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Homeopathy 2023; 112(04): 251-261
DOI: 10.1055/s-0042-1760339
Original Research Article

Double-Blind, Randomized, Placebo-Controlled Trial of Individualized Homeopathic Medicines in Atopic Dermatitis in Adults: A Replication Trial with 6 Months' Follow-up

Sanjukta Mandal 
1   Department of Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India
,
Shubhamoy Ghosh 
2   Department of Pathology and Microbiology, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India
3   Department of Pathology and Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India
,
Aakash Deep Das 
4   Department of Repertory, JIMS Homoeopathic Medical College and Hospital, Shamshabad, Telangana, India
5   Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India
,
Bikash Biswas 
5   Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India
6   Department of Health and Family Welfare, Homoeopathic Medical Officer, Rajganj State Homoeopathic Dispensary, Rajganj Government Medical College and Hospital, Uttar Dinajpur, West Bengal, India
,
Chithra Palanisamy 
5   Department of Repertory, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India
,
Nilanjana Guha 
1   Department of Materia Medica, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India
,
Shukdeb Maiti 
3   Department of Pathology and Microbiology, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India
7   Department of Pathology and Microbiology, National Tuberculosis Elimination Program Wing, Imambara Sadar Hospital, Hooghly, Govt. of West Bengal, India
,
Souvik Dutta 
8   Department of Organon of Medicine and Homoeopathic Philosophy, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India
,
Navin Kumar Singh 
9   Department of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India
,
Munmun Koley 
10   Department of Health and Family Welfare, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Govt. of West Bengal, India
,
Subhranil Saha 
11   Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
› Author Affiliations 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.
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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.

Keywords

atopic dermatitis - homeopathy - placebo - quality of life - randomized controlled trial

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.


Supplementary Material



Publication History

Received: 18 August 2022

Accepted: 07 November 2022

Article published online:
07 March 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 7 Gür Çetinkaya P, Şahiner UM. Childhood atopic dermatitis: current developments, treatment approaches, and future expectations. Turk J Med Sci 2019; 49: 963-984
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 11 Ernst E. Homeopathy for eczema: a systematic review of controlled clinical trials. Br J Dermatol 2012; 166: 1170-1172
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 16 Eizayaga JE, Eizayaga JI. Prospective observational study of 42 patients with atopic dermatitis treated with homeopathic medicines. Homeopathy 2012; 101: 21-27
    Article in Thieme ConnectPubMedGoogle Scholar
  • 17 Itamura R, Hosoya R. Homeopathic treatment of Japanese patients with intractable atopic dermatitis. Homeopathy 2003; 92: 108-114
    Article in Thieme ConnectPubMedGoogle Scholar
  • 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 20 Logan R. The Homeopathic Treatment of Eczema. South Asian Edition.. New Delhi: Elsevier; 2008
    Google Scholar
  • 21 Morrison R. Desktop Companion to Physical Pathology. California: Hahnemann Clinic Publishing; 1993
    Google Scholar
  • 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
    Google Scholar
  • 23 Allen JH. The Chronic Miasm, Vol. I & II. Reprint ed.. New Delhi: B. Jain Publishers Pvt. Ltd.; 1998
    Google Scholar
  • 24 Roberts HA. The Principles and Art of Cure by Homoeopathy. Reprint ed.. New Delhi: B. Jain Publishers Pvt. Ltd.; 2006
    Google Scholar
  • 25 Hempel CJ. The Science of Therapeutics, According to the Principles of Homoeopathy by Bernard Baehr; Vol. II. New York: Boericke & Tafel; 1870
    Google Scholar
  • 26 Lilienthal S. Homoeopathic Therapeutics. 24th Impression.. New Delhi: B. Jain Publishers Pvt. Ltd.; 2016
    Google Scholar
  • 27 Coulter HL. Homoeopathic Science and Modern Medicine – The Physics of Healing with Microdoses. Berkely: North Atlantic Books; 1980
    Google Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 34 Lewis V, Finlay AY. 10 years experience of the Dermatology Life Quality Index (DLQI). J Investig Dermatol Symp Proc 2004; 9: 169-180
    CrossrefPubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    Article in Thieme ConnectPubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 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
    PubMedGoogle Scholar
  • 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
    CrossrefPubMedGoogle Scholar
  • 44 Hahnemann CFS. Organon of Medicine. 5th ed. 12th impression. 2018. New Delhi: B. Jain Publishers Pvt. Ltd.; Aphorism 161, footnote 2:98
    Google Scholar
  • 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
    Google Scholar