Acupuncture for primary insomnia: Effectiveness, safety, mechanisms and recommendations for clinical practice.

Primary insomnia (PI) is an increasing concern in modern society. Cognitive-behavioral therapy for insomnia is the first-line recommendation, yet limited availability and cost impede its widespread use. While hypnotics are frequently used, balancing their benefits against the risk of adverse events poses challenges. This review summarizes the clinical and preclinical evidence of acupuncture as a treatment for PI, discussing its potential mechanisms and role in reliving insomnia. Clinical trials show that acupuncture improves subjective sleep quality, fatigue, cognitive impairments, and emotional symptoms with minimal adverse events. It also positively impacts objective sleep processes, including prolonging total sleep time, improving sleep efficiency, reducing sleep onset latency and wake after sleep onset, and enhancing sleep architecture/structure, including increasing N3% and REM%, and decreasing N1%. However, methodological shortcomings in some trials diminish the overall quality of evidence. Animal studies suggest that acupuncture restores circadian rhythms in sleep-deprived rodents and improves their performance in behavioral tests, possibly mediated by various clinical variables and pathways. These may involve neurotransmitters, brain-derived neurotrophic factors, inflammatory cytokines, the hypothalamic-pituitary-adrenal axis, gut microbiota, and other cellular events. While the existing findings support acupuncture as a promising therapeutic strategy for PI, additional high-quality trials are required to validate its benefits.

Identifying complementary and alternative medicine recommendations for anxiety treatment and care: a systematic review and critical assessment of comprehensive clinical practice guidelines.

Background: Clinical practice guidelines (CPGs) are used to guide decision-making, especially regarding complementary and alternative medicine (CAM) therapies that are unfamiliar to orthodox healthcare providers. This systematic review aimed to critically review and summarise CAM recommendations associated with anxiety management included in the existing CPGs. Methods: Seven databases, websites of six international guidelines developing institutions, and the National Centre for Complementary and Integrative Health website were systematically searched. Their reporting and methodological quality were evaluated using the Reporting Items for practice Guidelines in Healthcare checklist and the Appraisal of Guidelines for Research and Evaluation (2nd version) instrument, respectively. Results: Ten CPGs were included, with reporting rates between 51.4 and 88.6%. Seven of these were of moderate to high methodological quality. Seventeen CAM modalities were implicated, involving phytotherapeutics, mind-body practice, art therapy, and homeopathy. Applied relaxation was included in 70% CPGs, which varied in degree of support for its use in the treatment of generalised anxiety disorder. There were few recommendations for other therapies/products. Light therapy was not recommended for use in generalised anxiety disorder, and St John's wort and mindfulness were not recommended for use in social anxiety disorder in individual guidelines. Recommendations for the applicability of other therapies/products for treating a specific anxiety disorder were commonly graded as "unclear, unambiguous, or uncertain". No CAM recommendations were provided for separation anxiety disorder, specific phobia or selective mutism. Conclusion: Available guidelines are limited in providing logically explained graded CAM recommendations for anxiety treatment and care. A lack of high-quality evidence and multidisciplinary consultation during the guideline development are two major reasons. High quality and reliable clinical evidence and the engagement of a range of interdisciplinary stakeholders are needed for future CPG development and updating. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022373694, identifier CRD42022373694.

Managing depression with complementary and alternative medicine therapies: a scientometric analysis and visualization of research activities.

Background: Complementary and Alternative Medicine (CAM) interventions may prove to be an attractive option for the treatment of depression. The aim of this scientometric analysis is to determine the global scientific output of research regarding managing depression with CAM and identify the hotspots and frontiers within this theme. Methods: Publications regarding the utilization of CAM for treating depression were collected from the Web of Science Core Collection from 1993 to 2022, and analyzed and visualized by Bibliometrix R-package, VOSviewer, and CiteSpace. Results: A total of 1,710 publications were acquired. The number of annual publications showed an overall rapid upward trend, with the figure peaking at 179 in 2021. The USA was the leading research center. Totally 2,323 distinct institutions involving 7,638 scholars contributed to the research theme. However, most of the cooperation was limited to within the same country, institution or research team. The Journal of Alternative and Complementary Medicine was the most productive periodical. The CAM therapies of most interest to researchers were acupuncture and body-mind techniques, such as yoga, meditation and mindfulness. Systematic review and meta-analysis are commonly used methods. "Inflammation," "rating scale" and "psychological stress" were identified as the most studied trend topics recently. Conclusion: Managing depression with evidence-based CAM treatment is gaining attention globally. Body-mind techniques and acupuncture are growing research hotspots or emerging trending topics. Future studies are predicted to potentially investigate the possible mechanisms of action underlying CAM treatments in reducing depression in terms of modulation of psychological stress and inflammation levels. Cross-countries/institutes/team research collaborations should be encouraged and further enhanced.

Identifying complementary and alternative medicine recommendations for insomnia treatment and care: a systematic review and critical assessment of comprehensive clinical practice guidelines.

Background: There is a need for evidence-informed guidance on the use of complementary and alternative medicine (CAM) for insomnia because of its widespread utilization and a lack of guidance on the balance of benefits and harms. This systematic review aimed to identify and summarize the CAM recommendations associated with insomnia treatment and care from existing comprehensive clinical practice guidelines (CPGs). The quality of the eligible guidelines was appraised to assess the credibility of these recommendations. Methods: Formally published CPGs incorporating CAM recommendations for insomnia management were searched for in seven databases from their inception to January 2023. The NCCIH website and six websites of international guideline developing institutions were also retrieved. The methodological and reporting quality of each included guideline was appraised using the AGREE II instrument and RIGHT statement, respectively. Results: Seventeen eligible GCPs were included, and 14 were judged to be of moderate to high methodological and reporting quality. The reporting rate of eligible CPGs ranged from 42.9 to 97.1%. Twenty-two CAM modalities were implicated, involving nutritional or natural products, physical CAM, psychological CAM, homeopathy, aromatherapy, and mindful movements. Recommendations for these modalities were mostly unclear, unambiguous, uncertain, or conflicting. Logically explained graded recommendations supporting the CAM use in the treatment and/or care of insomnia were scarce, with bibliotherapy, Tai Chi, Yoga, and auriculotherapy positively recommended based on little and weak evidence. The only consensus was that four phytotherapeutics including valerian, chamomile, kava, and aromatherapy were not recommended for insomnia management because of risk profile and/or limited benefits. Conclusions: Existing guidelines are generally limited in providing clear, evidence-informed recommendations for the use of CAM therapies for insomnia management due to a lack of high-quality evidence and multidisciplinary consultation in CPG development. More well-designed studies to provide reliable clinical evidence are therefore urgently needed. Allowing the engagement of a range of interdisciplinary stakeholders in future updates of CPGs is also warranted. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=369155, identifier: CRD42022369155.

Acupuncture for comorbid depression and insomnia in perimenopause: A feasibility patient-assessor-blinded, randomized, and sham-controlled clinical trial.

Background and objective: Whilst 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. Methods: Seventy 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. Results: Sixty-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. Conclusion: Acupuncture 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.

The importance of setting and therapeutic relationships when delivering chiropractic care to those living with disadvantage.

BACKGROUND: Chiropractic is a mostly privatised health profession within Australia, with people experiencing disadvantage typically having limited access due to financial barriers. However, some universities within Australia offer community outreach clinics where students provide chiropractic care to people living with disadvantage. This demographic experiences higher rates of chronic conditions including musculoskeletal complaints and requires subsidisation to access privatised care. This need also offers opportunity for the chiropractic profession to work within community healthcare teams. A mixed-methods observational study was used to investigate how the unique setting of a student chiropractic community clinic may influence the experience and outcomes of those who attend. METHODS: Three patient-reported outcome measures (PROMs) investigated client outcomes: Measure Yourself Medical Outcome Profile (MYMOP); European Five Domain Five Level Quality of Life Questionnaire (EQ-5D-5L); and the Patient Enablement Instrument. The PROMs data were analysed descriptively and inferentially. Interviews were conducted with clients who had received chiropractic care, chiropractic students, clinical supervisors and staff of the centre. Interview data were coded using thematic analysis, and themes were formed using Bronfenbrenner's socio-ecological systems framework and non-participant observations. RESULTS: Thirty-seven participants completed baseline PROMs and 17 completed follow-ups after four treatments. Seventy-two percent of participants nominated their primary complaint as chronic. Significant change was noted in general health and wellbeing for the MYMOP, pain and disability for the EQ-5D-5L and index scores for the EQ-5D-5L suggested improved health and wellbeing. Most clients experienced higher levels of enablement post treatment. Twelve participants were interviewed (four were clients), with five themes emerging from the interview data. Clients reported their lived experiences impacted their health problems and attending the clinic offered benefits beyond improvement of pain and disability. CONCLUSIONS: Interview data suggested that these benefits were due to a combination of therapy, the setting and the relationships formed within that setting. Complementing this, PROM data suggested clients experienced better levels of health and wellbeing and decreased levels of pain and disability. Findings indicated that people who experienced disadvantage may receive broader benefits from attending community centres offering chiropractic care. Services such as chiropractic may be complementary in meeting the healthcare needs of those experiencing disadvantage.

Knowledge about, attitude toward, and practice of complementary and alternative medicine among nursing students: A systematic review of cross-sectional studies.

Background: The globally growing demand for complementary and alternative medicine (CAM) has attracted educators' attention to integrate CAM into conventional nursing programs. This systematic review aimed to understand the status quo of nursing students (NSs)' overall rated knowledge of, attitude/belief toward, and practice/previous use or experience (KAP) of CAM in surveys, given these factors may influence NSs' receptivity to CAM curricula, and may be of value in guiding the development of effective teaching strategies. Methods: Formally published cross-sectional quantitative studies investigating the primary outcome of KAP toward CAM by NSs were searched for from eight databases from their inception through to 28 April 2022. PRISMA 2020 guidelines were followed. Results: Twenty-six studies were included for analysis, 25 of which were judged to be of moderate to high quality. Despite limited and poorly informed knowledge of CAM therapies, the majority of NSs generally viewed them in a positive light. Furthermore, NSs usually reported an interest in further learning, and supported and welcomed the integration of CAM curricula, at least as elective modules, into existing nursing programs. Lack of evidence was perceived as a major barrier to the use or integration of CAM. Mass media and the internet were the main sources via which NSs access CAM information. Measurement of KAP in all included studies was via self-designed questionnaires/scales or adapted from previously developed questionnaires/scales. Conclusions: The need for integrating and strengthening CAM curricula into current nursing education is identified. Besides theoretical knowledge and matched clinical placement, skills training in literature searching and evidence-based practice are advised to be included in the curricula design. The experiential learning mode is strongly recommended for delivering specific CAM modalities. In addition, a standard instrumentation for determining NSs' KAP toward CAM should be designed and examined for use in different cultural settings. Systematic Review Registration: https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=300602, identifier: PROSPERO CRD42022300602.

The Role of Acupuncture in the Management of Insomnia as a Major or Residual Symptom Among Patients With Active or Previous Depression: A Systematic Review and Meta-Analysis.

Background: Due to concerns about risks associated with antidepressants and/or hypnotics, complementary therapies such as acupuncture have been sought by patients with active or previous depression to manage insomnia. This systematic review aimed to clarify if acupuncture is effective and safe enough to be recommended as an alternative or adjuvant therapy to standard care in ameliorating concomitant or residual insomnia, two types of insomnia associated with depression. Methods: Randomized controlled trials (RCTs) of depression-related insomnia (DI) treatment via acupuncture vs. waitlist-control or placebo-/sham-acupuncture and RCTs of DI treatment via acupuncture alone or combined with standard care [Western pharmacotherapy and/or cognitive-behavioral therapy (CBT)] vs. standard care alone were searched for from seven databases from inception to December 2021. Cochrane criteria were followed. Results: Twenty-one studies involving 1,571 participants were analyzed. For insomnia as a major symptom of active depression, meta-analyses suggested that acupuncture significantly reduced the global scores of both the Pittsburg Sleep Quality Index (PSQI) [MD = -3.12, 95% CI (-5.16, -1.08), p < 0.01] and Hamilton Depression Scale (HAMD) [SMD = -2.67, 95% CI (-3.51, -1.84), p < 0.01], in comparison with placebo-acupuncture. When compared with conventional pharmacotherapy (antidepressants and/or hypnotics), the results favored acupuncture in decreasing PSQI [MD = -1.17, 95% CI (-2.26, -0.08), p = 0.03] and HAMD [SMD = -0.47, 95% CI (-0.91, -0.02), p = 0.04]. Acupuncture was comparable to conventional pharmacotherapy in reducing scores of each domain of PSQI. For insomnia as a residual symptom of previous or partially remitted depression, acupuncture conferred a very limited, non-significant therapeutic advantage against sham-/placebo-acupuncture. Whether acupuncture has an add-on effect to conventional pharmacotherapy in this type of insomnia has not been investigated. Also, no study was available to address the efficacy differences between acupuncture and CBT or the synergistic effect of these two therapies. Conclusions: There is a low to moderate level of evidence supporting acupuncture as a safe and effective remedy alternative to or adjuvant to conventional pharmacotherapy (antidepressant and/or hypnotic) in improving insomnia and other depression symptoms among patients with active depression. Furthermore, the patients' complaint of disrupted sleep continuity is most likely to benefit from acupuncture. The benefit of acupuncture on residual insomnia associated with previous or partially remitted depression is limited. Future acupuncture studies need to consider applying optimal dosage and addressing deficiencies in trial quality.Systematic Review Registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42021269880, PROSPERO, identifier: CRD42021269880.

The Role of Acupuncture in Treating Perimenopausal Insomnia: An Overview and Quality Assessment of Systematic Reviews and Meta-Analyses.

OBJECTIVE: To summarize and critically assess the reliability of the methodological quality and outcome measures from systematic reviews (SRs)/meta-analyses (MAs) and provide an overall verdict about the therapeutic value of acupuncture for perimenopausal insomnia (PMI). METHODS: We conducted a comprehensive literature search for SRs/MAs of seven major databases (English and Chinese). For each included review, the methodological quality was appraised according to the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), the evidence quality was classified on the basis of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE), and reporting quality was evaluated complying with Preferred Reporting Items for Systematic Reviews and Meta-Analyses 2009 (PRISMA-2009). Veritas plots were used to quantify the quality of included SRs/MAs. RESULTS: Nine SRs/MAs were deemed eligible for the present overview. Considering the assessment of results from the AMSTAR-2 checklist, the methodological quality of one SR/MA was considered low, and the remaining eight were critically low. Major methodological deficiencies were concentrated on item 2 (the lack of protocol and/or registration information), item 7 (the lack of a list of excluded studies), and item 10 (the lack of reports on funding sources for individual studies included in the SRs/MAs). For the GRADE system, of the 25 outcomes, only three (12%) were rated as moderate-quality, while the remaining 22 were rated between low- and very low-quality. The PRISMA-2009 statement indicated three major reporting quality limitations in most SRs/MAs, namely: 1) only search terms without specific retrieval strategy; 2) incomplete descriptions for study characteristics, particularly the specific dosage and frequency of interventions in treatment/control groups; and 3) inadequate investigation and explanation of the source of high heterogeneity among original randomized control trials included. According to Veritas plots, quality rank scores of included SRs/MAs ranged from 3.3 to 8.3, with an average score of 6.4 ± 1.7. CONCLUSION: Acupuncture appears to be beneficial for PMI management, but the quality of evidence is weakened by the unsatisfactory quality of both SRs/MAs and original trials included.

Acupuncture: A Promising Approach for Comorbid Depression and Insomnia in Perimenopause.

Comorbid depression and insomnia are ubiquitous mental complaints among women going through the perimenopausal stage of life and can result in major decline in quality of life. Antidepressive agents combined with/without hypnotics, and/or hormone therapy are currently the most common treatment for perimenopausal depression (PMD) and insomnia (PMI). Balancing the benefits of these pharmacotherapies against the risk of adverse events (AEs) is a difficult task for both clinicians and women. There has been a growing body of research regarding the utilization of acupuncture for treatment of PMD or PMI, whereas no studies of acupuncture for comorbid PMD and PMI have appeared. In this review, we summarize the clinical and preclinical evidence of acupuncture as a treatment for PMD or PMI, and then discuss the potential mechanisms involved and the role of acupuncture in helping women during this transition. Most clinical trials indicate that acupuncture ameliorates not only PMD/PMI but also climacteric symptoms with minimal AEs. It also regulates serum hormone levels. The reliability of trials is however limited due to methodological flaws in most studies. Rodent studies suggest that acupuncture prolongs total sleep time and reduces depression-like behavior in PMI and PMD models, respectively. These effects are possibly mediated through multiple mechanisms of action, including modulating sex hormones, neurotransmitters, hypothalamic-pituitary-adrenal axis/hypothalamic-pituitary-ovary axis, oxidative stress, signaling pathways, and other cellular events. In conclusion, acupuncture is a promising therapeutic strategy for comorbid depression and insomnia during perimenopause. Neuroendocrine modulation is likely to play a major role in mediating those effects. High-quality trials are required to further validate acupuncture's effectiveness.

Acupuncture as an Independent or Adjuvant Management to Standard Care for Perimenopausal Depression: A Systematic Review and Meta-Analysis.

Background: Many women with perimenopausal depression (PMD) have sought alternative therapies such as acupuncture because of concerns about risks associated with antidepressant and hormone replacement therapy (HRT). This systematic review aimed to clarify if acupuncture is effective for PMD compared with waitlist control or placebo/sham acupuncture, and if acupuncture alone or combined with standard care (antidepressant and/or HRT) is more effective in ameliorating PMD in comparison with standard care alone. Methods: Randomized controlled trials (RCTs) of PMD treatment via acupuncture vs. waitlist control or placebo/sham acupuncture, and RCTs of PMD treatment via acupuncture alone or combined with Western pharmacotherapy vs. Western pharmacotherapy were searched for from seven databases from inception to December 2020. Cochrane criteria were followed. Results: Twenty-five studies involving 2,213 women were analyzed. Meta-analyses indicated that acupuncture significantly reduced the global scores of Hamilton Depression Scale (HAMD) [standardized mean difference (SMD) = -0.54, 95% CI (-0.91, -0.16), p < 0.01], compared with standard care. The therapeutic effect of acupuncture maintained at 2-, 4-, and 12-week follow-ups. Acupuncture combined with standard care was more effective than standard care alone in decreasing HAMD scores [SMD = -0.82, 95% CI (-1.07, -0.58), p < 0.01]. Too few RCTs were available to assess the clinical efficacy differences between acupuncture and placebo/sham acupuncture or HRT alone. Acupuncture also showed better effects in decreasing Kupperman index (KI) scores, whether compared with antidepressant alone [MD = -4.55, 95% CI (-8.46, -0.65), p = 0.02] or antidepressant combined with HRT [MD = -0.89, 95% CI (-1.34, -0.43), p < 0.01]. Conclusions: In comparison with standard care, acupuncture alone or combined with standard care was associated with significant improvements in PMD and reductions of other menopausal symptoms. This finding suggests that acupuncture may be a useful addition to treatment for PMD.

Comparative Utility of Acupuncture and Western Medication in the Management of Perimenopausal Insomnia: A Systematic Review and Meta-Analysis.

BACKGROUND: Many women with perimenopausal insomnia (PMI) have sought alternative therapies such as acupuncture because of concerns about risks associated with hormone replacement therapy (HRT) and/or psychotropic drugs. This systematic review aimed to clarify if acupuncture alone or combined with standard Western pharmacotherapy (HRT and/or psychotropic drugs) is more effective in ameliorating PMI in comparison to pharmacotherapy alone. METHODS: Randomized controlled trials (RCTs) of PMI treatment via acupuncture alone or combined with Western pharmacotherapy versus Western pharmacotherapy were searched for from eleven databases from inception to March 2020. Cochrane criteria were followed. RESULTS: Fifteen studies involving 1410 women were analyzed. Meta-analysis indicated that acupuncture significantly reduced the global scores of Pittsburgh Sleep Quality Index (PSQI) [MD = -2.38, 95% CI (-3.38, -1.37), p < 0.01] and Kupperman Index [MD = -5.95, 95% CI (-10.68, -1.21), p = 0.01], compared with hypnotics. Acupuncture combined with hypnotics was more effective than hypnotics alone in decreasing PSQI scores [MD = -3.13, 95% CI (-5.43, -0.83), p < 0.01]. Too few RCTs were available to investigate the clinical efficacy differences between acupuncture and HRT/psychotropic drugs other than hypnotics. CONCLUSIONS: Despite limited evidence, in comparison to hypnotics, acupuncture was associated with significant improvements in PMI, and reductions of other menopausal symptoms. This finding suggests that acupuncture may be a useful addition to treatment for PMI.

Can acupuncture improve objective sleep indices in patients with primary insomnia? A systematic review and meta-analysis.

BACKGROUND: The efficacy of acupuncture for treating primary insomnia (PI) has been explored in several meta-analyses where the outcomes measures were based on subjective self-reported sleep rating scales. Sleep state misperception is common in PI and self-reports underestimate sleep duration and quality. No systematic reviews or meta-analyses have investigated the efficacy of acupuncture in improving objective sleep measures in PI. OBJECTIVE: To perform a systematic review to determine whether objective sleep parameters are improved by acupuncture in patients with PI. METHODS: Randomized controlled trials treating PI via verum-acupuncture versus sham-/placebo-acupuncture or waitlist control were searched for in English [MEDLINE (via PubMed), Sciverse ScienceDirect, Cochrane Central Register of Controlled Trials (CENTRAL), AMED, Springer, EMBASE (Elsevier), Ebsco Medline, and PsycINFO (ProQuest)] and Chinese (SinoMed, CNKI, Wanfang and CQVIP) databases, from the dates of the databases' inception to January 2020. The parameters of polysomnography (PSG), actigraphy, or micromovement sensitive mattress/pillow sleep monitoring systems were considered as the primary outcome measures. Revman 5.3 and Stata 16.0 software were used to conduct the meta-analysis. Heterogeneity was examined by using I2 statistics and publication bias was assessed via Egger's test. RESULTS: Eleven studies involving 775 patients met the inclusion criteria. The results of meta-analysis suggested that acupuncture can increase total sleep time [MD = 55.29, 95%CI (29.16, 81.42), p < 0.01], increase sleep efficiency [MD = 8.96, 95%CI (3.97, 13.95), p < 0.01], decrease wake after sleep onset [MD = -49.54, 95%CI (-82.98, -16.09), p < 0.01], and reduce number of awakening times [MD = -6.29, 95%CI (-10.75, -1.82), p < 0.01] compared with either sham-/placebo-acupuncture or waitlist control. Subsequent analysis indicated a superior effect for verum-acupuncture in comparison with sham-/placebo-acupuncture or waitlist-control when the recommended lowest threshold dosage (12 sessions) was met. Despite positive outcomes, most studies reviewed were heterogeneous and at risk of bias due to methodological issues. CONCLUSIONS: Despite limited evidence, acupuncture was significantly associated with improvements in several objective sleep parameters (increases in total sleep time and sleep efficiency, and reductions in wake after sleep onset and number of awakening times) as well as subjective sleep quantity and quality in patients with PI. A minimum therapeutic threshold dosage (≥12 sessions) is recommended. Well-designed RCTs using PSG are required to clarify the influence of acupuncture on sleep architecture/structure and to promote better application of acupuncture as a treatment for PI.

Melatonin supplementation in patients with complete tetraplegia and poor sleep.

People with complete tetraplegia have interrupted melatonin production and commonly report poor sleep. Whether the two are related is unclear. This pilot study investigated whether nightly supplementation of 3 mg melatonin would improve objective and subjective sleep in tetraplegia. Five participants with motor and sensory complete tetraplegia ingested 3 mg melatonin (capsule) two hours prior to usual sleep time for two weeks. Full portable sleep studies were conducted in participants' homes on the night before commencing melatonin supplementation (baseline) and on the last night of the supplementation period. Endogenous melatonin levels were determined by assaying saliva samples collected the night of (just prior to sleep) and morning after (upon awakening) each sleep study. Prior to each sleep study measures of state sleepiness and sleep behaviour were collected. The results showed that 3 mg of melatonin increased salivary melatonin from near zero levels at baseline in all but one participant. A delay in time to Rapid Eye Movement sleep, and an increase in stage 2 sleep were observed along with improved subjective sleep experience with a reduction in time to fall asleep, improved quality of sleep and fewer awakenings during the night reported. Daytime sleepiness increased however. A randomised, placebo controlled trial with a larger sample is required to further explore and confirm these findings.