RSS-Feed abonnieren
PDF herunterladen
DOI: 10.1055/s-0042-1760339
Double-Blind, Randomized, Placebo-Controlled Trial of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults: A Replication Trial with 6 Months' Follow-up
Funding The authors received no external funding for the project. Institutional infrastructure was provided by Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal. The institution had no role to play in the analysis of the study results or submission of the paper for publication.
Abstract
Background Atopic dermatitis (AD) is a chronic relapsing and remitting inflammatory skin disease that can have a significant impact on quality of life. During the last four decades, a rising trend in AD has been observed in India. Homeopathic medicines are claimed to be beneficial in AD; however, convincing research evidence has been lacking. We compared the efficacy of individualized homeopathic medicines (IHMs) against placebos in the treatment of AD.
Methods In this double-blind, randomized, placebo-controlled trial of 6 months' duration (n = 60), adult patients were randomized to receive either IHMs (n = 30) or identical-looking placebos (n = 30). All participants received concomitant conventional care, which included the application of olive oil and maintaining local hygiene. The primary outcome measure was disease severity using the Patient-Oriented Scoring of Atopic Dermatitis (PO-SCORAD) scale; secondary outcomes were the Atopic Dermatitis Burden Scale for Adults (ADBSA) and Dermatological Life Quality Index (DLQI) – all were measured at baseline and every month, up to 6 months. Group differences were calculated on the intention-to-treat sample.
Results After 6 months of intervention, inter-group differences became statistically significant on PO-SCORAD, the primary outcome (−18.1; 95% confidence interval, −24.0 to −12.2), favoring IHMs against placebos (F 1, 52 = 14.735; p <0.001; two-way repeated measures analysis of variance). Inter-group differences for the secondary outcomes favored homeopathy, but were overall statistically non-significant (ADBSA: F 1, 52 = 0.019; p = 0.891; DLQI: F 1, 52 = 0.692; p = 0.409).
Conclusion IHMs performed significantly better than placebos in reducing the severity of AD in adults, though the medicines had no overall significant impact on AD burden or DLQI.
Data Availability
The data are available from the corresponding author upon reasonable request.
Authors' Contributions
S.M., S.G., A.D.D., B.B., C.P., N.G. and S.M. contributed to the literature search, study concept, conducting the trial, data collection, data evaluation and drafting the manuscript. S.D., N.K.S., M.K., and S.S. contributed to study design, data interpretation, statistical analysis, and drafting of the manuscript. All the authors reviewed and approved the final manuscript for submission.
Publikationsverlauf
Eingereicht: 18. August 2022
Angenommen: 07. November 2022
Artikel online veröffentlicht:
07. März 2023
© 2023. Faculty of Homeopathy. This article is published by Thieme.
Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany
-
References
- 1 Avena-Woods C. Overview of atopic dermatitis. Am J Manag Care 2017; S115-S123
- 2 Martin MJ, Estravís M, García-Sánchez A, Dávila I, Isidoro-Garc M, Sanz C. Genetics and epigenetics of atopic dermatitis: an updated systematic review. Genes (Basel) 2020; 11: 442
- 3 Singh S, Sharma BB, Salvi S. et al. Allergic rhinitis, rhinoconjunctivitis, and eczema: prevalence and associated factors in children. Clin Respir J 2018; 12: 547-556
- 4 Rajagopalan M, Chitkara AJ, Dalwai S. et al. Burden of disease, unmet needs in the diagnosis and management of atopic dermatitis: an Indian expert consensus. Clin Cosmet Investig Dermatol 2021; 14: 1755-1765
- 5 Kumar MK, Singh PK, Patel PK. Clinico-immunological profile and their correlation with severity of atopic dermatitis in Eastern Indian children. J Nat Sci Biol Med 2014; 5: 95-100
- 6 Reich K, Kabashima K, Peris K. et al. Efficacy and safety of baricitinib combined with topical corticosteroids for treatment of moderate to severe atopic dermatitis: a randomized clinical trial. JAMA Dermatol 2020; 156: 1333-1343
- 7 Gür Çetinkaya P, Şahiner UM. Childhood atopic dermatitis: current developments, treatment approaches, and future expectations. Turk J Med Sci 2019; 49: 963-984
- 8 Pols DHJ, Wartna JB, Moed H, van Alphen EI, Bohnen AM, Bindels PJE. Atopic dermatitis, asthma and allergic rhinitis in general practice and the open population: a systematic review. Scand J Prim Health Care 2016; 34: 143-150
- 9 Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: long-term results of a cohort study with 3981 patients. BMC Public Health 2005; 5: 115
- 10 Koley M, Saha S, Arya JS. et al. A study on drug utilization and prescription habits of physicians in a government homeopathic hospital in West Bengal, India. J Integr Med 2013; 11: 305-313
- 11 Ernst E. Homeopathy for eczema: a systematic review of controlled clinical trials. Br J Dermatol 2012; 166: 1170-1172
- 12 Siebenwirth J, Lüdtke R, Remy W, Rakoski J, Borelli S, Ring J. Wirksamkeit einer klassisch-homöopathischen Therapie bei atopischem Ekzem. Eine randomisierte, placebokontrollierte Doppelblindstudie. Forsch Komplement Med 2009; 16: 315-323
- 13 Keil T, Witt CM, Roll S. et al. Homoeopathic versus conventional treatment of children with eczema: a comparative cohort study. Complement Ther Med 2008; 16: 15-21
- 14 Fisher P, McCarney R, Hasford C, Vickers A. Evaluation of specific and non-specific effects in homeopathy: feasibility study for a randomised trial. Homeopathy 2006; 95: 215-222
- 15 Witt CM, Lüdtke R, Willich SN. Homeopathic treatment of children with atopic eczema: a prospective observational study with two years follow-up. Acta Derm Venereol 2009; 89: 182-183
- 16 Eizayaga JE, Eizayaga JI. Prospective observational study of 42 patients with atopic dermatitis treated with homeopathic medicines. Homeopathy 2012; 101: 21-27
- 17 Itamura R, Hosoya R. Homeopathic treatment of Japanese patients with intractable atopic dermatitis. Homeopathy 2003; 92: 108-114
- 18 Rossi E, Bartoli P, Bianchi A, Da Frè M. Homeopathy in paediatric atopic diseases: long-term results in children with atopic dermatitis. Homeopathy 2012; 101: 13-20
- 19 Dey S, Shaikh AR, Saha S. et al. Efficacy of individualized homeopathic medicines in the treatment of atopic dermatitis in adults: a double-blind, randomized, placebo-controlled, preliminary trial. Complement Med Res 2022; 29: 17-26
- 20 Logan R. The Homeopathic Treatment of Eczema. South Asian Edition.. New Delhi: Elsevier; 2008
- 21 Morrison R. Desktop Companion to Physical Pathology. California: Hahnemann Clinic Publishing; 1993
- 22 Boedler CR. Psychic Causes of Illness: Applying Homeopathy and Bach Flowers Therapy to Psychosomatic Illness. 2nd Augmented ed.. New Delhi: B. Jain Publishers Pvt. Ltd.; 2004
- 23 Allen JH. The Chronic Miasm, Vol. I & II. Reprint ed.. New Delhi: B. Jain Publishers Pvt. Ltd.; 1998
- 24 Roberts HA. The Principles and Art of Cure by Homoeopathy. Reprint ed.. New Delhi: B. Jain Publishers Pvt. Ltd.; 2006
- 25 Hempel CJ. The Science of Therapeutics, According to the Principles of Homoeopathy by Bernard Baehr; Vol. II. New York: Boericke & Tafel; 1870
- 26 Lilienthal S. Homoeopathic Therapeutics. 24th Impression.. New Delhi: B. Jain Publishers Pvt. Ltd.; 2016
- 27 Coulter HL. Homoeopathic Science and Modern Medicine – The Physics of Healing with Microdoses. Berkely: North Atlantic Books; 1980
- 28 Al-Waili NS. Topical application of natural honey, beeswax and olive oil mixture for atopic dermatitis or psoriasis: partially controlled, single-blinded study. Complement Ther Med 2003; 11: 226-234
- 29 Kunz B, Oranje AP, Labrèze L, Stalder JF, Ring J, Taïeb A. Clinical validation and guidelines for the SCORAD index: consensus report of the European Task Force on Atopic Dermatitis. Dermatology 1997; 195: 10-19
- 30 Barrett A, Hahn-Pedersen J, Kragh N, Evans E, Gnanasakthy A. Patient-reported outcome measures in atopic dermatitis and chronic hand eczema in adults. Patient 2019; 12: 445-459
- 31 Rehal B, Armstrong AW. Health outcome measures in atopic dermatitis: a systematic review of trends in disease severity and quality-of-life instruments 1985-2010. PLoS One 2011; 6: e17520
- 32 Finlay AY, Khan GK. Dermatology Life Quality Index (DLQI) – a simple practical measure for routine clinical use. Clin Exp Dermatol 1994; 19 (03) 210-216
- 33 Badia X, Mascaró JM, Lozano R. Measuring health-related quality of life in patients with mild to moderate eczema and psoriasis: clinical validity, reliability and sensitivity to change of the DLQI. Br J Dermatol 1999; 141: 698-702
- 34 Lewis V, Finlay AY. 10 years experience of the Dermatology Life Quality Index (DLQI). J Investig Dermatol Symp Proc 2004; 9: 169-180
- 35 Cardiff University. Dermatology Life Quality Index. Accessed March 12, 2019 at: https://www.cardiff.ac.uk/medicine/resources/quality-of-life-questionnaires/dermatology-life-quality-index
- 36 Taïeb A, Boralevi F, Seneschal J. et al. Atopic dermatitis burden scale for adults: development and validation of a new assessment tool. Acta Derm Venereol 2015; 95: 700-705
- 37 Agrawal E, Gautam AK, Shaikh AR. et al. Factor structure of the Bengali version of atopic dermatitis burden scale for adults. J Dermatol Dermatol Surg 2021; 25: 102-113
- 38 Naranjo CA, Busto U, Sellers EM. et al. A method for estimating the probability of adverse drug reactions. Clin Pharmacol Ther 1981; 30: 239-245
- 39 Schulz KF, Altman DG, Moher D. for the CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010; 152: 726-732
- 40
Dean ME,
Coulter MK,
Fisher P,
Jobst K,
Walach H.
Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Homeopathy
2007; 96: 42-45
MissingFormLabel
- 41 Drucker AM, Morra DE, Prieto-Merino D. et al. Systemic immunomodulatory treatments for atopic dermatitis: update of a living systematic review and network meta-analysis. JAMA Dermatol 2022; 158: 523-532
- 42 Shogenova MS, Hutueva SH, Shogenova LS. Principles of modern diagnosis and treatment of atopic dermatitis and bronchial asthma: clinical case. Ter Arkh 2022; 94: 427-433
- 43 Maruyama A, Tamagawa-Mineoka R, Nishigaki H, Masuda K, Katoh N. Exploratory analyses of biomarkers in blood and stratum corneum in patients with atopic dermatitis. Medicine (Baltimore) 2022; 101: e31267
- 44 Hahnemann CFS. Organon of Medicine. 5th ed. 12th impression. 2018. New Delhi: B. Jain Publishers Pvt. Ltd.; Aphorism 161, footnote 2:98
- 45 Roberts HA. Principles and Art of Cure by Homoeopathy. Ch. VIII: Taking the Case. Reprint ed.. New Delhi: Indian Books and Periodicals Publishers; 2006: 78