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DOI: 10.1055/s-0044-1791490
Presentation and Analysis of the Online Evidence Gap Map, “Clinical Effectiveness of Homeopathy”
Funding This work was organized by the Brazilian Academic Consortium for Integrative Health (CABSIN) as requested by the Brazilian Ministry of Health (2019), with grants given by the program FIOTEC—Fundação Para o Desenvolvimento Científico e Tecnológico em Saúde (grant number: VPGDI-014-FIO-20), and by BIREME/Centro Latino-Americano e do Caribe de Informação em Ciências da Saúde/Pan American Health Organization (PAHO).
Abstract
Introduction and Objective This study presents and analyzes the content of an online Evidence Gap Map (EGM), “Clinical Effectiveness of Homeopathy, 1st Edition”, which graphically represents evidence from systematic reviews (SRs) of human clinical trials in homeopathy that were published from 1991 to 2021. The EGM was built according to the guidelines of the International Initiative for Impact Evaluation (3ie), adapted for complex interventions, to represent visually relevant evidence and research gaps.
Presentation of Evidence Gap Map Content The interventions, classified as rows, are characterized in the EGM not only by the homeopathic therapeutic strategy but also by individual medicines and potencies. The outcomes are listed in columns. The associations between both are represented by “bubbles” that refer to the corresponding SRs and whose colors indicate their quality level.
Synthesis of Evidence Gap Map Content From 239 citations identified, 51 SRs underwent complete characterization for the final construction of the EGM. A further in-depth quality analysis of each SR was performed to list the studied intervention/outcome associations described in each mentioned trial. At this step, those trials considered to have a high risk of bias by the authors of each SR were excluded from the EGM inputs.
Analysis of Evidence Gap Map Content The methodological quality of each of the EGM's SRs was evaluated using the AMSTAR-2 criteria for level of confidence in an SR's results. Intervention–outcome associations were categorized into one of five effects of a homeopathic intervention: positive, potentially positive, ineffective, inconclusive, or negative.
Findings The EGM presents research evidence across a wide range of medical conditions, with substantial heterogeneity of homeopathic interventions and clinical outcomes. Forty-two of the 51 SRs yielded inconclusive findings. AMSTAR-2 analysis identified seven high-quality SRs, in which reliable primary studies presenting positive or potentially positive results for different categories of homeopathy are cited and related to specific clinical conditions: fibromyalgia, otitis media, diarrhea, respiratory infections, menopausal syndrome, irritable bowel syndrome, and attention deficit hyperactivity disorder in children.
Conclusion The EGM “Clinical Effectiveness of Homeopathy, 1st Edition” presents visually relevant research evidence that is scattered across a large number of medical conditions, showing substantial heterogeneity of homeopathic interventions, clinical outcomes, and research quality. To enhance the precision and relevance of future research, we recommend that the individualized homeopathic approach under investigation be standardized to the greatest extent feasible, and to use measures of well-being and quality of life as primary outcomes.
Publication History
Received: 02 January 2024
Accepted: 09 August 2024
Article published online:
24 December 2024
© 2024. Faculty of Homeopathy. This article is published by Thieme.
Georg Thieme Verlag KG
Oswald-Hesse-Straße 50, 70469 Stuttgart, Germany
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References
- 1 Campbell F, Wong R, Llewellyen JL, Stoniute A, Pearson F, Bond M. PROTOCOL: Methods used in the development, production and updating of evidence and gap maps: a scoping review. Campbell Syst Rev 2024; 20: e1402
- 2 International Initiative for Impact Evaluation (3ie). What are evidence gap maps? Accessed June 16, 2024 at: https://www.3ieimpact.org/evidence-hub/evidence-gap-maps
- 3 1st Edition Virtual Health Library. TCIM Americas. Traditional Complementary and Integrative Medicine. Evidence Maps. Accessed June 16, 2024 at: https://mtci.bvsalud.org/en/evidence-maps/
- 4 Evidence Map Clinical Effectiveness of Homeopathy 1st Edition. Sao Paulo. BIREME/OPAS/WHO; 2022. Available at: https://mtci.bvsalud.org/en/evidence-map-clinical-effectiveness-of-homeopathy/ . Accessed September 19, 2024
- 5 Page MJ, McKenzie JE, Bossuyt PM. et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ 2021; 372: n71
- 6 Snilstveit B, Bhatia R, Rankin K, Leach B. 3ie evidence gap maps: a starting point for strategic evidence production and use;. 2017 . Available at: http://3ieimpact.org/evidence-hub/publications/working-papers/3ie-evidence-gap-maps-starting-point-strategic-evidence .Accessed September 19, 2024
- 7 Brasil Ministério da Saúde Agência Nacional de Vigilância Sanitária. Farmacopeia Homeopática Brasileira 3rd ed. ANVISA, ed. Current Opinion in Neurology; 2011 . Accessed June 16, 2024 at: https://www.gov.br/anvisa/pt-br/assuntos/farmacopeia/farmacopeia-homeopatica/arquivos/8048json-file-1
- 8 Brasil Ministério da Saúde Agência Nacional de Vigilância Sanitária. RDC No 238, de 25 de julho de 2018 . Accessed June 16, 2024 at: https://bvs.saude.gov.br/bvs/saudelegis/anvisa/2018/rdc0238_25_07_2018.pdf
- 9 Bellavite P, Signorini A, Marzotto M, Moratti E, Bonafini C, Olioso D. Cell sensitivity, non-linearity and inverse effects. Homeopathy 2015; 104: 139-160
- 10 Bigagli E, Luceri C, Dei A, Bernardini S, Dolara P. Effects of extreme dilutions of Apis mellifica preparations on gene expression profiles of human cells. Dose Response 2016; 14: 1559325815626685
- 11 Magnani P, Conforti A, Zanolin E, Marzotto M, Bellavite P. Dose-effect study of Gelsemium sempervirens in high dilutions on anxiety-related responses in mice. Psychopharmacology (Berl) 2010; 210: 533-545
- 12 Pinto SAG, Nagai MYO, Alvares-Saraiva A. et al. Silicea terra and Zincum metallicum modulate the activity of macrophages challenged with BCG in vitro. Homeopathy 2021; 110: 52-61
- 13 Schünemann HJ, Higgins JPT, Vist GE. et al. Completing ‘Summary of findings’ tables and grading the certainty of the evidence. In: Cochrane Handbook for Systematic Reviews of Interventions Version 6.4.2023. . Accessed June 17, 2024 at: https://training.cochrane.org/handbook/current/chapter-14
- 14 Schünemann HJ, Brennan S, Akl EA. et al. The development methods of official GRADE articles and requirements for claiming the use of GRADE – A statement by the GRADE guidance group. J Clin Epidemiol 2023; 159: 79-84
- 15 Scottish Intercollegiate Guidelines Network. A guideline developer's handbook. (SIGN publication no. 50); 2019 . 1–62. Available at: https://www.sign.ac.uk/media/2038/sign50_2019.pdf . Accessed September 19, 2024
- 16 Jadad AR, Moore RA, Carroll D. et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary?. Control Clin Trials 1996; 17: 1-12
- 17 SCImago Journal & Country Rank. Available at: https://www.scimagojr.com/journalrank.php . Accessed September 5, 2022
- 18 Good Clinical Practice Network. ICH harmonised guideline integrated addendum to ICH E6(R1): Guideline for Good Clinical Practice ICH E6(R2); 2018 . Available at: https://ichgcp.net/ . Accessed September 19, 2024
- 19 Moher D, Schulz KF, Altman D. et al. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001; 285: 1987-1991
- 20 Dean ME, Coulter MK, Fisher P. et al Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Forsch Komplement Med 2006; 13: 368-371
- 21 Hamre HJ, Glockmann A, von Ammon K, Riley DS, Kiene H. Efficacy of homoeopathic treatment: systematic review of meta-analyses of randomised placebo-controlled homoeopathy trials for any indication. Syst Rev 2023; 12: 191
- 22 de Paula Coelho C, Motta PD, Petrillo M. et al. Homeopathic medicine Cantharis modulates uropathogenic E. coli (UPEC)-induced cystitis in susceptible mice. Cytokine 2017; 92: 103-109
- 23 Nagai MYDO, Mohammad SN, Pinto AAG. et al. Highly diluted glyphosate mitigates its effects on Artemia salina: physicochemical implications. Int J Mol Sci 2023; 24: 9478
- 24 López-Carvallo JA, Mazón-Suástegui JM, Hernández-Oñate MÁ. et al. Transcriptome analysis of Catarina scallop (Argopecten ventricosus) juveniles treated with highly-diluted immunomodulatory compounds reveals activation of non-self-recognition system. PLoS One 2020; 15: e0233064
- 25 Siqueira CM, Motta PD, Cardoso TN. et al. Homeopathic treatments modify inflammation but not behavioral response to influenza antigen challenge in BALB/c mice. Homeopathy 2016; 105: 257-264
- 26 Siqueira CM, Homsani F, da Veiga VF. et al. Homeopathic medicines for prevention of influenza and acute respiratory tract infections in children: blind, randomized, placebo-controlled clinical trial. Homeopathy 2016; 105: 71-77
- 27 Loeb M, Russell ML, Neupane B. et al. A randomized, blinded, placebo-controlled trial comparing antibody responses to homeopathic and conventional vaccines in university students. Vaccine 2018; 36: 7423-7429
- 28 Eizayaga JE. Homeopathic nosodes are not vaccines. Vaccine 2020; 38: 3517
- 29 Jacobs J, Springer DA, Crothers D. Homeopathic treatment of acute otitis media in children: a preliminary randomized placebo-controlled trial. Pediatr Infect Dis J 2001; 20: 177-183
- 30 Malapane E, Solomon EM, Pellow J. Efficacy of a homeopathic complex on acute viral tonsillitis. J Altern Complement Med 2014; 20: 868-873
- 31 Jacobs J, Taylor JA. A randomized controlled trial of a homeopathic syrup in the treatment of cold symptoms in young children. Complement Ther Med 2016; 29: 229-234
- 32 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
- 33 Rahlfs VW, Mössinger P. Treatment of irritable colon. A multicenter placebo-controlled double-blind study in general practice. [Zur Behandlung des Colon irritable: Ein multizentrischer plazebo-kontrollierter Doppelblindversuch in der Allgemeinen Praxis]. Arzneimittelforschung 1976; 26: 2230-2234
- 34 Rahlfs VW, Mössinger P. Asa foetida in the treatment of the irritable colon: a double-blind trial. [Asa foetida bei Colon irritabile: Doppelblindversuch]. Dtsch Med Wochenschr 1979; 104: 140-143
- 35 Bell IR, Lewis II DA, Brooks AJ. et al. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology (Oxford) 2004; 43: 577-582
- 36 Jacobs J, Jiménez LM, Gloyd SS, Gale JL, Crothers D. Treatment of acute childhood diarrhea with homeopathic medicine: a randomized clinical trial in Nicaragua. Pediatrics 1994; 93: 719-725
- 37 Colau JC, Vincent S, Marijnen P, Allaert FA. Efficacy of a non-hormonal treatment, BRN-01, on menopausal hot flashes: a multicenter, randomized, double-blind, placebo-controlled trial. Drugs R D 2012; 12: 107-119
- 38 Sinha MN, Siddiqui VA, Nayak C. et al. Randomized controlled pilot study to compare Homeopathy and Conventional therapy in Acute Otitis Media. Homeopathy 2012; 101: 5-12