Cost-Effectiveness Analysis of the Culturally Developed Diabetes Self-Management Education and Support Program among Type 2 Diabetes Mellitus Patients in Iraq.

Background: Diabetes mellitus (DM) is a chronic disease associated with a major economic burden on persons, health care systems, and countries. Diabetes self-management education and support (DSME(S)) programs are highly effective method in the management of T2DM patients. Therefore, this study aimed to determine the cost-effectiveness of the developed culturally-specific DSME(S) program regarding glycemic control, lipid profile, and body weight for Iraqi type 2 DM patients. Methods: A randomized controlled clinical trial design was used to assess the cost-effectiveness of the culturally-specific DSME(S) program from the perspective of health care providers. In the cost-effectiveness analysis (CEA), cost per patient and clinical outcomes over 6 months were compared between the intervention and control group. Incremental cost-effectiveness ratios (ICERs) were expressed as cost per unit improvement in glycosylated hemoglobin (HbA1c), fasting blood glucose (FBG), total cholesterol (TC), low-density lipoprotein-cholesterol (LDL-C), high density lipoprotein- cholesterol (HDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), and body weight. Results: The effectiveness of most outcomes was better in the intervention group compared with the control group. The ICER per unit improvement in HbA1c, SBP, DBP, serum TC, and TG levels was <1 of the minimum CET compared with the control group, thus meeting the definition of being highly cost-effective. Conclusion: The currently developed DSME(S) was cost effective method to improve glycemic control, blood pressure, TC, and TG for T2DM patients in Iraq.

Adverse effects associated with the use of N95 mask among health-care workers at the COVID-19 care units: A cross-sectional study in Sulaimani city, Iraq.

BACKGROUND: Health-care workers have to use the N95 mask as a part of the protection kit during the COVID-19 pandemic. The adverse effects of such practice are not fully elucidated. The study aims to evaluate negative impacts of N95 face masks on health-care personnel at COVID-19 care units. MATERIALS AND METHODS: One hundred and twenty-two health-care workers (aged 20-58 years) from various health-care settings in Sulaimani, Iraq, from January to August 2020, were enrolled in this prospective, cross-sectional study. The physiological variables (blood pressure, heart rate, and oxygen saturation) were recorded before putting on the N95 mask and postremoval of the mask. The incidence of adverse effects such as headache, difficulty breathing, redness, irritation, and dizziness were also reported as a number and percent at the end of the work shift. RESULTS: There was a statistically significant difference in the physiological parameters after removal of the mask compared with baseline. Only diastolic pressure was significantly lower in those working >6 h when compared to those working 1-6 h. The changes in physiological markers were poorly and nonsignificantly associated with the duration of wearing the mask. Moreover, 67.2%-70.5% of the participants complain of headaches and breathing difficulties, while 45.9%-51.6% reported signs of itching, redness, and irritation. However, health-care workers who put on the face mask >6 h showed signs of headache, breathing difficulties, and itching at the exposed areas higher than those working for 1-6 h. CONCLUSION: N95 mask negatively impacts the physiological variables of health-care providers. The adverse effects may lead to excessive exhaustion after long shifts in the intensive care unit during treatment of COVID-19 patients.

Association of cigarette and water-pipe smoking with increased visceral adiposity, glycemic intolerance and hematological derangement in Iraqi healthy smokers

Abstract The present study aims to investigate the impacts of cigarette smoking (CS) and water-pipe smoking (WPS) on the visceral adiposity index (VAI), hematological characteristics, and glycemic tolerance in Iraqi healthy smokers. A total of 528 healthy males from different locations of Baghdad city were allocated to three groups; nonsmokers (176), cigarette smokers (178), and WP smokers (174). Baseline characteristics, anthropometric and hematological markers and were reported. Glycemic control was evaluated using the glucose tolerance test. The evidence of elevated VAI, disrupted hematological markers, and impaired glucose tolerance was significantly (P<0.001) different compared with non-smokers and related to the duration of smoking. The impacts of WPS seem to be significantly greater than CS in certain parameters (hemoglobin, hematocrit, methemoglobin, and 2-hour glucose tolerance values). In conclusion, CS and WPS negatively impacted body fat distribution, glucose tolerance, and hematological markers. There is a positive association between the rate of smoking and obesity, glycemic intolerance in both groups

Gingko biloba extract improves the lipid profile, inflammatory markers, leptin level and the antioxidant status of T2DM patients poorly responding to metformin: A double- blind, randomized, placebo-controlled trial

Abstract The present study aims to evaluate the effects of Ginkgo biloba (GKB) extract as "add- on" therapy with metformin on the lipid profile, inflammatory markers, leptin and the total antioxidant capacity (TAOC) of patients with type 2 diabetes mellitus (T2DM). It is a multi- center, randomized, placebo-controlled double-blinded clinical study. Sixty patients were allocated into two groups: control and treatment groups; they received orally either 120 mg starch/capsule or 120mg GKB/capsule, respectively as an adjuvant with metformin for 90 days. Blood samples were obtained at zero time and after 90 days. The blood was utilized for analysis of the lipid profile, inflammatory markers, leptin, and TAOC. The GKB extract produced a significant decrease in the levels of TG, LDL-c, and CRP, with a significant increase in HDL-c compared to baseline values. There were no significant changes reported in the placebo-treated group. It also produced a significant decrease in the concentrations of IL-6, TNF-α, and leptin compared to baseline values and placebo-treated groups with a significant increase in TAOC compared to baseline values. In conclusion, GKB extract, as an adjuvant with metformin, decreases inflammatory mediators, leptin level and improves the antioxidant status and lipid profile of T2DM patients improperly managed with metformin

Validation of newly developed culturally specific diabetes self-management education and support program for Iraqi type 2 diabetes mellitus patients.

BACKGROUND: Diabetes self-management (DSM) is the cornerstone in diabetes mellitus (DM) management. Unfortunately, the practice of DSM by Iraqi type 2 DM (T2DM) patients is poor that mainly resulted from their poor knowledge about the required DSM behaviors. This lack of knowledge may be attributed to the lack of DSM education and support (DSMES) program in Iraq. Thus, this study was conducted with aim of developing and validating a culturally specific DSMES program for Iraqi T2DM patients. MATERIALS AND METHODS: The development and validation of the DSMES program was done according to the Hilda Taba model. Content validity of the program was done by a panel of 6 health-care experts in management of Iraqi DM patients. Face validity was confirmed by conducting a pilot study for six adults with uncontrolled T2DM at the National Diabetes Center, Baghdad, Iraq. Both the experts and patients were asked to evaluate the developed program in regard to its contents, design, and supporting material (booklet). The evaluation was done by filling in a questionnaire that based on a 5-point scale. Items with a score ≥4 by <70% of the experts and patients were subjected to revision and further assessment. RESULTS: No total disagreement for any item was expressed by all participants (experts and patients). Content and face validity was ensured through obtaining a positive feedback from all participants at which all items about the program had scores of ≥4 by at least 75% of participants. CONCLUSION: The developed culturally based DSMES program is highly suitable for educating Iraqi T2DM patients.

Correlation between serum pro inflammatory cytokines and clinical scores of knee osteoarthritic patients using resveratrol as a supplementary therapy with meloxicam.

OBJECTIVE: The objective of this study was to analyze the associations between the pro-inflammatory markers with the clinical outcomes of knee osteoarthritis (OA) in patients using resveratrol as an add-on treatment with meloxicam. MATERIALS AND METHODS: This was a double-blind controlled clinical investigation, with 110 eligible patients with OA assigned randomly to receive 15 mg a day meloxicam with either resveratrol 500 mg a day or placebo for 90 days. The standard tools for assessment of pain severity and physical functions were utilized. The tumor necrosis factor-α (TNF-α), interleukin-1ß (IL-1ß), and IL-6 in the blood were evaluated. Spearman's correlation coefficient test was used to determine the significance of correlations. RESULTS: The regression analysis to determine the correlation between reductions of the inflammatory biomarkers with the amelioration of the clinical scores showed a nonsignificant weak correlation between these variables. Total clinical scores of each assessment tool that was used "Knee Injury and OA Outcome Score (KOOS) and WOMAC" displayed a weak and nonsignificant correlation with TNF-α, IL-1ß blood level. The Spearman's correlation shows a relatively nonsignificant association between IL-6 levels and KOOS, WOMAC, and Visual Analog Scale scores after incorporating resveratrol as an adjuvant with meloxicam for 90 days. CONCLUSION: A weak and nonsignificant correlation between serum biomarkers and the clinical outcomes has been suggested in patients with painful knee OA treated with meloxicam and resveratrol.

Effectiveness of Diabetes Self-Management Educational Programs For Type 2 Diabetes Mellitus Patients In Middle East Countries: A Systematic Review.

AIM: This review study aimed to determine the effectiveness and factors affecting the success of DSME programs in T2DM patients living in ME countries. METHODS: An extensive manual literature search was conducted using PubMed and Google Scholar for clinical trials assessing the effect of diabetes self-management education (DSME) for type 2 diabetes mellitus patients in Middle East countries. Information from the included studies was summarized in relation to study population, sample size, duration of follow-up, characteristics of DSME program, and follow-up time, besides in addition to parameters used in assessment, results, and conclusions. The risk of bias in the included studies was assessed using the Cochrane risk of bias tool. The effect of DSME on clinical and patient-reported outcomes was measured by calculation of the percentage of DSME studies that produce a significant improvement in these outcomes for patients in intervention group as compared to those in control group. Additionally, the effect of DSME on each clinical outcome was assessed by calculating the mean for the absolute effect of DSME on that outcome. RESULTS: Twelve studies were included in this review. Heterogeneity was found among included studies in terms of DSME program characteristics, the enrolled patients, duration of follow-up, assessment methods, and obtained outcomes. All clinical glycemic outcomes (glycosylated hemoglobin, fasting, and non-fasting blood glucose), lipid profile (total cholesterol and triglycerides), and body mass index were significantly improved for patients in intervention group as compared to those in control group in at least 60% of the included studies. All patients' reported outcomes (medication adherence, self-management behavior, knowledge, self-efficacy, health belief and quality of life) were significantly improved by the DSME program. CONCLUSION: DSME programs are highly effective in improving glycemic control, lipid profile and BMI, and modestly effective in improving BP. Thus, they can reduce the risks of developing diabetes complications. Patient diabetes knowledge, DSM behaviors, adherence to medications, self-efficacy, and quality of life can also be significantly improved by DSME.

Association of Visceral Adiposity Index, Lipid Profile, and Serum Leptin with Glucose Intolerance Risks in Iraqi Obese Patients: A Cross-sectional Study.

AIMS: The aim of this study was to evaluate the possibility of using visceral adiposity index (VAI), serum leptin, and lipid profile as indicators of impaired glucose tolerance in Iraqi obese patients. SUBJECTS AND METHODS: A cross-sectional study was performed in Iraqi obese patients of both sexes. Body mass index (BMI), waist circumference, hip circumference, triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), VAI, waist-to-hip ratio (WHR), serum leptin, and 2-h glucose tolerance test (2-h GT) were determined and compared with those of healthy non-obese control group. A correlation analysis was performed to determine the strength of association between the studied markers. Data were adjusted to determine gender differences in this regard. STATISTICAL ANALYSIS: Kolmogorov-Smirnov, Shapiro-Wilk analyses, Mann-Whitney U test, and unpaired t test were used for the two-group comparisons once applicable. Pearson's and Spearman's correlation analyses were used to measure the relationship levels between the studied variables. RESULTS: A total of 144 obese patients were included; the mean age was 37.11 ± 8.2 years and 92 (63.9%) were females. Compared with non-obese subjects, the participants had significantly higher levels of BMI, WC, WHR, VAI, TG, leptin, and 2-h GTObese male subjects had significantly higher values of body weight, WC, HC, VAI, and TG compared with obese females. Elevated 2-h GT was significantly associated with VAI (r = 0.291, P = 0.0004), TG (r = 0.319, P = 0.0001), and LDL-C/HDL-C ratio (r = 0.435, P < 0.0001) in the obese patients only. CONCLUSIONS: The results provide evidence that VAI, TG, and LDL-C/HDL-C ratio can be suggested as potential markers for the risk assessment of impaired glucose tolerance in Iraqi obese patients.

Nigella sativa Oil Mouth Rinse Improves Chemotherapy-Induced Oral Mucositis in Patients with Acute Myeloid Leukemia.

OBJECTIVE: The present study aims at evaluating the beneficial effect of Nigella sativa (NS) oil mouth rinse in the management of chemotherapy- (CT-) induced oral mucositis (OM) in patients with acute myeloid leukemia (AML). METHODS: Fifty-four AML patients were participated in this study and randomly allocated to either the test group or a control group. The patients of the test group received NS oil mouth rinse during 28-day CT, while the participants of the control group received a "magic mouthwash" formula. The primary outcome of this study was the incidence and severity of CT-induced OM in terms of erythema and ulcer. The secondary outcomes were the pain severity score, swallowing function, and the salivary concentrations of interleukin-6 (IL-6) and tumor necrosis factor-alpha (TNF-α). RESULTS: NS oil mouth rinse attenuated the progression of CT-induced OM compared with the control formula (AUC = 5.9 vs. 38.4, P < 0.05) and significantly decreased the erythema and ulceration scores (AUC of total OMAS = 11.4 vs. 85.9, P < 0.001) compared with the magic mouthwash formula. It also reduced the pain score and enabled all the participants of this group to consume normal food during treatment. It significantly decreased salivary IL-6 (AUC = 7376 vs. 16599, P < 0.001), while the changes of TNF-α levels were not significant (AUC = 676.9 vs. 885.2, P > 0.05). CONCLUSIONS: NS oil mouth rinse is effective in attenuating the severity of CT-induced OM and improves the pain and swallowing function in AML patients.

Healthcare personnel's experience of reporting adverse drug reactions in Baghdad city: cross-sectional study.

Background Adverse drug reactions (ADRs) are undesirable effects to drugs at doses normally used in the clinical setting for diagnosis, treatment or prophylaxis of diseases. Spontaneous ADR reporting is currently considered as a critical part of ADRs detection. Objective The study aims to assess the knowledge, attitude, and practice of healthcare providers towards adverse drug reaction reporting in public and private settings within the Baghdad area. Method We follow a quantitative cross-sectional study design, using a self-administered questionnaire to collect data from the healthcare providers regarding their reporting practice. Main outcome The outcome measures include the experiences of reporting of adverse drug reactions and the available systems, in addition to the expected benefits to clinical practice. Results Among 485 respondents, 114 were able to differentiate ADRs from side effects. About half of them (47.6%) recognized the availability of reporting systems and 43.3% knew how to report adverse drug reactions. 43.7% of the respondents mentioned that ADRs should be reported only when they are life-threatening. Among the 188 respondents who encountered ADRs, 145 reported the events to the accessible local authority. Conclusion The healthcare providers working in Baghdad healthcare institutions have a good attitude toward ADR reporting. There is a relatively below-standard reporting culture of the encountered adverse reactions. The inadequate knowledge about adverse reactions and the unavailability of reporting forms played a major role in discouraging healthcare professionals to detect and report ADRs.

Self-management knowledge and practice of type 2 diabetes mellitus patients in Baghdad, Iraq: a qualitative study.

Background and aim: Diabetes self-management behaviors are necessary to ensure optimum glycemic control. However, limited data were available regarding the practice of self-management by the Iraqi diabetic patients. This study aims to understand the knowledge, behaviors, and barriers of diabetes self-management among Iraqi type 2 diabetes mellitus (T2DM) patients in addition to their opinions and views toward the diabetes self-management educational program. METHODS: A qualitative method approach was used to obtain the data from T2DM patients recruited from the National Diabetes Center, Baghdad, Iraq. Data were collected using a semi-structured interview guide, and a thematic analysis approach was used to process the data. RESULTS: Most participants agreed to the importance of self-management practices especially healthy eating, exercise, taking medications, and healthy coping with stress to control DM and prevent its complications. Healthy eating and physical activity recommendations were inadequately practiced by most of the participants. Most participants reported irregular self-monitoring of blood glucose. Most of the participants properly adhered to the anti-diabetic medications. They generally lack proper information/knowledge about the importance of self-management practices of foot care and managing diabetes during sick days and how such practices should be implemented. Most participants have positive attitudes toward diabetes self-management practices. Face-to-face educational sessions are preferred by most patients. CONCLUSION: The Iraqi diabetic patients have inadequate self-management behaviors. The main barrier to self-management practices was the lack of knowledge due to the absence of diabetes self-management educational programs in Iraq.

Efficacy and safety of co-administration of resveratrol with meloxicam in patients with knee osteoarthritis: a pilot interventional study.

BACKGROUND AND AIM: Resveratrol shows remarkable anti-inflammatory activities in experimental models. This study aims to evaluate the effect of resveratrol, as an adjuvant with meloxicam (Mlx), on the pain and functional activity during a 90-day period and monitor the adverse effects on kidney and liver functions, lipid profile, and hematological markers. PATIENTS AND METHODS: This study was a double-blind, placebo-controlled, randomized multi-center study that involved 110 patients with knee osteoarthritis (OA) and was performed at Sulaimani City, Iraq, from December 2016 to September 2017. To assess the effects of Mlx with or without resveratrol, pain severity and functional disability were evaluated at baseline and after 90 days using the Western Ontario and McMaster Universities Osteoarthritis Index. Fasting blood was collected to evaluate the lipid profile markers, hematological picture, and liver and kidney functions, in addition to vitamin D level. RESULTS: Resveratrol significantly improves pain, functions, and associated symptoms compared with placebo. The clinical and biochemical markers indicated that 500 mg/day of resveratrol, as an adjuvant with Mlx, is safe and well tolerated by the knee OA patients. CONCLUSION: Resveratrol, as an "add-on" medication with Mlx, was superior in terms of safety and efficacy to Mlx alone for the treatment of pain and improvement of physical function in patients with knee OA.

Azilsartan improves the effects of etanercept in patients with active rheumatoid arthritis: a pilot study.

BACKGROUND AND AIM: Much evidence has emerged documenting the involvement of the renin-angiotensin system (RAS) in inflammatory processes. The objective of this study was to evaluate the effects of blocking RAS with azilsartan (Azil) on the clinical efficacy of etanercept (Etan) in patients with active rheumatoid arthritis (RA). PATIENTS AND METHODS: Forty-two patients diagnosed with active RA and poorly responding to methotrexate were enrolled in this pilot clinical study. They were randomly allocated into two groups, and treated with either Etan (50 mg/week) and placebo or the same dose of Etan with Azil (20 mg/day) for 90 days. The clinical outcome was evaluated using the Disease Activity Score-28 joint (DAS-28), simplified disease activity index (SDAI), clinical disease activity index (CDAI) and the health assessment questionnaire disease index (HAQ-DI). Blood samples were obtained for the assessment of C-reactive protein and erythrocyte sedimentation rate at baseline and after 90 days. RESULTS: The markers of pain and disease activity, C-reactive protein and erythrocyte sedimentation rate were significantly improved when Azil was used, as an adjuvant with Etan, compared with the use of Etan and placebo. CONCLUSION: Blocking RAS with azilsartan may improve the effects of etanercept on the clinical markers of pain and disease severity of patients with active RA not responding to methotrexate.

Resveratrol Supplementation Reduces Pain and Inflammation in Knee Osteoarthritis Patients Treated with Meloxicam: A Randomized Placebo-Controlled Study.

Resveratrol, a polyphenolic compound, is a powerful antioxidant with remarkable anti-inflammatory properties. Inflammation and pain plays an important role in the pathogenesis of knee osteoarthritis (OA) and could cause tissue damage and morbidity. The aim of this study was to evaluate the anti-inflammatory and pain reduction activities of orally administered resveratrol in patients with knee OA. We carried out a 90-day pilot study to evaluate the ability of orally administered resveratrol, as an adjuvant with meloxicam, to decrease knee joint pain and biomarkers of inflammation in comparison with a placebo. One hundred ten men and women (45-75 years old) diagnosed with mild to moderate knee OA were treated with 15 mg per day meloxicam and either 500 mg per day resveratrol or placebo for 90 days in a double-blind, randomized control trial. Pain severity was evaluated at the beginning and at the end of treatment using Visual Analogue Scale-100 scores. Fasting blood was collected to determine serum interleukins 1ß and 6, tumor necrosis factor-α, C-reactive protein, and complement proteins C3 and C4. The resveratrol-treated group experienced a time-dependent significant decrease in pain severity (P < .001). Serum levels of the biochemical markers were significantly reduced compared with the placebo-treated group (P < .01). These findings suggest that resveratrol may be an effective "add-on" option with meloxicam in the treatment of patients with mild to moderate knee OA.

Efficacy and safety of Ginkgo biloba extract as an "add-on" treatment to metformin for patients with metabolic syndrome: a pilot clinical study.

BACKGROUND AND AIM: Ginkgo biloba (GKB) extract has shown to be beneficial in experimental models of metabolic and inflammatory disorders such as diabetes and metabolic syndrome (MTS). The objective of this pilot clinical study was to evaluate the effects of GKB extract as an "add-on" treatment with metformin (Met) in MTS patients. PATIENTS AND METHODS: We performed a randomized, placebo-controlled, double-blinded clinical study in subjects with MTS. Forty patients completed the 90-day clinical trial and were randomly allocated to administer either GKB extract (120 mg capsule/day) or placebo (120 mg starch/day) as an add-on treatment with their currently used doses of Met for 90 days. During the study, body mass index (BMI), waist circumference (WC), serum leptin, glycated hemoglobin (HbA1c), fasting serum glucose (FSG), insulin, insulin resistance (IR), visceral adiposity index (VAI), lipid profile, and the inflammatory markers high sensitive C-reactive protein (hsCRP), tumor necrosis factor-α (TNF-α), and interleukin-6 (IL-6) were evaluated. RESULTS: GKB extract significantly decreases HbA1c, FSG and insulin levels, IR, BMI, WC, VAI, serum leptin, and the inflammatory markers compared to baseline values. Simultaneously, GKB did not negatively affect the functions of the liver, kidney, and hematopoietic system. CONCLUSION: The use of GKB extract as an adjuvant with Met was effective in improving the outcome of patients with MTS.

Azilsartan as "Add-On" Treatment with Methotrexate Improves the Disease Activity of Rheumatoid Arthritis.

OBJECTIVE: The present study aimed to evaluate the efficacy and safety of azilsartan (Azil) as "add-on" treatment with methotrexate (MTX) in patients with active rheumatoid arthritis (RA). METHODS: This single center, randomized, placebo-controlled, double-blind, pilot study included 64 patients with active RA. Patients received either placebo or Azil in addition to their currently used MTX doses for 90 days. The primary outcomes were DAS-28, SDAI, HAQ-DI, CDAI, EGA, and swollen and tender joints count. The secondary outcomes were the changes in the pain visual analogue scale (VAS-100), serum levels of TNF-α, IL-1ß, IL-6, and anti-CCP, the lipid profile, and the markers of kidney and liver functions in the two groups at baseline and after 90 days. RESULTS: After 90 days, most clinical scores were significantly better in the Azil-treated group than in the placebo group. All inflammatory biomarkers were significantly improved after treatment with MTX + Azil compared to baseline and placebo group. No safety concerns were reported during the study period. CONCLUSIONS: Azilsartan improved the effects of methotrexate on the clinical scores and certain inflammatory biomarkers of patients with active RA. TRIAL REGISTRATION: The protocol was registered under the number 507/SA/1024 at the local clinical studies database, College of Medicine, Sulaimani University.

The efficacy and safety of Ginkgo biloba extract as an adjuvant in type 2 diabetes mellitus patients ineffectively managed with metformin: a double-blind, randomized, placebo-controlled trial.

BACKGROUND AND AIM: Type 2 diabetes mellitus (T2DM) is one of the major diseases confronting the health care systems. In diabetes mellitus (DM), combined use of oral hypoglycemic medications has been shown to be more effective than metformin (Met) alone in glycemic control. This study determined the effects of Ginkgo biloba (GKB) extract as an adjuvant to Met in patients with uncontrolled T2DM. SUBJECTS AND METHODS: Sixty T2DM patients were recruited in a randomized, placebo-controlled, double-blinded, and multicenter trial. The patients, currently using Met, were randomly grouped into those treated with either GKB extract (120 mg/day) or placebo (starch, 120 mg/day) for 90 days. Blood glycated hemoglobin (HbA1c), fasting serum glucose, serum insulin, body mass index (BMI), waist circumference (WC), insulin resistance, and visceral adiposity index (VAI) were determined before (baseline) and after 90 days of GKB extract treatment. RESULTS: GKB extract significantly decreased blood HbA1c (7.7%±1.2% vs baseline 8.6%±1.6%, P<0.001), fasting serum glucose (154.7±36.1 mg/dL vs baseline 194.4±66.1 mg/dL, P<0.001) and insulin (13.4±7.8 µU/mL vs baseline 18.5±8.9 µU/mL, P=0.006) levels, BMI (31.6±5.1 kg/m2 vs baseline 34.0±6.0 kg/m2, P<0.001), waist WC (102.6±10.5 cm vs baseline 106.0±10.9 cm, P<0.001), and VAI (158.9±67.2 vs baseline 192.0±86.2, P=0.007). GKB extract did not negatively impact the liver, kidney, or hematopoietic functions. CONCLUSION: GKB extract as an adjuvant was effective in improving Met treatment outcomes in T2DM patients. Thus, it is suggested that GKB extract is an effective dietary supplement for the control of DM in humans.

Clinical efficacy of resveratrol as an adjuvant with meloxican in the treatment of knee osteoarthritis patients: A double-blind, randomised, placebo-controlled trial

The present study aimed to evaluate the effect of the adjuvant use of resveratrol with meloxicam on the clinical scores of knee OA patients. This was a double-blind placebo-controlled randomised trial involving 100 patients with knee osteoarthritis performed at the Shar Teaching Hospital, Sulaimani General Hospital and Specialised Rheumatology Center, Sulaimani City from December 2016 to September 2017. The efficacy of the treatment was evaluated by measuring the changes from baseline in the KOOS score, WOMAC index, and VAS-100 score after 90 days of treatment. Resveratrol significantly improves the knee OA pain and associated symptoms compared with placebo, and both clinical scores were found to be eligible for following treatment outcomes. In conclusion, resveratrol, when used in combination with meloxicam, improves pain and symptom scores in patients with mild-to-moderate knee OA compared with placebo. The intervention with a dietary supplement may significantly impact the pain and overall quality of life in patients with knee OA.

Effects of Azilsartan, Aliskiren or their Combination on High Fat Diet-induced Non-alcoholic Liver Disease Model in Rats.

INTRODUCTION: In addition to its role in regulation of blood pressure, fluid and electrolyte homeostasis, the renin-angiotensin system (RAS) components were expressed in many other tissues suggesting potential roles in their functions. AIM: The present study aims to evaluate the protective effect aliskiren, when used alone or in combination with azilsartan against high fat diet-induced liver disease in rats. MATERIAL AND METHODS: Thirty-two Wistar male rats, weighing 150-200 gm were allocated evenly into four groups and treated as follow: group I, rats were fed a specially formulated high-fat diet for 8 weeks to induce non-alcoholic liver disease and considered as control group; groups II, III and IV, the rats were administered azilsartan (0.5 mg/kg), aliskiren (25 mg/kg) or their combination orally via gavage tube once daily, and maintained on high fat diet for 8 weeks. The possible treatment outcome was evaluated through measuring serum levels of glucose, insulin, lipid profile, TNF-α, IL-1ß and liver enzymes. Additionally, the liver tissue contents of glycogen and lipids and histological changes were also evaluated. RESULT: The results showed that azilsartan significantly improves the studied markers greater than aliskiren, and their combination o has no additive or synergistic effects on the activity of each one of them. CONCLUSION: Both azilsartan and aliskiren protects the rats against high-fat diet induced NAFLD with predominant effects for the former, and their combination showed no beneficial synergistic or additive effects.