Purpose
Up to 50% of women receiving aromatase inhibitor (AI) complain of AI-associated musculoskeletal symptoms (AIMSS) and 15% discontinue treatment. We conducted a randomized, sham-controlled trial to evaluate whether acupuncture improves AIMSS and to explore potential mechanisms.
Patients and Methods
Postmenopausal women with early stage breast cancer, experiencing AIMSS were randomized to 8 weekly real or sham acupuncture sessions. We evaluated changes in the Health Assessment Questionnaire Disability Index (HAQ-DI) and pain visual analog scale (VAS) following the intervention compared to baseline. Serum estradiol, β-endorphin and proinflammatory cytokine concentrations were measured pre and post-intervention.
Results
We enrolled 51 women, of whom 47 were evaluable, including 23 randomized to real and 24 to sham acupuncture. Baseline characteristics were balanced between groups with the exception of a higher HAQ-DI score in the real acupuncture group (p=0.047). We did not observe a statistically significant difference in reduction of HAQ-DI (p=0.30) or VAS (p=0.31) between the two groups. Following 8 weekly treatments, we observed a statistically significant reduction of IL-17 (p≤0.009) in both groups. No significant modulation was seen in estradiol, β-endorphin, or other proinflammatory cytokine concentrations in either group.
Conclusions
We did not observe a significant difference in AIMSS changes between real and sham acupuncture. As sham acupuncture used in this study may not be equivalent to placebo, further studies with a non-acupuncture arm may be required to establish whether acupuncture is beneficial for the treatment of AIMSS.
Background
Aromatase Inhibitors (AIs) have been associated with decrements in patient-reported outcomes (PROs).
Objectives
To assess if real acupuncture (RA) compared to sham acupuncture (SA) improves PROs in breast cancer patients taking adjuvant AI.
Methods
Postmenopausal women with a stage 0-III breast cancer on AI with treatment-associated musculoskeletal symptoms were randomized to 8 weekly RA vs SA in a dual-center randomized controlled trial. National Surgical Adjuvant Breast and Bowel Project (NSABP) menopausal symptoms questionnaire, Center for Epidemiological Studies Depression (CESD), Hospital Anxiety and Depression Scale (HADS), Pittsburgh Sleep Quality Index (PSQI), Hot Flash Daily Diary, Hot Flash Related Daily Interference Scale (HFRDI) and EuroQol survey were used to assess PROs at baseline, 4, 8, and 12 weeks.
Results
The intention-to-treat analysis included 23 RA and 24 SA patients. There were no significant differences in baseline characteristics between groups. Compared to baseline, scores of RA patients improved significantly at week 8 on CESD (p=0.022), hot flash severity (p=0.006), hot flash frequency (p=0.011), HFRDI (p=0.014) and NSABP menopausal symptoms (p=0.022); scores of SA patients improved significantly on EuroQol (p=0.022), HFRDI (p=0.043) and NSABP menopausal symptoms (p=0.005). Post hoc analysis indicated that African American (AA) patients (n=9) benefited more from RA than SA when compared to non-AA patients (n=38) in reducing hot flash severity (p<0.001) and frequency (p<0.001) scores.
Conclusion
RA and SA were both associated with improvement in PROs in breast cancer patients taking AIs. We detected no significant difference between arms. Racial difference in response to acupuncture warrants further study.
Sixty-six patients with acute scaphoid fractures were treated non-operatively in a below elbow plaster for 8 to 12 weeks and underwent CT scans along the longitudinal axis of the scaphoid at 12 to 18 weeks. These scans showed that 14 fractures had not united and that 30 had united throughout the whole cross-section of the scaphoid. The other 22 had partially united with bridging trabeculae in some areas of the cross-section. These 22 partial unions were graded as 0% to 24% union (0 cases), 25% to 49% union (5 cases), 50% to 74% union (7 cases), and 75% to 99% union (10 cases). The 12 patients who had less than 75% fracture union were followed-up further and nine underwent another CT scan at 23 to 40 weeks after the initial injury. These showed union across the whole of the cross-section of the fracture in seven cases and 75% to 99% union in the other two cases, who had full and painless wrist function. We conclude that partial union of the scaphoid is a common occurrence but, in most cases, it progresses to full union without the need for prolonged plaster immobilization.
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