Safety and efficacy of PDpoetin for management of anemia in patients with end stage renal disease on maintenance hemodialysis: Results from a phase IV clinical trial

Recombinant human erythropoietin (rHuEPO) is available for correcting anemia. PDpoetin, a new brand of rHuEPO, has been certified by Food and Drug Department of Ministry of Health and Medical Education of Iran for clinical use in patients with chronic kidney disease. We conducted this post-marketing survey to further evaluate the safety and efficacy of PDpoetin for management of anemia in patients on maintenance hemodialysis. Patients from 4 centers in Iran were enrolled for this multicenter, open-label, uncontrolled phase IV clinical trial. Changes in blood chemistry, hemoglobin and hematocrit levels, renal function, and other characteristics of the patients were recorded for 4 months; 501 of the patients recruited, completed this study. Mean age of the patients was 50.9 (±16.2) years. 48.7 of patients were female. Mean of the hemoglobin value in all of the 4 centers was 9.29 (±1.43) g/dL at beginning of the study and reached 10.96 (±2.23) g/dL after 4 months and showed significant increase overall (P<0.001). PDpoetin dose was stable at 50-100 U/kg thrice weekly. Hemorheologic disturbancesand changes in blood electrolytes was not observed. No case of immunological reactions to PDpoetin was observed. Our study, therefore, showed that PDpoetin has significantly raised the level of hemoglobin in the hemodialysis patients (about 1.7±0.6 g/dL). Anemia were successfully corrected in 49 of patients under study. Use of this biosimilar was shown to be safe and effective for the maintenance of hemoglobin in patients on maintenance hemodialysis. © A.N. Javidan et al., 2014

Effect of general health status on chronicity of low back pain in industrial workers

Recognizing patients at a higher risk of developing chronic low back pain (LBP) is important in industrial medicine. This study aimed to assess the power and quality of General Health Questionnaire (GHQ) for prediction of the odds of chronicity of acute LBP. This study was conducted on industrial workers. All subjects with acute LBP who met the inclusion criteria were enrolled. Demographic characteristics, occupational, physical, and mental parameters and the general health status of subjects were evaluated; they were followed up for developing chronic LBP for one year. Cigarette smoking, high body mass index, job stress, physical load and high GHQ scores were found to be the risk factors for the progression of acute LBP to chronic LBP (P0.05). High GHQ score can be a risk factor for progression of acute LBP to chronic LBP. The GHQ in combination with the Job Content Questionnaire can be used as a quick and simple screening tool for detection of subjects at high risk of chronic LBP when evaluating acute LBP in an occupational setting. © 2016 Tehran University of Medical Sciences. All rights reserved.

Efficacy of some non-conventional herbal medications (sulforaphane, tanshinone iia, and tetramethylpyrazine) in inducing neuroprotection in comparison with interleukin-10 after spinal cord injury: A meta-analysis

Context: Inflammation after spinal cord injury (SCI) may be responsible for further neural damages and therefore inhibition of inflammatory processes may exert a neuroprotection effect. Objectives: To assess the efficacy of some non-conventional herbal medications including sulforaphane, tanshinone IIA, and tetramethylpyrazine in reducing inflammation and compare them with a known effective anti-inflammatory agent (interleukin-10 (IL-10)). Methods: We searched relevant articles in Ovid database, Medline (PubMed) EMBASE, Google Scholar, Cochrane, and Scopus up to June 2013. The efficacy of each treatment and study powers were compared using random effects model of meta-analysis. To our knowledge, no conflict of interest exists. Results: Eighteen articles entered into the study. The meta-analysis revealed that exogenous IL-10 was more effective in comparison with the mentioned herbal extracts. The proposed pathways for each medication's effect on reducing the inflammation process are complex and many overlaps may exist. Conclusion: IL-10 has a strong effect in the induction of neuroprotection and neurorecovery after SCI by multiple pathways. Tetramethylpyrazine has an acceptable influence in reducing inflammation through the up-regulation of IL-10. Outcomes of sulforaphane and tanshinone IIA administration are acceptable but still weaker than IL-10. © The Academy of Spinal Cord Injury Professionals, Inc. 2015

Assessment of attention to clothing and impact of its restrictive factors in Iranian patients with traumatic spinal cord injury (ACIRF-SCI): Introduction of a new questionnaire

Background: Patients with spinal cord injury (SCI) deal with various restrictive factors regarding their clothing, such as disability and difficulty with access to shopping centers. Objectives: We designed a questionnaire to assess attention to clothing and impact of its restrictive factors among Iranian patients with SCI (ACIRF-SCI). Methods: The ACIRF-SCI has 5 domains: functional, medical, attitude, aesthetic, and emotional. The first 3 domains reflect the impact of restrictive factors (factors that restrict attention to clothing), and the last 2 domains reflect attention to clothing and fashion. Functional restrictive factors include disability and dependence. Medical restrictive factors include existence of specific medical conditions that interfere with clothing choice. Construct validity was assessed by factorial analysis, and reliability was expressed by Cronbach's alpha. Results: A total of 100 patients (75 men and 25 women) entered this study. Patients with a lower injury level had a higher total score (P < .0001), and similarly, patients with paraplegia had higher scores than those with tetraplegia (P < .0001), which illustrates an admissible discriminant validity. Postinjury duration was positively associated with total scores (r = 0.21, P = .04). Construct validity was 0.97, and Cronbach's alpha was 0.61. Conclusion: Iranian patients with SCI who have greater ability and independence experience a lower impact of restrictive factors related to clothing. The ACIRF-SCI reveals that this assumption is statistically significant, which shows its admissible discriminant validity. The measured construct validity (0.97) and reliability (internal consistency expressed by alpha = 0.61) are acceptable. © 2015 Thomas Land Publishers, Inc

Omega-3 fatty acids' effect on leptin and adiponectin concentrations in patients with spinal cord injury: A double-blinded randomized clinical trial

Context: Omega-3 fatty acids have been recently proposed to induce neural improvement in patients with spinal cord injury (SCI) while affecting some hormones including leptin and adiponectin. Objectives: We tried to evaluate the effect of omega-3 fatty acids on circulatory concentrations of leptin and adiponectin among these patients. Design: This study is a double-blinded randomized clinical trial with intervention duration of 14 months. Setting: A tertiary rehabilitation center. Participants: Total of 104 patients with SCI who did not meet our exclusion criteria entered the study. Those with history of diabetes, cancer, endocrinology disease, acute infection, and use of special medications were excluded. Patients were divided randomly into the treatment and control group by using permuted balanced block randomization. Intervention: The treatment group received two MorDHA® capsules per day (each capsule contain 465 mg of docosahexaenoic acid (DHA) and 63 mg of eicosapentaenoic acid (EPA)) for 14 months while the control group received placebo capsules with similar color, shape, and taste. Main outcomes measures: Leptin and adiponectin concentrations in plasma were measured at the beginning of trial and then after 6 and 14 months. Results: Fourteen months of treatment with DHA and EPA did not influence concentrations of leptin but adiponectin level was significantly decreased (P: 0.03). Weight was positively correlated with leptin level at stage 0 of trial (P: 0.008, r = 0.41) while this association was attenuated through stages of trial after intervention. Conclusion: Our data show that omega-3 fatty acids may not affect plasma concentrations of leptin but adiponectin level is decreased in patients with SCI. Moreover, this intervention influences the linear relationship between weight and leptin after 14 months administration of DHA and EPA. © The Academy of Spinal Cord Injury Professionals, Inc. 2015

Does consumption of omega-3 polyunsaturated fatty acids affect lipid profile and fasting blood glucose in patients with traumatic spinal cord injury? a double-blinded randomized clinical trial

Omega-3 polyunsaturated fatty acids (ù-3 PUFAs) have been shown to influence serum lipids. However, these effects have not yet been evaluated among patients with spinal cord injury. In this double-blinded randomized clinical trial, 104 subjects with spinal cord injury were randomly assigned to intervention and control group and were followed for 14 months. The treatment group received 2 MorDHA capsules (435 mg of docosahexaenoic acid and 65 mg of eicosapentaenoic acid, daily), and the control group received placebo capsules daily. There were no significant. © 2015 Wolters Kluwer Health, Inc. All rights reserved