title: A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use.
abstract: BACKGROUND
  Arthralgia is a common and debilitating side-effect experienced by breast cancer patients receiving aromatase inhibitors (AIs) and often results in premature drug discontinuation.
  
  
  METHODS
  We conducted a randomised controlled trial of electro-acupuncture (EA) as compared to waitlist control (WLC) and sham acupuncture (SA) in postmenopausal women with breast cancer who self-reported arthralgia attributable to AIs. Acupuncturists performed 10 EA/SA treatments over 8 weeks using a manualised protocol with 2 Hz electro-stimulation delivered by a TENS unit. Acupuncturists administered SA using Streitberger (non-penetrating) needles at non-traditional acupuncture points without electro-stimulation. The primary end-point was pain severity by Brief Pain Inventory (BPI) between EA and WLC at Week 8; durability of response at Week 12 and comparison of EA to SA were secondary aims.
  
  
  RESULTS
  Of the 67 randomly assigned patients, mean reduction in pain severity was greater in the EA group than in the WLC group at Week 8 (-2.2 versus -0.2, p=0.0004) and at Week 12 (-2.4 versus -0.2, p<0.0001). Pain-related interference measured by BPI also improved in the EA group compared to the WLC group at both Week 8 (-2.0 versus 0.2, p=0.0006) and Week 12 (-2.1 versus -0.1, p=0.0034). SA produced a magnitude of change in pain severity and pain-related interference at Week 8 (-2.3, -1.5 respectively) and Week 12 (-1.7, -1.3 respectively) similar to that of EA. Participants in both EA and SA groups reported few minor adverse events.
  
  
  CONCLUSIONS
  Compared to usual care, EA produced clinically important and durable improvement in arthralgia related to AIs in breast cancer patients, and SA had a similar effect. Both EA and SA were safe.
authors.affiliation: Department of Family Medicine and Community Health, Perelman School of Medicine at the University of Pennsylvania, PA, United States; Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, PA, United States; Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, PA, United States. Electronic address: jun.mao@uphs.upenn.edu.
authors.forename: Jun J
authors.initials: JJ
authors.lastname: Mao
authors.affiliation: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, PA, United States.
authors.forename: Sharon X
authors.initials: SX
authors.lastname: Xie
authors.affiliation: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, PA, United States; Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, PA, United States.
authors.forename: John T
authors.initials: JT
authors.lastname: Farrar
authors.affiliation: Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, PA, United States.
authors.forename: Carrie T
authors.initials: CT
authors.lastname: Stricker
authors.affiliation: Wright State University School of Medicine, United States.
authors.forename: Marjorie A
authors.initials: MA
authors.lastname: Bowman
authors.affiliation: Emory University School of Nursing, United States.
authors.forename: Deborah
authors.initials: D
authors.lastname: Bruner
authors.affiliation: Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, PA, United States; Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, PA, United States.
authors.forename: Angela
authors.initials: A
authors.lastname: DeMichele
mesh_terms: D015669:Acupuncture Points; D000328:Adult; D000368:Aged; D047072:Aromatase Inhibitors / Q000009:adverse effects*; D018771:Arthralgia / Q000139:chemically induced / Q000628:therapy*; D001943:Breast Neoplasms / Q000188:drug therapy*; D004311:Double-Blind Method; D015671:Electroacupuncture / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D010147:Pain Measurement / Q000379:methods; D013997:Time Factors; D016896:Treatment Outcome; D014850:Waiting Lists
chemical_list: D047072:Aromatase Inhibitors
keywords: Acupuncture; Adverse effects; Aromatase inhibitors; Breast neoplasm; Clinical trial; Joint pain; Musculoskeletal