Individualized Homeopathic Medicines for Low Back Pain in Lumbar Spondylosis: Double-Blind, Randomized, Placebo-Controlled Trial

Akshaya Prakash; Nitai Chand Bhowmik; Subhas Singh; Satarupa Sadhukhan; Shruti Rai; Suman Singh; Umesh Kumar; Fathima Rahim; Dharshna Balamurugan; Koushik Bhar; Navin Kumar Singh; Munmun Koley; Subhranil Saha

doi:10.1055/s-0042-1758132

Homeopathy, Inhaltsverzeichnis

Homeopathy 2023; 112(04): 240-250
DOI: 10.1055/s-0042-1758132

Original Research Article

Individualized Homeopathic Medicines for Low Back Pain in Lumbar Spondylosis: Double-Blind, Randomized, Placebo-Controlled Trial

Akshaya Prakash

¹Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

,

Nitai Chand Bhowmik

¹Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

,

Subhas Singh

²Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Block GE, Sector III, Salt Lake, Kolkata, West Bengal, India

,

Satarupa Sadhukhan

¹Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

,

Shruti Rai

¹Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

,

Suman Singh

¹Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

³Department of Homoeopathy, State Homoeopathic Dispensary, Karaila, Pratapgarh, Uttar Pradesh, India

,

Umesh Kumar

¹Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

⁴Department of Homoeopathy, State Homoeopathic Dispensary, Tulsipur, Shrawasti, Uttar Pradesh, India

,

Fathima Rahim

⁵Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

,

Dharshna Balamurugan

⁵Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

,

Koushik Bhar

⁵Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Salt Lake, Kolkata, West Bengal, India

⁶State Homoeopathic Dispensary, Mangalbari Rural Hospital, Matiali Block, Jalpaiguri, West Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India

,

Navin Kumar Singh

⁷Department of Repertory, The Calcutta Homoeopathic Medical College and Hospital, Govt. of West Bengal, Kolkata, West Bengal, India

,

Munmun Koley

⁸Department of Homoeopathy, East Bishnupur State Homoeopathic Dispensary, Chandi Daulatabad Block Primary Health Centre, Village and Post Office: Gouripur (South), Police Station Bishnupur, West Bengal, under Department of Health & Family Welfare, Govt. of West Bengal, India

,

Subhranil Saha

⁹Department of Repertory, D. N. De Homoeopathic Medical College and Hospital, Govt. of West Bengal, Tangra, Kolkata, West Bengal, India

› Institutsangaben

Abstract

Introduction Lumbar spondylosis (LS) is a degenerative disorder of the lumbar spine. Despite substantial research efforts, no gold-standard treatment for LS has been identified. The efficacy of individualized homeopathic medicines (IHMs) in LS has remained under-researched. In this study, the efficacy of IHMs was compared with identical-looking placebos in the treatment of low back pain associated with LS.

Methods A double-blind, randomized (1:1), placebo-controlled trial was conducted at the National Institute of Homoeopathy, West Bengal, India. Patients were randomized to receive IHMs or placebos, along with standardized concomitant care for both the groups. The Oswestry low back pain and disability questionnaire (ODQ) was the primary outcome; the Roland-Morris questionnaire (RMQ) and the short form of the McGill pain questionnaire (SF-MPQ) were the secondary outcomes. Each was measured at baseline and every month for 3 months. The intention-to-treat (ITT) sample was analyzed to detect any inter-group differences using two-way repeated measures analysis of variance models overall and by unpaired t-tests at different time points.

Results Enrolment was stopped prematurely because of time restrictions; 55 patients were randomized (verum: 28; control: 27); 49 were analyzed by ITT (verum: 26; control: 23). Inter-group differences in ODQ (F _{1, 47} = 0.001, p = 0.977), RMQ (F _{1, 47} = 0.190, p = 0.665) and SF-MPQ total score (F _{1, 47} = 3.183, p = 0.081) at 3 months were not statistically significant. SF-MPQ total score after 2 months (p = 0.030) revealed inter-group statistical significance, favoring IHMs against placebos. Some of the SF-MPQ sub-scales at different time points were also statistically significant: e.g., the SF-MPQ average pain score after 2 months (p = 0.002) and 3 months (p = 0.007). Rhus toxicodendron, Sulphur and Pulsatilla nigricans were the most frequently indicated medicines.

Conclusion Owing to failure in detecting a statistically significant effect for the primary outcome and in recruiting a sufficient number of participants, our trial remained inconclusive.

Trial registration CTRI/2019/11/021918.

Keywords

homeopathy - lumbar spondylosis - placebo - randomized controlled trial - low back pain

Volltext

Referenzen

References
1 van Tulder MW, Assendelft WJ, Koes BW, Bouter LM. Spinal radiographic findings and nonspecific low back pain. A systematic review of observational studies. Spine 1997; 22: 427-434
2 Wu A, March L, Zheng X. et al. Global low back pain prevalence and years lived with disability from 1990 to 2017: estimates from the Global Burden of Disease Study 2017. Ann Transl Med 2020; 8: 299
3 Pye SR, Reid DM, Smith R. et al. Radiographic features of lumbar disc degeneration and self-reported back pain. J Rheumatol 2004; 31: 753-758
4 Gupta S, Darokhan MA, Singh O, Muzaffar J. Low backache as an increasing health problem in India. JK Science 2016; 18: 172-176
5 Sankar AG, Revathi S, Kumar SG. et al. Prevalence of low back pain and its relation to quality of life and disability among women in rural area of Puducherry, India. Ind J Pain 2016; 30: 111-115
6 Joshi F, Mahanta V, Dudhamal TS, Gupta SK. Effect of Agnikarma (therapeutic heat burns) and Raktamokshana (therapeutic bloodletting) in the management of Kati Sandhigata Vata (lumbar spondylosis). Ayu 2019; 40: 79-88
7 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
8 Nath A, De M, Singh S. et al. The role of homoeopathic treatment in women suffering from post-caesarean backache: an open observational clinical trial. Indian J Res Homoeopathy 2019; 13: 81-90
9 Morris M, Pellow J, Solomon EM, Tsele-Tebakang T. Physiotherapy and a homeopathic complex for chronic low-back pain due to osteoarthritis: a randomized, controlled pilot study. Altern Ther Health Med 2016; 22: 48-56
10 Beer AM, Fey S, Zimmer M, Teske W, Schremmer D, Wiebelitz KR. Effectiveness and safety of a homeopathic drug combination in the treatment of chronic low back pain. A double-blind, randomized, placebo-controlled clinical trial. MMW Fortschr Med 2012; 154: 48-57
11 Pach D, Brinkhaus B, Roll S. et al. Efficacy of injections with Disci/Rhus toxicodendron compositum for chronic low back pain – a randomized placebo-controlled trial. PLoS One 2011; 6: e26166
12 Stam C, Bonnet MS, van Haselen RA. The efficacy and safety of a homeopathic gel in the treatment of acute low back pain: a multi-centre, randomised, double-blind comparative clinical trial. Br Homeopath J 2001; 90: 21-28
13 Vianin M. Psychometric properties and clinical usefulness of the Oswestry disability index. J Chiropr Med 2008; 7: 161-163
14 Fairbank JC, Pynsent PB. The Oswestry disability index. Spine 2000; 25: 2940-2952
15 Davidson M, Keating JL. A comparison of five low back disability questionnaires: reliability and responsiveness. Phys Ther 2002; 82: 8-24
16 Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine 1983; 8: 141-144
17 Hawker GA, Mian S, Kendzerska T, French M. Measures of adult pain: Visual analog scale for pain (VAS pain), numeric rating scale for pain (NRS pain), McGill pain questionnaire (MPQ), short form McGill pain questionnaire (SF-MPQ), chronic pain grade scale (CPGS), short form 36 bodily pain scale (SF-36 BPS), and measure of intermittent and constant osteoarthritis pain (ICOAP). Arthritis Care Res (Hoboken) 2011; 63: S240-S252
18 Melzack R. The short-form McGill pain questionnaire. Pain 1987; 30: 191-197
19 Schulz KF, Altman DG, Moher D. for the CONSORT Group. CONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c332
20 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
21 Hariton E, Locascio JJ. Randomised controlled trials – the gold standard for effectiveness research: study design: randomised controlled trials. BJOG 2018; 125: 1716
22 Hróbjartsson A, Gøtzsche PC. Is the placebo powerless? An analysis of clinical trials comparing placebo with no treatment. N Engl J Med 2001; 344: 1594-1602
23 Miller FG, Rosenstein DL. The nature and power of the placebo effect. J Clin Epidemiol 2006; 59: 331-335
24 Ernst E. Placebo: new insights into an old enigma. Drug Discov Today 2007; 12: 413-418
25 Greene PJ, Wayne PM, Kerr CE. et al. The powerful placebo: doubting the doubters. Adv Mind Body Med 2001; 17: 298-307
26 Gupta U, Verma M. Placebo in clinical trials. Perspect Clin Res 2013; 4: 49-52
27 Oken BS. Placebo effects: clinical aspects and neurobiology. Brain 2008; 131: 2812-2823
28 Colloca L, Benedetti F. Placebos and painkillers: is mind as real as matter?. Nat Rev Neurosci 2005; 6: 545-552
29 Moerman DE, Jonas WB. Deconstructing the placebo effect and finding the meaning response. Ann Intern Med 2002; 136: 471-476
30 Moerman DE. “Placebo” versus “meaning”: the case for a change in our use of language. Prev Treat 2003; 6: 1-5
31 Kleijnen J. The use and abuse of placebo in clinical trials. Forsch Komplementarmed 1998; 5: 125-127
32 Avins AL, Cherkin DC, Sherman KJ, Goldberg H, Pressman A. Should we reconsider the routine use of placebo controls in clinical research?. Trials 2012; 13: 44
33 Hahnemann S. The Chronic Diseases: their Peculiar Nature and their Homoeopathic Cure. New Delhi: B. Jain Publishers Pvt Ltd; 1991. :74–75, 152
34 Allen JH. The Chronic Miasms, with Repertory. 10th impression. New Delhi: B. Jain Publishers Pvt Ltd.; 2015. :191–196
35 Speight P. A Comparison of the Miasms (psora, psuedo-psora, syphilis, sycosis). New Delhi: Health Science Press Publishers Pvt Ltd; 1961. :74–79
36 Clarke JH. A Dictionary of Practical Materia Medica. New Delhi: B. Jain Publishers Pvt Ltd.; 1996
37 Dewey WA. Practical Homeopathic Therapeutics. Reprint ed. New Delhi: B. Jain Publishers Pvt Ltd.; 2005
38 Morrison R. Desktop Companion to Physical Pathology. California: Hahnemann Clinic Publishing; 1993
39 Lilienthal S. Homoeopathic Therapeutics. 24th impression. New Delhi: B. Jain Publishers Pvt Ltd.; 2016
40 Hempel CJ. The science of therapeutics, according to the principles of homoeopathy by Bernard Baehr; Vol. II. New York: Boericke & Tafel; 1870

Zusatzmaterial

Supplementary Material