According to the results of studies, daily intramuscular injections of 2 ml of Milgamma for acute back pain in terms of the effect on pain syndrome are comparable to daily injections of 75 mg of diclofenac, and a pronounced positive effect against the background of Milgamma was achieved even more often, and side effects were practically absent. In another clinical study, 24 patients with type 1 and type 2 diabetes mellitus were treated with Milgamma compositum and the effectiveness was judged by the speed of the nerve impulse. The first two weeks the drug was prescribed at a dose of 320 mg, and then at 120 mg over the next 10 weeks. In the treatment group, the indicators of the speed of impulse conduction along the nerve (n. peroneus) significantly improved.
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Finally, the placebo-controlled randomized trial BENDIP (BENfotiamine in the treatment of DIabetic Polyneuropathy, 2008) also showed a positive effect of benfotiamine on the symptoms of diabetic polyneuropathy. Thus, by improving glucose metabolism and other (antioxidant) effects, benfotiamine expands the treatment options for patients with diabetic polyneuropathy. Benfotiamine improved vibration sensitivity, muscle strength, and neuropathic scores in both groups treated with benfotiamine alone or in combination with other B vitamins.
In 2008, the efficacy and safety of the use of B vitamins in the treatment of polyneuropathy became the subject of a systematic Cochrane review (Ang CD, M.J.M. Alviar, A.L. Dans et al., 2008). Most of detrol included in the review concerned the use of various doses of benfotiamine. The authors' conclusions regarding the effectiveness of this intervention were not unequivocally positive (pointing to insufficient number of studies that met the inclusion criteria for the review), but there was a good tolerability of the drugs, according to all sources included.
The 14 people who participated in the study used benfotiamine orally at a dose of 450 mg/day for 2 weeks and then at a dose of 300 mg/day for an additional 4 weeks. A significant decrease in pain, sensory and motor deficits, and an improvement in EMG parameters were noted. But studies on the efficacy and safety of the use of Milgamma and Milgamma compositum in children exist (the reason for their conduct was, obviously, the encouraging results of previous studies on adults), and the authors assess the results as certainly positive.
So, at the Department of Endocrinology of Childhood and Adolescence of the RMAPE of the Ministry of Health of the Russian Federation (G.I. Sivous, 2005), an open controlled study of the efficacy and safety of Milgamma compositum in children, adolescents and young adults with diabetic peripheral sensory-motor polyneuropathy was conducted.
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V.R. Chistyakova (2003) cites positive results of Milgamma's use in acute neurosensory hearing loss in children. It is noted that the use tolterodine drug in a complex of rehabilitation measures allows to reduce the duration of therapy for sensorineural hearing loss by 3 times while achieving a more stable therapeutic effect. Milgamma did not cause side effects and was well tolerated by patients.
The degree of compensation of carbohydrate metabolism was determined by the level of HbAc1, metabolic changes - by the level of NO metabolites (analytical method).