Usage Pattern of Fixed-dose Combinations at ICMR Network of Rational Use of Medicine Centres across India: Recommendations for Policymakers and Prescribers

Aim: Irrational use of medicines is a global problem. In India, one contributing factor is the availability of a large number of fixed-dose combinations (FDCs). To improve rational use and to strengthen policies, it is important to assess the usage patterns and rationality of FDCs. Methods: This study was conducted as part of a 1-year prospective cross-sectional analysis of prescriptions in the outpatient clinics of broad specialities from 13 tertiary care hospitals across India. Five most commonly prescribed FDCs in each center were analyzed. In addition, all the prescribed FDCs were classified as per the Kokate Committee classification and it was noted whether any of the FDCs were irrational or banned as per the reference lists released by regulatory authorities. Results: A total of 4,838 prescriptions were analyzed. Of these, 2,093 (43.3%) prescriptions had at least one FDC. These 2,093 prescriptions had 366 different FDCs. Of the 366 FDCs, 241 were rational; 10 were irrational; 14 required further data generation; and the remaining 96 FDCs could not be categorized into any of the above. Vitamins and minerals/supplements, antibacterial for systemic use, and drugs for gastroesophageal reflux disease (GERD) and peptic ulcer were the most used FDCs. Conclusion: Based on the finding that some prescriptions contained irrational FDCs, it is recommended that a rigorous, regular, and uniform method of evaluation be implemented to approve/ban FDCs and that prescribers be periodically notified about the status of the bans.

Comparative evaluation of diode laser and simvastatin gel in pulpotomy of primary molars A randomized clinical trial

Background: Pulpotomy is a vital pulp therapy performed in carious pulp exposures in teeth in which the inflamed coronal pulp is removed and medicament is placed to conserve the vital root pulps. Recently, simvastatin which is a cholesterol-lowering drug has been found to be associated with the pulp regenerative potential. Aim: The aim of this parallel two-arm randomized control trial was to evaluate and compare the clinical and radiographic efficacy of diode laser (DL) and simvastatin gel (SG) in pulpotomy of carious primary molars. Methods: Hundred primary molars (in 98 children, 65 males, 33 females with age 4–8 years) requiring pulpotomy were randomized into the DL or SG group. Pulpotomy was performed as per the standardized protocol; thereafter, all teeth were restored with resin modified glass ionomer cement followed by stainless steel crowns. Follow-up evaluations were done at 3 and 12 months using clinical and radiographic criteria. Statistical analysis was done using Chi-square test at a significance level of 0.05. Results: At 12 months, out of 92 teeth available for clinical and radiographic evaluation by blinded evaluators, DL group showed clinical and radiographic success rates of 76.1% and 52.1%, while SG group showed 80.4% and 65.2% success rates, respectively. There was no statistically significant difference between the efficacy of two techniques clinically (P = 0.49) or radiographically (P = 0.30). Conclusions: Both SG and DL had similar efficacy for primary tooth pulpotomy, clinically and radiographically after 12 months. Considering its ease of application and low-cost, SG can be recommended as a potential pulpotomy medicament in primary molars.

The correlation between colposcopy, cervical cytology and histopathology in the diagnosis and management of cervical lesions: a cross sectional study

Background: The study was undertaken to see the correlation between cervical cytology, histopathology and colposcopy in the diagnosis and management of various cervical lesions.Methods: It is a cross sectional study conducted at a tertiary care hospital in Mumbai, in the department of obstetrics and gynecology from February 2007 to March 2008. A total 55 sexually active women were enrolled for the study who belonged to age group greater than 20 years with history of chronic leucorrhoea or post-coital bleeding/spotting, intermenstrual bleeding/spotting or examination findings of erosion, an unhealthy cervix, a lesion bleeding on touch or an abnormal or suspicious Papanicolaou smear. These women then underwent cytology, colposcopy and cervical biopsy.Results: The accuracy of cytology when compared to colposcopy was 81.82%. The accuracy of colpo-histopathology was 83.6%. The combined accuracy was 76.36%.Conclusions: The simultaneous use of cytological studies and screening colposcopy has been shown to increase the cervical cancer detection. Colposcopy offers an excellent tool in the hands of a gynaecologist to evaluate the uterine cervix and it is not possible to develop this kind of perspective by any other method.

Towards a more healthy conservation paradigm: integrating disease and molecular ecology to aid biological conservation†

Parasites, and the diseases they cause, are important from an ecological and evolutionary perspective because they can negatively affect host fitness and can regulate host populations. Consequently, conservation biology has long recognized the vital role that parasites can play in the process of species endangerment and recovery. However, we are only beginning to understand how deeply parasites are embedded in ecological systems, and there is a growing recognition of the important ways in which parasites affect ecosystem structure and function. Thus, there is an urgent need to revisit how parasites are viewed from a conservation perspective and broaden the role that disease ecology plays in conservation-related research and outcomes. This review broadly focusses on the role that disease ecology can play in biological conservation. Our review specifically emphasizes on how the integration of tools and analytical approaches associated with both disease and molecular ecology can be leveraged to aid conservation biology. Our review first concentrates on diseasemediated extinctions and wildlife epidemics. We then focus on elucidating how host–parasite interactions has improved our understanding of the eco-evolutionary dynamics affecting hosts at the individual, population, community and ecosystem scales. We believe that the role of parasites as drivers and indicators of ecosystem health is especially an exciting area of research that has the potential to fundamentally alter our view of parasites and their role in biological conservation. The review concludes with a broad overview of the current and potential applications of modern genomic tools in disease ecology to aid biological conservation

Successful outcome in a perplexing case of Roberts uterus: a rare uterine anomaly, a rare case report with review of literature

Robert uterus is a rare Mullerian development anomaly with very few cases reports available. It presents with triad of morphologic features of - Blind hemi cavity with or without unilateral hematometra, contralateral unicornuate uterine cavity and normal uterine fundus with or without small external indentation. The major difficulty lies in making the diagnosis of Robert’s uterus. All the reported cases of Robert’s uterus have been managed differently according to patient’s complaints. A 25-year-old married female, resident of Agra presented to gynecology OPD of Dr RML Hospital and associated PGIMER in June 2013, with primary infertility and cyclical left sided dysmenorrhoea since menarche. Patient was consulting at her hometown Agra for 2 years and had an USG and MRI pelvis report of Feb. 2013 with her showing unicornuate uterus with rudimentary horn. Infertility investigations were done in our hospital. HSG report was of localized spill on right with left tubal block. Patient was posted for diagnostic hystero-laproscopy which was further followed by laprotomy, after which we could reach to a diagnosis of Robert uterus with non-communicating left cavity and with severe endometriosis. Patient needed a second hysteroscopy for lysis of septum and subsequently conceived with IVF. She delivered a healthy male baby of 2.65 kg by elective LSCS at 37 weeks with associated breech presentation with gestational hypertension with severe IHCP on 20 June 2019. Paediatric surgeons and gynecologists should be aware of this rare atypical obstructive Mullerian malformation and its management to avoid inappropriate management delays in these patients. A timely diagnosis and definite treatment have a great impact on future reproductive and endocrine function.

Case series of pubic bone diastasis causing severe pelvic girdle pain in pregnancy

Pelvic girdle pain (PGP) is a pregnancy discomfort that causes pain and limitation of mobility and functioning in any of the three pelvic joints. The patient usually presents antenatally with persistent suprapubic pain which is exaggerated during moving, walking or climbing stairs. Intrapartum, this could be associated with disruption of sacroiliac joint, hematuria and bladder dysfunction in severe cases. Pelvic X-rays, ultrasound, and magnetic resonance imaging aid in confirmation of diagnosis by measuring the degree of separation of symphysis. Treatment modalities range from conservative management to orthopedic interventions in form of pelvic strapping, open reduction and internal fixation. Postpartum pain often masks clinicians to make the diagnosis of pubic symphysis diastasis. A case series of three cases which were diagnosed and confirmed with ultrasound and managed with orthopedic consultation. till their delivery and in post-partum period till recovery. Although there is still no specific consensus on treatment guideline, management generally of conservative management to surgical in the form of pelvic bracing or strapping. Awareness of this rare condition can help in management of pain and associated disability which improves post-delivery.

To Study The Efficacy Of Kanchnar Guggulu And Dashmool Matra Basti In The Management Of Vatashtheela W.s.r To Benign Prostatic Hyperplasia

Benign prostatic hyperplasia is a common senile disease. It is a non-cancerous [benign] enlargement of the prostate gland, also called as fibromyoadenoma. It is involuntary hyperplasia due to disturbance of the ratio and quantity of circulating androgens and estrogens. As the age advances the serum testosterone levels slowly but significantly decreases, but levels of oestrogenic steroids are not decreased equally. According to this theory the prostate enlarges because of increased oestrogenic effects. It is likely that the secretion of intermediate peptide growth factors plays a part in the development of BPH. Vatashtheela as described in Ayurveda, closely resembles benign prostatic hyperplasia of modern medicine in its signs and symptoms. In the Vatashtheela, Mutravaha Srotodushti and vitiation of Vata and Kapha Doshas are involved. So Vata Kapha pacifying drugs along with Matra Basti considered to be helpful in reducing the size of prostate and enhancing the tonicity of urinary bladder. This study was conducted to find out the potency of Ayurvedic regimen of Kanchnar Gugglu orally and Dashmool Tail Matra Basti for the treatment of Vatashtheela as the Kanchnar Gugglu is having Granthihar property and Dashmool Tail pacifies Vata and having Tridoshghana, Deepana, Anulomana, Shothghana and Shoolghana properties. The drug Kanchnar Gugglu was given to 30 patients of group -1, with the dose of 500mg TDS before meals for 30 days. And Dashmool Tail Matra Basti was given to 30 patients of group – 2, with the dose of 50ml once a day for 15 days.

Ashtvidha Shastra Karma With Suturing In Detail

Ayurveda is considered by many scholars to be the oldest healing science. In sanskrit, Ayurveda means "The Science of life". Ayurvedic knowledge originated in India more than 5000 years ago and is often called the "Mother of healing". Ancient surgical science- Shalya Tantra is one of the vital components of Ayurveda science which involves surgical and para-surgical interventions. The Shalya chikitsa deals with different surgical approaches for the management of various diseases such as Bhagandra, Pilonidal sinus, Arshas etc. Shalya Tantra embraces all processes aiming at the removal of factors responsible for producing pain or misery to the body or mind. Acharya sushruta has mentioned "Trividha Karma" and "Ashtavidha Shastra Karma" as versatile approaches for therapeutic purposes. The concept of Ashtavidha karma is a unique contribution of Acharya Sushruta. These eight specific surgical procedures are useful in the management of all the diseases which require surgical intervention. In the present time though modern surgery has developed a lot but the basic procedures used in major conditions remained same. These eight basic surgical procedures mentioned by Sushruta are equally applied even today with required modifications to manage the diseases which require surgery including surgical emergency conditions. This article summarizes role of Ashtvidha Shastra Karma in Shalya karma for the management of various surgical problems.

Chronic kidney disease in pregnancy and fetomaternal outcome

Background: Chronic kidney disease is a heterogeneous group of renal dysfunctions with complex and varied presentations in pregnancy. With a long asymptomatic course, timely diagnosis and management is crucial for fetomaternal wellbeing.Methods: A retrospective cohort study over a period of 3 years and 4 months included all obstetric in patients with known or newly diagnosed renal disorders. Maternal outcome was measured with regard to biochemical parameters presence /absence of proteinuria, hypertension, mode of pregnancy termination and complications. Fetal outcome was noted with respect to antenatal complications, weight, Apgar, NICU stay. Computation of results was done using percentages, mean and proportions.Results: Out of 13 women studied, 53.8% were pre-diagnosed cases of renal dysfunction and 46.2% were diagnosed during pregnancy. 38% had proteinuria at first visit and 50% remained so even after delivery. 60% had history of pregnancy induced hypertension in their previous pregnancies. Secondary hypertension and superimposed preeclampsia were seen in 30% and 38% cases respectively, with only one patient requiring magnesium sulphate prophylaxis in post-partum. Cardiac dysfunction was found to be coexisting in 15.3% cases with pre-existing renal leision. Intrauterine growth restriction was seen in 61.5% cases Average fetal weight was 2. 26kg with 30% having NICU stay. 30.6% had preterm delivery. Mode of delivery was caesarean section in 46% cases.Conclusions: Pregnancy with CKD is a high-risk pregnancy with adverse fetomaternal outcomes. For optimal pregnancy outcomes, an expert multidisciplinary team is required. With limited studies in south Asian population, there needs to be an upgradation in registry system.

Are acute infusion reactions after rituximab underreported?

Background: Rigorous premarketing trials may fail to capture safety issues associated with new drugs. This is more likely to happen in case of biopharmaceuticals. We take the case of rituximab, and anti CD20 monoclonal antibody, which was the first monoclonal antibody to get approval. This open label observational study was done with the objective of estimating the incidence of acute infusion reaction associated with rituximab infusion.Methods: The study population consisted of patients hospitalized for receiving rituximab, in day care centre(s) of a tertiary care hospital. Number and type of acute infusion reactions (AIR) were recorded on a case record form along with patient characteristics and medical history.Results: A total of 50 infusions were observed and all infusions were followed by at least one AIR. Total 71 AIRs were recorded among these 50 infusions (1.4 AIR per infusion). Non-Hodgkin’s lymphoma was the commonest indication for which patients were receiving rituximab. In a subset analysis, incidence of AIR was statistically lower in patients having received corticosteroids as premedication. However, brand of rituximab, gender of the patient and first or second cycle had no bearing on incidence of AIRs.Conclusions: AIRs are more common in real time clinical settings than what is reported. There is a need to formulate appropriate risk management plan depending on post marketing clinical data. Use of corticosteroids as premedication may be one such strategy. New drugs, esp biopharmaceuticals, may have unidentified/under reported safety issues and there is a need to undertake focussed pharmacovigilance endeavours to unravel them.

Endometrial evaluation with methylene blue staining in patients with normal hysteroscopy

Background: Normally, endometrium comprises of non-absorptive epithelium and does not take up stain. Conventional staining with methylene blue is explained on the basis of existence of apoptotic cells in endometrium.Methods: Of 50 patients of unexplained infertility, AUB, recurrent pregnancy loss were randomly selected and included in the study. Those with abnormal ultrasound and history of tuberculosis were excluded. Conventional hysteroscopy was performed using normal saline as distending medium and in those with grossly normal endometrium were subjected to staining with 5% methylene blue instilled trans cervically. After 5 min, irrespective of the size and pattern, focal dark blue stained areas were considered abnormal and randomly biopsied. Incidence of endometritis in both groups was compared after histopathological examination.Results: Of total 50 patients, histopathological report of only one patient with dark blue staining had evidence of endometritis. Rest had no evidence, of which 73.5% had light blue or unstained areas and 26.5% showed dark blue staining. No statistically significant difference was found between histopathological reports and light or dark blue staining (p=0.28). When percentage stained area was considered more than 50% only to be positive, sensitivity was 100%, specificity 94%, PPV 25% and NPV 100%. False positives were 75% and no false negatives were observed. Although p values improved but still statistically insignificant.Conclusions: Present study failed to establish any significant correlation between staining pattern and detection rate of endometritis. With no Indian studies published on chromohysteroscopy so far, role of methylene blue in detection of subtle endometrial changes in modern gynaecology in Indian subpopulation is yet to be established.

Objective assessment of handwriting in outpatient prescriptions of a tertiary care hospital

Background: Poor physician handwriting may lead to wrong comprehension and dispensing errors. This study was planned to objectively assess the quality of handwriting of doctors and their readability by physician, pharmacist and patient and to explore the impact of experience and familiarity of pharmacist on prescription readability.Methods: A 100 prescriptions were selected and were given to a pharmacist, a doctor and an educated lay person. They rated the readability of prescriptions on a scale of 1-10 and an average readability score was calculated. Prescriptions with average score 4 or less were subjected to analysis by a pharmacist working at the hospital dispensary (P1) and another pharmacist not working at hospital pharmacy (P2).Results: Average score of pharmacist, physician and lay person was 6.14, 5.2 and 3.14 respectively. A total of 28 prescriptions, containing 93 medicines, had an average readability score of 4 or less. P1 was not able to comprehend one medicine while P2 could not comprehend 19 medicines out of these 93. The performance of both pharmacists was compared by diagnostic tests (EPI 6.04D). The sensitivity of P2 was 80% (95% CI 70.6-87.7), specificity and positive predictive value were 100, and negative predictive value was 5.3 (0.3-28.1).Conclusions: Familiarity of the pharmacist with the prescribing physicians’ handwriting is an important factor in comprehension of poorly legible prescriptions. This could limit the patients to pharmacists around the prescribers. Implementation of appropriate steps need to be assured to minimize the prescription errors.

Epidemiological study on body mass index distribution and health awareness among women at an urban tertiary care centre of north India

Background: Obesity has become a new worldwide health problem and is gradually moving towards an epidemic. overweight and obesity implies an abnormal excessive fat accumulation that poses health risk. According to National Family Health Survey-4, prevalence of obesity has doubled in country over the last decade. Asian Indians stand at higher risk for development of obesity related non-communicable diseases at lower body mass index levels.Methods: It was an observational interpretive study carried on 1000 randomly selected women over 3 months in a tertiary center of urban northern India. BMI was obtained by dividing weight in kilograms and height in meters squares. Patients were enquired about any menstrual complains, known comorbidities, awareness of obesity in terms of its cause and effects, about weight reduction and benefits of exercise and its practice and details noted in a preformed performa. No prior intervention or health education was given to avoid bias.Results: Out of 1000 women, mean BMI was found to be 31.85±8.85kg/m2. BMI classification (Asian standards) stated that 8.1% were overweight and 78% of patients were pre obese and obese (maximum in age of 21-40 years). Menstrual complaints were present among 39% of overweight and obese groups. Among comorbidities, hypothyroidism was found to be maximum being 9.5% in the obese group, followed by hypertension and diabetes mellitus. Only 26.3% of obese women were aware of the factors causing obesity. Knowledge of exercise benefits was grossly limited, with only one fourth of the pre obese and obese population being aware of it.Conclusions: Rising obesity in Indian women needs measures for prevention. Though there is knowledge of the cure among Indian females but there is limited ability to implement the same. Health education of women regarding obesity related comorbidities along with the benefits of weight loss with exercises should be promoted strongly.

Psidium guajava leaf extract prevents intestinal colonization of Citrobacter rodentium in the mouse model.

Diarrheal diseases are the second highest cause of mortality of children under 5 years worldwide. There is a continuous search for developing a cost‑effective treatment for diarrhea as the present ones are facing challenges. Medicinal plants can be explored further as an alternative treatment for diarrhea. Psidium guajava leaves have been used as an antidiarrheal globally. Citrobacter rodentium, a common mouse pathogen, is known to mimic the pathogenecity of enteropathogenic and enterohemorrhagic E. coli. It can thus present an effective model to study infectious diarrhea. In the present study, the P. guajava leaf extract was tested for its efficacy in treating infectious diarrhea using a C. rodentium mouse model. The mice in the test group (treated with P. guajava leaf extract) showed quicker clearance of infection as compared with the control group. The bacterial load in the fecal sample of the mice in the test group was high on Day 4 as compared with that in the control group, suggesting a flush out of the bacteria. In the test group, 6/7 (85.71%) mice showed clearance of infection by Day 19. The control group continued to show infection till Day 29. P. guajava leaf extract thus has the potential for use in the treatment of infectious diarrhea.

Effect of clobazam as add-on antiepileptic drug in patients with epilepsy.

Background & objectives: The use of clobazam in epilepsy has increased since its introduction in 1975. However, it has not been audited for its overall usefulness in Indian set up. The present study was aimed to evaluate usage pattern, retention rate, effectiveness and tolerability of clobazam during routine practice in an outpatient epilepsy clinic of a tertiary care hospital in New Delhi, India. Methods: This study was performed on the patients prescribed antiepileptic medication who had clobazam as last added drug in their treatment regimen during October 2010 - March 2012. These patients were followed up for two OPD visits. The primary points evaluated were retention rate, percentage of seizure-free patients and reasons for discontinuing clobazam. Results: oOf the 417 consecutive patients, 132 (31.7%) were on clobazam treatment for more than four years (median 6 yr, range 4-15 yr). No seizure for previous 12 months was considered as seizure free and was observed in 151 (36.2%) patients. There was no improvement in seizure control in 32 (7.7%) patients. A decrease in seizure severity without any change in seizure frequency was observed in 76 (18.2%) patients. Clobazam was discontinued by 15 (3.6%) patients due to complaints like drowsiness (13), fatigue/tiredness (8), headache (6), poor memory (6), irritable behaviour (5), abdominal pain (3) and dizziness (3). Interpretation & conclusions: oOur results provide valuable information about the clinical use of clobazam as add-on antiepileptic drug therapy in the management of patients with epilepsy.

Cervical tuberculosis masquerading as cancer cervix: A report of three cases.

Summary: Tuberculosis is still frequently observed in third world countries like Africa and Asia. Here we report three cases of genital tuberculosis with variable presentations. First case was a lady of reproductive age group who presented with polymenorrhea and post-coital bleeding with unhealthy cervix. Histopathology of cervical tissue revealed tubercular cervicitis. Second and third cases presented with different complaints like discharge per vaginum, post-coital bleeding and pain in lower abdomen with growth over the cervix. Cervical biopsy was inconclusive of tuberculosis but endometrial tissue sampling for TB PCR was positive. This shows that newer diagnostic marker test can help us to detect secondary genital tuberculosis.

Antiobesity effect of Safoof Mohazzil, a polyherbal formulation, in cafeteria diet induced obesity in rats.

Obesity is reaching epidemic proportions all over the world yet it lacks adequate treatment. Most of the drugs have failed either due to ineffectiveness or adverse effects. Complementary and alternative system of medicine is being used since ancient times. However, many of them have not been tested for efficacy and safety using modern scientific methods. Therefore, the antiobesity effect of Safoof Mohazzil, a polyherbal formulation, was evaluated in cafeteria diet induced obesity in female Sprague Dawley rats. Animals weighing 100–150 g were divided into four groups (n=8) i.e. standard pellet diet, cafeteria diet control, cafeteria diet + Safoof Mohazzil and standard pellet diet plus Safoof Mohazzil. The formulation was administered orally at a dose of 1 g/kg/day for 14 weeks. At the end of study, cafeteria diet significantly increased body weight, Lee’s index, lipid profile (cholesterol and triglycerides), insulin and leptin levels as compared to standard pellet diet control group. Fourteen week treatment with Safoof Mohazzil significantly prevented the increase in body weight, Lee’s index, lipid profile, insulin and leptin levels as compared to cafeteria diet control group without affecting food and water intake. Safoof Mohazzil had no adverse effect on hepatic transaminases, locomotor activity and motor coordination. The study provides evidence for antiobesity effect of Safoof Mohazzil.