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A randomised trial of electro-acupuncture for arthralgia related to aromatase inhibitor use |
Mao JJ, Xie SX, Farrar JT, Stricker CT, Bowman MA, Bruner D, de Michele A |
European Journal of Cancer 2014 Jan;50(2):267-276 |
clinical trial |
9/10 [Eligibility criteria: No; Random allocation: Yes; Concealed allocation: Yes; Baseline comparability: Yes; Blind subjects: Yes; Blind therapists: No; Blind assessors: Yes; Adequate follow-up: Yes; Intention-to-treat analysis: Yes; Between-group comparisons: Yes; Point estimates and variability: Yes. Note: Eligibility criteria item does not contribute to total score] *This score has been confirmed* |
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. 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.
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