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      Five-day regimen of intramuscular or subcutaneous self-administered adrenocorticotropic hormone gel for acute exacerbations of multiple sclerosis: a prospective, randomized, open-label pilot trial

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          Abstract

          Background:

          Despite over 50 years of experience with adrenocorticotropic hormone (ACTH) as a treatment for acute exacerbations of multiple sclerosis, there have been no trials examining the options of the 2–3-week dosing regimen or intramuscular injection protocol used in the original trials. At our clinic, we performed a small, prospective, randomized pilot study to examine the efficacy and safety of, and patient satisfaction with, a short (five-day) self-administered ACTH dosing protocol for exacerbations of multiple sclerosis, and to compare the subcutaneous and intramuscular routes of administration.

          Methods:

          Patients for this study were recruited from an outpatient treatment clinic. Each patient self-administered natural ACTH gel 80 U/day by subcutaneous or intramuscular injection for five consecutive days and was evaluated at baseline and on days 7 and 14. Patient feedback was collected using the Patient Global Impression of Change (PGI-C, the primary efficacy measure), a patient global visual analog scale, the Expanded Disability Status Scale, a timed walk, the Nine-hole Peg Test, and the Clinical Global Impression of Change.

          Results:

          Of the 20 enrolled patients (mean age 39.5 years), 19 completed the study. On day 14, 61.1% of patients (11 of 18 with day 14 scores) were treatment responders, and rated their condition as “very much improved” or “much improved” on the PGI-C. The intramuscular group had numerically more responders, but there was no significant difference in the proportion of responders between the intramuscular and subcutaneous groups at day 14 ( P = 0.3). The intramuscular route of injection was associated with more injection site pain than the subcutaneous route.

          Conclusion:

          A shorter five-day course of intramuscular or subcutaneous ACTH gel may improve symptoms associated with acute exacerbations of multiple sclerosis. Larger studies with standard of care controls are needed to confirm whether this shorter course of intramuscular or subcutaneous ACTH gel is effective and could potentially be substituted for the standard 14-day treatment.

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          Most cited references 15

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          Adult norms for a commercially available Nine Hole Peg Test for finger dexterity.

          The Nine Hole Peg Test is commonly used by occupational therapists as a simple, quick assessment for finger dexterity. The purpose of this study was to evaluate the interrater and test-retest reliability of the commercially available Smith & Nephew Rehabilitation Division version of the Nine Hole Peg Test, and to establish new adult norms for the Nine Hole Peg Test for finger dexterity utilizing this particular version. Two of the researchers established interrater and test-retest reliability by evaluating 25 occupational therapy student volunteers. Seven hundred and three subjects, ranging in age from 21 to 71+ years, were tested to establish norms, using the standard protocol. Results showed high interrater reliability and only moderate test-retest reliability. Scores obtained by using the commercially available version were not statistically different from previously published norms (Mathiowetz, Weber, Kashman, & Volland, 1985). This study supports the original norms and further assists occupational therapists to evaluate dexterity accurately.
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            Mobility after stroke: reliability of measures of impairment and disability.

            This paper investigates the reliability of six measures of impairment and disability related to mobility after stroke: the Rivermead Motor Assessment (RMA, gross function subsection); gait speed (over 5 and 10 m); the motricity index (leg scores only); functional ambulation categories; sitting to standing (by observation); and mobility categories. Twenty-five patients who had suffered a stroke 2-6 years earlier leaving them with mobility disability were seen as part of a home-based physiotherapy trial. Assessments were made by three people on three occasions over 5 weeks. All six measures were reliable in statistical terms. A variation in gait speed of up to 25% and a difference of 3 points in the RMA were the actual limits of reliability.
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              Corticosteroids or ACTH for acute exacerbations in multiple sclerosis.

              Corticosteroids are often used to improve the rate of recovery from acute exacerbation in multiple sclerosis (MS) patients. However, it is still unclear just how relatively effective these agents are and the type of drug, optimal dose, frequency, duration of treatment and route of administration are unknown. The object of this review was to determine the efficacy and safety of corticosteroids or ACTH in reducing the short and long term morbidity from MS. Moreover, we wished to examine from indirect comparisons if the effect of corticosteroids is different according to different doses and drugs, routes of administration, length of treatment. A search strategy developed for the Cochrane MS Group (last searched: June 1999) completed with handsearching and personal contacts with trialists and pharmaceutical companies was used. All randomised, double-blind, unconfounded trials comparing corticosteroids or ACTH to placebo in patients with MS, treated for acute exacerbations, without any age or severity restrictions, were evaluated. Two reviewers independently selected articles for inclusion, assessed trials' quality and extracted the data. A third reviewer cross-checked them and disagreements were resolved by a joint discussion. Six trials contributed to this review; a total of 377 participants (199 treatment, 178 placebo) were randomised. The drugs analysed were methylprednisolone (MP) (four trials, 140 patients) and ACTH (two trials, 237 patients). Overall, MP or ACTH showed a protective effect against the disease getting worse or stable within the first five weeks of treatment (odds ratio[OR]=0.37, 95% confidence interval [CI] 0.24-0.57) with some but non significant greater effect for MP and intravenous administration. Short (five days) or long (15 days) duration of treatment with MP did not show any significant difference. Only one study (with 51 patients) reported data after one year of follow-up: no difference between oral MP and placebo in the prevention of new exacerbations or improvement in long term disability was detected. No data are available beyond one year of follow-up to indicate whether steroids or ACTH have any effect on long-term progression. One study reported that a short term treatment with high dose intravenous MP was not attended by adverse events. On the contrary, gastrointestinal symptoms and psychic disorders were significantly more common in the oral, high-dose MP than in the placebo group. Weight gain and edema were significantly more frequent in the ACTH group than in controls. We found evidence favouring the corticosteroid MP for acute exacerbation in MS patients. Data are insufficient to reliably estimate effect of corticosteroids on prevention of new exacerbations and reduction of long-term disability. Studies assessing long term risk/benefit and adverse effects of corticosteroids in MS patients are urgently needed.
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                Author and article information

                Journal
                Drug Des Devel Ther
                Drug Design, Development and Therapy
                Dove Medical Press
                1177-8881
                2011
                11 July 2011
                : 5
                : 381-389
                Affiliations
                Neurology Center of Fairfax Ltd, Fairfax, VA, USA
                Author notes
                Correspondence: James P Simsarian, Neurology Center of Fairfax Ltd, 3020, Hamaker Court, Suite 400, Fairfax, VA 22031-2220, USA, Tel +1 703 876 0801, Fax +1 703 876 0832, Email jsimsarian@ 123456neurologyfairfax.com
                Article
                dddt-5-381
                10.2147/DDDT.S19331
                3140290
                21792296
                © 2011 Simsarian et al, publisher and licensee Dove Medical Press Ltd.

                This is an Open Access article which permits unrestricted noncommercial use, provided the original work is properly cited.

                Categories
                Original Research

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