Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer.

To investigate the effect of electro-acupuncture (EA) as a non-pharmacological intervention to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients undergoing chemotherapy of taxane. Women with stage I-III breast cancer scheduled to receive taxane therapy were randomized to receive a standardized protocol of 12 true or sham EA (SEA) weekly treatments concurrent with taxane treatment. Subjects completed the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Taxane neurotoxicity subscale (FACT-NTX), and other assessments at baseline and weeks 6, 12, and 16. A total of 180 subjects were screened, 63 enrolled and 48 completed week 16 assessments. Mean age was 50 with 25 % white, 25 % black, and 43 % Hispanic; 52 % had no prior chemotherapy. At week 12, both groups reported an increase in mean BPI-SF worst pain score, but no mean differences were found between groups (SEA 2.8 vs. EA 2.6, P = .86). By week 16, the SEA group returned to baseline, while the EA group continued to worsen (SEA 1.7 vs. EA 3.4, P = .03). The increase in BPI-SF worst pain score was 1.62 points higher in the EA group than in the SEA group at week 16 (P = .04). In a randomized, sham-controlled trial of EA for prevention of taxane-induced CIPN, there were no differences in pain or neuropathy between groups at week 12. Of concern, subjects on EA had a slower recovery than SEA subjects. Future studies should focus on EA for treatment as opposed to prevention of CIPN.

Methods to Standardize a Multicenter Acupuncture Trial Protocol to Reduce Aromatase Inhibitor-related Joint Symptoms in Breast Cancer Patients.

Robust methods are needed to efficiently conduct large, multisite, randomized, controlled clinical trials of acupuncture protocols. The Southwest Oncology Group (SWOG) S1200 trial is a randomized, controlled (i.e., sham-controlled and waitlist-controlled) trial of a standardized acupuncture protocol for treating aromatase inhibitor (AI)-associated arthralgias in early-stage breast cancer patients (n = 228). The primary objective of this study was to determine whether true acupuncture administered twice weekly for 6 weeks, as compared to sham acupuncture or a waitlist control, reduced AI-associated joint pain at 6 weeks as assessed by patient reports. The study was conducted at 11 institutions across the United States. The true acupuncture protocol was developed using a consensus-based process. The true acupuncture and the sham acupuncture protocols each consisted of 12 sessions administered for 6 weeks, followed by one weekly session for 6 weeks. The true acupuncture protocol used standardized protocol points, and the standardized acupoints were tailored to a patient's joint symptoms. The similarly standardized sham acupuncture protocol utilized superficial needling of nonacupoints. Standardized methods were developed to train and monitor acupuncturists and included online and in-person training, study manuals, monthly phone calls, and remote quality assurance monitoring throughout the study period. The research staff similarly received online and in-person training and monthly phone calls.

The ADDOPT study (Acupuncture to Decrease Disparities in Outcomes of Pain Treatment): feasibility of offering acupuncture in the community health center setting.

OBJECTIVES: This article describes the feasibility and acceptability of the Acupuncture to Decrease Disparities in Outcomes of Pain Treatment (ADDOPT) trial, which incorporates acupuncture as an adjunct to usual treatment for chronic pain in urban health centers. DESIGN: The study assessed feasibility (ability to carry out in real-world practice; adequacy of resources; acceptability to patients, acupuncturists, and primary care clinicians). SETTING: Four (4) community health centers in the Bronx, NY, participating in the New York City Research and Improvement Networking Group (NYC RING), a practice-based research network dedicated to decreasing health disparities through primary care research and quality improvement in the urban safety net setting, were involved. SUBJECTS: The subjects comprised participants receiving care for chronic pain due to osteoarthritis, or neck or back pain at four Bronx health centers serving low-income families. INTERVENTION: The intervention involved up to 14 weekly acupuncture treatments. OUTCOME MEASURES: Pain and functional status are assessed during a 6-week run-in period before, during, and postacupuncture treatment using the Brief Pain Inventory and the 12-Item Short Form Health Survey. This article reports on baseline status, referral and recruitment, engagement with treatment, and delivery of the intervention across sites. RESULTS: Of 400 patients referred, 185 have initiated treatment. The majority of attending physicians have referred, most commonly for back pain (n=103; 60.6%). Participants' average age is 53.9 (standard deviation [SD] 14.1); 54.1% are Hispanic; and 57.6% are on Medicaid. Half (48%) report "poor" or "fair" overall health. Patients report an average disability score of 74 (SD 27.0) and baseline pain severity on the Brief Pain Inventory of 6 (SD 1.9). Patients have completed a mean of 8.0 (SD 4.7) treatments; 72.4% complete >5 sessions. CONCLUSIONS: Clinicians in this urban setting have incorporated acupuncture into chronic pain management. Despite disability and lack of familiarity, patients initiate acupuncture and show high levels of engagement with treatment.

Acupuncture and heart rate variability: a systems level approach to understanding mechanism.

Recent research has elucidated several different mechanisms for acupuncture. However, the interrelationship between these mechanisms and how acupuncture affects complex physiological systems is still not understood. Heart rate Variability (HRV), the beat-to-beat fluctuations in the rhythm of the heart, results from the regulation of the heart by the autonomic nervous system (ANS). Low HRV is associated with increased risk of all-cause mortality and is a marker for a wide range of diseases. Coherent HRV patterns are associated with increased synchronization between the two branches of the ANS, and when sustained for long periods of time result in increased synchronization and entrainment between multiple body systems. There is strong evidence from randomized placebo controlled trials that acupuncture modulates HRV. This may represent a mechanistic pathway for global physiological regulation, which is congruent with East Asian medical theory. The ability of acupuncture to improve HRV could be used as a tool in acupuncture research and practice to monitor treatment effectiveness and the impact on quality of life.