Evaluation of drug promotional brochures in a tertiary teaching hospital of Kannur, India

Background: Pharmaceutical industries worldwide are heavily involved in aggressive drug promotions. WHO has framed guidelines for ethical drug promotion in 1988. The transparency of pharmaceutical advertisements is important because decision of the physician is likely to be influenced by the claims made by the pharmaceutical companies in the promotional drug brochures and pharmaceutical industries treat their marketing material as “educational material” for doctors. Authors did this study to analyze the information given on drug promotional brochures by the drug companies using ethical criteria of drug promotion by WHO 1988 and to verify the authenticity of the claims given by the pharmaceutical companies in drug promotional brochures.Methods: Cross sectional study extending from 1/8/2012 to 31/7/2013. 612 drug promotional brochures satisfied our inclusion criteria. Drug brochures were analyzed with WHO ethical criteria 1988 and further categorizing the data into type of claims, number and source of references. Validity of journal articles were checked by using a validity measure developed by Cardarelli.Results: Total 612 brochures satisfied inclusion criteria. INN was mentioned in 93.8% of collected brochures. Brand name was mentioned in 100% brochures. Content of active ingredients was mentioned in 92% of brochures. Name of the other ingredients known to cause problem 28.4% of brochures. Dosage form or regimen was mentioned in 23.2% of brochures. Approved therapeutic use mentioned in 65.7% brochures. Side effects and major adverse drug reactions were mentioned in 31.4% brochures. Precautions and contraindications and warnings were mentioned in 30.4% drug promotional brochures. Drug interactions were mentioned in 26.5% brochures. Name and address was mentioned by 69.1% brochures. There were 1144 claims and 739 references. Efficacy claims were 84.88% of the total claims. Main source of reference was from journal articles (74.1%) and among them 49.65% were randomized control trials. Only 47.94 % of the journal references were valid.Conclusions: Brochures were lacking in vital information which included contraindication, warning, precaution, name of the other ingredients known to cause problem hence companies were found violating WHO ethical criteria. Claims were not well supported with references. Less than half of the given journal references were only valid. This study highlights the need of healthcare professionals to remain cautious about promotional material presented by pharmaceutical representatives

EFFECT OF MYOPIA ON PRIMARY OPEN ANGLE GLAUCOMA

Objective: It is a retrospective study to evaluate the effect of myopia on primary open-angle glaucoma by classifying the eyes into NMG (non-myopic glaucoma), HMG (highly myopic glaucoma) And MMG (mild to moderate myopic glaucoma). Methods: The study was performed on 120 patients with primary open-angle glaucoma who were medically treated. Any participant who had surgery done was excluded from the study. The relation between glaucoma and different myopia and progression were assessed on the basis of age, gender, risk factors. Results: Out of the 120 cases assessed, 46 [38 percent] were female and 74 [62 percent] were males. On the basis of age there were 9 cases between 31-40 y, 30 cases between the ages 41-50, 40 cases between 51-60, 32 cases between 61-70 and 9 cases between 71-80, on the basis of myopia 59 [49 percent] were NMG 47 [39 percent] were MMG and 14 [12 percent] were HMG. On the basis of risk factors,12 of them had Diabetes Mellitus, 7 had Hypertension, 7 had a history of steroid use, 3 had a history of migraines and 6 of them had a family history of glaucoma. In the observed one year period 73 percent if the cases were not progressive while 27 percent were progressive. In this study, it has been observed that the males are more commonly affected and the age group with the most cases was the 51 to 60 age group. The majority of the cases showed no risk factors though Diabetes Mellitus is the most common. The progression of the disease is seen more frequently in cases associated with Diabetes Mellitus and Hypertension. In MMG 12 out of the 47 cases were progressive and in NMG 15 out of the 59 cases were progressive. Conclusion: Though high myopia is important in the pathogenesis of glaucoma there was no evidence that high myopia increases the progression of the disease of the 14 cases, only 5 were progressive

Comparison of topical versus peribulbar anaesthesia for manual small incision cataract surgery with intraocular lens implantation

Background: Manual small incision cataract surgery (MSICS) is an alternative to phacoemulsification for high volume cataract surgery especially in developing countries. Aim of this study is to compare patient and surgeon satisfaction, anaesthesia related and post-operative complications following topical (TA) versus peribulbar anaesthesia (PA) for MSICS with intraocular lens (IOL) implantation.Methods: Observational study was done over a period of six months. Patients who underwent MSICS under TA and PA were prospectively evaluated for satisfaction with anaesthesia intraoperatively and four hours after surgery through a questionnaire. Any intraoperative or post-operative complications were also assessed. Surgeon satisfaction was also assessed by a questionnaire.Results: Out of 62 patients 28 underwent MSICS under TA and 34 patients under PA. There was no significant difference in age and co-morbidities between two groups. 88.24% had mild pain and 11.76% had moderate pain during PA which was statistically significant (P<0.05). 17.9% patients in TA group had mild pain at 4 hours while only 2.9% patients in PA group had pain (p<0.05). The intra operative complications were not significant. There was no statistically significant difference in post-operative complications and surgeon satisfaction between two groups.Conclusions: Although the administration of PA is painful compared to TA, the patient satisfaction was more post operatively in PA group. TA is a safe and effective alternative to PA in MSICS with proper selection and education of patient

ASSESSMENT OF THE INCIDENCE AND PREVALENCE OF DRY EYES IN DIABETIC INDIVIDUALS AND IT’S EFFECT ON VISUAL ACUITY

Objective: To find out the incidence and prevalence of Dry Eyes in Diabetic patients and find out its effect on visual acuity. Methods: A prospective study was conducted in Saveetha Medical College and Hospital. Schirmer’s test was done for 100 diabetic patients taking part in the research. Those with dry eyes were tested for their visual acuity and were asked to fill a questionnaire based on associated ocular symptoms. The collected data were analysed using Microsoft Excel. Results: There is about an incidence of 82% of dry eyes in diabetic patients. It’s more prevalent among elderly women. There seems to be a significant effect of dry eys on visual acuity as 31% of those tested with dry eyes have a moderate visual impairment. Conclusion: People with diabetes are at a higher risk of developing dry eye. So diabetic patients should undergo regular ocular examination and must be screened for dry eyes. Early diagnosis and treatment of dry eyes is the best choice to prevent ocular complications in the future

RETINAL CHANGES IN PREGNANCY INDUCED-HYPERTENSION

Objective: The aim is to determine the prevalence of retinal changes in Pregnancy Induced Hypertension (PIH) and its association with age, parity, proteinuria, blood pressureand severity of PIH. Methods: This is a tertiary hospital based Cross-Sectional study including all patients, clinically diagnosed with Pregnancy Induced Hypertension. General demographic details along with age, gravida, gestation period, proteinuria, blood pressure and severity of PIH were noted. Ophthalmic examination was performed and detailed fundus examination was done. Results: A total of 52 patients were included in this study. Their mean age was 24.9 y; 32 out of 52 patients were primigravida (61%) and 20 patients were multi gravida (39%). Out of 52 patients 34 (65.38%) had Gestational Hypertension, 16 (30.76%) had preeclampsia, and 2 (3.8%) had eclampsia. 3 (5.76%) out of 29 patients with BP&lt;160/100 mmHg and 10 (19.23%) out of 23 patients with BP&gt;160/100 mmHg had developed Hypertensive Retinopathy. Hypertensive Retinopathy was seen in 13 (25%). Proteinuria was seen in 10 (19.23%) patients ranging between+to+++on the dipstick. Conclusion: Statistically significant correlation between retinal changes and proteinuria, blood pressure and severity of Disease.The most important requisite in a case of Pregnancy Induced Hypertension is Fundoscopic examination of retina. The retinal vessels during PIH form a gateway to visualize changes in the body and placental vessels, and may play a key role in early detection and treatment of PIH for protection of the mother as well as the fetus

COMPARISON OF POSTOPERATIVE CORNEAL ASTIGMATISM IN PHACOEMULSIFICATION AND MANUAL SMALL INCISION CATARACT SURGERY

Objective: Globally a significant proportion of treatable blindness is caused by cataract, especially in India and southeast Asia. Treatment of cataract is surgical correction with intraocular lens implantation. The main drawback of surgical correction is induction of postoperative astigmatism in patients. The aim of this study was to compare the degree of astigmatism in manual small incision cataract surgery and phacoemulsification 3 mo postoperatively Methods: The study was a retrospective case study on postoperative corneal astigmatism after cataract surgery. It was conducted in a tertiary care hospital in Thandalam, Tamil Nadu. A total of 100 patients were selected and divided into two groups, group A (=50) underwent phacoemulsification and group B (=50) underwent manual small incision cataract surgery. Preoperative astigmatic status of the patients was noted from patient records. Both groups were evaluated 3 mo postoperatively using automated keratometry. The data collected was analyzed using Microsoft Excel Independent T test, p&lt;0.05 was considered statistically significant. Power of the study was 80% with an alpha error of 5%. Results: Mean postoperative astigmatism at 3 mo was 0.91±0.255D and 0.34±0.110D due to manual small incision cataract surgery and phacoemulsification, respectively. Conclusion: Postoperative astigmatism was greater in manual small incision cataract surgery than phacoemulsification. Improvement in preoperative astigmatism was seen in patients who underwent superotemporal incision phacoemulsificatio

A COMPARATIVE STUDY OF CONJUNCTIVAL AUTOGRAFT AND BARE SCLERA TECHNIQUES IN THE TREATMENT OF PTERYGIUM

Objective: Pterygium is a fibrovascular growth encroaching from the conjunctiva into the cornea. This study deals with the comparison of conjunctival autograft and bare sclera technique as treatment options for pterygium. Methods: This study was done in the ophthalmology department of Saveetha Medical College, Thandalam, Chennai. A total of 100 patients were diagnosed of pterygium was taken for the study, out of which 60 patients were operated on with conjunctival autograft and 40 patients were operated with bare sclera technique. Patients with hypertension, diabetes mellitus were excluded. Post-operative complications and recurrence were noted. All the patients were between the age group of 20-65 y. Results: The mean age of patients operated with conjunctival autograft was 43.6, whereas in bare sclera technique was 46.625. The maximum age was 63 and the minimum age was 23 in conjunctival autograft whereas in bare sclera technique, the maximum age was 64 and the minimum age was 22. The recurrence rate of pterygium in conjunctival autograft was 1 and the recurrence rate of pterygium in bare sclera technique was 4. Conclusion: The present study revealed that conjunctival autograft was a better treatment option compared to the bare sclera technique for excision of pterygiu

A STUDY TO ASSESS THE CONTRAST SENSITIVITY OF THE HUMAN VISUAL SYSTEM IN PATIENTS WITH OR WITHOUT DIABETES IN A TERTIARY CARE HOSPITAL

Objective: The objective of our study was to assess the variations in contrast sensitivity values of normoglycemic subjects and that of type II diabetic subjects of the same age group. It was also aimed at finding the visual acuities and study the associations of it with contrast sensitivity if any. Methods: It was a hospital-based comparative cross-sectional descriptive study conducted in the out-patient department of the Department of Ophthalmology, Saveetha Medical College, Hospital, Chennai. Visual Acuity and Contrast Sensitivity of 50 Type II Diabetic individuals and 50 age-equivalent control group subjects were measured using the Snellen’s chart and Pelli-Robson chart, respectively, during the months of January to March 2020. Results: Contrast Sensitivity measurements from 50 subjects with Non-Insulin dependent Diabetes Mellitus (NIDDM) were obtained. The subjects were the ones who had minimal or no diabetic retinopathy. It was observed that there is a significant association between reduced contrast sensitivity and Diabetes (P value&lt;.00008). We also noted that CS may be reduced without corresponding loss of Visual Acuity. Hence, both visual acuity and contrast sensitivity measurements are helpful in the assessment of visual impairment due to diabetic eye disease. Conclusion: The contrast sensitivity can be seen as an early marker for visual impairment in diabetic eye care

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

Cerebral microbleeds and intracranial haemorrhage risk in patients anticoagulated for atrial fibrillation after acute ischaemic stroke or transient ischaemic attack (CROMIS-2):a multicentre observational cohort study

Background: Cerebral microbleeds are a potential neuroimaging biomarker of cerebral small vessel diseases that are prone to intracranial bleeding. We aimed to determine whether presence of cerebral microbleeds can identify patients at high risk of symptomatic intracranial haemorrhage when anticoagulated for atrial fibrillation after recent ischaemic stroke or transient ischaemic attack. Methods: Our observational, multicentre, prospective inception cohort study recruited adults aged 18 years or older from 79 hospitals in the UK and one in the Netherlands with atrial fibrillation and recent acute ischaemic stroke or transient ischaemic attack, treated with a vitamin K antagonist or direct oral anticoagulant, and followed up for 24 months using general practitioner and patient postal questionnaires, telephone interviews, hospital visits, and National Health Service digital data on hospital admissions or death. We excluded patients if they could not undergo MRI, had a definite contraindication to anticoagulation, or had previously received therapeutic anticoagulation. The primary outcome was symptomatic intracranial haemorrhage occurring at any time before the final follow-up at 24 months. The log-rank test was used to compare rates of intracranial haemorrhage between those with and without cerebral microbleeds. We developed two prediction models using Cox regression: first, including all predictors associated with intracranial haemorrhage at the 20% level in univariable analysis; and second, including cerebral microbleed presence and HAS-BLED score. We then compared these with the HAS-BLED score alone. This study is registered with ClinicalTrials.gov, number NCT02513316. Findings: Between Aug 4, 2011, and July 31, 2015, we recruited 1490 participants of whom follow-up data were available for 1447 (97%), over a mean period of 850 days (SD 373; 3366 patient-years). The symptomatic intracranial haemorrhage rate in patients with cerebral microbleeds was 9·8 per 1000 patient-years (95% CI 4·0–20·3) compared with 2·6 per 1000 patient-years (95% CI 1·1–5·4) in those without cerebral microbleeds (adjusted hazard ratio 3·67, 95% CI 1·27–10·60). Compared with the HAS-BLED score alone (C-index 0·41, 95% CI 0·29–0·53), models including cerebral microbleeds and HAS-BLED (0·66, 0·53–0·80) and cerebral microbleeds, diabetes, anticoagulant type, and HAS-BLED (0·74, 0·60–0·88) predicted symptomatic intracranial haemorrhage significantly better (difference in C-index 0·25, 95% CI 0·07–0·43, p=0·0065; and 0·33, 0·14–0·51, p=0·00059, respectively). Interpretation: In patients with atrial fibrillation anticoagulated after recent ischaemic stroke or transient ischaemic attack, cerebral microbleed presence is independently associated with symptomatic intracranial haemorrhage risk and could be used to inform anticoagulation decisions. Large-scale collaborative observational cohort analyses are needed to refine and validate intracranial haemorrhage risk scores incorporating cerebral microbleeds to identify patients at risk of net harm from oral anticoagulation. Funding: The Stroke Association and the British Heart Foundation