Electro-acupuncture reduces arthralgia in cancer patients taking aromatase inhibitors

Study Type: Therapy
OE Level of Evidence: 1
Journal Level of Evidence: N/A
Synopsis
67 women with non-metastatic breast cancer (Stage I-III) experiencing joint pain attributed to the use of aromatase inhibitor (AI) were included in this study. Subjects were randomized to an intervention group, or a wait list control (WLC) group. Those randomized to Please login to view the rest of this report. Please login to view the rest of this report.
Funding: Non-Industry funded
Sponsor: National Institutes of Health/National Center for Complementary and Alternative Medicine
Conflicts: Consultant
CONTENT IS LOCKED
Why was this study needed now?
Arthralgia - or joint pain - is a common side-effect of aromatase inhibitors (AIs), which are normally prescribed for postmenopausal women with hormone receptor positive breast cancer. This side effect decreases patient adherence to the drug, and subsequently decreases their chances of overall breast cancer survival. Acupuncture, a practice in Traditional Chinese Medicine, has been studied as a means of pain reduction in these patients. This Phase II clinical trial examined the effect of electro-acupuncture (EA) on arthralgia and physical function in these women, compared to standard treatment (waitlist control group).
What was the principal research question?
Does electro-acupuncture compared to standard treatment reduce the incidence of aromatase inhibitor associated arthralgia, and improve function in postmenopausal women with breast cancer? Secondarily, how does electro-acupuncture compare to a sham acupuncture intervention for pain severity?
Population: 67 women with non-metastatic breast cancer (Stages I-III), currently taking an aromatase inhibitor (AI) (Anastrozole, Letrozole or Exemestane), and experiencing joint pain (attributed to the AI medication they were taking) for at least three months. Additionally, patients reported a worst pain rating of at least 4 on an 11-point numerical rating scale in the previous week, and reported at least 15 days of pain within the previous 30 days. The mean age was 59.7 years.
Intervention: Electro-acupuncture (EA) group: Patients in this group (n=22; 19 completed follow-up) underwent electro-acupuncture twice a week for 2 weeks, and weekly thereafter, until a total of 10 treatment sessions was reached. Needles (30 mm or 40 mm and 0.25 mm gauge, Seirin-America Inc., Weymouth, MA) were inserted in at least four separate locations around the most painful joint, until patients reported "De Qi" (sensation of soreness or tingling). These needles were stimulated with a 2-Hz electrical stimulation via a TENS unit. The acupuncture needles remained in place for 30 minutes, with manipulation at the beginning and end of the session. Additionally, a minimum of 4 distant points were used to treat pain-related symptoms, such as depression, anxiety and fatigue. (Mean age: 57.5 +/- 10.1 years)
Comparison: Sham acupuncture (SA) group: Patients in this group (n=22; 19 completed follow-up) underwent sham acupuncture at the same frequency and duration as the real acupuncture. The needles in this group, however, were Streitberger needles which retracted into the handle before puncturing the skin. With the needle's change in appearance, patients were led to believe that the needles were actually inserted into the skin. The acupuncturist selected 8-12 non-acupuncture, non-trigger points at least 5 cm from the most painful joint, no electrical stimulation was provided (the current was dialed down), and the needles were manipulated to avoid eliciting sensations other than skin contact. (Mean age: 60.9 +/- 6.5 years) Waitlist control group (WLC): Patients in this group (n=23; 21 completed follow-up) remained on a wait list and did not receive an intervention. (Mean age: 60.6 +/- 8.2 years).
Outcomes: The primary outcome was pain severity (assessed on the Brief Pain Inventory [BPI]) between the EA and WLC groups. Secondary outcomes included Global Impression of Change, the Western Ontario and McMasters Universities Osteoarthritis (WOMAC) Index, the Quick Disability of Arm, Shoulder, Hand (DASH) and the Physical Performance Test (PPT).
Methods: RCT; Single-Center; Double-blinded (patients & assessors)
Time: Outcomes were primarily assessed at 8 weeks, with a follow-up at 12 weeks (i.e. 4 weeks post-intervention).
What were the important findings?
What should I remember most?
How will this affect the care of my patients?
The authors responsible for this critical appraisal and ACE Report indicate no potential conflicts of interest relating to the content in the original publication.