human
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P < 0.05–0.01 ) . Meanwhile , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P < 0.01 ) when compared with the placebo group . In addition , extract administration reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT OBJECTIVE To examine the safety and efficacy of dapagliflozin , a sodium-glucose cotransporter-2 inhibitor , added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone . RESEARCH DESIGN AND METHODS Treatment-naive patients or those receiving metformin , sulfonylurea , or thiazolidinedione  entered a 10-week pioglitazone dose-optimization period with only pioglitazone . They were then r and omized , along with patients previously receiving pioglitazone ≥30 mg , to 48 weeks of double-blind dapagliflozin 5 ( n = 141 ) or 10 mg ( n = 140 ) or placebo  ( n = 139 ) every day plus open-label pioglitazone . The primary objective compared HbA1c change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24 . Primary analysis was based on ANCOVA model using last observation carried forward ; all remaining analyses used repeated- measures analysis . RESULTS At week 24 , the mean reduction from baseline in HbA1c was −0.42 % for placebo versus −0.82 and −0.97 % for dapagliflozin 5 and 10 mg groups , respectively ( P = 0.0007 and P < 0.0001 versus placebo ) . Patients receiving pioglitazone alone  had greater weight gain ( 3 kg ) than those receiving dapagliflozin plus pioglitazone ( 0.7–1.4 kg ) at week 48 . Through 48 weeks : hypoglycemia was rare ; more events suggestive of genital infection were reported with dapagliflozin ( 8.6–9.2 % ) than placebo ( 2.9 % ) ; events suggestive of urinary tract infection showed no clear drug effect ( 5.0–8.5 % for dapagliflozin and 7.9 % for placebo ) ; dapagliflozin plus pioglitazone groups had less edema ( 2.1–4.3 % ) compared with placebo plus pioglitazone ( 6.5 % ) ; and congestive heart failure and fractures were rare . CONCLUSIONS In patients with type 2 diabetes inadequately controlled on pioglitazone  , the addition of dapagliflozin further reduced HbA1c levels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk The antidiabetic effect of N. sativa seed ethanol extract ( NSE ) was assessed in Meriones shawi after development of diabetes . Meriones shawi were divided r and omly into four groups : normal control , diabetic control , diabetic treated with NSE ( 2 g eq plant/kg ) or with metformin ( 300 mg/kg ) positive control , both administered by daily intragastric gavage for 4 weeks . Glycaemia and body weight were evaluated weekly . At study 's end , an Oral Glucose Tolerance Test ( OGTT ) was performed to estimate insulin sensitivity . Upon sacrifice , plasma lipid profile , insulin , leptin , and adiponectin levels were assessed . ACC phosphorylation and Glut4 protein content were determined in liver and skeletal muscle . NSE animals showed a progressive normalization of glycaemia , albeit slower than that of metformin controls . Moreover , NSE increased insulinemia and HDL-cholesterol , compared to diabetic controls . Leptin and adiponectin were unchanged . NSE treatment decreased OGTT and tended to decrease liver and muscle triglyceride content .  NSE stimulated muscle and liver ACC phosphorylation and increased muscle Glut4 . These results confirm NSE 's previously reported hypoglycaemic and hypolipidemic activity . More significantly , our data demonstrate that in vivo treatment with NSE exerts an insulin-sensitizing action by enhancing ACC phosphorylation , a major component of the insulin-independent AMPK signaling pathway , and by enhancing muscle Glut4 expression BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) .  DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group . The N sativa group had a significant decline in TC , LDL-C , TC/HDL-C and LDL-C/HDL-C ratios , compared with the respective baseline data and the control group . HDL-C was significantly elevated in the N sativa group . The control group showed a significant elevation in MAP . The N sativa group had a significant reduction in SBP , DBP , MAP and HR and a significant decrease in DBP , MAP and HR as compared with the control group . CONCLUSION N sativa supplementation improves total cholesterol , mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents .  LIMITATIONS There were 9 subjects in each group lost to follow up ; thus the sample size could not be maintained as per the sample size calculation . The study was nonr and omized and thus there was a possibility of allocation bias . ( Clinical trial registration number : CTRI/2013/06/003781 , Clinical Trial Registry of India ) This experiment was carried out to investigate the effect of N. sativa L. on histopathology of pancreatic beta-cells , and blood insulin and glucose concentrations in streptozotocin-induced diabetic rats . Fifty male Wistar rats ( 200 - 250 g ) were divided into two experimental groups ( diabetics with no treatment and diabetics with N. sativa L. treatment ) , each containing twenty-five rats . Diabetes was induced in both groups by a single intraperitoneal injection of streptozotocin ( STZ ) ( 50 mg/kg ) . The experimental animals in both groups became diabetic within 24 hours after the administration of STZ . The rats in N. sativa L.-treated group were given the daily intraperitoneal injection of 0.20 ml/kg of N. sativa L. volatile oil for 30 days starting the day after STZ injection . Control rats received only the same amount of normal saline solution . The rats in both groups received the last injection 24 hours before the sacrification and 5 r and omly-selected rats in each group were sacrificed before , and the 1 , 10 , 20 and 30 days after the STZ injection to collect blood and pancreatic tissue sample s. The N. sativa L. treatment caused a decrease in the elevated serum glucose , an increase in the lowered serum insulin concentrations and partial regeneration/ proliferation of pancreatic beta-cells in STZ-induced diabetic rats with the elapse of the experiment . It is concluded that the hypoglycaemic action of N. sativa L. could be partly due to amelioration in the beta-cells of pancreatic islets causing an increase in insulin secretion . More studies are needed to demonstrate the exact mechanism of action of N. sativa L. on ameliorated blood glucose concentration in STZ-induced diabetes The constituents of Nigella sativa modulate the immune system . The aim of the present work was to study the effectiveness of Nigella sativa oil in RA patients . Data from 40 female RA patients diagnosed according to the 2010 ACR/EULAR were analysed and discussed . The patients took two placebo ( starch filled ) capsules daily for 1 month . This was followed by a month of Nigella sativa oil capsules 500 mg twice/day . The disease activity score ( DAS-28 ) significantly decreased after receiving the Nigella sativa capsules ( 4.55 ± 0.82 ) compared with before and after placebo ( 4.98 ± 0.79 and 4.99 ± 0.72 , respectively ) ( p = 0.017 ) . Similarly , the number of swollen joints and the duration of morning stiffness improved . A marked improvement in the disease activity was shown by both the ACR20 and EULAR response criteria in 42.5 % and 30 % of the patients , respectively , after intake of Nigella . Supplementation with Nigella sativa during DMARD therapy in RA may be considered an affordable potential adjuvant biological therapy UNLABELLED Diabetes mellitus is a common chronic disease affecting millions of people world wide . St and ard treatment is failing to achieve required correction of blood glucose in many patients . Therefore , there is a need for investigating potential hypoglycemic drugs or herbs to improve glycemic control in diabetic patients .  Nigella sativa seeds were used as an adjuvant therapy in patients with diabetes mellitus type 2 added to their anti-diabetic medications . A total of 94 patient were recruited and divided r and omly into three dose groups . Capsules containing Nigella sativa were administered orally in a dose of 1 , 2 and 3 gm/day for three months . The effect of Nigella sativa on the glycemic control was assessed through measurement of fasting blood glucose ( FBG ) , blood glucose level 2 hours postpr and ially ( 2 hPG ) , and glycosylated hemoglobin ( HbA1c ) . Serum C-peptide and changes in body weight were also measured . Insulin resistance and beta-cell function were calculated usin the homeostatic model assessment ( HOMA2 ) . Nigella sativa at a dose of 2 gm/day caused significant reductions in FBG , 2hPG , and HbA1 without significant change in body weight . Fasting blood glucose was reduced by an average of 45 , 62 and 56 mg/dl at 4 , 8 and 12 weeks respectively . HbAlC was reduced by 1.52 % at the end of the 12 weeks of treatment ( P<0.0001 ) . Insulin resistance calculated by HOMA2 was reduced significantly ( P<0.01 ) , while B-cell function was increased ( P<0.02 ) at 12 weeks of treatment . The use of Nigella sativa in a dose of 1 gm/day also showed trends in improvement in all the measured parameters but it was not statistically significant from the baseline . However , no further increment in the beneficial response was observed with the 3 gm/day dose . The three doses of Nigella sativa used in the study did not adversely affect either renal functions or hepatic functions of the diabetic patients throughout the study period . IN CONCLUSION the results of this study indicate that a dose of 2 gm/ day of Nigella sativa might be a beneficial adjuvant to oral hypoglycemic agents in type 2 diabetic patients Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diab 
    Output:
    
agent
Although , the meta- analysis conducted included a few number of studies , but has shown promising results on the effectiveness of N. sativa on glucose homeostasis and serum lipids .
***TASK*** the task is to summarize an input biomedical literature in six sentences 
    ***INPUT*** the input is a biomedical literature 
    ***OUTPUT*** the output is the summary of an input biomedical literature in six sentences 
    ***DOCUMENTATION*** 
    ***EXAMPLES*** 
    Input: Hypertension ( HT ) is a lifestyle‐related disease and dietary modifications are effective for its management and prevention . We conducted a r and omized , double‐blind , placebo‐controlled trial to evaluate the efficacy of treatment with an oral Nigella sativa ( NS ) seed extract supplement in patients with mild HT . Subjects were r and omized into three groups : a placebo and two test groups that received 100 and 200 mg of NS extract twice a day . After 8 weeks , systolic blood pressure ( SBP ) values in both case groups were found to be significantly reduced when compared with the baseline values for each group . In addition , the decrease in SBP in the two case groups was statistically significant relative to the placebo group ( P < 0.05–0.01 ) . Meanwhile , diastolic blood pressure ( DBP ) values in the case groups were found to be significantly reduced from the baseline and a significant reduction was also observed in these groups ( P < 0.01 ) when compared with the placebo group . In addition , extract administration reduced both SBP and DBP in a dose‐dependent manner . Meanwhile , NS extract caused a significant decline in the level of total and low‐density‐lipoprotein (LDL)‐cholesterol relative to baseline data . No complications caused by NS were observed . The results suggest that the daily use of NS seed extract for 2 months may have a blood pressure‐lowering effect in patients with mild HT OBJECTIVE To examine the safety and efficacy of dapagliflozin , a sodium-glucose cotransporter-2 inhibitor , added on to pioglitazone in type 2 diabetes inadequately controlled on pioglitazone . RESEARCH DESIGN AND METHODS Treatment-naive patients or those receiving metformin , sulfonylurea , or thiazolidinedione  entered a 10-week pioglitazone dose-optimization period with only pioglitazone . They were then r and omized , along with patients previously receiving pioglitazone ≥30 mg , to 48 weeks of double-blind dapagliflozin 5 ( n = 141 ) or 10 mg ( n = 140 ) or placebo  ( n = 139 ) every day plus open-label pioglitazone . The primary objective compared HbA1c change from baseline with dapagliflozin plus pioglitazone versus placebo plus pioglitazone at week 24 . Primary analysis was based on ANCOVA model using last observation carried forward ; all remaining analyses used repeated- measures analysis . RESULTS At week 24 , the mean reduction from baseline in HbA1c was −0.42 % for placebo versus −0.82 and −0.97 % for dapagliflozin 5 and 10 mg groups , respectively ( P = 0.0007 and P < 0.0001 versus placebo ) . Patients receiving pioglitazone alone  had greater weight gain ( 3 kg ) than those receiving dapagliflozin plus pioglitazone ( 0.7–1.4 kg ) at week 48 . Through 48 weeks : hypoglycemia was rare ; more events suggestive of genital infection were reported with dapagliflozin ( 8.6–9.2 % ) than placebo ( 2.9 % ) ; events suggestive of urinary tract infection showed no clear drug effect ( 5.0–8.5 % for dapagliflozin and 7.9 % for placebo ) ; dapagliflozin plus pioglitazone groups had less edema ( 2.1–4.3 % ) compared with placebo plus pioglitazone ( 6.5 % ) ; and congestive heart failure and fractures were rare . CONCLUSIONS In patients with type 2 diabetes inadequately controlled on pioglitazone  , the addition of dapagliflozin further reduced HbA1c levels and mitigated the pioglitazone-related weight gain without increasing hypoglycemia risk The antidiabetic effect of N. sativa seed ethanol extract ( NSE ) was assessed in Meriones shawi after development of diabetes . Meriones shawi were divided r and omly into four groups : normal control , diabetic control , diabetic treated with NSE ( 2 g eq plant/kg ) or with metformin ( 300 mg/kg ) positive control , both administered by daily intragastric gavage for 4 weeks . Glycaemia and body weight were evaluated weekly . At study 's end , an Oral Glucose Tolerance Test ( OGTT ) was performed to estimate insulin sensitivity . Upon sacrifice , plasma lipid profile , insulin , leptin , and adiponectin levels were assessed . ACC phosphorylation and Glut4 protein content were determined in liver and skeletal muscle . NSE animals showed a progressive normalization of glycaemia , albeit slower than that of metformin controls . Moreover , NSE increased insulinemia and HDL-cholesterol , compared to diabetic controls . Leptin and adiponectin were unchanged . NSE treatment decreased OGTT and tended to decrease liver and muscle triglyceride content .  NSE stimulated muscle and liver ACC phosphorylation and increased muscle Glut4 . These results confirm NSE 's previously reported hypoglycaemic and hypolipidemic activity . More significantly , our data demonstrate that in vivo treatment with NSE exerts an insulin-sensitizing action by enhancing ACC phosphorylation , a major component of the insulin-independent AMPK signaling pathway , and by enhancing muscle Glut4 expression BACKGROUND Diabetic patients with hypertension and dyslipidemia are at a high risk of cardiovascular complications . OBJECTIVES To determine the effect of Nigella sativa supplementation on the lipid profile , mean arterial pressure , and heart rate in persons with type 2 diabetes on oral hypoglycemic agents ( OHA ) .  DESIGN Single-blind , nonr and omized . SETTING Diabetes clinic of a university hospital in Saudi Arabia . PATIENTS AND METHODS Type-2 diabetic patients were recruited by purposive sampling and assigned to treatment or control at the discretion of the investigator with the patient blinded to treatment . Before the intervention and every 3 months thereafter until the end of the treatment period , the following parameters were measured : triglycerides ( TG ) , total cholesterol ( TC ) , low density lipoprotein cholesterol ( LDL-C ) , high density lipoprotein cholesterol ( HDL-C ) , systolic blood pressure ( SBP ) , diastolic blood pressure ( DBP ) , mean arterial pressure ( MAP ) , heart rate ( HR ) , and body mass index ( BMI ) . Results at the baseline and each subsequent visit were compared between the two groups . MAIN OUTCOME MEASURE(S ) Lipid and cardiovascular parameters , and BMI . RESULTS Fifty-seven patients were assigned to receive N sativa 2 g daily for one year and 57 were assigned to receive an identical regimen of placebo , along with OHA . A significant decrease in HDL-C and increase in the TC/HDL-C and LDL-C/HDL-C ratios were seen in the control group . The N sativa group had a significant decline in TC , LDL-C , TC/HDL-C and LDL-C/HDL-C ratios , compared with the respective baseline data and the control group . HDL-C was significantly elevated in the N sativa group . The control group showed a significant elevation in MAP . The N sativa group had a significant reduction in SBP , DBP , MAP and HR and a significant decrease in DBP , MAP and HR as compared with the control group . CONCLUSION N sativa supplementation improves total cholesterol , mean arterial pressure and heart rate in type 2 diabetes patients on oral hypoglycemic agents .  LIMITATIONS There were 9 subjects in each group lost to follow up ; thus the sample size could not be maintained as per the sample size calculation . The study was nonr and omized and thus there was a possibility of allocation bias . ( Clinical trial registration number : CTRI/2013/06/003781 , Clinical Trial Registry of India ) This experiment was carried out to investigate the effect of N. sativa L. on histopathology of pancreatic beta-cells , and blood insulin and glucose concentrations in streptozotocin-induced diabetic rats . Fifty male Wistar rats ( 200 - 250 g ) were divided into two experimental groups ( diabetics with no treatment and diabetics with N. sativa L. treatment ) , each containing twenty-five rats . Diabetes was induced in both groups by a single intraperitoneal injection of streptozotocin ( STZ ) ( 50 mg/kg ) . The experimental animals in both groups became diabetic within 24 hours after the administration of STZ . The rats in N. sativa L.-treated group were given the daily intraperitoneal injection of 0.20 ml/kg of N. sativa L. volatile oil for 30 days starting the day after STZ injection . Control rats received only the same amount of normal saline solution . The rats in both groups received the last injection 24 hours before the sacrification and 5 r and omly-selected rats in each group were sacrificed before , and the 1 , 10 , 20 and 30 days after the STZ injection to collect blood and pancreatic tissue sample s. The N. sativa L. treatment caused a decrease in the elevated serum glucose , an increase in the lowered serum insulin concentrations and partial regeneration/ proliferation of pancreatic beta-cells in STZ-induced diabetic rats with the elapse of the experiment . It is concluded that the hypoglycaemic action of N. sativa L. could be partly due to amelioration in the beta-cells of pancreatic islets causing an increase in insulin secretion . More studies are needed to demonstrate the exact mechanism of action of N. sativa L. on ameliorated blood glucose concentration in STZ-induced diabetes The constituents of Nigella sativa modulate the immune system . The aim of the present work was to study the effectiveness of Nigella sativa oil in RA patients . Data from 40 female RA patients diagnosed according to the 2010 ACR/EULAR were analysed and discussed . The patients took two placebo ( starch filled ) capsules daily for 1 month . This was followed by a month of Nigella sativa oil capsules 500 mg twice/day . The disease activity score ( DAS-28 ) significantly decreased after receiving the Nigella sativa capsules ( 4.55 ± 0.82 ) compared with before and after placebo ( 4.98 ± 0.79 and 4.99 ± 0.72 , respectively ) ( p = 0.017 ) . Similarly , the number of swollen joints and the duration of morning stiffness improved . A marked improvement in the disease activity was shown by both the ACR20 and EULAR response criteria in 42.5 % and 30 % of the patients , respectively , after intake of Nigella . Supplementation with Nigella sativa during DMARD therapy in RA may be considered an affordable potential adjuvant biological therapy UNLABELLED Diabetes mellitus is a common chronic disease affecting millions of people world wide . St and ard treatment is failing to achieve required correction of blood glucose in many patients . Therefore , there is a need for investigating potential hypoglycemic drugs or herbs to improve glycemic control in diabetic patients .  Nigella sativa seeds were used as an adjuvant therapy in patients with diabetes mellitus type 2 added to their anti-diabetic medications . A total of 94 patient were recruited and divided r and omly into three dose groups . Capsules containing Nigella sativa were administered orally in a dose of 1 , 2 and 3 gm/day for three months . The effect of Nigella sativa on the glycemic control was assessed through measurement of fasting blood glucose ( FBG ) , blood glucose level 2 hours postpr and ially ( 2 hPG ) , and glycosylated hemoglobin ( HbA1c ) . Serum C-peptide and changes in body weight were also measured . Insulin resistance and beta-cell function were calculated usin the homeostatic model assessment ( HOMA2 ) . Nigella sativa at a dose of 2 gm/day caused significant reductions in FBG , 2hPG , and HbA1 without significant change in body weight . Fasting blood glucose was reduced by an average of 45 , 62 and 56 mg/dl at 4 , 8 and 12 weeks respectively . HbAlC was reduced by 1.52 % at the end of the 12 weeks of treatment ( P<0.0001 ) . Insulin resistance calculated by HOMA2 was reduced significantly ( P<0.01 ) , while B-cell function was increased ( P<0.02 ) at 12 weeks of treatment . The use of Nigella sativa in a dose of 1 gm/day also showed trends in improvement in all the measured parameters but it was not statistically significant from the baseline . However , no further increment in the beneficial response was observed with the 3 gm/day dose . The three doses of Nigella sativa used in the study did not adversely affect either renal functions or hepatic functions of the diabetic patients throughout the study period . IN CONCLUSION the results of this study indicate that a dose of 2 gm/ day of Nigella sativa might be a beneficial adjuvant to oral hypoglycemic agents in type 2 diabetic patients Objective To determine the extent to which intensive dietary intervention can influence glycaemic control and risk factors for cardiovascular disease in patients with type 2 diab 
    Output:
    