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Purpose This study aimed to evaluate the impact of a topical lotion (CG428) on hair thickness and density in breast cancer survivors with permanent chemotherapy-induced alopecia (PCIA). Methods The study was a double-blind, randomized controlled trial which conducted from February 2016 to December 2016 at the Samsung Comprehensive Cancer Center in Seoul, South Korea. Breast cancer patients with PCIA were randomized on average of 3.5 years after chemotherapy. Topical lotion (Batch DT023) is a botanical drug under development containing a novel patented blend of 4 botanical ingredients: citrus, cocoa, guarana, and onion. Participants were asked to self-apply the study product or placebo twice per day for 6 months. Changes in hair density and thickness were assessed using a noninvasive bioengineering device, and patient-reported outcomes were evaluated at 3 and 6 months after randomization. Results A total of 35 patients were randomized to intervention ( N  = 18) or placebo ( N  = 17). Patients in the intervention group were older than those in the placebo group (52.1 vs. 41.6 years; P  < 0.001). The mean hair density (SD) at baseline was 97.6 (6.4) and 126.8 (30.3) hairs/cm 2 in the intervention and placebo group, respectively ( P  = 0.005). The corresponding values for hair thickness were 49.9 (12.7) and 48.1 (8.4) μm, respectively. After 6 months, hair density had increased by 34.7 and 24.9% compared with baseline in the intervention and control groups, respectively ( P  = 0.37). Corresponding values for hair thickness were 19.8 and 35.6%, respectively ( P  = 0.23). Similar findings were observed after age adjustment. Discussion In this pilot randomized clinical trial, we observed safety, tolerability, and a trend toward the efficacy of CG428 vs. placebo, especially regarding hair density and self-reported improvement.

A peanut-derived protein product, AR101, used in an oral desensitization protocol in children and adolescents with severe peanut allergy increased the amount of oral peanut protein tolerated in approximately two thirds of participants who received AR101, as compared with 1 of 25 controls.

Background: Climatic changes causing early pollen flight and new allergens prolonging the pollen season render up-dosing of allergen-specific subcutaneous immunotherapy (SCIT) outside the pollen season considerably more difficult. In addition, for patients with multiple pollen allergies, patients coming near the beginning of pollen season, and patients who wish to up-dose faster, an accelerated induction regimen would be helpful. Methods: In an open, randomized, parallel group, multicenter safety trial, an accelerated up-dosing regimen (0.1–0.3–0.5 ml in weekly intervals) was compared to conventional up-dosing (0.05–0.1–0.2–0.3–0.4–0.5 ml in weekly intervals) with an allergoid grass pollen SCIT preparation. After up-dosing, the maintenance dose was given in monthly intervals. Results: A total of 146 adult patients with rhinitis or rhinoconjunctivitis with or without mild asthma (FEV 1 >70%) due to grass pollen were randomized to either the conventional registered up-dosing or an accelerated regimen. In both groups (accelerated regimen, n = 69; conventional regimen, n = 75), a high proportion of patients (92.75 and 92.0%, respectively) successfully reached the maintenance dose without safety concerns. Furthermore, significant increases in specific IgG and IgG 4 after 4 months of treatment were observed in both groups. Conclusion: The accelerated SCIT regimen was found to be as safe as the conventional regimen and might be used to up-dose patients within 2 weeks. Moreover, the immunological effects of both up-dosing regimens were comparable.

Background Extracts of chicory root have anti-inflammatory properties in vitro and in animal models of arthritis. The primary objective of this investigator-initiated, Phase 1, placebo-controlled, double blind, dose-escalating trial was to determine the safety and tolerability of a proprietary bioactive extract of chicory root in patients with osteoarthritis (OA). Secondary objectives were to assess effects on the signs and symptoms of this disorder. Methods Individuals greater than 50 years of age with OA of the hip or knee were eligible for trial entry. A total of 40 patients were enrolled in 3 cohorts and were treated with escalating chicory doses of 600 mg/day, 1200 mg/day and 1800 mg/day for 1 month. The ratio of active treatment to placebo was 5:3 in cohorts 1 and 2 (8 patients) each and 16:8 in cohort 3 (24 patients). Safety evaluations included measurement of vital signs and routine lab tests at baseline and the end of the treatment period. Efficacy evaluations at baseline and final visits included self-assessment questionnaires and measurement of the 25-foot walking time. Results In the highest dose cohort, 18 patients who completed treatment per protocol were analyzed for efficacy. In this group, 13 patients showed at least 20% improvement in the defined response domains of pain, stiffness and global assessment: 9 of 10 (90%) patients randomized to active treatment with chicory and 4 of 8 (50%) patients randomized to placebo (P = 0.06). In general, the treatment was well-tolerated. Only one patient who was treated with the highest dose of chicory had to discontinue treatment due to an adverse event. Conclusions The results of this pilot study suggest that a proprietary bioactive extract of chicory root has a potential role in the management of OA and merits further investigation. Clinicaltrials.gov identifier: NCT 01010919.

Guggul, herbal extract from resin of the Commiphora mukul tree, is widely used in Asia as a cholesterol-lowering agent based on Indian Ayurvedic medicine. Its popularity for this use is increasing in the US and Western Europe. Guggulsterones, the presumed bioactive compounds of guggul, may antagonise two nuclear hormone receptors involved in cholesterol metabolism, which is a possible explanation for hypolipidemic effects of these extracts. However, publications of efficacy data on the use of guggul extracts in Western populations are scarce. To study the efficacy of a guggul-based formulation (short: guggul) on blood lipids in healthy adults with moderately increased cholesterol. Double-blind, randomised, placebo controlled trial in Norwegian general practice. 43 women and men, age 27–70, with moderately increased cholesterol, randomised to use 2160 mg guggul (4 capsules) daily, or placebo for 12 weeks. Mean change in total cholesterol, low-density lipoprotein cholesterol (LDL-C), triglycerides, high-density lipoprotein cholesterol (HDL-C) and total cholesterol/HDL-C ratio compared with baseline. Lipids were analysed at baseline, and at 6 and 12 weeks. In addition, unexpected events and adverse effects were recorded. Two dropouts, one withdrawal, and incomplete lab results for six persons left 34 participants to accomplish the trial (18-guggul, 16-placebo) with complete lab test data. After 12 weeks, mean levels of total cholesterol and HDL-C in the active group were significantly reduced compared with the placebo group. However, the mean levels of LDL-C, triglycerides, and total cholesterol/HDL-C ratio between the two groups did not change significantly. Ten guggul users (vs. four in the placebo group) reported side effects: mild gastrointestinal discomfort ( n = 7), possible thyroid problems ( n = 2), and generalized skin rash ( n = 1). The latter resulted in withdrawal from trial. Even if total cholesterol and HDL-C were significantly reduced, the clinical magnitude of this remains obscure. More and larger studies are needed to establish effects and safety of guggul-based formulations in the treatment for hypercholesterolemia.

Dietary avoidance is recommended for peanut allergies. We evaluated the sustained effects of peanut allergy oral immunotherapy (OIT) in a randomised long-term study in adults and children. In this randomised, double-blind, placebo-controlled, phase 2 study, we enrolled participants at the Sean N Parker Center for Allergy and Asthma Research at Stanford University (Stanford, CA, USA) with peanut allergy aged 7–55 years with a positive result from a double-blind, placebo-controlled, food challenge (DBPCFC; ≤500 mg of peanut protein), a positive skin-prick test (SPT) result (≥5 mm wheal diameter above the negative control), and peanut-specific immunoglobulin (Ig)E concentration of more than 4 kU/L. Participants were randomly assigned (2·4:1·4:1) in a two-by-two block design via a computerised system to be built up and maintained on 4000 mg peanut protein through to week 104 then discontinued on peanut (peanut-0 group), to be built up and maintained on 4000 mg peanut protein through to week 104 then to ingest 300 mg peanut protein daily (peanut-300 group) for 52 weeks, or to receive oat flour (placebo group). DBPCFCs to 4000 mg peanut protein were done at baseline and weeks 104, 117, 130, 143, and 156. The pharmacist assigned treatment on the basis of a randomised computer list. Peanut or placebo (oat) flour was administered orally and participants and the study team were masked throughout by use of oat flour that was similar in look and feel to the peanut flour and nose clips, as tolerated, to mask taste. The statistician was also masked. The primary endpoint was the proportion of participants who passed DBPCFCs to a cumulative dose of 4000 mg at both 104 and 117 weeks. The primary efficacy analysis was done in the intention-to-treat population. Safety was assessed in the intention-to-treat population. This trial is registered at ClinicalTrials.gov, NCT02103270. Between April 15, 2014, and March 2, 2016, of 152 individuals assessed, we enrolled 120 participants, who were randomly assigned to the peanut-0 (n=60), peanut-300 (n=35), and placebo groups (n=25). 21 (35%) of peanut-0 group participants and one (4%) placebo group participant passed the 4000 mg challenge at both 104 and 117 weeks (odds ratio [OR] 12·7, 95% CI 1·8–554·8; p=0·0024). Over the entire study, the most common adverse events were mild gastrointestinal symptoms, which were seen in 90 of 120 patients (50/60 in the peanut-0 group, 29/35 in the peanut-300 group, and 11/25 in the placebo group) and skin disorders, which were seen in 50/120 patients (26/60 in the peanut-0 group, 15/35 in the peanut-300 group, and 9/25 in the placebo group). Adverse events decreased over time in all groups. Two participants in the peanut groups had serious adverse events during the 3-year study. In the peanut-0 group, in which eight (13%) of 60 participants passed DBPCFCs at week 156, higher baseline peanut-specific IgG4 to IgE ratio and lower Ara h 2 IgE and basophil activation responses were associated with sustained unresponsiveness. No treatment-related deaths occurred. Our study suggests that peanut OIT could desensitise individuals with peanut allergy to 4000 mg peanut protein but discontinuation, or even reduction to 300 mg daily, could increase the likelihood of regaining clinical reactivity to peanut. Since baseline blood tests correlated with week 117 treatment outcomes, this study might aid in optimal patient selection for this therapy. National Institute of Allergy and Infectious Diseases.

Background: The 19-kD protein of buckwheat (BW) has been suggested to be a major allergen, but its characteristics and clinical significance are poorly defined. Methods: cDNA of the 19-kD BW allergen was cloned and expressed in Escherichia coli. Allergenicity and cross-allergenicity were confirmed by inhibition immunoblotting or by ELISA inhibition. The recombinant (r19-kD) protein was assessed for clinical utility in the diagnosis of BW reactivity in 18 BW-allergic and 19 BW-asymptomatic sensitized subjects using receiver operating characteristic analysis. Results: The 19-kD BW allergen, which is composed of 135 amino acids, has a weak homology to the vicilin-like allergens of cashew (Ana o 1), English walnut (Jug r 2) and 7 S globulin from Sesamum indicum. The r19-kD protein can inhibit sIgE binding to native 19-kD BW allergen. The maximum percentage inhibition of sIgE binding to crude BW extract was 56%. About 83.3% of the BW allergy patients had sIgE bound to r19-kD protein, compared to only 1 of the 19 BW-asymptomatic sensitized subjects. The areas under the receiver operating characteristic curves for the skin prick tests [0.925 (95% confidence interval: 0.839–1.012), p < 0.001] as well as r19-kD protein sIgE ELISAs [0.860 (95% confidence interval: 0.725–0.995), p <0.001] were higher than that of BW sIgE coated allergen particle test results [0.803 (95% confidence interval: 0.661–0.945), p = 0.002]. Conclusions: The 19-kD BW allergen may be the major allergen from BW. For the diagnosis of clinical reactivity to BW, the r19-kD protein sIgE ELISA test was more discriminative than the coated allergen particle sIgE measurement using whole BW extract.

Qurse-e-istisqua (Q-e-I), an Unani medicine commonly prescribed to treat liver disorders. To study efficacy and safety of Q-e-I in hepatitis C virus (HCV) infection. In this randomized double-blind exploratory study, 60 naive patients of HCV infection were assigned to receive either interferonα2a (IFNα2a) (3 mIU, subcutaneous, thrice weekly), ribavirin (RBV) (1000 mg, orally, twice daily in divided doses) and placebo (n = 30) or IFNα2a, RBV and Q-e-I (5 g, orally, thrice daily in divided doses) (n = 30). HCV RNA levels, serum hyaluronic acid (SHA), ultrasound image scoring for fibrosis, liver and renal function test, prothrombin time, were done at the baseline and thereafter periodically. Early virologic response (EVR), end of treatment response (ETR) and sustained virologic response (SVR) were 90%, 96.6% and 90% in the control group and 86.6%, 90.0% and 83.3% in the treatment group. SHA level was lower in the treatment group at the end of the treatment as compared to the control group. Mean end of follow-up ultrasound image scoring for fibrosis in the control and the treatment group was 1.37 ± 0.07 and 1.22 ± 0.06 respectively. Aspartate aminotransferase (AST) levels were significantly lower in the treatment group than the control group at 1-month. Commonly observed adverse drug reactions included fever, hair fall, fatigue, anemia, and diarrhea. Q-e-I was well tolerated and showed anti-fibrotic activity. EVR, ETR and SVR suggested that Q-e-I do not have any anti-HCV activity. Early recovery in AST and inhibition of progress of fibrosis in Q-e-I group was probably due to the anti-inflammatory and antioxidant activity of its ingredients.

The Mediterranean basin is a biodiversity hotspot of wild edible species, and their therapeutic and culinary uses have long been documented. Owing to the growing demand for wild edible species, there are increasing concerns about the safety, standardization, quality, and availability of products derived from these species collected in the wild. An efficient cultivation method for the species having promising nutraceutical values is highly desirable. In this backdrop, a hydroponic system could be considered as a reproducible and efficient agronomic practice to maximize yield, and also to selectively stimulate the biosynthesis of targeted metabolites. The aim of this report is to review the phytochemical and toxic compounds of some potentially interesting Mediterranean wild edible species. Herein, after a deep analysis of the literature, information on the main bioactive compounds, and some possibly toxic molecules, from fifteen wild edible species have been compiled. The traditional recipes prepared with these species are also listed. In addition, preliminary data about the performance of some selected species are also reported. In particular, germination tests performed on six selected species revealed that there are differences among the species, but not with crop species. “Domestication” of wild species seems a promising approach for exploiting these “new functional foods”.

Background Cannabidiol (CBD) is an anti-inflammatory cannabinoid shown to be beneficial in a mouse model of IBD. Lacking any central effect, cannabidiol is an attractive option for treating inflammatory diseases. Aim To assess the effects of cannabidiol on Crohn’s disease in a randomized placebo-controlled trial. Patients and Methods Twenty patients aged 18–75 years with a Crohn’s disease activity index (CDAI) >200 were randomized to receive oral (10 mg) CBD or placebo twice daily. Patients did not respond to standard treatment with steroids (11 patients), thiopurines (14), or TNF antagonists (11). Disease activity and laboratory parameters were assessed during 8 weeks of treatment and 2 weeks thereafter. Other medical treatment remained unchanged. Results Of 20 patients recruited 19 completed the study. Their mean age was 39 ± 15, and 11 were males. The average CDAI before cannabidiol consumption was 337 ± 108 and 308 ± 96 ( p  = NS) in the CBD and placebo groups, respectively. After 8 weeks of treatment, the index was 220 ± 122 and 216 ± 121 in the CBD and placebo groups, respectively ( p  = NS). Hemoglobin, albumin, and kidney and liver function tests remained unchanged. No side effects were observed. Conclusion In this study of moderately active Crohn’s disease, CBD was safe but had no beneficial effects. This could be due to lack of effect of CBD on Crohn’s disease, but could also be due to the small dose of CBD, the small number of patients in the study, or the lack of the necessary synergism with other cannabinoids. Further investigation is warranted. ClinicalTrials.gov NCT01037322.