Efficacy and safety of oral Nigella sativa oil for symptomatic treatment of knee osteoarthritis: A double-blind, randomized, placebo-controlled clinical trial.

BACKGROUND AND PURPOSE: The oil of Nigella sativa (NS) seeds has analgesic and anti-inflammatory effects. Therefore, the efficacy and safety of NS oil in the treatment of knee osteoarthritis were evaluated. MATERIALS AND METHODS: One hundred and sixteen patients aged 50-70 years were randomly assigned to take 2.5 mL NS oil (N = 58) or placebo (N = 58) orally every 8 h for 1 month. WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index) was the primary outcome measure and Visual Analog Scale (VAS) for pain, number of 500 mg acetaminophen tablets taken per day during the trial, patients' satisfaction with the interventions, complete blood count and the blood levels of alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine and blood urea nitrogen were the secondary outcome measures. RESULTS: Fifty two and 54 patients respectively in the NS oil and placebo groups completed the study. The VAS scores were decreased by 33.96 ± 17.04% (NS oil group) and 9.21 ± 0.32% (placebo group) (p < 0.001), and WOMAC total scores were decreased by 27.72 ± 18.61% (NS oil group) and 1.34 ± 2.31% (placebo group) (p < 0.001) compared to baseline. The NS oil reduced the dose of acetaminophen significantly compared with the placebo (p = 0.001). The patients were significantly more satisfied with the NS oil than the placebo (p < 0.001). The NS oil had no significant effect on the other variables. There was no side effect. CONCLUSION: Oral NS oil safely reduces the osteoarthritis symptoms and analgesic dose in the knee osteoarthritis patients.

Effects of standardized hydro-alcoholic extract of Vaccinium arctostaphylos leaf on hypertension and biochemical parameters in hypertensive hyperlipidemic type 2 diabetic patients: a randomized, double-blind and placebo-controlled clinical trial.

OBJECTIVE: To study the blood pressure, lipid and glycemic effects and safety of Vaccinium arctostaphylos leaf in the hypertensive hyperlipidemic type 2 diabetic patients. MATERIALS AND METHODS: The patients took 350 mg standardized plant leaf hydro-alcoholic extract capsule (n=50) or placebo capsule (n=50) three times daily alongside conventional drugs for 2 months. At the baseline and endpoint, systolic and diastolic blood pressures and blood levels of fasting glucose (FG), 2-hr postprandial glucose (2hPPG), glycosylated hemoglobin (HbA1c), total cholesterol (TC), LDL-C, triglyceride, HDL-C, SGOT, SGPT and creatinine were determined in both groups. To evaluate the extract safety, serum SGOT, SGPT and creatinine levels were tested; also, the patients were requested to report any adverse effects. RESULTS: FG, 2hPPG, HbA1c, TC, LDL-C, triglyceride and systolic and diastolic blood pressures were decreased, whereas HDL-C was increased significantly in the extract group compared to those of the placebo group at the endpoint (for all cases, p<0.05). The extract did not significantly influence other parameters and no adverse effects were reported. CONCLUSION: V. arctostaphylos leaf hydro-alcoholic extract as an adjunct to the conventional drugs has additional antihypertensive as well as anti-dyslipidemic and anti-hyperglycemic effects in hypertensive hyperlipidemic type 2 diabetic patients. Besides, the extract lacks hepatic, renal and patient-reported adverse effects.

Standardized Nigella sativa seed oil ameliorates hepatic steatosis, aminotransferase and lipid levels in non-alcoholic fatty liver disease: A randomized, double-blind and placebo-controlled clinical trial.

ETHNOPHARMACOLOGICAL EVIDENCE: Nigella sativa (N. sativa) seeds are used in the Iranian traditional medicine for the treatment of liver diseases. AIM OF STUDY: To study the efficacy and safety of N. sativa seed oil in the treatment of patients with non-alcoholic fatty liver disease (NAFLD). MATERIALS AND METHODS: Sixty patients received 2.5 mL fully standardized N. sativa seed oil every 12 h and 60 other patients received placebo for 3 months. At the baseline and endpoint, hepatic steatosis ultrasound grade and blood levels of triglycerides, LDL-C (low-density lipoprotein cholesterol), HDL-C (high-density lipoprotein cholesterol), ALT (alanine aminotransferase), AST (aspartate aminotransferase), blood urea nitrogen, creatinine and complete blood cell count as well as body mass index were determined in the oil and placebo groups and compared. RESULTS: Grade of hepatic steatosis was significantly reduced in the oil group compared to the placebo group (P = 0.004). Mean ±â€¯standard deviation of changes of variables in the oil and placebo groups were respectively 32.6 ±â€¯16.6 and 14.2 ±â€¯19.7% for ALT (P < 0/001), 29.4 ±â€¯16.3 and 12.3 ±â€¯16.8% for AST (P < 0.001), 10 ±â€¯13.9 and 0.22 ±â€¯18.2% for triglycerides (P = 0.001), 14.1 ±â€¯9.8 and 9.2 ±â€¯11.1% for LDL-C (P = 0.01), 9.5 ±â€¯7.7 and 4.8 ±â€¯6.5% for HDL-C (P = 0.001). However, the oil did not significantly affect the other outcome variables compared to the placebo (all P > 0.05). No adverse effect was observed. CONCLUSIONS: The N. sativa seed oil seems to be safe and improve liver steatosis and injury and blood levels of triglycerides, LDL-C and HDL-C in the NAFLD patients.

Efficacy of phospholipidated curcumin in nonalcoholic fatty liver disease: a clinical study.

Curcumin is a safe and dietary phytochemical that can improve different pathophysiologic features of non-alcoholic fatty liver disease (NAFLD). Here, we investigated the efficacy of phospholipidated curcumin supplementation in NAFLD patients. In this single-arm study, 36 patients were recruited. Each patient received three capsules a day (each containing 500 mg of phospholipidated curcumin [overall content of curcuminoids per capsule: 100 mg]) for a period of 8 weeks. The results indicated that phospholipidated curcumin supplementation reduced NAFLD severity and ameliorated ultrasonographic and biochemical measures (including liver transaminases and lipid profile) associated with disease progression.

Efficacy of artichoke leaf extract in non-alcoholic fatty liver disease: A pilot double-blind randomized controlled trial.

Non-alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide and is potentially treatable, though there are few therapeutic agents available. Artichoke leaf extract (ALE) has shown potential as a hepatoprotective agent. This study sought to determine if ALE had therapeutic utility in patients with established NAFLD. In this randomized double-blind placebo-controlled parallel-group trial, 100 subjects with ultrasound-diagnosed NAFLD were randomized to either ALE 600 mg daily or placebo for a 2-month period. NAFLD response was assessed by liver ultrasound and serological markers including the aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio and AST to platelet ratio index (APRI) score. Ninety patients completed the study (49 ALE and 41 placebo) with no side effects reported. ALE treatment compared with placebo: Doppler sonography showed increased hepatic vein flow (p < .001), reduced portal vein diameter (p < .001) and liver size (p < .001), reduction in serum ALT (p < .001) and AST (p < .001) levels, improvement in AST/ALT ratio and APRI scores (p < .01), and reduction in total bilirubin. ALE supplementation reduced total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, non-high-density lipoprotein cholesterol, and triglyceride concentrations (p = .01). This study has shown beneficial effects of ALE supplementation on both ultrasound liver parameters and liver serum parameters (ALT, AST, APRI ratio, and total bilirubin) in patients with NAFLD.

Silymarin, Olibanum, and Nettle, A Mixed Herbal Formulation in the Treatment of Type II Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial.

Silybum marianum (L) Gaertn (milk thistle) seeds, Urtica dioica L (nettle) leaves, and Boswellia serrata (olibanum gum) resin are used traditionally by Iranian diabetic patients. The aim of this study was to evaluate the antihyperglycemic effects of these herbs in an herbal formulation in patients with type II diabetes mellitus. Sixty patients diagnosed as type II diabetes mellitus with fasting blood glucose level from 150 to 180 mg/dL, glycosylated hemoglobin level from 7.5% to 8.5%, and on oral antihyperglycemic drugs, were allocated to receive the mix herbal formulation or placebo for 90 days in a double-blind randomized placebo-controlled clinical trial. The mean serum fasting blood glucose, glycosylated hemoglobin, and triglyceride in the herbal drug group were significantly less than placebo group's values after 3 months of the intervention. The study showed a potential antihyperglycemic and triglyceride lowering effect of the herbal formulation, while it did not have any significant cholesterol or blood pressure lowering effect.

Efficacy of Mentha pulegium extract in the treatment of functional dyspepsia: A randomized double-blind placebo-controlled clinical trial.

ETHNOPHARMACOLOGICAL EVIDENCE: Mentha pulegium L. leaves are used in the Iranian traditional medicine for the treatment of functional dyspepsia. AIM OF STUDY: To study the efficacy and safety of M. pulegium in the treatment of functional dyspepsia patients fulfilling the Rome III criteria. MATERIALS AND METHODS: The efficacy and safety of a standardized Mentha pulegium leaf extract (drug extract ratio: 15.9:1, extraction solvent: 70% v/v aqueous ethanol) (330mg three times daily taken for 2 months) as add-on to one famotidine 40mg tablet per day in the treatment of 50 functional dyspepsia patients were compared with those of a parallel placebo group (n =50). RESULTS: The extract significantly decreased the total dyspepsia score measured by the Hong Kong dyspepsia index compared to the placebo and baseline (P=0.011 and P<0.001 respectively). The stomach pain, upper abdominal bloating, upper abdominal dull ache, belching and total dyspepsia scores were decreased from baseline in the extract group significantly compared to the placebo (P<0.001, P<0.001, P=0.003, P<0.001 and P<0.001 respectively). However, the decreases of other dyspepsia symptoms scores from baseline in the extract group were not significant compared to the placebo (P>0.05). The extract improved the quality of life measured by the SF-36 questionnaire significantly compared to the placebo and baseline (P=0.003 and P<0.001 respectively). Moreover, the extract lowered the rate of H. pylori infection determined by the urease test significantly compared to the placebo and baseline (P=0.001 and P<0.001 respectively). The extract did not significantly affect the complete blood count and liver and kidney function tests (P>0.05). The patients did not experience any adverse drug effect. CONCLUSIONS: M. pulegium extract (genuine drug extract ratio: 19.4:1; extraction solvent: 70% v/v aqueous ethanol) 270mg three times daily taken for 2 months as adjunct to one famotidine 40mg tablet per day seems safe, improves dyspeptic symptoms and quality of life and eradicates H. pylori in functional dyspepsia patients.

Efficacy and Safety of Phytosomal Curcumin in Non-Alcoholic Fatty Liver Disease: A Randomized Controlled Trial.

Non-alcoholic fatty liver disease (NAFLD) is a common liver disease characterized by excess lipid deposition in the hepatic tissue and subsequent oxidative and inflammatory damage. Curcumin is a dietary polyphenol with lipid-modifying, antioxidant and anti-inflammatory properties. This study aimed to evaluate the efficacy and safety of supplementation with phytosomal curcumin in subjects with NAFLD.Patients diagnosed with NAFLD (grades 1-3 according to liver ultrasonography) were randomly assigned to the curcumin (phytosomal form; 1 000 mg/day in 2 divided doses) (n=50) or placebo group (n=52) for a period of 8 weeks. All patients received dietary and lifestyle advises before the start of trial. Anthropometric measurements, hepatic enzymes, and liver ultrasonography were assessed at baseline and after 8 weeks of follow-up.87 subjects (n=44 and 43 in the curcumin and control group, respectively) completed the trial. Supplementation with curcumin was associated with a reduction in body mass index (-0.99±1.25 vs. - 0.15±1.31 in the curcumin and placebo groups, respectively; p=0.003) and waist circumference (-1.74±2.58 vs. -0.23±3.49 in the curcumin and placebo groups, respectively; p=0.024). Ultrasonographic findings were improved in 75.0% of subjects in the curcumin group, while the rate of improvement in the control group was 4.7% (p<0.001). Serum levels of aspartate aminotransferase and alanine aminotransferase were reduced by the end of trial in the curcumin group (p<0.001) but elevated in the control group (p<0.001). Curcumin was safe and well tolerated during the course of trial.Short-term supplementation with curcumin improves liver fat and transaminase levels in patients with NAFLD.

Curcumin Lowers Serum Lipids and Uric Acid in Subjects With Nonalcoholic Fatty Liver Disease: A Randomized Controlled Trial.

BACKGROUND: Nonalcoholic fatty liver disease (NAFLD) is one of the most common hepatic diseases in the general adult population. Dyslipidemia, hyperuricemia, and insulin resistance are common risk factors and accompanying features of NAFLD. Curcumin is a dietary natural product with beneficial metabolic effects relevant to the treatment of NAFLD. AIM: To assess the effects of curcumin on metabolic profile in subjects with NAFLD. METHODS: Patients diagnosed with NAFLD (grades 1-3; according to liver sonography) were randomly assigned to curcumin (1000 mg/d in 2 divided doses) (n = 50) or control (n = 52) group for a period of 8 weeks. All patients received dietary and lifestyle advises before the start of trial. Anthropometric measurements, lipid profile, glucose, insulin, glycated hemoglobin, and uric acid concentrations were measured at baseline and after 8 weeks of follow-up. RESULTS: Eighty-seven subjects (n = 44 and 43 in the curcumin and control group, respectively) completed the trial. Supplementation with curcumin was associated with a reduction in serum levels of total cholesterol (P < 0.001), low-density lipoprotein cholesterol (P < 0.001), triglycerides (P < 0.001), non-high-density lipoprotein cholesterol (P < 0.001), and uric acid (P < 0.001), whereas serum levels of high-density lipoprotein cholesterol and glucose control parameters remained unaltered. Curcumin was safe and well tolerated during this study. CONCLUSION: Results of the present trial suggest that curcumin supplementation reduces serum lipids and uric acid concentrations in patients with NAFLD.

Efficacy and safety of honey based formulation of Nigella sativa seed oil in functional dyspepsia: A double blind randomized controlled clinical trial.

ETHNOPHARMACOLOGICAL RELEVANCE: A honey based formulation from Nigella sativa L. (N. sativa) has been used in Traditional Persian Medicine for upper gastrointestinal symptoms. Considering the traditional use of this formulation and its ingredients known pharmacologic effects, this study aimed to evaluate the efficacy and safety of N. sativa seed oil mixed with honey in treatment of patients with functional dyspepsia. METHODS AND MATERIALS: Seventy patients diagnosed with functional dyspepsia according to ROME III criteria and confirmed by upper gastrointestinal endoscopy were selected to receive a traditional honey based formulation of N. sativa (5 ml N. sativa oil orally daily) or placebo for 8 weeks in a double-blind randomized placebo-controlled clinical trial using a parallel design with a 1:1 allocation ratio. Patients were evaluated prior to and following 8 weeks of the intervention in terms of the Hong Kong index of dyspepsia severity, presence of Helicobacter pylori infection based on urease test, scores in different domains of short form (SF-36) health survey, and any observed adverse events. RESULTS: The mean scores of Hong Kong index of dyspepsia severity sores and the rate of H. pylori infection were significantly lower in the N. sativa group comparing the placebo group after the intervention (P<0.001). No serious adverse event was reported. CONCLUSION: This study showed that adjuvant supplementation of honey based formulation of N. sativa can cause significant symptomatic improvement of patients with functional dyspepsia whom received the standard anti-secretory therapy. The results should be investigated further in studies with longer duration and larger sample size.

Efficacy and safety of Aloe vera syrup for the treatment of gastroesophageal reflux disease: a pilot randomized positive-controlled trial.

OBJECTIVE: To investigate the use of Aloe vera (A. vera) for the treatment of gastroesophageal reflux disease (GERD) symptoms and compare its effects with those of omeprazole and ranitidine. METHODS: In this pilot, randomized controlled trial, 79 subjects were allocated to A. vera syrup (standardized to 5.0 mg polysaccharide per mL of syrup) at a dose of 10 mL/d, omeprazole capsule (20 g/d) or ranitidine tablet (150 mg in a fasted state in the morning and 150 mg 30 min before sleep at night) for a period of 4 weeks. The frequencies of eight main symptoms of GERD (heartburn, food regurgitation, flatulence, belching, dysphagia, nausea, vomiting and acid regurgitation) were assessed at weeks 2 and 4 of the trial. RESULTS: A. vera was safe and well tolerated and reduced the frequencies of all the assessed GERD symptoms, with no adverse events requiring withdrawal. CONCLUSION: A. vera may provide a safe and effective treatment for reducing the symptoms of GERD.

Effect of a Combination of Omeprazole Plus Sustained Release Baclofen Versus Omeprazole Alone on Symptoms of Patients with Gastroesophageal Reflux Disease (GERD).

Previous studies have reported the efficacy of baclofen in the treatment of Gastroesophageal Reflux Diseases (GERD). The objective of present study is to evaluate the effect of co-administration of omeprazole 20 mg/d plus sustained Release baclofen (SR baclofen) vs. omeprazole 20 mg/d plus placebo on alleviation of symptoms in patients with a diagnosis of GERD. A prospective, double blind, placebo controlled trial included 60 patients with diagnosis of GERD have been done. Patients were randomly selected to receive either SR baclofen or a placebo in addition to omeprazole 20 mg/d for a period of 2 weeks. Patients were questioned regarding heartburn, regurgitation, chest pain and hoarseness at the base line and after 2 weeks. All patients tolerated the medications and no patients failed to complete the study due to adverse drug reactions. A total of 53 patients completed the study, 25 in SR baclofen and 28 in placebo group. After 2 weeks, 1 patient (4%) in SR baclofen group reported heartburn and regurgitation. However 13(46.4%) and 15 (53.6%) of patients in the placebo group had heartburn and regurgitation respectively. The analysis of the data shows that there is a significant difference between the two groups in heartburn and regurgitation (p < 0.0001, p < 0.0001 respectively). Statistical analysis revealed a significant difference in two groups regarding total GERD score (p <0.0001). The results of the present study suggest that a combination of SR baclofen and omeprazole may be a more effective treatment for heartburn and regurgitation than omeprazole alone.

Elevated alanine aminotransferase activity is not associated with dyslipidemias, but related to insulin resistance and higher disease grades in non-diabetic non-alcoholic fatty liver disease.

OBJECTIVE: To explore demographic and metabolic factors associated with increased alanine aminotransferase (ALT) activity in non-diabetic non-alcoholic fatty liver disease (NAFLD) patients. METHODS: Overall 372 patients who consecutively attended to Gastroenterology Clinic of Baqiyatallah University of Medical Sciences, Tehran, Iran awere diagnosed as NAFLD entered into analysis. Exclusion criteria were having diabetes mellitus and fasting blood glucose over 126 mg/dL, active hepatitis B virus infection, having hepatitis C virus positive serology, and to be under corticosteroid therapy. ALT levels were considered pathologically high when it was over 30 IU/L for men and over 19 IU/L for women. RESULTS: Bivariate analyses using t test and chi-square test showed that patients with pathologically augmented ALT levels had significantly higher NAFLD grades in their ultrasonographic evaluations (P=0.003). Moreover, these patients represented significantly higher homeostatic model assessment levels (P=0.003), levels of serum insulin (P=0.002), fasting blood glucose (P<0.001), and uric acid (P=0.02). The prevalence of insulin resistance was also higher in patients with increased serum ALT concentrations. Multifactorial logistic regression models showed that ultrasonographic grading of NAFLD (P=0.027) and insulin resistance (P=0.013) were the only variables significantly associated with abnormal ALT levels. CONCLUSIONS: This study shows that the associations of increased ALT serum levels in NAFLD patients are different from what are supposed before. By excluding diabetic patients from our population, we find that increased ALT levels are not associated with dyslipidemias but are independently associated with insulin resistance and NAFLD grading on ultrasonographic evaluations. Further studies are needed to confirm our results.