The effects of pioglitazone adjuvant therapy on negative symptoms of patients with chronic schizophrenia: a double-blind and placebo-controlled trial.

OBJECTIVE: The evident central role of inflammation, oxidative stress, and metabolic derangement in pathophysiology of negative symptoms of schizophrenia has opened new insights into probable pharmacological options for these symptoms. Pioglitazone is an antidiabetic agent with anti-inflammatory and antioxidant properties. In this study, we evaluated the efficacy of pioglitazone as an adjunct to risperidone for reduction of negative symptoms in schizophrenia. METHODS: In this randomized, double-blind, placebo-controlled trial, 40 patients with chronic schizophrenia and a minimum score of 20 on the negative subscale of Positive and Negative Syndrome Scale (PANSS) were randomly allocated to receive risperidone plus either pioglitazone (30 mg/day) or placebo for 8 weeks. Patients' symptoms and adverse events were rated at baseline and weeks 2, 4, 6, and 8. The difference between the two groups in decline of PANSS negative subscale scores was considered as the primary outcome of this study. RESULTS: At the study endpoint, patients in the pioglitazone group showed significantly more improvement in PANSS negative subscale scores (p < 0.001) as well as PANSS total scores (p = 0.01) compared with the placebo group. CONCLUSION: These findings suggest the probable efficacy of pioglitazone as an augmentation therapy in reducing the negative symptoms of schizophrenia.

Simvastatin as an adjuvant therapy to fluoxetine in patients with moderate to severe major depression: A double-blind placebo-controlled trial.

Statins have been shown to decrease depressive symptoms in certain groups of patients, an effect that is mostly attributed to their anti-inflammatory and neurotransmitter modulatory potentials. We aimed to investigate the antidepressant effects of simvastatin as an adjuvant therapy in patients with moderate to severe depression. In this double-blind placebo-controlled clinical trial, 48 patients were randomly allocated to receive simvastatin or placebo as an adjunct to fluoxetine for six weeks. Patients were evaluated with the Hamilton Depression Rating Scale (HDRS) at baseline and weeks 2, 4 and 6. Probable clinical and laboratory adverse events were also monitored and compared between the two groups. Simvastatin-treated patients experienced significantly more reductions in HDRS scores compared to the placebo group by the end of the trial (p=0.02). Early improvement and response rates were significantly greater in the simvastatin group than the placebo group (p=0.02 and p=0.01, respectively) but remission rate was not significantly different between the two groups (p=0.36). No serious adverse event was reported during this trial. In conclusion, simvastatin seems to be a safe and effective adjuvant therapy for patients suffering from major depressive disorder. However, more confirmatory studies are warranted.

Comparing the efficacy and safety of Crocus sativus L. with memantine in patients with moderate to severe Alzheimer's disease: a double-blind randomized clinical trial.

OBJECTIVES: Limited pharmacological options are available for the management of Alzheimer's disease (AD) in severe stages. Cognitive-enhancing properties of saffron, the dried stigma of Crocus sativus L., have been evidenced in different studies. We aimed to compare the efficacy and safety of saffron extract versus memantine in reducing cognitive deterioration of patients with moderate to severe AD. METHODS: In this randomized double-blind parallel-group study, 68 patients with moderate to severe AD (Mini-Mental State Examination score of 8-14) received memantine (20 mg/day) or saffron extract (30 mg/day) capsules for 12 months. Participants were evaluated every month by Severe Cognitive Impairment Rating Scale (SCIRS) and Functional Assessment Staging (FAST) in addition to recording the probable adverse events. RESULTS: Both treatment groups showed similar outcomes as demonstrated by insignificant effect for time × treatment interaction on SCIRS scores [F(2.95, 194.78) = 2.25, p = 0.08]. There was no significant difference between the two groups in the scores changes from baseline to the endpoint on SCIRS (p = 0.38) and FAST (p = 0.87). The frequency of adverse events was not significantly different between the two groups as well. CONCLUSIONS: In addition to its favorable safety profile, 1-year administration of saffron extract capsules showed to be comparable with memantine in reducing cognitive decline in patients with moderate to severe AD. Confirmatory studies with larger sample sizes and longer follow-up periods are warranted.

Intranasal desmopressin as an adjunct to risperidone for negative symptoms of schizophrenia: a randomized, double-blind, placebo-controlled, clinical trial.

Considering the role of neurohypophyseal peptides in normal development and function of higher cortical processes along with their proven abnormalities in schizophrenic patients, these pathways have recently attracted greater attention as treatment targets for schizophrenia. Desmopressin (DDAVP) is a synthetic analog of vasopressin. This study aimed to evaluate the efficacy and safety of DDAVP nasal spray as an adjunct to risperidone in improving negative symptoms of schizophrenia. In this randomized double-blind placebo-controlled clinical trial, forty patients aged 18-50 years with a DSM IV-TR diagnosis of chronic schizophrenia and a minimum score of 60 on positive and negative syndrome scale (PANSS) were equally randomized to receive DDAVP nasal spray (20mcg/day) or placebo in addition to risperidone for 8 weeks. Patients were partially stabilized and treated with a stable dose of risperidone (5 or 6mg/day) for at least four weeks prior to entry. Participants were rated by PANSS every two weeks and decrease in the PANSS negative subscale score was considered as our primary outcome. By the study endpoint, DDAVP-treated patients showed significantly greater improvement in the negative symptoms (P=0.001) as well as the PANSS total and general psychopathology subscale scores (P=0.005 and P=0.003; respectively) compared to the placebo group. Treatment group was the strongest predictor of changes in negative symptoms (ß=-0.48, t=-3.67, P=001). No serious adverse event or fluid/electrolyte imbalance was reported in this trial. In conclusion, DDAVP nasal spray showed to be an effective and safe medication for improving negative symptoms in patients with chronic schizophrenia.

Do the different reasons for lactation discontinuation have similar impact on future breast problems?

BACKGROUND: Breast feeding is considered to be mutually beneficial for both mothers and infants, though the effect of lactation problems on development of breast lesions (whether benign or malignant) is not clear. OBJECTIVES: This study was conducted to identify possible relations between lactation problems and benign and malignant breast disease. MATERIALS AND METHODS: 308 patients referred to two referral breast clinics in Tehran, the capital city of IR Iran, between January 2008 and January 2011, were recruited. They were interviewed by a standard questionnaire regarding breast feeding problems. The study population was classified in 3 major groups; breast feeding without any problem, unwillingness to breast feed according to whether mothers' preference not to feed or some breast problems like mastitis, and finally insufficient milk that caused the mothers to feed their babies with formula. RESULTS: Recruiting binary logistic regression method, mother's unwillingness to feed her child by breast milk, and also breast problems such as mastitis and abscess during lactation period showed significant relation with both benign and malignant breast diseases (p value<0.01). Surprisingly, inadequate milk was not associated with any of these conditions. CONCLUSIONS: We concluded that lactation problems which involve normal milk drainage from the breast may play an important role in whether the mother wll subsequently develope both benign and malignant pathologies. In contrast in the situation that the production of the milk is not sufficient and there are no intentional or unintentional problems in drainage of the produced milk, future problems would not be more common.

Breast cancer research in Iran; essential data to organize research.

BACKGROUND: Considering that breast cancer is one of the most burdensome diseases our societies are facing, and given our lack of knowledge in the research field of the important disease, it is essential that we strategize research policies by identifying defects in research systems in each country. The goal of this study was to explore the published articles in this field and present the data required for the policy makers to re-organize the breast cancer research in Iran. METHODS: In this descriptive study, Pubmed searches were performed to find all the articles published on the title of breast "cancer", "tumor", "malignancy" and "Iran" from the beginning up to the end of January 2010. Different research categories of the articles were defined and validated by an expert panel. The abstracts of all 180 articles were reviewed and each article was put into the relevant category. RESULTS: Based on the available evidence the majority of articles have focused on molecular science (21%) and genetics (19%), while the remainder belonged to other categories like quality of life (9%), screening protocols (8%), epidemiology (7%), risk factor studies (6%), pathology (6%), patient knowledge and behavior (5%) and other clinical research fields (19%). The most used methodologies are cross-sectional (39%) and case-control (25%). The other articles are designed in formats such as experimental (8%), cohort (6%), case-report (6%), review article (4%) and others methodologies (12%). CONCLUSION: Despite the increasing body of literature under the title of breast cancer since 2000 from Iran, still there are limited published articles in some important categories with strong levels of evidence of relevance, which calls for extra efforts to reassess the research system policies and budgeting standards.