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Homeopathy 2021; 110(01): 013-026
DOI: 10.1055/s-0040-1715842
Original Research Article

Individualized Homeopathic Medicines in Chronic Rhinosinusitis: Randomized, Double-Blind, Placebo-Controlled Trial

Pankhuri Misra
1   Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Chintamani Nayak
1   Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Abhijit Chattopadhyay
1   Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Tarun Kumar Palit
2   Department of ENT, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Bharti Gupta
3   Department of Paediatrics, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Satarupa Sadhukhan
4   Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Koushik Bhar
1   Department of Materia Medica, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Shruti Rai
4   Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Maneet Parewa
5   Department of Repertory, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Sk. Swaif Ali
6   Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India
,
Anamika Basu
6   Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Govt. of West Bengal, Howrah, West Bengal, India
,
Arunava Nath
4   Department of Organon of Medicine and Homoeopathic Philosophy, National Institute of Homoeopathy, Ministry of AYUSH, Govt. of India, Kolkata, West Bengal, India
,
Munmun Koley
7   Independent Researcher, Hooghly, West Bengal, India
,
Subhranil Saha
8   Independent Researcher, Shibpur, Howrah, West Bengal, India
› Institutsangaben Funding None. The institution had no role to play in the analysis of the study results or the preparation of the paper.
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Abstract

Background Chronic rhinosinusitis (CRS) is a common disorder, with up to an estimated 134 million Indian sufferers, and having significant impact on quality of life (QOL) and health costs. Despite the evidence favoring homeopathy in CRS being inadequate, it is highly popular. This trial attempts to study the efficacy of individualized homeopathy (IH) medicines in comparison with placebo in patients with CRS.

Methods A double-blind, randomized (1:1), placebo-controlled, preliminary trial (n = 62) was conducted at the National Institute of Homoeopathy, West Bengal, India. Primary outcome measure was the sino-nasal outcome test-20 (SNOT-20) questionnaire; secondary outcomes were the EQ-5D-5L questionnaire and EQ-5D-5L visual analog scale scores, and five numeric rating scales (0–10) assessing intensity of sneezing, rhinorrhea, post-nasal drip, facial pain/pressure, and disturbance in sense of smell, all measured at baseline and after the 2nd and 4th months of intervention. Group differences and effect sizes (Cohen's d) were calculated on the intention-to-treat sample.

Results Groups were comparable at baseline. Attrition rate was 6.5% (IH: 1, Placebo: 3). Although improvements in both primary and secondary outcome measures were higher in the IH group than placebo, with small to medium effect sizes, the group differences were statistically non-significant (all p > 0.05, unpaired t-tests). Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines. No harmful or unintended effects, homeopathic aggravations or any serious adverse events were reported from either group.

Conclusion There was a small but non-significant direction of effect favoring homeopathy, which ultimately renders the trial as inconclusive. Rigorous trials and independent replications are recommended to arrive at a confirmatory conclusion. [Trial registration: CTRI/2018/03/012557; UTN: U1111–1210–7201].

Keywords

efficacy - homeopathy - chronic rhinosinusitis - sino-nasal outcome test - randomized controlled trial

Highlights

• A double-blind, randomized, placebo-controlled, clinical trial was conducted at the National Institute of Homoeopathy, West Bengal, India, in 62 patients suffering from chronic rhinosinusitis.


• Though improvements were greater in the homeopathy group than in the placebo group, with small to medium effect sizes, the group differences were statistically non-significant, thus rendering the trial inconclusive.


• Calcarea carbonica, Lycopodium clavatum, Sulphur, Natrum muriaticum and Pulsatilla nigricans were the most frequently prescribed medicines.


Authors' Contributions

P.M., C.N., A.C. and T.K.P. contributed to the study concept, literature search, conducting the clinical study, data acquisition, data interpretation, and drafting the manuscript. B.G., S.S., K.B., S.R. and M.P. contributed to conducting the clinical study and data acquisition. S.S.A. and A.B. contributed to data management. A.N., M.K. and S.S. contributed to study design, data interpretation, statistical analysis, and drafting the manuscript. All the authors reviewed and approved the final manuscript.


Note

The trial was performed as part of the postgraduate thesis of the corresponding author under the guidance of C.N. A.C. is the Head of the Department of Materia Medica, National Institute of Homoeopathy. Authors B.G., S.S., K.B., S.R. and M.P. are postgraduate trainees at the National Institute of Homoeopathy. A.N. is a former postgraduate trainee at the National Institute of Homoeopathy. S.A. and A.B. are interns at Mahesh Bhattacharyya Homoeopathic Medical College & Hospital. MK and S.S. are independent researchers.


Supplementary Material



Publikationsverlauf

Eingereicht: 29. März 2020

Angenommen: 26. Mai 2020

Artikel online veröffentlicht:
31. August 2020

© 2020. Faculty of Homeopathy. This article is published by Thieme.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

  • References

  • 1 Orlandi RR, Kingdom TT, Hwang PH. et al. International consensus statement on allergy and rhinology: rhinosinusitis. Int Forum Allergy Rhinol 2016; 6: S22-S209
    CrossrefPubMedGoogle Scholar
  • 2 Suh JD, Kennedy DW. Treatment options for chronic rhinosinusitis. Proc Am Thorac Soc 2011; 8: 132-140
    CrossrefPubMedGoogle Scholar
  • 3 Lohiya SS, Patel SV, Pawde AM, Bokare BD, Sakhare PT. Comparative study of diagnostic nasal endoscopy and CT paranasal sinuses in diagnosing chronic rhinosinusitis. Indian J Otolaryngol Head Neck Surg 2016; 68: 224-229
    CrossrefPubMedGoogle Scholar
  • 4 Rosenfeld RM, Piccirillo JF, Chandrasekhar SS. et al. Clinical practice guideline (update): adult sinusitis. Otolaryngol Head Neck Surg 2015; 152: S1-S39
    CrossrefPubMedGoogle Scholar
  • 5 Cox DR, Ashby S, DeConde AS. et al. Dyad of pain and depression in chronic rhinosinusitis. Int Forum Allergy Rhinol 2016; 6: 308-314
    CrossrefPubMedGoogle Scholar
  • 6 Alt JA, Smith TL, Schlosser RJ, Mace JC, Soler ZM. Sleep and quality of life improvements after endoscopic sinus surgery in patients with chronic rhinosinusitis. Int Forum Allergy Rhinol 2014; 4: 693-701
    CrossrefPubMedGoogle Scholar
  • 7 Alam ES, Musselman DL, Chyou D. et al. Somatization, depression, and anxiety disorders in a rhinology practice. Am J Rhinol Allergy 2019; 33: 470-477
    CrossrefPubMedGoogle Scholar
  • 8 Kariyawasam HH, Scadding GK. Chronic rhinosinusitis: therapeutic efficacy of anti-inflammatory and antibiotic approaches. Allergy Asthma Immunol Res 2011; 3: 226-235
    CrossrefPubMedGoogle Scholar
  • 9 DeConde AS, Soler ZM. Chronic rhinosinusitis: epidemiology and burden of disease. Am J Rhinol Allergy 2016; 30: 134-139
    CrossrefPubMedGoogle Scholar
  • 10 Meltzer EO, Bukstein DA. The economic impact of allergic rhinitis and current guidelines for treatment. Ann Allergy Asthma Immunol 2011; 106: S12-S16
    CrossrefPubMedGoogle Scholar
  • 11 Bhargava SK, Peethambaran K. Pharmacotherapy of chronic rhinosinusitis with a focus on clarithromycin: an expert opinion. J Assoc Physicians India 2018; 66: 74-79
    PubMedGoogle Scholar
  • 12 Young LC, Stow NW, Zhou L, Douglas RG. Efficacy of medical therapy in treatment of chronic rhinosinusitis. Allergy Rhinol (Providence) 2012; 3: e8-e12
    CrossrefPubMedGoogle Scholar
  • 13 McCaig LF, Hughes JM. Trends in antimicrobial drug prescribing among office-based physicians in the United States. JAMA 1995; 273: 214-219
    CrossrefPubMedGoogle Scholar
  • 14 Williams Jr JW, Aguilar C, Makela M. et al. Antibiotics for acute maxillary sinusitis (Review). Cochrane Database Syst Rev 2000; 2: CD000243
    PubMedGoogle Scholar
  • 15 Lemiengre MB, van Driel ML, Merenstein D, Young J, De Sutter AI. Antibiotics for clinically diagnosed acute rhinosinusitis in adults. Cochrane Database Syst Rev 2012; 10: CD006089
    PubMedGoogle Scholar
  • 16 Chaturvedi J, Dutt SN, Kadambi P. et al. Factors that delay definitive management of chronic rhinosinusitis in India: a survey based study. Glob J Otolaryngol. 2016; 2: 555586
    PubMedGoogle Scholar
  • 17 Witt C, Keil T, Selim D. et al. Outcome and costs of homoeopathic and conventional treatment strategies: a comparative cohort study in patients with chronic disorders. Complement Ther Med 2005; 13: 79-86
    CrossrefPubMedGoogle Scholar
  • 18 Esmail N. Complementary and Alternative Medicine: Use and Public Attitudes 1997, 2006, and 2016. Vancouver, BC: Frasser Institute; 2017
    Google Scholar
  • 19 Barnes PM, Bloom B, Nahin RL. Complementary and alternative medicine use among adults and children: United States, 2007. Natl Health Stat Rep 2008; 12: 1-23
    PubMedGoogle Scholar
  • 20 Krouse HJ, Krouse JH. Complementary therapeutic practices in patients with chronic sinusitis. Clin Excell Nurse Pract 1999; 3: 346-352
    PubMedGoogle Scholar
  • 21 Rotenberg BW, Bertens KA. Use of complementary and alternative medical therapies for chronic rhinosinusitis: a Canadian perspective. J Otolaryngol Head Neck Surg 2010; 39: 586-593
    PubMedGoogle Scholar
  • 22 Suh JD, Wu AW, Taw MB, Nguyen C, Wang MB. Treatment of recalcitrant chronic rhinosinusitis with integrative East-West medicine: a pilot study. Arch Otolaryngol Head Neck Surg 2012; 138: 294-300
    CrossrefPubMedGoogle Scholar
  • 23 Wu AW, Gettelfinger JD, Ting JY, Mort C, Higgins TS. Alternative therapies for sinusitis and rhinitis: a systematic review utilizing a modified Delphi method. Int Forum Allergy Rhinol 2020; 10: 496-504
    CrossrefPubMedGoogle Scholar
  • 24 Jin AJ, Chin CJ. Complementary and alternative medicine in chronic rhinosinusitis: a systematic review and qualitative analysis. Am J Rhinol Allergy 2019; 33: 194-202
    CrossrefPubMedGoogle Scholar
  • 25 Friese KH, Zabalotnyi DI. Homeopathy in acute rhinosinusitis: a double-blind, placebo controlled study shows the efficiency and tolerability of a homeopathic combination remedy [article in German]. HNO 2007; 55: 271-277
    CrossrefPubMedGoogle Scholar
  • 26 Zabolotnyi DI, Kneis KC, Richardson A. et al. Efficacy of a complex homeopathic medication (Sinfrontal) in patients with acute maxillary sinusitis: a prospective, randomized, double-blind, placebo-controlled, multicenter clinical trial. Explore (NY) 2007; 3: 98-109
    CrossrefPubMedGoogle Scholar
  • 27 Weber U, Luedtke R, Friese KH, Fischer I, Moeller H. A non-randomised pilot study to compare complementary and conventional treatments of acute sinusitis. Forsch Komplementarmed Klass Naturheilkd 2002; 9: 99-104
    PubMedGoogle Scholar
  • 28 Kneis KC, Gandjour A. Economic evaluation of sinfrontal in the treatment of acute maxillary sinusitis in adults. Appl Health Econ Health Policy 2009; 7: 181-191
    CrossrefPubMedGoogle Scholar
  • 29 Heidbreder D, Gerster G, Gracza E. Sinusitis—klinische prüfung verschiedener homöopathischer medikamente in unterschiedlichen potenzen. Therapeutikon 1988; 2: 701-706
    PubMedGoogle Scholar
  • 30 Heidl R. Statistische auswertung einer anwendungsbeobachtung mit SANUVIS Tropfen. SANUM Post 2009; 86: 23-25
    PubMedGoogle Scholar
  • 31 Schmidt S, Kaestle HJ, Steinhausen U. Homeopathic spagyric therapy of acute and uncomplicated rhinosinusitis: an observational trial on symptom severity in 2 general practitioner surgeries. Forsch Komplement Med 2016; 23: 303-305
    CrossrefPubMedGoogle Scholar
  • 32 Adler M. Efficacy and safety of a fixed-combination homeopathic therapy for sinusitis. Adv Ther 1999; 16: 103-111
    PubMedGoogle Scholar
  • 33 Ammerschläger H, Klein P, Weiser M, Oberbaum M. Treatment of inflammatory diseases of the upper respiratory tract—comparison of a homeopathic complex remedy with xylometazoline [article in German]. Forsch Komplementarmed Klass Naturheilkd 2005; 12: 24-31
    PubMedGoogle Scholar
  • 34 Suter A, Bommer S. Acute and chronic sinusitis: treatment with a homeopathic sinus spray. Schweiz Z Ganzheitsmed 2003; 15: 233-238
    PubMedGoogle Scholar
  • 35 Weiser M, Clasen BPE. Randomisierte lazebokontrollierte Doppelblindstudie zur Untersuchung der klinischen Wirksamkeit der homöopathischen Euphorbium compositum-Nasentropfen S bei chronischer Sinusitis. Forsch Komplementarmed 1994; 1: 251-259
    PubMedGoogle Scholar
  • 36 Wiesenauer M, Gaus W, Bohnacker U, Häussler S. Efficiency of homeopathic preparation combinations in sinusitis. Results of a randomized double blind study with general practitioners [article in German]. Arzneimittelforschung 1989; 39: 620-625
    PubMedGoogle Scholar
  • 37 Ricciotti F, Bernardini C, D'Aco L. et al. Studio pilota sulle rinosinusiti croniche per valutare l'efficacia e la tollerabilità di un trattamento antibiotico standard (Amoxicillina e acido Clavulanico) associato a un complesso omeopatico (Dr. Reckeweg R1). Rivista Ital Otolaringol Audiol Foniatria 2005; 25: 109-117
    PubMedGoogle Scholar
  • 38 Nayak C, Singh V, Singh VP. et al. Homeopathy in chronic sinusitis: a prospective multi-centric observational study. Homeopathy 2012; 101: 84-91
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 39 Sharma SR, Bhanu KM, Sahagal GC. et al. Clinical evaluation of homoeopathic medicines in sinusitis. Indian J Res Homeopathy 2008; 2: 26-37
    CrossrefPubMedGoogle Scholar
  • 40 Ramteke SS, Nayak C, Singh V. et al. An open clinical observational study on the usefulness of pre-defined homoeopathic medicines in the management of chronic sinusitis. Indian J Res Homoeopathy 2009; 3: 34-40
    CrossrefPubMedGoogle Scholar
  • 41 Witt CM, Lüdtke R, Willich SN. Homeopathic treatment of patients with chronic sinusitis: a prospective observational study with 8 years follow-up. BMC Ear Nose Throat Disord 2009; 9: 7
    CrossrefPubMedGoogle Scholar
  • 42 Manchanda RK. A randomised, double blind, placebo-controlled, multi-centric parallel arm trial to assess the effects of homoeopathic medicines on chronic rhinosinusitis. Indian J Res Homoeopathy 2014; 8: 123-128
    CrossrefPubMedGoogle Scholar
  • 43 Pynnonen MA, Kim HM, Terrell JE. Validation of the sino-nasal outcome test 20 (SNOT-20) domains in nonsurgical patients. Am J Rhinol Allergy 2009; 23: 40-45
    CrossrefPubMedGoogle Scholar
  • 44 EuroQol Research Foundation. EQ-5D–5L User Guide, 2019. Accessed January 29, 2018 at: https://euroqol.org/publications/user-guides
    PubMed
  • 45 McCaffery M, Beebe A. Pain: Clinical manual for nursing practice. Mosby St. Louis, MO; 1989. J Pain Symptom Manage 1990; 5: 338-339
    CrossrefPubMedGoogle Scholar
  • 46 Jund R, Mondigler M, Stammer H, Stierna P, Bachert C. Herbal drug BNO 1016 is safe and effective in the treatment of acute viral rhinosinusitis. Acta Otolaryngol 2015; 135: 42-50
    CrossrefPubMedGoogle Scholar
  • 47 Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ 2010; 340: c332
    CrossrefPubMedGoogle Scholar
  • 48 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
    Artikel in Thieme ConnectPubMedGoogle Scholar
  • 49 Banerjee A, Srivastava BP, Koley M, Saha S. An open-label observational trial to evaluate the possible effects of individualized homeopathic medicines in symptomatic nasal polyp. Bengal J Otolaryngol Head Neck Surg 2019; 27: 51-59
    CrossrefPubMedGoogle Scholar
  • 50 Vithoulkas G. Serious mistakes in meta-analysis of homeopathic research. J Med Life 2017; 10: 47-49
    PubMedGoogle Scholar
  • 51 Coulter HL. Homoeopathy and modern medical science. The Hahn Glean 1982; 49: 147-166
    PubMedGoogle Scholar
  • 52 Vithoulkas G. Talks on Classical Homoeopathy. New Delhi: B. Jain Publishers Pvt. Ltd.; 2013: 234-240
    Google Scholar
  • 53 Peters D, Taylor Reilly D, Feruguson A. et al. How I would treat chronic sinusitis. Complement Ther Med 1993; 1: 81-87
    CrossrefPubMedGoogle Scholar
  • 54 Nangia S, Giridher V, Chawla P. Evaluation of the role of nasal endoscopy and computed tomography individually in the diagnosis of chronic rhinosinusitis. Indian J Otolaryngol Head Neck Surg 2019; 71: 1711-1717
    CrossrefPubMedGoogle Scholar