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Homeopathy 2014; 103(02): 147-152
DOI: 10.1016/j.homp.2014.01.004
Original Paper
Copyright © The Faculty of Homeopathy 2014

Depression treated by homeopaths: a study protocol for a pragmatic cohort multiple randomised controlled trial

Petter Viksveen
,
Clare Relton
Further Information

Publication History

Received15 November 2013
revised10 January 2014

accepted22 January 2014

Publication Date:
22 December 2017 (online)

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Background: The most commonly recommended treatments for depression are psychological/psychotherapeutic treatments, and antidepressant drugs. However, 38 percent of patients with depression do not use these recommended treatments. Some patients seek homeopathic treatment for depression, but insufficient evidence exists to conclude as to the effectiveness, cost-effectiveness and safety of treatment by homeopaths for patients with depression. The aim of this trial is to evaluate the acceptability and comparative clinical and cost-effectiveness of the offer of adjunctive treatment provided by homeopaths for patients with self-reported depression.

Method: This pragmatic randomised controlled trial is embedded within the population based South Yorkshire Cohort (SYC) of whom nine percent self-report long-term depression. The SYC is designed to facilitate ‘cohort multiple’ randomised controlled trials (cmRCT). A self-completed questionnaire will be used to both screen and collect baseline data from potential trial participants. The primary outcome is PHQ-9. One-hundred-and-sixty-two participants will be randomly selected to the intervention group (Offer of treatment by a homeopath). The results of the Offer and the No Offer groups will be compared at 6 and 12 months using both an intention to treat (ITT) and complier average causal effect (CACE) analysis. Cost-effectiveness analysis will involve calculation of quality adjusted life year (QALY). In order to help interpret the quantitative findings a selection of up to 30 patients in the offer group will be invited to participate in qualitative interviews after the first consultation and after a minimum of 6 months. Interviews will be assessed by two researchers and results will be analysed using thematic analysis. Triangulation will be used to combine results from qualitative and quantitative methodologies at the interpretation stage, to see if results agree, offer complementary information on the same issue or contradict each other.

Keywords

Homeopathy - Depression - Cohort multiple randomised controlled trial - Effectiveness - Cost-effectiveness - Qualitative study - Mixed method
 

  • References

  • 1 World Health Organization (WHO). The global burden of disease: 2004 update. 2008. 978 92 4 156371 0
    Google Scholar
  • 2 Moussavi S., Chatterji S., Verdes E., Tandon A., Patel V., Ustun B.. Depression, chronic diseases, and decrements in health: results from the world health surveys. Lancet 2007; 370: 851-858.
    CrossrefPubMedGoogle Scholar
  • 3 National Collaborating Centre for Mental Health (NCCMH). Depression. The NICE guideline on the treatment and management of depression in adults. Updated edition 2010. 978-1-904671-85-5
    Google Scholar
  • 4 The Health and Social Care Information Centre, Prescribing and Primary Care Services. Prescriptions dispensed in the Community: England, statistics for 2001 to 2011. Report published 31 July 2011. Available at: http://www.hscic.gov.uk/article/2098/Anti-depressant-prescriptions-account-for-largest-annual-rise-in-items-dispensed-in-the-community (last visited 10.01.2014).
    PubMed
  • 5 Cipriani A., Santilli C., Furukawa T.A.. et al. Escitalopram versus other antidepressive agents for depression. Cochrane Database Syst Rev 2009; 2: CD006532 10.1002/14651858.CD006532.pub2
    PubMedGoogle Scholar
  • 6 Kirsch I., Deacon B.J., Huedo-Medina T.B., Scoboria A., Moore T.J., Johnson B.T.. Initial severity and antidepressant benefits: a meta-analysis of data submitted to the Food and Drug Administration. PLoS Med 5 (02) 2008; 260-268.
    PubMedGoogle Scholar
  • 7 Cipriani A., Brambilla P., Furukawa T.A.. et al. Fluoxetine versus other types of pharmacotherapy for depression. Cochrane Database Syst Rev 2005; 4: CD004185 10.1002/14651858.CD004185.pub2
    PubMedGoogle Scholar
  • 8 Arroll B., Elley C.R., Fishman T.. et al. Antidepressants versus placebo for depression in primary care. Cochrane Database Syst Rev 2009; 3: CD007954 http://dx.doi.org/10.1002/14651858.CD007954.
    CrossrefPubMedGoogle Scholar
  • 9 Reid S., Barbui C.. Long term treatment of depression with selective serotonin reuptake inhibitors and newer antidepressants. BMJ 2010; 340: c1468 http://dx.doi.org/10.1136/bmj.c1468
    CrossrefPubMedGoogle Scholar
  • 10 Cuijpers P., van Straten A., Bohlmeijer E., Hollon S.D., Andersson G.. The effects of psychotherapy for adult depression are overestimated: a meta-analysis of study quality and effect size. Psychol Med 2010; 40: 211-223.
    CrossrefPubMedGoogle Scholar
  • 11 Frass M., Strassl R.P., Friehs H., Müllner M., Kundi M., Kaye A.D.. Use and acceptance of complementary and alternative medicine among the general population and medical personnel: a systematic review. Ochsner J 12 (01) 2012; 45-56.
    PubMedGoogle Scholar
  • 12 Relton C., Chatfield K., Partington H., Foulkes L.. Patients treated by homeopaths registered with the Society of Homeopaths: a pilot study. Homeopathy 2007; 96: 87-89.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 13 Becker-Witt C., Lüdtke R., Weishuhna T.E.R., Willich S.N.. Diagnoses and treatment in homeopathic medical practice. Forsch Kompl Klass Nat 2004; 11: 98-103.
    PubMedGoogle Scholar
  • 14 Fisher P.. What is homeopathy? An introduction. Front Biosci E4 (01) 2012; 1669-1682.
    PubMedGoogle Scholar
  • 15 Ernst E.. A systematic review of systematic reviews of homeopathy. Br J Clin Pharmacol 2002; 54: 577-582.
    CrossrefPubMedGoogle Scholar
  • 16 Bornhöft G., Wolf U., von Ammon K.. et al. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – Summarized health technology assessment. Forsch Komplementärmed 13 (02) 2006; 19-29.
    PubMedGoogle Scholar
  • 17 Linde K., Mondras M., Vickers A., ter Riet G., Melchart D.. Systematic reviews of complementary therapies – an annotated bibliography. Part 3: Homeopathy. BMC Complement Altern Med 2001; 1: 4 Available at: http://www.biomedcentral.com/1472-6882/1/4 (last visited 10.01.2014)
    CrossrefPubMedGoogle Scholar
  • 18 Clover A.. Patient benefit survey: Tunbridge Wells Homoeopathic Hospital. Br Homeopath J 2000; 89: 68-72.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 19 Mathie R.T., Robinson T.W.. Outcomes from homeopathic prescribing in medical practice: A prospective, research-targeted, pilot study. Homeopathy 2006; 95: 199-205.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 20 Richardson W.R.. Patient benefit survey: Liverpool Regional Department of Homoeopathic Medicine. Br Homeopath J 90 (03) 2001; 158-162.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 21 Sevar R.. Audit of outcome in 455 consecutive patients treated with homeopathic medicines. Homeopathy 94 (04) 2005; 215-221.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 22 Sevar R.. Audit of outcome in 829 consecutive patients treated with homeopathic medicines. Br Homeopath J 89 (04) 2000; 178-187.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 23 Spence D.S., Thompson E.A., Barron S.J.. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med 11 (05) 2005; 793-798.
    CrossrefPubMedGoogle Scholar
  • 24 Adler U.C., Paiva N.M.P., Cesar A.T.. et al. Homeopathic individualized q-potencies versus Fluoxetine for moderate to severe depression: Double-blind, randomized non-inferiority trial. eCAM 2011; 1-7 10.1093/ecam/nep114 Article ID 520182
    PubMedGoogle Scholar
  • 25 Katz T., Fisher P., Katz A., Davidson J., Feder G.. The feasibility of a randomised, placebo-controlled clinical trial of homeopathic treatment of depression in general practice. Homeopathy 2005; 94: 145-152.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 26 Adler U.C., Krüger S., Teut M.. et al. Homeopathy for depression: A randomized, partially double-blind, placebo-controlled, four-armed study (DEP-HOM). PloS ONE 8 (09) 2013; e75537 10.1371/journal.pone.0074537
    CrossrefPubMedGoogle Scholar
  • 27 Relton C., Torgerson D., O'Cathain A., Nicholl J.. Rethinking pragmatic RCTs: introducing the ‘cohort multiple RCT’ design. BMJ 2010; 340: c1066
    CrossrefPubMedGoogle Scholar
  • 28 Kroenke K., Spitzer R.L.. The patient health questionnaire somatic, anxiety, and depressive symptom scales: a systematic review. Gen Hosp Psychiatry 2010; 32: 345-359.
    CrossrefPubMedGoogle Scholar
  • 29 Dunn G., Maracy M., Tomenson B.. Estimating treatment effects from randomized clinical trials with noncompliance and loss to follow-up: the role of instrumental variable methods. Stat Methods Med Res 2005; 14: 369 10.1191/0962280205sm403oa
    CrossrefPubMedGoogle Scholar
  • 30 Hewitt C.E., Torgerson D.J., Miles J.N.V.. Is there another way to take account of noncompliance in randomized controlled trials?. CMAJ 174 (04) 2006; 247-248.
    PubMedGoogle Scholar
  • 31 O'Cathain A., Murphy E., Nicholl J.. Three techniques for integrating data in mixed methods studies. BMJ 2010; 341: c4587 10.1136/bmj.c4587
    CrossrefPubMedGoogle Scholar
  • 32 Jacobs J., Chapman E.H., Crothers D.. Patient characteristics and practice patterns of physicians using homeopathy. Arch Fam Med 1998; 7: 537-540.
    CrossrefPubMedGoogle Scholar
  • 33 Weatherley-Jones E., Thompson E.A., Thomas K.J.. The placebo-controlled trial as a test of complementary and alternative medicine: observations from research experience of individualized homeopathic treatment. Homeopathy 2004; 93: 186-189.
    Article in Thieme ConnectPubMedGoogle Scholar
  • 34 Milgrom L.. Toward a topological description of the therapeutic process: Part 2. Practitioner and patient perspectives of the “Journey to cure.”. J Altern Complement Med 18 (02) 2012; 187-199.
    CrossrefPubMedGoogle Scholar
  • 35 Walach H.. Generalized entanglement: A new theoretical model for understanding the effects of complementary and alternative medicine. J Altern Complement Med 11 (03) 2005; 549-559.
    CrossrefPubMedGoogle Scholar
  • 36 Barlow F., Scott C., Coghlan B.. et al. How the psychosocial context of clinical trials differs from usual care: A qualitative study of acupuncture patients. BMC Med Res Methodol 2011; 11: 79 Available at: http://www.biomedcentral.com/1471-2288/11/79 (last visited 10.01.2014)
    CrossrefPubMedGoogle Scholar
  • 37 Relton C.. Implications of the ‘placebo effect’ for CAM research. Complement Ther Med 21 (02) 2013; 121-124.
    CrossrefPubMedGoogle Scholar
  • 38 Mitchell N., Hewitt C., Adamson J.. et al. A randomized evaluation of CollAborative care and active surveillance for Screen-Positive EldeRs with sub-threshold depression (CASPER): study protocol for a randomized controlled trial. Trials 2011; 12: 225
    CrossrefPubMedGoogle Scholar
  • 39 Richards D.. Improving recruitment into clinical trials. DiReCT Newsl 2012. December Available at: http://medicine.exeter.ac.uk/media/universityofexeter/medicalschool/research/healthservicesresearch/docs/complexinterventions/DiReCT_Newsletter-_December_2012.pdf (last visited 10.01.2014)
    Google Scholar
  • 40 Cameron I.M., Cardy A., Crawford J.R., du Toit S.W., Hay S., Lawton K.. et al. Measuring depression severity in general practice: discriminatory performance of the PHQ-9, HADS-D, and BDI-II. Br J Gen Pract 2011; e419-e426 10.3399/bjgp11X583209
    PubMedGoogle Scholar
  • 41 Gilbody S., Richards D., Barkham M.. Diagnosing depression in primary care using self-completed instruments: UK validation of PHQ-9 and CORE-OM. Br J Gen Pract 2007; 57: 650-652.
    PubMedGoogle Scholar
  • 42 Cameron I.M., Crawford J.R., Lawton K., Reid I.C.. Psychometric comparison of PHQ-9 and HADS for measuring depression severity in primary care. Br J Gen Pract 2008; 58: 32-36.
    CrossrefPubMedGoogle Scholar
  • 43 Berghöfer A., Hartwich A., Bauer M., Unützer J., Willich S.N., Pfennig A.. Efficacy of a systematic depression management program in high utilizers of primary care: a randomized trial. BMC Health Serv Res 2012; 12: 298 10.1186/1472-6963-12-298
    CrossrefPubMedGoogle Scholar
  • 44 Johansson R., Björklund M., Hornborg C.. et al. Affect-focused psychodynamic psychotherapy for depression and anxiety through the Internet: a randomized controlled trial. PeerJ 2013; 1: e102 http://dx.doi.org/10.7717/peerj.102
    CrossrefPubMedGoogle Scholar
  • 45 Mohr D.C., Duffecy J., Ho J., Kwasny M., Cai X.. et al. A randomized controlled trial evaluating a manualized telecoaching protocol for improving adherence to a web-based intervention for the treatment of depression. PLoS ONE 8 (08) 2013; e70086 http://dx.doi.org/10.1371/journal.pone.0070086
    CrossrefPubMedGoogle Scholar