Neurosurgery
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Randomized Controlled Trial
The Effect of Japanese Herbal Medicines (Kampo) Goreisan and Saireito on the Prevention of Recurrent Chronic Subdural Hematoma: A Prospective Randomized Study.
Chronic subdural hematoma (CSDH) sometimes recurs after surgical treatment and requires reoperation. In Japan, Japanese herbal medicines (Kampo), such as Goreisan and Saireito, have been used as adjunctive therapies to prevent the recurrence of CSDH. However, no prospective randomized study has proven the efficacy of Kampo medicine in all patients. To investigate whether Goreisan and Saireito reduce the postoperative recurrence of CSDH in a prospective randomized study. ⋯ This is the first study to show that Kampo medicine reduced the recurrence rate of CSDH in an overall population. This study demonstrated that byakujutsu Goreisan and Saireito may have favorable effects, unlike other studies, because byakujutsu has stronger anti-inflammatory activity than sojutsu.
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Randomized Controlled Trial
Six-Year Follow-up of a Randomized Controlled Trial of i-FACTOR Peptide-Enhanced Bone Graft Versus Local Autograft in Single-Level Anterior Cervical Discectomy and Fusion.
Previous analyses of the US Food and Drug Administration (FDA) Investigational Device Exemption study demonstrated the superiority of i-FACTOR compared with local autograft bone in single-level anterior cervical discectomy and fusion (ACDF) at 12 and 24 months postoperatively in a composite end point of overall success. ⋯ i-FACTOR met all 4 FDA-mandated noninferiority success criteria and demonstrated safety and efficacy in single-level anterior cervical discectomy and fusion for cervical radiculopathy through 6 years postoperatively. Safety outcomes are acceptable, and the clinical and functional outcomes observed at 12 and 24 months remained at 72 months.
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Randomized Controlled Trial Multicenter Study Controlled Clinical Trial
Placebo-Controlled Effectiveness of Idiopathic Normal Pressure Hydrocephalus Shunting: A Randomized Pilot Trial.
Multiple prospective nonrandomized studies have shown 60% to 70% of patients with idiopathic normal pressure hydrocephalus (iNPH) improve with shunt surgery, but multicenter placebo-controlled trial data are necessary to determine its effectiveness. ⋯ This multicenter, randomized pilot study demonstrates the effectiveness, safety, and feasibility of a placebo-controlled trial in iNPH, and found a trend suggesting gait velocity improves more in the open shunt group than in the placebo group.
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Randomized Controlled Trial
Does a Screening Trial for Spinal Cord Stimulation in Patients With Chronic Pain of Neuropathic Origin Have Clinical Utility (TRIAL-STIM)? 36-Month Results From a Randomized Controlled Trial.
Screening trials before full implantation of a spinal cord stimulation device are recommended by clinical guidelines and regulators, although there is limited evidence for their use. The TRIAL-STIM study showed that a screening trial strategy does not provide superior patient pain outcome at 6-month follow-up compared with not doing a screening trial and that it was not cost-effective. ⋯ The long-term results show no patient outcome benefit in undertaking an SCS screening trial.
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Randomized Controlled Trial
Duration of Prophylactic Levetiracetam After Surgery for Brain Tumor: A Prospective Randomized Trial.
Levetiracetam is commonly used as a prophylactic antiseizure medication in patients undergoing surgical resection of brain tumors. ⋯ The use of prophylactic levetiracetam did not result in significant neurotoxicity or depression when given for either 1 week or 6 weeks. The incidence of seizure after craniotomy for tumor resection is low regardless of duration of therapy.