Method for appraising model validity of randomised controlled trials of homeopathic treatment: Multi-rater concordance study

BMC Medical Research Methodology

Volumn 12, Issue , 2012, Pages

  Mathie, Robert T ^a   Roniger, Helmut ^b   Van Wassenhoven, Michel ^c   Frye, Joyce ^d   Jacobs, Jennifer ^e   Oberbaum, Menachem ^f   Bordet, Marie France ^g   Nayak, Chaturbhuja ^h   Chaufferin, Gilles ^g   Ives, John A ⁱ   Dantas, Flávio ^j   Fisher, Peter ^b  

^a BRITISH HOMEOPATHIC ASSOCIATION   (United Kingdom)

^b UCL Hospitals NHS Trust   (United Kingdom)

^c LMHI Research Secretariat   (Belgium)

^d UNIVERSITY OF MARYLAND SCHOOL OF MEDICINE   (United States)

^e UNIVERSITY OF WASHINGTON   (United States)

^f SHAARE ZEDEK MEDICAL CENTER   (Israel)

^g Boiron   (France)

^h GOVERNMENT OF INDIA   (India)

ⁱ SAMUELI INSTITUTE   (United States)

^j FEDERAL UNIVERSITY OF UBERLÂNDIA   (Brazil)

more..

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; HOMEOPATHY; HUMAN; METHODOLOGY; OUTCOME ASSESSMENT; RANDOMIZED CONTROLLED TRIAL (TOPIC); REPRODUCIBILITY; STANDARD;

HOMEOPATHY; HUMANS; OUTCOME ASSESSMENT (HEALTH CARE); RANDOMIZED CONTROLLED TRIALS AS TOPIC; REPRODUCIBILITY OF RESULTS;

EID: 84859748279     PISSN: None     EISSN: 14712288     Source Type: Journal    
DOI: 10.1186/1471-2288-12-49     Document Type: Article

References (38)

1. Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement. Quality of reporting of meta-analyses. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF, Lancet 1999 354 1896 1900 10.1016/S0140-6736(99)04149-5 10584742
2. Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Moher D, Liberati A, Tetzlaff J, Altman DG, PRISMA Group, J Clin Epidemiol 2009 62 1006 1012 10.1016/j.jclinepi.2009.06.005 19631508
3. Chapter 8: Assessing risk of bias in included studies. In: Higgins JPT, Green S (editors). Cochrane Handbook for Systematic Reviews of Interventions. Version 5.1.0 [updated March 2011]. The Cochrane Collaboration, Higgins JPT, Altman DG, Sterne JAC, 2011 http://www.cochrane-handbook.org
4. Checklist for the qualitative evaluation of clinical studies with particular focus on external validity and model validity. Bornhöft G, Maxion-Bergemann S, Wolf U, Kienle GS, Michalsen A, Vollmar HC, Gilbertson S, Matthiessen PF, BMC Med Res Methodol 2006 6 56 10.1186/1471-2288-6-56 17156475 (Pubitemid 46177990)
5. Assessing the validity of clinical trials. Akobeng AK, J Pediatr Gastroenterol Nutr 2008 47 277 282 10.1097/MPG.0b013e31816c749f 18728521
6. Assessing the quality of controlled clinical trials. Jüni P, Altman DG, Egger M, BMJ 2001 323 42 46 10.1136/bmj.323.7303.42 11440947
7. Complementary and alternative whole systems research: Beyond identification of inadequacies of the RCT. Verhoef MJ, Lewith G, Ritenbaugh C, Boon H, Fleishman S, Leis A, Complement Ther Med 2005 13 206 212 10.1016/j.ctim.2005.05.001 16150375 (Pubitemid 41258550)
8. Wein C, Qualitätsaspekte klinischer Studien zur Homöopathie [Quality aspects of clinical trials of homeopathy] Essen: KVC Verlag 2002 20924712
9. Are the clinical effects of homoeopathy placebo effects? A meta-analysis of placebo-controlled trials. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB, Lancet 1997 350 834 843 10.1016/S0140-6736(97)02293-9 9310601 (Pubitemid 27404344)
10. Are the clinical effects of homoeopathy placebo effects? Comparative study of placebo-controlled trials of homoeopathy and allopathy. Shang A, Huwiler-Muntener K, Nartey L, Juni P, Dorig S, Sterne JA, Pewsner D, Egger M, Lancet 2005 366 726 732 10.1016/S0140-6736(05)67177-2 16125589 (Pubitemid 41207234)
11. A systematic review of the quality of homeopathic clinical trials. Jonas WB, Anderson RL, Crawford CC, Lyons JS, BMC Complement Altern Med 2001 1 12 10.1186/1472-6882-1-12 11801202 (Pubitemid 38750915)
12. Homeopathy-what are the active ingredients? An exploratory study using the UK Medical Research Council's framework for the evaluation of complex interventions. Thompson TDB, Weiss M, BMC Complement Altern Med 2006 6 37 10.1186/1472-6882-6-37 17101037 (Pubitemid 44873317)
13. Die Wirksamkeit des Komplexmittels Phyto-Hypophyson® L bei weiblicher, hormonell bedingter Sterilität [The efficacy of the complex medication Phyto-Hypophyson® L in female, hormone-related sterility]. Bergmann J, Luft B, Boehmann S, Runnebaum B, Gerhard I, Forsch Komplementärmed Klass Naturheilkd 2000 7 190 199 10.1159/000021343
14. Commentary: a questionably positive effect of a homoeopathic complex medication in female infertility. Kraft K, Focus Altern Complement Ther 2001 6 23
15. Individualised homeopathy as an adjunct in the treatment of childhood asthma: a randomised placebo controlled trial. White A, Slade P, Hunt C, Hart A, Ernst E, Thorax 2003 58 317 321 10.1136/thorax.58.4.317 12668794 (Pubitemid 36411417)
16. Letter to the Editor: Homeopathy in childhood asthma. Brien SB, Lewith G, Thorax 2003 58 626 627
17. Treatment of seasonal allergic rhinitis using homeopathic preparation of common allergens in the southwest region of the US: a randomized, controlled clinical trial. Kim LS, Riedlinger JE, Baldwin CM, Hilli L, Khalsa SV, Messer SA, Waters RF, Ann Pharmacother 2005 39 617 624 10.1345/aph.1E387 15741420 (Pubitemid 40396613)
18. Seasonal allergic rhinitis study results of questionable relevance to homeopathy. O'Mathúna DP, Horgan JM, Ann Pharmacother 2005 39 736 738 10.1345/aph.1G095 15741411 (Pubitemid 40396631)
19. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. Dean ME, Coulter MK, Fisher P, Jobst K, Walach H, Homeopathy 2007 96 42 45 10.1016/j.homp.2006.11.006 17227747 (Pubitemid 46080726)
20. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R, Complement Ther Med 2001 9 246 249 10.1054/ctim.2001.0488 12184354 (Pubitemid 34506328)
21. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. Schulz KF, Altman DG, Moher D, CONSORT Group, BMJ 2010 340 332 10.1136/bmj.c332 20332509
22. Effectiveness, safety and cost-effectiveness of homeopathy in general practice-summarized health technology assessment. Bornhöft G, Wolf U, Ammon K, Righetti M, Maxion-Bergemann S, Baumgartner S, Thurneysen A, Matthiessen PF, Forsch Komplementmed 2006 13 Suppl 2 19 29 16883077
23. A controlled evaluation of a homoeopathic preparation in the treatment of influenza like syndromes. Ferley JP, Zmirou D, D'Adhemar D, Balducci F, Br J Clin Pharmacol 1989 27 329 335 2655683 (Pubitemid 19097443)
24. Treatment of acute childhood diarrhea with homeopathic medicine; a randomized clinical trial in Nicaragua. Jacobs J, Jimenez LM, Gloyds SS, Gale JL, Crothers D, Pediatrics 1994 93 719 725 8165068 (Pubitemid 24136102)
25. Does a homeopathic ultramolecular dilution of Thyroidinum 30cH affect the rate of body weight reduction in fasting patients? A randomized placebo-controlled double-blind clinical trial. Schmidt JM, Ostermayr B, Homeopathy 2002 91 197 206 10.1054/homp.2002.0049 12422922 (Pubitemid 36068207)
26. Use of ultramolecular potencies of allergen to treat asthmatic people allergic to house dust mite: double blind randomized controlled clinical trial. Lewith G, Watkins AD, Hyland ME, BMJ 2002 324 520 523 10.1136/bmj.324.7336.520 11872551 (Pubitemid 34185270)
27. Homoeopathic versus placebo therapy of children with warts on the hands: a randomized, double-blind clinical trial. Kainz JT, Kozel G, Haidvogl M, Smolle J, Dermatology 1996 193 318 320 10.1159/000246277 8993956 (Pubitemid 27007575)
28. Treatment of anxiety with a homeopathic remedy. McCutcheon LE, J Appl Nutr 1996 48 2 6 (Pubitemid 26320205)
29. Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Bell I, Lewis D, Brooks A, Schwartz G, Lewis S, Walsh B, Baldwin C, Rheumatology (Oxford) 2004 43 577 582 10.1093/rheumatology/keh111 (Pubitemid 38628186)
30. Homeopathic Arnica montana for post-tonsillectomy analgesia: a randomised placebo control trial. Robertson A, Suryanarayanan R, Banerjee A, Homeopathy 2007 96 17 21 10.1016/j.homp.2006.10.005 17227743 (Pubitemid 46080723)
31. Homeopathic individualized Q-potencies versus fluoxetine for moderate to severe depression: double-blind, randomized non-inferiority trial. Adler UC, Paiva NM, Cesar AT, Adler MS, Molina A, Padula AE, Calil HM, Evid Based Complement Alternat Med 2009 Epub ahead of print
32. World Health Organization, Towards a Common Language for Functioning, Disability and Health. ICF: The International Classification of Functioning, Disability and Health Geneva: World Health Organization 2002
33. Measuring nominal scale agreement among many raters. Fleiss JL, Psychol Bull 1971 76 378 382
34. The measurement of observer agreement for categorical data. Landis JR, Koch GG, Biometrics 1977 33 159 174 10.2307/2529310 843571 (Pubitemid 8054849)
35. Risk of bias versus quality assessment of randomised controlled trials: cross sectional study. Hartling L, Ospina M, Liang Y, Dryden DM, Hooton N, Saida JK, Klassen TP, BMJ 2009 339 4012 10.1136/bmj.b4012 19841007
36. Commentary: there is no clinical benefit of homoeopathic isopathy over placebo in asthma. Jonas WB, Crawford CC, Focus Altern Complement Ther 2002 7 263
37. Homeopathic practitioner views of changes in patients undergoing constitutional treatment for chronic disease. Bell IR, Koithan M, Gorman MM, Baldwin CM, J Altern Complement Med 2003 9 39 50 10.1089/107555303321222937 12676034 (Pubitemid 36292743)
38. Methodological implications of nonlinear dynamical systems models for whole systems of complementary and alternative medicine. Bell IR, Koithan M, Pincus D, Forsch Komplementmed 2012 19 suppl 1 15 21 22327547