A phase II study of i.v. methylprednisolone in secondary-progressive multiple sclerosis.

OBJECTIVE: To compare the tolerability and efficacy of two doses of i.v. methylprednisolone in patients with secondary-progressive MS. METHODS: I.v. methylprednisolone administered in high or low dose every other month for up to 2 years to 108 patients with secondary-progressive MS. RESULTS: No significant difference in efficacy with the primary outcome, a comparison of the proportions of patients in each treatment group who experienced sustained progression of disability. A relative treatment effect was detected with the high-dose regimen as measured by the preplanned secondary analysis, a comparison of time to onset of sustained progression of disability. Drug-related adverse events were observed more frequently in high-dose recipients but serious drug-related adverse events were uncommon, and cessation of study drug was only required in one patient. CONCLUSION: The results of the secondary analysis of this study suggest that a phase III trial of corticosteroids for secondary-progressive MS is warranted.

Therapeutic expectations of patients with multiple sclerosis upon initiating interferon beta-1b: relationship to adherence to treatment.

This study, conducted in three separate outpatient health care delivery settings, examined the therapeutic expectations of patients with multiple sclerosis (MS) before they initiated interferon beta-1b therapy, the results of current educational procedures to correct unrealistic expectations, and the relationship between post-education expectations and discontinuing therapy. Ninety-nine consecutive patients were seen in a university based outpatient MS clinic, an academic group practice outpatient MS clinic, or a health maintenance organization outpatient neurology clinic. Before the educational sessions, 57% of the patients expressed unrealistically optimistic expectations regarding reduction in attack rate and 34% expressed unrealistically optimistic expectations regarding improvement in functional status. Educational procedures significantly altered unrealistic expectations but the results were sub-optimal since 33% of the patients maintained overly optimistic expectations regarding reduction in attack rate. Post-education unrealistic expectations of improvement in functional status were significantly related to discontinuing therapy within 6 months. Three adverse effects of therapy also were related independently to adherence to treatment: depression and flu-like symptoms were related to discontinuing therapy while soreness at injection site was related to continuing therapy.

Side effect profile of interferon beta-1b in MS: results of an open label trial.

To determine which patients are prone to side effects from interferon beta-1b and which side effects are most troublesome, we studied 72 patients with clinically definite MS who were started on interferon beta-1b after its release and found that the side effects significantly associated with treatment included skin reactions, flu-like symptoms, fatigue, leukopenia, new or worsened depression, and new or worsened headache. Of these, only fatigue and depression were significantly associated with discontinuance of therapy. Moreover, the course of disease before initiation of treatment also had a significant impact on the likelihood of discontinuing medication. Thus, despite an apparently similar therapeutic benefit (as judged by the similarly reduced attack rate in each group), patients with a secondary chronic progressive course were more likely to discontinue treatment (63%) than patients with either a relapsing/progressive course (18%) or a remitting/relapsing course (7%). Indeed, in the final regression equation, the only factors significantly related (r = 0.875) to the discontinuance of therapy were fatigue (p < 0.0001), a fatigue-depression interaction (p < 0.0001), and a chronic progressive course of disease (p<0.0001). Thus, if future clinical trials are to provide useful information on the value of interferon beta-1b in progressive MS, the side effects of fatigue and depression will need to be ameliorated to limit the drop-out rate from such trials.

Nailing down a diagnosis.

Nails can act as a barometer of an individual's health, offer clues to nutritional disturbances and serve as windows through which to view capillary changes associated with constitutional disease. Understanding growth and development of normal nails is essential to the identification and interpretation of nail pathology. Causes of onychopathology include genetic disease, trauma, tumors, dermatologic disease, miscellaneous acquired disorders and generalized systemic disease. Diagnosis is aided by the realization that the nails have a limited number of reaction patterns when disturbed by disease. Any of these reactions may manifest a host of disorders. Clinicians should remember to include the nails in patient assessment. The nails are interesting anatomical and physiological areas that can help make a diagnosis.

Serum protein electrophoresis.

More than 100 serum proteins have been biochemically identified; relatively few have well-documented clinical significance. In an effort to discriminate between healthy and diseased individuals, investigators have studied many protein levels and patterns from birth throughout life. SPEP is a technique that profiles five plasma protein fractions. Certain patterns are frequently observed in disease states. The use of electrophoretic graphic data in the diagnosis of various diseases has increased markedly over the past two decades. Using this technique nurse practitioners add a new dimension to their diagnostic repertoire.