| Disease | TO DETECT ANY CONSISTANT PROGNOSTIC FACTOR THAT MIGHT HAVE INFLUENCED THE PRIMARY OR ANY SECONDARY OUTCOME MEASURES. THIS TRIAL DID NOT DEMONSTRATE ANY BENEFIT OF GALANTAMINE OVER PLACEBO IN THE TREATMENT OF PATIENTS WITH CFS.
THERE WAS NO STATISTICALLY SIGNIFICANT DIFFERENCES BETWEEN ANY OF THE GALANTAMINE OR PLACEBO GROUPS IN CLINICAL CONDITIONS ON THE CLINICIAN GLOBAL IMPRESSION SCALE, OR FOR ANY OF THE SECONDARY END POINTS. EXPLORATORY REGRESSION ANALYSIS FAILED
IMPACT QUESTIONAIRE, AND THE PITTSBURGH SLEEP QUALITY INDEX; CHANGES IN QUALITY OF LIFE ON THE NOTTINGHAM HEALTH PROFILE; AND ASSESSMENT OF PLASMA FREE CORTISOL LEVELS AND COGNITIVE PERFORMANCE ON A COMPUTER BASE BATTERY OF TESTS. AFTER 16 WKS
THE PRIMARY EFFICACY VARIABLE WAS THE GLOBAL CHANGE ON THE CLINICIAN GLOBAL IMPRESSION SCALE AFTER 4,8,12, AND 16 WKS OF TREATMENT. SECONDARY OUTCOMES WERE CHANGES IN CORE SYMPTOMS OF CFS ON THE CHALDER FATIGUE RATING SCALE, THE FIBROMYALGIA
GALANTAMINE HYDROBROMIDE; 86 PATIENTS, 5.0 MG; 91 PATIENTS, 7.5 MG; AND 86 PATIENTS, 10 MG (THESE PATIENTS RECEIVED MEDICINE IN THE TABLET FOR THREE TIMES PER DAY); A TOTAL OF 82 PATIENTS RECEIVED MATCHING PLACEBO TABLETS 3 TIMES PER DAY.
(N=2), SWEDEN (N=1), AND BELGIUM (N=1). THE STUDY INVOLVED 434 PATIENTS WITH CLINICAL DIAGNOSIS OF CFS (MODIFIED US CENTER FOR DISEASE CONTROL AND PREVENTION CRITERIA). A TOTAL OF 89 PATIENTS WERE RANDOMLY ASSIGNED TO RECEIVE 2.5 MG OF
TO COMPARE THE EFFICACY AND TOLERABILITY OF GALANTAMINE HYDROBROMIDE IN PATIENTS WITH CHRONIC FATIGUE SYNDROME A RANDOMIZED, DOUBLE-BLIND TRIAL CONDUCTED JUNE 1997 THROUGH 1999 AT 35 OUTPATIENT CENTERS IN UNITED KINGDOM (N=17), UNITED STATES (N=14), THE NETHERLANDS |