Does a placebo-effect exist in clinical trials on multiple sclerosis? Review of the literature

Italian Journal of Neurological Sciences

Volumn 17, Issue 2, 1996, Pages 135-139

  La Mantia, L ^a  

^a DEPARTMENT OF NEUROSURGERY   (Italy)

Author keywords

multiple sclerosis; placebo treatment; review; trials

Indexed keywords

ALPHA INTERFERON; AZATHIOPRINE; BETA INTERFERON; CYCLOPHOSPHAMIDE; CYCLOSPORIN A; GLATIRAMER; PLACEBO; PREDNISONE;

ADULT; ARTICLE; CLINICAL ARTICLE; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; FOLLOW UP; HUMAN; MULTIPLE SCLEROSIS; TREATMENT OUTCOME;

CLINICAL TRIALS; HUMANS; MULTIPLE SCLEROSIS; PLACEBO EFFECT; PROGNOSIS;

EID: 0030013369     PISSN: 03920461     EISSN: None     Source Type: Journal    
DOI: 10.1007/BF02000844     Document Type: Article

References (28)

1. Austims Research Group: Interferon alpha and transfer factor in the treatment of multiple sclerosis: a doubleblind, placebo-controlled trial. J. Neurol. Neurosurg. Psychiatry, 52: 566-574, 1989.
2. BORNSTEIN M.B., MILLER A., SLAGLE S., WEITZMAN M., CRYSTAL H., DREXLER E., KEILSON M., MERRIAM A., WASSERTHEIL-SOMMER S., SPADA V., WEISS W., ARNON R., JACOBSOHN L, TEITELBAUM D., SELA M.: A pilot trial of Cop 1 in exacerbating- remitting multiple sclerosis. N. Engl. J. Med. 317: 408-414, 1987.
3. BORNSTEIN M.B., MILLER A., SLAGLE S., WEITZMAN M., DREXLER E., KEILSON M., SPADA V., WEISS W., APPEL S., ROLAK L., HARATI Y., BROWN S., ARNON R., JACOBSOHN I., TEITELBAUM D., SELA M.: A placebo-controlled, double-blind, randomized, two-center, pilot trial of cop 1 in chronic progressive multiple sclerosis. Neurology 41: 533-539, 1991.
4. British and Dutch Multiple Sclerosis Azathioprine trial group: Double - masked trial of azathioprine in Multiple Sclerosis. Lancet ii: 178-183, 1988.
5. CAMENGA D.L., JOHNSON K.P., ALTER M., ENGELHARDT C.D., FISHMAN P.S., GREENSTEIN J.I., HALEY A.S., HIRSCH R.L., KLEINER J.E., KOPIE V.Y., KOSKI C.L., MARGILIES S.L., PANITCH H.S., VALERO R.: Systemic recombinant alpha-2 Interferon therapy in relapsing Multiple Sclerosis. Arch. Neurol. 43: 1239-1246, 1986.
6. ELLISON G.W., MYERS L.W., MICKEY M.R., GRAVES M.C., TOURTELLOTTE W.W., SYNDULKO K., HOLEVOETHOWSON M.I., LERNER C.D., FRANE M.V., PETTLER-JENNINGS P.: A placebo-controlled, randomized, doublemasked, variable dosage, clinical trial of azathioprine with and without methylprednisolone in Multiple Sclerosis. Neurology 39: 1018-1026, 1989.
7. GOODIN D.S.: The use of immunosuppressive agents in the treatment of MS: a critical review. Neurology 41: 980985, 1991.
8. GOODKIN D.E., HERTSGAARD D., RUDICK R.A.: Exacerbation rates and adherence to disease type in a prospectively followed-up population with multiple sclerosis. Implications for clinical trials. Arch. Neurol. 46: 1107-1112, 1989.
9. GOODKIN D.E., BAILY R.C., TEETZEN M.L., HERTSGAARD D., BEATTY W.W.: The efficacy of azathioprine in relapsing-remitting multiple sclerosis. Neurology 41: 20-25, 1991.
10. GOODKIN D.E., RUDICK R.A., MENDENDORP S.V., DAUGHTRY M.M., SCHWETZ K.M., FISCHER J., VAN DYKE C.: Low dose (7.5 mg) oral methotrexate reduces the rate of progression in chronic progressive multiple sclerosis. Ann. Neurol. 37: 30-40, 1995.
11. JACOBS L., SALAZAAR A.M., HERNDON R., REESE P.A., FREEMAN A., JOZEPOWICZ R., GUETTER A., HUSAIN F., SMITH W.A., EKES R., O'MALLEY J.A.: Intratechally administered natural human fibroblast Interferon reduces exacerbations of multiple sclerosis. Arch. Neurol., 44: 589-595, 1987.
12. KILLIAN J.M., BRESSLER R.B., ARMSTRONG R.M., HusTON O.P.: Controlled pilot trial of monthly intravenous cyclophosphamide in multiple sclerosis. Arch. Neurol. 45: 27-30, 1988.
13. KURTZKE J.F.. Rating neurologic impairment in multiple sclerosis: an expanded disability status scale (EDSS). Neurology, 33: 1444.1452, 1983.
14. LIKOSKI W.H., FIREMAN B., ELMORE R., ENO G., GALE K., GOODE G.B., IKEDA K., LASTER J., MOSHER C., ROZANCE J., RlCHMON J., ROSENNBERO S., SAMMAN A., STERNBACH R., WHALEY J., FEHRENBACHER L.: Intense immunosuppression in chronic progressive multiple sclerosis: the Kaiser study. J. Neurol. Neurosurg. Psychiatry, 54: 1055-1060, 1991.
15. MILANESE C., SALMAGGI A., LA MANTIA L., CAMPI A., EOLI M., SAVOIARDO M., BANCHI G., NESPOLO A.: Double-blind study of intrathecal beta-interferon in multiple sclerosis: clinical and laboratory results. J. Neurol. Neurosurg Psychiatry 53: 554-557, 1990.
16. MILANESE C., LA MANTIA L., SALMAGGI A., EOLI M.: A double-blind study of azathioprine efficacy in multiple sclerosis: final report. J. Neurol. 240: 295-298, 1993.
17. MYERS L.W., ELLISON G.W., LEAKE B.D.: Sample size estimates for therapeutic trials for multiple sclerosis. Ann. Neurol. 32(2): 258, 1992.
18. NOSEWORTHY J.H., VANDERWOORT M.K., WONG C.J., EBERS G.G., and the Canadian Cooperative MS Study Group: Inter-rater variability with the expanded Disability Status Scale (EDSS) and Functional System (FS) in a multiple sclerosis clinical trial. Neurology 40: 971-975, 1990.
19. SCHUMACHER G.A., BEEBE G.W., KlBLER R.F., KURLAND L.T., KURTZKE J.F., MCüOWELL F., NAGLER B., SlBLEY A.W., TOURTELLOTTE W.W., WlLLMONT L.: Problems of experimental trials of therapy in multiple sclerosis. Ann. NY Acad. Sei. 122: 552-568, 1965.
20. THE CANADIAN COOPERATIVE MULTIPLE SCLEROSIS STUDY GROUP: The Canadian Cooperative trial of cyclophosphamide and plasma exchange in progressive multiple sclerosis. Lancet 337: 441-446, 1991.
21. The IFNB Multiple Sclerosis Study Group: Interferon beta-1 b is effective in relapsing-remitting multiple sclerosis. I. Clinical results of a multicenter, randomized, double-blind, placebo-controlled trial. Neurology 43: 655661, 1993.
22. 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, 27: 591-605, 1990.
23. VAN HAVER H., LISSOIR F., KETELAER P., VAN HEES J., THEYS P., VERVLIET G., CLAEYS H., GAUTAMA K., VERMYLEN C., CARTON H.: Transfer factor therapy in multiple sclerosis: a three-year prospective double-blind clinical trial. Neurology 36: 1399-1402, 1986.
24. WEINSHENKER B.G., EBERS G.C.: The natural history of Multiple Sclerosis. Can. J. Neurol. Sei., 14: 255-261, 1987.
25. WEINSHENKER B.C., BASS B., RICE O.P.A., NOSEWORTHY J., CARRIERE W., BASKERVILLE J., EBERS G.C.: The natural history of multiple sclerosis: a geographically based study; 1. Clinical course and disability. Brain 112: 133-146, 1989.
26. WEINSHENKER B.C., RICE O.P.A., NOSEWORTHY J.H., CARRIERE W., BASKERVILLE J., EBERS G.C.: The natural history of multiple sclerosis: a geographically based study. 4. Applications to planning and interpretation of clinical therapeutic trials. Brain 114: 1057-1067, 1991.
27. WHITAKER J.N.: Expanded clinical trials of treatment for multiple sclerosis. Ann. Neurol, 34(6): 755-756, 1993.
28. YUDKIN P.L., ELLISON G.W., GHEZZI A., GOODKIN D.E., HUGHES R.A.C., MCPHERSON K., MERTIN J., MILANESE C.: Overview of azathioprine treatment in multiple sclerosis. The Lancet 338: 1051-1055, 1991.