Resveratrol as adjunctive therapy in treatment of irritability in children with autism: A double-blind and placebo-controlled randomized trial.

WHAT IS KNOWN AND OBJECTIVE: The underlying pathophysiology of autism spectrum disorder (ASD) has been linked to immune dysregulation, oxidative stress and excitation-inhibition imbalance. Among associated symptoms of ASD, management of irritability has gained considerable attention as it complicates adjustment of ASD patients and thus necessitates its pharmacological treatment. Resveratrol is a plant phytoalexin, which has been demonstrated to have neuroprotective effects through its anti-inflammatory and antioxidant properties. This double-blind, placebo-controlled randomized trial was designed to assess the potential therapeutic effects of resveratrol plus risperidone on irritability of ASD patients. METHODS: Sixty-two patients were assigned randomly into two groups of resveratrol and placebo. Both groups were treated with risperidone twice daily starting at a dose of 0.5 mg with a dose increase of 0.5 mg per week (for the first 3 weeks). Resveratrol dosage was 250 mg twice per day from the beginning of the study. Using the Aberrant Behavior Checklist-Community (ABC-C), patients were assessed for ASD-related behavioural symptoms at baseline, week 5 and week 10. The frequency of adverse events was recorded using a checklist containing 25 possible side effects, including general, gastrointestinal, neurological and cardiovascular complications. RESULTS AND DISCUSSION: Improvements in primary outcome measure (irritability) and three secondary outcome measures (lethargy/social withdrawal, stereotypic behaviour and inappropriate speech subscales) in the resveratrol group were statistically similar to those in the placebo group. The repeated measures analysis showed no time × treatment interaction on these subscale scores. In contrast, patients in the resveratrol group showed greater decline in hyperactivity/non-compliance score as a secondary outcome measure (mean difference [CI = 95%] = 4.51 [0.10-8.92], t = 2.04; P = .04), and repeated measures analysis showed significant effect for time × treatment effect on this subscale score (F = 3.81; df = 1.30; P = .043). There was no significant difference in number and severity of adverse events between the two groups. WHAT IS NEW AND CONCLUSION: This clinical trial demonstrated no significant effect for adjunctive treatment with resveratrol on irritability of patients with ASD. However, it provided preliminary evidence indicating that resveratrol could improve hyperactivity/non-compliance of ASD patients.

Current practice of percutaneous coronary intervention on patients with acute coronary syndrome in Iran: A prospective observational study.

Background: Frequent Percutaneous Coronary Intervention (PCI) procedures are being performed on a daily basis in Iran. However, no study has been reported on the current PCI practice in patients with acute coronary syndrome (ACS) in Iran. We aimed to describe the clinical characteristics and treatment patterns in Iranian ACS patients treated with PCI. Methods: Between February 2017 and July 2017, ACS patients presented to 5 referral hospitals in two major cities of Iran (Tehran and Shiraz) were included in this observational study if aged > 18 years and underwent PCI for ACS during hospitalization; and their clinical and procedural characteristics were collected. All data were entered into SPSS v.21 and descriptive statistics were performed. Results: Of a total of 314 patients, 228 (73%) were males, 162 (52%) were diagnosed with ST-elevation myocardial infarction and 152 (48%) with Unstable angina/ Non-ST elevation myocardial infarction. Trans-femoral approach was more often (64%) used for PCI procedures. Stent placement was the most frequent (98%) treatment strategy on PCI, with drug-eluting stent selected in the majority of subjects (98%). The overall rate of PCI success was 95%, with 4.1% PCI-related complications, and 1.6% post-PCI bleeding events. The vast majority of the study patients (99%) were discharged with dual anti-platelet therapy. Conclusion: In this study, we observed a high level of adherence to the currently accepted guidelines in the current PCI practice on ACS patients in Iran. Also we found our practice is highly in line with the global reduction trend in the PCI-related complications.

Ondansetron in patients with tinnitus: randomized double-blind placebo-controlled study.

The aim of this study was to assess the effect of ondansetron on symptoms of patients with subjective tinnitus accompanied by sensorineural hearing loss or normal hearing. Sixty patients with a chief complaint of tinnitus (with duration of more than 3 months) were equally randomized to ondansetron or placebo for 4 weeks. The dose of ondansetron was gradually increased from 4 mg/day (one tablet) to 16 mg/day (4 tablets) during 12 days and then continued up to 4 weeks. The exact number of tablets was prescribed in the placebo group. Patients underwent audiologic examinations and filled questionnaires at baseline and after 4 weeks of treatment. Our primary outcomes were changes in Tinnitus Handicap Inventory questionnaire (THI), Tinnitus Severity Index (TSI) and visual analog scale (VAS) scores. Our secondary outcomes were the changes in depression and anxiety based on Hospital Anxiety and Depression (HADS) questionnaire, side effects, tinnitus loudness matching, tinnitus pitch matching, pure tone audiometry and speech recognition threshold (SRT). In the ondansetron and placebo groups, 27 and 26 patients completed the study, respectively. The changes in VAS (P = 0.934), THI (P = 0.776), anxiety (P = 0.313) and depression (P = 0.163) scores were not different between the groups. TSI score decreased significantly in the ondansetron compared with the placebo group (P = 0.004). Changes in tinnitus loudness matching (P = 0.75) and pitch matching (P = 0.56) did not differ between the two groups. Ondansetron, but not placebo, decreased the SRT threshold (right, P < 0.001; left, P = 0.043) and mean PTA (right, P = 0.006; left, P < 0.001). In conclusion, ondansetron reduces the severity of tinnitus hypothetically through cochlear amplification.