Summary
The purpose of this review is to evaluate the clinical outcomes of drug therapy in the treatment of multiple sclerosis (MS) in those studies which purported to include an assessment of quality of life.
Pharmacological management of MS is primarily directed towards control of symptoms and prevention of disease progression or relapse. Although there are many drug and nondrug approaches used in the treatment of MS, this review focuses largely on approaches that incorporate some method of clinical outcome assessment. To aid in the interpretation of the data presented, a short descriptive summary of these assessment methods has been included.
Although most studies incorporate at least one clinical outcome measure into the evaluation of efficacy, only one study has examined the economic impact of intervention in MS. The authors of that study demonstrated good correlation between the level of disability assessed using conventional quality-of-life measures and associated healthcare costs.
Surprisingly, although many treatment approaches used in MS have significant associated toxicity and only modest benefits in terms of disease control, there is a remarkable paucity of data on the impact of these treatments on patients’ quality of life.Studies that incorporate pharmacoeconomic and health-related quality of- life consequences related to the treatment of MS are required.
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References
van Oosten BW, Truyen L, Barkhof F, et al. Multiple sclerosis therapy. Drugs 1995; 49 (2): 200–12
Schapiro RT, Langer SL. Symptomatic therapy of multiple sclerosis. Curr Opin Neurol 1994; 7: 229–33
Schapiro RT. Symptom management in multiple sclerosis. Ann Neurol 1994; 36 Suppl. 2: 123S–9S
Gill TM, Feinstein AR. A critical appraisal of the quality of quality of life measurements. JAMA 1994; 272: 619–26
Guyatt GH, Feeny DH, Patrick DL. Measuring health related quality of life. Ann Intern Med 1993; 118: 622–9
Bourdette DN, Prochazka AV, Mitchell W, et al. Health care costs of veterans with multiple sclerosis: implications for the rehabilitation of MS. Arch Phys Med Rehab 1993; 74: 26–31
Becker CC, Gidal BE, Fleming JO. Immunotherapy in multiple sclerosis: part 1. Am J Health-System Pharmacy 1995; 52: 1985–2000
Campi FM, Martinelli A, Rodegher M, et al. A brain MRI study of different types of chronic progressive multiple sclerosis. Acta Neurol Scand 1995; 91: 231–3
Beck RW, Cleary PA, Anderson MM, et al. A randomized controlled trial of corticosteroids in the treatment of acute optic neuritis: the Optic Neuritis Study Group. N Engl J Med 1992; 326: 581–8
Murray TJ. The psychological aspects of multiple sclerosis. Neurol Clin 1995; 13 (1): 197–223
Kennedy PGE, Steiner I. On the possible viral aetiology of multiple sclerosis. Q J Med 1994; 87: 523–8
Wolinsky JS. Multiple sclerosis. Curr Neurol 1993; 13: 167–207
Rodriguez M, Lennon VA. Immunoglobulins promote remyelination in the central nervous system. Ann Neurol 1990; 27: 12–7
Stefoski D, Davis FA, Faut M, et al. 4−Aminopyridine improves clinical signs in multiple sclerosis. Ann Neurol 1987; 21: 71–81
Frank JA, Stone LA, Smith ME, et al. Serial contrast enhanced magnetic resonance imaging in patients with early relapsingremitting multiple sclerosis: implications for treatment trials. Ann Neurol 1994; 36 Suppl. 2: 86S–90S
Noseworthy JH. Clinical scoring methods for multiple sclerosis. Ann Neurol 1994; 36 Suppl. 2: 80S–5S
Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology 1983; 33: 1444–52
Bergner M, Bobbit RA, Carter WB, et al. The Sickness Impact Profile: development and final revision of a health status measure. Med Care 1981; 19: 787–805
Weiner HL, Hohol MJ, Khoury SJ, et al. Therapy for multiple sclerosis. Neurol Clin 1995; 13 (1): 173–96
Ashworth B. Preliminary trial of carisoprodol in multiple sclerosis. Practitioner 1964; 192: 540–2
Emre M, Leslie GC, Muir C, et al. Correlations between dose, plasma concentrations and antispastic action of tizanidine (Sirdalud). J Neurol Neurosurg Psychiatry 1994; 57: 1355–9
Fawcett J, Sidney JS, Hanson MJ, et al. Use of alternative health therapies by people with multiple sclerosis: an exploratory study. Holist Nurs Pract 1994; 8 (2): 36–42
Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years experience. J Neurosurg 1992; 77: 236–40
Coffey RJ, Cahill D, Steers W, et al. Intrathecal baclofen for intractable spasticity of spinal origin: results of a long term multicenter study. J Neurosurg 1993; 78: 226–32
McLean BN. Intrathecal baclofen in severe spasticity. Br J Hosp Med 1993; 49: 262–7
Mitchell G. Update on multiple sclerosis therapy. Med Clin North Am 1993; 77: 231–49
Chan CH. Dantrolene sodium and hepatic injury. Neurology 1990; 40: 1427–32
Lapierre Y, Bouchard S, Tansey C, et al. Treatment of spasticity with tizanidine in multiple sclerosis. Can J Neurol Sci 1987; 14 Suppl. 3: 513S–7S
Smith C, Birnbaum G, Carter JL, et al. Tizanidine treatment of spasticity caused by multiple sclerosis. Neurology 1994; 44 Suppl. 9: S34–43
Snow BJ, Tsui JKC, Bhatt MH, et al. Treatment of spasticity with botulinum toxin: a double blind study. Ann Neurol 1990; 28: 512–5
Grazko MA, Polo KB, Jabbari B. Botulinum toxin A for spasticity, muscle spasms and rigidity. Neurology 1995; 45: 712–7
Hauser SL, Doolittle TH, Lopez-Bresnahan M, et al. An antispasmodic effect of threonine in multiple sclerosis. Arch Neurol 1992; 42: 923–6
Bever CT. The current status of studies of aminopyridines in patients with multiple sclerosis. Ann Neurol 1994; 36: S118–21
Polman CH, Bertelsmann FW, de Waal R, et al. 4−Aminopyridine is superior to 3,4−diaminopyridine in the treatment of patients with multiple sclerosis. Arch Neurol 1994; 51: 1136–9
Betts CD, D’Mellow T, Fowler CJ. Urinary symptoms and the neurological features of bladder dysfunction in multiple sclerosis. J Neurol Neurosurg Psychiatry 1993; 56: 245–50
O’Riordan JI, Doherty C, Javed M, et al. Do alpha blockers have a role in lower urinary tract dysfunction in multiple sclerosis? J Urol 1995; 153: 1114–6
Jacobs L, O’Malley J, Freeman A, et al. Intrathecal interferon reduces exacerbations of multiple sclerosis. Science 1981; 214: 1026–8
The IFN beta Multiple Sclerosis Study Group. Interferon beta 1b is effective in relapsing—remitting multiple sclerosis: I. Clinical results of a multicenter randomized double blind placebo—controlled trial. Neurology 1993; 43: 655–61
Paty DW, Li DKB, UBC MS/MRI Study Group, IFN beta Multiple Sclerosis Study Group. Interferon beta 1b is effective in relapsing-remitting multiple sclerosis: II. MRI analysis results of a multicenter randomized placebo controlled clinical trial. Neurology 1993; 43: 662–7
Goodkin DE. Interferon beta-1b. Lancet 1994; 344: 1057–60
Rudge P, Miller D, Crimlisk H, et al. Does interferon beta cause initial exacerbation of multiple sclerosis [letter]. Lancet 1995; 345: 580
Becker CC, Gidal BE, Fleming JO. Immunotherapy in multiple sclerosis: part 2. Am J Health-System Pharmacy 1995; 52: 2105–20
Hughes R. Immunotherapy for multiple sclerosis. J Neurol Neurosurg Psychiatry 1994; 57: 3–6
Beck RW, Cleary PA, Trobe JD, et al. The effects of corticosteroids for acute optic neuritis on the subsequent development of multiple sclerosis. N Engl J Med 1993; 329: 1764–9
Howard RS. Neurology. BMJ 1994; 309: 392–5
Alam SM, Kyriakides T, Lawden M, et al. Methylprednisolone in multiple sclerosis: a comparison of oral with intravenous therapy at equivalent high dose. J Neurol Neurosurg Psychiatry 1993; 56: 1219–30
Milligan NM, Miller DH, Compston DAS. A placebo controlled trial of isoprinosine in patients with multiple sclerosis. J Neurol Neurosurg Psychiatry 1994; 57: 164–8
Hauser SL, Dawson DM, Lehrich JR, et al. Intensive immunosuppression in progressive multiple sclerosis. N Engl J Med 1983; 308: 173–80
Achiron A, Pras E, Gilad R, et al. Open controlled therapeutic trial of intravenous immune globulin in relapsing-remitting multiple sclerosis. Arch Neurol 1992; 49: 1233–6
Goodkin DE, Rudick RA, VandeBrug Medendorp S, et al. Low dose (7.5mg) oral methotrexate reduces the rate of progression in chronic progressive multiple sclerosis. Ann Neurol 1995; 37: 30–40
Currier RD, Haerer AF, Meydrech EF. Low dose oral methotrexate treatment of multiple sclerosis: a pilot study. J Neurol Neurosurg Psychiatry 1993; 56: 1217–8
Yudin PL, Ellison GW, Ghezzi A, et al. Overview of azathioprine treatment in multiple sclerosis. Lancet 1991; 228: 1051–5
Weiner HL, Mackin GA, Orav EJ, et al. Intermittent cyclophosphamide pulse therapy in progressive multiple sclerosis: final report of the Northeast Co-operative Multiple Sclerosis Treatment Group. Neurology 1994; 43: 910–8
Canadian Cooperative Multiple Sclerosis Study Group. The Canadian cooperative trial of cyclophosphamide and plasma exchange in progressive multiple sclerosis. Lancet 1991; 337: 442–6
The Multiple Sclerosis Study Group. Efficacy and toxicity of cyclosporine in chronic progressive multiple sclerosis: a randomized, double-blinded, placebo-controlled clinical trial. Ann Neurol 1990; 27: 591–605
Pender MP. Cyclosporine and multiple sclerosis [letter]. Ann Neurol 1991; 29: 226
Bates D. New therapies in multiple sclerosis. Pharm J 1995; 255: 213–6
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Malone, M., Lomaestro, B. Outcomes Assessment of Drug Treatment in Multiple Sclerosis Clinical Trials. Pharmacoeconomics 9, 198–210 (1996). https://doi.org/10.2165/00019053-199609030-00003
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DOI: https://doi.org/10.2165/00019053-199609030-00003