The Effects of Different Temperaments on Vascular Parameters: A Pilot CrossOver Randomized Controlled Trial.

BACKGROUND: According to the Persian Medicine (PM) point of view, the function of the cardiovascular system and the risk of cardiovascular events would be different between subjects having warm and cold temperaments. Moreover, different foods in terms of temperament may lead to different acute and chronic effects on the body. OBJECTIVES: We investigated the postprandial effects of PM-based warm and cold test meals on arterial stiffness indices in healthy men with warm and cold temperaments. METHODS: Twenty-one eligible warm or cold temperament subjects with a similar range of age, weight, and heights were enrolled in this pilot cross-over randomized controlled trial study during February- October 2020. Two test meals (cold and warm PM-based temperament foods) were designed as different interventions. Pulse wave velocity (PWV) and pulse wave analysis (PWA) was obtained at the baseline state (following 12 hours fasting), 0.5, 2, and 4 hours after the test meal consumption during each test day. RESULTS: Warm temperament participants had higher values of lean body mass, total body water, and protein content (P = 0.03, 0.02, and 0.02, respectively). Cold temperament individuals had higher aortic heart rate (HR) following 12 hours of fasting (P <0.001). On the other hand, the augmentation pressure (AP) of warm temperament individuals was higher than the colds (P= <0.001). CONCLUSION: According to the results of the present study, although warm temperament individuals could have higher arterial stiffness at the fasting state, arterial stiffness indices had a greater reduction following warm-temperament meal intake compared to cold-temperament meal. TRIAL REGISTRATION NUMBER: International Clinical Trials Registry Platform IRCT20200417047105N1 (Where the full trial protocol can be accessed).

Three months of combination therapy with nano-curcumin reduces the inflammation and lipoprotein (a) in type 2 diabetic patients with mild to moderate coronary artery disease: Evidence of a randomized, double-blinded, placebo-controlled clinical trial.

Diabetes is one of the most common chronic diseases worldwide. Systemic inflammation (high-sensitivity C-reactive protein (hs-CRP)) and lipid metabolism disruption (lipoprotein A, LipoPr (a)) play a critical role in developing and progressing atherosclerosis and acute coronary syndrome in diabetic patients. The anti-oxidant and anti-inflammatory effects of curcumin have been emphasized previously. Therefore, we aimed to evaluate the impact of nano-curcumin on cardiovascular risk factors in type 2 diabetic patients with mild to moderate coronary artery disease (CAD). We performed a randomized, double-blinded, placebo-controlled clinical trial with type 2 diabetic patients (n = 64), and mild to moderate CAD (<70% stenosis in angiography). The patients received nano-curcumin (80 mg/day) or placebo along with optimal medications for 90 days. The biofactors, including hs-CRP and LipoPr (a), and lipid profile, were measured at the admission of patients and end of the study. Nano-curcumin significantly mitigated the hs-CRP and LipoPr (a) levels following 90 days of treatment (P < 0.001 and P = 0.043, respectively). In addition, the mean percentage of change (%Δ) in the hs-CRP and LipoPr (a) levels were meaningfully reduced in the nano-curcumin group compared to the placebo group (P < 0.001 and P = 0.007, respectively). Surprisingly, nano-curcumin notably propagated the number of patients with mild (34.35%) and moderate (62.5%) hs-CRP level category and strikingly diminished the number of patients with severe hs-CRP level category (3.125%) compared to the placebo group (P = 0.016). Nano-curcumin (80 mg/day) might prevent atherosclerosis progression and, in terms of attenuating hs-CRP levels as an inflammation index, succedent cardiovascular events in diabetic heart patients.

Comparing the Effects of a Herbal Drug based on Echium Amoenum With Fluvoxamine in the Treatment of Adolescents with Obsessive-compulsive Disorder.

BACKGROUND: Obsessive-compulsive disorder (OCD) is a severe and debilitating neuropsychiatric condition. Although selective serotonin reuptake inhibitors, tricyclic antidepressants, and cognitive- behavioral therapy are the first-line medication and treatment for OCD, an estimated 30% of patients are treatment-resistant, and complete functional recovery is rare. Natural products as adjuvant or alternative therapies should be examined to find safer and more effective ways to manage OCD. OBJECTIVES: To investigate the potential benefits of a combined herbal drug based on Echium amoenum in treating OCD. METHODS: Design and Setting: In the psychiatric clinics of Mashhad University of Medical Sciences, 40 patients who met the criteria for the obsessive-compulsive disorder based on DSM-5 were studied in a parallel, double-blind, randomized clinical trial. INTERVENTION: Subjects were randomly assigned to receive Echium amoenum-Melissa officinalis syrup and fluvoxamine or placebo syrup and fluvoxamine for 8 weeks. OUTCOME MEASURES: The efficacy of treatment and recurrence of disease were surveyed and compared according to the Yale-Brown Obsessive Compulsive Scale at weeks 0, 4, and 8. RESULTS: Evaluation at the 4th and 8th week showed no significant differences between the two groups (p-value = 0.11, p-value = 0.445, respectively). At the 8th week of treatment, patients in the intervention group showed a remarkable reduction in scores on the Yale-Brown Obsessive-Compulsive Scale questionnaire (p- value= 0.003), and patients in the control group didn't ((p- value= 0.180). This study showed that the E.amoneum-M.officinalis syrup was not significantly more efficacious than the fluvoxamine tablet, but the intervention group showed a significant improving trend (p-value= 0.001). CONCLUSION: While monotherapy is usually the gold standard methodology, combination or augmentation therapy may also be of merit. Consequently, studies with larger sample sizes and the inclusion of para-clinical assessments such as serologic tests can further shed light on the mechanism of action of the E. amoneum- M. officinalis syrup and deepen our understanding of its effects.

Clinical Evidence for the Effectiveness of Herbal Medicines in the Treatment of an Obsessive- Compulsive Disorder: A Review Study.

BACKGROUND: Obsessive-compulsive disorder (OCD) is a potentially debilitating disease that affects 1-4% of the general population. It is characterized by the presence of obsessions and compulsions which interfere with the individual's life and functioning. Although conventional treatments such as drug therapies and cognitive behavioral therapy exist for OCD, these treatments are not universally successful and can cause side effects, which has created a demand for alternative and complementary therapies. METHODS: In this review, we summarize randomized clinical trials on the effectiveness of herbal medicines for the treatment of OCD, and review the possible mechanisms of action for these medicines. A search in PubMed, Scopus, and The Cochrane Library found 1022 studies, of which 7 were included in our review. RESULTS: The studies that we found were conducted over 6 to 12 weeks, and had an average sample size of 37. The plant species studied included Crocus sativus, Echium amoenum, Hypericum perforatum, Silybum marianum, Valeriana officinalis, and Withania somnifera. The trials demonstrated the effectiveness of all plants as treatments for OCD except H. perforatum. The phytochemicals found in these plants produce their effects through a variety of means such as inhibiting the reuptake of monoamines, GABAergic effects, and neuroendocrine modulation. The small number of studies and their small sample sizes, poor methodology, and lack of replication highlight the need for further research into herbal medicines for the treatment of OCD. CONCLUSION: Overall, herbal medicines can be used as stand-alone therapies for OCD or in conjunction with other methods.

Effect of kefir beverage consumption on glycemic control: A systematic review and meta-analysis of randomized controlled clinical trials.

Kefir is a fermented beverage obtained as a result of lactic-alcoholic fermentation of milk by using kefir grains or a starter culture. Kefir beverage has numerous health benefits owing to its antimicrobial, anti-inflammatory and anti-diabetic properties, while it could also regulate the gut microbiota. This beverage is recommended as a nutritional approach to glycemic control. This systematic review and meta-analysis of randomized controlled trials (RCTs) aimed to evaluate the effects of kefir beverage on the glycemic control. For this purpose, a literature search was conducted via databases such as PubMed, Scopus, ISI Web of Science, and Google Scholar for the articles published until July 2020 with no limitation. The indicators of glycemic control were fasting blood sugar (FBS), hemoglobin A1c (HbA1c), and insulin. In total, six RCTs on a total sample size of 323 subjects were selected for the meta-analysis. Inverse-variance weighted mean difference (WMD) with a 95% confidence interval (CI) was calculated for the mean changes in HbA1c, FBG and insulin compared to baseline. Considering the clinical heterogeneity caused by the varied duration and dosage of kefir beverage treatment, a random effects model was used to estimate the pooled WMD. Findings indicated a more significant reduction in the FBS (WMD = -10.28; 95% CI: -16.53-4.02; P = 0.001) and insulin (WMD = -2.87; 95% CI: -3.96-1.78; P < 0.00001) in the kefir treatment group. Furthermore, kefir consumption could reduce HbA1c (HbA1c = -0.64 -1.36, 0.08), while this effect was not considered significant (-0.64; 95% CI: -1.36-0.08; P = 0.08). The results of our meta-analysis indicated that kefir beverage could reduce the FBS and insulin levels without a significant effect on HbA1c. In general, our findings showed that kefir beverages may have beneficial effects on glycemic control. However, more clinical data and research into the mechanism of probiotics are required to clarify the beneficial effects of probiotics on glycemic markers.

The Effect of Curcumin Supplementation on Pulse Wave Velocity in Patients with Metabolic Syndrome: A Randomized, Double-Blind, Placebo-Controlled Trial.

Cardiovascular disease is a leading cause of death in many societies. Arterial stiffness is an initial sign of structural and functional changes in the arterial wall. Pulse wave velocity (PWV) is the gold standard for non-invasive evaluation of aortic stiffness and a modifiable cardiovascular risk factor. Curcumin is a major component of turmeric with known anti-inflammatory and anti-oxidative effects. Since arterial stiffness is affected by inflammation and oxidative stress, it may be improved by curcumin supplementation. The purpose of this clinical trial was to investigate the potential effects of curcumin on improving arterial stiffness in patients with metabolic syndrome. This placebo-controlled, double-blind, randomized clinical trial was conducted among metabolic syndrome patients. Sixty-six eligible individuals were randomly assigned to active intervention or control groups. The active intervention group received curcumin supplement at a dose of 500 mg daily for 12 weeks, whereas the control group received placebo capsule. Physical activity, daily dietary energy intake, anthropometric body composition, and biochemical hemodynamic and arterial stiffness parameters were evaluated at baseline and at the end of the study. Body weight decreased significantly in the curcumin group compared to placebo. Also, curcumin intervention improved PWV, which remained significant after adjustment for potential confounding factors (p = 0.011). The current clinical trial demonstrated that daily intake of 500 mg of curcumin for 12 weeks can lead to the improvement of arterial stiffness and weight management among subjects with metabolic syndrome.

The effect of platelet-rich plasma-fibrin glue dressing in combination with oral vitamin E and C for treatment of non-healing diabetic foot ulcers: a randomized, double-blind, parallel-group, clinical trial.

OBJECTIVE: The current study assesses the effects of platelet-rich plasma-fibrin glue (PRP-FG) dressing along with oral vitamin E and C on wound healing and biochemical markers in patients with non-healing diabetic foot ulcers (non-healing DFU). METHODS: This randomized controlled trial was performed on 25 patients with non-healing DFU. Patients were treated with PRP-FG dressing plus oral vitamin E and C (intervention group) or PRP-FG dressing plus placebo (control group) for 8 weeks. RESULTS: Eight weeks after treatment, six wounds in the intervention group and two wounds in the control group were completely closed, and also wound size significantly reduced in both intervention and control groups (p < 0.05). This reduction in wound size was significantly greater in the intervention group compared to the control group (p = 0.019). Also, a significant decrease in prooxidant-antioxidant balance (PAB) , ESR, and hs-CRP was observed in the intervention group compared to the control group (p < 0.05). CONCLUSION: Our results showed that PRP-FG dressing along with oral vitamin E and C could be used to increase wound healing in patients with non-healing DFU by enhancing the wound healing process and reducing oxidative stress. TRIAL REGISTRATION: This trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT04315909).

Dietary Intake and Serum Selenium Levels Influence the Outcome of HTLV-1 Infection.

Human T cell leukemia virus type 1 (HTLV-1)-associated myelopathy/tropical spastic paraparesis (HAM/TSP), as the most common neurological emersion related to HTLV-1, is a debilitating and lifelong treating disease with no definitive treatment. Furthermore, it has been determined that dietary compositions (inflammatory and anti-inflammatory) and some micronutrients (such as vitamin D and selenium) have an effect on inflammatory and immune processes and with this background; the study was done to compare the nutritional status between age- and sex-matched with infected and non-infected HTLV-1. In a multi-center setting, 70 healthy controls (HCs), 35 asymptomatic carriers (ACs), and 35 HAM/TSP patients were recruited in the HTLV-1 Foundation, Ghaem Hospital, Mashhad University of Medical Sciences, Mashhad, Iran. Nutritional status including anthropometric indices, dietary (micro- and macronutrient) intake, and serum vitamin D, vitamin B12, zinc, and selenium were measured. In anthropometric indices, mean waist circumference (WC) in the carrier group was significantly higher than the patient and the control groups (p = 0.008). In the dietary intake, the patient group received less energy, protein, mono-unsaturated fatty acids (MUFA), and oleic, but more fat than the HTLV-1 carrier and control groups, and these differences were remarkable in three groups (p = 0.002, 0.005, 0.001, 0.01, and 0.001, respectively), whereas the carrier group received more saturated fatty acid and less poly-unsaturated fatty acids (PUFA), linoleic, and linolenic than patient and control groups with a different significant (p = 0.01, 0.007, 0.005, and 0.006, respectively) in three groups. In micronutrient intake, although selenium, zinc, and vitamins B12 and D were lower in the patient group than the carrier and control group, however, no significant differences were observed. In comparison with micronutrient serum concentrations, vitamins B12 and D and selenium in the patient group were lower than the carrier and control groups, but statistically, the considerable difference was found only in the selenium concentration (p = 0.001). The study showed that there were differences in dietary intake (including energy, macronutrients, and fatty acids), WC, and selenium serum levels between HAM/TSP patients and HTLV-1 carriers, suggesting that nutritional statues influence the inflammatory immune response in HTLV-1 infection.

Protective effects of propolis on hepatic steatosis and fibrosis among patients with nonalcoholic fatty liver disease (NAFLD) evaluated by real-time two-dimensional shear wave elastography: A randomized clinical trial.

Nonalcoholic fatty liver disease (NAFLD) is the most common chronic liver disease, while no drugs have been approved for its treatment. The pieces of evidence indicate that propolis as a novel anti-inflammatory agent might be a promising candidate to treat NAFLD. We aimed to evaluate the efficacy of propolis on hepatic steatosis and fibrosis in patients with NAFLD. This randomized clinical trial was conducted on 54 patients with NAFLD. Patients were randomly assigned to receive propolis tablets at a dose of 250 mg twice daily for 4 months or placebo. The improvement in hepatic steatosis and fibrosis was evaluated using two-dimensional shear wave elastography. Improvement in the hepatic steatosis was significantly higher in the propolis group than the placebo group, even after adjustment for baseline value and changes in weight, energy intake, and physical activity (odds ratio [OR]: 5.67; 95% confidence intervals [CI]: 1.41-22.8; p = .014). A significant reduction was observed on the liver stiffness in the propolis group (-0.65 ± 0.56 kPa; p = .001), whereas it increased in the placebo group (0.27 ± 0.59 kPa; p = .037). Also, the intake of propolis significantly decreased high-sensitivity C-reactive protein (hs-CRP) levels compared with the placebo group (-0.371; 95%CI: -0.582 to -0.16 mg/L; p = .01). Changes in serum levels of fasting blood sugar, alanine aminotransferase, aspartate aminotransferase, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, cholesterol, and triglyceride did not differ significantly between the two groups (p > .05). There was no significant improvement in insulin resistance in both groups (p > .05). Propolis seems to have protective effects on hepatic steatosis and fibrosis and to reduce the serum levels of hs-CRP in patients with NAFLD.

Evaluation of 1,25(OH)2D3 Effects on FOXP3, ROR-γt, GITR, and CTLA-4 Gene Expression in the PBMCs of Vitamin D-Deficient Women with Unexplained Recurrent Pregnancy Loss (URPL).

Background: Vitamin D insufficiency and deficiency can be associated with adverse effects on fetus and pregnancy outcomes. This study aimed at evaluating the effect of 1,25VitD3 on specific transcription factor and markers of Tregs and T helper 17 (Th17) cells in peripheral blood mononuclear cells (PBMCs) of women with unexplained recurrent pregnancy loss (URPL) as a case group and PBMCs of healthy women as a control group. Methods: Samples from 20 non-pregnant patients with a history of URPL were compared to 20 normal non-pregnant women. PBMCs were divided into three wells for each subject in the presence of 1,25VitD3 (50 nM, for 16 hours), phytohemagglutinin (10 µM; positive control), and without any treatment (negative control). By Real-time PCR (Taqman assay), specific transcription factors of Tregs and Th17 cells, forkhead box P3 (FOXP3), retinoic acid-related orphan receptor γt (ROR-γt), glucocorticoid-induced tumor necrosis factor receptor-related (GITR), and CTLA-4 mRNA expressions in two groups were measured. Results: FOXP3/ROR-γt mRNA expression in PBMCs decreased significantly in women experiencing URPL compared to the control group (p = 0.0001). Although 1,25VitD3 (50 nM) increased FOXP3 gene expression (p = 0.0001), it did not significantly affect ROR-γt gene expression. Besides, 1,25VitD3 treatment significantly increased FOXP3/ROR-γt mRNA expression from baseline in PBMCs of the fetal loss group compared to that of the control group (p = 0.01). The 1,25VitD3 also increased GITR gene expression (p = 0.017) in PBMCs of URPL women compared to the controls. Conclusion: Vitamin D deficiency may be a contributor to recurrent pregnancy loss and suggests that the supplementation of women with Vitamin D pre-pregnancy may be protective against URPL via affecting Tregs signature genes, FOXP3 and GITR.

Efficacy of a Herbal Formulation Based on Foeniculum Vulgare in Oligo/Amenorrhea: A Randomized Clinical Trial.

BACKGROUND: The aim of this study was to evaluate the efficacy of the herbal tea based on Foeniculum vulgare, on inducing regular bleeding in women with oligomenorrhea and secondary amenorrhea( oligo/amenorrhea). METHODS: Forty women aged 18- 40 with oligo/amenorrhea were enrolled in this randomized controlled clinical trial and were allocated to two groups equally. The women in the first group were treated by Fomentex (Foeniculum vulgare / Mentha longifolia / Vitex agnus-castus) herbal tea 11.2 g/day in 2 divided doses for 2 weeks and the second group were treated by medroxy progesterone acetate (MP)10 mg/day for the last 10 days of their menstrual cycles. The intervention was repeated in three cycles of menstruation in both groups. Bleeding pattern was documented by the patient on diary cards. The occurrence (yes/no) of bleeding, the regularity of bleeding pattern, the interval of cycles, the duration of bleeding, the volume of blood flow, the hormonal parameters (total testosterone, free testosterone luteinizing hormone and follicle-stimulating hormone), and the endometrial thickness in sonography before and after the intervention were evaluated and compared as outcomes. RESULTS: The number of women with bleeding during the first cycle was in the Fomentex group and the MP group 83.3% and 94.1% respectively (p = 0.61). The regularity of bleeding did not significantly differ in patients treated with Fomentex from those given MP (66.7% vs. 94.1%; p = 0.088). Mean interval of cycles decreased in both groups after intervention (P<0.001). Mean duration decreased significantly in MP group after the intervention but it was not different in patients treated with Fomentex. The difference between 2 groups was not significant (P=0.705). Volume of blood flow, with regard to Pictorial Blood Assessment Chart (PBAC), increased significantly in MP group after the intervention (P=0.001) and it was not different in patients treated with Fomentex (P=0.757); however, difference between 2 groups was not significant (P=0.063). The percentage of patients with on time menstruation in the next (drug-free) episode, was higher in the Fomentex group compared with the MP group (50% vs. 23.5%; p = 0.105). Secondary outcomes such as dysmenorrhea, acne and hirsutism reduced in the Fomentex group (P≤0.05), while they increased in the MP group (P=0.007). At the end of the treatment, there was a significant decrease in luteinizing hormone, total testosterone and free testosterone in patients taking Fomentex. The decrease of endometrial thickness, was significant in both groups after the intervention (P=0.001), but the difference between 2 groups was not significant (P=0.58). No notable complication or side effect was reported in relation to Fomentex. CONCLUSION: Fomentex herbal tea is a safe, well-tolerated, and effective choice in inducing bleeding and maintaining regular bleeding in women with oligo/amenorrhea.

Autologous Bone Marrow Stem Cell Transplantation in Liver Cirrhosis after Correcting Nutritional Anomalies, A Controlled Clinical Study.

OBJECTIVE: Liver transplantation is the gold standard approach for decompensated liver cirrhosis. In recent years, stem cell therapy has raised hopes that adjusting some clinical and laboratory parameters could lead to successful treatments for this disease. Cirrhotic patients may have multiple systemic abnormalities in peripheral blood and irregular cell populations in bone marrow (BM). Correcting these abnormalities before BM aspiration may improve the effectiveness of cell-based therapy of liver cirrhosis. MATERIALS AND METHODS: In this controlled clinical trial study, 20 patients with decompensated liver cirrhosis were enrolled. Patients were randomly assigned to control and experimental groups. Blood samples were obtained to measure vitamin B12, folate, serum iron, total iron bonding capacity (TIBC) and ferritin before any intervention. Furthermore, the iron storage and fibrosis level in BM biopsies, as well as the percentage of different cell populations, were evaluated. Prior to cell isolation for transplantation, we performed palliative supplement therapy followed by a correction of nutritional deficiencies. Mononuclear cells (MNCs) were then isolated from BM aspirates and transfused through peripheral vein in patients in the experimental group. The model of end-stage liver disease (MELD) score, The international normalized ratio (INR), serum albumin and bilirubin levels were assessed at 0 (baseline), 3 and 6 months after cell transplantation. RESULTS: The MELD score (P=0.0001), INR (P=0.012), bilirubin (P<0.0001) and total albumin (P<0.0001) levels improved significantly in the experimental group after cell transplantation compared to the baseline and control groups. Moreover, the increase in serum albumin levels of patients in the experimental group was statistically significant 6 months after transplantation. CONCLUSION: We have successfully improved the conditions of preparing -BM-derived stem cells for transplantation. Although these cells are relatively safe and have been shown to improve some clinical signs and symptoms temporarily, there need to be more basic studies regarding the preparation steps for effective clinical use (Registration number: IRCT2014091919217N1).

Urtica dioica in comparison with placebo and acupuncture: A new possibility for menopausal hot flashes: A randomized clinical trial.

OBJECTIVES: The purpose of this research was to investigate the effect of Urtica dioica in comparison with placebo, acupuncture and combined therapy on hot flashes and quality of life in postmenopausal women. METHODS: In a double-blinded randomized controlled trial, patients were treated for 7 weeks then followed up 4 weeks. Seventy-two postmenopausal women who reported at least 20 hot flashes attacks per week were randomly allocated into one of the 4 groups of Urtica dioica 450 mg/day and acupuncture 11 sessions (A), acupuncture and placebo (B), sham acupuncture and Urtica dioica (C), and sham acupuncture and placebo (D). The primary outcomes were the change in hot flashes score from baseline to the end of treatment and follow up; and the change in the quality of life (MENQOL) from baseline to the end of treatment. Secondary outcomes included changes in FSH, LH, and ESTRADIOL levels from baseline to the end of treatment. The trial was conducted from October 2017 to July 2018 in Acupuncture clinic of a teaching hospital in Iran. RESULTS: A total of 72 women 45-60 years old were enrolled, and 68 were included in the analyses. The median (IQR) hot flashes score decreased in the A group by 20.2 (31.7) and 21.1 (25.1), B group by 19 (18) and 17.3 (27), C group by 14.6 (25.4) and 20.8 (13), and D group by 1.6 (11.6) and 1 (13.3) at the end of treatment and follow up (P < 0.0001, P < 0.0001); no significant difference between A, B and C groups. The mean (SD) of MENQOL score decreased in the A group by 42.6 (21.1), B group by 40.7 (29.8), C group by 37.8 (26.8) and D group by 9.8 (14.3) at the end of treatment (P = 0.001); no significant difference between A, B and C groups. CONCLUSIONS: Urtica dioica can decrease menopausal hot flashes and increase the quality of life of postmenopausal women better than placebo-sham control but same as acupuncture. The combination of Urtica dioica and acupuncture did not add to the effects of those therapies.

Herbal medicines for suppressing appetite: A systematic review of randomized clinical trials.

The suppression of appetite with herbal medicines has become very popular in recent years. We conducted this systematic review to evaluate the recent scientific evidence regarding herbal medicines that are used to suppress appetite. We retrieved clinical trials from PubMed, Cochrane Central Register of Controlled Trials, Web of Science, Scientific Information Database, and IranMedex from January 1, 2013 to April 24, 2018. English and Persian language randomized clinical trials that used herbal medicines to suppress appetite in healthy or obese or overweight individuals were included. Risk of bias was assessed using Cochrane methodology. Out of 591 articles, 22 trials with 973 participants were included. One study on the Meratrim formulation which contained the Sphaeranthus indicus flower heads extract and Garcinia mangostana fruit, revealed longer-term evidence; while 6 studies on Ilex paraguariensis, Spinacia oleracea, Phaseolus vulgaris, Secale cereale, Sorghum bicolor and Plantago showed short-term evidence for suppressing appetite. No serious adverse events were reported. Despite some methodological concerns in the included studies, there is promising evidence for suppressing appetite with herbal medicines that needs to be confirmed in long-term clinical trials with adequate sample size and higher methodological quality with more attention to safety, effective dose and side effects.

Effect of Capparis spinosa Extract on Metabolic Parameters in Patients with Type-2 Diabetes: A Randomized Controlled Trial.

BACKGROUND: Experimental studies have reported beneficial effects of Capparis spinosa L., a perennial shrub from the Capparidaceae family, on the glycemic status and serum lipids in diabetic animals. OBJECTIVE: The aim of the present randomized triple-blind placebo-controlled clinical trial was to investigate the safety and efficacy of C. spinosa oxymel on blood glucose, lipid profile, and other diagnostic indexes of metabolic syndrome in patients with poorly controlled type 2 diabetes. METHOD: The C. spinosa oxymel was prepared by adding hydroalcoholic extract of C. spinosa fruit to simple oxymel (a mixture of grape vinegar and lactulose). Thirty diabetic patients with metabolic syndrome whose glycemic status was not controlled despite receiving full doses of oral hypoglycemic agents did not want to start insulin therapy and were randomly allocated to three groups to receive placebo, simple oxymel, or C. spinosa oxymel (10 mL/thrice daily for 3 months). All patients continued conventional therapy with hypolipidemic, antihyperlipidemic, and antihypertensive drugs during the study. RESULTS: C. spinosa oxymel significantly decreased the body weight and body mass index at the end of the study compared to the baseline. While the patients in the placebo and simple oxymel groups displayed further increase in the level of FBG or PPBG, administration of C. spinosa oxymel inhibited the progression of hyperglycemia. Nevertheless, there was not a significant difference between placebo and intervention groups regarding HbA1c at the end of the study. C. spinosa oxymel had no significant effect on the serum cholesterol but inhibited the progression of hypertriglyceridemia during the study. There were no significant changes in creatinine, microalbuminuria, AST, ALT, and ALP values following C. spinosa treatment, suggesting that it had no unwanted effects on kidney and liver function. CONCLUSION: The results suggest that although C. spinosa oxymel cannot enhance the effects of hypoglycemic and hypolipidemic drugs, it can prevent further increase of blood glucose and triglycerides in patients with poorly controlled diabetes.