Treatment of multiple sclerosis with hyperbaric oxygen. Results of a national registry
E. P. Kindwall, M. P. McQuillen, B. O. Khatri, H. W. Gruchow and M. L. Kindwall
Department of Plastic Surgery, Medical College of Wisconsin, Milwaukee 53226.
Three hundred twelve patients were entered into a long-term study of
effects of hyperbaric oxygen on multiple sclerosis. The protocol called for
an initial 20 treatments in either the monoplace or multiplace chamber on a
daily basis followed by monthly booster treatments for 2 years. One hundred
seventy neurologists and 22 institutions provided data for this study.
There was no control group, but the study was based on Schumacher's
postulation that a scientifically valid study to test the efficacy of a new
therapy was possible by choosing patients who were definitively diagnosed
with multiple sclerosis and following them up for 2 years after the imposed
treatment. If the overwhelming majority of the subjects failed to get worse
over the 2-year observation period, the efficacy of the treatment would be
manifest. The expanded Kurtzke Disability Status Scale (EDSS) was used to
assess the severity of the disease state. The dropout rate was high with
only 76% (237 of 312 patients) finishing the initial 20 treatments.
Twenty-two percent (69 of 312) finished 1 year of booster therapy, and 9%
(28 of 312) completed 2 years of monthly boosters. The mean deterioration
on the Kurtzke EDSS score was 0.93 or almost a full step from the beginning
of treatment until the last evaluation. There was no difference in outcome
between those who had the shortest and longest periods of time between
onset of symptoms and hyperbaric oxygen treatment. Treatment pressure made
no difference in outcome. Changes in the Kurtzke EDSS score bore no
relationship to the use of booster treatment. Patients who were reasonably
well off at the onset of treatment with initial Kurtzke EDSS scores of 1 or
2 (n = 21) deteriorated by an average of 1.7 Kurtzke points. Those patients
whose initial Kurtzke EDSS scores were greater than 2 (n = 164)
deteriorated on an average of 0.82 points. Of interest was that 19.5% (39
of 200) of the patients reported a temporary improvement in bladder
function, but improvement was maintained in only 11 patients (5.5%) at
2-year follow-up. Fifteen patients (7.5%) indicated long-term worsening.
There was no significant change in the working status of the patients
following hyperbaric oxygen treatment. Although this study treated the
patients in accordance with protocols reported to produce a benefit in
multiple sclerosis, we were unable to substantiate any useful long-term
effect of hyperbaric oxygen therapy.