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Homeopathy
DOI: 10.1055/s-0043-1771025
Original Research Article

Individualized Homeopathic Medicines in the Treatment of Knee Osteoarthritis: Double-Blind, Randomized, Placebo-Controlled Feasibility Trial

Soumya Bhattacharyya 
1   Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Kolkata; affiliated to The West Bengal University of Health Sciences, Kolkata, West Bengal, India
,
Chandrima Chatterjee 
1   Department of Materia Medica, D. N. De Homoeopathic Medical College and Hospital, Kolkata; affiliated to The West Bengal University of Health Sciences, Kolkata, West Bengal, India
,
Subhranil Saha 
2   Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Satyajit Naskar 
3   Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Pulakendu Bhattacharya 
3   Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Sk Monsur Alam 
2   Department of Repertory, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Sumana Sengupta 
4   Department of Practice of Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Sabir Ahamed 
5   Department of Surgery, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Abdur R. Shaikh 
4   Department of Practice of Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Munmun Koley 
6   Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, West Bengal, India
,
Priyanka Ghosh 
3   Department of Organon of Medicine and Homoeopathic Philosophy, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
,
Shyamal K. Mukherjee 
7   Department of Community Medicine, D.N. De Homoeopathic Medical College and Hospital, Kolkata, West Bengal, India
› Author Affiliations Funding None.
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Abstract

Introduction This study aimed at examining the feasibility issues of comparing individualized homeopathic medicines (IHMs) with identical-looking placebos for treating knee osteoarthritis (OA).

Methods Forty eligible patients participated in this double-blind, randomized (1:1), placebo-controlled feasibility trial in the outpatient clinics of a homeopathic hospital in West Bengal, India. Either IHMs or identical-looking placebos were administered, along with mutually agreed-upon concomitant care guidelines. The Knee Injury and Osteoarthritis Outcome Score (KOOS) was the primary outcome measure, and derived Western Ontario and McMaster Universities Arthritis Index (WOMAC) scores from KOOS, EQ-5D-5L questionnaire, and Visual Analog Scale (VAS) were the secondary outcomes; all measured at baseline and after 2 months. Group differences and effect sizes (Cohen's d) were estimated using an intention-to-treat approach. p-Values less than 0.05 (two-tailed) were considered statistically significant.

Results Enrolment/screening and trial retention rates were 43% and 85% respectively. Recruitment was difficult owing to the coronavirus disease 2019 (COVID-19) lockdown. Group differences were statistically significant, favoring IHMs against placebos in all the KOOS sub-scales: symptoms (p < 0.001), pain (p = 0.002), activities of daily living (p < 0.001), sports or recreation (p = 0.016), and quality of life (p = 0.002). Derived WOMAC scores from KOOS favored IHMs against placebos: stiffness (p < 0.001) and pain (p < 0.001). The EQ-5D-5L questionnaire score (p < 0.001) and EQ-5D-5L VAS scores (p < 0.001) also yielded significant results, favoring IHMs over placebos. All the effect sizes ranged from moderate to large. Sulphur was the most frequently prescribed homeopathic medication. Neither group reported any harm or serious adverse events.

Conclusion Although recruitment was sub-optimal due to prevailing COVID-19 conditions during the trial, the action of IHMs was found to be superior to that of placebos in the treatment of knee OA. Larger and more definitive studies, with independent replications, are required to substantiate the findings.

Trial registration: CTRI/2021/02/031453.

Keywords

homeopathy - osteoarthritis knee - placebo - quality of life - randomized controlled trial

Data Availability

All the findings of the study are available from the corresponding author upon reasonable request.


Authors' Contributions

S.B., C.C., S.S., S.N., P.B., S.M.A., P.G. and S.K.M.: concept and literature search. S.B., C.C., S.S., S.N., P.B., S.M.A., S.A., A.R.S. and P.G.: clinical study and data acquisition. S. Saha, P.G. and M.K.: data interpretation, statistical analysis, and preparation of the article. All the authors reviewed and approved the final article.


Supplementary Material



Publication History

Received: 18 March 2023

Accepted: 09 May 2023

Article published online:
25 September 2023

© 2023. Faculty of Homeopathy. This article is published by Thieme.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Munjal YP. ed. The Association of Physicians of India. Vol 2. 10th ed. New Delhi: Jaypee Brothers Medical Publishers (P) Ltd; 2015: 2479
    Google Scholar
  • 2 Cui A, Li H, Wang D, Zhong J, Chen Y, Lu H. Global, regional prevalence, incidence and risk factors of knee osteoarthritis in population-based studies. EClinicalMedicine 2020; 29-30: 100587
    CrossrefPubMedGoogle Scholar
  • 3 Jaiswal A, Goswami K, Haldar P, Salve HR, Singh U. Prevalence of knee osteoarthritis, its determinants, and impact on the quality of life in elderly persons in rural Ballabgarh, Haryana. J Family Med Prim Care 2021; 10: 354-360
    CrossrefPubMedGoogle Scholar
  • 4 Zamri N, Harith S, Mat-Hassan N, Ong YQ. Nutritional status and health-related quality of life among knee and hip osteoarthritis patients under rehabilitation care in Kuala Nerus, Terengganu, Malaysia. Malays Orthop J 2021; 15: 77-88
    CrossrefPubMedGoogle Scholar
  • 5 Abbott JH, Usiskin IM, Wilson R, Hansen P, Losina E. The quality-of-life burden of knee osteoarthritis in New Zealand adults: a model-based evaluation. PLoS One 2017; 12: e0185676
    CrossrefPubMedGoogle Scholar
  • 6 Richards MM, Maxwell JS, Weng L, Angelos MG, Golzarian J. Intra-articular treatment of knee osteoarthritis: from anti-inflammatories to products of regenerative medicine. Phys Sportsmed 2016; 44: 101-108
    CrossrefPubMedGoogle Scholar
  • 7 Teymouri S, Rakhshandeh H, Baghdar HN, Yousefi M, Salari R. Analgesic herbal medicines in the treatment of knee osteoarthritis: a systematic review. Curr Rheumatol Rev 2019; 15: 290-303
    CrossrefPubMedGoogle Scholar
  • 8 Ginnerup-Nielsen EM, Henriksen M, Christensen R. et al. Prevalence of self-reported knee symptoms and management strategies among elderly individuals from Frederiksberg municipality: protocol for a prospective and pragmatic Danish cohort study. BMJ Open 2019; 9: e028087
    CrossrefPubMedGoogle Scholar
  • 9 Gregori D, Giacovelli G, Minto C. et al. Association of pharmacological treatments with long-term pain control in patients with knee osteoarthritis: a systematic review and meta-analysis. JAMA 2018; 320: 2564-2579
    CrossrefPubMedGoogle Scholar
  • 10 Lee T, Lu N, Felson DT. et al. Use of non-steroidal anti-inflammatory drugs correlates with the risk of venous thromboembolism in knee osteoarthritis patients: a UK population-based case-control study. Rheumatology (Oxford) 2016; 55: 1099-1105
    CrossrefPubMedGoogle Scholar
  • 11 Kolasinski SL, Neogi T, Hochberg MC. et al. 2019 American College of Rheumatology/Arthritis Foundation guideline for the management of osteoarthritis of the hand, hip, and knee. Arthritis Care Res (Hoboken) 2020; 72: 149-162
    CrossrefPubMedGoogle Scholar
  • 12 Long L, Ernst E. Homeopathic remedies for the treatment of osteoarthritis: a systematic review. Br Homeopath J 2001; 90: 37-43
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Koley M, Saha S, Medhurst R. Clinical trials of homoeopathy in osteoarthritis: a systematic review. OA Alternative Medicine 2013; 1: 24
    CrossrefPubMedGoogle Scholar
  • 14 Shealy CN, Thomlinson RP, Cox RH. et al. Osteoarthritic pain: a comparison of homoeopathy and acetaminophen. Am J Pain Manage 1998; 8: 89-91
    PubMedGoogle Scholar
  • 15 van Haselen RA, Fisher PA. A randomized controlled trial comparing topical piroxicam gel with a homeopathic gel in osteoarthritis of the knee. Rheumatology (Oxford) 2000; 39: 714-719
    CrossrefPubMedGoogle Scholar
  • 16 Maronna U, Weiser M, Klein P. Oral treatment of osteoarthritis of the knee with Zeel comp. – results of a double-blind equivalence study versus diclofenac. Biol Med 2000; 29: 157-158
    PubMedGoogle Scholar
  • 17 Strösser W, Weiser M. Patienten mit Gonarthrose gewinnen ihre Mobilität zurϋck. Homöopathikum im Doppel-blind-Vergleich. [Patients with gonarthrosis gaining back mobility – a double-blind comparison of homeopathy]. Biol Med 2000; 29: 295-299
    PubMedGoogle Scholar
  • 18 Koley M, Saha S, Ghosh S. A double-blind randomized placebo-controlled feasibility study evaluating individualized homeopathy in managing pain of knee osteoarthritis. J Evid Based Complementary Altern Med 2015; 20: 186-191
    CrossrefPubMedGoogle Scholar
  • 19 Motiwala FF, Kundu T, Bagmar K. et al. Effect of homoeopathic treatment on activity of daily living (ADL) in knee osteoarthritis: a prospective observational study. Indian J Res Homoeopathy 2016; 10: 182-187
    CrossrefPubMedGoogle Scholar
  • 20 World Medical Association.. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ 2001; 79: 373-374
    PubMedGoogle Scholar
  • 21 Altman R, Asch E, Bloch D. et al; Diagnostic and Therapeutic Criteria Committee of the American Rheumatism Association. Development of criteria for the classification and reporting of osteoarthritis. Classification of osteoarthritis of the knee. Arthritis Rheum 1986; 29: 1039-1049
    CrossrefPubMedGoogle Scholar
  • 22 Roos EM, Roos HP, Lohmander LS, Ekdahl C, Beynnon BD. Knee Injury and Osteoarthritis Outcome Score (KOOS) – development of a self-administered outcome measure. J Orthop Sports Phys Ther 1998; 28: 88-96
    CrossrefPubMedGoogle Scholar
  • 23 Roos EM, Toksvig-Larsen S. Knee injury and Osteoarthritis Outcome Score (KOOS) – validation and comparison to the WOMAC in total knee replacement. Health Qual Life Outcomes 2003; 1: 17
    CrossrefPubMedGoogle Scholar
  • 24 Roos EM, Lohmander LS. The Knee injury and Osteoarthritis Outcome Score (KOOS): from joint injury to osteoarthritis. Health Qual Life Outcomes 2003; 1: 64
    CrossrefPubMedGoogle Scholar
  • 25 The Euro-QOL group. . EQ-5D–5L 2019 . Accessed November 6, 2020 at: http://www.euroqol.org/eq-5d-products/eq-5d-5l.html
    PubMed
  • 26 Herdman M, Gudex C, Lloyd A. et al. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L). Qual Life Res 2011; 20: 1727-1736
    CrossrefPubMedGoogle Scholar
  • 27 Eldridge SM, Chan CL, Campbell MJ. et al; PAFS Consensus Group. CONSORT 2010 statement: extension to randomised pilot and feasibility trials. BMJ 2016; 355: i5239
    CrossrefPubMedGoogle Scholar
  • 28 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
  • 29 Hering C. The Homoeopathic Domestic Physician, 11th American ed. Philadelphia: Boericke & Tafel; 1904: 414
    Google Scholar
  • 30 Burt WMH. Physiological Materia Medica. 5th ed. Chicago: Gross & Delbridge Co.; 1896: 899
    Google Scholar
  • 31 Saha S, Koley M, Ghosh S, Giri M, Das A, Goenka R. Documentation of prescriptions and clinical outcomes in a homeopathic hospital setting in West Bengal, India. J Evid Based Complementary Altern Med 2015; 20: 180-185
    CrossrefPubMedGoogle Scholar
  • 32 Kumar NR, Iyer NH. An observational study on the effect of individualized homoeopathic medicine administered based on totality of symptoms vis-à-vis personality in cases of osteoarthritis knee. Indian J Res Homoeopathy 2021; 15: 103-112
    CrossrefPubMedGoogle Scholar