East Meets West: Treating Pain with Acupuncture

Transcription

1 East Meets West: Treating Pain with Acupuncture Lixing Lao, Ph.D., L.Ac. Professor and Director TCM Research Program, Center for Integrative Medicine University of Maryland School of Medicine Center for Integrative Medicine, Health and Wellness Conference 2013, Baltimore, May 4, 2013

2 Overview Acupuncture Trials on Pain Conditions Acupuncture Trials on Non-Pain Conditions Findings of basic science studies on acupuncture and their clinical implications Safety of acupuncture practice

3 ACUPUNCTURE CLINICAL TRIALS ON PAIN -RELIEF

4 Acupuncture for Chronic Pain -- Individual Patient Data Meta-analysis Andrew J. Vickers, DPhil; Angel M. Cronin, MS; Alexandra C. Maschino, BS; George Lewith, MD; Hugh MacPherson, PhD; Nadine E. Foster, DPhil; Karen J. Sherman, PhD; Claudia M. Witt, MD; Klaus Linde, MD; for the Acupuncture Trialists Collaboration Arch Intern Med.Published online September 10, 2012.doi: /archinternmed

5 Background Although acupuncture is widely used for chronic pain, there remains considerable controversy as to its value Determine the effect size of acupuncture for 4 chronic pain conditions: back and neck pain, osteoarthritis, chronic headache, and shoulder pain

6 Methods identification of eligible RCTs collection, checking, and harmonization of raw data Individual patient data meta-analysis

7 Methods DATA SOURCES AND SEARCHES MEDLINE, the Cochrane Collaboration Central Register of Controlled Trials, the citation lists of systematic reviews. Initial search, current to November 2008, the individual patient data meta-analysis Second search, December 2010, summary data, used in a sensitivity analysis

8 Methods STUDY SELECTION Two reviewers applied inclusion criteria separately Randomized controlled trials current episode of pain: at least 4 weeks duration primary end point must: more than 4 weeks after the initial acupuncture treatment Adequate allocation concealment Contacted authors for further information concerning the exact randomization process

9 Methods Provide raw data from the RCT. DATA EXTRACTION AND QUALITY ASSESSMENT All results reported in the RCT publication were replicated. Assessed the quality of blinding for eligible RCTs with sham acupuncture control. A sensitivity analysis included only RCTs with a low risk of bias.

10 Methods: Flowchart

11 RESULTS 29 Usable raw data, including a total of patients Patients in all RCTs had access to analgesics and other standard treatments for pain Dropout rates were low DATA EXTRACTION AND QUALITY ASSESSMENT

12 RESULTS SYSTEMATIC REVIEW Control groups Sham RCTs No-acupuncture control groups a. needles inserted superficially b. sham acupuncture devices c. non-needle approaches varied usual care

13 RESULTS META-ANALYSIS

14 A. Osteoarthritis B. Chronic headache C. Musculoskeletal pain Figure 1. Forest plots for the comparison of acupuncture with no-acupuncture control

15 A. Osteoarthritis B. Chronic headache C. Musculoskeletal pain D. Shoulder pain Figure 2. Forest plots for the comparison of true and sham acupuncture

16 RESULTS META-ANALYSIS Effect sizes are larger for the comparison between acupuncture and no-acupuncture control than for the comparison between acupuncture and sham: 0.37, 0.26, and 0.15 in comparison with sham vs 0.55, 0.57, and 0.42 in comparison with no-acupuncture control

17 A COMPARISON TO A PAIN KILLER The ES for pain relief with acetaminophen comparing a placebo was from 0.21 (0.02, 0.41) to 0.14 (0.05, 0.22) But it was no longer significant when analysis was restricted to high quality trials (ES ¼ 0.10, 95% CI 0.0, 0.23) Ref: OARSI recommendations for the management of hip and knee osteoarthritis. Part III: changes in evidence following systematic cumulative update of research published through January Zhang, et al., Osteoarthritis and Cartilage, 2010, 18:

18 RESULTS META-ANALYSIS Estimate the potential impact of publication bias Repeated meta-analyses excluding RCTs with a sample size of less than 100. Only if there were 47 unpublished RCTs with n = 100 patients showing an advantage to sham of 0.25 ES would the difference between acupuncture and sham lose significance.

19 CONCLUSION Acupuncture is superior to both no-acupuncture control and sham acupuncture for the treatment of chronic pain. The total effects of acupuncture, include both the specific effects, nonspecific physiologic and psychological (placebo) effects. Acupuncture is effective for the treatment of chronic pain and is therefore a reasonable referral option.

20 Acupuncture as an adjunctive therapy to pharmacological treatment in patients with chronic pain due to osteoarthritis of the knee: A 3- armed, randomized, placebo-controlled trial Mavrommatis CI, et al. Pain Aug;153(8): Study Objective To compare acupuncture combined with pharmacological treatment, sham acupuncture plus pharmacological treatment, and pharmacological treatment alone.

21 Study Design A total of 120 patients with knee osteoarthritis were randomly allocated to 3 groups: Group I: acupuncture and etoricoxib, Group II: sham acupuncture and etoricoxib, Group III: etoricoxib alone. The primary outcome was WOMAC index and its subscales at the end of treatment at week 8. Secondary outcomes included the WOMAC index at the end of weeks 4 and 12, a VAS at the end of weeks 4, 8, and 12, and the SF- 36v2 health survey at the end of week 8.

22 Study flowchart

23 Results Patients who received real acupuncture exhibited statistically significant improvements in primary and secondary outcome measures, except for Short Form mental component, compared with the other treatment groups.

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27 Conclusion Acupuncture with etoricoxib is more effective than sham acupuncture with etoricoxib, or etoricoxib alone for the treatment of knee osteoarthritis.

28 ACUPUNCTURE CLINICAL TRIALS ON NON-PAIN CONDITIONS

29 A Randomized, Placebo-Controlled Trial of Acupuncture in Patients With Chronic Obstructive Pulmonary Disease (COPD) Masao Suzuki, et al, Arch Intern Med. 2012;172(11): Study Objective To determine whether acupuncture is superior to placebo needling in improving dspnea on exertion (DOE) in patients with COPD who are receiving standard medication.

30 111patients with COPD randomly assigned to traditional acupuncture and placebo Needling The primary end point was the modified Borg scale score evaluated immediately after the 6-minute walk test.

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32 Study flowchart

33 Results After 12 weeks, the Borg scale score after the 6- minute walk test was significantly better in the real acupuncture group compared with the placebo acupuncture group. Patients with COPD who received real acupuncture also experienced improvement in the 6-minute walk distance during exercise, indicating better exercise tolerance and reduced DOE.

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37 Conclusion This study clearly demonstrates that acupuncture is a useful adjunctive therapy in reducing DOE in patients with COPD.

38 Acupuncture in Patients With Seasonal Allergic Rhinitis: A Randomized Trial Benno Brinkhaus, et al. Ann Intern Med Feb 19;158(4): doi: / Background and Study Objective Acupuncture is frequently used to treat seasonal allergic rhinitis (SAR) despite limited scientific evidence. To evaluate the effects of acupuncture in patients with SAR.

39 Study Design 3-arms, randomized, controlled multicenter trial. 46 specialized physicians in 6 hospital clinics and 32 private outpatient clinics. 422 persons with SAR and IgE sensitization to birch and grass pollen. Group I: Acupuncture plus rescue medication (n=212), Group II: sham acupuncture plus RM (n=102), Group III: RM alone (n=108). Twelve treatments were provided over 8 weeks. Measurements: Changes in the Rhinitis Quality of Life Questionnaire (RQLQ) overall score and the RM score (RMS) from baseline to weeks 7 and 8 and week 16

40 Results Compared with sham acupuncture and with RM, acupuncture was associated with improvement in RQLQ score (sham vs. acupuncture mean difference, 0.5 point (P<0.001) RM vs. acupuncture mean difference, 0.7 point (P< 0.001) RMS (sham vs. acupuncture mean difference, 1.1 points (P<0.001); RM vs. acupuncture mean difference, 1.5 points (P<0.001) There were no differences after 16 weeks.

41 Conclusion Acupuncture led to statistically significant improvements in disease-specific quality of life and antihistamine use measures after 8 weeks of treatment compared with sham acupuncture and with RM alone, but the improvements may not be clinically significant.

42 BASIC SCIENCE STUDIES - HUMAN STUDIES

43 Brain circuitry for itch reduction by acupuncture Napadow V, et al. Cereb Cortex Dec 4. [Epub ahead of print] Study Objectives Functional magnetic resonance imaging (fmri) and validated temperature-modulation itch model were applied to evaluate the underlying brain circuitry supporting allergen-induced itch reduction in atopic dermatitis patients by acupuncture, antihistamine, and respective placebo treatments.

44 Background Itch is an aversive sensory experience and while systemic therapies, such as acupuncture, have shown promise in alleviating itch in patients suffering from chronic itch, their antipruritic mechanisms are unknown.

45 Study Design skin prick test 1 (allergen) skin prick test 2 (allergen) Temp fmri Scan (control) Itch fmri Scan 1 Structural MRI and / or therapy-specific fmri scans Itch fmri Scan 2 Time Verum Acupuncture (VAC), Placebo Acupuncture (PAC), Verum Solution (VSO), or Placebo Solution (PSO) Atopic dermatitis patients Napadow were subjected et al., to Cerebral an allergen Cortex, itch challenge at baseline 2012 and after acupuncture (or antihistamine or placebos on separate days) Itch sensation was modulated high-low using a temperature-probe to create a block design amenable to fmri data analyses

46 Results Brain response to allergen itch demonstrated phase dependency. During an increasing itch phase, activation was localized in anterior insula and striatum, regions associated with salience/interoception and motivation processing. Once itch reached peak plateau, robust activation was noted in prefrontal cognitive and premotor areas. Acupuncture reduced itch and itch-evoked activation in the insula, putamen, and premotor and prefrontal cortical areas. Neither itch sensation nor itch-evoked brain response was altered following antihistamine or placebo acupuncture.

47 Acupuncture reduced itch and itch-evoked activation in the insula, putamen, and premotor and prefrontal cortical areas.

48 Peripheral Mechanisms of Acupuncture on Inflammatory Persistent Pain

49 Spinal Mechanisms of Acupuncture on Pain

50 SAFETY OF ACUPUNCTURE TREATMENT

51 Acupuncture complications and adverse events from 1965 to Lao, et al, 2004

52 Acupuncture complications and adverse events from 2000 to Xu, et al, 2013

53 The research projects were/are funded by: The National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH) Grant #: P01 AT A1 The National Center for Complementary and Alternative Medicine (NCCAM), National Institutes of Health (NIH) Grant #: R24 AT Some of the slides were provided by Drs. Vitaly Napadow, Richard Harris and Ruixin Zhang. The slides preparation was assisted by Dr. Lizhen Wang