Lavender and metformin effectively propagate progesterone levels in patients with polycystic ovary syndrome: A randomized, double-blind clinical trial.

BACKGROUND: The present study aimed to evaluate the impacts of lavender and metformin on polycystic ovary syndrome (PCOS) patients. METHODS: We performed a randomized, double-blind clinical trial including 68 females aged 18 to 45, fulfilling the Rotterdam criteria for PCOS. The patients were randomized to receive lavender (250 mg twice daily) or metformin (500 mg three times a day) for 90 days. The serum progesterone was measured at baseline and after 90 days, one week before their expected menstruation. Moreover, the length of the menstrual cycle was documented. RESULTS: Our results showed that lavender and metformin treatment notably increased the progesterone levels in PCOS patients (increasing from 0.35 (0.66) and 0.8 (0.69) to 2.5 (6.2) and 2.74 (6.27) ng/mL, respectively, P < 0.001). However, we found no significant differences between the increasing effects of both treatments on progesterone levels. In addition, all patients in the lavender or metformin groups had baseline progesterone levels <3 ng/mL, reaching 14 (45.2%) patients >3 ng/mL. Lavender and metformin remarkably attenuated the menstrual cycle length in PCOS patients (decreasing from 56.0 (20.0) and 60 (12.0) to 42.0 (5.0) and 50.0 (14.0) days, respectively, P < 0.001). Furthermore, the decreasing effects of lavender on the menstrual cycle length were greater than the metformin group; however, it was not statistically significant (P = 0.06). CONCLUSION: Lavender effectively increased progesterone levels and regulated the menstrual cycles in PCOS patients, similar to metformin. Therefore, lavender may be a promising candidate for the treatment of PCOS.

Is Consumption of Pomegranate Supplementation Effective on Oxidative Stress Biomarkers Including MDA, ox-LDL, POX 1, GPX, TAC, and TBRAS? A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

Punica granatum (Family Lythraceae) comprises considerable content of phenolic components and it proves the antioxidant activity of pomegranate. Some clinical trial investigations display that consumption of pomegranate is able to boost the antioxidant status. This systematic review assessed the efficacy of pomegranate extract to reduce oxidative stress. Pomegranate was used in some studies as capsules (between 250 mg and 250 g) and some in liquid form (between 10 and 500 ml), and the follow-up duration varied from 3 weeks to 12 months. Standardized mean difference and its corresponding 95% confidence interval (CI) was used as the effect size of pomegranate supplementation on oxidative stress biomarkers. Based on the results, pomegranate decreased but it was not statistically significant and the same result was obtained for ox-LDL and POX 1. In addition, the results showed that pomegranate consumption can significantly increase GPX and TAC. Result of combination of on TBRAS showed significantly effect of pomegranate use on reduction of TBRAS. Since this study has evaluated mostly Eastern countries' studies it could be concluded that pomegranate supplements are effective in modifying oxidative stress in Eastern countries. The evidence to support this study is low, therefore, needs the future studies to confirm the results.

The effects of co-administration of artichoke leaf extract supplementation with metformin and vitamin E in patients with nonalcoholic fatty liver disease: A randomized clinical trial.

Medicinal plants are widely used as a complementary therapy to treat complex diseases, such as nonalcoholic fatty liver disease (NAFLD). Therefore, this study was done to investigate the effect of co-administration of artichoke leaf extract supplement (ALES) with conventional medicines on patients with NAFLD. The clinical trial was based on patients randomly divided into three groups involving metformin-vitamin E (ME), metformin-ALES (MA), and vitamin E-ALES (EA). The effectiveness of treatment in the treated groups was evaluated using liver ultrasonography and biochemical markers. After 12 weeks of treatment, the results showed that the rate of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) was significantly reduced within all the study groups (p < .05). Liver ultrasonographic findings revealed that the rate of fat accumulation in liver of patients was decreased significantly within all the study groups and it was increased in the subjects with grade 0 fatty liver (without fat accumulation) in the MA and EA groups by 23.3 and 17.2%, respectively. In summary, the results of the present study showed that the concomitant use of ALES with metformin and vitamin E can have beneficial effects on amelioration of complications in patients with NAFLD. However, larger-scale clinical trial studies are required in this regard.

Evaluation of the Effectiveness of Cinnamon Oil Soft Capsule in Patients with Functional Dyspepsia: A Randomized Double-Blind Placebo-Controlled Clinical Trial.

BACKGROUND: Different effects of cinnamon and its oil in traditional medicine in the treatment of diseases, including gastrointestinal diseases, were reported. The aim of this study is to evaluate the efficacy and safety of cinnamon oil (Cinnamomum zeylanicum) in patients with functional dyspepsia in a double-blind, randomized placebo-controlled trial. METHODS: Soft gelatin capsule was made using the rotary die process, and the final capsule was standardized based on its cinnamaldehyde amount and analyzed by high-performance liquid chromatography (HPLC) method. Sixty-four patients with symptomatic functional dyspepsia were randomized to receive cinnamon oil soft capsule (n = 29) or sesame oil soft capsule as placebo (n = 35) for 6 weeks. The primary efficacy variable was the sum score of the patient's gastrointestinal symptom (five-point scale). Secondary variables were the scores of each dyspeptic symptom including severity of vomiting, sickness, nausea, bloating, abdominal cramps, early satiety, acidic eructation/heartburn, loss of appetite, retrosternal discomfort, and epigastric pain/upper abdominal pain, as well as any reported adverse events. RESULTS: The results showed that, after 6 weeks of treatment, the cinnamon oil and placebo groups significantly decreased the total dyspepsia score compared to the baseline at the endpoint (P < 0.001). However, there was no significant difference between the cinnamon oil and placebo groups in terms of the baseline and endpoint values of the outcome variables (P=0.317 and P=0.174, respectively). Two patients in the cinnamon oil group complained of rashes, and three patients in the placebo group complained of nausea. CONCLUSION: This study showed significant improvements in gastrointestinal symptom score in both treatment and placebo groups. However, there was no significant difference between the cinnamon oil and sesame oil groups in terms of the baseline and endpoint values of the outcome variables. This study was registered as https://clinicaltrials.gov/ct2/show/IRCT20170802035460N2, 29 December 2017, in the Iranian Registry of Clinical Trials with https://www.IRCT.ir.

The effect of cinnamon supplementation on liver enzymes in adults: A systematic review and meta-analysis of randomized controlled trials.

AIMS: The aim of this study was to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) to examine the effect of cinnamon supplementation on liver enzymes. METHODS: A systematic search was performed in electronic databases including PubMed-Medline, Scopus, and ISI Web of Science up to November 2020. We used a random effects model to estimate pooled effect size of alanine aminotransferase (ALT), alkaline phosphatase (ALP), and aspartate aminotransferase (AST) levels. RESULTS: Seven RCTs (9 treatment arms) fulfilled the eligibility criteria of the present meta-analysis. Overall, meta-analysis could not show any beneficial effect of cinnamon supplementation on AST, ALT, and ALP. Subgroup analyses showed that the effect of cinnamon supplementation on ALT was significant at the dosages of <1500 mg/day (Hedges's: -0.61; 95 % CI: -1.11, -0.10; P = 0.002), in trials lasting>12 weeks (Hedges's: -0.83; 95 % CI: -1.36, -0.30; P = 0.01), and in trials conducted of both gender (Hedges's: -0.72; 95 % CI: -1.45, -0.01; P = 0.04). CONCLUSION: In summary, cinnamon supplementation had no significant effect on liver enzymes in adults. However, the effect of cinnamon on ALT levels was significant at the dosages of <1500 mg/day, in trials lasting>12 weeks, and in trials conducted of both gender. Nevertheless, further studies should be performed to confirm our results.

The effect of crocin supplementation on lipid concentrations and fasting blood glucose: A systematic review and meta-analysis and meta-regression of randomized controlled trials.

OBJECTIVE: This meta-analysis aimed to assess the effects of crocin supplementation on fasting blood glucose (FBG) and lipid profile levels in clinical trial studies. DESIGN: A systematic literature search was performed in PubMed, Scopus, Embase, Web of Science, and the Cochrane Library databases for clinical trials published from the beginning up to November 2019. Of the 547 papers identified from all searched databases, eight eligible studies with nine effect sizes have all needed criteria for inclusion in this meta-analysis. RESULTS: Results of the pooled random-effect size analysis showed just a significant decreasing effect of crocin supplementation on FBG (WMD: -6.52 mg/l, 95 % CI, -11.96, -1.08; p = 0.019) and TC (WMD: -4.64 mg/l, 95 % CI, -8.19, -1.09; p = 0.010). Crocin supplements did not have any significant effect on serum TG (p = 0.144) levels, LDL-C (p = 0.161), and HDL-C (p = 0.872) levels. Results showed that crocin supplementation could beneficially have effect on TG level only when trial duration less than 12 weeks and LDL-C levels in trials that used high dose intervention and trials that conducted on subjects with metabolic disorders. However, crocin supplementation did not significantly change FBG in trials that used low dose intervention. Meta-regression analysis indicated a linear relationship between the duration of intervention and significant change in FBG (p = 0.019). CONCLUSION: Results of this systematic review and meta-analysis study have shown that crocin supplementation can decrease significantly FBS and TC without any beneficial effects on TG, LDL-C, and HDL-C levels.

The effect of a hydrogel made by Nigella sativa L. on acne vulgaris: A randomized double-blind clinical trial.

Nigella sativa L. (black seed) is one of the main medicinal plants frequently cited in traditional Persian medicine manuscripts for management of acne vulgaris. The present study was designed to investigate the efficacy of a topical preparation from N. sativa in acne vulgaris. In a randomized double-blind controlled clinical trial, 60 patients (30 patients in treatment and 30 in placebo group) were randomly received N. sativa hydrogel (standardized based on thymoquinone) or placebo hydrogel, twice daily for 60 days. The Investigator's Global Assessment (IGA) grading score was recorded for each patient. Moreover, acne disability index (ADI) was evaluated using a standard questionnaire filled out by the patients at the beginning and end of the study. A 78% mean reduction in the IGA score on the N. sativa-treated group was recorded compared with 3.3% on the vehicle-treated one. Significant reductions in the number of comedones, papules, and pustules were observed in the treatment group compared with placebo after 2 months. Also, ADI was decreased 63.49% in the treatment versus 4.5% in the placebo groups. No adverse event was recorded. N. sativa hydrogel had significant effects on improving the symptoms of acne vulgaris with acceptable tolerability.

Effects of cinnamon on controlling metabolic parameters of polycystic ovary syndrome: A systematic review and meta-analysis.

ETHNOPHARMACOLOGICAL RELEVANCE: Cinnamon as a traditional medicine has been widely used in various disorders such as headache, toothache, common cold, diarrhea, flatulence, fever, amenorrhea frigidity. However, the effect of cinnamon supplementation on metabolic parameters of polycystic ovary syndrome (PCOS) patients has not been fully assessed. AIM OF THE STUDY: Clinical trials have shown contradictory effects of cinnamon supplementation on metabolic parameters of polycystic PCOS patients. Therefore, we evaluated the effect of cinnamon supplementation on metabolic parameters of PCOS patients through a systematic review and meta-analysis of clinical trials. MATERIALS AND METHODS: PubMed, Embase, the Cochrane library, Scopus and Web of Science databases (until August 2019) were searched to identify potential clinical trials with information on cinnamon supplementation on metabolic parameters among PCOS patients. Weighted Mean Differences was pooled using a random-effects model. Standard methods were used for assessment of heterogeneity, publication bias and sensitivity analysis. RESULTS: Pooling five clinical trials (five treatment arms) together did not show any significant effect on body weight (WMD: -0.74 kg, 95% CI: -3.17 to 1.69) and body mass index (BMI) (WMD: -1.47, 95% CI: -4.07 to 1.12). Our results illustrated that a significant decrease of fasting blood sugar (WMD: -5.32, mg/dL95% CI: -10.46 to -0.17), fasting insulin (WMD: -4.10, µIU/dL95% CI: -6.76 to -0.144) and HOMA-IR (WMD: -0.69 95% CI: -1.37 to -0.004) were observed after cinnamon treatment. Moreover, our findings demonstrated that oral cinnamon supplementation in PCOS patients led to significant reduction of serum level of LDL-C, total cholesterol, and triacylglycerol. Besides, an improvement of serum concentration of HDL-C was shown by cinnamon supplementation. CONCLUSION: Generally, present study indicated that cinnamon supplementation may help PCOS patients to manage their metabolic parameters. Future prospective randomized clinical trials with longer intervention duration are warranted to obtain a precise conclusion.

Efficacy and safety of a standardized extract from Achillea wilhelmsii C. Koch in patients with ulcerative colitis: A randomized double blind placebo-controlled clinical trial.

BACKGROUND: Using Achillea wilhelmsii as a dietary supplement for gastrointestinal disorders is common in Persian traditional medicine. Its anti-inflammatory, anti-spasmodic and antibacterial properties have been proven by different in vitro and in vivo studies, yet it has not been evaluated in a controlled clinical trial. AIM: This study intended to evaluate the efficacy and safety of A. wilhelmsii in patients with mild to moderate active ulcerative colitis in a randomized, double-blinded, placebo-controlled clinical trial. The hydroalcoholic extract of A. wilhelmsii was standardized based on caffeic acid. METHODS: Forty-nine patients were randomly received A. wilhelmsii capsules or placebo, twice daily for 4 weeks in a 1:1 ratio. The disease activity index (DAI) (Partial Mayo Score), haemoglobin, platelet count, erythrocyte sedimentation rate (ESR) and serum level of C-reactive protein (CRP) were measured at the entry and the end of the treatment. To standardize the extract, caffeic acid was detected and measured in the plant extract using high performance liquid chromatography (HPLC). RESULTS: Of 49 patients who entered the trial, 40 patients completed the study. In both treatment and placebo groups, significant reductions were observed in stool frequency, rectal bleeding, physician global assessment and partial mayo score. There was no significant difference in stool frequency (P = 0.176), rectal bleeding (P = 0.523), physician global assessment (P = 0.341) and partial mayo score (P = 1) in the treatment versus the placebo groups. Laboratory variables including hemoglobin, platelet count, ESR and CRP showed no significant difference between the treatment and the placebo group. Of all participants, only one patient in the treatment group complained about skin rash (grade 1 based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0). CONCLUSION: Oral administration of A. wilhelmsii powder for 4 weeks did not create a clinical response more than placebo. It seemed to be safe in UC patients. Further studies are obligatory to evaluate the therapeutic potential of A. wilhelmsii in the form of extract in UC patients.