The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial

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• 作者：Seung-Yeon Cho (1)
  Dong-Hyuk Lee (1)
  Hee Sup Shin (2)
  Seung Hwan Lee (2)
  Jun Seok Koh (2)
  Woo-Sang Jung (1)
  Sang-Kwan Moon (1)
  Jung-Mi Park (1)
  Chang-Nam Ko (1)
  Ho Kim (3)
  Seong-Uk Park (1) (4)
  
  1. Department of Cardiology and Neurology ; College of Korean Medicine ; Kyung Hee University ; 26 Kyungheedae-ro ; Dongdaemun-gu ; Seoul ; 130-701 ; Republic of Korea
  2. Department of Neurosurgery ; College of Medicine ; Kyung Hee University ; 26 Kyungheedae-ro ; Dongdaemun-gu ; Seoul ; 130-701 ; Republic of Korea
  3. Department of Epidemiology and Biostatistics ; Graduate School of Public Health & Institute of Health and Environment ; Seoul National University ; 1 Gwanak-ro ; Gwanak-gu ; Seoul ; 151-742 ; Republic of Korea
  4. Stroke & Neurological Disorders Center ; Kyung Hee University Hospital at Gangdong ; 892 Dongnam-ro ; Gangdong-gu ; Seoul ; 134-727 ; Republic of Korea
  
• 关键词：Subarachnoid hemorrhage ; Vasospasm ; Delayed ischemic neurological deficit ; Acupuncture
• 刊名：Trials
• 出版年：2015
• 出版时间：December 2015
• 年：2015
• 卷：16
• 期：1
• 全文大小：515 KB
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• 刊物主题：Medicine/Public Health, general; Biomedicine general; Statistics for Life Sciences, Medicine, Health Sciences;
• 出版者：BioMed Central
• ISSN：1745-6215

文摘

Background Subarachnoid hemorrhage (SAH) is a neurological disease with a high mortality rate. Several serious complications frequently arise after successful surgery for this condition. Cerebral vasospasm, one such complication, occurs in 50 to 70% of SAH patients. These patients suffer neurological symptoms known as delayed ischemic neurological deficit (DIND); however, the effect of treatment of vasospasm is limited. The major pathogenesis of cerebral vasospasm is the reduction of nitric oxide (NO) and activation of vasoconstrictors. Acupuncture is known to increase the production and activity of vascular endothelial cell-derived NO and improve endothelium-dependent vasodilatation. A preliminary retrospective case study to investigate the ability of acupuncture to prevent the occurrence of cerebral vasospasm has been conducted. However, no randomized, controlled clinical trials have been carried out to evaluate the efficacy of acupuncture for cerebral vasospasm. Methods/Design This trial will be a single-center, randomized, placebo-controlled, parallel group, patient-assessor-blinded clinical trial. A total of 80 patients with SAH will be randomized into two groups: a study group given acupuncture, electroacupuncture, and intradermal acupuncture, and a control group given mock transcutaneous electrical nerve stimulation and sham intradermal acupuncture. Intervention will start within 96 h after SAH, and a total of 12 sessions will be performed during a 2-week period. The primary outcome measure will be the occurrence of DIND, and the secondary outcomes will be vasospasm as measured by cerebral angiography, transcranial Doppler, clinical symptoms, vasospasm-related infarcts, NO and endothelin-1 plasma levels, mortality, and modified Rankin Scale scores. Discussion This trial will examine the efficacy and safety of acupuncture for cerebral vasospasm after SAH. The placebo effect will be excluded and the mechanism of action of the treatments will be evaluated through blood testing. Trial registration ClinicalTrials.gov NCT02275949, Registration date: 26 October 2014.