US Army Medical Materiel Development Activity, Fort Detrick, Maryland2currently with the Uniformed Services University of the Health Sciences, Bethesda, Maryland.
Department of Medicine, University of Utah School of Medicine, Salt Lake City4Department of Hyperbaric Medicine, LDS Hospital, Salt Lake City, Utah.
JAMA Intern Med. 2015 Jan;175(1):43-52. doi: 10.1001/jamainternmed.2014.5479.
Improvement has been anecdotally observed in patients with persistent postconcussion symptoms (PCS) after mild traumatic brain injury following treatment with hyperbaric oxygen (HBO). The effectiveness of HBO as an adjunctive treatment for PCS is unknown to date.
To compare the safety of and to estimate the efficacy for symptomatic outcomes from standard PCS care alone, care supplemented with HBO, or a sham procedure.
DESIGN, SETTING, AND PARTICIPANTS: Multicenter, double-blind, sham-controlled clinical trial of 72 military service members with ongoing symptoms at least 4 months after mild traumatic brain injury enrolled at military hospitals in Colorado, North Carolina, California, and Georgia between April 26, 2011, and August 24, 2012. Assessments occurred before randomization, at the midpoint, and within 1 month after completing the interventions.
Routine PCS care was provided in specialized clinics. In addition, participants were randomized 1:1:1 to 40 HBO sessions administered at 1.5 atmospheres absolute (ATA), 40 sham sessions consisting of room air at 1.2 ATA, or no supplemental chamber procedures.
The Rivermead Post-Concussion Symptoms Questionnaire (RPQ) served as the primary outcome measure. A change score of at least 2 points on the RPQ-3 subscale (range, 0-12) was defined as clinically significant. Change scores from baseline were calculated for the RPQ-3 and for the total RPQ. Secondary measures included additional patient-reported outcomes and automated neuropsychometric testing.
On average, participants had sustained 3 lifetime mild traumatic brain injuries; the most recent occurred 23 months before enrollment. No differences were observed between groups for improvement of at least 2 points on the RPQ-3 subscale (25% in the no intervention group, 52% in the HBO group, and 33% in the sham group; P = .24). Compared with the no intervention group (mean change score, 0.5; 95% CI, -4.8 to 5.8; P = .91), both groups undergoing supplemental chamber procedures showed improvement in symptoms on the RPQ (mean change score, 5.4; 95% CI, -0.5 to 11.3; P = .008 in the HBO group and 7.0; 95% CI, 1.0-12.9; P = .02 in the sham group). No difference between the HBO group and the sham group was observed (P = .70). Chamber sessions were well tolerated.
Among service members with persistent PCS, HBO showed no benefits over sham compressions. Both intervention groups demonstrated improved outcomes compared with PCS care alone. This finding suggests that the observed improvements were not oxygen mediated but may reflect nonspecific improvements related to placebo effects.
clinicaltrials.gov Identifier: NCT01306968.
在经历轻度创伤性脑损伤后持续出现脑震荡后症状（PCS）的患者中，高压氧（HBO）治疗后已观察到改善。HBO 作为 PCS 的辅助治疗的有效性目前尚不清楚。
比较标准 PCS 护理单独、HBO 补充护理或假手术治疗的安全性，并估计症状结果的疗效。
设计、地点和参与者：2011 年 4 月 26 日至 2012 年 8 月 24 日，在科罗拉多州、北卡罗来纳州、加利福尼亚州和佐治亚州的军事医院，对 72 名军事人员进行了多中心、双盲、假对照临床试验，这些人员在经历轻度创伤性脑损伤后至少 4 个月仍存在持续性症状。评估在随机分组前、中点和干预完成后 1 个月内进行。
在专门的诊所提供常规 PCS 护理。此外，参与者以 1:1:1 的比例随机分为 40 次 HBO 治疗组，在 1.5 个大气压（ATA）下进行治疗，40 次假治疗组，接受 1.2ATA 的室内空气治疗，或不进行补充舱室治疗。
Rivermead 脑震荡后症状问卷（RPQ）是主要的结果测量指标。RPQ-3 子量表的评分至少提高 2 分（范围 0-12）被定义为具有临床意义。从基线计算 RPQ-3 和总 RPQ 的变化评分。次要措施包括其他患者报告的结果和自动化神经心理测试。
平均而言，参与者经历了 3 次终身性轻度创伤性脑损伤；最近一次发生在入组前 23 个月。在 RPQ-3 子量表评分至少提高 2 分方面，三组之间无差异（无干预组为 25%，HBO 组为 52%，假手术组为 33%；P =.24）。与无干预组相比（平均变化评分，0.5；95%置信区间，-4.8 至 5.8；P =.91），接受补充舱室治疗的两组在 RPQ 上的症状均有所改善（HBO 组的平均变化评分，5.4；95%置信区间，0.5-11.3；P =.008，假手术组为 7.0；95%置信区间，1.0-12.9；P =.02）。HBO 组和假手术组之间没有差异（P =.70）。舱室治疗耐受良好。
在持续存在 PCS 的军人中，HBO 并没有比假压缩治疗有优势。与单独接受 PCS 护理相比，两组干预措施都显示出改善的结果。这一发现表明，观察到的改善不是由氧气介导的，而是可能反映与安慰剂效应相关的非特异性改善。
clinicaltrials.gov 标识符：NCT01306968。
