Effect of Mastiha supplementation on NAFLD: The MAST4HEALTH Randomised, Controlled Trial.

SCOPE: Nonalcoholic fatty liver disease (NAFLD) is the most common liver disease with poor therapeutic strategies. Mastiha possesses antioxidant/anti-inflammatory and lipid-lowering properties. The authors investigate the effectiveness of Mastiha as a nonpharmacological intervention in NAFLD. METHODS AND RESULTS: Ninety-eight patients with NAFLD in three countries (Greece, Italy, Serbia) are randomly allocated to either Mastiha or Placebo for 6 months, as part of a multicenter, randomized, double-blind, placebo-controlled, parallel-group clinical trial. The authors assess NAFLD severity via magnetic resonance imaging (MRI) scanning and LiverMultiScan technique and evaluate the effectiveness of Mastiha through medical, anthropometric, biochemical, metabolomic, and microbiota assessment. Mastiha is not superior to Placebo on changes in iron-corrected T1 (cT1) and Liver Inflammation Fibrosis score (LIF) in entire patient population; however, after BMI stratification (BMI ≤ 35 kg m-2 and BMI > 35 kg m-2 ), severely obese patients show an improvement in cT1 and LIF in Mastiha versus Placebo. Mastiha increases dissimilarity of gut microbiota, as shown by the Bray-Curtis index, downregulates Flavonifractor, a known inflammatory taxon and decreases Lysophosphatidylcholines-(LysoPC) 18:1, Lysophosphatidylethanolamines-(LysoPE) 18:1, and cholic acid compared to Placebo. CONCLUSION: Mastiha supplementation improves microbiota dysbiosis and lipid metabolite levels in patients with NAFLD, although it reduces parameters of liver inflammation/fibrosis only in severely obese patients.

A First-in-Human Phase 1 Randomized Single and Multiple Ascending Dose Study of RPh201 in Healthy Volunteers.

RPh201 is a drug extracted from gum mastic that has been studied for its anti-inflammatory and antibacterial properties. Preclinical studies of RPh201 demonstrated neuroprotective and neuroenhancing effects. Toxicology studies in animals did not reveal safety concerns or genotoxic effects. This single-center, phase 1, randomized, placebo-controlled, double-masked study in healthy volunteers assessed the safety and tolerability of RPh201, and determined the highest tolerated dose. There were 2 parts: a single ascending dose (SAD) stage, followed by a multiple ascending dose (MAD) stage. Three dosing arms were included in each stage (5 mg, 10 mg, and 20 mg). Safety data in the lower dosing arms were evaluated before higher doses were initiated. Eighteen participants were randomized in the SAD stage: 12 to RPh201 (4 at each dose) and 4 to placebo. Twenty-one participants were randomized in the MAD stage, of which 13 received RPh201. All 18 participants in the SAD stage completed treatment. Sixteen of the 21 participants in the MAD stage completed treatment. The most frequently reported adverse events were local injection site pain and erythema. No deaths or adverse events related to changes in vital signs or electrocardiograms were reported. No occurrences of suicidal behavior or ideation were reported.

The Effect of Fixation Technique on Continuous Interscalene Nerve Block Catheter Success: A Randomized, Double-Blind Trial.

BACKGROUND: Continuous peripheral nerve blocks offer advantages over single-injection blocks, including extended analgesia and reduction in opioid consumption. These benefits require that the perineural catheter remain intact for the duration of the planned local anesthetic infusion. Mechanical displacement of catheters, leaking, and consequent failure are known complications. The aim of this study was to evaluate continuous perineural catheter tip-to-nerve apposition in vivo over 48 hours comparing 2 different simple fixation strategies. METHODS: Subjects presenting for a continuous interscalene nerve block were randomized to perineural catheter fixation with 1 of 2 types of adhesive: Dermabond (2-octylcyanoacrylate) or Mastisol (alcohol 23A, gum mastic, storax, and methyl salicylate), covered with a simple transparent dressing. The primary outcome was the evaluation of catheter-to-nerve apposition maintenance over 48 hours via both a blinded ultrasound evaluation of local anesthetic distribution and a blinded clinical assessment. Secondary outcomes included leakage at the catheter site, pain scores, opioid consumption, catheter-to-skin migration at the insertion site, and patient satisfaction. RESULTS: Sixty-six subjects were recruited and randomized to compare adhesive group catheter tip-to-nerve apposition on postoperative day 2 (POD 2). Within the intention-to-treat cohort, a statistically significant decrease of perineural catheter tip-to-nerve apposition in the Mastisol group (64.7%) compared with the Dermabond group (90.6%) on POD 2 (odds ratios [OR] 0.19; 95% confidence interval [CI] 0.05-0.75; P = .012) was observed. Similar results were observed on POD 1 (OR 0.19; 95% CI 0.03-1.38; P = NS) and POD 2 (OR 0.14; 95% CI 0.02-0.97; P = .008) within the as-treated cohort. Catheter leakage (OR 67; 95% CI 7.3-589) and median catheter migration difference at the skin insertion site (2.0 cm; 95% CI 0.5-2.5) were also significantly greater in the Mastisol group than in the Dermabond group from POD 0 to POD 2 (P < .001). Median postoperative opioid consumption difference in morphine equivalents (3.2 mg; 95% CI - 9.0 to 14.2) was not significantly different between the Dermabond and the Mastisol groups through POD 2 (P = .542). CONCLUSIONS: Perineural catheter fixation with Dermabond in continuous interscalene nerve block improves maintenance of catheter-to-nerve apposition when compared with Mastisol.

Effects of Chios mastic gum on cholesterol and glucose levels of healthy volunteers: A prospective, randomized, placebo-controlled, pilot study (CHIOS-MASTIHA).

BACKGROUND: Chios mastic gum (CMG) possesses anti-oxidant, anti-inflammatory, anti-atheromatic, lipid- and glucose-lowering properties. We evaluated the effects of CMG on cholesterol and fasting plasma glucose (FPG) levels of healthy volunteers. DESIGN: A prospective, randomized, placebo-controlled, pilot study. METHODS: One hundred and seventy nine volunteers with total cholesterol levels >200 mg/dl were randomized to four groups. Finally, 156 volunteers completed the follow-up period and were analysed: (1) control group (C, n = 23), receiving placebo; (2) total mastic (TM, n = 72) receiving daily a total dose of 1 g of crude CMG (330 mg capsules, tid); (3) polymer-free mastic (PFM, n = 33), receiving daily a total dose of 1 g of polymer free mastic (330 mg caps, tid); and (4) powder mastic (PM, n = 28), receiving daily a total dose of 2 g of crude CMG. RESULTS: After eight weeks, the TM group reduced total cholesterol by 11.5 mg/dl (p < 0.05) and FPG by 4.5 mg/dl (p < 0.05) adjusted for age, gender, BMI and baseline characteristics. The effect was stronger in overweight and obese patients (BMI > 25), with an estimated mean reduction of total cholesterol by 13.5 mg/dl (p < 0.05) and FPG by 5.1 mg/dl (p < 0.05). Administration of PFM and PM resulted in no statistically significant alteration. No effect was observed on LDL, HDL, triglycerides, uric acid and CRP. No gastrointestinal, liver or renal adverse events were recorded. CONCLUSIONS: CMG has a significant lowering effect on total cholesterol and glucose levels of healthy volunteers, with excellent tolerance and no detectable side effects, especially in overweight and obese individuals.