Saccharomyces boulardii improves clinical and paraclinical indices in overweight/obese knee osteoarthritis patients: a randomized triple-blind placebo-controlled trial.

PURPOSE: This study aimed to determine the effect of the probiotic Saccharomyces boulardii (S. boulardii) in patients with knee osteoarthritis (KOA). METHODS: In this study, 70 patients with KOA were recruited via outpatient clinics between 2020 and 2021 and randomly assigned to receive probiotics or placebo supplements for 12 weeks. The primary outcome was a change in pain intensity according to the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score. RESULTS: Sixty-three patients completed the trial. A linear mixed analysis of covariance (ANCOVA) model analysis showed that probiotic was better than placebo in decreasing the pain intensity measured by visual analogue scale (VAS) [-2.11 (-2.59, -1.62) in probiotic group and -0.90 (-1.32, -0.48) in placebo group, p = 0.002] and WOMAC pain score [-3.57 (-4.66, -2.49) in probiotic group and -1.43 (-2.33, -0.53) in placebo group, p < 0.001]. The daily intake of acetaminophen for pain management significantly decreased in the probiotic group [-267.18 (-400.47, -133.89) mg, p < 0.001] that was significantly better than placebo (p = 0.006). Probiotic significantly decreased the serum levels of high-sensitivity C-reactive protein (hs-CRP) inflammatory index [-2.72 (-3.24, -2.20) µg/ml] and malondialdehyde (MDA) oxidative stress index [-1.61 (-2.11, -1.11) nmol/ml] compared to the placebo (p = 0.002 and p < 0.001, respectively). Probiotic was better than placebo in increasing the scores of role disorder due to physical health (p = 0.023), pain (p = 0.048) and physical health (p = 0.031). CONCLUSION: Probiotic S. boulardii supplementation in patients with KOA significantly improved pain intensity, some dimensions of QoL, and inflammatory and oxidative stress biomarkers with no severe side effects. TRIAL REGISTRY: Registered on the Iranian clinical trial website ( http://www.irct.ir : IRCT20161022030424N4) on 2019-09-02.

The effect of an anti-inflammatory in comparison with a low caloric diet on physical and mental health in overweight and obese women with knee osteoarthritis: a randomized clinical trial.

PURPOSE: To evaluate the effect of an anti-inflammatory compared to a low-calorie diet on the physical and mental health of patients with knee OA. METHODS: In this randomized parallel clinical trial, participants were selected among overweight and obese women aged 40 years or older with mild to moderate OA. Sixty women with a ratio of 1:1 were randomly assigned to receive either low-calorie or anti-inflammatory accompanied by a low-calorie diet for two months. The dietary intake and weight of participants were measured. Study variables were assessed using the Western Ontario and McMaster Index (WOMAC), visual analog pain scale (VAS), Beck Depression Inventory (BDI-II), Beck Anxiety Inventory (BAI-I), and the Short Form 36 Health Survey Questionnaire (SF-36) to indicate the quality of life (QoL). RESULTS: There was no statistically significant difference between the two groups in demographic and baseline variables except for the emotional well-being subscale of QoL. There was significant difference in anti-inflammatory compared to low-calorie diet in terms of weight (MD (95% CI): - 4.02 kg (- 6.77 to - 1.28); p = 0.005), VAS (MD (95% CI): - 0.97 (- 1.53 to - 0.41); p = 0.001), WOMAC-total score (MD (95% CI): - 9.91 (- 15.05 to - 4.78); p < 0.001), WOMAC-pain subscale (MD (95% CI): - 3.30 (- 5.30 to - 1.29); p = 0.002), WOMAC-physical function (MD(95% CI): - 5.48 (- 9.41 to - 1.53); p = 0.007), depression (p = 0.003), anxiety (p = 0.011), QoL-physical functioning (0.041), and QoL-pain (0.010) after the intervention. CONCLUSION: An anti-inflammatory accompanied by a low-calorie diet resulted in greater weight loss and greater improvement in pain intensity, functional status, depression, anxiety, and some dimension of QoL in overweight and obese women with knee OA compared to the low-calorie diet. Trial registration number and date of registration: IRCT201610220030424N2; 2018-04-23.

Effectiveness of acromioclavicular joint mobilization and physical therapy vs physical therapy alone in patients with frozen shoulder: A randomized clinical trial.

OBJECTIVES: The objective of this trial was to compare the efficacy of acromioclavicular joint mobilization and standard physical-therapy versus physical-therapy alone in the treatment of the frozen shoulder. DESIGN: Single-blind randomized clinical trial. SETTING: Outpatient setting. SUBJECTS: Patients with frozen shoulder. INTERVENTION: Participants were randomly allocated into mobilization + physical-therapy (n = 28), and physical-therapy alone (n = 28) groups for one month. MAIN MEASURES: The primary outcomes were the shoulder pain and disability index and the shoulder range of motion. The secondary outcome was the visual analogue scale. Measures were performed at the baseline, immediately and one month after the beginning of the treatment. RESULTS: Visual analogue scale and the shoulder pain and disability index improved more significantly in the mobilization group compared to the physical-therapy group immediately [-4.63 (-5.58--3.67) vs. -2.22 (-2.96--1.47), P < 0.001 and -23.08 (-28.63--17.53) vs. -13.04 (-17.93--8.16), P = 0.008, respectively] and one month after the beginning of the treatment [-5.58 (-6.45--4.72) vs. -3.61 (-4.60--2.62), P < 0.001 and -33.43 (-40.85--26.01) vs. -20.03 (-26.00--14.07), P = 0.001, respectively]. Active abduction range of motion was also improved more significantly immediately after the treatment in the mobilization group compared to the physical-therapy group [25.83 (11.45-40.13) vs. 10.17 (1.02-19.15), P = 0.025], however there were no significant differences between two groups concerning other measured range of motions. CONCLUSIONS: Adding acromioclavicular mobilization to standard physical-therapy was more efficient in decreasing pain and disability and improving active abduction range of motion compared to standard physical-therapy in frozen shoulder patients.

Use of autologous conditioned serum dressings in hard-to-heal wounds: a randomised prospective clinical trial.

OBJECTIVE: In this study, we aimed to assess both the efficacy and tolerability of autologous conditioned serum (ACS) as an innovative wound dressing in the local management of hard-to-heal wounds. METHOD: In this single-blinded randomised controlled trial, patients with hard-to-heal wounds were randomly assigned to receive either ACS treatment or normal saline (NS) dressings. The treatment was applied once a week for three weeks with a final assessment at three weeks from the first ACS application. RESULTS: A total of 30 patients took part in the study. Analysis of wound assessment data demonstrated statistically significant differences for wound surface area and Pressure Ulcer Scale for Healing scores (area score, exudate and tissue) from baseline to the end of the study in patients who received the ACS dressing, but not in patients who received the normal saline dressing. There were statistically significant differences in changes in: the wound surface area at week three (-6.4±2.69cm2 versus +0.4±2.52cm2); area score at week three (-2.2±1.08 versus +0.2±0.86); exudate at week two (-1.2±0.70 versus +0.0±0.45) and at week 3 (-1.3±0.72 versus -0.1±0.63); tissue at week two (-1.1±0.35 versus +0.0±0.53) and at week three (-1.8±0.65 versus -0.1±0.63); and the PUSH total score at week one (-1.6±0.98 versus +0.4±1.22), week two (-3.2±0.86 versus +0.4±0.98) and week three (-5.3±1.17 versus -0.0±1.33) between the ACS and NS groups, respectively. CONCLUSION: This trial revealed a significant decrease in wound surface area as well as a considerable improvement in wound healing in the ACS dressing group.

Association of depression, anxiety and menopausal-related symptoms with demographic, anthropometric and body composition indices in healthy postmenopausal women.

BACKGROUND: The termination of the menstrual cycle is correlated with a number of physiological alterations and symptoms that can negatively impact emotion and mood. We aimed to investigate the association of anxiety, depression, and menopausal related symptoms with demographic, anthropometric, and body composition indices in healthy postmenopausal women. METHODS: A total of 320 menopausal women were selected randomly from referrals of health centers between January and June 2018 in Tabriz/Iran. All participants completed a demographic questionnaire. Bioelectrical impedance analysis was applied to evaluate body fat mass (BFM), soft lean mass (SLM), and lean body mass (LBM) of participants. The modified Kupperman index, Beck's depression inventory-II, and Spielberger's state-trait anxiety inventory were applied to measure the severity of menopausal-related symptoms, the frequency, and severity of the symptoms of depression and state (SA) and trait anxiety (TA), respectively. RESULTS: Finally, 245 postmenopausal women with age of 55.33 ± 4.48 years and body mass index (BMI) of 27.96 ± 3.22 kg/m2 were studied. Women with the age of 55 years and older (OR 3.928, 95% CI 1.504-10.256) and also women with mild physical activity (OR 10.104, 95% CI 3.785-26.976) had a greater possibility of having mild and moderate depression in comparison with women less than 50 years old and women with moderate and severe physical activity. Moderate and severe physical activity was correlated with a lower possibility of having medium upward, relatively severe and severe TA in comparison with participants with mild physical activity in these women (OR 0.372, 95% CI 0.151-0.917). Women with higher BMI and BFM had and more severe menopause-related symptoms (r = 0.143, p = 0.025 and r = 0.139, p = 0.030, respectively) and more severe TA symptoms (r = 0.198, p = 0.018 and r = 0.151, p = 0.021, respectively). Women with lower LBM (r = - 0.139, p = 0.031) and lower SLM (r = - 0.128, p = 0.047) had more severe depressive symptoms. CONCLUSION: Postmenopausal women with higher age and lower physical activity had a greater possibility of having mild and moderate depression. Lower physical activity was also correlated with a greater possibility of having medium upward to severe TA symptoms. Postmenopausal women with higher BMI and BFM had more severe menopause-related and TA symptoms. Women with lower LBM and SLM had more severe depressive symptoms.

Effectiveness of extracorporeal shock wave therapy versus standard care in the treatment of neck and upper back myofascial pain: a single blinded randomised clinical trial.

OBJECTIVES: To compare the efficacy of extracorporeal shock wave therapy versus standard care (ultrasound + hot pack + self-stretch-exercises) in treatment of neck and upper back myofascial pain syndrome. DESIGN: Single-blind randomised clinical trial. SETTING: Outpatients setting. SUBJECTS: Patients with neck and upper back myofascial pain. INTERVENTION: Participants were randomly allocated into shock wave group (n = 24), standard care (ultrasound + hot pack + self-stretch-exercises) group (n = 24) and control (self-stretch-exercises) group (n = 24) for four weeks. MAIN MEASURES: The primary outcomes were pain intensity (visual analogue scale), pain pressure threshold (algometer) and disability (neck disability index). Measures were performed at baseline (week 0), week 1 and post-intervention (week 4). RESULTS: Shock wave and ultrasound improved visual analogue scale (7.50 ± 1.71 to 5.72 ± 2.20 and 6.22 ± 2.54 to 4.95 ± 2.86, respectively, P = 0.083) and disability index (54.24 ± 15.53 to 39.04 ± 19.58 50.23 ± 19.57 to 32.10 ± 18.34, respectively, P = 0.495) similarly at first week examinations that were significantly higher than control (P < 0.05). In week 4 measurements, additional improvements were achieved concerning visual analogue scale and disability index in the shock wave (-4.00 ± 2.22 and -20.24 ± 16.56, respectively) and ultrasound (-2.18 ± 2.71 and -21.79 ± 10.56, respectively) groups. However, visual analogue scale improved more significantly in shock wave group than ultrasound group in fourth week measurements (P = 0.012). CONCLUSION: Extracorporeal shock wave therapy was more effective in controlling of the pain intensity compared to ultrasound one month after treatment. However it had no superiority over ultrasound in improving neck disability index at this time point.Trial registrationwww.irct.ir, IRCT201608154104N5, registered 2016-09-25.

Association between dietary inflammatory index and inflammatory biomarkers with outcomes of in vitro fertilization treatment.

AIM: To investigate associations between dietary inflammatory index (DII), high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6) with outcomes of in vitro fertilization treatment. METHODS: This observational prospective study included 144 women undergoing fresh in vitro fertilization cycles who attended infertility center of Al-Zahra Hospital in Tabriz, Iran. DII was computed based on dietary intake assessed using a 3-day 24-h food record diary. Outcomes of in vitro fertilization in this study were considered fertilization rate, embryo quality and positive pregnancy test. Inflammatory biomarkers were measured on the day of embryo transfer. RESULTS: There was no statistically significant difference between pregnant and nonpregnant women in terms of infertility and demographic characteristics, quantity of retrieved and fertilized oocytes, fertilization rate and number of transferred embryos (P > 0.05). The mean quality scores of resultant embryos (P < 0.001) and transferred embryos (P = 0.019) were significantly lower in the group of pregnant women, indicating the better quality among them. Median (percentile 25-75th) DII in the pregnant women was 1.8 (0.5-2.7) and in the nonpregnant women was 1.6 (0.3-2.6). DII was significantly related to hs-CRP (r = 0.198, P = 0.017) but not to IL-6. There were no significant relationships between DII, serum hs-CRP, IL-6 and in vitro fertilization outcomes (P > 0.05). CONCLUSION: These findings demonstrate that serum hs-CRP and IL-6 concentration and DII are not predictive markers of in vitro fertilization cycle outcomes in women undergoing in vitro fertilization.

Lower serum levels of alpha tocopherol and lycopene are associated with higher pain and physical disability in subjects with primary knee osteoarthritis: A case-control study.

Background: We aimed to determine dietary intake and serum concentration of α-tocopherol and lycopene in subjects with knee osteoarthritis (KOA) in relation to pain intensity and functional status and comparing them with healthy controls. Methods: This case-control study was conducted among 35 patients with primary KOA and 35 matched healthy subjects selected using convenience sampling method. Dietary intakes of alpha-tocopherol and lycopene were estimated from 24-hour dietary records. Visual Analogue Scale (VAS) and Western Ontario and McMaster (WOMAC) index were used to assess the pain and functional status, respectively. Results: Serum concentrations of alpha-tocopherol (0.024 ± 0.005 vs. 0.028 ± 0.007 µmol/ml, p-value =  0.021) and lycopene (0.616 ± 0.191 vs. 0.727 ± 0.159 µmol/l, p-value = 0.011) were significantly lower in OA patients in comparison with healthy controls. Dietary intake of alpha-tocopherol was negatively associated with total WOMAC score (r = -0.401, p-value = 0.021) and pain (r = -0.356, p-value = 0.042) and physical function (r = -0.355, p-value = 0.043) subscales. Dietary intake of lycopene was negatively associated with total WOMAC score (r = -0.616, p-value < 0.001) and pain (r = -0.348, p-value = 0.047) and physical function (r = -0.606, p-value < 0.001) subscales. Additionally, serum concentration of alpha-tocopherol was negatively associated with total WOMAC score (r = -0.574, p-value < 0.001) and physical function subscale (r = -0.571, p-value < 0.001). Serum concentration of lycopene was negatively associated with total WOMAC score (r = -0.360, p-value = 0.040) and physical function subscale (r = -0.350, p-value = 0.046) Conclusion: Serum concentrations of α-tocopherol and lycopene were significantly lower in patients with KOA than in healthy controls. Significant negative association was detected between serum concentration and dietary intake of α-tocopherol and lycopene with functional disability in patients with KOA.

Relative Effectiveness of Electroacupuncture and Biofeedback in the Treatment of Neck and Upper Back Myofascial Pain: A Randomized Clinical Trial.

OBJECTIVE: To determine the differences between clinical effects of electroacupuncture and biofeedback therapy in addition to conventional treatment in patients with cervical myofascial pain syndrome (MPS). DESIGN: Randomized clinical trial. SETTING: Physical medicine and rehabilitation clinic of a university hospital. PARTICIPANTS: Fifty patients (N=50) aged 25-55 years of both sexes with chronic neck pain diagnosed with MPS (characterized by trigger points within taut bands) were randomly assigned to 2 equal groups of 25 individuals. INTERVENTIONS: The patients in electroacupuncture group were treated with standard acupuncture and concomitant electrical stimulation; those in biofeedback group received visual electromyography biofeedback therapy for muscle activity and relaxation. Both groups received the intervention 2 times a week for a total of 6 sessions. Basic exercise training and medicines were administered for all the patients. MAIN OUTCOME MEASURES: Pain severity based on the visual analog scale (VAS), functional status using Neck Disability Index (NDI), cervical range of motion (ROM) using and inclinometer, and pressure pain threshold (PPT) using an algometer were evaluated before and at 3 and 12 weeks after the treatment. Primary outcome was defined as 20% reduction in the 3-month neck pain and dysfunction compared to baseline, assessed through the NDI. RESULTS: Fifty patients (39 women, 11 men) with a mean age (years) ± SD of 39.0±5.5 and neck pain duration (weeks) of 6.0±2.2 were analyzed. All parameters, except for PPT of the lower trapezius and paravertebral muscles were improved significantly in both groups, while baseline values were controlled. The primary outcome was achieved more significantly in the acupuncture group than in the biofeedback group: 20 (80.0%) vs 10 (40.0%); rate ratio=2 with 95% confidence interval (CI), 1.19-3.36; number needed to treat (NNT)=2.5 with 95% CI, 1.54-6.58. Advantages of acupuncture over biofeedback were observed according to values obtained from the NDI, VAS, extension and left lateral-bending ROM, and PPT on the left upper trapezius after the last session of intervention until 3 months (P<.05). CONCLUSIONS: Both electroacupuncture and biofeedback therapies were found to be effective in management of MPS when integrated with conventional treatment. However, intergroup differences showed priority of acupuncture in some parameters vs biofeedback. Thus, electroacupuncture seems to be a better complementary modality for treatment of MPS in the neck and upper back area.

Comparison of efficacy of corticosteroid injection versus extracorporeal shock wave therapy on inferior trigger points in the quadratus lumborum muscle: a randomized clinical trial.

BACKGROUND: In this study, we aimed to compare the efficacy of corticosteroid trigger point injection (TPI) versus extracorporeal shock wave therapy (ESWT) on inferior trigger points in the quadratus lumborum (QL) muscle. METHODS: In this single-blind randomized clinical trial, 54 low back pain patients with myofascial trigger points on QL muscle were investigated. Participants were randomly allocated into two groups with A and B pockets. Patients in group A underwent radial ESWT and received 5 treatment sessions (1 per week) and actually were not followed-up. However, patients in group B received corticosteroid TPI and received one session of corticosteroid treatment and followed-up for 4 weeks after injection. Oswestry Disability Index (ODI), visual analogue scale (VAS), pain pressure threshold (PPT) and short form (36) health survey (SF-36) were measured in both groups before, two weeks after and four weeks after intervention. RESULTS: The between group comparison indicated that corticosteroid TPI leaded to significant higher improvements of ODI (P-value< 0.01), VAS (P value< 0.001), and PPT (P-value = 0.001) scores compared to the ESWT group at two-week follow-up time-point. ESWT group recorded significant higher improvement of ODI (P-value< 0.01) and SF-36 (P-value< 0.001) compared to the corticosteroid TPI at 4th week post treatment evaluation. At four-week follow-up time-point, the patients in the ESWT group were 1.46 times more likely to achieve 30% reduction in VAS, 2.67 times more likely to achieve 30% reduction in ODI, and 2.30 times more likely to achieve 20% improvement in SF-36 compared to the participants in corticosteroid TPI group. These results refer to large effect size for all study outcomes in ESWT group (d = 4.72, d = 1.58, d = 5.48, and d = 7.47 for ODI, PPT, SF-36, and VAS, respectively). CONCLUSION: Corticosteroid TPI was more effective compared to ESWT in short-term controlling of pain and disability caused by myofascial pain syndrome of QL muscle. However, after 4 weeks treatment, ESWT further improved the quality of life and disability and was related with more probability of achievement the minimal clinically important difference concerning pain, disability and quality of life and large effect size for all study outcomes in treated patients compared to corticosteroid TPI. TRIAL REGISTRATION: www.irct.ir , IRCT20100827004641N14 , retrospectively registered 2019-01-19.

Screening of depression in overweight and obese pregnant women and its predictors.

AIM: The aim of this study was to investigate the screening result of depression and its predictors in overweight and obese pregnant women in second and third trimester of pregnancy. METHODS: The present cross-sectional study was carried out on 232 overweight or obese pregnant women older than 18 years in the second and third trimesters of pregnancy. Edinburgh Postnatal Depression Scale questionnaire, the International Physical Activity Questionnaire and the Food Record were used. Independent t-test, Man-Whitney U, Pearson and Spearman correlation test, independent t-test, one-way analysis of variance and, multivariate linear regression were applied for data analysis using spss 21. RESULTS: The results of the study showed that the mean (standard deviation) score of depression was 10.1 (4.4), and it was similar in both overweight and obese women (P = 0.784). Median (quartile 25-75) of physical activity was 891.0 (495.0-1336.0) metabolic equivalent of task -min/week. The total physical activity in obese women was statistically higher than overweight ones (P = 0.032). In linear regression model, the variables of parity, body mass index, physical activity education, protein, fat, oleic acid, monounsaturated fatty acids, potassium, magnesium, and zinc were the strong predictors of depression, and along with the others explained the 80% of variances. CONCLUSION: Considering the fact that nearly one-third of overweight and obese women in the present study were positive for depression screening, it is important to pay attention to strong predictors of depression in these women.

Maternal and Neonatal Metabolic Outcomes of Vitamin D Supplementation in Gestational Diabetes Mellitus: A Systematic Review and Meta-Analysis.

INTRODUCTION: Many scientists have revealed the association between vitamin D deficiency and gestational diabetes mellitus (GDM). The purpose of this review was to evaluate the impact of vitamin D supplementation on maternal and neonatal health measures in GDM. METHODS: A comprehensive systematic literature search in the electronic databases including Cochrane Central Register of Controlled Trials, MEDLINE (PubMed), Scopus, Web of Sciences, EMBASE, Google Scholar, Clininaltrial.gov, and ProQuest as well as SID, Magiran, Irandoc, and Iranmedex for Persian literature review carried out up to January 2018. All RCTs and quasi-experimental studies that compared vitamin D supplementation with placebo or without supplementation on GDM women were included in this review. RESULTS: Five randomized controlled trials involving 310 women were included in the meta-analysis. There were significant differences in fasting Plasma Glucose (FPG; mean difference [MD] -12.54, 95% CI -15.03 to -10.05; 3 trials, 223 participants); total cholesterol (TC; MD -24.77, 95% CI -32.57 to -16.98; 3 trials, 223 participants); low-density lipoprotein (LDL) cholesterol (MD -18.92, 95% CI -24.97 to -12.88; 3 trials, 223 participants); high-density lipoprotein (HDL) cholesterol (MD, 3.87, 95% CI 1.20-6.55; 3 trials, 223 participants); high sensitivity C-reactive protein -(hs-CRP; MD -1.35, 95% CI -2.41 to -0.28; 2 trials, 126 participants); and Newborns' hyperbilirubinemia (OR 0.33, 95% CI 0.13-0.80; 2 trials, 129 participants). CONCLUSIONS: Supplementation of GDM women with vitamin D may lead to an improvement in FPG, TC, LDL, HDL, hs-CRP serum levels as well as in newborns' hyperbilirubinemia.

Effects of adjuvant ozone autohemotherapy combined with routine treatment on clinical and paraclinical features of mechanically ventilated COVID-19 patients in the intensive care unit: a pilot randomized controlled trial.

Until the availability of an effective and practical vaccine, there is a serious need to recognize alternative treatments for coronavirus disease 2019 (COVID-19). This study aimed to determine whether major ozonated autohemotherapy (MOAH) can improve the clinical and paraclinical parameters in critically-ill patients with COVID-19 requiring mechanical ventilation. In this controlled trial, we enrolled 40 critically ill COVID-19 patients receiving invasive mechanical ventilation. The enrolled patients were then randomized into the MOAH and control groups. The patients in the MOAH group received MOAH three times per week (10 times in total) in addition to routine treatment and standard critical supportive care. Patients in the control group were only given regular treatment and standard critical supportive care. The patients in the MOAH group had more days of breathing with no aid than those in the control group. Moreover, the length of stay in the intensive-care unit was significantly lower in the MOAH group than in the control group. MOAH resulted in higher ventilation-free days and less intensive-care unit stay compared with the control treatment. In COVID-19 patients undergoing mechanical ventilation, MOAH with routine treatment resulted in more ventilator-free days and less intensive-care unit stay compared with the standard therapy.

Reproductive history is associated with functional disabilities and symptoms in women with knee osteoarthritis: a case-control study.

OBJECTIVES: Studies that have examined the correlation between reproductive history and knee osteoarthritis (KOA) have had heterogeneous findings. We aimed to investigate the reproductive history and its relationship with pain and physical dysfunction in women with KOA. This case-control study, comprising 204 women aged 50 and older with and without KOA recruited through random cluster sampling, was executed from February 2018 to October 2018 in the health centers of Tabriz City. The reproductive history questionnaire was completed for the subjects in two groups. Pain intensity and functional dysfunction caused by KOA were evaluated using the Visual analogue scale and the Western Ontario and McMaster index, respectively. RESULTS: The women's age of menarche in the case group was significantly lower (p = 0.031), and the number of pregnancies (p = 0.017) and the average duration of breastfeeding (p = 0.039) were substantially higher than those of the control group. Older age at the first menstruation (OR = 0.851) was a protective factor, and higher parity (OR = 8.726) was a risk factor for KOA. In the women with KOA, the younger age of the mother at the birth of the first alive baby and the longer duration of breastfeeding were associated with higher pain intensity and functional disorders.

The effect of curcumin and high-content eicosapentaenoic acid supplementations in type 2 diabetes mellitus patients: a double-blinded randomized clinical trial.

BACKGROUND/OBJECTIVES: The present study investigated the effect of curcumin and eicosapentaenoic acid, as one the main components of omega-3 polyunsaturated fatty acids, on anthropometric, glucose homeostasis, and gene expression markers of cardio-metabolic risk in patients with type 2 diabetes mellitus. SUBJECTS/METHODS: This clinical trial was conducted at the Endocrinology Clinic of Imam Reza Hospital in Tabriz. It aimed to determine the impact of Eicosapentaenoic Acid (EPA), Docosahexaenoic Acid (DHA), and curcumin supplements on various health indicators in patients with Type 2 Diabetes Mellitus (DM2) from 2021.02.01 to 2022.02.01. The study was a randomized double-blinded clinical trial and conducted over 12 weeks with 100 participants randomly divided into four groups. Stratified randomization was used to assign participants to two months of supplementation based on sex and Body Mass Index (BMI). The study comprised four groups: Group 1 received 2 capsules of 500 mg EPA and 200 mg DHA, along with 1 nano-curcumin placebo; Group 2 received 1 capsule of 80 mg nano-curcumin and 2 omega 3 Fatty Acids placebos; Group 3 received 2 capsules of 500 mg EPA and 200 mg DHA, and 1 capsule of 80 mg nano-curcumin; Group 4, the control, received 2 omega 3 Fatty Acids placebos and 1 nano-curcumin placebo. RESULTS: After twelve weeks of taking EPA + Nano-curcumin supplements, the patients experienced a statistically significant reduction in insulin levels in their blood [MD: -1.44 (-2.70, -0.17)]. This decrease was significantly greater than the changes observed in the placebo group [MD: -0.63 (-1.97, 0.69)]. The EPA + Nano-curcumin group also showed a significant decrease in High-Sensitivity C-Reactive Protein (hs-CRP) levels compared to the placebo group (p < 0.05). Additionally, the EPA + Nano-curcumin group had a significant increase in Total Antioxidant Capacity (TAC) levels compared to the placebo group (p < 0.01). However, there were no significant differences in Fasting Blood Sugar (FBS), Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index, Quantitative Insulin Sensitivity Check Index (QUICKI), or Hemoglobin A1c (HbA1C) levels between the four groups (all p > 0.05). There were significant differences between the Nano-curcumin and EPA groups [MD: -17.02 (-32.99, -1.05)], and between the Nano-curcumin and control groups [MD: -20.76 (-36.73, -4.79)] in terms of lowering the serum cholesterol level. The difference in Triglycerides (TG) serum levels between the EPA + Nano-curcumin and placebo groups were not statistically significant (p = 0.093). The Nano-curcumin group showed significant decreases in Low-Density Lipoprotein (LDL) levels compared to the EPA group [MD: -20.12 (-36.90, -3.34)] and the control group [MD: -20.79 (-37.57, -4.01)]. There was a near-to-significant difference in High-Density Lipoprotein (HDL) serum levels between the EPA + Nano-curcumin and EPA groups (p = 0.056). Finally, there were significant differences in the decrease of serum Vascular Endothelial Growth Factor (VEGF) levels between the EPA and Nano-curcumin groups [MD: -127.50 (-247.91, -7.09)], the EPA and placebo groups [MD: 126.25 (5.83, 246.66)], the EPA + Nano-curcumin and Nano-curcumin groups [MD: -122.76 (-243.17, -2.35)], and the EPA + Nano- curcumin and placebo groups [MD: 121.50 (1.09, 241.92)]. CONCLUSIONS: The findings of the present study suggest that 12-week supplementation with EPA and Nano-curcumin may positively impact inflammation, oxidative stress, and metabolic parameters in patients with diabetes. The supplementation of EPA and Nano-curcumin may be a potential intervention to manage diabetes and reduce the risk of complications associated with diabetes. However, further research is needed to validate the study's findings and establish the long-term effects of EPA and Nano-curcumin supplementation in patients with diabetes.

Vasculitis presenting as carpal tunnel syndrome: a case report.

BACKGROUND: Carpal tunnel syndrome is the most common focal mononeuropathy which presents with pain in the wrist and hand, paresthesia, loss of sensation in the distribution of the median nerve, and in more severe cases, weakness and atrophy of the thenar muscles. Meanwhile, carpal tunnel syndrome can present as an initial manifestation of underlying systemic vasculitis disorder and result in severe physical disabilities. CASE PRESENTATION: A 27-year-old Iranian man was referred to our electrodiagnosis center with a clinical diagnosis of carpal tunnel syndrome in April 2020. Surgical intervention had been taken into account for him because of unsuccessful conservative therapies. On admission, thenar eminence was reduced. Electrodiagnostic findings were not compatible with median nerve entrapment at the wrist. All sensory modalities in the distribution of the right median nerve were decreased. Additionally, a mild increase in erythrocyte sedimentation rate was noted in laboratory tests. Because of the high vasculitis suspicion, we recommended the nerve biopsy and/or starting a high-dose corticosteroid. However, the surgery release was performed. After 6 months, the patient was referred for progressive weakness and numbness in the upper and lower limbs. After documentation of vasculitis neuropathy by biopsy, a diagnosis of non-systemic vasculitic neuropathy was confirmed. A rehabilitation program started immediately. Rehabilitation led to gradual improvement and recovery of function and muscle strength, and no complications remained, except mild leg paralysis. CONCLUSIONS: Physicians should be suspicious of the median nerve vasculitis mononeuropathy in a patient with carpal tunnel syndrome-like symptoms. Median nerve vasculitis mononeuropathy as an initial presenting feature of vasculitis neuropathy can further result in severe physical impairments and disabilities.

Effectiveness of Botulinum Toxin on Hand Tremor Intensity and Upper Limb Function in Patients with Parkinson's Disease: Results of a Systematic Review.

Background: Hand tremor is a common symptom of Parkinson's disease (PD). Tremors may be resistant to drug treatments. Therefore, Botulinum toxin (BoNT) could be a good alternative. This study aimed to review and analyze studies on the efficacy and safety of BoNT injection in hand tremor intensity and upper limb function in patients with idiopathic PD. Methods: A comprehensive search was conducted for studies on the effect of local BoNT injections on tremors in PD patients from 1990 to December 2021. Electronic databases such as Cochrane Central Control Records, PubMed, Scopus, Web of Science, EMBASE, Google Scholar, Clinicaltrial.gov, ProQuest, Science Direct, CINAHL, and Psychoinfo were searched systematically. Results: Ten studies, comprising one double-blinded randomized clinical trial and nine pilot open-labeled studies with 131 participants, met eligibility criteria. The reported tremor intensity ranged from 1 to 3, and the average tremor duration of 5.93 ± 2.08 years. The injectable dose was 68-100 units of onabotulinum-toxin-A in each upper limb muscle, mostly wrist flexors. The results showed a decrease in unified Parkinson's disease rating scale (UPDRS)_20 and UPDRS_21 indices by 1.22 ± 1.1 and 1.20 ± 0.9, respectively, without causing severe side effects. The BoNT relative effectiveness in the forearm and arm muscles was reported 6-16 weeks after injection. Discussion: The kinematic, electromyography-guided, and electrical stimulation evaluations allow for accurate muscle localization and minimize the possibility of BoNT diffusion and antibody formation. More extensive randomized clinical trials with uniform measurement criteria are recommended to reduce bias and provide more accurate conclusions. Highlight: Tremor treatment in Parkinson's-disease (PD) is challenging. Drugs effect is temporary, and surgery is critical management. This study reviews the Botulinum-toxin injection efficacy in hand tremor intensity and upper limb function. The results showed a decrease in unified Parkinson's disease rating scale (UPDRS)_20 and UPDRS_21 by 1.22 ± 1.1 and 1.20 ± 0.9, respectively, 6-16 weeks after injection.

The efficacy of Nigella sativa L. oil on serum biomarkers of inflammation and oxidative stress and quality of life in patients with knee osteoarthritis: A parallel triple-arm double-blind randomized controlled trial.

The aim of this double-blind clinical trial was to investigate the effects of Nigella sativa oil on serum inflammatory and oxidative stress biomarkers and quality of life in patients with knee osteoarthritis (OA). Forty-five patients who met the eligibility criteria were randomly divided into three groups with a ratio of 1:1:1. The first group received 2.5 mL oral N. sativa oil twice/day plus placebo topical oil, the second group received 2.5 mL topical N. sativa oil three times/day plus placebo oral oil, and the third group received oral and topical oil placebos. There were no intergroup differences in baseline characteristics. After 6 weeks of supplementation, oral N. sativa caused a significant improvement in the serum levels of hs-CRP (p = .003), MDA (p = .003), and TAC (p = .001). Oral N. sativa oil compared to placebo (aMD (95% CI): -0.81 (-1.45 to -0.19); p = .012) and topical N. sativa oil [aMD (95% CI): -0.76 (-1.38 to -0.15); p = .016] significantly reduced hs-CRP serum levels. Significant improvements were observed in the general, physical, and mental health subscales in the oral and topical N. sativa oil compared to the placebo group (p < .05). The six-week oral N. sativa oil supplementation was effective in improving inflammatory biomarkers in knee OA. Both oral and topical N. sativa oil increased the quality of life.

The effect of probiotic supplementation on the clinical and para-clinical findings of multiple sclerosis: a randomized clinical trial.

Multiple Sclerosis (MS) is a chronic demyelination disease of the central nervous system (CNS). The gut-brain axis involves communication between the nervous, endocrine, and immune systems. Probiotics can positively impact immune and inflammatory responses by regulating gut microbiota. A total of 40 MS patients (average age of 34.38 ± 6.65) were examined to determine the effect of the Saccharomyces boulardii supplement for four months compared to a placebo. The results showed that the Saccharomyces boulardii significantly decreased the inflammatory marker high-sensitivity C-reactive protein (hs-CRP) compared to the placebo (P < 0.001). The serum antioxidant capacity (TAC) also increased significantly in the probiotic group compared to the placebo (p = 0.004). Both the probiotic and placebo groups showed a reduction in the oxidative stress indicator malondialdehyde (MDA), but there was no significant difference between the two groups. Pain intensity (measured by Visual Analogue Scale) and fatigue severity (measured by Fatigue Severity Scale) significantly decreased in the probiotic group compared to the placebo (p = 0.004 and p = 0.01, respectively). The probiotic group experienced significant improvement in some quality of life scales (measured by 36-Item Short Form Survey) and somatic and social dysfunction subscale of General Health Questionnaire scores compared to the placebo group (p = 0.01). The study suggests that the Saccharomyces boulardii probiotic supplement may benefit inflammatory markers, oxidative stress indicators, pain, fatigue, and quality of life in MS patients.

Effect of berry-based supplements and foods on cognitive function: a systematic review.

In the current decade, a growing body of evidence has proposed the correlation between diet and cognitive function or dementia in the ageing population. This study was designed to appraise discoveries from the randomized controlled trials to confirm the effects of berry-based supplements or foods on cognitive function in older adults. PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, Web of Science, Scopus, EMBASE, Google Scholar, and ProQuest as well as SID, Magiran, and Iranmedex electronic databases were explored for human interventional studies up to March 2021. In total, eleven articles were identified using frozen blueberry (n = 4 studies), blueberry concentrate (n = 2), beverage (n = 3), capsule (n = 1), extract and powder (n = 1). These studies had been performed among older people with no recognized cognitive impairment or mild cognitive impairment (MCI). The primary outcomes included global cognitive function, psychomotor function, learning and memory, working memory capacity, executive functions, and brain perfusion/activity. To our knowledge, this is the first systematic review of available clinical trials on the effects of berry-based supplements and foods on cognitive performances as well as brain perfusion parameters among the elderly with normal cognition or MCI. Existing evidence concludes that berry-based supplements and foods have beneficial effects on resting brain perfusion, cognitive function, memory performance, executive functioning, processing speed, and attention indices.