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 randomized 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 ten EA/SA treatments over eight weeks using a manualized 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 endpoint 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 vs. −0.2, p=0.0004) and at Week 12 (−2.4 vs. −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 vs. 0.2, p=0.0006) and Week 12 (−2.1 vs. −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.

Acupuncture for Chemoradiation Therapy-Related Dysphagia in Head and Neck Cancer: A Pilot Randomized Sham-Controlled Trial

“…Finally, it is possible that the current study may have employed an inadequate dose of acupuncture which could also have led to an underestimate of the true benefit from active acupuncture. Compared with other cancer studies, treatment provided once every 2 weeks represents a very low frequency, and other studies have reported that more acupuncture sessions are associated with better outcomes [4,5,31]. Given the severity of concurrent CRT toxicity, a higher frequency of acupuncture sessions, for example, three times per week, should be considered in a future trial.…”

“…Acupuncture is a traditional Chinese medical technique that has been found to reduce symptoms and side effects associated with primary cancer therapy [3][4][5]. More recently, research has begun to evaluate the efficacy and underlying mechanisms through which acupuncture may reduce dysphagia, including in HNC patients [6,7].…”

Expectancy in Real and Sham Electroacupuncture: Does Believing Make It So?

“…In addition, the majority of acupuncture studies evaluating response expectancy to date have measured expectancy only once at Baseline, when expectancy can change over time (10). Thus, this study aims to evaluate the association between response expectancy as measured by the Acupuncture Expectancy Scale (AES) (11,12), and treatment response to real and sham electroacupuncture (EA) for the treatment of aromatase inhibitor (AI)-associated arthralgia among women with breast cancer (13). The specific research questions of the study were: 1) Does Baseline expectancy predict pain reduction in the EA or SA groups?…”

“…The details of the original trial have been published elsewhere (13). In brief, women with breast cancer who were experiencing arthralgia attributed to aromatase inhibitor therapy were randomized to an EA, SA, or a wait list control (WLC) usual care group.…”

“…The sample size for the study was set by the parent trial with the primary intention to determine the effect of EA as compared with WLC (13). We evaluated the AES score descriptively over time in the WLC group as well as in the EA/SA groups stratified by responder status.…”