Subscribe to RSS
Methodological Considerations in the Assessment of Effectiveness of Homeopathic Care: A Critical Review of the EPI3 StudyFunding Support This review was sponsored by Boiron.
Background EPI3 is an observational study of a representative sample of general practitioners (GPs) and patients in France, demonstrating that patient characteristics differ according to the prescribing preferences of their GPs for homeopathy. For selected conditions (musculoskeletal disorders, sleep disorders, anxiety/depression, upper respiratory tract infections), progression of symptoms and adverse events over follow-up in the homeopathy preference group did not significantly differ from other practice preferences, but there was a two-fold to four-fold lower usage of conventional medicines. The EPI3 study's validity was challenged due to absence of head-to-head comparison of medicines to conclude on a causal association between homeopathy and outcomes.
Methods A critical review of the nine EPI3 publications was conducted, focusing on generalizability, selection bias, outcome measurements and confounding.
Results The conceptual framework of EPI3 rests on a systemic construct, i.e., the homeopathic treatment concept assessed using the type of GP prescribing preference, taking into account the clinical, human and social aspects. The enrollment process enhanced the generalizability of findings. Validated instruments for outcome measurements were used for three conditions, and control of confounding was rigorous.
Conclusion EPI3 was conducted according to best practices. Homeopathy prescribing preference met specific patient needs with less use of conventional medicines and without an apparent loss in therapeutic opportunity.
Received: 31 March 2021
Accepted: 21 June 2021
14 September 2021 (online)
© 2021. Faculty of Homeopathy. This article is published by Thieme.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
- 1 Lert F, Grimaldi-Bensouda L, Rouillon F. et al; EPI3-LA-SER Group. Characteristics of patients consulting their regular primary care physician according to their prescribing preferences for homeopathy and complementary medicine. Homeopathy 2014; 103: 51-57
- 2 Grimaldi-Bensouda L, Engel P, Massol J. et al; EPI3-LA-SER group. Who seeks primary care for sleep, anxiety and depressive disorders from physicians prescribing homeopathic and other complementary medicine? Results from the EPI3 population survey. BMJ Open 2012; 2: e001498
- 3 Grimaldi-Bensouda L, Bégaud B, Rossignol M. et al. Management of upper respiratory tract infections by different medical practices, including homeopathy, and consumption of antibiotics in primary care: the EPI3 cohort study in France 2007-2008. PLoS One 2014; 9: e89990
- 4 Rossignol M, Begaud B, Engel P. et al; EPI3-LA-SER group. Impact of physician preferences for homeopathic or conventional medicines on patients with musculoskeletal disorders: results from the EPI3-MSD cohort. Pharmacoepidemiol Drug Saf 2012; 21: 1093-1101
- 5 Grimaldi-Bensouda L, Abenhaim L, Massol J. et al; EPI3-LA-SER Group. Utilization of psychotropic drugs by patients consulting for sleeping disorders in homeopathic and conventional primary care settings: the EPI3 cohort study. Homeopathy 2015; 104: 170-175
- 6 Grimaldi-Bensouda L, Abenhaim L, Massol J. et al; EPI3-LA-SER group. Homeopathic medical practice for anxiety and depression in primary care: the EPI3 cohort study. BMC Complement Altern Med 2016; 16: 125
- 7 Haute Autorité De Santé. Commission de la Transparence. Évaluation des Médicaments Homéopathiques Soumis à la Procédure d'Enregistrement Prévue à l'Article L.5121-13 du CSP. Accessed March 24, 2021 at: https://www.has-sante.fr/upload/docs/application/pdf/201906/homeopathie_pic_avis3_cteval415.pdf
- 8 Colas A, Danno K, Tabar C, Ehreth J, Duru G. Economic impact of homeopathic practice in general medicine in France. Health Econ Rev 2015; 5: 55
- 9 Danno K, Joubert C, Duru G, Vetel JM. Physician practicing preferences for conventional or homeopathic medicines in elderly subjects with musculoskeletal disorders in the EPI3-MSD cohort. Clin Epidemiol 2014; 6: 333-341
- 10 Danno K, Duru G, Vetel JM. Management of anxiety and depressive disorders in patients ≥ 65 years of age by homeopath general practitioners versus conventional general practitioners, with overview of the EPI3-LASER study results. Homeopathy 2018; 107: 81-89
- 11 Public Policy Committee, International Society for Pharmacoepidemiology. Guidelines for good pharmacoepidemiology practice (GPP). Pharmacoepidemiol Drug Saf 2016; 25: 2-10
- 12 European Network of Centers for Pharmacoepidemiology and Pharmacovigilance. ENCePP Guide on Methodological Standards in Pharmacoepidemiology. Accessed March 24, 2021 at: http://www.encepp.eu/standards_and_guidances/methodologicalGuide.shtml
- 13 Joanna Briggs Institute Critical Appraisal Tools. Accessed March 24, 2021 at: https://jbi.global/critical-appraisal-tools
- 14 McGill E, Marks D, Er V, Penney T, Petticrew M, Egan M. Qualitative process evaluation from a complex systems perspective: a systematic review and framework for public health evaluators. PLoS Med 2020; 17: e1003368
- 15 Deville JC, Sarndal CE. Calibration estimators in survey sampling. J Am Stat Assoc 1992; 87: 376-382
- 16 Howe CJ, Cole SR, Lau B, Napravnik S, Eron Jr JJ. Selection bias due to loss to follow-up in cohort studies. Epidemiology 2016; 27: 91-97
- 17 Teague S, Youssef GJ, Macdonald JA. et al; SEED Lifecourse Sciences Theme. Retention strategies in longitudinal cohort studies: a systematic review and meta-analysis. BMC Med Res Methodol 2018; 18: 151
- 18 Grimaldi-Bensouda L, Rossignol M, Aubrun E, Benichou J, Abenhaim L. PGRx Study Group. Agreement between patients' self-report and physicians' prescriptions on cardiovascular drug exposure: the PGRx database experience. Pharmacoepidemiol Drug Saf 2010; 19: 591-595
- 19 Grimaldi-Bensouda L, Rossignol M, Aubrun E, Benichou J, Abenhaim L. PGRx Study Group. Agreement between patients' self-report and physicians' prescriptions on nonsteroidal anti-inflammatory drugs and other drugs used in musculoskeletal disorders: the international Pharmacoepidemiologic General Research eXtension database. Pharmacoepidemiol Drug Saf 2012; 21: 753-759
- 20 Coste J, Le Parc JM, Berge E, Delecoeuillerie G, Paolaggi JB. French validation of a disability rating scale for the evaluation of low back pain (EIFEL questionnaire). Rev Rhum 1993; 60: 335-341
- 21 Beaton DE, Wright JG, Katz JN. Upper Extremity Collaborative Group. Development of the QuickDASH: comparison of three item-reduction approaches. J Bone Joint Surg Am 2005; 87: 1038-1046
- 22 Lequesne MG, Méry C, Samson M, Marty M. Comparison between the WOMAC and the Lequesne indices in patients with knee and hip osteoarthritis. Osteoarthritis Cartilage 1998; 6: 441-442
- 23 Maughan EF, Lewis JS. Outcome measures in chronic low back pain. Eur Spine J 2010; 19: 1484-1494
- 24 Bjelland I, Dahl AA, Haug TT, Neckelmann D. The validity of the Hospital Anxiety and Depression Scale. An updated literature review. J Psychosom Res 2002; 52: 69-77
- 25 Backhaus J, Junghanns K, Broocks A, Riemann D, Hohagen F. Test-retest reliability and validity of the Pittsburgh Sleep Quality Index in primary insomnia. J Psychosom Res 2002; 53: 737-740
- 26 Austin PC, Jembere N, Chiu M. Propensity score matching and complex surveys. Stat Methods Med Res 2018; 27: 1240-1257