By Will Boggs, MD
Combination therapy with lofepramine, L-phenylalanine, and vitamin B-12, the so-called "Cari Loder regime," may slightly reduce disability in patients with multiple sclerosis, according to a report in the September Journal of Neurology, Neurosurgery, and Psychiatry.
Cari Loder espoused this regimen in her 1996 book, the authors explain, but no controlled studies have been reported and data supporting the scientific rationale--a potential increase in noradrenaline levels--is scant.
Dr. Derick Wade from Oxford Centre for Enablement in Oxford, UK, and colleagues used a double-blind, randomized, placebo-controlled trial design to study the Cari Loder regime in 138 patients with clinically definite multiple sclerosis whose disability was measured using the Kurtzke extended disability status scale (EDSS) and the Guy's neurological disability scale (GNDS).
GNDS scores improved by 2 points in both groups (all patients received injections of vitamin B-12), the authors report. After 24 weeks of treatment, GNDS scores had fallen (improved) by 3.6 points in the treatment group and 2.3 points in the placebo group, an insignificant difference. Kurtzke scores showed little change in either group.
Analysis of repeated measures revealed slight benefits of GNDS (0.6 point) in the treatment group, and analysis of variance measures showed a possible effect of the combination in reducing fatigue by a small amount.
Most patients in both groups reported adverse effects, the researchers note, though those reported by the treatment group included symptoms expected from the drugs used in the study.
"There is insufficient evidence to support the use of this triple combination therapy routinely in patients with multiple sclerosis," the authors conclude. "There are trends suggesting some symptomatic improvement, and a small beneficial effect cannot be ruled out."
"I would not recommend the treatment, as the effect is trivial (compared with large placebo effect seen)," Dr. Wade told Reuters Health, "but if individual patients want to take it, then there is no obvious reason why they should not."
"One might speculate about the role of increased noradrenaline in facilitating cerebral plasticity to account for statistically significant difference that might be present," Dr. Wade added.
J Neurol Neurosurg Psychiatry 2002;73:246-249.
Copyright © 2002 Reuters Limited