Trial reportBMJ open2016
Effect of acupuncture on sleep quality and hyperarousal state in patients with primary insomnia: study protocol for a randomised controlled trial.
Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 27 citations in OpenAlex.
- A systematic review and quality assessment of complementary and alternative medicine recommendations in insomnia clinical practice guidelines.BMC complementary medicine and therapies · 2021Pooled it
- Therapeutic efficacy of zolpidem combined with cognitive-behavioral therapy on primary insomnia.Medicine · 2019Pooled it
- Effects of Shallow Needling for Chronic Primary Insomnia: Protocol for a Randomized Controlled Trial.JMIR research protocols · 2025Article
- Article
- Randomized controlled trial of acupuncture for anxiety and depression in patients with chronic insomnia.Annals of translational medicine · 2021Article
- The efficacy of acupuncture in postoperative sleep quality: a literature review.Sleep & breathing = Schlaf & Atmung · 2021Review
- The fMRI study for acupuncture on shift work sleep disorder: Study protocol for a randomized controlled neuroimaging trial.Medicine · 2020Article
- Hyperarousal Scale: Italian Cultural Validation, Age and Gender Differences in a Nonclinical Population.International journal of environmental research and public health · 2020Article
- Using Nonlinear Dynamics and Multivariate Statistics to Analyze EEG Signals of Insomniacs with the Intervention of Superficial Acupuncture.Evidence-based complementary and alternative medicine : eCAM · 2020Article
- Ataxic Severity Is Positively Correlated With Fatigue in Spinocerebellar Ataxia Type 3 Patients.Frontiers in neurology · 2020Article
- Effects of Acupuncture Treatment in Reducing Sleep Disorder and Gut Microbiota Alterations in PCPA-Induced Insomnia Mice.Evidence-based complementary and alternative medicine : eCAM · 2020Article
- Effects of exercise training and exercise plus acupuncture on chronic insomnia: a feasibility study.Sleep science (Sao Paulo, Brazil)Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
6 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionPrimary insomnia (PI) is commonly defined as a state of having disturbed daytime activities due to poor night-time sleep quality. Studies have demonstrated that it is a disorder of 24 h hyperarousal, expressed in terms of physiological, cognitive and cortical activation. Acupuncture is considered to be beneficial to restore the normal sleep-wake cycle. The aim of the trial is to assess the therapeutic effects of acupuncture on sleep quality and hyperarousal state in patients with PI. METHODS AND ANALYSIS: This study is a randomised, patient-assessor-blinded, sham controlled trial. -88 eligible patients with PI will be randomised in a ratio of 1:1 to the intervention group (real acupuncture) and control group (sham acupuncture, superficial insertion at irrelevant acupuncture points). Acupuncture intervention will be given to all participants three times a week for 4 weeks, followed up for 8 weeks.The primary outcome measures are the Pittsburgh Sleep Quality Index (PSQI) and Hyperarousal scale (HAS). The secondary outcomes are Fatigue scale-14 (FS-14), polysomnography (PSG), heart rate variability (HRV) and Morning Salivary Cortisol Level (MSCL). Outcomes will be evaluated at baseline, post-treatment period and 8 weeks follow-up. All main analyses will be carried out on the basis of the intention-to-treat principle. ETHICS/DISSEMINATION: This protocol has been approved by the Medical Ethical Committee of Beijing Traditional Chinese Medicine Hospital (Beijing TCM Hospital) on 5 January 2015. The permission number is 2014BL-056-02. The study will present data concerning the clinical effects of treating primary insomnia with acupuncture. The results will help to demonstrate if acupuncture is an effective therapy for improving sleep quality in association with a decreased hyperarousal level as a possible underlying mechanism. The findings from this study will be shared with the healthcare professionals, general public and relevant organisations through publication of manuscripts and conference presentations. TRIAL REGISTRATION NUMBER: ISRCTN16079489; Pre-results.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.