Efficacy and safety of electroacupuncture combined with Suanzaoren decoction for insomnia following stroke: study protocol for a randomized controlled trial

Abstract

Background Insomnia is a common but frequently overlooked sleep disorder after stroke, and there are limited effective therapies for insomnia following stroke. Traditional Chinese medicine (TCM), including acupuncture and the Chinese herbal medication (CHM) Suanzaoren decoction (SZRD), has been reported as an alternative option for insomnia relief after stroke in China for thousands of years. Here, this study aims to investigate the efficacy and safety of electroacupuncture (EA) in combination with SZRD in the treatment of insomnia following stroke. Methods A total of 240 patients with post-stroke insomnia will be included and randomized into four groups: the EA group, SZRD group, EA & SZRD group, and sham group. The same acupoints (GV20, GV24, HT7, and SP6) will be used in the EA group, EA & SZRD group, and sham group, and these patients will receive the EA treatment or sham manipulation every other day for 4 consecutive weeks. SZRD treatments will be given to participants in the SZRD group and EA & SZRD group twice a day for 4 consecutive weeks. The primary outcome measures include Pittsburgh Sleep Quality Index scores and polysomnography. Secondary outcome measures include the Insomnia Severity Index, the National Institutes of Health Stroke Scale, the Hospital Anxiety and Depression Scale, brain magnetic resonance imaging, functional magnetic resonance imaging, and nocturnal melatonin concentrations. The primary and secondary outcomes will be assessed at baseline (before treatment), during the 2nd and 4th weeks of the intervention, and at the 8th and 12th weeks of follow-up. Safety assessments will be evaluated at baseline and during the 4th week of the intervention. Discussion This study will contribute to assessing whether the combination of these two therapies is more beneficial for post-stroke insomnia than their independent use, and the results of this clinical trial will improve our understanding of the possible mechanisms underlying the effects of combination therapies. Trial registration Chinese Clinical Trials Register ChiCTR2000031413. Registered on March 30, 2020

Dysregulation of Serum miR-138-5p and Its Clinical Significance in Patients with Acute Cerebral Infarction

“…During the same period, 130 healthy volunteers were recruited and classified as the healthy control group (HC group). All ACI patients enrolled in the study were first diagnosed and fulfilled the diagnostic criteria of stroke based on the Chinese guidelines for diagnosis and treatment of acute IS 2018 [15]. All patients received intravenous thrombolytic therapy.…”

Transcutaneous Electrical Nerve Stimulation (TENS) Alleviates Brain Ischemic Injury by Regulating Neuronal Oxidative Stress, Pyroptosis, and Mitophagy

“…In addition, Xie et al reported that the EA stimulation in Baihui (GV20) and Hegu (L14) acupoints could improve the recovery of neurological function and mediate angiogenesis following ischemic stroke [56]. In clinical practice, these two acupoints were adopted to relieve post-stroke symptoms, including depression, anxiety, and insomnia [57][58][59]. Therefore, we selected the acupoints of Baihui (GV20) and Hegu (LI4) as the stimulating areas of TENS protocol.…”