An N-of-1 Feasibility Study of Homeopathic Treatment for Fatigue in Patients Receiving Chemotherapy
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Notice bibliographique
Résumé
BACKGROUND: Cancer-related fatigue has been described as a subjective feeling of physical, emotional, and/or cognitive tiredness. Homeopathy has been widely used to treat side effects of chemotherapy. The n-of-1 design is a single-patient trial method to study a clinical condition that is either short lived and reversible or is chronic and stable. The n-of-1 design requires a washout/reset period. The feasibility of performing an n-of-1 study in homeopathy has not previously been tested. METHODS: A feasibility n-of-1 trial of individualized homeopathic treatment for fatigue in a single adult undergoing chemotherapy administered periodically was performed. For each matched pair of treatments, the participant was randomly allocated either placebo or verum for the period between treatments. For the subsequent treatment period, the opposite allocation was given. Participant and practitioner were blinded to the allocation. Ongoing conventional treatments were permitted. The ability to recruit and retain was monitored and changes in fatigue and quality of life were measured using two validated outcome measures. RESULTS: Sixty-eight patients were assessed between February 2014 and February 2015. Four patients were eligible for the study and one consented to participate. The participant enrolled in the study for six cycles of chemotherapy and completed all treatment and outcome measures. There was no improvement under homeopathic treatment compared to placebo. There were multiple confounding events such as conventional medication changes and an adverse event unrelated to therapy. CONCLUSION: Adequate recruitment was not feasible in this setting. The n-of-1 study design is feasible in this population from the perspective of the ability to complete the trial. No conclusion on the efficacy of homeopathy for this individual can be made. It is unclear as to whether multiple treatments of chemotherapy would be an appropriate clinical situation in which to apply the n-of-1 trial methodology. Future studies should pilot adaptations to this study design.
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Prédiction distillée sur la base complète
Imitation des enseignantsNi prévalence calibrée, ni vérité terrain. Validation humaine à venir. Apprise à partir de 10 348 étiquettes directes de Codex et de 10 348 étiquettes directes de Gemma. Le mode candidate est l'union des têtes enseignantes seuillées; le consensus est leur intersection. Ces sorties portent le statut machine_predicted_unvalidated et ne sont ni des étiquettes humaines ni des étiquettes directes de modèles de pointe.
Scores Codex et Gemma par catégorie
| Catégorie | Codex | Gemma |
|---|---|---|
| Métarecherche | 0,000 | 0,000 |
| Méta-épidémiologie (sens strict) | 0,000 | 0,000 |
| Méta-épidémiologie (sens large) | 0,001 | 0,000 |
| Bibliométrie | 0,000 | 0,000 |
| Études des sciences et des technologies | 0,000 | 0,000 |
| Communication savante | 0,000 | 0,000 |
| Science ouverte | 0,000 | 0,000 |
| Intégrité de la recherche | 0,000 | 0,000 |
| Charge utile insuffisante (le modèle a refusé de juger) | 0,000 | 0,000 |
Scores machine (provisoires)
Les deux têtes enseignantes du modèle étudiant, lues sur ce travail. Un score ordonne la base pour la relecture; il n'affirme jamais une catégorie, et le statut de validation accompagne chaque rangée tel quel.
Scores de référence d'un modèle non mature (critères de maturité non atteints, 7 itérations). Un score ordonne; il n'affirme jamais une catégorie.
score_only:v0-immature-baseline · tel quel depuis la passe de notation : score_only signifie que le nombre peut ordonner les travaux, et qu'aucune étiquette de catégorie n'en découle