Download PDF
Homeopathy 2018; 107(02): 143-149
DOI: 10.1055/s-0038-1637009
Original Research Article
The Faculty of Homeopathy

Homeopathy for Perennial Asthma in Adolescents: Pilot Feasibility Study Testing a Randomised Withdrawal Design

Livia Mitchiguian Hotta
1   Ambulatório da Criança e do Adolescente da Prefeitura de Guarulhos
,
Ubiratan Cardinalli Adler
2   Departamento de Medicina, Universidade Federal de São Carlos, São Carlos, São Paulo, Brazil
,
Amarilys de Toledo Cesar
3   HN Cristiano Homeopatia
,
Edson Zangiacomi Martinez
4   Departamento de Medicina Social, Faculdade de Medicina de Ribeirão Preto Universidade de São Paulo, Brazil
,
Marcelo Marcos Piva Demarzo
5   Departamento de Medicina Preventiva, Universidade Federal de São Paulo, São Paulo, Brazil
› Author Affiliations Funding Authors declare that there was no funding source, apart from the provision of study medication.
Further Information

Publication History

02 November 2017

05 February 2018

Publication Date:
26 March 2018 (online)

    Permissions and Reprints

Abstract

Introduction Previous findings from a pragmatic trial suggest that usual care compared with usual care plus individualised homeopathy is not a feasible design to address homeopathic interventions for asthma.

Objective The main purpose of this article was to investigate the feasibility of the randomised withdrawal design as a strategy to assess the effectiveness of a standardised clinical–pharmaceutical homeopathic protocol (Organon.modus) on perennial asthma in adolescents.

Methods Randomised withdrawal, double-blind, parallel, placebo-controlled, 12-week study. Patients: 12 to 17 years old adolescents, with the diagnosis of perennial asthma, using inhalatory beclomethasone (plus fenoterol for wheezing episodes), who achieved 3 months of well-controlled asthma, after a variable period of individualised homeopathic treatment according to Organon.modus protocol. Setting: a secondary care medical specialist centre. Intervention: continuation with the individualised homeopathic medicine or with indistinguishable placebo during 12 weeks of beclomethasone step-down. Primary outcome: number of days of well-controlled asthma. Secondary measures: number of days of fenoterol use, number of visits to an emergency service (without hospitalisation) and percentage of patients excluded due to an exacerbation characterising a partly controlled asthma. Tolerability was assessed by Adverse Events, registered at every visit.

Results Nineteen patients were randomised to continue treatment with homeopathy and 21 with placebo. Effectiveness measures for the homeopathy and placebo groups respectively were median number of days of good clinical control: 84 versus 30 (p = 0.18); median number of days of fenoterol use per patient: 3 versus 5 (p = 0.41); visits to an emergency room: 1 versus 6 (p = 0.35); percentage of exclusion due to partly controlled asthma: 36.8% versus 71.4% (p = 0.05). Few Adverse Events were reported.

Conclusions This pilot study supports the feasibility of the double-blind randomised withdrawal design in studies investigating homeopathy on teenage asthma, when performed by specialists following a standardised clinical–pharmaceutical homeopathic protocol.

Clinical Trial Registration RBR-6XTS8Z.

Keywords

perennial asthma - beclomethasone - homeopathy
 

  • References

  • 1 Hossny E, Rosario N, Lee BW. , et al. The use of inhaled corticosteroids in pediatric asthma: update. World Allergy Organ J 2016; 9: 26
    CrossrefPubMedGoogle Scholar
  • 2 Misra SM. The current evidence of integrative approaches to pediatric asthma. Curr Probl Pediatr Adolesc Health Care 2016; 46: 190-194
    PubMedGoogle Scholar
  • 3 BRASIL. Ministério da Saúde. Portaria GM n° 971 de 03 de maio de 2006. Available at: http://bvsms.saude.gov.br/bvs/saudelegis/gm/2006/prt0971_03_05_2006.html . Accessed July 21, 2017
    PubMedGoogle Scholar
  • 4 Adler UC, Cesar AT, Adler MS, Padula AE, Garozzo EN, Galhardi WP. From pharmaceutical standardizing to clinical research: 20 years of experience with fifty-millesimal potencies. Int J High Dilution Res 2009; 8: 173-182 Available at: http://highdilution.org/index.php/ijhdr/article/view/367 . Accessed March 01, 2018
    PubMedGoogle Scholar
  • 5 Thompson EA, Shaw A, Nichol J. , et al. The feasibility of a pragmatic randomised controlled trial to compare usual care with usual care plus individualised homeopathy, in children requiring secondary care for asthma. Homeopathy 2011; 100: 122-130
    Article in Thieme ConnectPubMedGoogle Scholar
  • 6 U.S. Department of Health and Human Services Food and Drug Administration. Enrichment Strategies for Clinical Trials to Support Approval of Human Drugs and Biological Products. Draft Guidance for Industry, 2012. Available at: https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM332181.pdf. . Accessed February 5, 2018
    PubMedGoogle Scholar
  • 7 Global Strategy for Asthma Management and Prevention. Update 2017. Available at: www.ginasthma.org . Accessed February 5, 2018
    PubMedGoogle Scholar
  • 8 Hahnemann S. Organon der Heilkunst 6. Auflage. Leipsig: Schwabe;1921 - Heidelberg: Haug; 1992
    Google Scholar
  • 9 Haynes W. Wilcoxon rank sum test. In: Dubitzky W, Wolkenhauer O, Cho KH, Yokota H. , eds. Reference Work Entry: Encyclopedia of Systems Biology. New York, NY: Springer; 2013
    Google Scholar
  • 10 Wilcox RR. A review of the beta-binomial model and its extensions. J Educ Behav Stat 1981; 6: 3-32
    PubMedGoogle Scholar
  • 11 Perera BJ. Successful withdrawal of inhaled corticosteroids in childhood asthma. Respirology 2005; 10: 385-388
    CrossrefPubMedGoogle Scholar
  • 12 White A, Slade P, Hunt C, Hart A, Ernst E. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax 2003; 58: 317-321
    CrossrefPubMedGoogle Scholar
  • 13 Dantas F. Comment on individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax 2003; 58: 826 , author reply 828
    CrossrefPubMedGoogle Scholar
  • 14 Fisher P, Chatfield K, Mathie R. Comment on individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. Thorax 2003; 58: 827 , author reply 828
    PubMedGoogle Scholar
  • 15 Borges S, Chen YF, Laughren TP. , et al. Review of maintenance trials for major depressive disorder: a 25-year perspective from the US Food and Drug Administration. J Clin Psychiatry 2014; 75: 205-214
    CrossrefPubMedGoogle Scholar
  • 16 Galvao TF, Zimmermann IR, da Mota LM, Silva MT, Pereira MG. Withdrawal of biologic agents in rheumatoid arthritis: a systematic review and meta-analysis. Clin Rheumatol 2016; 35: 1659-1668
    CrossrefPubMedGoogle Scholar
  • 17 Hnin K, Nguyen C, Carson KV, Evans DJ, Greenstone M, Smith BJ. Prolonged antibiotics for non-cystic fibrosis bronchiectasis in children and adults. Cochrane Database Syst Rev 2015; CD001392
    PubMedGoogle Scholar
  • 18 Buitelaar J, Asherson P, Soutullo C. , et al. Differences in maintenance of response upon discontinuation across medication treatments in attention-deficit/hyperactivity disorder. Eur Neuropsychopharmacol 2015; 25: 1611-1621
    CrossrefPubMedGoogle Scholar
  • 19 Frei H, Everts R, von Ammon K. , et al. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Eur J Pediatr 2005; 164: 758-767
    CrossrefPubMedGoogle Scholar
  • 20 Anderson SF, Kelley K, Maxwell SE. Sample-size planning for more accurate statistical power: a method adjusting sample effect sizes for publication bias and uncertainty. Psychol Sci 2017; 28: 1547-1562
    CrossrefPubMedGoogle Scholar