Homeopathy for depression--DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study

Ubiratan C Adler, Stephanie Krüger, Michael Teut, Rainer Lüdtke, Iris Bartsch, Lena Schützler, Friedericke Melcher, Stefan N Willich, Klaus Linde, Claudia M Witt, Ubiratan C Adler, Stephanie Krüger, Michael Teut, Rainer Lüdtke, Iris Bartsch, Lena Schützler, Friedericke Melcher, Stefan N Willich, Klaus Linde, Claudia M Witt

Abstract

Background: Homeopathy is often sought by patients with depression. In classical homeopathy, the treatment consists of two main elements: the case history and the prescription of an individually selected homeopathic remedy. Previous data suggest that individualized homeopathic Q-potencies were not inferior to the antidepressant fluoxetine in a sample of patients with moderate to severe depression. However, the question remains whether individualized homeopathic Q-potencies and/or the type of the homeopathic case history have a specific therapeutical effect in acute depression as this has not yet been investigated. The study aims to assess the two components of individualized homeopathic treatment for acute depression, i.e., to investigate the specific effect of individualized Q-potencies versus placebo and to investigate the effect of different approaches to the homeopathic case history.

Methods/design: A randomized, partially double-blind, placebo-controlled, four-armed trial using a 2 x 2 factorial design with a six-week study duration per patient will be performed. 228 patients diagnosed with major depression (moderate episode) by a psychiatrist will be included. The primary endpoint is the total score on the 17-item Hamilton Depression Rating Scale after six weeks. Secondary end points are: Hamilton Depression Rating Scale total score after two and four weeks; response and remission rates, Beck Depression inventory total score, quality of life and safety at two, four and six weeks. Statistical analyses will be by intention-to-treat. The main endpoint will be analysed by a two-factorial analysis of covariance. Within this model generalized estimation equations will be used to estimate differences between verum and placebo, and between both types of case history.

Discussion: For the first time this study evaluates both the specific effect of homeopathic medicines and of a homeopathic case taking in patients with depression. It is an attempt to deal with the challenges of homeopathic research and the results might be useful information in the current discussion about the evidence on homeopathy

Trial registration: ClinicalTrials.gov: NCT01178255.

Figures

Figure 1
Figure 1
Flow chart of the study groups.

References

    1. World Health Organization (WHO) 10 facts on the global burden of disease. 2008.
    1. World Health Organization (WHO) The global burden of disease, 2004 update. 2008.
    1. Ayuso-Mateos JL, Vázquez-Barquero JL, Dowrick C, Lehtinen V, Dalgard OS, Casey P, Wilkinson C, Lasa L, Page H, Dunn G, Wilkinson G. ODIN Group. Depressive disorders in Europe: prevalence figures from the ODIN study. Br J Psychiatry. 2001;179:308–16. doi: 10.1192/bjp.179.4.308.
    1. Meinlschmidt G. Daten des Gesundheits- und Sozialwesens. Senatsverwaltung für Gesundheit, Umwelt und Verbraucherschutz., Berlin; Basisbericht 2009. Gesundheitsberichterstattung Berlin. Herausgeber.
    1. Wedegärtner F, Sittaro NA, Emrich HM, Dietrich DE. Invalidisierung durch affektive Erkrankungen - Lehren aus den Daten der Gesundheitsberichterstattung des Bundes. Psychiatr Prax. 2007;34:S252–S255.
    1. Deutschen Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde. S3-Leitlinie/NVL Unipolare Depression, 2009.
    1. National Institute for Health and Clinical Excellence. Depression: the treatment and management of depression in adults (update) 2009. (Clinical guideline 90.)
    1. Khan A, Leventhal RM, Khan SR, Brown WA. Severity of depression and response to antidepressants and placebo: an analysis of the Food and Drug Administration database. J Clin Psychopharmacol. 2002;22(1):40–45. doi: 10.1097/00004714-200202000-00007.
    1. Fournier JC, DeRubeis RJ, Hollon SD, Dimidjian S, Amsterdam JD, Shelton RC, Fawcett J. Antidepressant Drug Effects and Depression Severity: A Patient-Level Meta-analysis. JAMA. 2010;303(1):47–53. doi: 10.1001/jama.2009.1943.
    1. Wu P, Fuller C, Liu X, Lee HC, Fan B, Hoven CW, Mandell D, Wade C, Kronenberg F. Use of complementary and alternative medicine among women with depression: results of a national survey. Psychiatr Serv. 2007;58(3):349–356. doi: 10.1176/appi.ps.58.3.349.
    1. Fox P, Coughlan B, Butler M, Kelleher C. Complementary alternative medicine (CAM) use in Ireland: a secondary analysis of SLAN data. Complement Ther Med. 2010;18(2):95–103. doi: 10.1016/j.ctim.2010.02.001.
    1. Thompson EA, Mathie RT, Baitson ES, Barron SJ, Berkovitz SR, Brands M, Fisher P, Kirby TM, Leckridge RW, Mercer SW, Nielsen HJ, Ratsey DH, Reilly D, Roniger H, Whitmarsh TE. Towards standard setting for patient-reported outcomes in the NHS homeopathic hospitals. Homeopathy. 2008;97(3):114–121. doi: 10.1016/j.homp.2008.06.005.
    1. Jonas W, Jacobs J. Healing with Homeopathy. New York, Warner; 1996.
    1. Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997;350:834–843. doi: 10.1016/S0140-6736(97)02293-9.
    1. Frei H. Polarity analysis, a new approach to increase the precision of homeopathic prescriptions. Homeopathy. 2009;98(1):49–55. doi: 10.1016/j.homp.2008.10.002.
    1. Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: long-term results of a cohort with 3981 patientes. BMC Publich Health. 2005;5:115. doi: 10.1186/1471-2458-5-115.
    1. Adler UC, Paiva NMP, Cesar AT, Adler MS, Molina A, Padula AE, Calil HM. Homeopathic individualized Q-potencies versus fluoxetine for moderate to severe depression: double-blind, randomized non-inferiority trial. Evid Based Complement Altern Med. 2009. Advance Access published on August 17,
    1. Girardi P, Pompili M, Innamorati M, Mancini M, Serafini G, Mazzarini L, Del Casale A, Tatarelli R, Baldessarini RJ. Duloxetine in acute major depression: review of comparisons to placebo and standard antidepressants using dissimilar methods. Hum Psychopharmacol. 2009;3:177–190. doi: 10.1002/hup.1005.
    1. Posner K, Brent C, Lucas C, Gould M, Stanley B, Brown G, Fisher P, Zelazny J, Burke A, Oquendo M, Mann J. Columbia-Beurteilungsskala zur Suizidalität. C-SSRS.
    1. Hahnemann CFS. Organon der Heilkunst: aude sapere. 6. Aufl., hrsg. u. mit Vorw. vers. von Richard Haehl, Leipzig, Schwuabe, 1921. Heidelberg, Haug; 1988. § 246, 248, 270.
    1. 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(29):173–182.
    1. Collegium Internationale Psychiatriae Scalarum (Hrsg.) Internationale Skalen für Psychiatrie. 2005. Weyer, F (redakt.Bearb.) Beltz Test - 5. Auflage.
    1. Hautzinger M, Bailer M, Worall H, Keller F. Das Beck-Depressions-Inventar:BDI. Bern: Huber Verlag; 1994.
    1. Zeger SL, Liang KY, Albert PS. Models for Longitudinal Data: A Generalized Estimating Equation Approach. Biometrics. 1988;44(4):1049–1060. doi: 10.2307/2531734.
    1. Holm S. A simple sequentially rejective Bonferroni test procedure. Scand J Stat. 1979;6:65–70.
    1. EMEA. Note for guidance on clinical investigation of medical products in the treatment of depression.
    1. Sartorius N, Baghai TC, Baldwin DS, Barrett B, Brand U, Fleischhacker W, Goodwin G, Grunze H, Knapp M, Leonard BE, Lieberman J, Nakane Y, Pinder RM, Schatzberg AF, Svestka J, Baumann P, Ghalib K, Markowitz JC, Padberg F, Fink M, Furukawa T, Fountoulakis KN, Jensen P, Kanba S, Riecher-Rössler A. Antidepressant medications and other treatments of depressive disorders: a CINP Task Force report based on a review of evidence. Int J Neuropsychopharmacol. 2007;10(Suppl 1):S1–207.
    1. AMG 15. Novelle zur Änderung des AMG. 2009. vom 23.07.
    1. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;24(3):e1000251. doi: 10.1371/journal.pmed.1000251. 7.
    1. Dean ME, Coulter MK, Fisher P, Jobst KA, Walach H. Reporting data on homeopathic treatments (RedHot): a supplement to CONSORT. J Altern Complement Med. 2007;13(1):19–23. doi: 10.1089/acm.2006.6352.
    1. Frei H, Everts R, von Ammon K, Kaufmann F, Walther D, Hsu-Schmitz SF, Collenberg M, Fuhrer K, Hassink R, Steinlin M, Thurneysen A. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomized, double blind, placebo controlled crossover trial. Eur J Pediatr 2005. pp. 758–67.
    1. Bell I. Depression research in homeopathy: Hopeless or hopeful? Homeopathy. 2005;94:141–144. doi: 10.1016/j.homp.2005.05.002.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться