Melissa officinalis is a plenteous source of antioxidant flavonols and flavonoids that contain health‐promoting and antidiabetic properties, so this study was undertaken to provide the first assessment of the antidiabetic properties of hydroalcoholic extract of M. officinalis in type 2 diabetic patients. We did a randomized, placebo‐controlled trial which included 62 patients, receiving either M. officinalis capsules (700 mg/d; n = 31) or the placebo (n = 31) twice daily for 12 weeks. There were significant differences in serum FBS (P = 0.007), HbA1c (P = 0.002), β‐cell activity (P = 0.05), TG (P = 0.04), HDL‐c (P = 0.05), hs‐CRP (P = 0.001), and systolic blood pressure (P = 0.04) between the two groups at the end of the study; but total cholesterol, LDL‐c, insulin, and HOMA‐IR showed no significant changes between the groups. In M. officinalis group, there was a significant change in HDL‐c (P = 0.009) and QUICKI (P = 0.005) compared with baseline values. No adverse effects were observed. It seems that M. officinalis is safe and effective in improvement of lipid profile, glycemic control, and reduction of inflammation.
Recent evidence indicates a beneficial effect of Melissa officinalis (MO) intake on several chronic diseases. However, the effects of MO intake have not yet been systematically reviewed. Therefore, we conducted a systematic review and meta-analysis of randomized controlled trials (RCTs) to evaluate the effect of MO intake and focused on several cardiometabolic outcomes. MEDLINE, Scopus, EMBASE, Web of Science and the Cochrane Central Register of Controlled Trials were searched for MO-RCTs evaluating cardiometabolic outcomes. Random-effects meta-analyses estimated the pooled standardized mean differences (SMD) between intervention and control groups. Risk of bias was assessed with the Cochrane Collaboration's tool for assessing the risk of bias in RCTs. Seven RCTs were finally deemed eligible. MO intake was associated with a reduced total cholesterol (TC) (SMD: −0.26; 95% CI: −0.52, −0.01; I 2 = 13.7%; k = 6) and a reduced systolic blood pressure (SBP) (SMD: −0.56; 95% CI: −0.85, −0.27; I 2 = 00.0%; k = 3). MO intake was not associated with statistically significant changes in triglycerides, low-density lipoprotein, diastolic blood pressure, high sensitivity c-reactive protein levels, fasting blood sugar, HbA1c, insulin or high-density lipoprotein levels. No serious adverse events were reported. The risk of bias was high in a considerable amount of studies. Our study suggests that MO is a safe supplement with beneficial effects on TC and SBP. However, the findings of our study must be seen in the light of major limitations such as a low number of included studies and a serious risk of bias. High-quality RCTs are needed for firm conclusions concerning the effects of MO on cardiometabolic outcomes.
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.
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