Quality of Life Assessment in Patients with Multiple Sclerosis Receiving Interferon Beta-1a: A Comparative Longitudinal Study of Avonex and Its Biosimilar CinnoVex.

Background. Multiple sclerosis (MS) is an autoimmune inflammatory disease of central nervous system (CNS). MS affects quality of Life (QOL) due to physical disability and other associated problems. Disease-modifying agents like interferon beta (IFNB) have been widely utilized in this patient population; however, their frequency, route of administration, side effects, high cost, and also the question of whether they are truly beneficial for longer-term outcomes and QOL need to be further investigated. Objectives. To assess QOL in patients with multiple sclerosis receiving interferon beta-1a (Avonex or CinnoVex) and in order to compare QOL in groups receiving Avonex and CinnoVex, respectively, also, to evaluate whether the more cost-effective biosimilar form of IFNB (CinnoVex) has the same effect on QOL and can be substituted for Avonex. Methods. We conducted a 30-month, nonrandomized longitudinal study and recruited a total of 92 patients diagnosed with relapsing-remitting MS. The patients were distributed in Avonex and CinnoVex groups with 46 patients in each group. Quality of life was assessed by means of MSQOL-54 questionnaire, four times a year, at baseline and at months 4, 8, and 12 of the study. Results. Mean age ± SD was 30.5 ± 8.9 and 32.3 ± 9.0 years in Avonex and CinnoVex groups, respectively, and P value of gender was different (P value : 0.036). The physical health composite scores were 61.8 and 59.8 (P values 0.677 and 0.884) for Avonex and CinnoVex groups, in that order. The results of the study revealed no significant difference between the two groups with regard to physical health, health perception, energy, and role limitations due to physical problems, pain, sexual and social function, and physical health distress scores. Further, interferon therapy did not significantly impact patients' QOL after a year of treatment with either Avonex or CinnoVex. Conclusions. According to the present study, treatment with IFNB (Avonex or CinnoVex) did not affect QOL during a year of therapy. Further studies with longer follow-up periods are required to assess the value of interferons on long-term outcomes and patient's QOL.

Safety and Efficacy of MLC601 in Iranian Patients after Stroke: A Double-Blind, Placebo-Controlled Clinical Trial.

Objective. To investigate the safety and efficacy of MLC601 (NeuroAid) as a traditional Chinese medicine on motor recovery after ischemic stroke. Methods. This study was a double-blind, placebo-controlled clinical trial on 150 patients with a recent (less than 3 month) ischemic stroke. All patients were given either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard stroke treatment for 3 months. Results. Sex, age, elapsed time from stroke onset, and risk factors in the treatment group were not significantly different from placebo group at baseline (P > .05). Repeated measures analysis showed that Fugl-Meyer assessment was significantly higher in the treatment group during 12 weeks after stroke (P < .001). Good tolerability to treatment was shown, and adverse events were mild and transient. Conclusion. MLC601 showed better motor recovery than placebo and was safe on top of standard ischemic stroke medications especially in the severe and moderate cases.

Gabapentin for prevention of hypobaric hypoxia-induced headache: randomized double-blind clinical trial.

BACKGROUND: High-altitude headache (HAH) is a hypobaric hypoxia-induced symptom that is commonly experienced by newcomers to high-altitude areas. OBJECTIVE: To assess the efficacy of gabapentin in the prevention of HAH. METHODS: A placebo-controlled randomised trial was performed at an altitude of 3500 m. Two hundred and four unacclimatised 15-65-year-old (mean age (+/-SD), 31.5 (SD 11.7)) hotel guests were randomly assigned to a 600 mg single-dose of gabapentin capsule or identical placebo. HAH incidence and intensity were measured to assess gabapentin efficacy. Intention-to-treat analysis was performed. RESULTS: HAH incidence was not significantly different between subjects under gabapentin (44 (43.1%)) compared with placebo (56 (54.9%); p = 0.09). In contrast, moderate/severe HAH had a lower incidence in the gabapentin group (27 (26.5%)) versus the placebo group (42 (41.2%)), showing that gabapentin reduced HAH attack intensity (p = 0.03). CONCLUSIONS: Gabapentin was effective for the prevention of HAH and had satisfactory tolerability. TRIAL REGISTRATION NUMBER: ISRCTN26123577.