ABSTRACT
OBJECTIVE: To access the effect of Relatox, the first Russian botulinum toxin type A, in patients with chronic migraine (CM) and medication overuse (MO). MATERIAL AND METHODS: In phase IIIb single-blind randomized multicenter active-controlled parallel-group study, patients with CM were randomized to once intramuscular injections of Relatox (n=101) or onabotulinumtoxin A injections - Botox (n=108). This subgroup analysis evaluated the percentage of patients who transition from medication overuse to non overuse status from baseline; mean changes in the number of headache days, migraine headache days, acute headache medication intakes days, headache intensity, proportion of patients who had a ≥50% reduction in headache days, proportion of the patients with severe (≥60) Headache Impact Test-6 score and with a severe (≥21) MIDAS score in a 28-day periods in each treatment among patients with baseline acute medication overuse via repeated measures. RESULTS: Of 209 patients with CM, 100% met medication overuse criteria. Relatox and Botox demonstrated significant improvement for overall least squares mean change in headache days, migraine headache days, headache intensity; and headache-related disability and quality of life in CM patients with baseline MO, without differences between the groups. 75% and 70% patients in the Relatox and Botox groups, respectively, achieved ≥50% reduction in headache days from baseline (OR 1.58, CI 95% 0.84; 3.02, p=0.155). Furthermore, Relatox and Botox significant reduced average medication overuse rates in patient with CM and MO at baseline. 62% of patients in the Relatox group and 48% of patients in the Botox group transitioned from medication overuse to non overuse status compared from baseline (OR 2.07, CI 95% 0.91; 4.62, p=0.044). Relatox group had greater reductions than the Botox group in the percentage of patients with acute migraine-specific medication (triptan) overuse (p=0.050). CONCLUSION: The results demonstrate highly prevalent of medication overuse among individuals with CM. This analysis provides evidence that the Russian botulinum toxin type A Relatox significantly improves measures of headache symptoms, quality of life and headache-related disability, and also significantly greater, compared to Botox, reduces migraine-specific medication consumption in patients with chronic migraine who overuse acute medications.
Subject(s)
Botulinum Toxins, Type A , Migraine Disorders , Humans , Botulinum Toxins, Type A/therapeutic use , Headache , Migraine Disorders/drug therapy , Prescription Drug Overuse , Quality of Life , Single-Blind MethodABSTRACT
OBJECTIVE: To access the efficacy and safety of the first Russian botulinum toxin type A (Relatox) as a headache prophylaxis in adult with chronic migraine (CM). MATERIAL AND METHODS: The randomized, one-blind, multicenter, active-controlled, parallel-group trial study involved 209 patients with CM aged from 19 to 65 years. The patients were randomized to injections of the Russian botulinum toxin type A - Relatox (n=101) or onabotulinumtoxinA injections - Botox (n=108). The duration of the study was 16 weeks, which included five visits of patients every 4 weeks. Relatox and Botox were injected once into seven muscle groups of the head and neck at a dose of 155-195 units. Primary efficacy variable was mean change from baseline in frequency of headache days after 12 weeks. Secondary efficacy variables were mean changes from the baseline to week 12 in frequency of migraine days, acute headache pain medication intakes days; headache intensity; proportion of patients achieving ≥50% reduction from baseline in headache days, the proportion of the patients with medication overuse, the proportion of the patients with severe (≥60) Headache Impact Test-6 score and with a severe (≥21) MIDAS score. RESULTS: Analyses demonstrated a large mean decrease from baseline in frequency of headache days, without statistically significant between-group differences Relatox vs Botox at week 12 (-10.89 vs -10.06; p=0.365) and at other time points. Significant differences from baseline were also observed for all secondary efficacy variables at all time points without differences between the groups. The proportion of patients achieving ≥50% reduction from baseline in headache days was 75.0% and 70% in the Relatox and Botox groups, respectively (OR, CI 95% 1.58 [0.84; 3.02], p=0.155). Adverse events (AE) occurred in 15.8% of Relatox patients and 15.7% of Botox patients (p=1.000). No unexpected AE were identified. CONCLUSION: The results demonstrate that the first Russian botulinum toxin type A (Relatox) is an effective prophylactic treatment for CM in adult patients. Relatox led to significant improvements from baseline in multiple measures of headache symptoms, headache-related disability and quality of life. For the first time, a comparative analysis of two botulinum toxin type A products in parallel groups showed no less (not inferior) efficacy and safety of Relatox relative to Botox in the treatment of CM in adults.
Subject(s)
Acute Pain , Botulinum Toxins, Type A , Migraine Disorders , Adult , Humans , Botulinum Toxins, Type A/adverse effects , Headache , Migraine Disorders/drug therapy , Quality of Life , Young Adult , Middle Aged , AgedABSTRACT
OBJECTIVE: To analyze mutations and polymorphisms in exons 2, 7, 8, 9, 10 and 11 of the glucocerebrosidase (GBA) gene in patients of the Krasnoyarsk region diagnosed with Parkinson's disease (PD). MATERIAL AND METHODS: Seventy-five patients with sporadic and familial forms of PD were examined. Genomic DNA was isolated from the whole blood of patients. The above mentioned exons of GBA were analyzed using Sanger sequencing. RESULTS: Various changes in the DNA structure of GBA were detected in 11 patients, thus, the overall frequency of variants was 14.7%, and the frequency of pathologically significant mutations (p.L444P, p.D409H, p.H255Q) was 5.3%. CONCLUSION: The frequencies of variants in GBA, one of the most common high-risk factors for PD, in patients of the Krasnoyarsk region turned out to be quite high and comparable to that in patients in other populations of the world. Thus, screening for GBA mutations is relevant for PD patients living in the Krasnoyarsk region as part of genetic counseling at present, and in the future it may be necessary for personalized treatment.
Subject(s)
Glucosylceramidase , Parkinson Disease , Humans , Genetic Predisposition to Disease , Glucosylceramidase/genetics , Mutation , Parkinson Disease/genetics , Polymorphism, GeneticABSTRACT
OBJECTIVE: To study tremor and olfactory dysfunction in patients with Parkinson's disease (PD), patients with essential tremor and healthy people for the differential diagnosis and to verify the hypothesis on the inverse dependence between tremor and olfactory dysfunction. MATERIAL AND METHODS: Olfactory dysfunction was studied in 45 patients with PD, 40 patients with essential tremor and 64 healthy controls. Tremor was studied in 90 people, including 30 controls and 30 patients with PD and essential tremor. The olfactory function was tested with Sniffin' Sticks test. Tremor parameters were studied with wireless monitoring instrument for electrophysiological signals record, where three essential data flows have been recorded: electromyogram, gyroscope and acceleration. The instrument recorded the frequency and amplitude of each parameter. The data were analyzed with IBM SPSS Statistica 2.3 software using standard methods. Besides, non-linear statistics using ViDaExpert software with elastic map technique was utilized. RESULTS AND CONCLUSION: The elastic map perfectly separated the patients with PD and essential tremor, as well as healthy controls. Three clusters were observed. The analysis of composition of the clusters proved the better quality of olfactory function of the patients with essential tremor compared to the patients with PD. This bias confirms the hypothesis on the inverse dependence between the tremor level and olfactory dysfunction.
Subject(s)
Essential Tremor , Parkinson Disease , Diagnosis, Differential , Essential Tremor/diagnosis , Humans , Parkinson Disease/complications , Parkinson Disease/diagnosis , Smell , Tremor/diagnosisABSTRACT
In this article, non-drug methods of treatment of Parkinson's disease are reviewed. Particular attention is given to the motor symptoms of disease, specifically to gait disorders. Information about objective methods of gait impairment is presented. Own results that confirm the effect of a method of tempo-rhythmical correction of walk in patients with Parkinson's disease (PD) and vascular parkinsonism as well as a device for assessment of gait parameters developed by the authors are analyzed. The efficacy of other methods of gait correction using external cues, study design and level of evidence are analyzed as well. Information about possibilities of physical therapy and ergotherapy for correction of different symptoms of Parkinson's disease is presented. Positive and negative results of transcranial magnetic stimulation, light therapy and transcranial micropolarization in PD are analyzed. Basis non-drug methods of PD treatment, which currently have insufficient level of evidence (methods of mental relaxation and auditory training, methods of whole body vibration (vibromassage), laser therapy (photoacoustic therapy), acupuncture), are described in brief. Perspectives of the method of gait recovery in PD using tempo-rhythmic correction are emphasized.
Subject(s)
Parkinson Disease/therapy , Walking , Humans , Mobility Limitation , Parkinson Disease/diagnosis , Parkinson Disease/physiopathology , Relaxation Therapy , Transcranial Magnetic StimulationABSTRACT
OBJECTIVE: To evaluate the effectiveness of the method of tempo-rhythmic correction (TRC) of gait on slowing of the disease progression in patients with Parkinson's disease (PD). MATERIAL AND METHODS: Authors have used the device to determine step-speed performance parameters, method TRC of gait, a quality of life questionnaire (PDQ-39). RESULTS: The method of TRC improved gait and quality of life in patients with Parkinson's disease, reduced the pharmacoeconomic cost of treatment. CONCLUSION: A neuroprotective effect of the method of TRC may take place due to increasing the interval between PD stages, more recent emergence of new symptoms.
Subject(s)
Exercise Therapy/methods , Gait Disorders, Neurologic/rehabilitation , Gait/physiology , Parkinson Disease/rehabilitation , Aged , Aged, 80 and over , Female , Gait Disorders, Neurologic/etiology , Humans , Male , Middle Aged , Parkinson Disease/complications , Periodicity , Quality of Life , Surveys and QuestionnairesABSTRACT
Thirty patients with Parkinson's disease (PD) and 30--with vascular parkinsonism (VP) have been studied. A soft-hardware-controlled complex "Dorozhka" elaborated previously by the authors was used to assess objectively the step length. The coefficient of step length variability (CSLV) which normal value is about 1 has been calculated. A method of tempo-rhythmic correction of gait including the synchronization of step with the rate of individually tailored exogenic sound stimulation has been applied. The dose of antiparkinsonian drugs was not changed during the rehabilitation. The decrease of mean step length and CSLV in patients with PD and VP was found. There were differential-diagnostic differences between individual gait profiles of PD and VP patients: patients with PD had the relatively even decrease of the length of all steps and in patients with VP the initiation of gait with the following increase of step length was affected. The significant increase of step length and CSLV (p<0.01), improvement on GABS and PDQ-39 scales were observed during and after the tempo-rhythmic correction of gait. The improvement of gait was correlated mostly with the increase of CSLV (two-fold in PD and 3-fold in VP). Therefore, the assessment of step variability allows to objectively differentiate the gait in patients with PD and VP and the method of tempo-rhythmic correction of gait with sound stimulation allows to improve significantly parameters of gait and patient's quality of life without changing the dose of antiparkinsonian drugs.
Subject(s)
Exercise Therapy/instrumentation , Gait Disorders, Neurologic/rehabilitation , Parkinson Disease, Secondary/complications , Parkinson Disease/complications , Aged , Antiparkinson Agents/administration & dosage , Combined Modality Therapy , Female , Gait Disorders, Neurologic/drug therapy , Gait Disorders, Neurologic/etiology , Humans , Levodopa/administration & dosage , Male , Middle AgedABSTRACT
Thirty-five patients with vestibular (25) and cerebellar (10) ataxy were medicated by betacerc during 21 days. A status of balance function was estimated, using stabilometric complex MBN "Biomechanika", before and after the treatment course. After the end of the treatment, symptoms of static ataxy and vertigo were reduced. An analysis of stabilogramm has confirmed a tendency to normalization of static balance parameters as a result of betacerc treatment of vestibular and cerebella types of ataxy, with significant decrease of general length of the way, area of support and velocity of gravity center displacement.
Subject(s)
Ataxia/drug therapy , Betahistine/therapeutic use , Histamine Agonists/therapeutic use , Vasodilator Agents/therapeutic use , Vertigo/drug therapy , Aged , Aged, 80 and over , Ataxia/diagnosis , Ataxia/etiology , Betahistine/administration & dosage , Cerebellar Ataxia/diagnosis , Cerebellar Ataxia/drug therapy , Female , Histamine Agonists/administration & dosage , Humans , Male , Middle Aged , Syndrome , Time Factors , Vasodilator Agents/administration & dosage , Vertigo/diagnosis , Vertigo/etiologyABSTRACT
A new method for treating amblyopia is proposed, making use of the phenomenon of polarized light interference. It helps act simultaneously on the brightness, contrast frequency, and color sensitivity in response to patterns. The method was used in the treatment of 36 children. In group 1 (n = 20) it was combined with the traditional methods. Such treatment was more effective than in controls treated routinely. Group 2 consisted of 16 children in whom previous therapy was of no avail. Visual function was improved in 7 of them.