Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design to assess homeopathic treatment in depression Petter Viksveen Post-graduate Research Student University of Sheffield Supervisors: Prof. Paul Bissell, Dr. Clare Relton Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design to assess homeopathic treatment in depression Aim: • acceptability & clinical & cost effectiveness • homeopathic treatment • in addition to usual care Depression in South Yorkshire (DEPSY) Using the ‘cohort multiple’ RCT design to assess homeopathic treatment in depression Aim: • acceptability & clinical & cost effectiveness • homeopathic treatment • in addition to usual care • self-reported depression We hope the cmRCT model will help with • Improved recruitment rates • Representative population • Reduced attrition rates We hope the cmRCT model will help with • Improved recruitment rates • Representative population • Reduced attrition rates • Save time South Yorkshire Cohort (n=20,000) Self-reported long-standing depression (n=1,800) Mail out Mood & Health Questionnaire Completed Mood & Health Questionnaire (est. n=700) References Adler U.C., Kruger S., Teut M., Ludtke R., Bartsch I., Schutzler L., Melcher F., Willich S.N., Linde K., & Witt C.M. (2011). Homeopathy for depression – DEP-HOM: study protocol for a randomized, partially double-blind, placebo controlled, four armed study. Trials, 12:43. Doi:10.1186/1745-6215-12-43. Adler U.C., Paiva N.M.P., Cesar A.T., Adler M.S., Molina A., Padula A.E., & Calil H.M. (2009). Homeopathic individualized q-potencies versus Fluoxetine for moderate to severe depression: Doubleblind, randomized non-inferiority trial. eCAM. Doi:10.1093/ecam/nep114 Bell I.R., Lewis D.A., Brooks A.J., Schwartz G.E., Lewis S.E., Walsh B.T., & Baldwin C.M. (2004). Improved clinical status in fibromyalgia patients treated with individualized homeopathic remedies versus placebo. Rheumatology. Doi:10.1093/rheumatology/keh111 Clover A. (2000). Patient benefit survey: Tunbridge Wells Homoeopathic Hospital. Br Homeopath J, 89:68.72. Davidson J.R.T., Morrison RM., Shore J., Davison R.T., & Bedayn G. (1997). Homeopathic treatment of depression and anxiety. Altern Ther Health Med, 3(1):46–49. EU Clinical Trials Register. (2011). EudraCT Number: 2009-017458-11. Heulluy B. (1982). Essai randomize ouvert de L 72 (spécialité homéopathique) contre diazepam 2 dans les états anxiodépressifs. [Open randomized trial comparing L.72 with Diazepam 2 in states of nervous depression.] [French] Metz: Laboratoires Lehning. Unpublished study. Katz T., Fisher P., Katz A., Davidson J., & Feder G. (2005). The feasibility of a randomised, placebocontrolled clinical trial of homeopathic treatment of depression in general practice. Homeopathy, 94:145152. Mathie R.T., & Robinson T.W. (2006). Outcomes from homeopathic prescribing in medical practice: A prospective, research-targeted, pilot study. Homeopathy, 95:199-205. McDade D. (2008). Evaluation – Complementary and alternative medicines pilot project in Northern Ireland. Department of Health, Social Services and Public Safety. May. Pilkington K., Kirkwood G., Rampes H., Fisher P., & Richardson J. (2005). Homeopathy for depression: a systematic review of the research evidence. Homeopathy, 94:153-163. Relton C., Torgerson D., O’Cathain A., & Nicholl J. (2010). Rethinking pragmatic RCTs: introducing the ‘cohort multiple RCT’ design. BMJ, 340:c1066. Richardson W.R. (2001). Patient benefit survey: Liverpool Regional Department of Homoeopathic Medicine. Br Homeopath J, 90(3):158-62. Sevar R. (2000). Audit of outcome in 829 consecutive patients treated with homeopathic medicines. Br Homoeopat J, 89(4):178-87. Sevar R. (2005). Audit of outcome in 455 consecutive patients treated with homeopathic medicines. Homeopathy, 94(4):215-21. Slade K., Chohan B.P.S., & Barker P.J. (2004). Evaluation of a GP practice based homeopathy service. Homeopathy, 93(2):67-70. Spence D.S., Thompson E.A., & Barron S.J. (2005). Homeopathic treatment for chronic disease: a 6year, university-hospital outpatient observational study. J Altern Complement Med, 11(5):793-8. Thompson E.A., Reilly D. (2002). The homeopathic approach to symptom control in the cancer patient: a prospective observational study. Palliat Med, 16 (3):227-33. Thompson E.A., Reilly D. (2003). The homeopathic approach to the treatment of symptoms of oestrogen withdrawal in breast cancer patients. A prospective observational study. Homeopathy, 92(3):131-4. Tölg M. (2006). Amanita muscaria: The efficacy and safety of a homeopathic drug in patients with nervous states of disquiet and excitation - Results of an observational study. Ärztezeit Naturheilverf Regul, 47(6):415-419.