WASHINGTON--A small--and controversial--study offers hints that low-pressure hyperbaric oxygen therapy might kick start healing in patients with chronic traumatic brain injury.
Critics say methodological flaws and financial entanglements cast doubt upon the work done by Dr. Paul Harch, a hyperbaric medicine expert from New Orleans. But even as those questions arise, the U.S. military is forging ahead with three of its own studies on hyperbaric oxygen and brain injury, suggesting that the military believes at least some of the reported benefits might be real.
Dr. Harch, medical director for the Louisiana State University Hyperbaric Medicine Department, presented his latest findings at the World Congress on Brain Injury. After 40 treatments of hyperbaric oxygen therapy, all but one of the soldiers he treated for blast-induced traumatic brain injury showed significant improvements in neuropsychological and physical function. Single-photon emission CT (SPECT) brain imaging supported these findings, showing increased cerebral blood flow after just one treatment of hyperbaric oxygen therapy (HB[O.sub.2]), Dr. Harch said at the meeting.
Dr. Harch said he has treated hundreds of patients with chronic traumatic brain injuries (TBIs) at his hyperbaric center in New Orleans. He has published just one case report that detailed his treatment of an Iraq veteran with postconcussive TBI and posttraumatic stress disorder (Cases J. 2009;2:6538). But word of his work has spread rapidly.
The Department of Veterans Affairs "has received a lot of interest in this topic, mostly about treatment at Dr. Harch's lab and heard that it was helping a lot of people who were injured in Iraq," said Dr. David Cifu, national director of the Physical Medicine and Rehabilitation Program Office for the VA. So great was the word-of-mouth interest that that the VA and Department of Defense held a summit meeting last year to examine the existing literature and decide whether HB[O.sub.2] could have a legitimate place in helping veterans with concussion injuries.
The review found six human studies that examined HB[O.sub.2] for traumatic brain injury, said Dr. Cifu, a member of the meeting's steering committee. Some hinted at a positive effect, but none of the studies was considered strong or bias free. The committee decided that while HB[O.sub.2] could not be accepted as a standard of care for TBI, the military should conduct research to determine whether the treatment had any real potential.
Dr. Cifu will head one of the three studies--a three-armed pilot trial that will examine the effect of 100% oxygen delivered at two different pressures (1.5 and 2.0 atmospheres), compared to a sham treatment. Investigators hope to recruit 60 subjects for this study.
The second trial is being conducted in San Antonio and pits HB[O.sub.2] at 2.4 atmospheres against a sham treatment of air at minimal pressure. Of 50 planned subjects, 32 have completed the treatment, according to Dr. Lindell Weaver, medical director and chief of the division of hyperbaric medicine at the LDS Hospital in Salt Lake City. The trial includes a biomarker study and a sophisticated imaging protocol, with quantification of total brain volume, gray and white matter, and the hippocampus, and diffusion tensor imaging across 100 domains.
Dr. Weaver is the principal investigator of the final military study--a phase III, sham-controlled trial. …