Background. Non-pharmacological treatments based on collagen as a dietary supplement are emerging as a new area of interest to support preventive or therapeutic effects in patients with osteoarthritis (OA). Aim. In a multicenter, prospective, double-blind, placebo-controlled, randomized study, to evaluate the effectiveness and safety of the use of the Artneo complex containing undenatured chicken collagen type II in patients with OA of the knee joints. Materials and methods. The study enrolled 212 outpatients from 12 centers in the Russian Federation with knee OA, stages II and III according to the Kellgren–Lawrence classification. The participants included 171 women (80.7%) and 41 men (19.3%), with an average age of 60.2±9.0 years (range: 40 to 75 years). The study population was randomly allocated in equal proportions into two groups using an interactive web response system (IWRS). Group 1 (Artneo) consisted of 106 patients who took one capsule of the drug once daily for 180 days. Group 2 (Placebo) also had 106 patients, with the dosage form and regimen identical to Group 1. During the treatment period, the following outcomes were assessed: WOMAC index, KOOS, pain according to VAS, quality of life using the EQ-5D questionnaire, and the need for NSAIDs. All patients underwent a clinical blood test, general urine analysis, biochemical blood test, and ultrasound examination of the affected knee joint. Results. In a prospective, double-blind, placebo-controlled, randomized study, it was demonstrated that the Artneo combination, containing undenatured chicken collagen type II, has a positive effect on all clinical manifestations of OA: it effectively reduces pain, stiffness, and improves the functional state of joints and quality of life. It has a good safety profile and is superior to placebo in all parameters studied. Conclusion. The results of the study confirm the good effectiveness and safety of the Artneo combination in patients with OA of the knee joints.

Objective: to analyze the extent of analgesic effect and to determine predictors of inadequate response to local therapy with non-steroidal antiinflammatory drugs (NSAIDs) in a prospective, comparative, randomized trial of the efficacy and safety of Artoxan® gel 1% versus Diclofenac gel 1% in patients with knee OA.Material and methods. The study included 60 patients with a definite diagnosis of stage II–III Kеllgren–Lawrence knee OA who fulfilled ACR criteria and were observed on an outpatient basis in V.A. Nasonova Research Institute of Rheumatology. Patients were 40–80 years old (mean 62.50±8.04 years), body mass index (BMI) 24.9±4.67 kg/m2 , median OA duration 5.7 [3;15] years. According to the randomization scheme, the patients were divided into two groups. In the 1st group (n=30), local therapy with 1% Artoxan gel was applied to the target area of the knee twice daily for 14 days. Patients in the 2nd group (n=30) were prescribed local therapy with the comparator drug, 1% Diclofenac gel with a similar application regimen. Patients in both groups were comparable in terms of the main parameters.Results and discussion. Patients in both groups showed a significant decrease in pain intensity in the target joint during walking according to the visual analogue scale (VAS) after two weeks of treatment (p <0.05). A decrease in pain (to mild or moderate) in the target joint to <40 mm according to VAS after 7 days of therapy reported 43.3% of patients in the 1st group, and 63.3% of patients after 14 days of therapy (p=0.09). In the 2nd group, 43.3 % of patients also reported a reduction in pain in the target joint to <40 mm according to VAS after 7 days of therapy, and after 14 days it was observed in 56.7% of cases (p=0.22). Although the differences between the groups did not reach statistical significance, a reduction in pain to <40 mm according to VAS and a high BMI (r= -0.28; p=0.029).Conclusion. The results of the study demonstrate a significant analgesic effect of local NSAIDs in knee OA. In most patients, pain was <40 mm according to VAS after 2 weeks of local NSAID therapy. At the same time, there was a tendency towards a higher frequency of pain reduction to <40 mm according to VAS in the group receiving local therapy with 1% Artoxan gel. It was concluded that excessive body weight and high BMI may be predictors of inadequate analgesic effect in patients with knee OA.

Despite the successes of conventional medicine, the search for optimal remedies for the treatment of osteoarthritis does not lose its relevance. Currently, new combination products are entering the market, combining well-studied pharmaceutical ingredients such as glucosamine and chondroitin sulfate with well-known and promising new nutraceutical components. Pharmaconutraceutical Theraflex Ultra refers to such drugs, and the possibilities of its effect on the symptoms and quality of life of patients are of great interest. To study the effect of Theraflex Ultra on clinical symptoms in comparison with the well-known drug Theraflex, an open randomized comparative observational study was organized at the V.A. Nasonova Research Institute of Rheumatology. Currently, intermediate results have been obtained after 1 month of using Theraflex Ultra, which demonstrate pronounced benefit and relief of symptoms, improvement of quality of life.

Local forms of non-steroidal anti-inflammatory drugs (NSAIDs) are characterized by a high safety profile due to low systemic absorption. They do not increase the risk of developing class-specific gastrointestinal, cardiovascular and kidney adverse events (AEs), which makes it possible to prescribe them even in severe comorbid pathology, which is typical for patients with osteoarthritis (OA). Objective : to evaluate the efficacy and safety of Artoxan gel (tenoxicam) 1% in comparison with Diclofenac gel 1% in patients with knee OA in a prospective comparative randomized trial. Material and methods . The study included 60 patients with Kellgren–Lawrence stages II–III knee OA, aged 41 to 78 years. The patients were randomly divided into two groups: the 1st group received Artoxan gel 1%, 5 cm 2 times a day for 14 days; 2nd – Diclofenac gel 1% according to the same scheme. During therapy, we assessed pain using a visual analog scale, the WOMAC index, quality of life using the EQ-5D questionnaire, satisfaction with therapy, and time to effect. Results and discussion . It has been demonstrated that local forms of NSAIDs have a positive effect on all clinical manifestations of OA: effectively reduce pain, stiffness, improve the functional state of the joints and quality of life. They also have a good safety profile and a fast symptomatic response. Comparison of the two groups showed that in patients receiving the local form of tenoxicam, there was a tendency to a more rapid and pronounced analgesic effect. Conclusion . The results of the study confirm the good efficacy and safety of local forms of NSAIDs.

Along with familial Mediterranean fever (FMF), it is now considered an autoinflammatory disease and gout. The commonality of the basic mechanisms of inflammation underlying the pathogenesis of FMF and gout predetermines the possibility of using similar therapies aimed at stopping and preventing seizures (colchicine and IL-1 inhibitors). A clinical case is presented describing the presence of a combination of FMF and gout in a patient. The patient was prescribed anakinra, which proved to be effective both as a treatment for FMF and gout. The appointment of an IL-1 inhibitor fully justified expectations: already after the first injection of anakinra, the intensity of swelling and pain in the joints decreased in the patient.

Objective: to evaluate the effect of the generic drug of zoledronic acid on bone mineral density (BMD) and markers of bone metabolism in patients with osteoporosis (OP), as well as possible long-term adverse reactions (AR) 12 months after drug administration.Patients and methods. The study included 30 postmenopausal women with OP (mean age 64±8 years) who signed an informed consent of participance in clinical observation. Patients received a single dose of generic zoledronic acid (5 mg) as a 15-minute infusion. All patients additionally took calcium and vitamin D. The dynamics of BMD and bone metabolism markers, as well as the safety and tolerability of the drug, were evaluated. Fractures that might have occurred during follow-up should have been reported as ARs.Results and discussion. During treatment with generic zoledronic acid, the increase in BMD in the lumbar region was 4.9% (p<0.0001), in the femoral neck –2.7% (p<0.01), and in the femur as a whole – 3.0% (p<0.0001). Positive dynamics (increase in BMD>2%) in the spine was detected in 26 (86.7%) patients, in the proximal femur – in 20 (66.7%) patients. There was a decrease in the intensity of pain in both the thoracic (by 62%; p=0.038) and lumbar (by 29%; p=0.022) spine. Three months after the administration of the drug, a decrease in the level of bone metabolism markers was revealed: CTX – by an average of 29.7%, and P1NP – by an average of 25.5%. ARs were post-dose reactions that occurred within the first 48 hours after drug infusion. Remote ARs, fractures of peripheral bones and vertebrae were not recorded.Conclusion. The use of the generic drug of zoledronic acid has demonstrated its positive effect on BMD and markers of bone metabolism, as well as safety.

Objective: assessment of safety and tolerability of a new generic drug of zoledronic acid (Osteostatics) in patients.Patients and methods. Clinical observation included 30 postmenopausal women aged 45 years and older (mean age 64±8 years). To determine the safety of the drug of zoledronic acid, all patients underwent biochemical blood test; to assess the tolerability, adverse effects (AE) associated with the administration of the drug were recorded. Fractures that may have occurred during follow-up were also required to be recorded as AE.Results and discussion. AE was reported by 15 (50.0%) patients. In 13 (43.3%) of them flu-like syndrome (FLS) was noted, including 12 with an increase in body temperature on average to 38.4 [38.0; 38.6] ° C, in 1 (7.7%) – with abdominal pain and nausea, 5 (38.5%) women noted myalgia and/or arthralgia, and 2 (15.4%) – redness and pain in the eyes. In patients who had not previously received bisphosphonate (BP) therapy, AEs were recorded in 62.5% of cases, and in those who had already received such treatment in 15.4%. In most cases, AEs occurred in the first 48 hours, and their duration averaged 2 days.Conclusion. The incidence of AE was 50.0%, which did not exceed that when using the original zoledronic acid in real clinical practice. The majority of AEs occurred in “naive” patients, developed in the first 2 days after drug administration, and resolved on average within the next 2 days.

Objective: to investigate the effect of diacerein (Diaflex) on some components of metabolic syndrome (MS) in patients with knee osteoarthritis (OA).Subjects and methods. The multicenter open-label prospective study covered 55 patients aged 45 to 74 years with Kellgren–Lawrence Stage II–III knee OA and MS, with a pain intensity of >40 mm on a visual analogue scale, and with a disease duration of 1 to 30 years. The therapy duration was 6 months: Diaflex 50 mg/day for one month, then 50 mg twice daily for 5 months; the patients were followed up for the succeeding 3 months. During each visit, the efficiency and safety of treatment were evaluated; moreover, blood biochemical values were taken into account at the beginning and at the end of therapy.Results and discussion. There was a statistically significant improvement in WOMAC index (all its components and total value) and quality of life using EQ-5D in the first month of therapy and throughout the follow-up. Analysis based on the OMERACT-OARSI criteria indicated high treatment response rates in 92.5% of the patients at the end of therapy and in 92.2% three months after its completion. The body mass index and levels of low-density lipoproteins, triglycerides, glucose, and uric acid significantly decreased during treatment. Adverse events were detected in a small number (5.5%) of cases.Conclusion. Diaflex is an effective and safe drug in the treatment of knee OA in patients with MS. During therapy, there is a rapid and considerable reduction in pain and stiffness and an improvement in the functional state. In addition, the pleiotropic effects of the drug make it possible not only to effectively reduce weight, but also perhaps to improve the course of MS-associated conditions by the observed corrections of metabolic disturbances.

Background Intensive pain is one of key predictors of OA progression, although it remains unclear which key factors are responsible for the development of intensive pain. Objectives To study the risk factors for developing intensive knee pain in OA pts in a multicenter prospective study. Methods A prospective 5 year study included 185 female-patients from 6 RF territorial entities aged 40–75 y. with confirmed knee OA (ACR criteria), stages I-III (Kellgren J.-Lawrence J), who signed an informed consent. Mean age was 59±8,1 y., the age at knee pain onset was 49±8,7 y., and average OA duration was 11±8,4 y. Individual annual medical file included patient’s anthropometric parameters, case history, clinical examination findings, evaluation of knee pain intensity by VAS, WOMAC scale, the knee joint status, comorbidities and therapeutic modalities used during the follow up period. Instrumental diagnostic methods included plain radiography of knee joints, dual energy X-ray absorptiometry (DEXA) of the lumbar spine, femoral neck and of subchondral bone of the hip and tibia, ultrasonography (US) and MRI examination of knee joints. Stage II of knee OA was documented in 135 (73%) out of 185 pts, and stage III – in 50 (27%). Statistica10.0 and SPSS 15.0 packages were used for statistical analysis. Results Based on pain intensity pts were divided into two groups: Group I – pts with more intensive pain (>70 mm VAS) – 16,8%, and Group II – pts with less intensive knee pain (<70 mm VAS) – 83,2%. Both groups were comparable in terms of age 58,8±7,68 vs 61,06±5,91 y., and disease duration 10(5–17 vs 12(6–18 y. Although, pts from Group I had statistically significantly higher body weight 82,7±13,8 vs 74,8±12 kg (p=0,002), higher pain estimations by WOMAC 374(348–382 vs 225(172–268 mm (p<0,0001), stiffness 100(80–125 vs 80(60–110 mm (p=0,01), FI 1102 (970–1238) vs 820(646–935) mm (p<0,0001) and total WOMAC 1541 (1462–1702) vs 1130(880–1291) mm (p<0,0001). Besides, pts from Group I had greater percentages of varus knee deformity – 80,6% vs 29,2% (RR=2,76, 95% CI 2,04–3,73, p <0,0001) and of H.valgus 87,1% vs 59,1% (RR=1,47, 95% CI 1,22–1,78, p=0,002). MRI showed higher rate of bone marrow oedema in medial tibia in Group I: 51,9% vs 31,1% (RR=1,67, 95% CI 1,07–2,59, p=0,03) compared to pts from Group II with less pronounced pain. A multivariate (discriminant) analysis showed that the most important risk factors for developing intensive knee pain in OA pts were: significant functional impairment, presence of knee varus deformity and Heberden’s nodes, cartilage abnormalities (MRI finding) in medial tibial compartment, familial OA. A model capable of predicting development of intensive knee pain in an individual patient with high accuracy (area under the ROC-curve 0910 (95% CI 0,860–0,961) has been developed based on identified RF and their coefficients. Model accuracy is 87%. Conclusions In a prospective multicenter study, using comprehensive instrumental modalities (knee radiography, ultrasonography, MRI and BMD of peripheral bones and subchondral hip and tibia) it has been demonstrated that intensive knee pain (>70 mm VAS) is caused by excessive functional impairment, presence of knee varus deformity, Heberden’s nodes, OA in parents, and cartilage destruction in the medial tibial compartment. Disclosure of Interest None declared

Objective/introduction. Evaluation of efficacy and safety of diacerein therapy in patients with knee joint osteoarthritis (OA) and metabolic syndrome (MS). Materials and methods. 55 outpatients (50 women and 5 men) with MS and stage 2-3 OA of knee joint according to Kellgren-Lawrence, with intensity of pain syndrome > 40 mm according to visual analogue scale (VAS) from 4 Russian Federation subjects were enrolled in the study. Average age of patients was 59.7 ± 7.3 years , mean BMI is 33 ± 5,49 kg/m2, the duration of the disease is 8 (5-10 years). Duration of the study was 9 months (6 months of therapy: 1 capsule (50 mg) per day for the first month, 2 capsules (100 mg) per day for the next 5 months, and follow-up for 3 months). Evaluation of the efficacy and safety of the treatment was conducted according to generally accepted criteria. All patients were underwent biochemical tests at the beginning and at the end of therapy. Results. The study resulted in a statistically significant reduction in pain when walking according to VAS as early as in 1 month from the beginning of treatment; the further significant improvement was observed during the entire 6-month therapy. Withdrawal of therapy (the observation period was 3 months) didn’t increase the pain syndrome. Evaluation according to Womac index also revealed identical regularity. A statistically significant improvement in the quality of life according to EQ-5D was also identified during the whole period of observation. By the end of the therapy, 92.5% of the patients were OMERACT - OARSI - responders and 64.2% of patients had completely withdrawn from NSAID. Against the background of the therapy, there was a significant decrease in BMI, LDL, TG, glucose, uric acid levels. Conclusion: The data obtained make it possible to recommend diacerein as a basic therapy for OA in patients with MS. On the background of therapy, the patients showed statistically significantly reduction in pain, stiffness, the need for NSAIDs, improved the quality of life and the function of the joints. In addition, the body weight decreases reliably, the lipidogram, carbohydrate and protein metabolism parameters also improved.

Objective: to evaluate the efficacy, tolerability, and safety of intra-articular hyaluronic acid (hyalurom) in patients with knee osteoarthritis (OA).Patients and methods. A 6-month prospective trial enrolled 20 women aged 45–75 years (61±7 years) with primary knee OA of Kellgren–Lawrence grades II (85%) and III (15%) who needed nonsteroidal anti-inflammatory drugs (NSAIDs). The disease duration averaged 6.6±2.4 years. The mean body mass index was 33±5 kg/m2. Intra-articular administration of hyalurom was made; its cycle included 3 injections at a 1-week interval; a further follow-up was performed during 6 months. All the participants completed the trial.Results. In the first month of therapy, its effect was developed in the majority (75%) of the patients. There was a substantial reduction in total WOMAC scores by an average of 29% at 1 month, by 27% at 3 and 6 months (p<0.01); pain by 35% at 1 month, by 32% at 3 months, and by 36% at 6 months (p<0.01); stiffness, by 37, 38, and 39% (p<0.01); and functional failure by 29, 25, and 23%, respectively (p<0.01). The effect of therapy in most (80%) patients persisted throughout the follow-up period; only 10% of patients continued to take NSAIDs with the same frequency at 6 months; 60% used them on-demand, and 30% did not need NSAID therapy. No adverse reactions associated with the therapy performed were detected during the follow-up period.Conclusion. Hyalurom has a significant symptomatic effect and a good tolerability in the treatment of knee OA.

Diacerein (D) belongs to a class of symptomatic slow-acting agents, has an original mechanism of action, and is widely used as a diseasemodifying antirheumatic drug to treat osteoarthritis (OA) in Russia and many countries of the world. The ability of the drug to affect the main symptoms and progression of OA has been shown in a number of well-organized clinical trials. Objective: to evaluate the efficacy and safety of D in patients with knee OA. Patients and methods . An open-label trial evaluating the efficacy and safety of D (diaflex) in patients with knee OA was conducted in accordance with the multicenter program «Osteoarthrosis: Assessment of Progression in Real Clinical Practice». The trial included 80 patients of both sexes with Stage II–III knee OA; mean age, 60.8±6.8 years (47–75 years); mean body mass index, 31.8±5.9 kg/m2; disease duration, 10.3±5.7 years (2–30 years). The duration of the trial was 9 months (6 months of therapy and 3 months of follow-up). Results . There was a statistically significant reduction in visual analog scale pain on walking just 1 month after therapy initiation (57.1±9.7 and 44.7±13.9 mm; p<0.0001) and a further significant improvement throughout the 6-month therapy. Pain did not increase after the drug was discontinued (the follow-up period was 3 months). The same pattern was observed in the assessment of the WOMAC index (pain during early therapy, 243.8±73.9; pain at the end of therapy, 137.5±78.9; stiffness, 97.8±41.1 and 57.7±38.6; functional failure, 875.8±250.4 and 525±305.7 respectively; p<0.0001). Statistically significantly improved quality of life indicators measured by EQ-5D were noted throughout the follow-up period: 0.43±0.23 at the beginning of therapy, 0.61±0.14 at its end, and 0.63±0.11 at 3 months following treatment completion (p<0.0001). By the time of therapy completion, 71.3% of the patients completely refused to take nonsteroidal anti-inflammatory drugs (NSAIDs). Both the patient and the physician evaluated the efficiency of treatment identically. By the end of therapy, 87.5% of the patients were observed to have improvement. Adverse reactions (ARs) were recorded in 10 (12.5%) patients and mainly associated with more frequent stools; ARs were not a cause of treatment interruptions or protocol deviations. Conclusion. Diaflex has a good symptomatic and anti-inflammatory effect: the therapy statistically significantly reduces pain, stiffness, and the need for NSAIDs and improves quality of life and joint function. The drug has a good safety profile and after-effects, which is seen at least 3 months after therapy discontinuation.

Objective. To evaluate the efficacy, tolerability and safety of the drug Diacerein (Artrocker) in patients with osteoarthritis (OA) of the hip joints after continuous administration for 4 months and the duration of the drug effects for 2 months. Materials and methods. The study included 30 patients with significant (by ARA criteria) OA of the hip joints of Stage 2-3 according to Kellgren-Lawrence. The average age of patients was 63.6 ± 5.8 years. Patients took Artrocker for the first 2 weeks by 50 mg (1 capsule), and then by 100 per day (2 capsules). Evaluation of the therapy effectiveness was evaluated by the WOMAC index (pain, stiffness and functional impairment), dynamics of the index in % relative to the initial visit; the health questionnaire EQ-5D; the test «get up and go», assessment of the therapy effectiveness by physician and patient overall assessment of tolerability. Results. The decrease in the intensity of pain and stiffness on the WOMAC index were noted by the end of the first month of therapy and persisted for the whole observation period (245,6 ± 64,3 and 142.5 ± 67,3 and 97.8 ± 35.6 and 64,3 ± 30,1; p = 0,000 respectively). Significant improvement of the functional status of the joints was achieved at the end of the treatment period, which remained until the end of observation (854,6 ± 306,8 and 637,2 ± of 253.7, p = 0.000). The decrease in total WOMAC index was recorded at visit 3 (1182,6 ± 834,2 358,6 and ± 322,1 p = 0,000). Statistically significant improvement of the test «get up and go» assessment of general health and quality of life according to EQ-5D were observed from the third visit to the end of the observation. Evaluation of tolerance to treatment done by a patient and a doctor did not differ from each other: the excellent tolerability was noted for 27.5% of patients, good-65,5%, and satisfactory - for 7% of patients. Only one adverse event – nausea – was noted in the study, which was the reason for the discontinuation of the drug and withdrawl of the patient from the study.

Diacerein (D) belongs to a class of symptomatic slow-acting agents, has an original mechanism of action, and is widely used as a diseasemodifying antirheumatic drug to treat osteoarthritis (OA) in Russia and many countries of the world. The ability of the drug to affect the main symptoms and progression of OA has been shown in a number of well-organized clinical trials.Objective: to evaluate the efficacy and safety of D in patients with knee OA.Patients and methods. An open-label trial evaluating the efficacy and safety of D (diaflex) in patients with knee OA was conducted in accordance with the multicenter program «Osteoarthrosis: Assessment of Progression in Real Clinical Practice». The trial included 80 patients of both sexes with Stage II–III knee OA; mean age, 60.8±6.8 years (47–75 years); mean body mass index, 31.8±5.9 kg/m2; disease duration, 10.3±5.7 years (2–30 years). The duration of the trial was 9 months (6 months of therapy and 3 months of follow-up).Results. There was a statistically significant reduction in visual analog scale pain on walking just 1 month after therapy initiation (57.1±9.7 and 44.7±13.9 mm; p<0.0001) and a further significant improvement throughout the 6-month therapy. Pain did not increase after the drug was discontinued (the follow-up period was 3 months). The same pattern was observed in the assessment of the WOMAC index (pain during early therapy, 243.8±73.9; pain at the end of therapy, 137.5±78.9; stiffness, 97.8±41.1 and 57.7±38.6; functional failure, 875.8±250.4 and 525±305.7 respectively; p<0.0001). Statistically significantly improved quality of life indicators measured by EQ-5D were noted throughout the follow-up period: 0.43±0.23 at the beginning of therapy, 0.61±0.14 at its end, and 0.63±0.11 at 3 months following treatment completion (p<0.0001). By the time of therapy completion, 71.3% of the patients completely refused to take nonsteroidal anti-inflammatory drugs (NSAIDs). Both the patient and the physician evaluated the efficiency of treatment identically. By the end of therapy, 87.5% of the patients were observed to have improvement. Adverse reactions (ARs) were recorded in 10 (12.5%) patients and mainly associated with more frequent stools; ARs were not a cause of treatment interruptions or protocol deviations.Conclusion. Diaflex has a good symptomatic and anti-inflammatory effect: the therapy statistically significantly reduces pain, stiffness, and the need for NSAIDs and improves quality of life and joint function. The drug has a good safety profile and after-effects, which is seen at least 3 months after therapy discontinuation.

Динамическая электронейростимуляция (ДЭНС) - вид ЧЭНС, основанный на применении слабых (200-400мкА), низкочастотных (10-200 Гц) импульсных токов, изменяющих форму в зависимости от электрического сопротивления (импенданса) в подэлектродном участке кожи, для воздействия на биологически активные зоны и точки. Цель исследования: изучить клиническую эффективность терапии аппаратом ДиаДЭНС-ПК в лечении остеоартроза коленных суставов (ОА КС). Материалы и методы. Проведено многоцентровое рандомизированное двойное слепое плацебо-контролируемое исследование. Включено 132 пациента с ОА КС с интенсивностью болевого синдрома более 40 мм по ВАШ, с индексом Лекена > 4 и < 12. Группа ДЭНС (66 чел.) получала лечение аппаратом ДиаДЭНС-ПК с помощью выносного электрода - аппликатора на область коленного сустава- мишени в режиме стимуляции - «Терапия», частотой 77 Гц, уровнем мощности - 15 единиц. Курс лечения - 10 процедур, по 30 минут. Группы были исходно сопоставимы по оцениваемым показателям кроме возраста: пациенты группы плацебо были старше группы ДЭНС в среднем на 3,2 года. Осмотр и опрос пациентов проводился до и после 1,3,6,10й процедур лечения, опрос на визитах наблюдения через 2 и 4 недели после окончания курса терапии. Первичная конечная точка исследования: интенсивность боли по ВАШ (мм), вторичные: тест «Встань и иди» (сек), альгофункциональный индекс Лекена, индекс WOMAC. Результаты. Статистически значимое различие в уменьшении боли по ВАШ в сравниваемых группах наблюдалось после первой процедуры лечения (р=0,014) и далее сохранялось по окончании 3й (р=0,018), и 6й процедур (р=0,047) и на визите наблюдения через 2 недели после окончания лечения (р=0,003). Индекс Лекена статистически значимо различался между группами на 10м последнем визите лечения (р=0,001) и через 4 недели на визите наблюдения (р=0,001). Статистически значимая разница между группами показателя теста «Встань и иди» наблюдалась после 6й процедуры лечения (р=0,041), перед 10-й процедурой (р=0,010), и на визитах наблюдения через 2 недели (р=0,018) и через 4 недели (р=0,025). Индекс WOMAC статистически достоверно не различался между группами. Суточная потребность пациентов в нестероидных противовоспалительных препаратах статистически значимо не различалась между группами. Врачи и пациенты достоверно положительно оценили эффективность лечения в конце курса терапии в ДЭНС группе: при оценке пациентами (р=0,004), при оценке врачами (р <0,0001). ДЭНС терапия хорошо переносилась пациентами, частота нежелательных явлений статистически достоверно не различалась между группами (р=0,999). Заключение: ДЭНС-терапия - эффективный способ лечения ОА КС, купирующий болевой синдром и улучшающий функцию суставов.

Aim. To study the clinical efficacy and safety of the combined medication ARTRA MSM FORTE (400 mg chondroitin sulfate, 500 mg glucosamine hydrochloride, 300 mg methylsulfonylmethane (MSM), and 10 mg sodium hyaluronate calculated with reference to hyaluronic acid) in patients with knee osteoarthritis (OA).Subjects and methods. The study enrolled 100 patients with Kellgren-Lawrence grades 2-3 knee OA with obvious pain syndrome (pain intensity scores on a visual analog scale (VAS)) equal or greater than 40 mm during walking. The patients were examined monthly; changes in WOMAC index scores, Get-Up and Go test results, the efficiency of therapy in the opinion of a physician and a patient, and quality of life according to the EQ-5D questionnaire were estimated. They were randomized into 2 groups: 1) 50 patients took ARTRA MSM as 2 tablets daily for one month, then 1 tablet daily; 2) 50 received ARTRA in accordance with the same scheme. Clinical examination was performed before and at 30, 60, 90 and 120 days of the study.Results. All the 100 patients completed treatment. Analysis of the results showed a significant decrease in pain on VAS in both groups. Reduced pain intensity was observed by the end of the first month of therapy and remained throughout the follow-up. Both medications diminished stiffness just after a month of therapy. They alleviated joint function and reduced total WOMAC scores at Visit 2. Analysis of Get-Up and Go test results indicated significantly less spent time in both groups; however, these differences reached the statistical significance in the ARTRA MSM group just at Visit 2 and in the ARTRA group only at Visit 3. The effect ARTRA MSM occurred more rapidly. This was confirmed by the patient and physician evaluations of the efficiency of treatment, which indicated that its positive effect occurred more rapidly in the ARTRA MSM group (p=0.02). Estimation of EQ-5D scores also showed positive results: there was a significant improvement of these indicators in the two compared groups at Visit 3. Both medications were very well tolerated and caused no adverse reactions; therapy was not discontinued.Conclusion. ARTRA MSM is rapider in its effect: a significant improvement in Get-Up and Go test results and patient and physician evaluations of the efficiency of treatment. Additional interviews of the patients taking ARTRA MSM demonstrated that 36 (72%) of them reported a prompter pain relief than the ARTRA-treated patients. ARTRA MSM may be recommended for the treatment of OA in clinical practice.

Dynamic electroneurostimulation (DENS) is a type of percutaneous electroneurostimulation with a differentiation approach to choosing exposure areas and to optimizing electrocutaneous therapeutic action on the reflexogenic areas and acupuncture points for analgesia and for the treatment of functional disorders.Objective: to study the clinical efficiency and safety of therapy using a DiaDENS-PC apparatus in the treatment of knee osteoarthritis (OA).Subjects and methods. A multicenter randomized double-blind placebo-controlled study was conducted in 132 knee OA patients with pain value above 40 mm on visual analogue scale (VAS) and Lequesne’s index of 4–12. In a study group (n = 66), DENS was carried outwith a DiaDENS-PC apparatus using a trailing electrode applicator to the knee target in a Therapy stimulation mode at a frequency 77 Hz, a power of 15 units. In the placebo group, the similar procedure was performed with a switched-on placebo apparatus that did not differ in appearance from the working apparatus; but produced no electrical pulses. The treatment cycle consisted of 10 sessions lasting 30 min. Changes in Lequesne’s algofunctional index were primary end point. The results of the Get-Up to Go test (in seconds) and changes pain on VAS and WOMAC were used as secondary end points.Results and discussion. Both groups showed a statistically significant reduction of painand improvement of Get-Up and to Go test results by the end of the treatment course (p < 0.0001). Therewas a statistically significant difference in pain in the compared groups after a treatment session during the first (p = 0.037) and second (p = 0.010) visits. The analgesic effect of therapy was observed to persist in the DENS group 2 weeks (p = 0.006) and 1 month (p = 0.070) after treatment termination. After 10 sessions, there was a statistically significant difference between the groups in the Get-Up and Go test (p = 0.033) and Lequesne’s index (p = 0.022). Both groups exhibited a significant decrease in the total WOMAC scores. In the DENS group, positive changes in all subscales were statistically significant starting from the second visit whereas in the control group, the total WOMAC scores improvedonly at the expense of the pain subscale.

Adherence to treatment with antiosteoporotic drugs is one of the most important factors contributing to their efficacy during longterm therapy. The adherence is assessed by two main lines: firstly, how long a drug is taken and, secondly, whether its dosage regimen is adhered.Subjects and methods. The paper gives the data of a 12-month prospective follow-up study of 40 women with postmenopausal osteoporosis (OP) who initiated treatment with the biological agent denosumab.Results and discussion. After the 12-month follow-up, the significant bone mineral density increase was 4.9% in the lumbar spine, 3.2% in the femoral neck, and 3.0% in the total hip. The previous administration of other antiosteoporotic drugs did not lower the efficiency of denosumab therapy. There were no cases of osteoporotic fractures during 1-year follow-up. 95% of the patients received two denosumab injections (an annual cycle); moreover, 90% of the women were noted to adhere to the dosage regimen. Age, marital status, level of education, time taken to reach the clinic, parental femoral fractures, a history of fractures, duration of OP, and previous therapy had no impact on treatment adherence during 12 months.Conclusion. The one-year prospective follow-up study of the outpatients demonstrated that denosumab was an effective and safe agent for the treatment of patients with postmenopausal OP and its dosage regimen implying its rare subcutaneous administration (twice yearly) ensured the high patient adherence to therapy.