TCM - National College of Natural Medicine

Report
Whole Systems Research in Traditional
Chinese Medicine (TCM) for
Temporomandibular Dysfunction (TMD):
Reflecting Clinical Practice in Research
Cheryl Ritenbaugh, PhD, MPH, University of Arizona
Mikel Aickin, PhD, University of Arizona
Scott Mist, PhD, MAOM, Oregon Health & Science University
Richard Hammerschlag, PhD, Oregon College of Oriental Medicine
Whole Systems Research
The goals of Whole Systems Research (WSR)
are to assess and compare real-world, multimodality systems of care in which the research
reflects unique features of the intervention
theory and therapeutic context.
Temporomandibular Dysfunction
(TMD)
Presents as a spectrum of dysfunction
– Localized: pain in face, jaw, neck, head,
shoulders
– Systemic: Multiple co-morbidities, including
fibromyalgia, depression, headache, sleep
and GI disorders
Complexity of TMD warrants whole systems
approach to compare real-world treatment options
•
NCCAM P50: Phase I/II pilot RCT of Traditional
Chinese Medicine (TCM), Naturopathic Medicine
(NM) and Dental Specialty Care (SC) for TMD
– Ritenbaugh et al JACM 2008;14(5):475-87
• Provided necessary information for Phase II
whole systems trial design
–
–
–
–
–
Entry criteria
Inclusion TCM diagnoses (basis for herbal IND)
Need for standardized self-care arm
TMD class important for all
Longer time window needed for treatments
TCM for TMD: Main Aims of Phase II Study
1. To further develop methods to evaluate real-
world TCM for pts with TMD and specified TCM
diagnoses compared to self-care therapy
2. To implement a randomized, stepped-care phase
II trial of TCM and/or Self-Care (SC – a validated
psychosocial intervention) among pts with
elevated pain
TCM for TMD: Design
– NCCAM U01 dual site trial (n=80/site)
• Univ Arizona (Tucson), PI: Cheryl Ritenbaugh, PhD, MPH
• OCOM (Portland), PI: Richard Hammerschlag, PhD
– Stepped-care comparison of whole systems:
TCM and “Self Care” (pain clinic model)
– Pt population
• Inclusion criteria: m/f 18-70; WFP5; TMD dx; one
of 8 TCM dx; willing to remain non-pregnant
• Exclusion Criteria: unwilling for allocation or
acupuncture; acupuncture in past 6 months, ever
for TMD; meds with known herb interaction; TMD
surgery
TCM for TMD: Design
– Outcome measures
• WFP & Characteristic pain (short- and long-term)
• Pain interference with activities
• Pt experience via qualitative interviews
• Other: AIOS/global health/decreased co-morbidities
– Challenges
• FDA (IND and lab work for safety reasons)
• R01  U01 (OCRA/NCCAM)
TCM Protocol
– Up to 20 acupuncture visits over 1 year;
patients’ choice of timing
– Treatment based on TCM diagnosis-specific
treatment guidelines
– Practitioner calibration of diagnoses (Mist et al,
JACM 2009;15(7):703-9)
– Acupuncture (up to 20 needles per session)
• Listed points for TMD; by TCM dx;
• Px flexibility for tailoring to co-morbidities
– Herbs
• Formulas for each TCM dx from 67-herb FDA approved list
• Px flexibility to adjust for side effects, dx
Self-Care Protocol
• TMD Class – 2 hrs (part of run-in)
– Basic information on etiology, physiology, and prognosis of
TMD
– Basic self-care techniques
• First 8 weeks: validated Self-Care intervention
– Protocol-based self-care training; manual, workbook
– 2 x 1.5 hr visits; 3 x 30 min phone calls
– Basic self-care: symptom monitoring, stress management,
specific techniques
• Subsequent 8 weeks: Time and attention control
– Resiliency: lay Cognitive Behavioral Therapy -- materials
developed for this study
– Same schedule as first 8 weeks
Study Objectives
• Short-term
– Does TCM offer greater benefit than Self Care for pts with
high pain levels?
• Long-term
– Does TCM provide benefit to patients over the long term?
At what levels?
– Is benefit from TCM (if found) maintained post-tx?
– Do patients who start with Self Care receive added longterm benefit relative to those who receive only TCM?
• Other
– Does a stepped-care research design make sense as a
model of real-world care?
Baseline demographics (n=168)
Variable
Value
Female (%)
Age: mean (SD)
Ethnicity (%)
White
Hispanic
Other
Duration of pain (%)
0-5 years
5-10 years
10 + years
87.5
42.9 (12.7)
86.7
10.3
3.0
37.5
20.2
32.3
Most prominent TCM dx at baseline (n=168)
TCM dx
Frequency
Percent
Liver Qi Stagnation
76
45.2
Qi & Blood Stagnation
70
41.6
Kidney Yin Xu
9
5.4
Liver Blood Xu
4
2.4
Spleen Damp
3
1.8
Kidney Jing Xu
2
1.2
Liver Yin Xu
2
1.2
Heart Xu
1
0.6
Spleen Qi Xu
1
0.6
Short-term Results
Comparative Effects of TCM and Self-care
TCM Effect (p-value)
Wk 2  wk 10
wk 10  wk 18
Outcome
Baseline
(mean)
Worst facial pain
8.5
-0.28 (.528)
-0.85 (.024)
-0.58 (.045)
Characteristic
facial pain*
6.3
-0.41 (.310)
-0.79 (.033)
-0.62 (.023)
Social activities
3.3
-0.21 (.689)
-1.34 (.001)
-0.81 (.016)
AIOS (overall
well-being)
5.9
0.46 (.212)
0.58 (.065)
0.58 (.022)
(pts to TCM or SC (pts to TCM or SC
at week 2)
at week 10)
Total
*Average of worst facial pain, average when having pain, facial pain now
Distribution of
TCM visits
by participant
(up to 20 within
one year)
Change in CFP on TCM: all
Pain score (2-6)
Pain percent of baseline (100-50)
Distribution
of follow-up
data to 6
months
post-TCM
Change in CFP after TCM: all
Pain score (2.5-4)
Pain percent of baseline (100-65)
What is the effect of
combining self-care and TCM?
Comparison of long-term
outcomes for those randomized at
first point to self-care or TCM…
Change in CFP on TCM:
TCM first (solid) v. SC first (dashed)
Pain score (2-6)
Pain percent of baseline (100-50)
Change in CFP after TCM:
TCM first (solid) v. SC first (dashed)
Pain score (3-4.5)
Pain percent of baseline (100-60)
Conclusions/Lessons learned
• TCM can help TMD patients achieve clinically meaningful
improvement in Characteristic Facial Pain
• This improvement in CFP continued up to 6 months beyond
the last TCM visit
• The combination of self-care with TCM may improve longterm outcomes
• 8 practitioners across 2 sites can implement a flexible
protocol
• As a design, ‘stepped-care’ made researchers happy but
did not please patients
Acknowledgements
Acknowledgements
• Richard Hammerschlag (Portland PI)
• Mikel Aickin (design and analysis)
• Scott Mist (TCM protocol, IND, practitioner training &
calibration (Mist et al, JACM 2009;15(7):703-9) )
• Sam Dworkin (TMD expert; SC intervention)
• Mark Nichter (qualitative design)
• Charles Elder, Ed Paul (medical directors)
• Cheryl Glass, Josh Metlyng (management)
• Emery Eaves, Liz Sutherland (interviews)
• Partap Khalsa (& Richard Nahin), NCCAM
• Steering Committee/DSMB
This work is supported by a cooperative agreement
grant from
National Center for Complementary and Alternative Medicine
National Institutes of Health
U.S. Department of Health and Human Services
www.nccam.nih.gov
Join the
International Society for Complementary
Medicine Research
• Go online at www.iscmr.org
• The website finally works (we think…)
• Save the date: May 15-18, 2012
– International Research Congress on
Integrative Medicine and Health, Portland OR
Long-term change in WFP as a function
of initial pain levels from start of TCM
8
10
Worst Facial Pain by Value at Baseline
%
6
33.3
4
28.5
2
23.5
1
2
3
4
Study Follow-ups on TCM
WFP 1-4
M ean +/- Standard Deviation of the Mean
WFP 5-7
5
WFP 8-10
6
Long-term change in CFP as a function of
WFP levels from start of TCM
6
8
Characteristic Facial Pain by WFP at Baseline
%
4
36.2
0
2
30.1
12.5
1
2
3
4
Study Follow-ups on TCM
WFP 1-4
M ean +/- Standard Deviation of the Mean
WFP 5-7
5
WFP 8-10
6
Allocations to Treatment Groups at
Weeks 2 & 10: Basis for Short-term Outcomes
Wk 2:
wfp8 T/S
wfp<8 (s)
Wk 10 SC:
wfp5 T/S
wfp<5 (s)
Complexity of TMD warrants whole systems
approach to compare real-world treatment options
• NIH P50: Phase I/II pilot clinical trial of Traditional
Chinese Medicine (TCM), Naturopathic Medicine
(NM) and Dental Specialty Care (SC) for TMD
– Ritenbaugh et al JACM 2008;14(5):475-87
• Individual tailoring of care in each arm (n=50)
– TCM: Acupuncture, Herbs, Tuina, lifestyle counseling
– NM: Herbal/nutritional supplements, physical medicine,
stress management, exercise techniques
– SC: Bite splints, pain management, self-care counseling,
referrals to physical therapy, bio-behavioral therapies
TCM, NM, SC for TMD: Results
Ritenbaugh et al JACM 2008;14(5):475-87
• TCM and NM > SC for reducing in-treatment worst facial
pain (WFP), the primary endpoint
• TCM>SC for reducing average pain (also prim e/p)
• Clinically meaningful reduction in WFP ( 30% from
baseline) by end of tx and 3-month post-tx:
% of pts: SC (18,27); NM (28,34); TCM (32,46)
• Conclusion: WSR design can be implemented
Lessons learned to guide phase II trial
•
•
•
•
•
•
•
Need to clarify I/E entry criteria, e.g. pain level
Pts willing to accept randomization
Identified TCM diagnoses for TMD
Identified commonly used herbs (basis for IND)
Usual care comparison was too variable
WFP correlated with other pain measures
Pts reported…
– TMD class was useful
– Longer time frame desired for treatments
– Measurement burden
Baseline co-morbidities of TMD pts (n=168)
in present study
25
20
# pts
15
10
5
0
0
2
4
6
8 10 12 14 16 18
# pt-reported medical conditions
Baseline demographics (n=168)
Variable
Finding (%)
Nature of Facial Pain
Continuous
Intermittent
49.7
50.3
Biosocial Impact
Limits chewing
Limits smiling/laughing
Limits kissing
Limits yawning
79.2
34.5
23.2
70.8
TCM for TMD trial design
• SC assigned to those doing well at week 2
• Balanced randomization* to TCM or SC at weeks 2
& 10 for pts doing less well
*based on WFP, gender, age, depression
• Once on TCM, always on TCM
• Short-term outcomes: baseline vs. wks 10 & 18
• Long-term outcomes: through 18 months
Long-term results:
Weeks from first to last TCM visit
Change in WFP on TCM: all
Pain score (4-7)
Pain percent of baseline (100-60)
Change in WFP after TCM: all
Pain score (4.5-6.5)
Pain percent of baseline (100-70)
Change in WFP on TCM:
TCM first (solid) v. SC first (dashed)
Pain score (2-8)
Pain percent of baseline (100-50)
Change in WFP after TCM:
T first (solid) v. SC first (dashed)
Pain score (5-7.5)
Pain percent of baseline (110-70)
Other analyses in progress
• TCM pattern distribution: change over time
• TCM pattern relative to outcome
• Px variability in tx plan (point selection, herbs)
• TUC/PDX differences (relative to climate?)
• Who does best on which tx?

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