Selective serotonin reuptake inhibitors and the risk of bleeding

Background: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed agents for various conditions in general psychiatry. There is a strong consensus that blockade of serotonin reuptake affects primary hemostasis, namely platelet activity, thus resulting in a bleeding tendency. Considering that SSRIs are commonly prescribed, this study was conducted to assess if they were associated with an increased risk of bleeding.Methods: This was a prospective, open-label study of 30 patients attending the Psychiatry out-patient department, Dr. B. R. Ambedkar Medical College, Bangalore who satisfied DSM-IV criteria for a primary diagnosis of depression, treated with SSRIs. Bleeding time, clotting time, prothrombin time, partial thromboplastin time and platelet count were assessed at baseline and at the end of 6 weeks of treatment or occurrence of bleeding symptom.Results: The patients aged between 18-55 years of whom 21 were females, were treated with an SSRI (fluoxetine 12, escitalopram 12 and sertraline 6 patients). Six patients had overt symptoms of bleeding (upper gastrointestinal bleeding (hematemesis) 4; epistaxis 2 and petechiae 2) of whom one patient gave a history of both hematemesis and petechiae and another of hematemesis and epistaxis. The average day after treatment beginning, on which patients reported with bleeding was 30.33 (26-40 days). There was a significant increase in the bleeding time (p=0.028) and clotting time (p=0.042), implying derangement in platelet aggregation. There was no significant change in the other parameters.Conclusion: Treatment with SSRIs increases the risk of bleeding. However, large, randomized controlled trials are required to re-affirm these findings

A randomized, open-labelled study of the sedative, analgesic and anxiolytic effect of dexmedetomidine and tramadol in postoperative patients

Background: In the post-operative period, it has always been an important consideration for clinicians, to keep the patient comfortable, calm and pain free. So there is a constant need for an ideal sedative for postoperative patients. Alpha 2 adrenoreceptor agonists such as dexmedetomidine could provide an answer to this problem because they have several relevant physiological properties like sedation, anxiolysis, analgesia and arousability. This prospective, randomized trial was conducted to compare the safety and efficacy of dexmedetomidine and tramadol in the management of postoperative pain.Methods: In the present study 60 patients operated under general anaesthesia with a pain score of 1-3 were randomly allocated into two groups to receive either dexmedetomidine (group D) or tramadol (group T). In both groups, pain score, sedation score, heart rate, blood pressure, SPO2, respiratory rate were monitored for every 5 min for first 30 min, every 10 min for next 1hr, every 15 min for next 1 h, every 30 min for the next 1 h, every 1 h for 3 h and 6th hourly till 24 h. The need for rescue analgesic was also noted. The data were tabulated and analysed using descriptive statistical tool. Mean, standard deviation and comparison between the groups was done by student’s ‘t’ test. A p value less than 0.0001 was considered significant.Results: Mean duration of sedation of dexmedetomidine was 129.6±41.02 and for tramadol was 117.3 ± 47.75 (p=0.14), mean degree of sedation in both group was -1, mean duration of analgesia 139 min in Group D and 280 min in Group T (p<0.0001), rescue analgesia was required at 169th min in Group D and 288th min in Group T (p<0.0001), mean heart rate in Group D was 67.8±5.24 and 69.4±4.79 (p=0.12), mean Mean Arterial Pressure (MAP) in Group D was 78.0±8.97 and in Group T was 89.2±10.63 (p<0.00001), mean respiratory rate in Group D was 15.8±2.33 and in Group T was 15.9±2.09 (p=0.41), mean SPO2 in Group D was 99.5±0.56 and in Group T was 99.4±0.62 (p=0.14). There was no significant difference in degree and duration of sedation, duration of analgesia, vital parameters, and adverse effects in both groups but there was a statistical difference in the duration of analgesia and the need for rescue analgesia in Group D.Conclusion: Though there is no statistical difference in both groups, dexmedetomidine significantly reduced anxiety, agitation and produced calmness in postoperative patients which was not seen with tramadol

Benign breast diseases: experience at a teaching hospital in rural India

Background: Though benign breast diseases are very common with nearly 1/3 of women suffering some time during their life time, not many studies have focused on this entity, especially in rural areas. Our teaching hospital situated amongst the villages in rural part of India provided the right background for the study.  Objective: To determine the frequency of benign breast diseases in a teaching hospital situated in the rural setting and to analyze the role of triple assessment in assessing benign breast diseases.Study design: Prospective, descriptive study.Setting: MVJ Medical College and Research Hospital, Hoskote, Bangalore Rural district, Karnataka, India.Method of study: Data including age, complaints, clinical examination, radiological investigations and histopathological diagnosis was collected from patients presenting to the department of surgery with breast complaints. Patients with carcinoma of the breast were excluded from the study.Results: A total of 110 patients were studied between November 2009 to March 2011. Mean age of patients was 28.6 years. Fibroadenoma was the most common diagnosis in 56.4% followed by fibroadenosis in 20.9%. There was one case each of lipoma, tuberculosis and duct ectasia and two cases of atypical ductal hyperplasia. The sensitivity of clinical diagnosis in our study was 91.1% and FNAC was 100% accurate in all patients with fibroadenoma but had a sensitivity of only 78% in the diagnosis of fibroadenosis. Only 3.3% of cases of fibroadenoma were treated conservatively

A pilot single centre, double blind, placebo controlled, randomized, parallel study of Calmagen® dermaceutical cream and lotion for the topical treatment of tinea and onychomycosis

Abstract Background Most of the current anti-fungal treatments are chemical-based, fungistatic, have low efficacy in the treatment of tinea and toxicity concerns, while onychomycosis remains recalcitrant to most antifungal therapies. The study aimed to establish the fungicidal, efficacy and safety profile of Calmagen® dermaceutical cream and lotion containing AMYCOT® as a topical treatment in patients with severe to very severe presentations of fungal skin (tinea) and nail infections (onychomycosis). Methods A randomized, placebo-controlled, double blind, parallel, single centre study was conducted on 28 subjects with severe to very severe tinea or onychomycosis. All patients were randomized in a ratio of 1:1 for treatment or placebo group. Subjects in the treatment arm received Calmagen® cream or lotion, while subjects in the placebo arm received a similar inert topical preparation. Tinea subjects were treated with cream for four weeks, while onychomycosis subjects were treated with lotion for 12 weeks. Mycological cure, the primary endpoint, was assessed by three parameters: KOH (potassium hydroxide) smear, fungal culture and live spore count. Clinical cure was defined as Investigator Global Assessment (IGA) response of ‘cleared’ or ‘excellent’. Results All three parameters constituting mycological cure were confirmed in 92.8% (13/14) of subjects in the treatment arm, while all 14 subjects in the placebo arm remained positive for KOH smear. Calmagen® cream and lotion treatment showed a significant improvement in all three parameters: KOH smear, (95% CI (Calmagen): 79.4, 100.0; 95% CI (placebo): 0.0, 0.0; p < 0.0001); fungal culture (95% CI (Calmagen); 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019); and live spore count (95% CI (Calmagen): 100.0, 100.0; 95% CI (Placebo): 17.0, 100.0; p < 0.0019). Clinical cure was achieved in all subjects in the treatment arm while none in the placebo arm were clinically cured. No treatment-related adverse effects were observed in either group. Conclusions The Calmagen® cream and lotion containing AMYCOT® represent a potentially safe and efficacious natural alternative in the treatment of Tinea and onychomycosis. Trial registration This trial has been registered with the clinical trial registry-India (CTRI; registration number: CTRI/2012/03/002522 )