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; WFP5; 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: wfp8 T/S wfp<8 (s) Wk 10 SC: wfp5 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?