OBJECTIVE: To determine the feasibility, in terms of acceptability to patients, physicians and other staff; data return and statistical power of a study to elucidate the relative contributions of specific and non-specific effects in homeopathic treatment of dermatitis. DESIGN: Randomised, controlled 4-arm trial, 2 arms double-blind. SETTING: Outpatient clinic, Royal London Homoeopathic Hospital. PARTICIPANTS: Seventy-five adult patients with dermatitis. INTERVENTIONS: Patients were randomly allocated to: 'fast track' open verum homeopathy, 'fast track' double-blind verum homeopathy, 'fast track' double-blind placebo homeopathy or waiting list control. MAIN OUTCOME MEASURES: One hundred millimeter visual analogue scale of overall symptom severity; 10 point digital scores of sleep, itching, skin condition; weekly 5-point Likert scale of topical steroid use; Dermatology Life Quality Index at entry and completion. RESULTS: Recruitment was below target, but the study was acceptable to staff and feasible. Blinded patients were more likely to withdraw (P=0.021, chi2 test). After correction for baseline differences and multiple comparisons, no outcome measure showed statistically significant between group differences. Blindness appeared to have a negative effect, but this was confounded by differential withdrawal. CONCLUSIONS: A definitive trial of this design is unlikely to discriminate the relative contributions of the non-specific and specific effects to the outcome of homeopathic treatment of dermatitis, because of patient preference issues.
RCT Entities:
OBJECTIVE: To determine the feasibility, in terms of acceptability to patients, physicians and other staff; data return and statistical power of a study to elucidate the relative contributions of specific and non-specific effects in homeopathic treatment of dermatitis. DESIGN: Randomised, controlled 4-arm trial, 2 arms double-blind. SETTING:Outpatient clinic, Royal London Homoeopathic Hospital. PARTICIPANTS: Seventy-five adult patients with dermatitis. INTERVENTIONS:Patients were randomly allocated to: 'fast track' open verum homeopathy, 'fast track' double-blind verum homeopathy, 'fast track' double-blind placebo homeopathy or waiting list control. MAIN OUTCOME MEASURES: One hundred millimeter visual analogue scale of overall symptom severity; 10 point digital scores of sleep, itching, skin condition; weekly 5-point Likert scale of topical steroid use; Dermatology Life Quality Index at entry and completion. RESULTS: Recruitment was below target, but the study was acceptable to staff and feasible. Blinded patients were more likely to withdraw (P=0.021, chi2 test). After correction for baseline differences and multiple comparisons, no outcome measure showed statistically significant between group differences. Blindness appeared to have a negative effect, but this was confounded by differential withdrawal. CONCLUSIONS: A definitive trial of this design is unlikely to discriminate the relative contributions of the non-specific and specific effects to the outcome of homeopathic treatment of dermatitis, because of patient preference issues.
Authors: Gabriel S Tajeu; Lucia Juarez; Jessica H Williams; Jewell Halanych; Irena Stepanikova; April A Agne; Jeff Stone; Andrea L Cherrington Journal: J Gen Intern Med Date: 2022-03-09 Impact factor: 6.473
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Authors: Polykarpos Angelos Nomikos; Michelle C Hall; Amy Fuller; Reuben Ogollah; Ana M Valdes; Michael Doherty; David Andrew Walsh; Roshan das Nair; Abhishek Abhishek Journal: PLoS One Date: 2022-01-13 Impact factor: 3.240
Authors: Sigurlaug H Hafliðadóttir; Carsten B Juhl; Sabrina M Nielsen; Marius Henriksen; Ian A Harris; Henning Bliddal; Robin Christensen Journal: Trials Date: 2021-07-26 Impact factor: 2.279