Lancet Neurology: The safety and effectiveness of the treatment of multiple sclerosis fatigue with amines, modaphines and methyls: a randomized, crossover, double-blind trial

Fatigue, defined as a subjective lack of physical or mental energy that an individual feels in their daily activities, is one of the most common and disabling symptoms of multiple sclerosis (MS) and affects more than 75% of patients at some point during the illness.
has a negative impact on health-related quality of life, with more than 50 percent of patients describing it as the most severe symptom of the disease.
is a subjective symptom that is difficult to distinguish from excessive daytime drowsiness or exercise and cognitive fatigue.
sleep disorders, thyroid insemuction and anemia can also exacerbate the severity of fatigue.
often associated with depression in patients with MS fatigue, and worsening MS may exacerbate chronic fatigue.
methylphenidate, modaphamine and amphetamine are commonly used drugs to relieve fatigue in MS patients, but evidence to support its efficacy is rare and contradictory.
goal of this paper is to compare the efficacy of these three drugs and placebos in PATIENTs with MS-related fatigue.
In this randomized, double-blind, placebo-controlled, phase four cross-trial trial, the researchers recruited MS patients who reported fatigue and improved fatigue impact scale (MFIS) scores of more than 33 points at two MS academic centers in the United States.
A total of 141 subjects were given oral acetaminophen (twice daily, up to 100 mg), modaphine (twice a day, up to 100 mg), methylphenidate (twice a day, up to 10 mg) or a placebo for 6 weeks at a time.
Of these, 35 patients were assigned to the macadamin, placebo, modaphetamine, and methylate sequences;
all patients received all four study drugs in turn, with a two-week interval between the two drugs.
the main efficacy indicators in this study were MFIS measured when taking the highest toned dose in the fifth week of each drug cycle, and analyzed using linear mixed-effect regression models.
data from 136 subjects were used for intent therapy analysis of the main results.
average of MFIS total score (95%CI) and maximum to-dosage at baseline: baseline 51.3 (49.0-53.6), placebo group 40.6 (38.2-43.1), King Kong The alkamine group 41.3 (38.8-43.7), the Modaphini group 39.0 (36.6-41.4), and the methylphenidate group 38.6 (36.2-41.0).
compared to the placebo group of 38 patients (31%), a higher proportion of the subjects were taking acetaminoamine (49 patients (39%)) and modalfinib (50 patients) Adverse events were reported at the time of 40%) and methylphenidate (51 patients (40%), including pulmonary embolism and myocarditis when taking acetaminophen, and MS deterioration requiring hospitalization when taking modaphe.
above, acetaminophen, modaphine, and methylphenidate are not superior to placebos (assessed by effective results) in improving MS fatigue and lead to more frequent adverse events.
Nourbakhsh, Bardia et al. Safety and efficacy of amantadine, modafinil, and methylphenidate for fatigue in multiple sclerosis: a randomised, placebo-controlled, crossover, double-blind trial. The Lancet Neurology, Volume 20, Issue 1, 38 - 48MedSci Original Source: MedSci Original Copyright Notice: All text, images and audio and video materials on this website that state "Source: Mets Medicine" or "Source: MedSci Original" are owned by Mets Medical and are not authorized to reproduce, and any media, website or individual may not reproduce them with the words "Source: Met Medical".
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