155 Eligible n=45 Ineligible or Not Approached n=110 Refused n=36 Consented n=9 Not interested (n=30) Too busy (n=3) Too sick (n=2) Fatigue not a problem (n=1) Completed n=8 Withdrew n=1 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)

31 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).

32 Symptom Distress Scale scores significantly improved during the observation time frame (β=-0.08, standard error (SE)=0.02; P=0.0005).

33 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)

34 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

35 SDS Score 5 SDS score by Time Time Calcarea Phosphorica 6CH administered here

36 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.

37 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)

38 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.

39

40 Collaboration with a team at the Canadian College of Naturopathic Medicine and the Ottawa Integrative Cancer Centre

41 The n-of-1 design requires a washout period which returns the trial participant to baseline before every intervention. Randomly assigned Randomly assigned Randomly assigned chemo Verum/p lacebo chemo Placebo/ verum chemo Placebo/v erum chemo Verum/ placebo chemo Placebo/v erum chemo Verum/ placebo In this study, regular rounds of chemotherapy act as the washout period.

42 Rigorous scientifically Inexpensive Homogeneity - able to follow single participant and draw robust conclusions

43 Requires a condition that can be washed out. Questionable generalizability (unsure whether the results of this study are typical of the population in general)

44 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

45 1 participant recruited at time of initial chemotherapy with scheduled 6 rounds of chemotherapy forthcoming Homeopath followed the participant with inperson and telephone consultations (contact 2 times per week). Able to prescribe and change remedy and potency at any time through the treatment period.

46 Study staff performed coin-toss randomization. Clinician and participant blinded to randomization. Remedy and instructions sent to participant immediately following prescription.

47 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

48 Trial design is feasible Need to explore other recruitment strategies

49 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

50 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 other

51 UCLAN Canadian Universities University of Toronto University of Alberta University of Lethbridge University of Calgary Université de Montréal

52

53

54