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

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

Effects of Tai Chi and cognitive behavioral therapy for insomnia on improving sleep in older adults: Study protocol for a non-inferiority trial.

Background: Insomnia is a prevailing health problem among older adults. Tai Chi, a popular mind-body exercise practiced by older people in various oriental communities, has been shown to improve sleep. However, Tai Chi has not been directly compared to cognitive behavioral therapy for insomnia (CBT-I), which is the first-line non-pharmacological treatment for insomnia in older adults. This study aims to examine whether Tai Chi is non-inferior to CBT-I as a treatment for insomnia in older adults. Methods: This is a single-center, assessor-blinded, non-inferiority randomized controlled trial comparing Tai Chi and CBT-I in 180 older adults aged ≥50 years with chronic insomnia according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition. Participants will be randomly assigned to either the Tai Chi or CBT-I group. Interventions will last for 3 months with a 12-month follow-up. The primary outcome is self-perceived insomnia severity measured by Insomnia Severity Index (ISI) at 3 months and at 15 months. The secondary outcomes include the remission rate of chronic insomnia, insomnia treatment response, subjective sleep quantity and quality, 7-day actigraphy, 7-day sleep diary, sleep medication, health-related quality of life, mental health, body balance and lower extremity function, adverse events, habitual physical activity, and dietary intake. Measurements will be conducted at baseline, 3 months, and 15 months by outcome assessors who are blinded to the group allocation. Discussion: This will be the first non-inferiority randomized controlled trial to compare the efficacy and long-term outcomes of Tai Chi versus CBT-I for treating insomnia in older adults. This study will be of clinical importance as it supports the use of Tai Chi as an alternative non-pharmacological approach for insomnia treatment and sustainable management.

Self-administered acupressure for insomnia disorder: A randomized controlled trial.

BACKGROUND: Insomnia is a significant health problem in the community. Self-administered acupressure (SAA) may be an alternative strategy to alleviate insomnia. PURPOSE: This study is the first to investigate the effects of SAA delivered through a training course in alleviating insomnia disorder compared with sleep hygiene education (SHE). METHODS: A randomized controlled trial was conducted on 200 participants with insomnia disorder. The eligible participants were randomized into the SAA or SHE group. Both groups attended the allocated training courses (two sessions, 2 h each) and then were followed up at weeks 4 and 8. The primary outcome was the severity of insomnia symptoms and related daytime impairment as measured by the Insomnia Severity Index (ISI). Other measures included a 7-day sleep diary and actigraphy, Hospital Anxiety and Depression Scale (HADS), and Short-Form Six-Dimension (SF6D). RESULTS: The SAA group showed a significantly greater improvement in ISI score than the SHE group at week 4 (mean difference: -1.89 units, 95% CI: 0.85, 2.93; Cohen's d = 0.51, p < 0.001) and week 8 (mean difference: -2.89 units, 95% CI: 1.67, 4.11; d = 0.67, p < 0.001). In addition, the SAA group showed a greater reduction in the HADS anxiety score and HADS depression score and increase in SF6D at week 8. CONCLUSIONS: SAA taught in a short training course is a feasible and effective approach to improve sleep and related daytime impairment and mood problems in individuals with insomnia disorder.

Impact of mind-body intervention on proinflammatory cytokines interleukin 6 and 1ß: A three-arm randomized controlled trial for persons with sleep disturbance and depression.

Depressed people are prone to sleep disturbance, which may in return perpetuate the depression. Both depression and sleep disturbance influence proinflammatory cytokines interleukin (IL) 6 and 1ß. Thus interventions for depression should consider the effect on sleep disturbance, and vice versa. Integrative Body-Mind-Spirit (IBMS) and Qigong interventions have been applied in a wide range of health and mental health conditions, including depression and sleep disturbance. This study aimed to evaluate the effect of these two mind-body therapies for persons with both depressive symptoms and sleep disturbance. A three-arm randomized controlled trial was conducted among 281 participants, who were randomly assigned to either IBMS, Qigong or wait list control group. Participants in IBMS and Qigong groups received eight weekly sessions of intervention. Outcome measures were plasma concentrations of IL-6 and IL-1ß, and a questionnaire containing Pittsburgh Sleep Quality Index, Center for Epidemiologic Studies Depression Scale, Somatic Symptom Inventory, Perceived Stress Scale and Body-Mind-Spirit Holistic Well-being Scale. Outcomes were assessed at baseline (T0), immediate post-intervention (T1) and at three-months post-intervention (T2). Besides intervention efficacy analysis, path analysis was performed to explore the relations among perceived stress, depression, sleep disturbance, and IL-6 and IL-1ß values. The study found both IBMS and Qigong reduced depression, sleep disturbance, painful and painless somatic symptoms, IL-6 and IL-1ß levels, and increased holistic well-being. The effect sizes of IBMS and Qigong, mostly in the medium magnitude range, were approximatively equivalent. Path analysis models revealed a predictive role of perceived stress in depression and sleep disturbance, a bidirectional relationship between depression and sleep disturbance, and significant influence of depression and sleep disturbance on IL-6 and IL-1ß. Compared with control, the findings support the efficacy of IBMS and Qigong interventions in relieving depression and sleep disturbance, and in reducing IL-6 and IL-1ß levels.

Electroacupuncture Plus Auricular Acupressure on Chemotherapy-Related Insomnia in Patients With Breast Cancer (EACRI): Study Protocol for a Randomized, Sham-Controlled Trial.

OBJECTIVE: Insomnia is a highly prevalent and disturbing symptom in breast cancer patients under or post chemotherapy. If not appropriately treated, it can persist for years after the completion of cancer treatments. Acupuncture has been widely used for alleviating insomnia. The aim of this study is to examine the feasibility, efficacy and safety of acupuncture for chemotherapy-related insomnia among patients with breast cancer. MATERIALS AND METHODS: This is a trial protocol for a randomized, sham-controlled, subject- and assessor-blinded clinical trial. A total of 138 eligible participants will be assigned randomly to acupuncture or sham control group at a ratio of 1:1. Participants in acupuncture group will receive electroacupuncture (EA) plus auricular acupressure (AA) treatment, while subjects in sham acupuncture group will receive sham EA plus sham AA. Both acupuncture and sham treatments will be given twice weekly for 6 weeks, followed by maintenance treatments once every 4 weeks for 12 weeks (15 sessions totally). The primary outcome is the change of Insomnia Severity Index score between baseline and the end of 6-week treatment. Secondary outcome measurements include Actiwatch, sleep diary, Pittsburgh Sleep Quality Index, Functional Assessment of Cancer Therapy-Breast Cancer, Hospital Anxiety and Depression Scale, Brief Pain Inventory-Short Form, Brief Fatigue Inventory, Acupuncture Expectancy Scale, credibility, and adverse events. Participants will be followed up to 42 weeks. CONCLUSIONS: This trial will expand our understanding of the feasibility, efficacy, and safety of acupuncture as a treatment for alleviating chemotherapy-related insomnia in patients with breast cancer. EA plus AA, if proven to be effective, can be implemented into routine settings to play a role in insomnia management for patients with breast cancer.

The efficacy of integrated cognitive behavioral therapy (CBT) and acupressure versus CBT for insomnia: a three-arm pilot randomized controlled trial.

OBJECTIVES: This pilot study aimed to examine the efficacy of integrated cognitive behavioral therapy (CBT) and acupressure in treating insomnia and its daytime impairments in a Chinese adult population. METHODS: 40 eligible participants with insomnia were randomly assigned to either the integrated CBT and acupressure (CBTAcup) group (n = 14), the CBT group (n = 13), or the waitlist control (WL) group (n = 13). Participants in the CBTAcup group attended a 2-hour integrated CBT and self-administered acupressure group treatment once per week for six consecutive weeks, while participants in the CBT group attended six weekly 2-hour CBT for insomnia. Sleep, mood, daytime impairments, quality of life, and treatment credibility and adherence were assessed at baseline, immediate post-treatment (Week 7), and 4-week post-treatment (Week 11). RESULTS: Linear mixed-effects models showed that both the CBTAcup and CBT groups had significantly lower insomnia severity (d = -1.74 and d = -2.61), dysfunctional beliefs related to sleep (d = -2.17 and -2.76), and mental fatigue (d = -1.43 and -1.60) compared with the WL group at Week 7. The CBTAcup group provided additional benefits in reducing total fatigue (d = -1.43) and physical fatigue (d = -1.45). Treatment credibility was found to be improved in the CBTAcup group from baseline to Week 7. CONCLUSIONS: Integrated CBT and acupressure demonstrated comparable efficacy to pure CBT in treating insomnia symptoms, with additional advantages to improve fatigue symptoms and acceptability in the Chinese population. Further methodologically rigorous studies on a larger scale and longer follow-up are warranted to confirm these findings.

Effects of a group-based lifestyle medicine for depression: A pilot randomized controlled trial.

Given the growing evidence that a range of lifestyle factors are involved in the etiology of depression, a 'lifestyle medicine' approach can be potentially safe and cost-effective to prevent or treat depression. To examine the effects and acceptability of a group-based, integrative lifestyle medicine intervention as a standalone treatment for managing depressive symptoms, a pilot randomized controlled trial (RCT) was conducted in a Chinese adult population in 2018. Participants (n = 31) with PHQ-9 score above the cut-off of ≥ 10, which was indicative of moderate to severe depression, were recruited from the general community in Hong Kong and randomly assigned to lifestyle medicine group (LM group) or care-as-usual group (CAU group) in a ratio of 1:1. Participants in the LM group received 2-hour group sessions once per week for six consecutive weeks, which covered diet, exercise, mindfulness, psychoeducation, and sleep management. Linear mixed-effects model analyses showed that the LM group had a significant reduction in PHQ-9 scores compared to the CAU group at immediate posttreatment and 12-week posttreatment follow-up (d = 0.69 and 0.73, respectively). Moreover, there were significantly greater improvements in anxiety, stress, and insomnia symptoms (measured by DASS-21 and ISI) at all time points in the LM group (d = 0.42-1.16). The results suggests that our 6-week group-based, integrative lifestyle intervention program is effective in lowering depressive, anxiety, stress, and insomnia symptoms in the Chinese population. Further studies in clinical populations with a larger sample size and longer follow-up are warranted.

Semi-Individualized Acupuncture for Insomnia Disorder and Oxidative Stress: A Randomized, Double-Blind, Sham-Controlled Trial.

BACKGROUND: Acupuncture is an alternative treatment for improving sleep, and it may attenuate oxidative stress, which is a possible pathophysiological factor in insomnia. The aim of this study was to examine the efficacy and safety of a semi-individualized acupuncture in improving sleep and explore its effect on oxidative stress parameters in adults with insomnia disorder. METHODS: In this randomized sham-controlled trial, 140 participants were randomly assigned to either a 4-week semi-individualized traditional acupuncture (TA) or noninvasive sham acupuncture (SA). The primary outcome measure was the sleep-diary-derived sleep efficiency. Other outcomes included sleep diary and actigraphy, Insomnia Severity Index, anxiety and depressive symptoms, and quality of life. Blood samples were taken to measure oxidative stress parameters (malondialdehyde, glutathione peroxidase, paraoxonase, and arylesterase). RESULTS: Although no significant difference was found in the primary outcome measure, both sleep-diary-derived and actigraphy-derived total sleep time (TST) were significantly increased in the TA group at 1-week posttreatment (mean difference in sleep diary = 22.0 min, p = 0.01, actigraphy = 18.8 min, p = 0.02). At 5-week posttreatment follow-up, a significantly higher proportion of participants in the TA group showed sleep-diary-derived sleep efficiency (SE) ≥ 85% than in the SA group (55.6% versus 36.4%, p = 0.03). CONCLUSION: TA and SA did not significantly differ in improving subjective sleep efficiency in individuals with insomnia disorder. However, the TA group showed a short-term effect on improving TST as measured by both sleep diary and actigraphy at 1-week posttreatment, but there were no differences in the oxidative stress parameters. CLINICAL TRIAL REGISTRATION: Registry: ClinicalTrials.gov; Title: Acupuncture in the Modulation of Peripheral Oxidative Stress Insomnia; Identifier NCT03447587; URL: https://clinicaltrials.gov/ct2/show/NCT03447587.

Effects of Tai Chi or Exercise on Sleep in Older Adults With Insomnia: A Randomized Clinical Trial.

Importance: Previous studies that have shown tai chi to improve sleep were mainly based on subjective assessments, which might have produced results confounded by self-reporting bias. Objective: To compare the effectiveness of tai chi for improving sleep in older adults with insomnia with conventional exercise and a passive control group using actigraphy-based objective measurements. Design, Setting, and Participants: This randomized, 3-arm, parallel group, assessor-masked clinical trial was conducted at a single research unit in Hong Kong between August 2014 and August 2018. Eligible participants, aged 60 years or older and with chronic insomnia, were randomly allocated into tai chi training, exercise, and control groups. Interventions: 12-week tai chi training, 12-week conventional exercise, and no intervention control. Main Outcomes and Measures: Primary outcomes were measures taken from actigraphy sleep assessment. Secondary outcomes included remission of insomnia, insomnia treatment response, Pittsburgh Sleep Quality Index score, Insomnia Severity Index score, and self-reported sleep using a 7-day sleep diary. Assessments were performed at baseline, end of the intervention (postintervention), and 24 months after the intervention (follow-up). Data analysis was performed from September 2018 to August 2020. Results: A total of 320 participants (mean [SD] age, 67.3 [6.8] years; mean [SD] insomnia duration, 124.4 [134.5] months; 256 [80.0%] women) were randomly allocated into control (110 participants), exercise (105 participants), and tai chi (105 participants) groups and included in the data analysis. Compared with the control group, the exercise and tai chi groups showed improved sleep efficiency (exercise vs control: adjusted mean difference, +3.5%; 95% CI, 1.8-5.2; P < .001; tai chi vs control: adjusted mean difference, +3.4%; 95% CI, 1.6-5.1; P < .001) and reductions of wake time after sleep onset (exercise vs control: -17.0 minutes; 95% CI, -24.9 to -9.0; P < .001; tai chi vs control: -13.3 minutes; 95% CI, -21.3 to -5.2; P = .001) and number of awakenings (exercise vs control: -2.8 times; 95% CI, -4.0 to -1.6; P < .001; tai chi vs control: -2.2 times; 95% CI, -3.5 to -1.0; P < .001) as assessed by actigraphy at postintervention; although there were no significant differences between the exercise and tai chi groups. The actigraphy-assessed beneficial effects were maintained in both intervention groups at follow-up. Conclusions and Relevance: Conventional exercise and tai chi improved sleep and the beneficial effects sustained for 24 months, although the absolute improvements in sleep parameters were modest. Improvements in objective sleep parameters were not different between the tai chi and exercise groups, suggesting that tai chi can be an alternative approach for managing insomnia. Trial Registration: ClinicalTrials.gov Identifier: NCT02260843.

Electroacupuncture for tapering off long-term benzodiazepine use: A randomized controlled trial.

OBJECTIVE: To evaluate the efficacy of using electroacupuncture as an adjunct treatment in enhancing the benzodiazepine cessation rate in long-term benzodiazepine users. METHODS: This was a randomized, assessor- and subject-blinded, controlled trial. One hundred and forty-four long-term benzodiazepine users were randomly assigned to receive either electroacupuncture or placebo acupuncture (a sham itervention using non-invasive placebo needles) combined with a gradual benzodiazepine tapering schedule for 4 weeks. The primary outcome was the cessation rate of benzodiazepine use. Subjects were assessed on their benzodiazepine usage, benzodiazepine withdrawal symptoms, insomnia severity, and anxiety and depressive symptoms at baseline, week 6 and week 16. RESULTS: The cessation rates of the electroacupuncture and placebo acupuncture groups at 12 weeks post-treatment were 9.17% and 10.83%, respectively. Both groups showed a reduction in benzodiazepine usage by a self-completed drug record at week 16 (compared to baseline: electroacupuncture group -40.23% versus placebo acupuncture group -48.76%). However, no significant between-group differences were found in the benzodiazepine cessation rate, reduction in benzodiazepine usage, and other secondary measures across all the study time points. CONCLUSIONS: Electroacupuncture showed a similar cessation rate in benzodiazepine use to that of non-invasive placebo acupuncture in long-term users during a 4-week gradual tapering schedule. The evidence did not support advantages of electroacupuncture over non-invasive placebo acupuncture on reducing insomnia, anxiety, depression, or other withdrawal symptoms during the gradual tapering schedule. Despite a 40% decrease in the benzodiazepine usage in both groups, the effects may be attributed to the non-specific effects of acupuncture. TRIAL REGISTRATION: ClinicalTrials.gov # NCT02475538.

Hypnotherapy for insomnia: A randomized controlled trial comparing generic and disease-specific suggestions.

STUDY OBJECTIVES: Hypnotherapy is commonly used for treating insomnia, but a definite conclusion regarding its safety and effectiveness is unavailable due to a lack of adverse event monitoring and comparison between generic and disease-specific hypnotic suggestions in previous studies. DESIGN: Randomized controlled, participant-blind, parallel-group with subject recruitment after trial registry. INTERVENTIONS: Sixty participants were randomized to receive 4-week once-weekly 1-hour hypnotherapy with disease-specific suggestions (using counter-hyperarousal hypnotic exercise and screen visualization technique targeted at insomnia-related anxieties) or generic suggestions (using thought distraction technique and suggestions for self-confidence and self-care enhancement). MAIN OUTCOME MEASURES: Primary outcome was sleep efficiency (SE) derived from 1-week sleep diary at weeks 4, 6 and 9. Secondary outcomes included other sleep-diary parameters, Insomnia Severity Index, Hospital Anxiety and Depression Scale, and Sheehan Disability Index. Treatment expectancy, adverse events (AEs), and subjective experiences were obtained after hypnotherapy sessions 2 and 4. RESULTS: Mixed linear modeling showed that time effect was significant for most variables. Within-group effect size of sleep-diary-derived SE from baseline to follow-up ranged from 0.70 to 0.90 for disease-specific suggestions (mean difference: 8.5-10.4%); for generic suggestions, it was 0.65-0.69 (mean difference: 6.8-8.3%); however, no significant between-group difference was found. Discontinuation rate was 10%, report of unpleasantness varied from 5.5 to 7.4%, while the incidence of AEs ranged from 37.0 to 51.8%, depending on session content. CONCLUSION: Hypnotherapy using disease-specific and generic suggestions produced similar improvements in sleep and daytime functioning. AEs were common but mostly mild. The finding raises doubts about the value of disease-specific suggestions in hypnotherapy for insomnia. TRIAL REGISTRATION: This clinical trial was registered on 23 May 2014 at the University of Hong Kong Clinical Trials Registry as "Hypnotherapy for insomnia: a randomized placebo-controlled trial" (HKUCTR-1874).

Revealing the Neural Mechanisms Underlying the Beneficial Effects of Tai Chi: A Neuroimaging Perspective.

Tai Chi Chuan (TCC), a traditional Chinese martial art, is well-documented to result in beneficial consequences in physical and mental health. TCC is regarded as a mind-body exercise that is comprised of physical exercise and meditation. Favorable effects of TCC on body balance, gait, bone mineral density, metabolic parameters, anxiety, depression, cognitive function, and sleep have been previously reported. However, the underlying mechanisms explaining the effects of TCC remain largely unclear. Recently, advances in neuroimaging technology have offered new investigative opportunities to reveal the effects of TCC on anatomical morphologies and neurological activities in different regions of the brain. These neuroimaging findings have provided new clues for revealing the mechanisms behind the observed effects of TCC. In this review paper, we discussed the possible effects of TCC-induced modulation of brain morphology, functional homogeneity and connectivity, regional activity and macro-scale network activity on health. Moreover, we identified possible links between the alterations in brain and beneficial effects of TCC, such as improved motor functions, pain perception, metabolic profile, cognitive functions, mental health and sleep quality. This paper aimed to stimulate further mechanistic neuroimaging studies in TCC and its effects on brain morphology, functional homogeneity and connectivity, regional activity and macro-scale network activity, which ultimately lead to a better understanding of the mechanisms responsible for the beneficial effects of TCC on human health.

Acupuncture with or without combined auricular acupuncture for insomnia: a randomised, waitlist-controlled trial.

BACKGROUND: Few high-quality, large-scale, controlled trials comparing the effectiveness and safety of acupuncture, auricular acupuncture and combined acupuncture treatment for insomnia are available. OBJECTIVE: To carry out a randomised, assessor-blinded, waitlist-controlled trial to test the superiority of combination treatment. METHODS: After in-person and polysomnography screening, 224 subjects (mean age 53.4 years; 75.4% female) with DSM-5 insomnia disorder, who were free from major psychiatric disorders and with sleep-diary-derived sleep efficiency averaged over 1 week of <85%, were randomised to acupuncture alone, acupuncture plus auricular acupuncture (combination treatment), or a waitlist in a 3:3:1 ratio. Standardised acupuncture and combination treatment were provided three times weekly for 3 weeks. The primary outcome was sleep-diary-derived sleep efficiency. Secondary outcomes included wrist actigraphy and self-reported scales on insomnia, anxiety and depression, fatigue, sleepiness and functioning. Assessments were conducted at baseline, 1 week, 4 weeks and 13 weeks after treatment. Participants on the waitlist were re-randomised to receive acupuncture or combination treatment after the second post-baseline assessment. RESULTS: There was no significant difference between acupuncture and combination treatment in the primary outcome and most secondary outcomes at all time points. However, both treatments were better than waitlist in reducing insomnia, anxiety/depressive symptoms and fatigue, and improving function. Within-group improvements were maintained at 13 weeks after treatment. Of 260 adverse events, 243 were mild (93.5%). Discontinuation due to adverse events was 2.1% and 3.1% for acupuncture and combination treatment, respectively. CONCLUSIONS: Limited by short-term treatment and follow-up, the attempt to augment acupuncture by auricular acupuncture was not supported. Acupuncture and combination treatment were safe and had mild hypnotic effects, which lasted for at least 13 weeks. TRIAL REGISTRATION NUMBER: NCT01891097; Results.

Sleep hygiene education as a treatment of insomnia: a systematic review and meta-analysis.

Background: Sleep hygiene education (SHE) is commonly used as a treatment of insomnia in general practice. Whether SHE or cognitive-behavioural therapy for insomnia (CBT-I), a treatment with stronger evidence base, should be provided first remains unclear. Objective: To review the efficacy of SHE for poor sleep or insomnia. Methods: We systematically searched six key electronic databases up until May 2017. Two researchers independently selected relevant publications, extracted data and evaluated methodological quality according to the Cochrane criteria. Results: Twelve of 15 studies compared SHE with CBT-I, three with mindfulness-based therapy, but none with sham or no treatment. General knowledge about sleep, substance use, regular exercise and bedroom arrangement were commonly covered; sleep-wake regularity and avoidance of daytime naps in seven programs, but stress management in only five programs. Major findings include (i) there were significant pre- to post-treatment improvements following SHE, with small to medium effect size; (ii) SHE was significantly less efficacious than CBT-I, with difference in effect size ranging from medium to large; (iii) pre- to post-treatment improvement and SHE-CBT-I difference averaged at 5% and 8% in sleep-diary-derived sleep efficiency, respectively, and two points in Pittsburgh Sleep Quality Index; (iv) only subjective measures were significant and (v) no data on acceptability, adherence, understanding and cost-effectiveness. Conclusions: Although SHE is less effective than CBT-I, unanswered methodological and implementation issues prevent a firm conclusion to be made on whether SHE has a role in a stepped-care model for insomnia in primary care.

Self-administered acupressure for insomnia disorder: a pilot randomized controlled trial.

Self-administered acupressure has potential as a low-cost alternative treatment for insomnia. To evaluate the short-term effects of self-administered acupressure for alleviating insomnia, a pilot randomized controlled trial was conducted. Thirty-one subjects (mean age: 53.2 years; 77.4% female) with insomnia disorder were recruited from a community. The participants were randomized to receive two lessons on either self-administered acupressure or sleep hygiene education. The subjects in the self-administered acupressure group (n = 15) were taught to practise self-administered acupressure daily for 4 weeks. The subjects in the comparison group (n = 16) were advised to follow sleep hygiene education. The primary outcome was the Insomnia Severity Index (ISI). Other measures included a sleep diary, Hospital Anxiety and Depression Scale and Short-form Six-Dimension. The subjects in the self-administered acupressure group had a significantly lower ISI score than the subjects in the sleep hygiene education group at week 8 (effect size = 0.56, P = 0.03). However, this observed group difference did not reach a statistically significant level after Bonferroni correction. With regard to the secondary outcomes, moderate between-group effect sizes were observed in sleep onset latency and wake after sleep onset based on the sleep diary, although the differences were not significant. The adherence to self-administered acupressure practice was satisfactory, with 92.3% of the subjects who completed the lessons still practising acupressure at week 8. In conclusion, self-administered acupressure taught in a short training course may be a feasible approach to improve insomnia. Further fully powered confirmatory trials are warranted.

Electroacupuncture for tapering off long-term benzodiazepine use: study protocol of randomized controlled trial.

BACKGROUND: Conventional approaches for benzodiazepine tapering have their limitations. Anecdotal studies have shown that acupuncture is a potential treatment for facilitating successful benzodiazepine tapering. As of today, there was no randomized controlled trial examining its efficacy and safety. The purpose of the study is to evaluate the efficacy of using electroacupuncture as an adjunct treatment to gradual tapering of benzodiazepine doses in complete benzodiazepine cessation in long-term benzodiazepine users. METHODS/DESIGN: The study protocol of a randomized, assessor- and subject-blinded, controlled trial is presented. One hundred and forty-four patients with histories of using benzodiazepines in ≥50% of days for more than 3 months will be randomly assigned in a 1:1 ratio to receive either electroacupuncture or placebo electroacupuncture combined with gradual benzodiazepine tapering schedule. Both experimental and placebo treatments will be delivered twice per week for 4 weeks. Major assessments will be conducted at baseline, week 6 and week 16 post-randomization. Primary outcome is the cessation rate of benzodiazepine use. Secondary outcomes include the percentage change in the doses of benzodiazepine usage and the severity of withdrawal symptoms experienced based on the Benzodiazepine Withdrawal Symptom Questionnaire, insomnia as measured by the Insomnia Severity Index, and anxiety and depressive symptoms as evaluated by the Hospital Anxiety and Depression Scale. Adverse events will also be measured at each study visit. DISCUSSION: Results of this study will provide high quality evidence of the efficacy and safety of electroacupuncture as an adjunct treatment for benzodiazepine tapering in long-term users. TRIAL REGISTRATION: ClinicalTrials.gov NCT02475538 .

The interrelationship between sleep and depression: a secondary analysis of a randomized controlled trial on mind-body-spirit intervention.

OBJECTIVES: To conduct a secondary analysis of a randomized controlled trial (RCT) that aims to understand the mediating effects embedded in a mind-body-spirit intervention for sleep and mood disturbances. METHODS: 126 adults with mild to moderate depression and subjective sleep disturbance, defined as Center for Epidemiologic Studies Depression Scale (CESD) scores from 10 to 34 and Pittsburgh Sleep Quality Index (PSQI) score > 5, participated in a waitlist-controlled RCT of an integrative mind-body-spirit intervention (I-BMS). Holistic well-being scale (HWS), a measure of the state of affliction and equanimity in mind, body and spirit, was included as a possible mediator. Data was collected at baseline and three-month follow-up. Mediation analyses were adopted to examine the pathways leading to sleep and mood improvements. RESULTS: After adjustments of baseline severities, changes in depressive symptoms partially mediated the effect of I-BMS on nighttime symptoms of insomnia (95% CI: 0.12-0.96), while exerting a full mediating effect on daytime symptoms of insomnia (95% CI: 0.14-0.64). The effect of I-BMS on mood was mediated by daytime symptoms of insomnia and spiritual orientation, but not by nighttime symptoms of insomnia (95% CI: 0.93-4.62). CONCLUSION: A bidirectional relationship was found between sleep disturbances and depressive symptoms following a mind-body-spirit intervention. The relationship between daytime symptoms and depressive symptoms was especially strong. Of the HWS variables, spiritual orientation was the only significant mediator of mood improvement following I-BMS. Our findings suggest that efforts to optimize the treatment of comorbid sleep disturbances and depression are needed, especially the treatment of daytime impairments along with sleep and mood disruptions.

What predicts a positive response to acupuncture? A secondary analysis of three randomised controlled trials of insomnia.

OBJECTIVE: Few studies have investigated the predictors of the specific and non-specific effects of acupuncture. The aim of this secondary analysis was to determine patient characteristics that may predict a better treatment response to acupuncture for insomnia. METHODS: We pooled the data of three randomised, double-blind, placebo-controlled trials of acupuncture for insomnia to examine sociodemographic variables, clinical characteristics, baseline sleep-wake variables, and treatment expectancy in relation to acupuncture response. Subjects with an improvement in insomnia severity index (ISI) scores of ≥8 points from baseline to 1 week post-treatment were classified as responders. Factors were compared between responders and non-responders, and also by univariate and multivariate logistic regression analysis. RESULTS: A total of 116 subjects who received traditional needle acupuncture were included, of which 37 (31.9%) were classified as responders. Acupuncture responders had a higher educational level (p<0.01) and higher baseline ISI score (p<0.05), compared to non-responders. In the multivariate logistic regression analysis, only the number of years spent in full-time education remained significant as a predictor of treatment response (OR 1.21, 95% CI 1.06 to 1.38, p<0.01). CONCLUSIONS: Consistent with previous studies, our data suggest that the response to acupuncture is difficult to predict. Although the predictive power of educational level is weak overall, our findings provide potentially valuable information that could be built upon in further research (including a larger sample size), and may help to inform patient selection for the treatment of chronic insomnia with acupuncture in the future. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov: #NCT00839592; Results, #NCT00838994; Results, and #NCT01707706; Results.