The N-of-1 Clinical Trial: A Timely Research Opportunity in Homeopathy

Ulbrich-Zürni, Susanne; Teut, Michael; Roll, Stephanie; Mathie, Robert T.

doi:10.1055/s-0037-1621731

Cited by 9 publications

(11 citation statements)

References 61 publications

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“…TCIM researchers may thus prudently consider n-of-1 design adaptations, a point scant raised in previous related literature. 134,135 Huang et al's actively -controlled n-of-1 design furthermore addresses challenges in recruiting patients to placebo -controlled trials in the Chinese national context 80 ; ethno-culturally situated considerations such as these warrant greater attention by WSR scholars, given TCIM's globalized context.…”

Section: Results Overviewmentioning

confidence: 99%

Whole Systems Research Methods in Health Care: A Scoping Review

Ijaz

Rioux²,

Elder

et al. 2019

The Journal of Alternative and Complementary Medicine

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Objectives: This scoping review evaluates two decades of methodological advances made by “whole systems research” (WSR) pioneers in the fields of traditional, complementary, and integrative medicine (TCIM). Rooted in critiques of the classical randomized controlled trial (RCT)'s suitability for evaluating holistic, complex TCIM interventions, WSR centralizes the principle of “model validity,” representing a “fit” between research design and therapeutic paradigm. Design: In consultation with field experts, 41 clinical research exemplars were selected for review from across 13 TCIM disciplines, with the aim of mapping the range and methodological characteristics of WSR studies. Using an analytic charting approach, these studies' primary and secondary features are characterized with reference to three focal areas: research method, intervention design, and outcome assessment. Results: The reviewed WSR exemplars investigate a wide range of multimodal and multicomponent TCIM interventions, typified by wellness-geared, multitarget, and multimorbid therapeutic aims. Most studies include a behavioral focus, at times in multidisciplinary or team-based contexts. Treatments are variously individualized, often with reference to “dual” (biomedical and paradigm-specific) diagnoses. Prospective and retrospective study designs substantially reflect established biomedical research methods. Pragmatic, randomized, open label comparative effectiveness designs with “usual care” comparators are most widely used, at times with factorial treatment arms. Only two studies adopt a double-blind, placebo-controlled RCT format. Some cohort-based controlled trials engage nonrandomized allocation strategies (e.g., matched controls, preference-based assignment, and minimization); other key designs include single-cohort pre–post studies, modified n-of-1 series, case series, case report, and ethnography. Mixed methods designs (i.e., qualitative research and economic evaluations) are evident in about one-third of exemplars. Primary and secondary outcomes are predominantly assessed, at multiple intervals, through patient-reported measures for symptom severity, quality of life/wellness, and/or treatment satisfaction; some studies concurrently evaluate objective outcomes. Conclusions: Aligned with trends emphasizing “fit-for-purpose” research designs to study the “real-world” effectiveness of complex, personalized clinical interventions, WSR has emerged as a maturing scholarly discipline. The field is distinguished by its patient-centered salutogenic focus and engagement with nonbiomedical diagnostic and treatment frameworks. The rigorous pursuit of model validity may be further advanced by emphasizing complex analytic models, paradigm-specific outcome assessment, inter-rater reliability, and ethnographically informed designs. Policy makers and funders seeking to support best practices in TCIM research may refer to this review ...

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Section: Results Overviewmentioning

confidence: 99%

Whole Systems Research Methods in Health Care: A Scoping Review

Ijaz

Rioux²,

Elder

et al. 2019

The Journal of Alternative and Complementary Medicine

View full text Add to dashboard Cite

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“…Our review does not address single-case experimental study designs, such as single-case experiments, multiple baseline designs, and n-of-1 randomized controlled trials. Readers interested in performing experimental research with single patients are referred to Teut, 32 Guyatt, 33 Baker, 34 Teut & Linde, 35 Kravitz et al, 36 and Ulbrich-Zürni et al 37 for further information.…”

Section: Discussionmentioning

confidence: 99%

Case Reporting in Homeopathy—An Overview of Guidelines and Scientific Tools

Teut

Haselen²,

Rutten³

et al. 2021

Homeopathy

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Case reports have been of central importance to the development of homeopathy over the past 200 years. With a special focus on homeopathy, we give an overview on guidelines and tools that may help to improve the quality of case reports. Reporting guidelines such as CARE (Case Report), HOM-CASE (Homeopathic Clinical Case Reports), and the WissHom Documentation Standard help to improve the quality of reporting and strengthen the scientific value of a case report. Additional scientific tools such as prospective outcome assessment, prognostic factor research, cognition-based medicine, and the Modified Naranjo Criteria for Homeopathy (MONARCH) score may be helpful in improving case documentation and evaluation.

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“…To obtain more robust evidence for homeopathy in rare co-morbid conditions such as the current example, an N-of-1 clinical trial design might be the most feasible to determine the effectiveness of an individualized homeopathic intervention in an individual subject. 38…”

Section: Discussionmentioning

confidence: 99%

A Co-morbid Condition of Warts and Vitiligo Treated with Individualized Homeopathy: An Evidence-Based Case Report

Prusty

Bhandari

2021

Homeopathy

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Background Whilst warts and vitiligo are both common skin diseases, their co-morbidity is rare. Here we present a clinical case of warts with vitiligo to illustrate the utility of individualized homeopathic treatment. Method The homeopathic medicine Sepia officinalis was prescribed, based on individualization. During follow-up, changes were documented by photographs. The non-invasive methods ORIDL (Outcome Related to Impact on Daily Living), VASI (Vitiligo Area and Scoring Index), and VETF (Vitiligo European Task Force) were used to assess treatment progress. Possible causal attribution of outcome with treatment was evaluated using the Modified Naranjo Criteria for Homeopathy (MONARCH). Result There was a marked improvement of vitiligo, along with the disappearance of warts, as evidenced photographically. VASI and VETF scores were significantly reduced. Main complaints, as well as overall well-being, improved on the ORIDL scale (+3). The MONARCH score (+9) suggested that the clinical improvement was attributable to the homeopathic intervention. Conclusion The study suggests a significant role for individualized homeopathic treatment in the co-morbidity of warts and vitiligo.

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The N-of-1 Clinical Trial: A Timely Research Opportunity in Homeopathy

Abstract: The N-of-1 trial design offers important new investigative possibilities in homeopathy and should be explored as a means to optimise individualised health care or investigate effectiveness of the homeopathic intervention compared with placebo in individual subjects.

Cited by 9 publications

References 61 publications

Whole Systems Research Methods in Health Care: A Scoping Review

Whole Systems Research Methods in Health Care: A Scoping Review

Case Reporting in Homeopathy—An Overview of Guidelines and Scientific Tools

A Co-morbid Condition of Warts and Vitiligo Treated with Individualized Homeopathy: An Evidence-Based Case Report

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