A randomised placebo controlled exploratory study of vitamin B-12, lofepramine, and L-phenylalanine (the "Cari Loder regime") in the treatment of multiple sclerosis

Abstract

Objective: To determine whether combination therapy with lofepramine, L-phenylalanine, and intramuscular vitamin B-12 (the "Cari Loder regime") reduces disability in patients with multiple sclerosis. Methods: A placebo controlled, double blind, randomised study carried out in five United Kingdom centres on outpatients with clinically definite multiple sclerosis, measurable disability on Guy's neurological disability scale (GNDS), no relapse in the preceding six months, and not on antidepressant drugs. Over 24 weeks all patients received vitamin B-12, 1 mg intramuscularly weekly, and either lofepramine 70 mg and L-phenylalanine 500 mg twice daily, or matching placebo tablets. Outcome was assessed using the GNDS, the Kurtzke expanded disability status scale; the Beck depression inventory, the Chalder fatigue scale, and the Gulick MS specific symptom scale. Results: 138 patients were entered, and two were lost from each group. There was no statistically significant difference between the groups at entry or at follow up. Analysis of covariance suggested that treated patients had better outcomes on four of the five scales used. Both groups showed a reduction of 2 GNDS points within the first two weeks, and when data from all time points were considered, the treated group had a significant improvement of 0.6 GNDS points from two weeks onwards.Conclusions: Patients with multiple sclerosis improved by 2 GNDS points after starting vitamin B-12 injections. The addition of lofepramine and L-phenylalanine added a further 0.6 points benefit. More research is needed to confirm and explore the significance of this clinically small difference.

A Population-Based Study of the Prevalence of Fatigue After Transient Ischemic Attack and Minor Stroke

“…First, there is no gold standard for the measurement of fatigue. 32,34,35 However, the Chalder fatigue scale has been used previously in studies of patients with neurological conditions 36 and has been shown to be valid and reliable in multiple different disease states [25][26][27][28][29] and in the general population. 30,37 Rates of fatigue, defined as a Chalder score Ͼ3, of 10% to 18% have been reported in healthy younger populations, increasing to 22% in the general population older than 60 38,39 Thus, our stroke patients were more fatigued than would be expected in the general population of a similar age, whereas the TIA patients were probably not.…”

“…22 To determine whether the presence of fatigue was associated with the patients' subjective impressions of their recovery from the stroke or TIA, we also administered the Simple Questions scale for recovery from stroke at the 6-month follow-up. 23 Fatigue was measured with the Chalder 24 fatigue scale, which has been used widely in chronic fatigue, 25 multiple sclerosis, 26 Gulf War syndrome, 27 migraine, 28 HIV, 29 and in healthy populations. 30 The score consists of 11 short questions on tiredness, energy, and the need to rest, and it does not specifically ask about "fatigue."…”

Nutrition in multiple sclerosis

“…could not be separated from other agents (67). An open label study used a massive dose of methyl vitamin B12 (60 mg every day for 6 months) in 6 patients with chronic progressive MS.…”

Validation of the brazilian version of Guy's neurological disability scale

“…The GNDS has been useful to MS researchers undertaking a variety of clinical studies. For instance, the GNDS was used to assess disability in clinical trials [11][12][13] , as well as one of the methods used to evaluate differences among MS outcome measures [14][15][16][17][18] .…”