The effects of melissa officinalis on depression and anxiety in type 2 diabetes patients with depression: a randomized double-blinded placebo-controlled clinical trial.

BACKGROUND: Depression is more common in diabetic patients, with a 1.5-fold increased risk of death.Melissa officinalis (M. officinalis) have anti-diabetic and anti-depression activities. The study aimed to determine the efficacy of M. officinalis extract on depression, anxiety, and sleep quality in patients with type 2 diabetes with depressive symptoms. METHODS: In this double-blind clinical trial, 60 volunteer patients (age range 20-65 years) with type 2 diabetes mellitus with symptoms of depression were randomized into the intervention (received 700 mg/day hydroalcoholic extract; n = 30) or control group (received 700 mg/day toasted flour; n = 30). Dietary intake, physical activity, anthropometric indices, FBS (Fasting blood sugar), hs-CRP(High-sensitivity C-reactiveprotein), depression, anxiety, and sleep quality were determined at the beginning and end of the study. Depression and anxiety were assessed by Beck Depression Inventory-II (BDI-II) and Beck Anxiety Inventory (BAI), respectively; sleep quality was evaluated using the Pittsburgh Sleep Quality Index (PSQI). RESULTS: Sixty participants received M. officinalis extract or placebo, of which 44 patients completed the 12-week double-blind clinical trial. After 12-week the mean change of depression and anxiety scores were statistically significant between the two groups (p < 0.001 and p = 0.04, respectively), but no significant differences were observed in FBS, hs-CRP, anthropometric indices, sleep quality, and blood pressure.In the intervention group, there was a significant decrease in depression and anxiety severity(p < 0.001 and p = 0.01, respectively) at the end of the study compared to the baseline. TRIAL REGISTRATION: All protocols in this study were followed in accordance with the Helsinki Declaration (1989 revision). Ethical approval for this study was obtained from the Iran University of Medical Sciences Ethics committee (IR.IUMS.FMD.REC 1396.9413468004; research.iums.ac.ir). The study was registered at the Iranian Registry of Clinical Trials (IRCT201709239472N16); Registration date: 09/10/2017.

Safety and efficacy of Melissa officinalis (lemon balm) on ApoA-I, Apo B, lipid ratio and ICAM-1 in type 2 diabetes patients: A randomized, double-blinded clinical trial.

BACKGROUND: The purpose of this study was to investigate the safety and effects of Melissa officinalis, a good source of bioactive components, on apolipoprotein (Apo)B, Apo A-I, and their ratio, lipids ratios and intercellular adhesion molecule-1(ICAM-1) in patients with type 2 diabetes. METHODS: For the present randomized, double-blinded, placebo-controlled clinical trial, 70 type 2 diabetic patients aged 20-65 years old were randomly assigned to receive hydroalcoholic extract of M. officinalis (HEMO) (700 mg/d) or placebo twice-daily for 12 weeks. RESULTS: There were significant differences in serum Apo A-I, TC/ HDL-c and LDL-c/ HDL-c between the two groups at the end of the study (p < 0.05), but we did not show significant differences in the values for Apo B, Apo B/Apo A-I, TG/HDL-c, ICAM-1 and liver enzymes include AST, ALT, and ALP between the study groups. Although both groups showed a significant reduction in ICAM-1, AST and, ALP (p < 0.05), no significant differences in ICAM-1, AST and, ALP were observed. At end, in M. officinalis group, there was a significant increase in Apo A-I (p = 0.003) and significant reduction in TG/HDL-c (p = 0.05) compared with initial values, as well as in placebo group, there was a significant rising in Apo B/Apo A-I (p = 0.02) and significant reduction in Apo A-I (p = 0.001) compared with baseline values. CONCLUSIONS: M. officinalis is safe and effective in improvement of Apo A-I, Apo B/Apo A-I, and lipids ratios as key factors promoting cardiovascular disease (CVD) in type II diabetic patients.

Effect of Royal Jelly Intake on Serum Glucose, Apolipoprotein A-I (ApoA-I), Apolipoprotein B (ApoB) and ApoB/ApoA-I Ratios in Patients with Type 2 Diabetes: A Randomized, Double-Blind Clinical Trial Study.

OBJECTIVES: Type 2 diabetes is the most common metabolic disorder worldwide. Evidence supports a role for royal jelly (RJ) in reduction of serum glucose and lipids in animals and healthy subjects. The purpose of this study was to determine the effect of RJ intake on serum glucose, apolipoprotein A-I (ApoA-I), apolipoprotein B (ApoB) and ApoB/ApoA-I ratios in patients with type 2 diabetes. METHODS: Fifty patients with type 2 diabetes participated in a double-blind, placebo-controlled study. The participants were randomly divided into RJ and placebo groups and were given doses of 1000 mg royal jelly or placebo 3 times a day for 8 weeks, respectively. Weight, height, fasting blood glucose, ApoA-I and ApoB were measured at baseline and endpoint. RESULTS: There were no significant differences in baseline characteristics and dietary intakes between groups. The mean difference in glucose concentrations decreased in the RJ group (-9.4 mg/dL vs. 4 mg/dL; p=0.011). The mean difference in ApoA-I concentrations increased in the RJ group (34.4 mg/dL vs. -1.08 mg/dL; p=0.013). There was a significant decrease in mean difference of ApoB/ApoA-I in the RJ group compared with the placebo group (0.008 vs. 0.13; p<0.044), respectively. CONCLUSIONS: These data suggest that RJ intake may have desirable effects on serum glucose, Apo-A-I concentrations and ApoB/ApoA-I ratios in people with type 2 diabetes.

Onset of Labor in Post-Term Pregnancy by Chamomile.

BACKGROUND: Post-term pregnancy is an important factor in perinatal mortality and morbidity. Generally, to reduce perinatal mortality in pregnancy, the delivery is done before adverse perinatal morbidity occurs. To prevent prolonged pregnancy, labor is induced with chemical drugs and complementary therapies. Due to the side effects and contraindications of chemical medicine, the use of herbs has been investigated in the induction of labor in post-term pregnancy. OBJECTIVES: This study was done to identify the effect of chamomile on inducing labor in women with post-term pregnancy of Shahid Akbarabadi hospital in Tehran in 2013. PATIENTS AND METHODS: This double-blind clinical trial study was performed in Iran on 80 post-term pregnant women with a gestational age of 40 weeks or more, a single pregnancy, 18 - 35 years old, cephalic presentation, an estimated fetal weight of 2500 - 4000 grams, an absence of uterine contraction, a cervical Bishop score of less than 4, the safety of the membrane, and low-risk pregnancy; they were randomly assigned to one of two groups of 40 women. Each of the participants was given a bottle containing 42 capsules (500 mg each) and took 2 capsules every 8 hours. The data were collected through the questionnaire of demographic observational, and examinal characteristics. Descriptive statistics, independent samples t-test, and Fisher's exact test using SPSS (16/win) were used to determine and compare the effects of drugs on inducing labor in the groups. RESULTS: After a week of using the first dose, the results showed that in 92.5% of the chamomile group and 62.5% in the placebo group, delivery symptoms started after taking the oral capsules, and there were significant statistical differences between the two groups for the onset of labor (P = 0.003) There was a noticeable statistical difference between the two groups regarding the mean interval time to the onset of labor pain after taking the capsules (P = 0.000). CONCLUSIONS: In this study¸ chamomile stimulated labor in post-term pregnancy. With further studies, chamomile, which has no chemical side effects, can be suggested for stimulating labor in post-term pregnancy.

Does Supplementation with Royal Jelly Improve Oxidative Stress and Insulin Resistance in Type 2 Diabetic Patients?

BACKGROUND: Animal studies have shown antioxidant effects of Royal Jelly (RJ) and its effect on insulin resistance as the most common complication of Type 2 diabetes. This study was conducted to determine the effect of RJ intake on serum total antioxidant capacity, Malondialdehyde and insulin resistance in T2DM. METHODS: In this randomized controlled trial, forty-six type 2 diabetic patients, aged 25-65 years, with BMI of 20-30 kg/m(2), and HbA1c of 6-8% were included. The patients were randomly assigned to receive 1000 mg of RJ supplement or placebo, 3 times daily for 8 weeks. HOMA-IR, anthropometric measurements, fasting blood glucose, serum insulin, total antioxidant capacity and malondialdehyde level were measured. RESULTS: In comparison with placebo, HOMA-IR decreased (P=0.015) while serum total antioxidant capacity increased significantly in RJ group (P=0.016). No significant difference was detected for serum insulin and MDA in two groups. CONCLUSIONS: RJ intake may have favorable effects on serum TAC and HOMA-IR in diabetic patients.