title: The efficacy and safety of acupuncture for cerebral vasospasm after subarachnoid hemorrhage: study protocol for a randomized controlled trial.
abstract: 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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02275949 , Registration date: 26 October 2014.
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. sycho83@gmail.com.
authors.forename: Seung-Yeon
authors.initials: SY
authors.lastname: Cho
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. leedh1103@naver.com.
authors.forename: Dong-Hyuk
authors.initials: DH
authors.lastname: Lee
authors.affiliation: Department of Neurosurgery, College of Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. realponym@hanmail.net.
authors.forename: Hee Sup
authors.initials: HS
authors.lastname: Shin
authors.affiliation: Department of Neurosurgery, College of Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. toast2000@hanmail.net.
authors.forename: Seung Hwan
authors.initials: SH
authors.lastname: Lee
authors.affiliation: Department of Neurosurgery, College of Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. neurokoh@hanmail.net.
authors.forename: Jun Seok
authors.initials: JS
authors.lastname: Koh
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. wsjung@khu.ac.kr.
authors.forename: Woo-Sang
authors.initials: WS
authors.lastname: Jung
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. skmoon@khu.ac.kr.
authors.forename: Sang-Kwan
authors.initials: SK
authors.lastname: Moon
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. pajama@khu.ac.kr.
authors.forename: Jung-Mi
authors.initials: JM
authors.lastname: Park
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. kcn202@khu.ac.kr.
authors.forename: Chang-Nam
authors.initials: CN
authors.lastname: Ko
authors.affiliation: 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. hokim@snu.ac.kr.
authors.forename: Ho
authors.initials: H
authors.lastname: Kim
authors.affiliation: Department of Cardiology and Neurology, College of Korean Medicine, Kyung Hee University, 26 Kyungheedae-ro, Dongdaemun-gu, Seoul, 130-701, Republic of Korea. seonguk.kr@gmail.com.|Stroke & Neurological Disorders Center, Kyung Hee University Hospital at Gangdong, 892 Dongnam-ro, Gangdong-gu, Seoul, 134-727, Republic of Korea. seonguk.kr@gmail.com.
authors.forename: Seong-Uk
authors.initials: SU
authors.lastname: Park
mesh_terms: D015670:Acupuncture Therapy / Q000009:adverse effects; D002985:Clinical Protocols; D003627:Data Interpretation, Statistical; D006801:Humans; D009569:Nitric Oxide / Q000502:physiology; D017063:Outcome Assessment, Health Care; D018401:Sample Size; D013345:Subarachnoid Hemorrhage / Q000150:complications*; D020301:Vasospasm, Intracranial / Q000628:therapy*
chemical_list: D009569:Nitric Oxide