Saffron (Crocus sativus) versus duloxetine for treatment of patients with fibromyalgia: A randomized double-blind clinical trial

Objective: Saffron was found efficient and safe in treatment of neuropsychiatric disorders, in particular depression. We compared the efficacy of saffron with duloxetine in treatment of patients with fibromyalgia. Materials and Methods: In this double-blind parallel-group clinical trial, outpatients with fibromyalgia were randomized to receive either saffron 15 mg or duloxetine 30 mg starting with 1 capsule per day in the first week followed by 2 capsules per day from week 2 until the end of week 8. Participants were men and women aged 18-60 years diagnosed with fibromyalgia based on the American College of Rheumatology 2010 criteria who also had a pain score ≥40 based on visual analogue scale. Participants were excluded in case they had rheumatologic diseases, inflammatory/infectious/autoimmune arthritis, comorbid neuropsychiatric disorders except depressive disorders, pain due to traumatic injuries, drug history of duloxetine or saffron use, current use of psychoactive medications, recent use of muscle relaxants, steroids, opioid analgesics, benzodiazepines, anti-epileptics, or injective analgesics. Primary outcomes included differences in mean score changes from baseline to endpoint between the treatment arms for Hamilton Rating Scale for Depression, Fibromyalgia Impact Questionnaire, and Brief Pain Inventory. Results: Socio-demographic characteristics and baseline scores were similarly distributed between the two treatment arms (2n=46). No significant difference was detected for any of the scales neither in terms of score changes from baseline to endpoint between the two treatment arms (Mean score changes: -4.26 to 2.37; p-values: 0.182-0.900) nor in terms of time´treatment interactions (p-values: 0.209-0.964). Conclusions: Saffron and duloxetine demonstrated comparable efficacy in treatment of fibromyalgia symptoms

The Effect of Psychoeducation on Quality of Life and Dependency in Elderlies

Introduction: Quality of life and dependency are two important issues in elderly population. The aim of this study was to investigate the effectiveness of the elderly psychoeducation on their quality of life and dependency in a day care center in Iran.   Methods: A pre-post interventional design was used to evaluate the effectiveness of a psychoeducation program on a convenient sample of 130 elderlies with randomized control group. Intervention procedure included a healthcare package which contained healthy lifestyle education, memory telling sessions, physical education, prayer meetings, art workshops and arranging excursions, all of which was delivered within 3 months. Quality of life short form (SF-12) and Lawton index of  instumental activities of daily living (IADL) were assessed at baseline, after one month and three months later by a trained research coordinator. Covariance analysis was used to examine the effectiveness of the elderly psychoeducation on their psychophysical quality of life and their IADL status.   Results: The mean score of physical quality of life at pretest in the experimental group was 35.70  ±8.80. These score,were 38.53 ± 8.32 and 39.27 ± 7.80 in the first and second posttestrespectively. In terms of psychological quality of life, the mean of pretest score in the experimental group was 41.59 ± 9.47. It was 43.26 ± 9.09 and 47.19 ± 8.98 in the first and second post-test but in the control group the mean had decreased. The mean score of IADL in pretest for the experimental group was 9.98 ± 2.56 in the post-test it was 10.49 ± 2.31and 10.69 ± 2.34 in the first and second post-test, respectively.   Conclusion: These results suggest that psychoeducation for elderlies had a significant positive effect on psycho-physical quality of life and dependency. Therfore,  psychoeducation can be helpful in day care centers

Epidemiology of mental health disorders in the citizens of Tehran: a report from Tehran Cohort Study

BackgroundMental health disorders (MHD) impose a considerable burden on public health systems. With an increasing worldwide trend in urbanization, urban mental health stressors are affecting a larger population. In this study, we evaluated the epidemiology of mental health disorders in the citizens of Tehran using the Tehran Cohort Study (TeCS) data.MethodsWe utilized data from the TeCS recruitment phase. A total of 10,247 permanent residents of Tehran metropolitan (aged 15 years and older) were enrolled in the study from March 2016 to 2019 via systematic random sampling from all 22 districts of Tehran. The participant's demographic, socioeconomic, and medical characteristics were evaluated by conducting comprehensive interviews. The standardized Persian version of the General Health Questionnaire version 28 was utilized to assess the mental status of the patients according to four central mental health disorders.ResultsAlmost 37.1% of Tehran residents suffered mental health problems (45.0% of women and 28.0% of men). The greatest incidence of MHDs was seen in the 25-34 and over 75 age groups. The most common mental health disorders were depression (43%) and anxiety (40%), followed by somatization (30%) and social dysfunction (8.1%). Mental health disorders were more frequent in the southeast regions of the city.ConclusionsTehran residents have a significantly higher rate of mental health disorders compared to nationwide studies, with an estimated 2.7 million citizens requiring mental health care services. Awareness of mental health disorders and identifying vulnerable groups are crucial in developing mental health care programs by public health authorities

Evaluating the Potential Effect of Melatonin on the post-Cardiac Surgery Sleep Disorder

Background: Postoperative neurological injuries, including cognitive dysfunction, sleep disorder, delirium, and anxiety, are the important consequences of coronary artery bypass graft surgery (CABG). Evidence has shown that postoperative sleep disturbance is partly due to disturbed melatonin secretion in the perioperative period. The aim of this study was to evaluate the effect of melatonin on postoperative sleep disorder in patients undergoing CABG. Method: One hundred forty-five elective CABG patients participated in a randomized double-blind study during the preoperative period. The patients were randomized to receive either 3 mg of melatonin or 10 mg of Oxazepam one hour before sleep time. Each group received the medication from 3 days before surgery until the time of discharge. Sleep quality was evaluated using the Groningen Sleep Quality Score (GSQS), and the incidence of delirium was evaluated by nursing records. Sleep quality and anxiety scores were compared before and after surgery through the Wilcoxon signed-rank test. The analysis of covariance (ANCOVA) and independent t-test were used to compare the sleep and anxiety scores between the groups. P values ≤ 0.05 were considered statistically significant. Results: Totally, 137 patients at a mean age of 60 years completed the study (76% male). The analysis of the data showed that sleep was significantly disturbed after surgery in both groups. The patients in the Oxazepam group demonstrated significantly higher disturbance in their mean postoperative GSQS score than did their counterparts in the melatonin group (p value < 0.001). A smaller proportion of the participants experienced delirium in the melatonin group (0.06%) than in the Oxazepam group (0.12%); however, this difference was not statistically significant. Conclusion: The result of the present study revealed that melatonin improved sleep in post-cardiac surgery patients more than what was observed with Oxazepam. Therefore, melatonin may be considered an effective alternative for Benzodiazepines in the management of postoperative sleep disorder

Atomoxetine as an adjunct to nonpharmacological treatments for preventing vasovagal attacks in patients with recurrent vasovagal syncope: A pilot randomized-controlled trial

Background: Despite the reduced quality of life in patients with recurrent vasovagal syncope (VVS), pharmacologic treatment options remain limited. Studies indicate that norepinephrine reuptake inhibition reduces tilt-induced syncope/pre-syncope. This study aimed to evaluate the effects of atomoxetine on syncopal/pre-syncopal episodes in patients with recurrent VVS. Methods: In a placebo-controlled trial, we randomized patients with newly diagnosed VVS who experienced ≥3 syncopal episodes in the past three months to receive either atomoxetine (20 mg daily for two weeks followed by 40 mg daily for two weeks) or placebo. The primary endpoint was the combined number of syncopal and pre-syncopal episodes. Results: Among 843 patients initially screened, 46 were randomized (N = 23 in each group) and reevaluated at one and three months. Compared to placebo, atomoxetine significantly reduced the primary endpoint after three months (P < 0.001). In the atomoxetine arm, the median time to first pre-syncopal episode was 55 days (95% confidence interval (CI): 41.21–68.79), while this was 27 days (95% CI: 14.48–39.52) for the placebo group (P < 0.001). In a subgroup analysis of patients with systolic blood pressure < 110 mmHg, atomoxetine reduced the primary endpoint, and the number of syncopal and pre-syncopal episodes after one and three months. In this subgroup, the median time to first pre-syncopal attack was 56 days in the atomoxetine group as opposed to 9 days in the placebo group. Conclusions: In this pilot study, the promising effects of atomoxetine in reducing syncopal/pre-syncopal episodes in recurrent VVS, especially with low blood pressure phenotype, warrant the conduction of future randomized trials

Association between Perioperative Parameters and

Background: Postoperative cognitive dysfunction (POCD) has been an important complication of cardiac surgery over the years. Neurocognitive dysfunction can affect quality of life and lead to social, functional, emotional, and financial problems in the patient’s life. To reduce POCD, we sought to identify the association between cognitive dysfunction and perioperative factors in patients undergoing cardiac surgery. Methods: One hundred one patients aged between 45 and 75 years undergoing elective cardiac surgery were enrolled in this study. All the surgeries were performed on-pump by the same medical team. A brief Wechsler Memory Test (WMT) was administered before surgery, 3 to 5 days after the surgery, and 3 months after discharge. All related perioperative parameters were collected in order to study the effect of these parameters on the postoperative WMT scores and WMT score change. Results: The study population consisted of 101 patients, comprising 14 (13.8%) females and 87 (86.2%) males aged between 45 and 75 years. In univariate analysis, the baseline WMT score, serum levels of lactate dehydrogenase and T3, cross-clamp time, and preexistence of chronic obstructive pulmonary disease showed significant effects on the postoperative WMT score (p value < 0.05), whereas only the baseline WMT score and chronic obstructive pulmonary disease showed strong effects on the postoperative WMT score in the multiple regression model. In addition, the multiple regression model demonstrated a significant association between the baseline WMT score, serum creatinine level, and nitrate administration and the WMT score change. Conclusion: Our study showed that preexisting chronic obstructive pulmonary disease and preoperative high serum creatinine levels negatively affected cognitive function after surgery. In addition, there was a strong relationship between the patients’ basic cognition and POCD. Preoperative nitrate administration led to a significant improvement in POCD. It is also concluded that the preoperative administration of specific medicines like nitrates can reduce neurological complications after cardiac surgery

Introducing the Tehran Heart Center's Premature Coronary Atherosclerosis Cohort: THC-PAC Study

Background: Data on premature coronary artery disease (CAD) are scarce. The Tehran Heart Center's Premature Coronary Atherosclerosis Cohort Study (THC-PAC) is the first study of its kind in the Middle East to assess major adverse cardiac events (MACE) in young CAD patients. Methods: The cohort consists of CAD patients, males ≤ 45 years old and females ≤ 55 years old. The participants are residents of Tehran or its suburbs and underwent coronary angiography between June 2004 and July 2011. A 10-year follow-up, via either clinical visits or telephone calls at least once a year, was commenced in August 2012. The end point is considered MACE, encompassing death, myocardial infarction, stroke, new coronary involvement, percutaneous coronary intervention, and coronary artery bypass grafting. Results: The cohort comprises 1232 eligible patients (613 [49.8%] males) at a mean age of 45.1 years (SD = 5.8). High frequencies of conventional risk factors, including hyperlipidemia (884 [71.8%]), hypertension (575 [46.7%]), positive family history (539 [43.8%]), cigarette smoking (479 [38.8%]), and diabetes mellitus (390 [31.7%]), were seen in the participants. The mean body mass index (BMI) of the enrolled patients was high (29.2 ± 4.8 kg/m2), and 532 (43.3%) and 440 (35.8%) of them were overweight and obese, respectively. The females’ BMI was higher (30.4 ± 5.3 vs. 28.0 ± 3.9 kg/m2; P < 0.001) and they had a greater mean abdominal circumference (99.9 ± 13.5 vs. 98.1 ± 9.3 cm; P = 0.035). Between August 2012 and August 2013, follow-up was successful in 1173 (95.2%) patients (median follow-up duration = 55.3 months, 95%CI: 53.5-57.0 months). Conclusion: Our younger patients with CAD had a high frequency of risk factors compared to the same-age general population and all-age CAD patients, which may predispose them to higher incidence of recurrent MACE

Factors Associated with Depressive Symptoms in Young Adults with Coronary Artery Disease: Tehran Heart Center's Premature Coronary Atherosclerosis Cohort (THC-PAC) Study

Objective: Depressed coronary artery disease (CAD) patients may experience a poorer prognosis than non-depressed patients. The aim of this study was to find the associated factors for depressive symptoms in young adults with CAD. Method: This was a cross-sectional study within Tehran Heart Center's Premature Coronary Atherosclerosis Cohort (THC-PAC) study. Young adult CAD patients (men ≤ 45 year-old and women ≤ 55 year-old) were visited from March 2013 to February 2014. Demographic, clinical and laboratory data were collected and all patients were asked to fill in the Beck Depression Inventory II. Informed consent was obtained from all participants. A logistic regression model was used to find multiple associated factors of depressive symptoms. Results: Seven hundred seventy patients (mean ±SD age: 45.34 ±5.75 y, men: 47.7%) were visited. The point prevalence of depressive symptoms was 46.9% in women and 30.2% in men (p < 0.001). Logistic regressions model revealed that the most important associated factors for depressive symptoms in the male premature CAD patients were opium usage (OR: 2.4, 95% CI: 1.33-4.43), major adverse cardiac events (MACE) (OR: 2.2, 95% CI: 1.17-3.93), initial coronary artery bypass grafting (CABG) treatment (OR: 2.1, 95% CI: 1.07-4.06), positive family history for CAD (OR: 1.8, 95% CI: 1.11-3.01) and cigarette smoking (OR: 1.7, 95% CI: 0.97-2.98). Hypertension showed a protective role in this group of patients (OR = 0.5, CI = 0.29-0.92). In the female patients, hypertension (OR = 1.5, CI = 0.96-2.22) and body mass index (BMI) (OR = 1.1, CI = 1.02-1.10) were associated with depressive symptoms. Conclusion: In premature CAD male patients, opium usage, MACE, initial CABG treatment, positive family history for CAD and cigarette smoking were associated with depressive symptoms; and hypertension and BMI were associated with depressive symptoms in women

Tehran cohort study (TeCS) on cardiovascular diseases, injury, and mental health: Design, methods, and recruitment data.

Cardiovascular disease, mental health, and injury are among the top health issues globally. In Tehran Cohort Study, we aimed to determine the prevalence, incidence, and trend of cardiovascular diseases, psychiatric symptoms, injury, and risk factors in Tehran households. We enrolled 4215 households in the recruitment phase from March 2016 to March 2019. Demographic characteristics, past medical history, medications, and familial history of the participants were collected. Rose angina pectoris, general health Questionnaire-28 (GHQ-28), and injury questionnaires were completed. Fasting blood samples were collected to measure routine biochemistry and store samples in the biobank. Anthropometric and physiological measurements and electrocardiograms were performed. The participants are followed every three years for up to 12 years. In total, 8296 individuals participated in the cardiovascular section, 10247 completed the GHQ-28, and 4167 households completed the injury questionnaire. The mean age of the participants was 48.2 (16.41), and 46.5% were male. 64.3% of recruited individuals had no symptoms of psychiatric disorders, and 3729 (89.5%) households did not have any severe injury requiring treatment. The participants diversity and their invaluable data will help us provide a general picture of the current prevalence and incidence of the main study objectives