Lyme Disease - Pilot Program as Texas A&M University
K.K. Jain: Textbook of Hyperbaric Medicine p.151
A pilot program to assess the possible benefit of HBOT in mitigating chronic Lyme symptoms was carried out at Texas A&M University and was approved by the Institutional Review Board. It was initiated in the 1990s and lasted 6 years. Potential subjects were referred by physicians who were experienced in the treatment of Lyme disease. All subjects presented with a positive diagnosis of Lyme according to the CDC criteria. All had failed intravenous antibiotics and many were continuing to deteriorate even though still on various antibiotics. Some patients were wheelchair-bound due to arthritis, one was semicomatose, and several were children. Those already on antibiotics (67%) continued with their pre-HBO regimen while treatments were in progress.
Subjects were educated regarding the risks of HBOT and signed an informed consent. All were treated at 2.36 ATA in a multiplace hyperbaric oxygen chamber compress with air and provided with 100% oxygen via a standard plastic “head tent.” Treatments were 60 minutes in duration and were administered twice a day for five consecutive days, followed by a two day period of rest. From 10 to 30 treatments were followed by a re-assessment. One subject received 145 treatments over three months.
Ninety one subjects completed a total of 1995 HBOT sessions (average 21.9 treatments per patient). Subject evaluation was carried out by an abbreviated questionnaire derived from an evaluation used by Lyme specialists. This questionnaire was designed so that zero reflected no symptoms and 10 reflected severe symptoms. Using the questionnaire, 84.4% of patients showed significant improvement based on a decrease or elimination of symptoms. Eleven subjects (12%) claimed no benefit. Prior to treatment, subjects had an average score of 114.12 (of a possible 270), and following treatment, an average of 49.27 (p=0.000). The standard deviation of scores was 56.00 prior to treatment and 44.14 after treatment (p=0.057 by Fisher’s F-test). Further 58% of subjects reduced their score by 41.86 points or more.
All but one of 91 subjects developed severe Jarisch Herxheimer (JH) reaction, similar to the effect of aggressive and extensive antibiotic treatment, within three days of HBOT initiation (Pound & May 2005). This was manifested by myalgias, chills, and low grade temperature. Typically the reaction abated after 2-3 weeks, although in many cases the reaction continued throughout the series of treatments. After discontinuation, many subjects continued to show improvement for up to eight months.
Follow up (from 6 years to 6 weeks) showed that the benefit was sustained in approximately 70% of patients. Many patients claimed improved cognitive abilities including improved concentration; others who had depression reported much improvement or disappearance of this symptom. No adverse symptoms were reported. Return to Lyme Disease: A Combined Therapy Approach