Presentation Outline 1. Overview of Acupuncture History, Theory, and Practice 2. Trends in Usage and Integration 3. State of Clinical Research 4. State of Mechanistic Research 5. NESA’s NIH Research Center 6. Questions and Discussion History and Background Acupuncture is one branch of a much larger, 3000- 4000 year old East Asian Medicine (EAM) system. Other components include: • Herbal medicine • Manual Therapies (Massage, Cupping) • Physical and Meditative Exercise (e.g. Tai Chi) • Moxibustion • Diet and Lifestyle Key Phases in History of Acupuncture • Early history of acupuncture still sketchy • Earliest acupuncture texts attributed to Yellow Emperor who lived between 2697-2596 B.C. Written version dated to 200 B.C. • Acupuncture brought to the west in 17th Century by Jesuit missionaries • Nixon’s visit to China in 1971 (James Reston, NY Times) “I’ve seen the past, and it works” • NESA founded in 1975, first acupuncture college in the U.S.; 2004 first NIH DCRC 1 Acupuncture in the United States • Increasing in popularity • Between 4-10% Americans have tried acupuncture; 2.1 million (1.1%) used it in 20021 • Number of Licensed Acupuncturists tripled between 1992-2000, and expected to quadruple by 20152 • Conditions3 commonly used in clinics: Pain relief, psychological well being, stroke rehab., nausea, headaches, addictions, & gynecology (infertility) 1. Barnes PM. 2004 Adv Data No. 343: 1-20; Acu Today 2004 2. Cooper et al 1998; JAMA 3. Cassidy CM 1998 J. Alt Comp Med; Xu 2001; S Med J Acupuncture in the United States • Among CAM modalities, acupuncture 2nd highest in credibility and #’s referrals by physicians1 • Acupuncture increasingly becoming integrated with conventional medicine • Recent study reported 8 of 13 Harvard-affiliated hospitals provide acupuncture2 --Pain Service, Oncology, Women’s Health, HIV Clinic (8 ambulatory, 1 inpatient) • NESA Clinics (n=12: e.g. Mt Auburn, Dimock, Roxbury, BMC, Winchester, Malden) 1. 2. Astin JA. Archives Intermal Medicine 1998; 158: 2303-2310 Highfield ES. Compl Ther in Med 2003; 11(3):177-83. Acupuncture Theory/Philosophy • Based on a holistic/ecological concept of nature • Everything in nature is inter-dependent and mutually interactive: “The web that has no weaver” (T. Kaptchuk) • Nothing can be understood with out its reference to the whole • Physical symptoms, emotional state, beliefs, social and environmental factors all interconnected • Emphasis on treating the whole person 2 Principle of Yin and Yang • Central to EAM is dialectical concept of YinYang (Tai Chi) • Both in nature and in human body, dynamic and cyclic interplay of complementary forces • Yin – more material, condensing (e.g. shade, water winter, cool, body, stillness ) • Yang – more immaterial, expanding (sun, fire, summer, warm, mind, movement) • Health - constant state of dynamic balance Yin/Yang Signs & Symptoms Yin Yang Fatigue, drowsiness Restlessness, throws off covers Flushed complexion Likes cold Constipation Noisy, loud mouthed Facial pallor Desires heat Diarrhea/ watery stools Likes quiet, no desire to talk Copious clear urine Dark, scanty urine Principle of Five Elements 3 Principles Qi • “Vital Energy” • Permeates all things • Travels through meridian • Can be stagnant, depleted, collapsed, rebellious The Practice of Acupuncture • Acupuncture: family of procedures involving stimulation of anatomical points on the body • Needles, electricity, heat, manual pressure, laser, sound, magnets • 365 acupuncture points • 14 major meridians • Styles – Chinese, Japanese, Korean, British, French, American, ear, scalp, hand Practice: Diagnosis and Tx • Evaluation – 4 Inquiries (Listen, touch, look, smell) • Diagnostic classes: no1:1 mapping with biomedicine (e.g. Hypertension; liver fire, kidney def., phlem) • Treatments individualized (acupoints, stimulation, frequency) • ~1 hour session, seen 1-2x week • Total number of sessions variable • Needles inserted and left for 10-30 mins 4 But, does it ‘work’? Evidence: Clinical Research • 1997 NIH Consensus Statement – > 500 Acupuncture trials, over half RCT’s – “A List”: Very strong support of efficacy for: dental pain, post-operative nausea, chemotherapy related nausea – “B List”: May be helpful for: addiction,headache, fibromyalgia, stroke rehabilitation, osteoarthritis, low back pain, asthma, carpal tunnel syndrome, and menstrual cramps – Clearly negative: tinnitus, smoking cessation – Safe – Significant methodological Issues Methodological Issues Problems common to all clinical trials • e.g. Small sample size; randomization; statistical analysis Problems unique to acupuncture research • • • • • Appropriate Control Groups Patient and Practitioner Blinding Individualized vs. Standardized Protocols Dosage (Length/frequency of treatments; stimulation) Experience and style of acupuncturists Recent studies have overcome these problems 5 Knee Osteoarthritis (Berman et al 2004; Ann Intern Med) Aim: Evaluate acupuncture as an adjunctive treatment Design: Phase III trial based on 2 pilot studies • RCT w/ 3 arms (n=570): -active acupuncture (fixed protocol; manual + EA) -sham acupuncture (taped guide tubes + decoys) -education-attention control (12h meeting+mailings) • Acupuncture/Sham Dosage: 23 Tx of 26 weeks • Experienced, licensed practitioners Primary Outcome: WOMAC Pain and Function Knee Osteoarthritis (Berman et al 2004; Ann Intern Med) Results • Sham Tx masked and credible • After 26 weeks, in active acupuncture group: - Pain reduced by 42% (vs. 33% and 19% in sham and education; p=0.003) -Function improved 40% (vs. 31% and 22% in sham and education; p=0.01) Conclusion: Acupuncture effective adjunct therapy for knee osteoarthritis -Methodologically sound, sham-controlled, trials possible -Dosage and samples sizes important (8 vs. 26 wks) Acupuncture for Chronic Stroke Symptoms (Wayne et al 2006) Background: Result of stroke studies to date mixed/limited; methodological issues (dosage,standardized Tx, control); all acute to sub-acute. Aim: Evaluate acupuncture on upper extremity (UE) function in long-term stroke survivors w/ persistent dysfunction Design: • Pilot RCT w/ 2 arms (n=33) • Post-recovery stage (> 6 months; 0.8 to 24 y post-stroke) • 20 Tx over 10 weeks in private office of senior practitioners • active acupuncture (individualized protocol; manual + EA) • sham acupuncture (sham needle device) 6 Acupuncture for Chronic Stroke Symptoms (Wayne et al 2006) Outcomes: UE motor function (FM), spasticity (Ashworth), range of motion, mood (CES-D), and QOL (Nottingham); Somatosensory function (fMRI) on subset (n=7) Results: • Treatment masking successful; < 50% guessed; those who did guess were equally right/wrong. • Relative to sham, active protocol-compliant subjects had better outcomes w/r/t -wrist spasticity (P<0.01) -wrist and shoulder ROM (P<0.01) -motor function (P=0.09) Acupuncture and Chronic Stroke: fMRI data (J. Schaechter et al 2007) • n=7; BOLD fMRI • Responses of motor and somatosenory cortices to sensorimotor testing before & after 20 acu Tx • Composite SMF change score from clinical results • Changes in ipsilesional SM cortex parallel changes in SMF after acupuncture CONCLUSION • Promising; additional research warranted Acupuncture for Chronic Headaches (Vickers et al, BMJ 2004) Aim: Determine effects of acupuncture on headache pain, health status, and number sick days off in patients with chronic headaches (predominantly migraine) Design: -Pragmatic Trial (n=401) funded by NHS -Patients randomized to acupuncture practitioners (12 Tx over 3 months, no set protocol) or to usual care 7 Acupuncture for Chronic Headaches (Vickers et al. BMJ 2004) Results: At 12 months, in the acupuncture group: •Weekly headache scores reduced by 34% (vs. 16 in control; P=0.0002) • 22 fewer HA day/s per year • 15% less medication • 15% fewer days off sick Cost effectiveness analysis (Wonderling et al 2004, BMJ) • acupuncture for headaches favorable cost-benefit profile Adverse effects Mechanistic Studies & Credibility 8 Mechanistic Studies Three important areas of studies 1. Neurohormonal 2. fMRI 3. Connective tissue MEK AS=met-enkephalin; DYN AS=dynorphin A Electroacupuncture at Low and High Frequencies Releases Different CNS Opioids Han et al (1991) Pain 47:295-298. 9 Functional MRI • Measures deoxyhemoglobin – paramagnetic oxygen-depleted carrier molecule • Proxy for neuronal activity - increased energy demand – increased blood flow – changes in deoxyhgb Visual (light) stimulation in comparison with ‘vision’-related acupoint (Bl 67) and non-acupoint control (Cho, Z. H. et al. (1998) Proc. Natl. Acad. Sci. USA 95, 2670-2673) Cho, Z. H. et al. (1998) Proc. Natl. Acad. Sci. USA 95, 2670-2673 Copyright ©1998 by the National Academy of Sciences 10