symposium for portland area research in cam (sparc) april 16, 2011 ryan j milley, macom, lac
DESCRIPTION
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. - PowerPoint PPT PresentationTRANSCRIPT
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, LAcResearch Associate
22
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
44
55
66
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 Thus some of the material is likely to be out of date, and at worst simply wrong.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.
77
8
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Outdated statement 600+ RCTs have been conducted since 1997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
Conclusions from NIH Consensus Development Conference
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:10.1155/2011/18391013
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
Differing Lenses
18
EfficacySham
acupuncture control. Better than placebo?
CER Usual care
control. At least as good as usual care?
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
NIH Consensus Development Conference Category
Distribution of RCTs (n)
NIH “Showing efficacy” list 5% (7)
NIH “May be useful” list 50% (66)
NIH “Potential Future Research” list 45% (60)
21
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
Results
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
23
Pregnancy & Labor Related Condition Trials (n) OutcomePain During Labor 4 4+
Emesis in Pregnancy 3 2+; 1-
Initiation of Labor 3 2+; 1-
Pain During IVF Procedures 3 3+
Pregnancy Rate with IVF Procedures 3 2+; 1-
Breech Presentation 1 1+
Pelvic Pain During Pregnancy 1 1+
TOTAL 18 15+; 3-
Primary outcome assessed as: Positive: + or Negative: -
2424
Top 5 Investigated Conditions
Condition Trials (n) OutcomeChronic Low Back Pain 13 11+; 2-
Headache (Migraine & TTH) 11 4+; 7-Osteoarthritis (Knee) 10 8+; 2-Neck & Shoulder Pain 10 8+; 2-
Primary outcome assessed as: Positive: + or Negative: -
2525
Top 5 Investigated Conditions
Condition Trials (n) OutcomeChronic Low Back Pain 13 11+; 2-
Headache (Migraine & TTH) 11 4+; 7-Osteoarthritis (Knee) 10 8+; 2-Neck & Shoulder Pain 10 8+; 2-
Primary outcome assessed as: Positive: + or Negative: -
2626
Conditions Effectiveness Efficacy+ - + -
Chronic Low Back Pain(n=13; #Combo n=2) 10*# 2 3 0
Headache Conditions(n=11; #Combo n=1) 4 1 1 6#
Osteoarthritic Conditions(n=10; #Combo n=2) 7 1 3 # 1#
Neck & Shoulder Conditions(n=10; #Combo n=1) 4 2 5# 0
*No Treatment Control, #Both CER & Efficacy Designs
Differing Lenses
2727
Conditions Effectiveness Efficacy+ - + -
Chronic Low Back Pain(n=13; #Combo n=2) 10*# 2 3 0
Headache Conditions(n=11; #Combo n=1) 4 1 1 6#
Osteoarthritic Conditions(n=10; #Combo n=2) 7 1 3 # 1#
Neck & Shoulder Conditions(n=10; #Combo n=1) 4 2 5# 0
Differing Lenses
*No Treatment Control, #Both CER & Efficacy Designs
2828
Conditions Effectiveness Efficacy+ - + -
Chronic Low Back Pain(n=13; #Combo n=2) 10*# 2 3 0
Headache Conditions(n=11; #Combo n=1) 4 1 1 6#
Osteoarthritic Conditions(n=10; #Combo n=2) 7 1 3 # 1#
Neck & Shoulder Conditions(n=10; #Combo n=1) 4 2 5# 0
Differing Lenses
*No Treatment Control, #Both CER & Efficacy Designs
2929
Conditions Effectiveness Efficacy+ - + -
Chronic Low Back Pain(n=13; #Combo n=2) 10*# 2 3 0
Headache Conditions(n=11; #Combo n=1) 4 1 1 6#
Osteoarthritic Conditions(n=10; #Combo n=2) 7 1 3 # 1#
Neck & Shoulder Conditions(n=10; #Combo n=1) 4 2 5# 0
Differing Lenses
*No Treatment Control, #Both CER & Efficacy Designs
3030
Pregnancy & Labor (n=18) Effectiveness Efficacy
+ - + -Pain During Labor (n=4) 2 0 2 0
Emesis in Pregnancy (n=3) 1 0 0 2Initiation of Labor (n=3) 2 1 0 0
Pain During IVF Procedures (n=3) 2 0 1 0Pregnancy Rate with IVF Procedures (n=3) 1 0 1 1
Breech Presentation (n=1) 1* 0 0 0Pelvic Pain During Pregnancy (n=1) 1 0 0 0
TOTAL 10 1 4 3*No Treatment Control
Differing Lenses
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, PhD
Agatha Colbert, MD, LAcScott Mist, PhD, LAc
Jeffrey Weih, LAcBeth Yohalem-Ilsley, LAc
35
Many Thanks to the OCSI TEAM
Richard Hammerschag, PhDMikel Aikin, PhD
Agatha Colbert, MDScott Mist, PhD, Lac
Jeffrey Weih, LacBeth Yohalem-Ilsley, Lac