Agomelatine augmentation of sertraline in the treatment of moderate to severe obsessive-compulsive disorder: a randomized double-blinded placebo-controlled clinical trial.

BACKGROUND: As 40-60% of the patients with obsessive-compulsive disorder (OCD) do not adequately respond to the first-line treatment, finding an effective second-line treatment is required. Our aim was to assess the efficacy and safety of agomelatine (a selective melatonin receptor agonist and a 5-hydroxytryptamine (HT)2 C antagonist) augmentation of sertraline in the treatment of patients with moderate to severe OCD. METHODS: In this 12-week randomized, double-blinded, placebo-controlled, parallel-group clinical trial, 65 patients with moderate to severe OCD according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth edition (DSM-5) criteria and a Yale-Brown obsessive compulsive scale (Y-BOCS) score of over 21, were included. They were assigned with sertraline (100 mg/day for the first 4 weeks and 200 mg/day for the next 8 weeks) and either agomelatine (25 mg/day) or placebo. The primary outcome was OCD symptoms measured by the Y-BOCS. RESULTS: Fifty patients (24 in agomelatine group and 26 in placebo group) completed the trial. The Y-BOCS scores in total (MD (95% CI) = 12.25 (11.00, 13.49) (P < 0.001) vs. MD (95% CI) = 12.46 (6.65, 15.74) (P < 0.001)), the obsession subscale (MD (95% CI) = 5.04 (4.19, 5.88) (P < 0.001) vs. MD (95% CI) = 5.00 (3.84, 6.16) (P = 0.0001)), and compulsion subscale (MD (95% CI) = 7.21 (6.34, 8.07) (P < 0.001) vs. MD (95% CI) = 7.460 (6.50, 8.42) (P < 0.001)) significantly decreased in both groups. Although, at the end of the trial, no significant difference was observed between the scores of the two groups in total (MD (95% CI) = 0.480 (-1.23, 2.19) (P = 0.78)), the obsession subscale (MD (95% CI) = 1.020 (-0.15, 2.19) (P = 0.38)), and the compulsion subscale (MD (95% CI) = 0.540 (-0.34, 1.42) (P = 0.54)). No major adverse effects were recorded, and the frequency of side effects was not significantly different between the groups. CONCLUSION: Agomelatine in augmentation with sertraline is safe and tolerable in patients with moderate to severe OCD. However, our study does not support its efficacy in improving OCD symptoms, compared to placebo. TRIAL REGISTRATION: The trial was registered at the Iranian Registry of Clinical Trials on 14/07/2020 ( www.irct.ir ; IRCT ID: IRCT20170123032145N5).

Perceived Stress among Iranians during COVID-19 Pandemic; Stressors and Coping Mechanisms: A Mixed-methods Approach.

OBJECTIVE: New coronavirus (COVID-19) pandemic socioeconomically affected the world. In this study, we measured the perceived stress in response to the COVID-19 pandemic among Iranians to determine the groups at both extremes of the spectrum followed by identifying the stressors and coping mechanisms. METHODS: This study was a mixed-methods study. We distributed a web-based 10-item perceived stress scale (PSS-10), to measure perceived stress score (PSS), through social networks from March 12 to 23, 2020. Then, we interviewed 42 students, 31 homemakers, 27 healthcare providers, and 21 male participants to identify the sources of stress and coping mechanisms. RESULTS: Finally, 13,454 participants completed the questionnaires. The median and interquartile range (IQR) of the participants' PSS was 21 (15-25). Students, homemakers, and healthcare workers (HCWs) showed a higher median (IQR) of PSS compared to other groups (23 [18 to 27], 22 [16 to 26], and 19 [14 to 24], respectively). Male participants showed a lower median (IQR) PSS (17 [12 to 23]). Content analysis of 121 participants' answers showed that the most common stressors were school-related issues mentioned by students, family-related issues mentioned by homemakers, and COVID-19-related issues mentioned by healthcare providers. Male participants' coping mechanisms were mostly related to the perception of their abilities to cope with the current crisis. CONCLUSION: Our participants clinically showed a moderate level of PSS. The main stressors among students, homemakers, and HCWs were related to their principal role in this period, and male participants' coping mechanisms were inspired by the self-image retrieved from the social perspectives.

Evaluation of 6 Patients with Genital Melanoma from Onset of Symptoms to Death: Evaluate the Factors Affecting the Prognosis of the Disease.

BACKGROUND: Genital melanoma is a rare but deadly cancer in women and the prognosis is often poor. PURPOSE: This study assesses the impact of possible risk factors on the end prognosis of the patients, with the ultimate goal of improving survival of disease. METHODS: This is a report of 6 patients diagnosed and treated as genital melanoma. Parameters reviewed included: age at diagnose, presenting symptoms, location size and Breslow depth of lesion, stage at diagnose, adjuvant therapies, hysterectomy and salpingo-oophorectomy, metastasis or recurrence in follow-up, chemotherapy for metastatic disease. RESULTS: The mean age at the time of diagnosis, was 44.67 years, the average size of lesion was 2.91 cm; the average Breslow depth of lesion was 1.93 mm. The mean interval between the onsets of symptoms to diagnosis was 16.7 months; the average life expectancy was 23.5 months. There is no significant relationship between the initial location of the lesion and prognosis (P: 0.98). Patients diagnosed in < 7 months, were in lower stages at diagnose (P: 0.018), and the survival of them was better (P: 0.035). Patients diagnosed in early stages had better survival at last (P: 0.035) Adjuvant radiotherapy improves survival markedly (P: 0.018). Hysterectomy and salpingo-oophorectomy had no significant effect on prognosis (P: 0.7). Chemotherapy in metastatic disease had no significant effect on prognosis (P: 0.46). CONCLUSION: The survival markedly improved if the disease diagnosed in a short distance from onset of symptoms and specially in early stages. Adjuvant radiotherapy can improve the survival significantly, but for the early hysterectomy and salpingo-oophorectomy and also for chemotherapy in metastatic disease, the impact on prognosis is uncertain, but positive.

Can Subcision with the Cannula be an Acceptable Alternative Method in Treatment of Acne Scars?

BACKGROUND AND OBJECTIVES: Most people who experience the acne suffer from damage under the surface of their skin which causes saucer-like depressions or pits on their skin. Sometimes the skin loses its underlying support and develops fibrous bands of tissue between the skin and subcutaneous layer, which pull on the epidermis and cause a wavy texture called as rolling scar. Treatment of acne scars is a therapeutic challenge that may require multiple modalities. Subcision is a procedure that has been reported as a beneficial method in the treatment of rolling acne scars. Although Subcision is a valuable method, its efficacy is mild to moderate because of the high recurrence rate and patients dissatisfaction due to some side effects include post procedure inflammation. MATERIALS AND METHODS: This pilot study is a clinical trial. The 8 patients suffered from mild to severe rolling acne scars on their face with symmetrical distribution of lesions, underwent Subcision with the Cannula No 18 and 21 and followed-up for 3 months. Outcomes of Subcision procedures were assessed by 3 board certified dermatologists (blind) after 2 session of treatment. The patients' satisfaction was considered to compare with dermatologist's opinions. The degree of improvement and satisfaction of the treatment estimated with these points: poor: 0, fine: 1-3, good: 4-6, and very good: 7-9. The data were finally analyzed with SPSS-18 software. RESULTS: Subcision with the Cannula showed good and very good improvement in about 88% of patient with a satisfaction good and very good improvement in all of patients (100%). Assessment of photographic data showed 100% improvement in scar depth, topography and overall appearance of acne scars. The average numbers of lesions before the treatment were 24.8 ± 12.1 and after treatment it was reduced to 12.8 ± 2.1 (p<0.05). CONCLUSION: Subcision with the Cannula appears to be a safe method with high efficacy in the treatment and high satisfaction in patients as we observed an interesting cure rate (more than 50% after 2 sessions). It demonstrates to be a safe procedure because it performed by single perforation in each side instead of multiple perforations that helps to reduce the patients' pain and risk of scars. In other hand Cannula-based Subcision needs considerable fewer sessions of surgery and also less recovery time.

Up-regulation of miR-130b expression level and down-regulation of miR-218 serve as potential biomarker in the early detection of human osteosarcoma.

BACKGROUND: Osteosarcoma (OS) is a primary malignant bone tumor with high morbidity that principally emerges in children and adolescents. MiRNAs regulate a variety of normal physiologic processes and are involved in tumorigenesis and development of multiple malignancies, including OS. This study was aimed to evaluate the clinical significance of miR-130b and miR-218 in osteosarcoma patient. METHODS: We utilized quantitative real-time PCR to evaluate the level of miR-130b and miR-218 expressions in OS patients and normal tissues and their relationship with clinicopathological features and survival in OS patients. RESULTS: QRT-PCR indicated that miR-130b expression in tumor tissues was strongly elevated than adjacent non-tumor tissues (P < 0.001), while the level of miR-218 expression in osteosarcoma tissues was down-regulated than adjacent non-tumor tissues (P < 0.001). We evaluated the clinical significance of miR-130b and miR-218 in osteosarcoma. Clinical correlation analysis showed that increased expression of miR-130b and decreased expression of miR-218 were significantly associated with advanced tumor stage (x (2) = 6.285, P < 0.009; x (2) = 7.172, P < 0.007), distant metastasis (x (2) = 5.528; P < 0.001; x (2) = 4.617, P < 0.001) and size of tumor (x (2) = 5.01, P = 0.013; x (2) = 4.271, P = 0.019). CONCLUSIONS: Taken together, our data indicated that high miR-130b level and low level of miR-218 are associated with poor clinicopathological characteristics. Furthermore, miR-130b may play a key role in the progression of osteosarcoma.