“Heaven and Space” Medicine “Heaven and Space” Medicine Why is research important? • ADS competency #6: Able to demonstrate familiarity with research and outcome results of NADA programs • Currency of Western thought and allopathic medicine. • Necessary for outreach/advocacy, funding and crediblity. Challenges to the “gold standard” the RCT for NADA research. • Can’t do double blind • SHAM is ACTIVE • The NADA protocol is not the five points, it is a clientcentered style of treatment integrated with the right mix of bio/psycho/social services with a reasonable amount of frequency/intensity/duration/dosage. • NADA • standard needle combination but • varies widely in application. The Journal of Substance Abuse and Rehabilitation (JSAR) • Approached Libby Stuyt wanting an article: Auricular acupuncture to support patients with substance abuse disorders: current perspectives • ADDED: “The National Acupuncture Detoxification Association protocol” and “behavioral health” • Added History of NADA and a History of NADA research https://www.ncbi.nlm.nih.gov/pubmed/2799 4492 Stuyt & Voyles Review article • NOT a systematic review: • Keywords searched: NADA, National Acupuncture Detoxification Association, acudetox • No restrictions on populations or type of trial • Full text English • Published in peer-reviewed journal • 2011 – 2016 • Only NADA protocol using up to five points without e-stim Review of Reviews • Overall the research is “INCONCLUSIVE” • Design flaws White, A. (2013). Trials of acupuncture for drug dependence: a recommendation for hypotheses based on the literature. Acupunct Med , 0, 1-8. Systematic review: 48 studies (include body points, other protocols) Some benefit but inconsistent. Points to variables in protocol/measures/controls Continued use by providers despite “unsupportive evidence” means “mismatch”. Recommendations: Use inactive controls 75% + with non-acu controls vs 34% with sham needling (active) Look at wider range of outcomes Most trials looked at abstinence, attrition, craving and withdrawal Further study using full body acupuncture, electric stimulation, and bilateral needling. White, A. (2013) Review cont. NADA protocol highly valued by clients and programs/systems. Economical and easy to use in large numbers. “Some evidence to support it” 80 % studies with non-needle controls were positive. 33% with Sham, possibly active controls Cowan review 2011: Cowan D. (2011) Methodological issues in evaluating auricular acupuncture therapy for problems arising from the use of drugs and alcohol. Acupunct Med., 29(3):227–229. • Extensive use despite insufficient research evidence • Sham not neutral use existing treatment control group. • Recommend “conditions that reflect actual practice….concentration on clinical significance”. Cost Effectiveness HMO Pilot Santasiero, R. P. Neussle, G. (2007). Cost-effectiveness of auricular acupuncture for treating substance abuse In an HMO setting: A pilot study. Medical Acupuncture. 16 (3). • Cost effectiveness study. Compared standard care with acudetoxadded care. N = 44 • At 6-mo, acu group vs control • Higher program completion 74 vs 44% • More negative urines 96 vs 85% • Few inpatient days, fewer psychiatric days, fewer outpt detox. • Costs: $15,580 +acudetox, $17,890 standard nb, authors note that start up costs for acudetox included in initial numbers…PROJECTED costs comparisons more significant. Carter KO, Olshan-Perlmutter M, Norton HJ, Smith MO. (2011) NADA acupuncture prospective trial in patients with substance use disorders and seven common health symptoms. Med Acupunct., 23(3):131–135. • Prospective trial 167 non-randomized pts, 28-day residential • Usual Care + Control (group study hall) vs UC + NADA (group, 2x/wk, 2wk, 30-45 min) • Significant symptom severity reduction w/5NP added: • Cravings • Depression • Anxiety • Anger • Body/Headaches • Poor concentration • Decreased energy Black S, Carey E, Webber A, Neish N, Gilbert R. (2011) Determining the efficacy of auricular acupuncture for reducing anxiety in patients withdrawing from psychoactive drugs. J Subst Abuse Treat, 41(3):279–287. • RCT. UC + NADA (n=45), sham-5 helix (n=54), relaxation (n=41). ALL subjects treated together. 3 tx total, 2 weeks. • Outcomes: withdrawal anxiety, HR, BP sign decrease in all. No differences bw groups. • Problems: • ALL subjects treated together. • Minimal treatment: max 3 tx total in 2 weeks (only 1/3), many only got 1-2 tx. • No usual care control. Janssen PA, Demorest LC, Kelly A, Thiessen P, Abrahams R. (2012) Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol. Subst Abuse Treat Prev Policy, 7:48. • RCT. Pregnant. Usual care (n=39) vs NADA added (n=50) • Outcomes: With NADA, larger reductions in methadone pre-delivery, babies 2 less days of morphine, shorter NAS. • Problems: only 28% protocol compliance with NADA. Chang and Sommers, Chang BH, Sommers E. (2014) Acupuncture and relaxation response for craving and anxiety reduction among military veterans in . recovery from substance use disorder. Am J Addict., 23:129–136 • RCT. Homeless veterans rehab x 10 wks. (n=67) • UC , UC + NADA 2x/wk, UC + Relaxation Response RR (1x/wk + daily self practice) • Both NADA and RR, sign decreased cravings and anxiety levels, with continual improvement with more sessions. Equally effective. Stuyt EB. (2014). Ear acupuncture for co-occurring substance abuse and borderline personality disorder: an aid to encourage treatment retention and tobacco cessation. Acupunct Med., 32:318–324. • Outcome study-90 day tobacco-free, dual dx inpatient. NADA voluntary 4x/wk • Use of NADA positively correlated w/successful program completion AND tobacco cessation. • Most significant with BPD-- hypothesis, NADA helped with “distress tolerance” Bergdahl L, Berman AH, Haglund K. (2014) Patients’ experience of auricular acupuncture during protracted withdrawal. J Psych Men Health Nurs., . 21:163–169 • Qualitative study: 15 patients reporting NADA experiences. • No major AE. Some minor AE: pain w/insertion, time-consuming. • Many PE: • Reduced w/d sx and cravings • Improved sleep • Peacefulness • Increased well-being • Increased energy • Decreased physical discomfort • Decreased irritability Reilly PM, Buchanan TM, Vafides C, Breakey S, Dykes P. (2014) Auricular acupuncture to relieve health care workers’ stress and anxiety. Dimens Crit Care Nurs., . 33(3):151–159 • Mixed methods. Vol/non-randomized. NADA 1x/wk x 16 wks. • Pop: Healthcare workers on surgical burn/trauma units • Methods: pre/post surveys anxiety, burnout & compassion fatigue. Significant reduction compared to baseline. Kuo et al, 2016 Kuo SY, Tsai SH, Chen SL, Tzeng YL. Auricular acupressure relieves anxiety and fatigue, and reduces cortisol levels in post-cesarean section women: a single-blind, randomized controlled study. Int J Nurs Stud. 2016;53:17–26. • RCT Post-cesarean section in hospital care x 5 days • UC (n=37) vs UC + Shen Men seeds pressure 2x/day (n=39) • Acupressure sign diff in validated tool self ratings of anxiety and fatigue; decreased HR, and mean serum cortisol levels. DeLorent et al, 2016 De Lorent L, Agorastos A, Yassouridis A, Kellner M, Muhtz C. Auricular acupuncture versus progressive muscle relaxation in patients with anxiety disorders or major depressive disorder: a prospective parallel group clinical trial. J Acupunct Meridian Stud. 2016;9:191–199. • Prospective, parallel group clinical trail. • Pop: Anxiety or Major Depressive Disorders (n=162), in multimodality tx • NADA or Progressive Muscle Relaxation (PMR) groups 2x/wk x 4 wks • Pre/post tx VAS tension, anxiety, anger/aggression, mood. • Both sign improvement on all. No bw group diffs. • No UC control. Ahlberg R, Skarberg K, Brus O, Kjellin L. (2016) Auricular acupuncture for substance use: a randomized controlled trial of effects on anxiety, sleep, drug use and use of addiction treatment services. Subst Abuse Treat Prev Policy, 11:24 • RCT. Swedish substance abuse treatment, n= 280. • UC 3 mos + NADA 15tx, “LP” (same points???) 10tx, music/relaxation. • Self-report anxiety, sleep and substance abuse. • No differences. • Design flaws: no UC control. Uneven distribution (120 to relax, 80 ea to acu), significant dropout/did not meet own power calculations, did not look at retention rates bw groups, individual treatments. Bergdahl L, Broman JE, Berman AH, Haglund K, von Knorring L, Markstrom A. (2016) Auricular acupuncture and cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Disord.,2016:7057282 • RCT • NADA vs Cognitive Behavioral Therapy (CBT) for Insomnia (chronic, not responsive to Rx). • NADA (n=32) 2x/wk, 45 min x 4 wks (practitioner left room) • CBT-I (n=35) 90 min 2x/wk x 6 wks • Self reported Insomnia Severity Index post tx and 6 mo fu • Both sign reduction in score. CBT-I better at sx reduction & belief chg Kailasam VK, Anand P, Melyan Z. (2016) Establishing an animal model for National Acupuncture Detoxification Association (NADA) auricular acupuncture protocol. Neurosci Lett., 624:29–33. • Animal Study. Morphine-dependent rats. • NADA vs 5 sham helix. Interdermal 25-30 min x 6 days. • Decreased behavior associated with craving, decreased morphine tolerence, faster analgesia. • Authors conclusions: • Confirms rat model • Validates NADA for craving reduction • NADA could be helpful with human opioid chronic pain management. Recommendations: • Study the real NADA protocol, (3-5pt, integrated with appropriate care, sufficient frequency/duration), compared with “usual care,” not sham control. • Replicate other acupuncture studies using NADA. • Create large passive collection system with common set of questions over large NADA applications. : •“Although is does not have the compelling force of large replicated RCTs, the preponderance of small varied trials collectively paints a picture supporting acudetox as an evidence-based practice” References • Ahlberg R, Skarberg K, Brus O, Kjellin L. (2016) Auricular acupuncture for substance use: a randomized controlled trial of effects on anxiety, sleep, drug use and use of addiction treatment services. Subst Abuse Treat Prev Policy, 11:24. • Avants, S.K., Margolin, A., Holford, T.R., Kosten, T.R. (2000). A randomized controlled trial of auricular acupuncture for cocaine dependence. Archives of Internal Medicine, 160(5), 2305-2312. • Bier, I.D., Wilson, J., Studt, P., Shakleton, M. (2002). Auricular acupuncture, education and smoking cessation: A randomized, sham controlled trial. American Journal of Public Health. (92), 1642 – 1647. • Bergdahl L, Berman AH, Haglund K. (2014) Patients’ experience of auricular acupuncture during protracted withdrawal. J Psych Men Health Nurs., 21:163–169. • Bergdahl L, Broman JE, Berman AH, Haglund K, von Knorring L, Markstrom A. (2016) Auricular acupuncture and cognitive behavioral therapy for insomnia: a randomized controlled trial. Sleep Disord.,2016:7057282. • Black S, Carey E, Webber A, Neish N, Gilbert R. (2011) Determining the efficacy of auricular acupuncture for reducing anxiety in patients withdrawing from psychoactive drugs. J Subst Abuse Treat, 41(3):279–287. • Bullock, M.L., Culliton, P.C., Olander, R.T. (1989). Controlled trial of acupuncture for severe recidivistic alcoholism. The Lancet. 1(8652), • Carter KO, Olshan-Perlmutter M, Norton HJ, Smith MO. (2011) NADA acupuncture prospective trial in patients with substance use disorders and seven common health symptoms. Med Acupunct., 23(3):131–135. • Chang BH, Sommers E. (2014) Acupuncture and relaxation response for craving and anxiety reduction among military veterans in recovery from substance use disorder. Am J Addict., 23:129–136. • Cowan D. (2011) Methodological issues in evaluating auricular acupuncture therapy for problems arising from the use of drugs and alcohol. Acupunct Med., 29(3):227–229. • De Lorent L, Agorastos A, Yassouridis A, Kellner M, Muhtz C. (2016) Auricular acupuncture versus progressive muscle relaxation in patients with anxiety disorders or major depressive disorder: a prospective parallel group clinical trial. J Acupunct Meridian Stud., 9:191–199. • Janssen PA, Demorest LC, Kelly A, Thiessen P, Abrahams R. (2012) Auricular acupuncture for chemically dependent pregnant women: a randomized controlled trial of the NADA protocol. Subst Abuse Treat Prev Policy, 7:48. • Kailasam VK, Anand P, Melyan Z. (2016) Establishing an animal model for National Acupuncture Detoxification Association (NADA) auricular acupuncture protocol. Neurosci Lett., 624:29–33. • Kuo SY, Tsai SH, Chen SL, Tzeng YL. (2016) Auricular acupressure relieves anxiety and fatigue, and reduces cortisol levels in post-cesarean section women: a single-blind, randomized controlled study. Int J Nurs Stud.,53:17–26. • Margolin, A, Kleber, HD, Avants, SK, et al. Acupuncture for the treatment of cocaine addiction: a randomized trail. (2002), JAMA. 287:55-6 • Reilly PM, Buchanan TM, Vafides C, Breakey S, Dykes P. (2014) Auricular acupuncture to relieve health care workers’ stress and anxiety. Dimens Crit Care Nurs., 33(3):151–159. • Santasiero, R. P. Neussle, G. (2007). Cost-effectiveness of auricular acupuncture for treating substance abuse In an HMO setting: A pilot study. Medical Acupuncture. 16 (3). • Shwartz, M., Saitz, R., Mulvey, K., Brannigan, P. (1999). The value of acupuncture detoxification programs in a substance abuse treatment system. Journal of Substance Abuse Treatment. 17(4), 305-312. • Stuyt, E.B., Meeker, J.L. (2006). Benefits of auricular acupuncture in tobacco-free inpatient dual-diagnosis treatment. Journal of Dual Diagnosis, 2(4), 41-52. • Stuyt EB. (2014). Ear acupuncture for co-occurring substance abuse and borderline personality disorder: an aid to encourage treatment retention and tobacco cessation. Acupunct Med., 32:318–324. • Wen HL, Cheng SYC (1973). Treatment of drug addiction by acupuncture and electrical stimulation. Asian Journal of Medicine, 9, 138-141. • White, A. (2013). Trials of acupuncture for drug dependence: a recommendation for hypotheses based on the literature. Acupunct Med , 0, 1-8. 1435-1439.
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