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

Cho SY, Lee DH, Shin HS, Lee SH, Koh JS, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU - Trials (2015)

Bottom Line: Subarachnoid hemorrhage (SAH) is a neurological disease with a high mortality rate.Several serious complications frequently arise after successful surgery for this condition.The major pathogenesis of cerebral vasospasm is the reduction of nitric oxide (NO) and activation of vasoconstrictors.

View Article: PubMed Central - PubMed

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.

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/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.

No MeSH data available.


Related in: MedlinePlus

The flow chart. HHS, the Hunt and Hess Scale; FG, the Fisher grade; mRS, modified Rankin Scale; NO, nitric oxide; DIND, delayed ischemic neurological deficit.
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Fig1: The flow chart. HHS, the Hunt and Hess Scale; FG, the Fisher grade; mRS, modified Rankin Scale; NO, nitric oxide; DIND, delayed ischemic neurological deficit.

Mentions: A total of 80 participants will be recruited for this trial. Patients with SAH admitted to our hospital are potential candidates for the study. Eligible participants will be randomized to the study group or the control group after written informed consent is obtained. Concealed allocation will be achieved by randomization and allocation by an assigned researcher without patient contact. Randomization will be done using a computer-generated allocation list by an assigned researcher not involved in the intervention or assessment. Stratified block randomization will be carried out according to sex and the Hunt and Hess Scale (HHS) [25]. The physician involved in the intervention will receive a random number by phone after the informed consent form has been signed and the HHS has been evaluated. A flow chart of the study is presented in FigureĀ 1.Figure 1


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

Cho SY, Lee DH, Shin HS, Lee SH, Koh JS, Jung WS, Moon SK, Park JM, Ko CN, Kim H, Park SU - Trials (2015)

The flow chart. HHS, the Hunt and Hess Scale; FG, the Fisher grade; mRS, modified Rankin Scale; NO, nitric oxide; DIND, delayed ischemic neurological deficit.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4352281&req=5

Fig1: The flow chart. HHS, the Hunt and Hess Scale; FG, the Fisher grade; mRS, modified Rankin Scale; NO, nitric oxide; DIND, delayed ischemic neurological deficit.
Mentions: A total of 80 participants will be recruited for this trial. Patients with SAH admitted to our hospital are potential candidates for the study. Eligible participants will be randomized to the study group or the control group after written informed consent is obtained. Concealed allocation will be achieved by randomization and allocation by an assigned researcher without patient contact. Randomization will be done using a computer-generated allocation list by an assigned researcher not involved in the intervention or assessment. Stratified block randomization will be carried out according to sex and the Hunt and Hess Scale (HHS) [25]. The physician involved in the intervention will receive a random number by phone after the informed consent form has been signed and the HHS has been evaluated. A flow chart of the study is presented in FigureĀ 1.Figure 1

Bottom Line: Subarachnoid hemorrhage (SAH) is a neurological disease with a high mortality rate.Several serious complications frequently arise after successful surgery for this condition.The major pathogenesis of cerebral vasospasm is the reduction of nitric oxide (NO) and activation of vasoconstrictors.

View Article: PubMed Central - PubMed

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.

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/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.

No MeSH data available.


Related in: MedlinePlus