Patient‐reported outcomes in women with breast cancer enrolled in a dual‐center, double‐blind, randomized controlled trial assessing the effect of acupuncture in reducing aromatase inhibitor‐induced musculoskeletal symptoms

Abstract

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.

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].…”

Acupuncture Efficacy on Ischemic Stroke Recovery

“…Furthermore, sham acupuncture may not be truly inert and may have underlying physiological effects, and hence may not be a proper control group. 28,29 To enable us to design a large pragmatic trial, we decided not to use sham acupuncture as control in this study. In contrast to previous Chinese trial in stroke, we used binary outcome as primary outcome (dependency or independency according to BI score) because the systematic review suggested that placebos had no significant effects on objective or binary outcomes in clinical trials.…”

Discovery of novel aromatase inhibitors using a homogeneous time-resolved fluorescence assay

“…Non-steroidal AIs include anastrozole, vorozole, and letrozole [12,13] . Previous studies have demonstrated that AIs provide an increased survival benefit compared with other therapies and have acceptable toxicity profiles with decreased virginal bleeding and thromboembolism and increased rash, diarrhea and vomiting [14,15] . As AIs sometimes have more severe bone, brain and heart side effects, research for alternative compounds is necessary [15][16][17] .…”

“…Previous studies have demonstrated that AIs provide an increased survival benefit compared with other therapies and have acceptable toxicity profiles with decreased virginal bleeding and thromboembolism and increased rash, diarrhea and vomiting [14,15] . As AIs sometimes have more severe bone, brain and heart side effects, research for alternative compounds is necessary [15][16][17] .Natural products, extracted from traditional medicines and foods, may be helpful for discovering novel AIs that may selectively target aromatase in the breast and reduce systemic toxicity [18] . Among these compounds, flavonoids [19] are the most commonly investigated agents due to their prominent aromatase inhibitory activity and high breast selectivity [18] .…”