The Effects of Ginger (Zingiber Officinale Roscoe) on Non-Alcoholic Fatty Liver Disease in Patients with Type 2 Diabetes Mellitus: A Randomized Double-Blinded Placebo-Controlled Clinical Trial.

Nonalcoholic fatty liver disease (NAFLD) is a prominent etiological factor for liver cirrhosis worldwide. It is frequently associated with obesity, diabetes, dyslipidemia, and hypertension. The objective of this study is to assess the efficacy and safety of ginger (Zingiber officinale Roscoe) supplementation in patients with type 2 diabetes mellitus (T2DM) who have NAFLD. In a two-arm, double-blind, placebo-controlled clinical trial, seventy-six patients diagnosed with both T2DM and NAFLD were randomly assigned to receive either ginger powder capsules (1000 mg, twice daily) or placebo capsules (administered in the same manner) for a period of three months. Anthropometric measurements, blood pressure readings, biochemical profiles, and imaging parameters were assessed before and after the intervention. Safety measures were also evaluated. In both the ginger and placebo groups, there was a significant reduction in mean body mass index (BMI), waist and hip circumferences, as well as liver transaminase levels. Moreover, significant improvements in mean systolic and diastolic blood pressures were observed in the ginger group (p = 0.02 and < 0.0001, respectively). Within the ginger group, there was a decrease in serum insulin levels and insulin resistance (HOMA-IR) (p = 0.002 and 0.004, respectively). Furthermore, the ginger group exhibited an improvement in serum HDL-cholesterol level (p = 0.01). However, there were no significant changes in the assessed inflammatory markers or the indices obtained from fibroscan imaging, including steatosis percent and controlled attenuation parameter. This study demonstrates that ginger supplementation can significantly improve mean systolic and diastolic blood pressures. However, it does not have a significant impact on inflammatory markers or fibroscan imaging indices. Nonetheless, the three-month use of ginger improves serum insulin level, insulin resistance (HOMA-IR), and HDL-cholesterol level compared to baseline values. Further investigations with longer durations and larger sample sizes are recommended.

The effects of soymilk plus probiotics supplementation on cardiovascular risk factors in patients with type 2 diabetes mellitus: a randomized clinical trial.

OBJECTIVE: Type 2 diabetes mellitus (T2DM) is associated with an increased risk of cardiovascular diseases. This study aimed to assess the effects of soymilk plus probiotics co-administration on cardiovascular risk factors in T2DM patients. METHODS: One hundred patients with T2DM (aged 40-75 years old) were randomly assigned into 4 groups (soymilk + probiotics supplement, soymilk + placebo, conventional milk + placebo, and probiotics supplement) for 6 weeks. Standard protocols were followed for the collection of fasting blood samples, dietary intakes, and anthropometric measurements. RESULTS: It was shown that soymilk + probiotics consumption significantly decreased diastolic blood pressure (DBP) (p = 0.001), triglycerides (TG) (P < 0.001), total cholesterol (TC) (p < 0.01), and insulin (P < 0.003) levels and significantly increased high-density lipoprotein cholesterol (HDL-C) (P = 0.002) levels. Soymilk + placebo administration significantly decreased DBP (p = 0.01), insulin (p = 0.006), and TG (p = 0.001) levels and significantly increased HDL-C (p = 0.03) levels. A significant decrease in insulin (p = 0.003) and systolic blood pressure (SBP) (p = 0.01) levels and an increase in HDL-C (p = 0.04) levels were observed after supplementation with probiotics. Findings from between-group comparisons showed a significant decrease in SBP levels in the probiotics supplement group compared to conventional milk group (p < 0.05). CONCLUSION: Soymilk and probiotics consumption might improve some cardiovascular risk factors in patients with T2DM. However, possible synergic effects while consumption of soymilk plus probiotics supplement didn't show in this study which warranted further research.

Efficacy of Ginger Supplementation in Relieving Persistent Hypothyroid Symptoms in Patients with Controlled Primary Hypothyroidism: A Pilot Randomized, Double-Blind, Placebo-Controlled Clinical Trial.

Primary hypothyroidism is a common disease. Some patients have persistent symptoms despite normal serum thyroid-stimulating hormone (TSH) levels. Ginger is reported to be beneficial in relieving similar symptoms. Our aim was to evaluate the efficacy of ginger supplementation in relieving persistent symptoms in these patients. In this randomized, double-blind, placebo-controlled clinical trial, 60 hypothyroid patients aged 20-60 years with normal serum TSH concentrations were randomly allocated to two equal parallel study groups of ginger (500 mg twice a day) or placebo for 30 days. Hypothyroid symptoms were evaluated as the primary outcome using the Thyroid Symptom Rating Questionnaire (ThySRQ) before and after the intervention. Anthropometric measures and laboratory indices including TSH, triglyceride (TG), total cholesterol (TChol), and fasting blood sugar (FBS) were considered as secondary outcomes. A significant lower mean total ThySRQ score (8.63 ± 5.47 vs. 15.76 ± 6.09, P < 0.001) was observed in the ginger group compared to the control group. Ginger led to significant improvements in the mean scores of the weight gain, cold intolerance, constipation, dry skin, appetite, memory loss, concentration disturbance, and feeling giddy or dizzy domains (P < 0.001). However, no significant improvements were observed in hair loss, nail fragility, hearing, hoarseness, speech, and depression or feeling down (P > 0.05). Ginger supplementation also led to a significant decrease in body weight, body mass index, waist circumference, serum TSH, FBS, TG, and TChol levels compared to the placebo. In summary according to preliminary results of this study, ginger supplementation can help relieve persistent hypothyroid symptoms. Also, it may have beneficial effects in terms of weight reduction and regulation of the FBS and lipid profile in hypothyroid patients.

Educating Health Science Students About Peace through Health Topic; A Panel Discussion.

This report describes an experience of the first international health for peace conference held in November 2018 in Shiraz University of Medical Sciences. This paper discusses the panel on peace education in medical and paramedical schools and the way for the future.

Efficacy of inhaled Lavandula angustifolia Mill. Essential oil on sleep quality, quality of life and metabolic control in patients with diabetes mellitus type II and insomnia.

ETHNOPHARMACOLOGIC RELEVANCE: Lavandula angustifolia Mill (lavender) odor was traditionally used as sleep enhancer. Previous studies have shown interaction between insomnia, quality of life and control of diabetes mellitus (DM). Insomnia is suggested to increase the risk of depression and decrease the quality of life in diabetic patients. The aim of this study was to evaluate the efficacy of inhaled Lavandula angustifolia Mill. as a complementary therapy for insomnia in diabetic patients. METHODS: In a randomized crossover placebo-controlled clinical trial, 52 patients with type II diabetes mellitus (DM) and insomnia, defined as Pittsburgh Insomnia Rating Scale-20(PIRS-20)>5,were treated with inhaled lavender or placebo for two periods of 4 weeks duration with one week interval as washing period. Sleep quality, quality of life and mood status were assessed by PIRS-20, WHO Quality of Life-BREF(WHOQOL-BREF) Questionnaire and Beck Depression Inventory (BDI) scale respectively, at baseline and end of each period of study. Fasting blood glucose (FBS), calorie intake and physical activity were measured before and after the interventions. RESULTS: At the end of study, data of 37 patients (all received both lavender and placebo in cross-over design) were analyzed. Based on crossover analysis the first treatment was not effective on the second treatment. Inhaled lavender resulted in a significant better outcome compared to placebo according to mean PIRS-20, WHOQOL-BREF and Beck Depression Inventory scores in both crossover arms. Likewise there was a significant better outcome in PIRS-20 domains for quality and quantity of sleep after Inhaled lavender compared to placebo. No significant improvement was observed in fasting glucose in lavender compared to placebo administration period. CONCLUSION: Inhaled lavender can improve sleep quality and quantity, quality of life and mood in diabetic patients suffering from insomnia with no significant effect on metabolic status.

Effects of Citrullus colocynthis L. in a rat model of diabetic neuropathy.

OBJECTIVE: This study investigated the biochemical, histopathological and physiological effects of Citrullus colocynthis on peripheral neuropathy in rats with streptozotocin (STZ)-induced diabetes. METHODS: Seventy adult male Sprague-Dawley rats were included in the present study. Diabetes was induced in 60 rats, with a single intraperitoneal injection of STZ (65 mg/kg). After 4 weeks, the diabetic rats were assessed for neuropathy. Then, the diabetic rats with neuropathy were randomly divided into 6 groups for a 4-week treatment with gabapentin, oral administration of C. colocynthis fruit pulp powder (100 and 300 mg/kg per day), topical preparations as oil-based solution and ointment, or placebo. Changes in metabolic, physiological, biochemical and histological parameters were considered as treatment outcomes. RESULTS: Metabolic outcomes (body weight and blood glucose level) were improved in the C. colocynthis-treated groups as compared to placebo. Tail-flick and hot-plate tests also had lower latency in the C. colocynthis-treated groups. Measurement of oxidative stress markers (malondialdehyde, superoxide dismutase and catalase) showed the antioxidant effect of C. colocynthis. Histological evaluation of the sciatic nerve showed that C. colocynthis decreased the number of demyelinated and degenerated nerve fibers. Among the C. colocynthis-treated groups, the one receiving 100 mg/kg power per day orally had the best treatment outcomes. CONCLUSION: The present study showed that C. colocynthis fruit, through its antioxidant and hypoglycemic activities, has a positive effect in the treatment of diabetic neuropathy.

Efficacy of cinnamon in patients with type II diabetes mellitus: A randomized controlled clinical trial.

BACKGROUND & AIMS: Multiple studies have evaluated the hypoglycemic effect of cinnamon in patients with diabetes mellitus (DM) type II, with conflicting results. Differences in Baseline Body Mass Index (BMI) of patients may be able to explain the observed differences in the results. This study was designed to evaluate the effect of cinnamon supplementation on anthropometric, glycemic and lipid outcomes of patients with DM type II based on their baseline BMI. METHODS: The study was designed as a triple-blind placebo-controlled randomized clinical trial, using a parallel design. One hundred and forty patients referred to Diabetes Clinic of Yazd University of Medical Sciences with diagnosis of DM type II were randomly assigned in four groups: cinnamon (BMI ≥ 27, BMI < 27) and Placebo (BMI ≥ 27, BMI < 27). Patients received cinnamon bark powder or placebo in 500 mg capsules twice daily for 3 months. Anthropometric, glycemic and lipid outcomes were measured before and after the intervention. RESULT: Cinnamon supplementation led to improvement of all anthropometric (BMI, body fat, and visceral fat), glycemic (FPG, 2hpp, HbA1C, Fasting Insulin, and Insulin Resistance), and lipids (Cholesterol Total, LDL-c and HDL-c) outcomes (except for triglycerides level). All observed changes (except for Cholesterol Total and LDL-c) were significantly more prominent in patients with higher baseline BMI (BMI ≥ 27). CONCLUSION: Based on the study findings, cinnamon may improve anthropometric parameters, glycemic indices and lipid profile of patients with type II diabetes. These benefits are significantly more prominent in patients with higher baseline BMI (BMI ≥ 27). The trial protocol was registered in Iranian Registry of Clinical Trials database (registration ID: IRCT2017031133015N1).

The effects of Zataria multiflora Boiss. (Shirazi thyme) on nonalcoholic fatty liver disease and insulin resistance: A randomized double-blind placebo-controlled clinical trial.

OBJECTIVE: The aim of the study is to evaluate the effects of Zataria multiflora Boiss. (Shirazi thyme) (ZM) supplementation on nonalcoholic fatty liver disease (NAFLD) and related insulin resistance (IR). DESIGN: In this randomized double-blind placebo-controlled clinical trial, 85 patients with NAFLD were administered either 700 mg ZM powder or placebo twice daily for 12 weeks. All patients were advised to follow the recommendations for diet modification. RESULTS: ZM supplementation resulted in a significant reduction in serum insulin level (-2.72 ± 0.80 vs -0.67 ± 0.90, P=0.030), insulin resistance (-0.80 ± 0.22 vs 0.06 ± 0.22, P=0.023), systolic (-3.44 ± 1.05 vs 1.03 ± 0.98, P= 0.002) and diastolic (-2.33 ± 0.77 vs 0.26 ± 0.63, P= 0.009) blood pressure in patients with NAFLD in comparison with the placebo group. There was no significant difference between two groups regarding serum levels of alanine aminotransferase (ALT), high sensitive C-reactive protein (hs-CRP), Tumor necrosis factor-α (TNF-α), grade of fatty liver in ultrasonography, lipid profiles, and other outcomes. CONCLUSION: ZM supplementation with daily dose of 1400 mg for 12 weeks improved insulin resistance in patients with NAFLD. Further studies with longer duration and larger sample size are recommended.

Medicinal plants' use among patients with dyslipidemia: an Iranian cross-sectional survey.

Background Despite growing demand for medicinal plants, there is little data about their use by patients with dyslipidemia. We aimed to determine the prevalence, pattern, and associated factors for the use of medicinal plants among patients with dyslipidemia. Methods A 17-item semi-structured questionnaire was filled out by 195 patients with dyslipidemia in a cross-sectional study carried out in two academic endocrinology clinics in Shiraz, Iran. The questionnaire comprised of three main domains of demographic data (6 questions), clinical data (2 of them), and data related to the use of medicinal plants (totally 9 questions). Results A total of 77.4% of patients took medicinal plants. The most common medicinal herbs used by dyslipidemic patients were Zataria multiflora, Cinnamomum zeylanicum, and Zingiber officinale. Duration of dyslipidemia was significantly longer in herbal users than non-herbal users (p=0.04). Patients believing that concomitant use of conventional drugs and herbal preparations had synergic positive effects in addition to those persuaded that herbal preparations possessed less side effects, were significantly more likely to use medicinal plants (p=0.008 and 0.005, respectively). Additionally, most of the medicinal herb users (87.4%) changed neither the pattern nor the dosage of their medications all during herbal preparations use. Conclusions This study demonstrated a high prevalence of medicinal plants' use among patients with dyslipidemia, which was associated with the duration of dyslipidemia, patients' viewpoints about herbal preparations' synergic positive effects, and their fewer side effects.

Rhus coriaria L. increases serum apolipoprotein-A1 and high-density lipoprotein cholesterol levels: a double-blind placebo-controlled randomized clinical trial.

BACKGROUND: Lipid-lowering effect of Rhus coriaria L. (Rhus) has been investigated in multiple animal studies with promising results. Nonetheless, its clinical efficacy has not been adequately examined. OBJECTIVE: The aim of this study was to evaluate the lipid-lowering effects of Rhus among patients with hyperlipidemia. DESIGN, SETTING, PARTICIPANTS AND INTERVENTIONS: The study was designed as a two-arm, double-blind placebo-controlled randomized clinical trial, using a parallel design. Eighty patients with primary hyperlipidemia were randomly assigned to receive Rhus capsules or placebo for 6 weeks. MAIN OUTCOME MEASURES: The serum lipid levels, apolipoprotein-A1 (Apo-A1) and apolipoprotein-B (Apo-B) were measured. RESULTS: Mean serum high-density lipoprotein cholesterol (HDL-C) and Apo-A1 levels were significantly increased in the Rhus group, compared with the placebo group, after 6 weeks of intervention (P = 0.001). The analysis of covariance test including age, gender, body mass index (BMI), and smoking as co-variables revealed that the increase in HDL-C and Apo-A1 levels remained significant, and increases in HDL-C were dependent on the increase in Apo-A1 levels. No significant difference was observed between Rhus and placebo groups in terms of mean reductions in total cholesterol, low-density lipoprotein cholesterol and triglyceride levels; however, more significant improvement was observed among obese patients (BMI ≥ 30 kg/m2). CONCLUSION: The study showed significant increases in HDL-C and Apo-A1 levels in response to Rhus supplementation in patients with hyperlipidemia. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT02295293.

A Traditional Mouthwash (Punica granatum var pleniflora) for Controlling Gingivitis of Diabetic Patients: A Double-Blind Randomized Controlled Clinical Trial.

This study evaluates the safety and efficacy of Punica granatum var pleniflora mouthwash in treatment of diabetic gingivitis. In a double-blind randomized clinical trial 80 patients with diabetes mellitus and gingivitis were assigned to Golnaar and chlorhexidine 0.2% groups. After using mouthwashes for 2 weeks; participants underwent tooth scaling and the last visit was 2 weeks after scaling. The primary outcome measures were plaque, modified gingival and gingival bleeding indices, and pocket depth. Both interventions had significant improvement on all of the gingival and plaque indices (P < .001 for all indices). There were no significant differences between Golnaar and chlorhexidine in primary outcome measures except for modified gingival index for which Golnaar mouthwash had a superiority after 2 weeks when comparing with chlorhexidine (P = .039). Meanwhile, Golnaar mouthwash had no staining effect. Golnaar mouthwash is safe and effective in treatment of gingivitis in diabetic patients although further studies are recommended.

Gingivitis from the Viewpoint of Traditional Persian Medicine.

BACKGROUND: Gingivitis is among the top general health problems in the world, especially in developing countries. Meanwhile, it may be associated with pulmonary and cardiovascular diseases. In a qualitative study, we tried to identify the corresponding terminology to gingivitis in traditional Persian medicine (TPM) and to explain its potential mechanisms, treatments, and prevention characteristics. METHODS: In a literature review, 4 modern textbooks and 18 related articles, 2 traditional medical dictionaries and 12 traditional medical and 4 traditional pharmaceutical texts were assessed by a specific method. Initially, traditional scripts were searched for signs and symptoms of gingivitis as well as related keywords such as bleeding, swollen and loosen gum, oral or gingival ulcers, teeth, or gingival pain. Then the disease/s or disorder/s, which matched gingivitis in TPM, was appraised in details. Finally, potential mechanisms, prevention and therapeutic protocols presented by TPM were collated and summarized. RESULTS: "Lasse-e-Dâmiyeh" (bleeding gum) or "Khoon-Reezi az Goosht-e Bon-e Dandân" (bleeding from under teeth flesh) was the main disease comparable to gingivitis. Based on TPM, the leading etiologies are insufficient gum feeding mechanism, pouring and gathering of excessive fluid in the gum and accumulation of excessive blood in it or in the whole body. Although there were remarkable similarities in the subjects of different TPM texts over the centuries, particularly in oral and teeth hygiene and overall approach to gingivitis, we faced notable differences in recipes (herbal drugs) that each text proposed. CONCLUSION: While there are overlapping terminologies to gingivitis in TPM, "Lasse-e-Dâmiyeh" is the closest disease that relates to it. Meanwhile, adjusting diet and lifestyle, having appropriate oral hygiene, obtaining a vast variety of herbal medications, cupping, phlebotomy, leech therapy, etc. are the different TPM modalities for the prevention and treatment of gingivitis that can be considered as therapeutic and/or research issues.

Topical Citrullus colocynthis (bitter apple) extract oil in painful diabetic neuropathy: A double-blind randomized placebo-controlled clinical trial.

BACKGROUND: The aim of the present study was to examine the safety and efficacy of a topical formulation of Citrullus colocynthis in patients with painful diabetic polyneuropathy (PDPN). METHODS: The study was designed as a two-arm double-blind randomized placebo-controlled clinical trial using a parallel design. Sixty patients with PDPN were randomly allocated to receive either a topical formulation of C. colocynthis or placebo (1:1 allocation ratio) for 3 months. Patients were evaluated before and after the intervention using the neuropathic pain scale, electrodiagnostic findings, World Health Organization Biomedical Research and Education Foundation (BREF) quality of life (WHOQOL-BREF) scores, and reported adverse events. RESULTS: There was a significantly greater decrease in mean pain score after 3 months in the C. colocynthis (-3.89; 95% confidence interval [CI] -3.19, -4.60) than placebo (-2.28; 95% CI -1.66, -2.90) group (P < 0.001). Mean changes in nerve conduction velocity of the tibial nerve, distal latency of the superficial peroneal nerve and sural nerve, and sensory amplitude of the sural nerve were significantly higher in the intervention than placebo group (P < 0.001) in favour of the intervention. In the different domains of WHOQOL-BREF, there was a significant improvement only for the mean score in the physical domain. CONCLUSIONS: Application of a topical formulation of C. colocynthis fruit extract can decrease pain in patients with PDPN. It also may have some uncertain effects on nerve function and the physical domain of quality of life, which require further investigation in studies with larger sample sizes and of longer duration.

Complementary and alternative medicine use in Iranian patients with diabetes mellitus.

OBJECTIVE: There is increasing interest in complementary and alternative medicine generally, and especially by those affected by chronic diseases, such as diabetes mellitus. We aimed to determine the prevalence and pattern of complementary and alternative medicine use among patients suffering from diabetes mellitus in Shiraz, southern Iran. Another objective was to explore associated factors for use of complementary and alternative medicine among patients with diabetes mellitus. METHODS: A 19-item semi-structured questionnaire (open- and close-ended) was administered to 239 patients with diabetes mellitus in this cross-sectional study. It was carried out in two outpatient diabetes clinics affiliated with the Shiraz University of Medical Sciences, Shiraz, Iran. RESULTS: One hundred and eighty patients (75.3%) used at least one type of complementary and alternative medicine in the last year prior to the interview. Patients with diabetes mellitus who were living in a large family (≥5 members), not taking insulin, and believed that complementary and alternative medicine have synergistic effects with conventional medicine, were independently and significantly (P values: 0.02, 0.04, and 0.01, respectively) more likely to use complementary and alternative medicine. Most of the users (97.7%) reported use of herbal preparations, and 89.4% of users did not change their medication, neither in medication schedule nor its dosage. CONCLUSION: The use of complementary and alternative medicine, especially herbal remedies, is popular among diabetes patients in Shiraz, Iran. This use is associated with patients' family size, type of conventional medications and their view about concomitant use of complementary and conventional medicine.