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Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment.

Publication ,  Journal Article
Mathie, RT; Van Wassenhoven, M; Jacobs, J; Oberbaum, M; Frye, J; Manchanda, RK; Roniger, H; Dantas, F; Legg, LA; Clausen, J; Moss, S; Ford, I ...
Published in: Complement Ther Med
April 2016

BACKGROUND: To date, our programme of systematic reviews has assessed randomised controlled trials (RCTs) of individualised homeopathy separately for risk of bias (RoB) and for model validity of homeopathic treatment (MVHT). OBJECTIVES: The purpose of the present paper was to bring together our published RoB and MVHT findings and, using an approach based on GRADE methods, to merge the quality appraisals of these same RCTs, examining the impact on meta-analysis results. DESIGN: Systematic review with meta-analysis. METHODS: As previously, 31 papers (reporting a total of 32 RCTs) were eligible for systematic review and were the subject of study. MAIN OUTCOME MEASURES: For each trial, the separate ratings for RoB and MVHT were merged to obtain a single overall quality designation ('high', 'moderate, "low", 'very low'), based on the GRADE principle of 'downgrading'. RESULTS: Merging the assessment of MVHT and RoB identified three trials of 'high quality', eight of 'moderate quality', 18 of 'low quality' and three of 'very low quality'. There was no association between a trial's MVHT and its RoB or its direction of treatment effect (P>0.05). The three 'high quality' trials were those already labelled 'reliable evidence' based on RoB, and so no change was found in meta-analysis based on best-quality evidence: a small, statistically significant, effect favouring homeopathy. CONCLUSION: Accommodating MVHT in overall quality designation of RCTs has not modified our pre-existing conclusion that the medicines prescribed in individualised homeopathy may have small, specific, treatment effects.

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Published In

Complement Ther Med

DOI

EISSN

1873-6963

Publication Date

April 2016

Volume

25

Start / End Page

120 / 125

Location

Scotland

Related Subject Headings

  • Risk
  • Randomized Controlled Trials as Topic
  • Placebos
  • Humans
  • Homeopathy
  • Complementary & Alternative Medicine
  • Bias
  • 4208 Traditional, complementary and integrative medicine
  • 1701 Psychology
  • 1104 Complementary and Alternative Medicine
 

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Mathie, R. T., Van Wassenhoven, M., Jacobs, J., Oberbaum, M., Frye, J., Manchanda, R. K., … Fisher, P. (2016). Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med, 25, 120–125. https://doi.org/10.1016/j.ctim.2016.01.005
Mathie, Robert T., Michel Van Wassenhoven, Jennifer Jacobs, Menachem Oberbaum, Joyce Frye, Raj K. Manchanda, Helmut Roniger, et al. “Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment.Complement Ther Med 25 (April 2016): 120–25. https://doi.org/10.1016/j.ctim.2016.01.005.
Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Frye J, Manchanda RK, et al. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med. 2016 Apr;25:120–5.
Mathie, Robert T., et al. “Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment.Complement Ther Med, vol. 25, Apr. 2016, pp. 120–25. Pubmed, doi:10.1016/j.ctim.2016.01.005.
Mathie RT, Van Wassenhoven M, Jacobs J, Oberbaum M, Frye J, Manchanda RK, Roniger H, Dantas F, Legg LA, Clausen J, Moss S, Davidson JRT, Lloyd SM, Ford I, Fisher P. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med. 2016 Apr;25:120–125.
Journal cover image

Published In

Complement Ther Med

DOI

EISSN

1873-6963

Publication Date

April 2016

Volume

25

Start / End Page

120 / 125

Location

Scotland

Related Subject Headings

  • Risk
  • Randomized Controlled Trials as Topic
  • Placebos
  • Humans
  • Homeopathy
  • Complementary & Alternative Medicine
  • Bias
  • 4208 Traditional, complementary and integrative medicine
  • 1701 Psychology
  • 1104 Complementary and Alternative Medicine