Jun J Mao1, Sharon X Xie2, John T Farrar3, Carrie T Stricker4, Marjorie A Bowman5, Deborah Bruner6, Angela DeMichele3. 1. 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. 2. Center for Clinical Epidemiology and Biostatistics and Department of Biostatistics and Epidemiology, Perelman School of Medicine at the University of Pennsylvania, PA, United States. 3. 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. 4. Abramson Cancer Center, Perelman School of Medicine at the University of Pennsylvania, PA, United States. 5. Wright State University School of Medicine, United States. 6. Emory University School of Nursing, United States.
Abstract
BACKGROUND:Arthralgia is a common and debilitating side-effect experienced by breast cancer patients receivingaromatase 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. FINDINGS: 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. INTERPRETATIONS: 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.
RCT Entities:
BACKGROUND:Arthralgia is a common and debilitating side-effect experienced by breast cancerpatients 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. FINDINGS: 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. INTERPRETATIONS: Compared to usual care, EA produced clinically important and durable improvement in arthralgia related to AIs in breast cancerpatients, and SA had a similar effect. Both EA and SA were safe.
Authors: Clémentine Lopez; Cécile Charles; Pascal Rouby; Diane Boinon; Sophie Laurent; Annie Rey; Marc Spielmann; Sarah Dauchy Journal: Support Care Cancer Date: 2015-04-17 Impact factor: 3.603
Authors: M Kay Garcia; Jennifer McQuade; Richard Lee; Robin Haddad; Michael Spano; Lorenzo Cohen Journal: Curr Oncol Rep Date: 2014-12 Impact factor: 5.075
Authors: Heather Greenlee; Melissa J DuPont-Reyes; Lynda G Balneaves; Linda E Carlson; Misha R Cohen; Gary Deng; Jillian A Johnson; Matthew Mumber; Dugald Seely; Suzanna M Zick; Lindsay M Boyce; Debu Tripathy Journal: CA Cancer J Clin Date: 2017-04-24 Impact factor: 508.702