A Randomized Controlled Trial to Assess the Efficacy of Topical Besifloxacin 0.6% Versus Moxifloxacin 0.5% in Bacterial Conjunctivitis

BACKGROUND: Bacterial conjunctivitis is an inflammation of the conjunctiva is defined as conjunctival hyperaemia associated with a mucopurulent or purulent discharge. The increasing prevalence of drug resistant ocular isolates highlights the need for the development of newer agents for the treatment of bacterial infections. Besifloxacin is a topical fluoroquinolone and developed specifically for ophthalmic use. The broad spectrum activity of besifloxacin includes potent activity against drug resistant strain of various bacteria. Hence the current study was designed to evaluate the clinical outcome & tolerability of besifloxacin ophthalmic suspension. AIM OF THE STUDY: To compare the efficacy and tolerability of two drugs, Topical Besifloxacin 0.6% and Topical Moxifloxacin 0.5% in patients diagnosed with bacterial conjunctivitis in outpatient department of Ophthalmology in a tertiary care hospital in Chengalpattu. METHODOLOGY: After approval from Institutional Ethical Committee, 163 patients were recruited and randomised into either group A to receive Topical Besifloxacin 0.6% ophthalmic suspension one drop tid/5 days or group B to receive Topical Moxifloxacin 0.5% solution one drop tid/5 days. Demographic details and complete history were recorded during enrollment. Clinical examination, screening with Cumulative sum scale score (CSS) and lab investigations were done at baseline, 4th day, and 7th day. Efficacy was measured by improvement of symptoms assessed by CSS scoring. Tolerability was ensured by assessing the patient outcome at 10th day using four step scale. RESULTS: The mean CSS score reduction from 9.85 at baseline to 0.88 in Group A (Besifloxacin)and from 10.49 at baseline to 1.08 in Group B (Moxifloxacin) on 4th day of the treatment and on 7th day of the treatment the scores were reduced to 0.00.The reduction in CSS score was statistically significant within groups.(p value <0.001) The mean CSS score reduction between Group A and Group B did not show statistically significant difference.(P value = 0.40) Score for tolerability on 10th day showed no significant difference between the group statistically.(p value = 0.193) CONCLUSION: This study confirms that both Besifloxacin and Moxifloxacin are equally effective in the treatment for bacterial conjunctivitis. Tolerability profile is better for Besifloxacin suspension than Moxifloxacin solution. Hence Topical Besifloxacin suspension is found to be an alternative to Topical Moxifloxacin solution in the treatment for bacterial conjunctivitis

Analysis of individual case safety reports of spontaneous reporting in adverse drug reaction monitoring centre at a tertiary care hospital

Background: In developing countries like India, the increased economic burden in healthcare system is due to adverse drug reactions (ADRs) related hospitalizations which in turn are related to polypharmacy associated with increased potential of ADRs. World Health Organization (WHO) started the program for international drug monitoring (WHO PIDM) in the year 1968. India is one of the member countries under WHO PIDM using the Vigibase for analysis of individual case safety reports (ICSRs). Aim of the study was to analyse the ICSRs by spontaneous reporting at ADR monitoring centre.Methods: The present study was focused on analyzing the ICSRs of spontaneous reporting using Vigiflow data from the ADR monitoring centre (AMC), Madras Medical College, Chennai.Results: A total of 541 ICSRs from the period between July 2017 and June 2018 were analysed. Among 541 ICSRs, 814 ADRs were analysed and found that the majority of the ADRs belonged to SOC of gastrointestinal disorders and the most of the ADRs were implicated by antimicrobial agents followed by non-steroidal anti-inflammatory drugs (NSAIDs). Among all the ICSRs, majority of the ADRs occurred in males (n=292) and the maximum number of ADRs were in the age group of 45-60 years (n=197). Of the 541 ICSRs, 313 were found to be of “serious” category and majority of the ICSRs outcome was found to be “recovered” (n=262). The causality assessment of the ICSRs were anlysed and found that the maximum number of ICSRs were under “probable” category as per WHO-UMC scale.Conclusions: Robust pharmacovigilance activities plays important role in minimizing the ADRs for better patient safety

Pre and post test clinical study to assess the combined effect of Brahmigritha-Nasya, Ksheerabalataila-Abhyanga and Saraswatha-Churna in reducing the symptoms of Generalized Anxiety Disorder on Hamilton anxiety rating scale

Generalized Anxiety Disorder (GAD) is the most frequently occurring anxiety disorder. It is characterized by tension, persistent worry about a variety of everyday problems and other anxiety symptoms for at least 6 months. Although there have been significant improvements over the years in its treatment, GAD remains the least successfully treated among anxiety disorders. This paper aims to explore the efficacy of Ayurvedic treatment protocol in providing a remedy for GAD. A clinical trial was conducted with 20 patients in the proposed age group of 20 years to 60 years, diagnosed with GAD according to ICD 10 F 41.1 Criteria, and having a score between 17-24 (mild to moderate) on Hamilton Anxiety Rating Scale. The patients were administered 7 days of Sarvanga-Abhyanga (full body massage) with Ksheerabalataila and Brahmigritha-Nasya, followed by internal intake of Saraswatha-Churna for 21 days. The assessment was done using Hamilton Anxiety Rating Scale at baseline and after treatment. Patients ranged in the age from 27 to 60 years. Maximum incidence of the disease was seen in the age-wise classification group 20-29 years. There were 8 male subjects and 12 female subjects. After 28 days of treatment, the mean scores of Hamilton Anxiety Rating Scale, which was 21 before treatment, reduced to 9.8 with a mean difference of 11.2 and a statistically significant p-value of 0.01. Thus the present protocol was effective in reducing the symptoms of Generalized Anxiety Disorder within a short time-span and without producing any side effects.

Modulatory effect of quercetin on azathioprine induced membrane changes in the mouse spleen

132-136<span style="font-size: 15.5pt;mso-bidi-font-size:8.5pt;font-family:" times="" new="" roman","serif""="">Modulatory effect of quercetin on azathioprine induced toxic changes was studied in spleen of experimental animals. Azathioprine treatment caused an increase in serum albumin/globin ratio and a decrease in total protein in spleen tissue. An increase in a membrane bound ATPases was also noted. Supplementation of quercetin with azathioprine increased the protein content and lowered the activities of membrane ATPase in spleen. There was a decrease in serum albumin globulin ratio. It was concluded that quercetin modulated the protein and membrane bound ATPase activities and protected the spleen from azathioprine induced membrane damage. </span

Pre and post test clinical study to assess the combined effect of Brahmi Gritha-Nasya, Ksheerabala Taila-Abhyanga and Saraswatha-Churna in reducing the symptoms of Generalized Anxiety Disorder on Hamilton Anxiety Rating Scale

63-67Generalized Anxiety Disorder (GAD) is the most frequently occurring anxiety disorder. It is characterized by tension, persistent worry about a variety of everyday problems and other anxiety symptoms for at least 6 months. Although there have been significant improvements over the years in its treatment, GAD remains the least successfully treated among anxiety disorders. This paper aims to explore the efficacy of Ayurvedic treatment protocol in providing a remedy for GAD. A clinical trial was conducted with 20 patients in the proposed age group of 20 years to 60 years, diagnosed with GAD according to ICD 10 F 41.1 Criteria, and having a score between 17-24 (mild to moderate) on Hamilton Anxiety Rating Scale. The patients were administered 7 days of Sarvanga-Abhyanga (full body massage) with Ksheerabalataila and Brahmigritha-Nasya, followed by internal intake of Saraswatha-Churna for 21 days. The assessment was done using Hamilton Anxiety Rating Scale at baseline and after treatment. Patients’ age ranged from 27 to 60 years. Maximum incidence of the disease was seen in the age-wise classification group 20-29 years. There were 8 male subjects and 12 female subjects. After 28 days of treatment, the mean scores of Hamilton Anxiety Rating Scale, which was 21 before treatment, reduced to 9.8 with a mean difference of 11.2 and a statistically significant p-value of 0.01. Thus the present protocol was effective in reducing the symptoms of GAD within a short time-span and without producing any side effects

Endoscopic exploratory tympanotomy findings in conductive hearing loss: a surgical review

Background: Conductive hearing loss continue to remain undiagnosed in a large number of patients with intact membrane. Endoscope assisted tympanotomy provides an alternative technique for diagnosis and also facilitates treatment. Methods: A prospective analysis over a 5 year period of 72 exploratory tympanotomies for conductive hearing loss was performed in patients with intact tympanic membrane. Per operative findings were treated in the same sitting. Post-operative follow up of the patient was done up to 6 months. Results: The most common operative diagnosis was found to be otosclerosis (66%), followed by traumatic ossicular dislocation, tympanosclerotic patch, middle ear adhesions, foreign bodies etc. Small fenestra Stapedotomy with prosthesis insertion was the preferred surgical procedure performed in this study, resulting in perceptible hearing improvement post operatively. Conclusion: Endoscope assisted tympanotomy and associated middle ear surgeries serves as an effective diagnostic and therapeutic option. This study is of value in assessing the surgical challenges in diagnosis and definitive treatment for conductive hearing loss with an intact tympanic membrane