Acupuncture for chemotherapy-associated insomnia in breast cancer patients: an assessor-participant blinded, randomized, sham-controlled trial

Abstract

Background Insomnia is a highly prevalent symptom occurred during and post-chemotherapy. Acupuncture may have beneficial effects in the management of chemotherapy-associated insomnia. This study was conducted to determine the efficacy and safety of acupuncture in improving chemotherapy-associated insomnia in breast cancer patients. Methods This assessor-participant blinded, randomized, sham-controlled trial was conducted from November 2019 to January 2022 (follow-up completed July 2022). Participants were referred by oncologists from two Hong Kong hospitals. Assessments and interventions were conducted at the outpatient clinic of School of Chinese Medicine, the University of Hong Kong. The 138 breast cancer patients with chemotherapy-associated insomnia were randomly assigned to receive either 15 sessions of active acupuncture regimen by combining needling into body acupoints and acupressure on auricular acupoints or sham acupuncture control (69 each) for 18 weeks, followed by 24 weeks of follow-up. The primary outcome was measured using Insomnia Severity Index (ISI). Secondary outcomes included the Pittsburgh Sleep Quality Index, Actiwatch and sleep diary for sleep parameters, depression and anxiety, fatigue and pain, and quality of life. Results There were 87.7% (121/138) participants who completed the primary endpoint (week-6). The active acupuncture regimen was not superior to the sham control in reducing ISI score from baseline to 6 weeks (mean difference: − 0.4, 95% CI − 1.8–1.1; P = 0.609), but produced short-term treatment and long-term follow-up better outcomes in improving sleep onset latency, total sleep time, sleep efficiency, anxiety, depression, and quality of life. Participants of the active acupuncture group had a pronouncedly higher cessation rate of sleeping medications than the sham control (56.5% vs. 14.3%, P = 0.011). All treatment-related adverse events were mild. No participants discontinued treatments due to adverse events. Conclusion The active acupuncture regimen could be considered as an effective option for the management of chemotherapy-associated insomnia. It also could serve as a tapering approach to reduce and even replace the use of sleeping medications in breast cancer patients. Trial registrationClinicaltrials.gov: NCT04144309. Registered 30 October 2019.

Efficacy of acupuncture treatment for breast cancer-related insomnia: study protocol for a multicenter randomized controlled trial

“…Finally, another limitation of this study is that the point selections are all fixed. In some previous clinical studies ( 30 , 61 ), the acupuncture group was selected on an individualized basis using semi-individualized, reflecting the strict adherence to TCM norms of evidence-based treatment for the specific symptoms of the participants. However, these shortcomings will be further improved in future clinical trials.…”

“…It has been shown that acupuncture can increase sleep quality while addressing symptoms of mental and emotional distress ( 28 ). Additionally, acupuncture is now being used to improve patients’ sleep problems in cancer centers ( 29 , 30 ). Although there have been a few clinical reports about acupuncture for cancer-caused insomnia ( 31 – 33 ), these studies fail to classify different types of cancer, and have small sample sizes, or the subjects come from a single center.…”

Neurological mechanism and efficacy of acupuncture for breast cancer-related insomnia: a study protocol for randomized clinical trial

“…The seven-item questionnaire uses a 0-4 scale, yielding a total score range of 0-28. Scores correspond to absence (0-7), mild (8)(9)(10)(11)(12)(13)(14), moderate (15)(16)(17)(18)(19)(20)(21), or severe (22-28) insomnia. The ISI is a concise, reliable tool commonly employed in general practice, sensitive to treatment response (14).…”

“…Notably, the comparisons with positive drugs should be interpreted with caution as these agents are not specifically targeted for sleep-related conditions. Moreover, studies have revealed that acupuncture treatment can improve sleep onset latency, total sleep time, and sleep efficiency; however, compared to sham control, acupuncture does not exhibit a significant difference in reducing ISI ( 21 ). Therefore, the confirmation of acupuncture’s superiority over sham control remains unresolved.…”

Acupuncture versus sham acupuncture and usual care for Antiandrogen-Induced hot fLashes in prostate cancer (AVAIL): study protocol for a randomized clinical trial

“…Adverse events are defined as any new untoward medical event (symptoms, side-effect, or reaction) in a patient after interventions. This study will not be monitored by an independent data and safety monitoring committee because acupuncture or sham acupuncture is considered a minimal-risk study in numerous clinical trials and that they were not associated with any serious AEs, low frequency of low-grade AEs potentially related to acupuncture was observed during our previous studies [ 25 , 26 ]. Any AE-related data will be collected by questioning the patient after each treatment or self-reported by participants within 24 h. AEs will be reported electronically within 5 calendar days.…”