Dataset Information

Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

ABSTRACT:

Introduction

Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patients with cancer with insomnia using a subjective method, patient-reported questionnaires and an objective tool, actigraphy, to measure the quality of sleep.

Methods and analysis

This is a study protocol for a randomised, three-arm, multicentre, pilot clinical trial. A total of 45 patients with cancer who have continuous insomnia related to cancer treatment or cancer itself will be randomly allocated to an EA group, sham EA group or usual care group in equal proportions. The EA group will receive 10 sessions of EA treatment over 4 weeks. The sham EA group will receive sham EA at non-acupoints using non-penetrating Streitberger acupuncture needles with mock EA. The usual care group will not receive EA treatment. All participants will be provided a brochure on the management of sleep disorders regardless of their group assignment. The primary outcome measure is the mean change in the insomnia severity index from the baseline to week 5. Information related to sleep quality will also be obtained through the Pittsburgh Sleep Quality Index, a sleep diary and actigraphy. Participants will complete the trial by visiting the research centre at week 9 for follow-up assessment.

Ethics and dissemination

This study protocol was approved by the institutional review boards of each research centre. Written informed consent will be obtained from all participants. The result of this study will be published in peer-reviewed journals or presented at academic conferences.

Trial registration number

KCT0002162; Pre-results.

SUBMITTER: Kim M

PROVIDER: S-EPMC5629657 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

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Publications

Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

Kim Mikyung M Kim Jung-Eun JE Lee Hye-Yoon HY Kim Ae-Ran AR Park Hyo-Ju HJ Kwon O-Jin OJ Kim Bo-Kyung BK Cho Jung Hyo JH Kim Joo-Hee JH

BMJ open 20170811 8

<h4>Introduction</h4>Although insomnia is one of the most prevalent and disturbing symptoms among patients with cancer, it has not been properly managed. Electroacupuncture (EA) has received attention as a promising intervention for insomnia, and a few previous studies have reported that this intervention may be beneficial for treating insomnia in patients with cancer. The aim of this pilot study is to explore the feasibility and preliminary effectiveness of EA on the sleep disturbance of patien ...[more]

PMID: 28801421

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Project description:BackgroundInsomnia is one of the most frequent symptoms in people with cancer. Electroacupuncture has been widely used in people with cancer or insomnia. We explored the feasibility and preliminary effectiveness of electroacupuncture for cancer-related insomnia.MethodsPeople with cancer and insomnia disorder were randomly allocated to electroacupuncture, sham-electroacupuncture, or usual care groups. Participants received either 10 sessions of electroacupuncture at real acupoints, sham-electroacupuncture at non-acupoints, or usual care in each group for 4 weeks. We calculated the recruitment, adherence, and completion rates of participants. The Insomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), sleep diary and actigraphy-derived sleep parameters, Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Montreal Cognitive Assessment (MoCA), and salivary levels of cortisol and melatonin were evaluated as outcome measures.ResultsTwenty-two participants were enrolled (8, 6, and 8 respectively in the electroacupuncture, sham-electroacupuncture, and usual care groups) and 20 participants completed the trials (8, 4, and 8 respectively). The recruitment, adherence, and completion rates were 78.57% (22/28), 95.45% (21/22), and 90.91% (20/22), respectively. Most of the participants had previously received conventional treatment for insomnia, but few had received Korean medicine treatment, without any demographic or clinical differences between groups. In the electroacupuncture group, there was a statistically significant reduction of 10.13 (mean) ± 8.15 (standard deviation) and 5 ± 3.70 points in mean ISI and PSQI scores at 4 weeks post-treatment (P = .0098 and .0066), compared with sham-electroacupuncture (2.06 ± 7.15 and 1.61 ± 4.34; P = .4796 and .3632) and usual care (3.25 ± 2.60 and 1.38 ± 2.13; P = .0096 and .1112). Although there was no significant difference in ISI score between groups at 4 weeks post-treatment, the electroacupuncture group continued to improve significantly at 4 weeks' follow-up, showing borderline and significant differences compared to the sham-electroacupuncture and usual care (P = .0614 and .0015). The FACT-F scores in electroacupuncture group showed a significant improvement compared with the sham-electroacupuncture group (P = .0305). No electroacupuncture-related adverse events were reported.ConclusionsElectroacupuncture might be feasible for cancer-related insomnia, despite slow participant recruitment. Additional trials with adequately powered sample sizes and a substantial change to the recruitment procedure are needed.Trial registrationClinical Research Information Service, KCT0002162 . Submitted 27 October 2016, Registered 2 December 2016 - Retrospectively registered (The first participant enrolment: 28 November 2016).

Project description:Objective:To evaluate the efficacy of electroacupuncture (EA) on treating insomnia in patients with depression. Patients and Methods:In a patient-assessor-blind, randomized and sham controlled trial, 90 depression patients with insomnia were assigned into three different groups, receiving EA in the treatment group, superficial acupuncture at sham points in the control group A, or Streitberger non-insertion sham acupuncture in the control group B. Treatment was applied 3 times weekly for 8 consecutive weeks. The primary outcome was measured using the Pittsburgh Sleep Quality Index (PSQI). Secondary outcomes were sleep parameters including sleep efficiency (SE), total sleep time (TST) and numbers of sleep awakenings (SA) recorded in the actigraphy, as well as applying the Hamilton Rating Scale for Depression (HAMD-17), Self-Rating Depression Scale (SDS) and Hamilton Rating Scale for Anxiety (HAMA). Assessments were performed at the baseline (week 0), week 4, week 8, and week 12. Linear mixed-effects models were used for analyses and all statistical tests were two-sided. Results:Patients in the EA group had more significant improvement in PSQI scores than those in the control groups over time (respectively p<0.001 and p=0.04 for treatment and time interaction). At 8-week posttreatment, the EA group reported a reduction of -6.64 points in PSQI scores compared with -2.23 points in the control group A (95% CI= -5.74 to -2.39) and -2.94 points in the control group B (95% CI= -5.73 to -2.47). Compared with the two control groups, significant between-group differences were seen in SE (both p<0.01) and TST (both p<0.01) at week 8; similar results can be found in HAMD-17, SDS, and HAMA scores as well. However, there were no between-group differences in SA (respectively p=0.24 and p=0.08) after 8-weeks of treatment. Conclusion:Electroacupuncture may improve the sleep quality of patients with depression. Trial Registration:Chinese Clinical Trial Registry (ChiCTR); URL: http://www.chictr.org.cn/showproj.aspx?proj=12327; Trial ID: ChiCTR-IIR-16008058.

Project description:ImportanceElectroacupuncture (EA) is a widely recognized therapy for depression and sleep disorders in clinical practice, but its efficacy in the treatment of comorbid insomnia and depression remains uncertain.ObjectiveTo assess the efficacy and safety of EA as an alternative therapy in improving sleep quality and mental state for patients with insomnia and depression.Design, setting, and participantsA 32-week patient- and assessor-blinded, randomized, sham-controlled clinical trial (8-week intervention plus 24-week observational follow-up) was conducted from September 1, 2016, to July 30, 2019, at 3 tertiary hospitals in Shanghai, China. Patients were randomized to receive EA treatment and standard care, sham acupuncture (SA) treatment and standard care, or standard care only as control. Patients were 18 to 70 years of age, had insomnia, and met the criteria for depression as classified in the Diagnostic and Statistical Manual of Mental Disorders (Fifth Edition). Data were analyzed from May 4 to September 13, 2020.InterventionsAll patients in the 3 groups were provided with standard care guided by psychiatrists. Patients in the EA and SA groups received real or sham acupuncture treatment, 3 sessions per week for 8 weeks, for a total of 24 sessions.Main outcomes and measuresThe primary outcome was change in Pittsburgh Sleep Quality Index (PSQI) from baseline to week 8. Secondary outcomes included PSQI at 12, 20, and 32 weeks of follow-up; sleep parameters recorded in actigraphy; Insomnia Severity Index; 17-item Hamilton Depression Rating Scale score; and Self-rating Anxiety Scale score.ResultsAmong the 270 patients (194 women [71.9%] and 76 men [28.1%]; mean [SD] age, 50.3 [14.2] years) included in the intention-to-treat analysis, 247 (91.5%) completed all outcome measurements at week 32, and 23 (8.5%) dropped out of the trial. The mean difference in PSQI from baseline to week 8 within the EA group was -6.2 (95% CI, -6.9 to -5.6). At week 8, the difference in PSQI score was -3.6 (95% CI, -4.4 to -2.8; P < .001) between the EA and SA groups and -5.1 (95% CI, -6.0 to -4.2; P < .001) between the EA and control groups. The efficacy of EA in treating insomnia was sustained during the 24-week postintervention follow-up. Significant improvement in the 17-item Hamilton Depression Rating Scale (-10.7 [95% CI, -11.8 to -9.7]), Insomnia Severity Index (-7.6 [95% CI, -8.5 to -6.7]), and Self-rating Anxiety Scale (-2.9 [95% CI, -4.1 to -1.7]) scores and the total sleep time recorded in the actigraphy (29.1 [95% CI, 21.5-36.7] minutes) was observed in the EA group during the 8-week intervention period (P < .001 for all). No between-group differences were found in the frequency of sleep awakenings. No serious adverse events were reported.Conclusions and relevanceIn this randomized clinical trial of EA treatment for insomnia in patients with depression, quality of sleep improved significantly in the EA group compared with the SA or control group at week 8 and was sustained at week 32.Trial registrationClinicalTrials.gov Identifier: NCT03122080.

Project description:IntroductionInsomnia is a prevalent sleep disorder that negatively impacts daytime functioning and quality of life. Breast cancer patients report higher rates of insomnia and more circadian disruption than other cancer groups. Approximately 50% of patients experience acute insomnia following breast cancer diagnosis, which often persists during cancer treatment and rehabilitation. Sleep Restriction Therapy (SRT) is a clinically effective and tolerable treatment for persistent insomnia in breast cancer survivors. However, SRT has never been tested on patients with early signs of sleep disturbance who are undergoing cancer treatment. The aim of this pilot randomised controlled trial is to explore the feasibility and preliminary effectiveness of nurse delivered SRT for newly diagnosed breast cancer patients with acute insomnia. The trial has been registered on ClinicalTrials.gov (identifier: NCT06294041).MethodsThe INVEST (INvestigating the Value of Early Sleep Therapy) trial will recruit 50 newly diagnosed breast cancer patients who meet criteria for acute insomnia. Patients will be recruited from breast cancer results clinics within two Scottish health boards (NHS Grampian and NHS Greater Glasgow and Clyde) and will be block randomised (1:1) to receive nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions comprising two face-to-face meetings (either in person or online) and two telephone calls, whereas SHE will be administered in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomisation. Primary outcomes in this trial relate to the feasibility of SRT for newly diagnosed breast cancer patients with acute insomnia. Specifically, we will explore (i) rates of patient recruitment and retention, (ii) intervention fidelity, (iii) data collection procedures and outcome measure completion, (iv) intervention acceptability. Secondary outcomes will focus on preliminary evaluation of patient responses to SRT, including insomnia severity, rest-activity rhythms, and mental health.DisseminationOur dissemination plan comprises publishing trial outcomes in high-impact, peer-reviewed journals and on breast cancer charity websites and other patient resources. The outcomes from this pilot trial will also inform the development of a full-scale, multicentre RCT of SRT for acute insomnia in newly diagnosed breast cancer patients. University of Strathclyde is the sponsor (reference: UEC23/52). Protocol version v1.2 4 October 2023.Strengths and limitations of this studyThis trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients.This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness.An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care.Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.

Project description:Study objectivesTo evaluate the short-term efficacy and safety of electroacupuncture for the treatment of primary insomnia.DesignRandomized, single-blind, placebo-controlled, parallel-group.SettingA university-based sleep clinic.ParticipantsCommunity sample of 60 Chinese adult volunteers who report having insomnia 3 or more nights per week, whose symptoms meet the DSM-IV criteria for primary insomnia for at least 3 months, and who have an Insomnia Severity Index total score of at least 15. Participants were screened with polysomnography and the Structured Clinical Interview for the DSM-IV prior to randomization.InterventionElectroacupuncture at Yintang (EX-HN3), Baihui (GV20), bilateral ear Shenmen, Sishencong (EX-HN1), and Anmian (EX) 3 times per week for 3 weeks or placebo acupuncture using Streitberger needles at the same points.Measurements and resultsSelf-reported questionnaires, 1-week sleep diaries, and 3-day actigraphy were collected at baseline and 1 week after treatment. The Insomnia Severity Index was used as the primary outcome measure. Both groups showed significant improvement compared with the pretreatment baseline. One-way analysis of covariance adjusted for baseline scores showed that there were significantly greater improvements in sleep efficiency by sleep diary and actigraphy in the electroacupuncture group. However, no significant between-group differences were observed in the Insomnia Severity Index and other outcome measures. The proportions of subjects having less than 30 minutes of wake after sleep onset and a sleep efficiency of at least 85% at the posttreatment visit were significantly higher in the electroacupuncture group. All adverse events were mild in severity.ConclusionWe found a slight advantage of electroacupuncture over placebo acupuncture in the short-term treatment of primary insomnia. Because of some limitations of the current study, further studies are necessary to verify the effectiveness of acupuncture for insomnia.

Dataset Information

Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

Introduction

Methods and analysis

Ethics and dissemination

Trial registration number

Publications

Electroacupuncture for treating insomnia in patients with cancer: a study protocol for a randomised pilot clinical trial.

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