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economic model of vaccine programs has far-reaching ef- fects for both global health and economic sustainability. Keywords: Autism, Developmental delays, Infectious disease, Vaccination, Homeopathic nosodes, Long-term health outcomes A critical examination of evidence regarding the use of individualised homeopathy in the treatment of bipolar spectrum disorders Kimberlee Blyden-Taylor E-mail: [email protected] (K. Blyden-Taylor) Introduction: Diagnosis of bipolar spectrum disorders (BSD) has substantially expanded in scope due to changing diagnostic criteria. As a result, the societal impact of these disorders has garnered greater public awareness and concern. The aim of this paper is to identify evidence in re- gards to individualised homeopathic treatment of patients with symptoms of BSD. Method: A literature review was undertaken to deter- mine published evidence of the effect of individualised ho- meopathic treatment for bipolar spectrum disorders. Results: Ten relevant articles were identified. Claims for the effect of homeopathy for BSD exclusively include documentation of single cases presented as informal abbre- viated interviews or as summaries. Strengths of single case reports include detailed descriptions of patients’ symptom pictures and length of follow-up periods. Weaknesses include the varied quality of published case reports, lack of diagnostic criteria, lack of triangulation for content vali- dation, and a lack of standardization making cross case comparison unreliable. Case reports are typically retro- spective and generally do not include rival explanations for positive changes. To date, no clinical trials have been published. Conclusion: Documentation of the successful effect of individualised homeopathy in treatment of bipolar spectrum cannot reliably be said to exist at this time. Informal single case reports are a historical backbone of knowledge transfer in the homeopathic community and have provided great depth of insight into practitioners’ methodology as well as patient experience. However, lack of consistency in the style and quality of case reporting and in the rigour of analysis limits cross-case comparison and generalizability. Thompson’s (2004) innovative Formal Case Study (FCS) approach offers a viable alternative to the standard case report. FCS is grounded in established practices of qualita- tive research; it utilizes grounded propositions which are tested by a variety of analytic tools, focusing on identifica- tion of deviant cases and rival explanations of outcomes. Although it requires more work on the part of the homeo- path-author, the FCS offers the potential for building a clin- ically useful database of cases amenable to cross-case comparison and generalizability. Whole Systems Research (WSR) offers further research potential into the synergistic effects inherent in complex treatment systems. Treatment of chemotherapy related fatigue: an opportunity to use the n-of-1 trial design in individualized homeopathy David Brul e 1, * and Dugald Seely 2 1 Riverdale Homeopathic Clinic, Toronto, Canada 2 Ottawa Integrative Cancer Centre, Ottawa, Canada *Corresponding author. E-mail: [email protected] (D. Brul e) Background: Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Fatigue has a multidimensional component with correlations to other symptoms such as pain, insomnia, anorexia, nausea, vomiting, anxiety and depression. Homeopathic treatments show some potential in relieving cancer-related fatigue, are easy to deliver and demonstrate strong compliance. The n-of-1 trial design is a scientifically rigourous method of studying particular clinical conditions. The method in- volves the administration of either verum or placebo accord- ing to a binary randomization allocation sequence unknown to both the clinician and participant. During the subsequent treatment period the participant will be given the other allo- cation (verum or placebo). The following pairs of alloca- tions will also be randomized with treatment continuing for as long as the participant is in the trial. Using the n-of-1 design to test the efficacy of homeopa- thy is challenging primarily due to the unpredictability of the length of time of the effects of homeopathic treatment. On the plus side, the individualization of homeopathic treatment can be harnessed by repeated testing in a single participant. This may be especially fruitful in an individual who is sensitive to or who seems to respond actively to ho- meopathic substances. Methods/Design: An n-of-1 pilot trial of individualized homeopathic treatment of fatigue in a single adult who is undergoing any type of chemotherapy administered inter- mittently (i.e. not continuously) will be performed. The participant will have a homeopathic consultation within 3 days of a round of chemotherapy (“treatment period”) and will be administered either verum or placebo according to the n-of-1 design. The pairs of allocations will continue for as long as the participant is undergoing chemotherapy treatment. Each round of chemotherapy will provide a consistent washout thus reversing any of the prior effects of the homeopathic remedy. The washout and reversibility in this particular clinical context (in which a highly toxic chemotherapy and antidote is given) will provide one of the key requirements for effective application of the n-of- 1 design. Abstracts - Poster Presentations 83 Homeopathy

A critical examination of evidence regarding the use of individualised homeopathy in the treatment of bipolar spectrum disorders

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Abstracts - Poster Presentations

83

economic model of vaccine programs has far-reaching ef-fects for both global health and economic sustainability.Keywords: Autism, Developmental delays, Infectious

disease, Vaccination, Homeopathic nosodes, Long-termhealth outcomes

A critical examination of evidenceregarding the use ofindividualised homeopathy in thetreatment of bipolar spectrumdisorders

Kimberlee Blyden-Taylor

E-mail: [email protected] (K. Blyden-Taylor)

Introduction: Diagnosis of bipolar spectrum disorders(BSD) has substantially expanded in scope due to changingdiagnostic criteria. As a result, the societal impact of thesedisorders has garnered greater public awareness andconcern. The aim of this paper is to identify evidence in re-gards to individualised homeopathic treatment of patientswith symptoms of BSD.Method: A literature review was undertaken to deter-

mine published evidence of the effect of individualised ho-meopathic treatment for bipolar spectrum disorders.Results: Ten relevant articles were identified. Claims for

the effect of homeopathy for BSD exclusively includedocumentation of single cases presented as informal abbre-viated interviews or as summaries. Strengths of single casereports include detailed descriptions of patients’ symptompictures and length of follow-up periods. Weaknessesinclude the varied quality of published case reports, lackof diagnostic criteria, lack of triangulation for content vali-dation, and a lack of standardization making cross casecomparison unreliable. Case reports are typically retro-spective and generally do not include rival explanationsfor positive changes. To date, no clinical trials have beenpublished.Conclusion: Documentation of the successful effect of

individualised homeopathy in treatment of bipolar spectrumcannot reliably be said to exist at this time. Informal singlecase reports are a historical backbone of knowledge transferin the homeopathic community and have provided greatdepth of insight into practitioners’ methodology as well aspatient experience. However, lack of consistency in the styleand quality of case reporting and in the rigour of analysislimits cross-case comparison and generalizability.Thompson’s (2004) innovative Formal Case Study (FCS)

approach offers a viable alternative to the standard casereport. FCS is grounded in established practices of qualita-tive research; it utilizes grounded propositions which aretested by a variety of analytic tools, focusing on identifica-tion of deviant cases and rival explanations of outcomes.Although it requires more work on the part of the homeo-path-author, the FCS offers the potential for building a clin-ically useful database of cases amenable to cross-case

comparison and generalizability. Whole Systems Research(WSR) offers further research potential into the synergisticeffects inherent in complex treatment systems.

Treatment of chemotherapyrelated fatigue: an opportunity touse the n-of-1 trial design inindividualized homeopathy

David Brul�e1,* and Dugald Seely2

1Riverdale Homeopathic Clinic, Toronto, Canada2Ottawa Integrative Cancer Centre, Ottawa, Canada

*Corresponding author.E-mail: [email protected] (D. Brul�e)

Background: Cancer-related fatigue has been describedas a subjective feeling of physical, emotional, and/orcognitive tiredness. Fatigue has a multidimensionalcomponent with correlations to other symptoms such aspain, insomnia, anorexia, nausea, vomiting, anxiety anddepression. Homeopathic treatments show some potentialin relieving cancer-related fatigue, are easy to deliver anddemonstrate strong compliance.The n-of-1 trial design is a scientifically rigourousmethod

of studying particular clinical conditions. The method in-volves the administration of either verum or placebo accord-ing to a binary randomization allocation sequence unknownto both the clinician and participant. During the subsequenttreatment period the participant will be given the other allo-cation (verum or placebo). The following pairs of alloca-tions will also be randomized with treatment continuingfor as long as the participant is in the trial.Using the n-of-1 design to test the efficacy of homeopa-

thy is challenging primarily due to the unpredictability ofthe length of time of the effects of homeopathic treatment.On the plus side, the individualization of homeopathictreatment can be harnessed by repeated testing in a singleparticipant. This may be especially fruitful in an individualwho is sensitive to or who seems to respond actively to ho-meopathic substances.Methods/Design: An n-of-1 pilot trial of individualized

homeopathic treatment of fatigue in a single adult who isundergoing any type of chemotherapy administered inter-mittently (i.e. not continuously) will be performed. Theparticipant will have a homeopathic consultation within 3days of a round of chemotherapy (“treatment period”)and will be administered either verum or placebo accordingto the n-of-1 design. The pairs of allocations will continuefor as long as the participant is undergoing chemotherapytreatment. Each round of chemotherapy will provide aconsistent washout thus reversing any of the prior effectsof the homeopathic remedy. The washout and reversibilityin this particular clinical context (in which a highly toxicchemotherapy and antidote is given) will provide one ofthe key requirements for effective application of the n-of-1 design.

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