A randomized controlled trial on the seeds of Sophora alopecuroides var. alopecuroides for the treatment of acute heroin withdrawal syndrome.

BACKGROUND: and purpose: The seeds of Sophora alopecuroides var. alopecuroides have attenuated the acute opium withdrawal syndrome in humans. Therefore, the efficacy and safety of a standardized extract of the plant for the treatment of acute heroin withdrawal syndrome was evaluated in abstinent heroin addicts. MATERIALS AND METHODS: The patients were randomized to take three 400 mg extract capsules (N = 50) or placebo (N = 50) once per day orally for eight days. The severity of withdrawal syndrome was assessed by the clinical opiate withdrawal scale (COWS) as the primary outcome measure at the baseline and on the days 3 and 8. The hepatic and renal functions and complete blood count were the secondary outcome measures tested at the baseline and end of the study. RESULTS: The COWS score decreased in both groups after eight days, but the decrease was significantly higher in the experimental group (p < 0.001); the effect size of the decrease was 2.64. The groups had significant differences in the COWS scores on the days 3 and 8 (p < 0.001 for both). The extract had no significant effect on the other parameters. No side effect was noted. CONCLUSION: The extract seems to alleviate acute heroin withdrawal syndrome safely.

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.

PVA based nanofiber containing CQDs modified with silica NPs and silk fibroin accelerates wound healing in a rat model.

In recent years, applying various wound dressings with antibacterial activities to expedite tissue repair stages has gained remarkable attention. The intertwined three-dimensional structure of nanofibers provides unique spaces for carrying drugs and repair agents during the wound healing process. In this research, a carbon quantum dot (CQD)/silica nanoparticle (Si NP)/silk fibroin (SF) nanocomposite was synthesized, and two novel wound dressings, a BC-CQD/Si NP/SF nanocomposite and a PVA-CQD/Si NP/SF nanofiber, were prepared by Spray Printing and Electrospinning methods and successfully characterized. The water-uptake capacity of the BC-CQD/Si NP/SF nanocomposite has been optimized to evaluate its swelling behavior. To determine the antibacterial effects of the synthesized materials both MIC and Optical Density (OD) methods were performed, and the results imply that materials have high antibacterial activity and could successfully inhibit the growth of both S. aureus and E. coli bacteria. Cell toxicity, viability, and proliferation on NIH 3T3 fibroblast cells with the MTT assay have proved that the CQD/Si NP/SF nanocomposite not only has no toxicity but also can accelerate cell viability and proliferation. To assess the effect of the CQD/Si NP/SF nanocomposite on cell migration and in vitro wound healing scratch, a wound assay was performed, and the nanocomposite exhibits the ability to promote wound healing. The PVA-CQD/Si NP/SF nanofiber was used to investigate wound healing in an animal model. The results show that the PVA-CQD/Si NP/SF nanofiber effectively accelerates the skin and hair follicle regeneration. Therefore, the PVA-CQD/Si NP/SF nanofiber is a promising wound dressing for inhibiting bacterial growth and promoting skin wound repair and hair regeneration.

Efficacy and safety of Sophora alopecuroides var. alopecuroides seed extract for opioid detoxification: A randomized, double-blind, and placebo-controlled clinical trial.

The seeds of Sophora alopecuroides L. var. alopecuroides (S. alopecuroides) have alleviated morphine withdrawal in mice. Therefore, in this study, the alkaloid composition of S. alopecuroides extract was determined by gas chromatography (GC) and gas chromatography-mass spectrometry (GC-MS) analysis. Moreover, 50 abstinent opium addicts consumed three 400 mg extract capsules once daily and 50 other patients took placebo for 8 days. At the baseline and days 3 and 8, the clinical opiate withdrawal scale (COWS) was used to assess withdrawal symptoms. At the baseline and Day 8, the patients' blood levels of serum glutamate oxaloacetate transferase; serum glutamate pyruvate transferase; alkaline phosphatase; total, direct, and indirect bilirubins; creatinine and blood urea nitrogen; complete blood count; and prothrombine time were measured. The groups' parameter values were also compared. Sophocarpine, matrine, and sophoramine were the major alkaloids constituting, respectively, 32.85, 26.55, and 6.91% of the extract. The extract decreased the COWS score at Days 3 and 8 significantly compared with the placebo (p < .001). The extract did not significantly affect the blood parameters' values compared with the placebo (p > .05). There was no adverse drug effect. In conclusion, the extract reduces the acute opioid withdrawal symptoms and seems to have good safety and tolerability.

Antihypertensive efficacy and safety of Vaccinium arctostaphylos berry extract in overweight/obese hypertensive patients: A randomized, double-blind and placebo-controlled clinical trial.

OBJECTIVES: To evaluate the antihypertensive efficacy and safety of a standardized Vaccinium arctostaphylos (V. arctostaphylos) berry hydro-alcoholic extract in the overweight/obese hypertensive patients. DESIGN: Randomized placebo-controlled trial. SETTING: Baqiyatallah hospital (Tehran, Iran). INTERVENTIONS: The antihypertensive efficacy and safety of 3-month intake of 400 mg extract capsule three times daily alongside standardized anti-hypertensive regimen in the treatment of 50 patients was compared with the placebo (n = 50). MAIN OUTCOME MEASURES: SBP (systolic blood pressure), DBP (diastolic blood pressure), body mass index, waist circumference, CBC (complete blood count), blood levels of AST (aspartate aminotransferase), ALT (alanine aminotransferase), ALP (alkaline phosphatase), BUN (blood urea nitrogen) and creatinine. RESULTS: SBP decreased from 152.1 ± 7.7 to 140.5 ± 10.7 in the V. arctostaphylos group and from 152.9 ± 8.1 to 150.8 ± 9.3 in the placebo group (P < 0.001). DBP decreased from 90.3±8 to 82.1±8.8 in the V. arctostaphylos group and from 89.6 ± 7.8 to 87.6 ± 7.9 in the placebo group (P < 0.001). The extract capsule had no significant effect on the other parameters (P > 0.05). Moreover, no drug side effect and adverse interaction with other antihypertensive drugs was observed in the patients. CONCLUSIONS: V. arctostaphylosberry extract improves blood pressure control and has safety and tolerability in the overweight/obese hypertensive patients taking standard antihypertensive drugs.

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.

A systematic review on the cardiovascular pharmacology of Emblica officinalis Gaertn.

Introduction: The Emblica officinalis (EO) fruit has traditionally been considered as a cardioactive medication and has demonstrated remarkable cardiovascular effects in the pharmacological literature. The present study systematically reviews EO's potential for prevention and therapy of cardiovascular diseases (CVD). Methods: PubMed, ScienceDirect, Scopus, Proquest, Ebsco, Google, Google Scholar, Ovid, and Cochrane databases were searched from 1966 to 2017 for the English and non-English literature using the terms including the cognates of EO including amla, Emblic myrobalan, Emblica officinalis, Emblica pectinata , Indian gooseberry, and Phyllanthus emblica together with antioxidant, arrhythmia, cardioprotective, cardiotoxicity, heart disease, heart failure, hyperlipidemia, hypertension, myocardial dysfunction, and oxidative stress. The inclusion criteria were in vitro, animal, and clinical cardiovascular pharmacological studies conducted on EO and full-text accessibility. The exclusion criterion was studies in which a combination of EO and at least one other plant was investigated. The reference lists of the retrieved articles were also searched manually for additional eligible articles. The methodological quality of clinical trials was assessed by the Jadad scale, and animal studies were evaluated by the ARRIVE checklist. Results: Nineteen articles concerning the cardiovascular pharmacological effects of EO were included in this review. The plant has shown antiatherogenic, anticoagulant, hypolipidemic, antihypertensive, antioxidant, antiplatelet, and vasodilatory effects as well as lipid deposition inhibitory properties. Moreover, it prevents from doxorubicin and isoproterenol cardiotoxicity and myocardial ischemia/reperfusion injury, and improves vascular endothelial function in animal studies. Some high-quality clinical studies report the vasodilatory and myocardial antioxidant properties as well as anti-platelet aggregation effects of this plant. Conclusion: EO influences various cardiovascular risk-factors. However, there is not sufficient evidence to confirm the plant efficacy in preventing and treating CVD.

Effects of an Herbal Combination on Glycemic Control and Lipid Profile in Diabetic Women: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

The present study was conducted to explore the efficacy and safety of a herbal combination in the treatment of women with hyperlipidemic type 2 diabetes. The herbal combination capsule (600 mg) contained Terminalia chebula fruit extract (200 mg), Commiphora mukul (200 mg), and Commiphora myrrha oleo-gum-resin (200 mg), and the placebo capsule contained 600 mg toast powder. The patients in one group took the herbal combination and those in the other group took placebo capsules 3 times a day for 3 months. In the herbal combination-treated patients, the fasting blood glucose, total cholesterol, and low-density lipoprotein cholesterol levels were decreased and hidh-density lipoprotein cholesterol levels was increased significantly at the endpoint compared with the placebo and baseline. Other blood parameters such as glycosylated hemoglobin, triglyceride, blood urea nitrogen, creatinine, SGOT, and SGPT levels were not significantly changed after 3 months in both groups. In conclusion, the herbal combination improves glycemic control and lipid profile in women with hyperlipidemic type 2 diabetes without any adverse events.

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.

Salvia officinalis (Sage) Leaf Extract as Add-on to Statin Therapy in Hypercholesterolemic Type 2 Diabetic Patients: a Randomized Clinical Trial.

The efficacy and safety of Salvia officinalis combined with statin have not been evaluated in dyslipidemic diabetes mellitus type 2 (DDMT2) so far. The plant extract antioxidant activity was determined by the DPPH radical scavenging assay. The total flavonoid, total phenolic and quercetin contents of the capsules containing the plant extract were also measured. Moreover, the effects of 2-month extract intake (500 mg capsule three times a day) as add-on to daily use of 15 mg glyburide, 2000 mg metformin and 10 mg atorvastatin on the blood levels of fasting glucose (FG), 2 h postprandial glucose (2hPPG), glycosylated hemoglobin (HbA1c), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), triglyceride, high-density lipoprotein cholesterol (HDL-C), serum aspartate aminotransferase (AST), serum alanine aminotransferase (ALT), creatinine and body mass index were studied in 50 patients and compared with the placebo group (n=50).The extract IC50 in the DPPH assay was 87.26±0.003 µg/mL (mean±SD), whereas the ascorbic acid IC50 was 5.626± 0.001 µg/mL (mean±SD). The total flavonoid, total phenolic and quercetin contents of the capsule containing the plant extract were 39.76±3.58 mg of rutin equivalents (mean±SD), 30.33±1.23 mg of gallic acid (mean±SD) and 0.13 mg, respectively. The extract lowered FG, 2hPPG, HbA1c, TC, LDL-C and triglyceride levels, but increased HDL-C level compared to the placebo at the endpoint (P<0.05). The extract did not affect the other parameters significantly and no adverse effect was reported. The extract has substantial antioxidant activity which may be beneficial for the prevention of the cardiovascular complications of DDMT2. Moreover, addition of the extract to statin therapy is apparently safe and further improves lipid profile.

Sophora alopecuroides L. var. alopecuroides alleviates morphine withdrawal syndrome in mice: involvement of alkaloid fraction and matrine.

OBJECTIVES: Evaluation of the Sophora alopecuroides var. alopecuroides seed effects on morphine withdrawal syndrome in mice and determination of the alkaloid composition of the seed total extract. MATERIALS AND METHODS: The effects of the seed total extract, alkaloid fraction and major compound matrine on the mice morphine withdrawal syndrome were compared to saline and methadone. Mice were made dependent on morphine by morphine sulfate injection 3 times a day for 3 days. The withdrawal jumping and diarrhea were induced by administration of naloxone 2 hr after the 10th injection of morphine sulfate on the day 4. The total extract (100, 200, 300 mg/kg), alkaloid fraction (5, 10, 20 mg/kg), matrine (5, 15, 30 mg/kg), methadone (10 mg/kg) or saline were injected 30 min before naloxone. All drugs were administered by subcutaneous injection. The total extract alkaloid composition was also determined by gas chromatography (GC) and GC-MS analysis. RESULTS: All doses of the total extract, alkaloid fraction and matrine as well as methadone decreased jumping and diarrhea significantly compared to the saline. The effects of the total extract and alkaloid fraction were not significantly different from methadone. But, there were significant differences between the effects of matrine and methadone. Matrine, cytisine, sophoridine, n-methyl cytisine, sophocarpine and sophoramine were the major alkaloids. There was no nicotine in the total extract. CONCLUSION: S. alopecuroides var. alopecuroides suppresses opioid withdrawal with efficacy comparable to methadone. Matrine may be one of the alkaloids responsible for the effect of the plant.

Effectiveness of Topical Nigella sativa Seed Oil in the Treatment of Cyclic Mastalgia: A Randomized, Triple-Blind, Active, and Placebo-Controlled Clinical Trial.

Cyclic mastalgia is common in women and has no optimal therapy. Analgesic effects of Nigella sativa have been reported. Thus, the effect of a standardized N. sativa seed oil (600 mg applied to the site of pain bis in die for 2 months) on the 10-centimeter visual analog scale scores of pain severity in 52 women with cyclic mastalgia was compared to that of topical diclofenac (20 mg bis in die) (n = 51) and placebo (n = 53). There was no significant difference between the 1- and 2-month pain scores in the active treatment groups (p > 0.05). The pain scores of the active treatment groups did not differ significantly at 1 and 2 months (p > 0.05). The endpoint pain scores of the active treatment groups decreased significantly compared with the baseline (both p < 0.001). The pain scores of the active treatment groups at 1 and 2 months were significantly smaller than those of the placebo group (both p < 0.001). The pain scores of the placebo group at 1 and 2 months were not significantly different from the baseline (p > 0.05). No adverse effect was observed. In conclusion, topical N. sativa seed oil is safe, more effective than placebo, and has clinical effectiveness comparable to topical diclofenac in the treatment of cyclic mastalgia.

Improved glycemic control in patients with advanced type 2 diabetes mellitus taking Urtica dioica leaf extract: a randomized double-blind placebo-controlled clinical trial.

BACKGROUND: Advanced type 2 diabetes mellitus (T2DM) needing insulin therapy is common. Most conventional anti-hyperglycemic drugs have limited efficacies and significant side effects, so that better anti-hyperglycemic agents are needed. Urtica dioica L. (nettle) leaves have insulin secretagogue, PPARgamma agonistic, and alpha-glucosidase inhibitory effects. Moreover, nettle leaves are used in traditional medicine as an anti-hyperglycemic agent to treat diabetes mellitus. Thus, efficacy and safety of nettle in the treatment of patients with advanced type 2 diabetes mellitus needing insulin were studied. METHODS: In this randomized double-blind placebo-controlled clinical trial, we evaluated the effects of taking nettle leaf extract (one 500 mg capsule every 8 hours for 3 months) combined with the conventional oral anti-hyperglycemic drugs on the blood levels of fasting glucose, postprandial glucose, glycosylated hemoglobin (HbA1c), creatinine and liver enzymes SGOT and SGPT, and systolic and diastolic blood pressures in 46 patients and compared with the placebo group (n = 46). RESULTS: At the endpoint, the extract lowered the blood levels of fasting glucose, 2 hours postprandial glucose, and HbA1c significantly (p < 0.001, p = 0.009, and p = 0.006, respectively) without any significant effects on the other parameters (p > 0.05) compared with placebo. CONCLUSIONS: Nettle may safely improve glycemic control in type 2 diabetic patients needing insulin therapy.

Capparis spinosa L. (Caper) fruit extract in treatment of type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial.

OBJECTIVES: Capparis spinosa L. (Caper) fruit is traditionally used as an anti-hyperglycemic food by Iranian diabetic patients. But yet, no controlled human study has determined its efficacy in treatment of hyperglycemia in type 2 diabetic patients. DESIGN: The present study was undertaken to explore the possible anti-hyperglycemic effects of the caper fruit extract in type 2 diabetic patients. A randomized clinical trial was conducted in 54 type 2 diabetic patients. Two groups 28 and 26 patients on standard anti-diabetic therapy, received 400mg caper fruit extract and placebo capsules three times a day respectively for two months. MAIN OUTCOME MEASURES: The patients fasting blood glucose, glycosylated hemoglobin, lipids levels, liver and renal function tests were determined at baseline and endpoint. RESULTS: Results showed significant decrease in fasting blood glucose levels (p=0.037) and glycosylated hemoglobin (p=0.043) in caper treated patients compared to control group at the end of the study. Triglyceride level also decreased significantly (p=0.29) in caper treated group at the end of the study compared to baseline. No liver, kidney and other side effects were observed in these two groups. CONCLUSIONS: Caper fruit extract may be a safe anti-hyperglycemic and anti-hypertriglyceridemic agent for type 2 diabetic patients.

Anti-hyperglycemic effect of Vaccinium arctostaphylos in type 2 diabetic patients: a randomized controlled trial.

BACKGROUND: Type 2 diabetes mellitus is a common disease. Preliminary data indicate that Vaccinium arctostaphylos L. (Caucasian whortleberry) has a potential effect in glycemic control. Thus, the efficacy and safety of a standardized whortleberry fruit hydroalcoholic extract in the treatment of type 2 diabetic patients were studied. METHODS: This randomized double-blind placebo-controlled clinical trial consisted of 37 patients aged 40-60 years with type 2 diabetes who were resistant to conventional oral anti-hyperglycemic drugs. The patients were treated with the whortleberry fruit hydroalcoholic extract (1 capsule = 350 mg, every 8 h for 2 months) in combination with anti-hyperglycemic drugs, and the effects on the blood levels of fasting glucose, 2-hour postprandial glucose, glycosylated hemoglobin (HbA1c), and liver/kidney function were tested, evaluated, and compared with a placebo group (n = 37). RESULTS: The extract significantly lowered the blood levels of fasting glucose, 2-h postprandial glucose, and HbA1c (p = 0.007, p <0.001, and p = 0.005, respectively) without any significant effects on the liver/kidney function (p >0.05) compared with placebo at the end. No adverse effects were reported. CONCLUSION: Whortleberry may safely improve glycemic control in type 2 diabetic patients.

Immune phenomena in neonates of women with depression during pregnancy: a case-control study.

OBJECTIVE: To evaluate the effects of major and minor depression during pregnancy on the maternal and neonatal immunities. METHODS: Peripheral venous blood from depressed women and cord venous blood from their neonates taken simultaneously and immediately after parturition were used. The serum levels of immunoglobulins IgG, IgM and IgA and complements C3 and C4 were determined through single radial immunodiffusion with the kits manufactured by the Biogen company (Mashhad, Iran). To reduce error, all the ring diameters were measured by one experimenter unaware of the study groups. The blood leukocyte and lymphocyte counts and lymphocyte percentage were determined with a H1 counter and for more accuracy also with a Hycel counter. RESULTS: The immune parameters of depressed women were not significantly different from controls. The lymphocyte counts in neonates of women with major and minor depression were increased, whereas ratio of the cord blood level of IgG to the maternal blood level of IgG in neonates of women with major depression were decreased compared to controls. CONCLUSIONS: Major depression during pregnancy reduces the prenatal transfer of IgG from mother to neonate. The low prenatal transfer of IgG may have clinical significance, because it can compromise immune competence in neonates.

Effect of Zingiber officinale R. rhizomes (ginger) on pain relief in primary dysmenorrhea: a placebo randomized trial.

BACKGROUND: Zingiber officinale R. rhizome (ginger) is a popular spice that has traditionally been used to combat the effects of various inflammatory diseases. The aim of this study was to evaluate the effects of ginger on pain relief in primary dysmenorrhea. METHOD: This was a randomized, controlled trial. The study was based on a sample of one hundred and twenty students with moderate or severe primary dysmenorrhea. The students were all residents of the dormitories of Shahed University. They were randomly assigned into two equal groups, one for ginger and the other for placebo in two different treatment protocols with monthly intervals. The ginger and placebo groups in both protocols received 500 mg capsules of ginger root powder or placebo three times a day. In the first protocol ginger and placebo were given two days before the onset of the menstrual period and continued through the first three days of the menstrual period. In the second protocol ginger and placebo were given only for the first three days of the menstrual period. Severity of pain was determined by a verbal multidimensional scoring system and a visual analogue scale. RESULTS: There was no difference in the baseline characteristics of the two groups (placebo n = 46, ginger n = 56). The results of this study showed that there were significant differences in the severity of pain between ginger and placebo groups for protocol one (P = 0.015) and protocol two (P = 0.029). There was also significant difference in duration of pain between the two groups for protocol one (P = 0.017) but not for protocol two (P = 0.210). CONCLUSION: Treatment of primary dysmenorrhea in students with ginger for 5 days had a statistically significant effect on relieving intensity and duration of pain. TRIAL REGISTRATION: IRCT201105266206N3.

High copper and low zinc serum levels in Iranian patients with multiple sclerosis: a case control study.

BACKGROUND: The purpose of this study was to evaluate the levels of zinc (Zn) and copper (Cu) in the serum of Iranian patients with multiple sclerosis (MS). METHODS: The serum levels of zinc (Zn) and copper (Cu) were measured in sixty Iranian patients with MS and compared with sixty age-, gender- and socioeconomic status-matched healthy subjects without any neurological disorders as controls from the same geographical area. RESULTS: Significantly lower serum Zn and higher serum Cu levels were found in the MS patients compared with the controls (p < 0.0001 and p = 0.002, respectively). The serum Zn level of the secondary-progressive MS patients was significantly lower compared with the relapsing-remitting MS patients (p = 0.009). There was no significant difference between the serum Cu levels of the two subgroup of MS patients (p = 0.42). CONCLUSIONS: The results suggest significant deviations of the Iranian MS patients' serum Zn and Cu levels from the norm.

Anti-hyperglycemic and anti-hypercholesterolemic effects of Aloe vera leaf gel in hyperlipidemic type 2 diabetic patients: a randomized double-blind placebo-controlled clinical trial.

Diabetes mellitus type 2 with dyslipidemia is a common disease. Previous studies suggest that aloe (Aloe vera L.) leaf gel may positively affect the blood glucose and lipid levels in dyslipidemic type 2 diabetic patients. Thus, in this randomized double-blind placebo-controlled clinical trial with hyperlipidemic (hypercholesterolemic and/or hypertriglyceridemic) type 2 diabetic patients aged 40 to 60 years not using other anti-hyperlipidemic agents and resistant to daily intake of two 5 mg glyburide tablets and two 500 mg metformin tablets, the efficacy and safety of taking aloe gel (one 300 mg capsule every 12 hours for 2 months) combined with the aforementioned drugs in treatment of 30 patients were evaluated and compared with the placebo group (n = 30). The aloe gel lowered the fasting blood glucose, HbA1c, total cholesterol, and LDL levels significantly (p = 0.036, p = 0.036, p = 0.006, and p = 0.004, respectively) without any significant effects on the other blood lipid levels and liver/kidney function tests (p > 0.05) compared with the placebo at the endpoint. No adverse effects were reported. The results suggest that aloe gel may be a safe anti-hyperglycemic and anti-hypercholesterolemic agent for hyperlipidemic type 2 diabetic patients.