Dataset Information

Randomized controlled trial of acupuncture for anxiety and depression in patients with chronic insomnia.

ABSTRACT:

Background

Acupuncture treatment of chronic insomnia (CI) was effective. Anxiety and depression symptoms of the CI patients were improved to varying degrees after acupuncture treatment. Corticosterone (CORT) and 5-hydroxytryptamine (5-HT) are involved in the occurrence and development of comorbidity of insomnia, anxiety, and depression. Whether acupuncture can treat insomnia and accompany anxiety and depression symptoms by regulating CORT and 5-HT is still unclear.

Methods

This was a randomized, single-blind (participant), parallel, placebo-controlled trial. Sixty CI patients were randomly divided into acupuncture and sham acupuncture groups, with 30 patients in each group. In the acupuncture group, acupuncture was applied at Baihui (GV20), Yintang (GV29), Shenmen (HT7, bilateral), and Sanyinjiao (SP6, bilateral), while in the sham acupuncture group, superficial needles were used on non-disorder-related acupoints. Both groups were treated 3 times a week (once every other day) for 4 weeks and at the 3-month follow-up. The patients were assessed using the Pittsburgh Sleep Quality Index (PQSI), Hamilton Anxiety Rating Scale (HAMA), and Hamilton Depression Rating Scale (HAMD). The serum concentrations of CORT and 5-HT were also measured before and after treatment.

Results

After treatment, the decrease in serum CORT and the increase in serum 5-HT were significantly greater in the acupuncture group than in the sham acupuncture group. At follow-up, the PSQI, HAMA, and HAMD scores in the acupuncture group were significantly lower than those in the sham acupuncture group.

Conclusions

Elevated serum CORT and decreased serum 5-HT levels may be associated with mood regulation disorders in CI patients. Acupuncture can significantly improve the sleep quality, efficiency, and latency of CI patients, and it can alleviate anxiety and depression in such patients. Compared with the sham acupuncture group, the acupuncture group showed a stable long-term efficacy.

Trial registration

Chinese Clinical Trials Register ChiCTR1800020298.

SUBMITTER: Liu C

PROVIDER: S-EPMC8506741 | biostudies-literature | 2021 Sep

REPOSITORIES: biostudies-literature

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Publications

Randomized controlled trial of acupuncture for anxiety and depression in patients with chronic insomnia.

Liu Chenyong C Zhao Yanan Y Qin Shan S Wang Xiaoqiu X Jiang Yuanyuan Y Wu Wenzhong W

Annals of translational medicine 20210901 18

<h4>Background</h4>Acupuncture treatment of chronic insomnia (CI) was effective. Anxiety and depression symptoms of the CI patients were improved to varying degrees after acupuncture treatment. Corticosterone (CORT) and 5-hydroxytryptamine (5-HT) are involved in the occurrence and development of comorbidity of insomnia, anxiety, and depression. Whether acupuncture can treat insomnia and accompany anxiety and depression symptoms by regulating CORT and 5-HT is still unclear.<h4>Methods</h4>This wa ...[more]

PMID: 34733978

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Project description:BackgroundHypnotic drugs tend to be the dominant form of treatment of insomnia, but these come with a number of reported side effects. Acupuncture has been studied as an alternative, resulting in a rising need for methodological research towards verifying its efficacy as insomnia treatment.Methods/designWe describe a proposal for a single-center, patient-assessor-blinded, randomized controlled trial with two parallel arms. A total of 38 patients complete screening tests at the first visit, are registered into the clinical trial, and then randomly assigned to the experimental or sham control groups (19 patients for each group). All subjects are clinical insomnia patients who score a 6 or above on the Pittsburgh Sleep Quality Index (PSQI) and meet all inclusion criteria. All subjects are treated with acupuncture and intradermal acupuncture (IDA) three times during the first week. Five sham acupoints are used in the control group. In the experimental group, five real acupoints (PC6, SP6, HT7, KI6, and BL62) are used unilaterally in turn. Sham acupoints are over 1 cm away from each real acupoint.The primary outcomes are the scores on the Insomnia Severity Index (ISI) and PSQI. Secondary outcomes are the sleep log, the Beck Depression Inventory (BDI), the State-Trait Anxiety Inventory (STAI), the World Health Organization Quality of Life Abbreviated Version (WHOQOL-BREF), the Korean-Auditory Verbal Learning Test (K-AVLT), the Digit Span Test (DS), Event Related Potentials (ERPs) and heart rate variability (HRV) to assess emotional states, sleep quality, cognitive functioning, and electro-physiological changes.Subjects are assessed at three time points: baseline, post-treatment and follow-up. The duration of the clinical trial is 18 days.DiscussionTo study the enhancement of the effectiveness of acupuncture for insomnia, we test the intradermal acupuncture method, which is performed continuously on the subject's skin and stimulated at home by the subject every night. In the trial, objective measurements including ERPs and HRV are used to evaluate states of cognition and autonomic nervous system functioning and subjective self-report questionnaires assess insomnia symptoms.'Sham' acupuncture points provided by STRICTA are used for the control group.Trial registrationClinicalTrials.gov: NCT01956760, registered 5 September 2013.

Project description:Background and objectiveWhilst acupuncture is widely used for treating psychosomatic diseases, there is little high-quality evidence supporting its application in comorbid perimenopausal depression (PMD) and insomnia (PMI) which are common complaints during climacteric. This feasibility, patient-assessor-blinded, randomized, sham-controlled clinical trial addresses this gap by investigating the efficacy and safety of acupuncture on depressed mood and poor sleep in women with comorbid PMD and PMI.MethodsSeventy eligible participants were randomly assigned to either real-acupuncture (RA) or sham-acupuncture (SA) groups. Either RA or SA treatment were delivered in 17 sessions over 8 weeks. The primary outcomes for mood and sleep were changes on 17-items Hamilton Depression Rating Scale (HAM-D17) and Pittsburgh Sleep Quality Index (PSQI) scores, from baseline to 16-week follow-up. Secondary outcome measures involved anxiety symptoms, perimenopausal symptoms, quality of life, participants' experience of and satisfaction with the acupuncture treatment. Blood samples were taken to measure reproductive hormone levels. Intention-To-Treat and Per-Protocol analyses were conducted with linear mixed-effects models. The James' and Bang's blinding indices were used to assess the adequacy of blinding.ResultsSixty-five participants completed all treatment sessions, and 54 and 41 participants completed the eight- and 16-week follow-ups, respectively. At post-treatment and 8-week follow-up, the RA group showed a significantly greater reduction in PSQI scores than the SA group did; although the reduction of HAM-D17 scores in RA group was significant, the change was not statistically different from that of SA. There were no significant mean differences between baseline and 16-week follow-up in either HAM-D17 or PSQI in either group. There were no significant between-group differences in serum reproductive hormone levels. All treatments were tolerable and no serious adverse events were reported, and the blinding was successful.ConclusionAcupuncture is safe and can contribute to clinically relevant improvements in comorbid PMD and PMI, with satisfactory short-and medium-term effects. Whether the anti-depressive benefit of acupuncture is specific or non-specific remains to be determined. No evidence was found for any longer-term benefit of acupuncture compared to sham at 16 weeks. Further research is required to elucidate mechanisms underlying the short to medium term effects of acupuncture.

Project description: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. 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. 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. 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 registration Clinicaltrials.gov : NCT04144309. Registered 30 October 2019.

Project description:Study objectivesPatients with comorbid insomnia and sleep apnea (COMISA) report increased severity of depression, anxiety, and stress symptoms compared to patients with either insomnia or sleep apnea alone. Although cognitive behavioral therapy for insomnia (CBTi) is an effective treatment for COMISA, previous research suggests a reduced response to CBTi by patients with insomnia and depression, anxiety, and stress symptoms. Therefore, we used randomized controlled trial data to investigate the impact of depression, anxiety, and stress symptoms before treatment on changes in insomnia after CBTi vs control in patients with COMISA.Methods145 patients with COMISA (insomnia as defined by the International Classification of Sleep Disorders, third edition and apnea-hypopnea index ≥ 15 events/h) were randomized to CBTi (n = 72) or no-treatment control (n = 73). One-week sleep diaries and standardized questionnaire measures of insomnia, sleepiness, fatigue, depression, anxiety, and stress were completed pretreatment and posttreatment. Mixed models were used to examine interactions between depression, anxiety, and stress symptoms before treatment, intervention-group (CBTi, control), and time (pretreatment, posttreatment) on insomnia symptoms.ResultsApproximately half of this COMISA sample reported at least mild symptoms of depression (57%), anxiety (53%), and stress (48%) before treatment. Patients reporting greater depression, anxiety, and stress symptoms before treatment also reported increased severity of insomnia, daytime fatigue, and sleepiness. Improvements in questionnaire and diary-measured insomnia symptoms improved during CBTi and were not moderated by severity of depression, anxiety, or stress symptoms before treatment (all interaction P ≥ .11).ConclusionsWe found no evidence that symptoms of depression, anxiety, or stress impair the effectiveness of CBTi in improving insomnia symptoms in patients with COMISA. Patients with COMISA and comorbid symptoms of depression, anxiety, and stress should be referred for CBTi to treat insomnia and improve subsequent management of their obstructive sleep apnea.Clinical trial registrationRegistry: Australian New Zealand Clinical Trials Registry; Name: Treating comorbid insomnia with obstructive sleep apnea (COMISA) study: A new treatment strategy for patients with combined insomnia and sleep apnea; URL: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=365184; Identifier: ACTRN12613001178730.

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.

Dataset Information

Randomized controlled trial of acupuncture for anxiety and depression in patients with chronic insomnia.

Background

Methods

Results

Conclusions

Trial registration

Publications

Randomized controlled trial of acupuncture for anxiety and depression in patients with chronic insomnia.

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