Abstract
BackgroundSubarachnoid 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/DesignThis 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.DiscussionThis 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 registrationClinicalTrials.gov NCT02275949, Registration date: 26 October 2014.
Highlights
Subarachnoid hemorrhage (SAH) is a neurological disease with a high mortality rate
The rate of SAH is low when compared to cerebral hemorrhage or cerebral infarction; this condition is a large burden to both individual patients and society because of high mortality rates and treatment costs in neurological intensive care units [5,6,7]
The results indicated the possibility of acupuncture treatment in preventing the occurrence of cerebral vasospasm after SAH [24]
Summary
Subarachnoid hemorrhage (SAH) is a neurological disease with a high mortality rate. Several serious complications frequently arise after successful surgery for this condition. Treatment of SAH involves early ligation of the aneurysm or insertion of a coil; complications such as cerebral vasospasm, rebleeding, or hydrocephalus frequently occur after successful surgery [2,3,4,7,8]. Such complications increase the mortality rate of SAH or lead to patient sequelae [4]. Vasospasm occurs in 50 to 70% of SAH patients, and about 50% of these patients suffer neurological symptoms such as deterioration of consciousness and language disorders [3,11,13] Such symptoms are known as delayed ischemic neurological deficit (DIND). 30% of patients die of DIND [4,7]
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