Acupuncture for chronic pain when combined with depression Hugh MacPherson 1
Back history of research at York into acupuncture for depression: Two successful feasibility studies Five large grant applications (~ 500k) Pragmatic design: Acupuncture plus usual care vs. usual care alone Five rejections New plan.. 2
Research questions: A. Is acupuncture clinically effective / costeffective for depression? B. Is counselling clinically effective / costeffective for depression? C. How do acupuncture and counselling compare? (adjusting for time and attention) 3
Acupuncture intervention: Individualised TCM Flexible protocol based on consensus process* Drawing on members of British Acupuncture Council Three year degree in acupuncture or equivalent Minimum three years post-qualification experience * MacPherson et al, Comp Ther in Med, 2007 4
Counselling intervention: Humanistic, non-directive Flexible protocol Already provided by 9,000 primary care practices in UK Well established professional body - British Association for Counselling and Psychotherapy (BACP) Competences defined by Skills for Health 5
Trial design Three arm pragmatic randomised controlled trial (RCT): 1. Acupuncture plus usual care up to 12 sessions 2. Counselling plus usual care up to 12 sessions 3. Usual care alone
Study flow chart GPs contacted 9503 patients Randomly allocated 755 15 x weekly SMS follow ups Acupuncture 302 (40%) 3 month Counselling 302 (40%) 3 month Usual GP Care 151 (20%) 3 month Practitioner interviews n=35 6 month 9 month 6 month 6 month 9 month 9 month Questionnaire follow ups Patient interviews n=54 12 month 12 month 12 month Analysis
Outcomes at baseline, 3, 6, 9 and 12 mo: PHQ9 primary outcome at 3 months SF36 Bodily Pain subscale Beck Depression Inventory-II EQ-5D - Euroquol Primary clinical analysis (intention-to-treat) 1. analysis of covariance at 3 months 2. 'area under the curve' at 12 months Cost-effectiveness analysis at 12 months 8
Setting - 27 primary care practices in Yorkshire and North-east Eligibility criteria: 18 years of age and over Diagnosed with depression by GP Baseline score 20 or above on BDI-II ( moderate to severe depression) Exclusion criteria: patients receiving acupuncture or counselling terminal illness, transmissible blood disorder, pregnant, recently bereaved 9
Recruitment 10
Baseline characteristics Predominantly female (73%) Mean age 44 yrs Age at first major depressive episode 25 yrs Majority (62%) reporting severe depression 69% taking anti-depressant medication Uptake of interventions (offer of up to 12) acupuncture mean of 10 sessions counselling mean of 9 sessions 11
Over an 18-month period, 23 acupuncturists delivered 2741 treatments to 266 patients, an average of 10 sessions per patient. Ref: MacPherson et al, ecam 2013 12
Primary outcome PHQ-9 Unadjusted PHQ-9 scores from baseline to 12 months MacPherson et al. (2013) PLoS Medicine, 10(9): e1001518 13
Clinical outcomes on PHQ-9, after adjusting for expectations and preferences: Effect size at 3 months: Counselling vs usual care: -0.27 (p<0.05) Acupuncture vs usual care: -0.39 (p<0.05) Area under curve significant at 12 months for both interventions Acupuncture vs. Counselling No sig diff (P>0.05), when adjusting for time and attention: Adverse events: no serious events related to treatment Primary outcomes 14
Publication: PLoS Medicine - Open Access Patients attended a mean of ten sessions for acupuncture. there was a statistically significant reduction in... depression scores at 3 months and over 12 months MacPherson et al. PLoS Medicine, 2013, 10 (9): e 1001518 15
Strengths Pragmatic design Rigorous methods Large sample size Good attendance levels Limitations Non-specific effects unmeasured We don t know what aspects of treatment worked better or worse 16
Related sub-studies Sub-studies 1. Health economic analysis 2. Texted depression scores 3. Patient experience 4. Depression and pain outcomes 5. Practitioner thoughts on long-term impact 17
Sub-study 1 Cost-effectiveness? (given NICE threshold of 20,000/QALY gained) counselling (vs. usual care) = 7,935/QALY Based on 65 per session 1 acupuncture (vs. usual care) = 4,560/QALY Based on 47.50 first and 37.50 subsequent sessions 2 1 National rate as set by Personal Social Services Research Unit 2 Average of range from NHS Choices: http://www.nhs.uk/conditions/acupuncture/pages/introduction.aspx Ref: Spackman et al, PLoS One 2014 18
Sub-study 2 SMS outcome trajectories by treatment Mean SMS text scores by trial arm (1 = not at all depressed, 9 = extremely depressed) texted depression scores Time to significant difference Ref: Richmond et al, BMC Psychiatry, 2015, in press 19
Sub-study 3 Patient experience of depression (n=52 interviews) Ref: Hopton et al, BMJ Open, 2014 20
Sub-study 4 Relationship between pain and depression: quantitative sub-analysis At baseline on EQ5D pain categories: 371 (49%) patients reported no pain 384 (51%) reported moderate or extreme pain Worse pain at baseline was associated with poorer depression outcomes at 3 months Ref: Hopton et al, BMJ Open, 2014 21
Sub-study 4 PHQ-9 depression scores comparing subgroup by treatment: Pain sub-group No-pain sub-group 22
Sub-study 4 PHQ-9 depression scores comparing subgroup by treatment: Pain sub-group No-pain sub-group 23
SF-36 pain scores comparing sub-group by treatment: Pain sub-group Sub-study 4 No-pain sub-group 24
SF-36 pain scores comparing sub-group by treatment: Pain sub-group Sub-study 4 No-pain sub-group 25
Sub-study 5 Practitioner focus on long-term impact (based on interviews) Treatment components identified as important for sustained benefit Individual approach Address root causes Value incremental change Address concurrent physical symptoms Support lifestyle change Therapeutic relationship Timing and pacing depending on readiness for change Ref: MacPherson et al, BMJ Open, 2014 26
Unresolved questions To what extent are observed benefits due to the non-specific effects of acupuncture and counselling? And how important is this question? How can large scale pragmatic trials impact on routine practice? How can we know what aspects of treatment are helpful or not? 27
Conclusions The largest trial of acupuncture (and of counselling) for depression Results show acupuncture and counselling both outperform usual care Both treatments are cost-effective at 12 months If comorbid depression and pain, both symptoms improve with acupuncture, and faster than with counselling 28
Acknowledgements Stewart Richmond (trial manager) Martin Bland Stephen Brealey Janet Eldred Rhian Gabe Ann Hopton Ada Keding Harriet Lansdown Sara Perren Sylvia Schroer Mark Sculpher Eldon Spackman David Torgerson Ian Watt This is independent research commissioned by the National Institute for Health Research (NIHR) under Programme Grants for Applied Research (Grant No. RP-PG-0707-10186). The views expressed in this presentation are those of the author and not necessarily those of the NHS, the NIHR or the Department of Health. 29
Publications to date: MacPherson H, Schroer S. Acupuncture as a complex intervention for depression: a consensus method to develop a standardised treatment protocol for a randomised controlled trial. Complementary Therapies in Medicine 2007; 15(2): 92-100. MacPherson H, Richmond S, Bland MJ, Lansdown H, Hopton A, Kang'ombe A, et al. Acupuncture, Counseling, and Usual care for Depression (ACUDep): study protocol for a randomized controlled trial. Trials, 2012 Nov 14; 13(1): 209. MacPherson H, Elliot B, Hopton A, Lansdown H, Richmond S. Acupuncture for Depression: Patterns of diagnosis and Treatment within a Randomised Controlled Trial. Evid Based Complement Alternat Med. 2013; 2013: 286048. MacPherson H, Richmond S, Bland, Brealey S, Gabe R, et al. Acupuncture and Counselling for Depression in Primary Care: A randomised Controlled Trial. PLoS Medicine, 2013; 10(9): e1001518 Spackman E, Richmond S, Sculpher M, Bland M, Brealey S, Gabe R, Hopton A, Keding A, Lansdown H, Perren S, Torgerson D, Watt I, MacPherson H. Cost-Effectiveness Analysis of Acupuncture, Counselling and Usual Care in Treating Patients with Depression: The Results of the ACUDep Trial. PLoS ONE. 2014;9(11):e113726 Hopton A, Eldred J, MacPherson H. Patients experiences of acupuncture and counselling for depression and comorbid pain: a qualitative study nested within a randomised controlled trial. BMJ Open. 2014;4(6):e005144. Hopton A, MacPherson H, Keding A, Morley S. Acupuncture, counselling or usual care for depression and comorbid pain: secondary analysis of a randomised controlled trial. BMJ Open 2014;4(5):e004964. MacPherson H, Newbronner L, Chamberlain R, Richmond SJ, Lansdown H, Perren S, et al. Practitioner Perspectives on Strategies to Promote Longer-Term Benefits of Acupuncture or Counselling for Depression: A Qualitative Study. PLoS ONE. 2014 Sep 8;9(9):e104077 Richmond R, Keding A, Hover M, Gabe, R, Torgerson D, MacPherson H. Feasibility, acceptability and validity of SMS text messaging for measuring change in depression during a randomised controlled trial. BMC Psychiatry, 2015, in press. 30