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.
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.
Keywords
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Article info
Publication history
Published online: October 28, 2013
Footnotes
Clinical Trial Registration: NCT01013337.
Identification
Copyright
© 2013 Elsevier Ltd. Published by Elsevier Inc. All rights reserved.