An investigation of the effects of curcumin on iron overload,hepcidin level,and liver function in β‐thalassemia major patients: A double‐blind randomized controlled clinical trial

This study investigated the effects of curcumin, the active polyphenol in turmeric, on iron overload, hepcidin level, and liver function in β‐thalassemia major patients. This double‐blind randomized controlled clinical trial was conducted on 68 β‐thalassemia major patients. The subjects were randomly divided into 2 groups to receive either 500 mg curcumin capsules (total: 1,000 mg) twice daily or placebo for 12 weeks. Dietary intakes and biochemical variables including hemoglobin, transferrin saturation, total iron binding capacity, nontransferrin bound iron (NTBI), ferritin, hepcidin, alanine aminotransferase (ALT), and aspartate aminotransferase (AST) were assessed at the beginning and end of the trial. Curcumin significantly reduced serum levels of NTBI (2.83 ± 1.08 compared with 2.22 ± 0.97 μmol/L, p = .001), ALT (42.86 ± 11.15 compared with 40.60 ± 9.89 U/L, p = .018), and AST (49.45 ± 12.39 compared with 46.30 ± 10.85 U/L, p = .002) at the end of the study. Based on analysis of covariance, a significant decrease was also observed in levels of NTBI (2.22 ± 0.97 vs. 2.55 ± 0.94 μmol/L, p = .026), ALT (40.60 ± 9.89 vs. 45.01 ± 10.42 U/L, p = .004), and AST (46.30 ± 10.85 vs. 50.99 ± 9.36 U/L, p = .009) in curcumin group in comparison with placebo group. There were no significant changes in hepcidin and other variables in any of the 2 groups. Curcumin administration alleviated iron burden and liver dysfunction by reducing NTBI, ALT, and AST levels in patients with β‐thalassemia major.

     

The effects of wheat germ supplementation on metabolic profile in patients with type 2 diabetes mellitus: A randomized,double‐blind,placebo‐controlled trial

The aim of the present trial was to examine the effects of wheat germ (WG) consumption on metabolic control and oxidative stress status of type 2 diabetes mellitus (T2DM) patients. Eighty participants with T2DM were randomly allocated to receive 20‐g WG (n = 40) or placebo (n = 40) in a randomized double‐blind clinical trial for 12 weeks. Serum lipid profiles, glycaemic indices, total antioxidant capacity, and malondialdhyde (MDA) were assessed. A total of 75 subjects completed the trial. Compared with the placebo, WG consumption led to significant reduction in total cholesterol (TC) concentrations (p = .04). There was a trend regarding TC to high density lipoprotein ratio (p = .08) following 12 weeks WG consumption, although they were not statistically significant after correcting for multiple testing. In addition, within‐group comparison revealed a significant rise in total antioxidant capacity concentration (p = .001) in WG group. We observed no significant effects of WG intake on glycaemic status, blood pressure, MDA, triglyceride, and low density lipoprotein levels. WG consumption for 12 weeks could decrease serum TC levels and had no significant effects on other metabolic variables and MDA in patients with T2DM. Though observed health benefit effects were small, it might lead to a major impact on wider public health.     

Metabolic effect of berberine–silymarin association: A meta‐analysis of randomized,double‐blind,placebo‐controlled clinical trials

The aim of this study is to assess the impact of a combination of berberine and silymarin on serum lipids and fasting plasma glucose (FPG) through a systematic review of literature and meta‐analysis of the available randomized, double‐blind, placebo‐controlled clinical trials (RCTs). A systematic literature search in SCOPUS, PubMed‐Medline, ISI Web of Science, and Google Scholar databases was conducted up to October 2, 2018, in order to identify RCTs assessing changes in plasma concentrations of total cholesterol (TC), triglycerides (TG), high‐density lipoprotein cholesterol (HDL‐C), low‐density lipoprotein cholesterol (LDL‐C) and FPG during treatment with berberine and silymarin in combination. Two review authors independently extracted data on study characteristics, methods, and outcomes. Quantitative data synthesis was performed using a random‐effects model. We identified five eligible RCTs, with 497 subjects overall included. Berberine and silymarin combination treatment exerted a positive effect on TC (mean difference [MD]: ?25.3, 95% CI [?39.2, ?11.4] mg/dl; p < 0.001), TG (MD: ?28, 95% CI [?35.3, ?20.6] mg/dl; p < 0.001), HDL‐C [MD: 6, 95% CI [3.2, 8.8] mg/dl; p < 0.001), LDL‐C (MD: ?29.1, 95% CI [?39.7, ?18.6] mg/dl; p < 0.001), and FPG (MD: ?7.5, 95% CI [?13, ?1.9] mg/dl; p = 0.008). The present findings suggest that the coadministration of berberine and silymarin is associated with an advantageous improvement in lipid and glucose profile, suggesting the possible use of this nutraceutical combination in order to promote the cardiometabolic health.     

Valerian extract alters functional brain connectivity: A randomized double‐blind placebo‐controlled trial

Valerian root is the most commonly used herbal supplement for sedation and anxiolysis, but it is unknown whether it may affect functional brain connectivity. Our goal was to use electroencephalography (EEG) to investigate whether valerian root extract (VRE) affects resting‐state connectivity changes and whether such changes are associated with clinical symptoms. This 4‐week, double‐blinded, randomized, placebo‐controlled clinical trial was conducted with 64 nonclinical volunteers suffering psychological stress. The participants received VRE (100 mg) or a placebo thrice daily. We examined VRE's therapeutic effects on anxiety and stress‐related psychological constructs. Functional brain connectivity changes were measured as EEG coherence in the alpha and theta frequency bands. The VRE and placebo groups both exhibited significant postintervention improvements on all clinical scales, but no significant between‐group differences in these changes were noted. Compared with the placebo group, the VRE group exhibited significantly greater increases in frontal brain region alpha coherence across four electrode pairs, and these changes were significantly correlated with anxiolysis. The VRE group also exhibited significantly greater decreases in theta coherence across another four electrodes pairs. Our findings indicate that VRE alters functional brain connectivity in relation to anxiety. Further EEG studies are needed to confirm VRE's neurophysiological effects.     

Efficacy of artichoke leaf extract in non‐alcoholic fatty liver disease: A pilot double‐blind randomized controlled trial

Non‐alcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease worldwide and is potentially treatable, though there are few therapeutic agents available. Artichoke leaf extract (ALE) has shown potential as a hepatoprotective agent. This study sought to determine if ALE had therapeutic utility in patients with established NAFLD. In this randomized double‐blind placebo‐controlled parallel‐group trial, 100 subjects with ultrasound‐diagnosed NAFLD were randomized to either ALE 600 mg daily or placebo for a 2‐month period. NAFLD response was assessed by liver ultrasound and serological markers including the aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ratio and AST to platelet ratio index (APRI) score. Ninety patients completed the study (49 ALE and 41 placebo) with no side effects reported. ALE treatment compared with placebo: Doppler sonography showed increased hepatic vein flow (p < .001), reduced portal vein diameter (p < .001) and liver size (p < .001), reduction in serum ALT (p < .001) and AST (p < .001) levels, improvement in AST/ALT ratio and APRI scores (p < .01), and reduction in total bilirubin. ALE supplementation reduced total cholesterol, low‐density lipoprotein cholesterol, high‐density lipoprotein cholesterol, non‐high‐density lipoprotein cholesterol, and triglyceride concentrations (p = .01). This study has shown beneficial effects of ALE supplementation on both ultrasound liver parameters and liver serum parameters (ALT, AST, APRI ratio, and total bilirubin) in patients with NAFLD.     

The effects of spirulina on glycemic control and serum lipoproteins in patients with metabolic syndrome and related disorders: A systematic review and meta‐analysis of randomized controlled trials

The aim of this systematic review and meta‐analysis was to evaluate the effects of spirulina on glycemic control and serum lipoproteins in patients with metabolic syndrome (MetS) and related disorders. Two independent authors systematically searched online database including EMBASE, Scopus, PubMed, Cochrane Library, and Web of Science from inception until April 30, 2019. The Cochrane Collaboration's risk of bias tool was applied to assess the methodological quality of included trials. The heterogeneity among the included studies was assessed using Cochrane's Q test and I‐square (I²) statistic. Pooling effect sizes from studies showed a significant reduction in fasting plasma glucose (FPG; weighted mean difference [WMD]: ?10.31; 95% confidence interval, CI [?16.21, ?4.42]) and insulin concentrations (WMD: ?0.53; 95% CI [?0.62, ?0.44]) following the administration of spirulina. Pooled analysis showed also a significant reduction in total cholesterol (WMD: ?20.50; 95% CI [?38.25, ?2.74]), low‐density lipoprotein cholesterol (LDL‐C; WMD: ?19.02; 95% CI [?36.27, ?1.78]), and very low‐density lipoprotein cholesterol (VLDL‐C) concentrations (WMD: ?6.72; 95% CI [?9.19, ?4.26]) and a significant increase in high‐density lipoprotein cholesterol (HDL‐C) levels (WMD: 1.42; 95% CI [0.16, 2.68]) following spirulina therapy. This meta‐analysis demonstrated the beneficial effects of spirulina supplementation on improving FPG, insulin, total cholesterol, LDL‐C, VLDL‐C, and HDL‐C levels in patients with MetS and related disorders.     

Effect of tomato consumption on fasting blood glucose and lipid profiles: A systematic review and meta‐analysis of randomized controlled trials

Tomato (Solanum lycopersicum) phytochemicals, which include phytoene, phytofluene, beta‐carotene, flavonoids, lycopene, and polyphenols, have been shown to improve the effects of fasting on plasma triglyceride (TG), low‐density lipoprotein cholesterol (LDL), high‐density lipoprotein cholesterol (HDL), total cholesterol (TC), and fasting blood sugar (FBS). The aim of this study was to systematically evaluate the effects of Tomato TC, TG, HDL, LDL, and FBS in humans. A systematic literature search was conducted in PubMed/MEDLINE, Web of sciences, and SCOPUS databases by two researchers for studies published until August of 2019 without language and time limitations. Results were combined with random effect models. Six studies were included in this meta‐analysis. Combined results reveal a significant reduction in cholesterol (weighted mean difference [WMD]: ?4.39 mg/dl, 95% CI: ?7.09, ?1.68, I² = % 48, p heterogeneity: .05), TG (WMD: ?3.94 mg/dl, 95% CI: ?7.67, ?0.21, I² = % 90, p heterogeneity: .001), LDL levels (WMD: ?2.09 mg/dl, 95% CI: ?3.73, ?0.81, I² = % 78, p heterogeneity: .001), and increasing in HDL levels (WMD: 2.25 mg/dl, 95% CI: 0.41, 4.10, I² = % 97, p heterogeneity: .001). Tomato was found to have a higher reduction effect on TG and LDL in younger participants. While pooled results indicate no significant effect on FBS levels (WMD: 0.59 mg/dl, 95% CI: ?0.28, 1.46, I² = % 95, p heterogeneity: .001). In conclusion, the results indicate a significant reduction in total cholesterol, TG, and LDL and increase in HDL levels that is caused by tomato consumption.     

Beneficial effects of Codonopsis lanceolata extract on systolic blood pressure levels in prehypertensive adults: A double‐blind,randomized controlled trial

Codonopsis lanceolata (CL) extract was shown to have antihypertensive effects in hypertensive rats. This randomized controlled trial was designed to investigate the ability of CL extract to prevent hypertension (HTN) in prehypertensive subjects. Eighty subjects aged 19–60 years with a systolic blood pressure (BP) of 120–139 mmHg and a diastolic BP of 80–89 mmHg were recruited over 3 months. Subjects were randomized 1:1 to a CL group and a placebo (PL) group and administered CL extract and starch, respectively, for 6 weeks. (BP) was measured and blood sampled at baseline and at the end of the trial. Relative to baseline, systolic BP was significantly decreased, and catalase activity was significantly increased following CL treatment in both the elevated systolic BP and stage 1 HTN subgroups. In the elevated systolic BP subgroup, serum nitrite concentration relative to baseline was significantly increased in CL compared to PL treated subjects (p = .038). In subjects with stage 1 HTN, high sensitivity C‐reactive protein (p = .020) and malondialdehyde (p = .039) showed significantly greater reductions from baseline in the CL than in the PL group. In summary, CL was effective in preventing endothelial dysfunction, inflammation, and lipid peroxidation in prehypertensive subjects, with these effects differing according to baseline systolic BP levels.     

Insulin resistance improvement by cinnamon powder in polycystic ovary syndrome: A randomized double‐blind placebo controlled clinical trial

Our aim is to assess the effect of cinnamon powder capsules on insulin resistance, anthropometric measurements, glucose and lipid profiles, and androgens of women with polycystic ovarian syndrome (PCOS). Out of 80 women that were diagnosed as PCOS by Rotterdam Criteria, 66 were enrolled in this randomized double‐blind placebo‐controlled clinical trial. All of the PCOS women were taking medroxy progesterone acetate 10 mg/day for the last 10 days of their menstrual cycles. The cases were randomly allocated to 2 groups. The women in the first group were treated by cinnamon powder capsules 1.5 g/day in 3 divided doses for 12 weeks and the second group by similar placebo capsules. Anthropometric measurements, fasting blood sugar, fasting insulin, blood glucose 2 hr after taking 75 g oral glucose, HbA1c, testosterone, dehydroepiandrosterone sulphate, homeostatic model assessment for insulin resistance, triglyceride, and cholesterol (low‐density lipoprotein, high‐density lipoprotein, and total) before and after the intervention were evaluated and compared as outcome measures. Fasting insulin (p = .024) and homeostatic model assessment for insulin resistance (p = .014) were reduced after 12 weeks in the cinnamon group compared with the placebo. There was also a significant decrease in low‐density lipoprotein in cinnamon group (p = .004) as compared with baseline that caused significant difference with placebo (p = .049). However, changes in other outcome measurements did not lead to statistically significant difference with placebo. The present results suggest that complementary supplementation of cinnamon significantly reduced fasting insulin and insulin resistance in women with PCOS.     

Improvement of seminal parameters with Prelox®: a randomized,double‐blind,placebo‐controlled,cross‐over trial

In a randomly allocated, double‐blind, placebo‐controlled, cross‐over design, 50 infertile patients were treated for 1 month with placebo or a combination of l ‐arginine aspartate and Pycnogenol^® (Prelox^®). Semen samples were examined at 4 week intervals according to WHO criteria. Treatment with Prelox increased significantly the semen volume, concentration of spermatozoa, percentage of motile spermatozoa and percentage of spermatozoa with normal morphology compared with placebo. The placebo had no influence on the parameters of seminological analysis. Intake of Pycnogenol for 1 month improved the fertility index to normal values. After treatment, the fertility index decreased again to infertile status. No unwanted effects were reported. Prelox seems to be a promising alternative to treat patients with mild infertility. Copyright © 2009 John Wiley & Sons, Ltd.     

The effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active rheumatoid arthritis: A randomized,double‐blind,placebo‐controlled clinical trial

Rheumatoid arthritis (RA) is a systemic autoimmune and inflammatory disease. Our study aimed to determine the effect of saffron supplement on clinical outcomes and metabolic profiles in patients with active RA. In this randomized, double‐blind, placebo‐controlled trial, 66 women older than 18 years old received 100 mg/day either saffron supplement in the intervention group (n = 33) or matched placebo in the placebo group (n = 33) for a period of 12 weeks. Sixty‐one patients (30 in the control and 31 in the saffron group) remained for the final analysis. No adverse effects were reported by the patients. Saffron supplementation significantly decreased the number of tender (?1.38 ± 1.66 vs. 0.10 ± 0.40, p < .001) and swollen (?2.12 ± 2.34 vs. 0.63 ± 2.79, p < .001) joints, pain intensity based on visual analogue scale (?18.36 ± 15.07 vs. ?2.33 ± 5.04), p < .001), and disease activity score (DAS28) (?0.75 ± 0.67 vs. 0.26 ± 0.77, p < .001) at the end of intervention between the two groups and in saffron group compared with baseline values. Physician Global Assessment (p = .002) and erythrocyte sedimentation rate were significantly improved after intervention (24.06 ± 12.66 vs. 32.00 ± 14.75, p = 0.028). High‐sensitivity C‐reactive protein reduced at the end of the intervention in the saffron group compared with baseline values (12.00 ± 7.40 vs. 8.82 ± 7.930, p = .004). Tumor necrosis factor alpha, interferon gamma, and malondialdehyde were decreased, and total antioxidant capacity were increased, but their differences between the two groups were not significant (p > .05). According to the results, saffron supplements could positively and significantly improve clinical outcomes in RA patients.     

The effects of grape seed extract on glycemic control,serum lipoproteins,inflammation, and body weight: A systematic review and meta‐analysis of randomized controlled trials

The aim of this systematic review and meta‐analysis was to analyze the effects of grape seed extract (GSE) on glycemic control and serum lipoproteins, inflammation and body weight. Two independent authors systematically searched online databases including EMBASE, Scopus, PubMed, Cochrane Library, and Web of Science from inception until May 30, 2019. Cochrane Collaboration risk of bias tool was applied to assess the methodological quality of included trials. The heterogeneity among the included studies was assessed using Cochrane's Q test and I‐square (I²) statistic. Data were pooled using a random‐effects model and weighted mean difference (WMD) was considered as the overall effect size. Fifty trials were included in this meta‐analysis. Pooling effect sizes from studies demonstrated a significant decrease in fasting plasma glucose (FPG) (WMD): ?2.01; 95% confidence interval (CI): ?3.14, ?0.86), total cholesterol (TC; WMD: ?6.03; 95% CI: ?9.71, ?2.35), low‐density lipoprotein (LDL) cholesterol (WMD: ?4.97; 95% CI: ?8.37, ?1.57), triglycerides (WMD: ?6.55; 95% CI: ?9.28, ?3.83), and C‐reactive protein (CRP) concentrations (WMD: ?0.81; 95% CI: ?1.25, ?0.38) following GSE therapy. Grape seed did not influence HbA1c, HDL cholesterol levels, and anthropometric measurements. This meta‐analysis demonstrated that GSE intake significantly reduced FPG, TC, LDL cholesterol, triglycerides, and CRP levels.     

Efficacy and safety of Sophora alopecuroides var. alopecuroides seed extract for opioid detoxification: A randomized,double‐blind,and placebo‐controlled clinical trial

The seeds of Sophora alopecuroides L. var. alopecuroides (S. alopecuroides) have alleviated morphine withdrawal in mice. Therefore, in this study, the alkaloid composition of S. alopecuroides extract was determined by gas chromatography (GC) and gas chromatography–mass spectrometry (GC–MS) analysis. Moreover, 50 abstinent opium addicts consumed three 400 mg extract capsules once daily and 50 other patients took placebo for 8 days. At the baseline and days 3 and 8, the clinical opiate withdrawal scale (COWS) was used to assess withdrawal symptoms. At the baseline and Day 8, the patients' blood levels of serum glutamate oxaloacetate transferase; serum glutamate pyruvate transferase; alkaline phosphatase; total, direct, and indirect bilirubins; creatinine and blood urea nitrogen; complete blood count; and prothrombine time were measured. The groups' parameter values were also compared. Sophocarpine, matrine, and sophoramine were the major alkaloids constituting, respectively, 32.85, 26.55, and 6.91% of the extract. The extract decreased the COWS score at Days 3 and 8 significantly compared with the placebo (p < .001). The extract did not significantly affect the blood parameters' values compared with the placebo (p > .05). There was no adverse drug effect. In conclusion, the extract reduces the acute opioid withdrawal symptoms and seems to have good safety and tolerability.     

The effect of green tea ointment on episiotomy pain and wound healing in primiparous women: A randomized,double‐blind,placebo‐controlled clinical trial

The delayed healing of episiotomy wound and its associated pain is a major problem in obstetrics. Because green tea has analgesic and wound‐healing properties, the present study was conducted to determine the effect of green tea ointment on episiotomy pain and wound‐healing. The green tea extract was also standardized by measuring its Phenolic and flavonoid compounds, antioxidant activity, and one of its active components, that is, Epigallocatechin gallate. The present clinical trial was conducted on 99 primiparous women visiting Afzalipour Hospital in Kerman in 2015. The subjects were randomly divided into 3 groups, including a green tea ointment group, a placebo ointment group, and a routine care group. The 2 ointment groups smeared 2 cm of the green tea or placebo ointments onto their sutured area twice daily for a total of 10 days. The severity of pain was assessed in the subjects using the visual pain scale and wound‐healing using the Redness, Edema, Ecchymosis, Discharge, Approximation (REEDA) scale before the intervention and on the 5th and 10th days after delivery. To standardize the extract, Epigallocatechin gallate was measured by high‐performance liquid chromatography (HPLC). Phenolic and flavonoid compounds, as well as antioxidant activity of the extract were also determined by spectrometry methods. Before the intervention, no significant differences were observed between the 3 groups in terms of their personal and obstetric details (p > .05), the severity of pain (p = .118), and the REEDA score (p = .212). On the 5th and 10th days after delivery, the severity of pain was significantly lower in the green tea group than in the other 2 groups (p < .0001). The mean REEDA score on the 5th and 10th days showed a better and faster healing in the green tea group compared to the other 2 groups (p < .0001). Total content of phenolic and flavonoids contents of green tea were 74.2 mg/g Gallic acid equivalent and 16.3 mg/g Rutin equivalent, respectively, and its antioxidant capacity was 46% of b‐carotene. Green tea ointment appears to be effective in relieving episiotomy pain and improving wound‐healing in this study. Further studies are recommended to be conducted on the effectiveness and safety of the different doses of green tea ointment.     

Herbal formulation “turmeric extract,black pepper,and ginger” versus Naproxen for chronic knee osteoarthritis: A randomized,double‐blind,controlled clinical trial

Osteoarthritis is the most common articular disease that can lead to chronic pain and severe disability. Curcumin—an effective ingredient in turmeric with anti inflammatory property—plays an important role in protecting the joints against destructive factors. Gingerols and piperine, are the effective ingredients of ginger and black pepper, which may potentially enhance and sustain the effect of curcumin in this direction. To determine the effect of cosupplementation with turmeric extract, black pepper, and ginger on prostaglandin E₂ (PGE₂) in patients with chronic knee osteoarthritis, compared with Naproxen. Sixty patients with two different levels of knee osteoarthritis (Grade 2 and 3) were studied. Individuals were randomly assigned to receive daily turmeric extract, ginger, and black pepper together or Naproxen capsule for 4 weeks. PGE₂ was evaluated by ELISA method. 24‐hr recall was also assessed. All of participants completed the study. PGE₂ decreased significantly in both groups (p < .001), but there was no significant differences between groups. The results of this study indicated that intake of the selected herbs twice a day for 4 weeks may improve the PGE₂ levels in patients with chronic knee osteoarthritis similar to Naproxen drug.     

A pilot,randomized, double‐blind,placebo‐controlled trial to assess the safety and efficacy of a novel Boswellia serrata extract in the management of osteoarthritis of the knee

A double‐blind, placebo‐controlled human trial was conducted to evaluate the safety and efficacy of a standardized oral supplementation of Boswellin®, a novel extract of Boswellia serrata extract (BSE) containing 3‐acetyl‐11‐keto‐β‐boswellic acid (AKBBA) with β‐boswellic acid (BBA). A total of 48 patients with osteoarthritis (OA) of the knee were randomized and allocated to the BSE and placebo groups for intervention. Patients were administered BSE or placebo for a period of 120 days. The trial results revealed that BSE treatment significantly improved the physical function of the patients by reducing pain and stiffness compared with placebo. Radiographic assessments showed improved knee joint gap and reduced osteophytes (spur) confirming the efficacy of BSE treatment. BSE also significantly reduced the serum levels of high‐sensitive C‐reactive protein, a potential inflammatory marker associated with OA of the knee. No serious adverse events were reported. This is the first study with BSE conducted for a period of 120 days, longer than any other previous clinical trial on patients with OA of the knee. The findings provide evidence that biologically active constituents of BSE, namely, AKBBA and BBA, act synergistically to exert anti‐inflammatory/anti‐arthritic activity showing improvement in physical and functional ability and reducing the pain and stiffness.     

Topical silymarin administration for prevention of acute radiodermatitis in breast cancer patients: A randomized,double‐blind,placebo‐controlled clinical trial

Radiation‐induced dermatitis is one of the most common side effects of radiotherapy. Silymarin, a flavonoid extracted from the Silybum marianum, exhibits antioxidant and anti‐inflammatory activities. The purpose of this study was to investigate the efficacy of silymarin gel in prevention of radiodermatitis in patients with breast cancer. During this randomized, double‐blinded, placebo‐controlled clinical trial, the preventive effect of silymarin 1% gel was assessed in comparison with placebo, on radiodermatitis occurrence. Forty patients randomly received silymarin gel or placebo formulation on chest wall skin following modified radical mastectomy, once daily starting at the first day of radiotherapy for 5 weeks. Radiodermatitis severity was assessed weekly based on Radiation Therapy Oncology Group (RTOG) and National Cancer Institute Common Terminology for Adverse Events (NCI‐CTCAE) criteria radiodermatits grading scale for 5 weeks. The median NCI‐CTCAE and RTOG scores were significantly lower in silymarin group at the end of the third to fifth weeks (p value < 0.05). The scores increased significantly in both placebo and silymarin groups during radiotherapy, but there was a delay in radiodermatitis development and progression in silymarin group. Prophylactic administration of silymarin gel could significantly reduce the severity of radiodermatitis and delay its occurrence after 5 weeks of application.     

Efficacy of topical Citrullus colocynthis (bitter apple) extract oil in chemotherapy‐induced peripheral neuropathy: A pilot double‐blind randomized placebo‐controlled clinical trial

Chemotherapy‐induced peripheral neuropathy (CIPN) is one of the most common complications in patients with cancer. Citrullus colocynthis (bitter apple) has been used in traditional Persian medicine as an effective pain relief, especially for neuralgia. We designed a pilot clinical trial to evaluate the safety and efficacy of topical C. colocynthis oil in management of CIPN in breast cancer patients. Thirty‐four cancer patients with CIPN were randomly enrolled in two arms of a randomized, double‐blind, placebo‐controlled clinical trial. The patients were treated by topical C. colocynthis oil or placebo, two times per day for 2 months. Functional Assessment of Cancer Therapy/Gynecologic Oncology Group (FACT/GOG)‐Neurotoxicity (Ntx) score was set as the primary outcome measure. No significant improvement was observed in the total score of FACT/GOG‐Ntx scale (2.40 ± 1.90 vs. 1.05 ± 1.36, p = .879) in drug and placebo groups, respectively. There was also no significant improvement in the mean scores of FACT/GOG‐Ntx in the sensory, motor, hearing, and functional domains in the two study groups. According to the results of this preliminary study, topical C. colocynthis oil failed to improve the symptoms of CIPN compared with placebo.     

Efficacy of black seed (Nigella sativa L.) on kidney stone dissolution: A randomized,double‐blind,placebo‐controlled,clinical trial

Preclinical studies have shown beneficial effects of black seed (Nigella sativa L.) in the prevention and treatment of renal stones. Hence, we designed a study to evaluate the renal‐stone‐dissolving efficacy of black seed. Sixty patients with renal stones were randomly enrolled in two arms of a randomized, triple‐blind, placebo‐controlled, clinical trial. The patients were treated by black seed capsules (500 mg) or placebo two times per day for 10 weeks. Patients were assessed in terms of size of renal stones by using sonography before and after intervention. In the black seed group, 44.4% of patients excreted their stones completely, and the size of the stones remained unchanged and decreased in 3.7% and 51.8% of patients, respectively. In contrast, in the placebo group, 15.3% of the patients excreted their stones completely, 11.5% had reduction in stone size, 15.3% had increase in stone size, and 57.6% had no change in their stone size. The difference in the mean size of renal stones after the study was significant between the two groups (p < 0.05). N. sativa L., as compared with placebo, is demonstrated to have significant positive effects on disappearance or reduction of size of kidney stones.