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Symposium for Portland Area Research in CAM (SPARC) April 16, 2011 Ryan J Milley, MAcOM, LAc

Reporting Quality in Acupuncture Trials: An Assessment of the Literature to Update the NIH Consensus Conference. Symposium for Portland Area Research in CAM (SPARC) April 16, 2011 Ryan J Milley, MAcOM, LAc Research Associate. 1. 2. Conclusions from NIH Consensus Development Conference.

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Symposium for Portland Area Research in CAM (SPARC) April 16, 2011 Ryan J Milley, MAcOM, LAc

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  1. Reporting Quality in Acupuncture Trials: An Assessment of the Literature to Update the NIH Consensus Conference • Symposium for Portland Area Research in CAM (SPARC) • April 16, 2011 • Ryan J Milley, MAcOM, LAc • Research Associate 1

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  3. Conclusions from NIH Consensus Development Conference • “…promising results have emerged … showing efficacy of acupuncture in adult postoperative and chemotherapy related nausea and vomiting and in postoperative dental pain…” • “...acupuncture may be useful as an adjunct treatment, or an acceptable alternative…in addiction, stroke rehabilitation, headache, menstrual cramps, tennis elbow, fibromyalgia, myofascial pain, osteoarthritis, low back pain, carpal tunnel syndrome, and asthma...” 3

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  6. This statement is more than five years old and is provided solely for historical purposes. Due to the cumulative nature of medical research, new knowledge has inevitably accumulated in this subject area in the time since the statement was initially prepared. Thus some of the material is likely to be out of date, and at worst simply wrong. For reliable, current information...we recommend consulting the National Institutes of Health's MedlinePlus. 6

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  8. Conclusions from NIH Consensus Development Conference • Continues to be cited as a definitive source for conditions in which acupuncture is effective • Outdated statement • 600+ RCTs have been conducted since 1997 • Numerous RCTs on previously unstudied conditions have been conducted 8

  9. Aim: Update the NIH recommendations • Develop an objective & comprehensive quality of reporting instrument • Systematic reviews and meta-analyses use a heterogenous group of subjective instruments • Couple quality score findings with primary study outcome(s) • Consider the value of differing research trial designs, e.g. sham or usual care controls 9

  10. Methods • Developed the Oregon CONSORT STRICTA Instrument (OCSI) • CONSORT: Consolidated Standards of Reporting Trials [22 item guideline] • Published 1996, updated 2001 & 2010 • STRICTA: Standards for Reporting Interventions in Controlled Trials of Acupuncture [6 item guideline] • Modifies CONSORT to reflect acupuncture interventions; published 2001, updated 2010 10

  11. Methods: OCSI Development • Adapts CONSORT and STRICTA guidelines to a 27 question instrument • Comprehensive in nature • Most items contain sub-questions - 63 total • Items range from aspects pertaining to • Bias (randomization) • Treatment relevance (Practitioner experience with the condition) • External validity (generalizabilty of findings) 11

  12. OCSI Development & Findings • Scores questions as Yes=2, Partial=1, No=0, or N/A • 333 RCTs met the inclusion criteria • From 27 countries and 141 journals 12

  13. OCSI Development & Findings • Scores questions as Yes=2, Partial=1, No=0, or N/A • 333 RCTs met the inclusion criteria • From 27 countries and 141 journals • Evid Based Complement Alternat Med. 2011. doi:10.1155/2011/183910 13

  14. 30.9% (P<0.001)

  15. 30.9% (P<0.001) Mean OCSI Score 63% SD 16.5

  16. Methods • Assessed quality of reporting in the 333 acupuncture RCTs published in English from 1998-2007 • Inclusion criteria: • Treatment with acupuncture needles using manual and/or electro-stimulation • Control groups of no treatment, a sham procedure, or usual biomedical care • Clinical end points; not experimental 16

  17. Methods • Quality threshold set at 70% OCSI score • Indexed variables of each RCT related to treatment methodologies and outcomes • RCTs categorized as: • Efficacy Trials • Comparative Effectiveness Research (CER) Trials 17

  18. Efficacy Sham acupuncture control. Better than placebo? CER Usual care control. At least as good as usual care? Differing Lenses 18

  19. Results • 133 (40%) RCTs scored ≥70% on OCSI • Represent 43 varied conditions • Published in 76 differing journals • Conducted in 21 countries • Germany & USA - 31 RCTs each • UK - 16 RCTs • Sweden - 12 RCTs • Norway - 7 RCTs 19

  20. Results 20

  21. Results • Efficacy Trial Designs, i.e. sham acupuncture control • 58% (70/133) • Comparative Effectiveness Research Trial Designs, i.e. Usual care control • 32% (42/133) • Combined Efficacy & CER Trial Designs • 10% (12/133) 21

  22. Results • Top 5 most investigated areas • Pregnancy & labor related conditions (n=18) • Chronic low back pain (n=13) • Headache conditions(n= 11) • Osteoarthritic conditions (n=10) • Neck & shoulder pain conditions (n=10) 22

  23. Top 5 Investigated Conditions Primary outcome assessed as: Positive: + or Negative: - 23

  24. Top 5 Investigated Conditions Primary outcome assessed as: Positive: + or Negative: - 24

  25. Top 5 Investigated Conditions Primary outcome assessed as: Positive: + or Negative: - 25

  26. Differing Lenses *No Treatment Control, #Both CER & Efficacy Designs 26

  27. Differing Lenses *No Treatment Control, #Both CER & Efficacy Designs 27

  28. Differing Lenses *No Treatment Control, #Both CER & Efficacy Designs 28

  29. Differing Lenses *No Treatment Control, #Both CER & Efficacy Designs 29

  30. Differing Lenses *No Treatment Control 30

  31. Conclusions • A significant focus of research (45%) has been on previously understudied conditions • The lens of comparative effectiveness research, lends clarity • Acupuncture has demonstrated consistent benefit for the treatment of each of the five most often investigated areas 31

  32. Conclusions • We suggest new recommendations regarding the benefits of acupuncture • “Showing efficacy” list • Chronic low back pain (11+/2-) • Headache conditions (4+/7-, CER Lens 4+/1-) • Osteoarthritic conditions (8+/2-) • Neck & shoulder pain conditions (8+/2-) • Pregnancy & labor related conditions • Pain during labor (4+/0-) 32

  33. Conclusions • We suggest new recommendations regarding the benefits of acupuncture • “May be Useful” list • Peri-op/Post-op Pain (7+/1-) • Anxiety (3+/1-) • Pregnancy & labor related conditions • Pain during IVF procedures • Rhinitis (3+/0-) 33

  34. Future Directions • Update currently underway of RCTs published from 2008-2010 • ~150 RCTs • Consider ways to assess clinical relevance e.g. ecological validity 34

  35. Many Thanks to the OCSI Team:Richard Hammerschlag, PhDMikel Aikin, PhDAgatha Colbert, MD, LAcScott Mist, PhD, LAcJeffrey Weih, LAcBeth Yohalem-Ilsley, LAcQuestions?RMilley@ocom.edu Many Thanks to the OCSI TEAM Richard Hammerschag, PhD MikelAikin, PhD Agatha Colbert, MD Scott Mist, PhD, Lac Jeffrey Weih, Lac Beth Yohalem-Ilsley, Lac Questions? Rmilley@ocom.edu 35

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