A Retrospective Study of Ethics Committee Monitoring Checklists of the Audiovisual Consent Process: An Ethical Perspective.

Clinical trial regulations for new drugs in India released a gazette notification for obtaining audiovisual (AV) consent from all trial participants in November 2013. The reports of AV recordings of the studies from October 2013 to February 2017 submitted to the institutional ethics committee were analyzed in view of the Indian regulations on AV consenting. The reports of AV recording were checked: number of AV consents for each project, adequacy of AV recording, number of persons in the video, informed consent document elements (ICD) covered as per Schedule Y, confirmation of understanding by the participant, the time taken to complete the procedure, maintenance of confidentiality, and whether reconsent was taken. Seven studies of AV consent were monitored. Eighty-five (85) AV-consented and filled checklists were evaluated. The AV recording was not clear in 31/85, ICD elements were missing in 49/85 consents, time taken to complete the procedure was 20.03 ± 10.83 with the number of pages being 14.24 ± 7.52 (R= 0.29 p<0.041). In 19/85 consents, privacy was not maintained and on 22 occasions, reconsent were taken. There were deficits found in the AV consent process.

S-adenosyl methionine improves motor co-ordination with reduced oxidative stress, dopaminergic neuronal loss, and DNA methylation in the brain striatum of 6-hydroxydopamine-induced neurodegeneration in rats.

PURPOSE: Parkinson's disease (PD) is the most common age-related neurodegenerative disease worldwide. S-adenosyl methionine (SAMe), a methyl donor that plays an important role in DNA methylation, could replenish the cellular antioxidant glutathione (GSH). Herein, we investigated the neuroprotective effects of SAMe in 6-hydroxydopamine (6-OHDA) rat models of PD and elucidated the underlying mechanism. METHODS: PD model rats were developed by injecting 6-OHDA stereotaxically into the striatum. In Phase 1 of the study, we performed the neurobehavioral tests, GSH assay, and histopathology to evaluate the neuroprotective effects of SAMe. The animals were treated with SAMe (150 or 300 mg/kg body weight) orally for 28 days. The positive control group received selegiline (5 mg/kg), whereas the disease control group received normal saline. In Phase 2, we evaluated the striatal dopamine levels and performed DNA methylation assay to uncover the mechanism of action of SAMe. In this phase, a higher dose of SAMe (300 mg/kg) was used. RESULTS: SAMe (300 mg/kg) treatment for 4 weeks significantly attenuated the abnormal circling behavior in PD rats (p < 0.05). Moreover, SAMe at both doses (150 and 300 mg/kg) enhanced the performance of PD rats in the open field test and stepping test (p < 0.05). SAMe treatment significantly increased the GSH levels, and at high dose, SAMe restricted neuronal loss in the striatum of PD-model rats (p < 0.05). Moreover, SAMe treatment led to a significant recovery in the dopamine levels and improved the DNA methylation status in the dopaminergic neurons (p < 0.05) of PD model rats. CONCLUSION: SAMe exhibits antioxidant activity and DNA methylation modulating effects in 6-OHDA model PD rats. Moreover, SAMe prevents neuronal loss in PD rats suggesting that SAMe has therapeutic potential in preventing PD development. The neuroprotective potential of SAMe is greater at high doses.

Evaluation of Antidepressant Effect of Minocycline in Alcohol Abstinence-Induced Depression Model in Mice.

Introduction Depression is one of the common comorbidities seen in chronic alcohol use disorder. Also, alcohol withdrawal induces depression and anxiety, which is associated with relapse in alcohol consumption. Minocycline, a tetracycline derivative, has shown an antidepressant effect in preclinical models. However, their effect on alcohol withdrawal-induced depression has not been studied. Therefore, the current study has been undertaken to evaluate the effect of minocycline on alcohol abstinence-induced depression models in mice. Method We conducted the study in two models. C57bl/6 mice were given a two-bottle choice (alcohol + water) for 28 days. During alcohol abstinence of 14 days, mice were treated with 10 mg/kg, 30 mg/kg, and 50 mg/kg of minocycline and were evaluated for behavioral changes using the forced swim test (FST) and tail suspension test (TST). A sucrose preference test was carried out where mice were exposed to binge alcohol drinking protocol for 12 days, where a two-bottle choice (alcohol or water) was given. This was followed by exposing the mice to a two-bottle choice paradigm (alcohol + sucrose) and they were divided into groups - no treatment group, vehicle-treated, minocycline 30 mg/kg or minocycline 50 mg/kg treated - and consumption of sucrose was assessed. Result In the forced swim test, a significant decrease in immobility time (p<0.05) was observed in the high-dose minocycline group (82.75±19.09) as compared to the vehicle control group (128.12±35.44). In the tail suspension test also, a significant decrease in immobility time (p<0.05) was seen in the high-dose minocycline group (83.75±18.61) as compared to the vehicle control group (122.25±18.51). The water and alcohol intake were comparable among all groups. In the sucrose preference test, it was found that the minocycline 50 mg/kg group had the highest sucrose preference (55%) followed by the minocycline 30 mg/kg group (50%) as compared to 42% in the vehicle control group. Significant reduction in brain-derived neurotrophic factor (BDNF) levels was seen with minocycline 50 mg/kg (p<0.05) and minocycline 30 mg/kg group (p<0.05) in BDNF levels when compared to the normal control group. Conclusion Minocycline in a higher dose (50 mg/kg) has shown an effect in alcohol withdrawal-induced depression in the abstinence-induced two-bottle choice model in mice. Both doses of minocycline have shown an effect in the sucrose preference test in the alcohol withdrawal-induced depression model.

A Cross-Sectional, Questionnaire-Based Study on Drug Treatment Awareness in Schizophrenia Patients and Caregivers: An Unexplored Avenue.

Background: Schizophrenia is associated with high relapse rates, and medication nonadherence is a major factor contributing toward relapse. Since medication adherence and treatment awareness are linked, an alarming need was felt to evaluate the level of drug treatment awareness in patients who have schizophrenia. Besides, patients who have schizophrenia are often dependent on their caregivers for medications. Hence, the current study was also designed to look into drug treatment awareness among caregivers. Methods: This was a cross-sectional, questionnaire-based study. Patients diagnosed with schizophrenia as per The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition were included, provided they had good insight and had been prescribed medications at the study center for at least three months. Caregivers were included using the Pollak and Perlick criteria. The sociodemographic profile of the patients and caregivers was recorded, and further assessment for treatment awareness was done using the prevalidated Drug Treatment Awareness Questionnaire (DTAQ). Results: A total of 166 patients and 157 caregivers were enrolled. Mean drug awareness scores among patients and caregivers did not show statistically significant differences (P= 0.22). Mean ± SD DTAQ awareness scores in patients and caregivers were 12.57 ± 1.81 and 12.84 ± 1.91, respectively. The majority of patients and caregivers (> 90%) possessed awareness in domains related to past medication records and in that of re-visit/re-contact instructions. Awareness was least commonly seen in relation to side effects of medications and details of the prescribed medications, where only about 50% of patients and caregivers possessed awareness. No clinically significant correlation was found between sociodemographic factors and drug treatment awareness scores. Conclusion: Drug treatment awareness in patients and caregivers was comparable and was not reliant on the sociodemographic factors. Special interventions should be conducted to raise drug treatment awareness among patients having insight and their caregivers.

Antipsychotic Drug Utilization and Adverse Drug Reaction Profiling in Patients With Schizophrenia at a Tertiary Care Hospital in Western India.

Introduction Prescription pattern studies conducted in patients with schizophrenia have shown variability in the utilization of antipsychotics based on the geographical location of the study setting. Moreover, there is only a sparse number of studies specifically related to adverse drug reactions (ADRs) in schizophrenia. Hence, a need was felt to study the antipsychotic utilization pattern and adverse drug reactions in patients with schizophrenia in our setting. Methods This was a cross-sectional, observational study conducted at the psychiatry outpatient department (OPD) of a tertiary care hospital in India. Patients diagnosed to have schizophrenia as per the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) were included in the study provided they had been prescribed antipsychotic medications at the study center for at least three months. The sociodemographic profile of the patients and caregivers was recorded, and prescription pattern assessment was done using WHO core drug use indicators. Information related to ADRs was recorded, and further assessment was done based on the causality, severity, and preventability of ADRs. Results A total of 250 patients were enrolled in the study. Risperidone (40.25%) and olanzapine (26.32%) were the most commonly prescribed antipsychotic drugs, while trihexyphenidyl was the most frequently prescribed concomitant medication. Among the 37 cases of adverse drug reactions that were recorded, amenorrhea, sedation, and weight gain were found to be the most common. The majority of ADRs were of mild severity in addition to being non-preventable. Conclusion It was observed that atypical antipsychotics were commonly prescribed in the study center, and the majority of the ADRs were mild and not preventable, which shows the adequacy of prescribing practices in the current setting.

A Study to Assess the Quality of Reporting of Animal Research Studies Published in PubMed Indexed Journals: A Retrospective, Cross-Sectional Content Analysis.

OBJECTIVES: A complete and concise pre-clinical experimental research gives detailed information about the disease-specific model, prevents duplication, and saves animal life, money, as well as time. It will also allow readers to effectively interpret and evaluate the work and ensure that others can replicate the experiments described. The present study was conducted to assess the adequacy of animal details provided in published experimental animal studies. METHODS:  All in vivo studies published as full-text articles in two PubMed indexed journals (one Indian and one international) from January 2011 to December 2019 and satisfying the inclusion norms were included. A checklist consisting of 27 discrete items subdivided under three domains, viz. animal details, disease model, and guidelines, was used. Every article was assessed by two investigators independently for determining the reporting quality. RESULTS:  One hundred and seventy-seven studies satisfied the inclusion criteria. Age or age range was reported in 20.34% of the articles in the Indian journal and 5.88% articles in the international journal (p=0.019). Housing and husbandry details were reported in all the articles published in the international journal and 82.7% of the articles in the Indian journal (p=0.001). The disease/pathology studied was given in 70.62% of articles published in the Indian journal and 86.27% of articles published in the international journal (p=0.029). None of the studies provided details of genetic modification, health status, sample size calculation, steps taken to minimize bias, and implementation of randomization. CONCLUSION: There is a need for optimal reporting of certain relevant animal details, disease models, experimental procedures, sample size calculation, and adherence to guidelines by the researchers for which the reporting was found to be sub-par to improve reproducibility and validity of animal research.

Drug use pattern for emergency psychiatric conditions in a tertiary care hospital: A prospective observational study.

PURPOSE: Psychiatric emergencies (PEs) are defined as acute disturbances of thought, mood, behavior, or social relationships requiring immediate interventions. The common emergency psychiatrics are attempted suicide, severe anxiety, schizophrenia, acute psychosis, substance abuse, acute panic attacks, drug toxicities, and extrapyramidal reactions. Emergency physicians in the general hospital may face the challenge of assessing and managing patients in PEs. This study was conducted to evaluate the clinical pattern and drug use pattern for PEs at a tertiary care hospital. MATERIALS AND METHODS: This was a cross-sectional, observational study where patients presenting to emergency medical services of a tertiary care hospital were recruited after approval from Institutional Ethics Committee and written informed consent. Demographic details, diagnosis, medication details, cost of the treatment, and adherence to guidelines in the management of emergency psychiatric conditions were assessed using a validated questionnaire. Descriptive statistics was applied to analyze the data. RESULTS: In 110 patients, a total number of drugs prescribed were 463 (mean: 4.21 drugs/prescription). The most commonly used psychotropic drug in emergency setting was found to be risperidone (19.39%), followed by lorazepam (13.60%) and clonazepam (4.28%). The most common diagnoses were substance abuse (32.72%) and schizophrenia (21.81%). About 74.5% of the physicians prescribed drugs abiding by the standard guidelines. The average total cost incurred by patients was about Rs. 366. CONCLUSION: The most commonly used drugs in emergency treatment found in this study are risperidone, followed by lorazepam and haloperidol.

Assessing completion reports for compliance with institutional ethics committee-approved protocols: An observational study.

BACKGROUND: Protocol non-compliance in clinical research studies is common and can affect both patient safety and data integrity. There are no published studies which actively looked for non-compliance. The present study was carried out, against this background, with the objective of assessing the proportion of protocol non-compliance and evaluating those aspects of protocol where there was non-compliance. METHODS: The study completion reports that were submitted to the institutional ethics committee for the period January 2017 to December 2017 were compared with the approved protocol. A checklist for recording protocol non-compliance was developed, which was validated by five experts and consisted of a 12-point checklist with responses such as yes, no, not applicable, and insufficient information. RESULTS: Out of 193 studies, prospective observational studies were n = 120 (62.17 %), retrospective studies were n = 39 (20.21%), interventional studies n = 28 (14.51 %), and observational studies with both prospective and retrospective study design were n = 6 (3.11%). The study objective was modified in n=18 (9.32%) studies. Only n = 14 (7.24%) satisfied the selection criteria. Six studies (3.10%) did not collect the data as mentioned in the protocol. Fifty-eight studies (30.05%) did not achieve the calculated sample size, whereas n = 78 (40.41%) did not complete the study as per the stipulated study duration. Contrary to 180 protocol deviations found in this study, only 14 protocol deviations were reported by the principal investigator. Aspects like blinding and randomisation, which are relevant to interventional studies (n = 28), showed 100 % compliance. CONCLUSION: The research protocol is not adhered to in all aspects. Adequate training to investigators will help prevent non-compliance and enable us to conduct studies with higher ethical and scientific integrity.

Reports of site monitoring visits by institutional ethics committees in an Indian tertiary care hospital: A retrospective analysis.

The monitoring of clinical trials is an integral function of the institutional ethics committee (IEC)to ensure the ethical conduct of research. The National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017, of the Indian Council of Medical Research, underline a strong need for active monitoring of clinical trials. A previous study by the authors, of research studies initiated between 2008 and 2010, had found many lapses after site monitoring. In the present study, 12 clinical studies-both sponsored and investigator initiated-were monitored by members of the King Edward Memorial Hospital (Mumbai) IEC between 2011 and 2017. The most common violations seen were related to informed consent (8/12 sites). The other violation themes were lack of investigator understanding of protocol (6/12), deviation from the investigational plan (5/12), non-reporting of the study's progress to the IEC (4/12), and patient recruitment prior to IEC approval (2/12). The IEC took various corrective actions, such as ordering retaking of consent and good clinical practice (GCP) re-training and requiring interim reports, explanations for deviations, upgradation of facilities, and payment of pending compensation. The IEC even froze review of protocols from a frequently defaulting Principal Investigator's (PI) site and put study recruitment on hold for the same PI. This study demonstrates that active site monitoring by IECs is a must for ensuring the ethical conduct of studies.

Perception of postgraduate students in pharmacology toward animal simulation model.

OBJECTIVE: The objective of the study is to evaluate the perception of postgraduate pharmacology students toward computer-simulated method (CSM) in comparison to the prevalent isolated live tissue-based bioassay method. MATERIALS AND METHODS: A questionnaire-based survey was conducted in 30 postgraduate pharmacology students who had used the animal simulation software and had completed at least five isolated tissue experiments. Students' opinions on the usage, logistics, advantages, disadvantages, and usefulness of CSM compared to live animal experiments (LAE) were analyzed. RESULTS: Four tissues were used for LAE, whereas with CSM, students could perform experiments using 11 different tissues. Of the total nine bioassay methods, students had performed six assay methods using both LAE and CSM. Majority of the students (23/30) agreed that CSM reduces anxiety, technical errors and is less time consuming when used before LAE. Most of the students agreed that CSM can be used for difficult, lengthy experiments (19/30), and for UG/PG teaching (19/30). However, opinions regarding replacing LAE with CSM in PG teaching were divided (agree: 7, neutral: 12, and disagree: 12). CONCLUSION: CSM should be integrated alongside LAE to complement, reinforce, and enhance learning from other techniques.

Intra-articular injections of ketamine and 25% dextrose improve clinical and pathological outcomes in the monosodium iodoacetate model of osteoarthritis.

BACKGROUND: The study evaluated the effect of intra-articular injections of ketamine and 25% dextrose with triamcinolone acetate (TA) and hyaluronic acid (HA) on joint pathology and pain behavior in monosodium iodoacetate (MIA)-induced osteoarthritis (OA) in experimental mice. METHODS: In phase I, the MIA-induced OA model was standardized. In phase II, mice were divided into three groups: disease controls (DC), ketamine 12 mg/kg (K12) and ketamine 24 mg/kg (K24) to select an effective dose of ketamine for phase III. In phase III, the groups were: DC, normal controls (NC), K24, 25% dextrose (D25) - 10 µL, TA 6 mg/kg, and HA - 3.5 mg/kg. The effect of ketamine was compared with the standard drugs - TA and HA. In phases II and III, after 7 days following the induction of OA, animals were subjected to weekly behavioral tests and biweekly drug administration from week 2 to week 4. Subsequently, after 4 weeks knee joint samples were collected and sent for histopathological evaluation to a veterinary pathologist. RESULTS: In phase I, the DC group showed significant OA changes as compared to NC on knee joint histopathology scoring. In phase II, all the behavioral tests and knee joint histopathology results demonstrated a significant improvement with K24 as compared to DC. In phase III, significant differences were found between DC vs. HA, DC vs. D25, DC vs. K24, K24 vs. TA, HA vs. TA for open field test and hot plate test (p<0.001), whereas HA and ketamine showed comparable results for these tests. There was a significant improvement in D25, TA and K24, HA groups as compared to DC in histopathology scores, (p<0.05). CONCLUSIONS: The NMDA antagonist effect of ketamine and the proliferative effect of 25% dextrose showed a reduction in pain and disease activity in the OA model.

Implementation of a module to promote competency in adverse drug reaction reporting in undergraduate medical students.

OBJECTIVES: Underreporting and poor quality of adverse drug reaction (ADR) reports pose a challenge for the Pharmacovigilance Program of India. A module to impart knowledge and skills of ADR reporting to MBBS students was developed and evaluated. MATERIALS AND METHODS: The module consisted of (a) e-mailing an ADR narrative and online filling of the "suspected ADR reporting form" (SARF) and (b) a week later, practical on ADR reporting was conducted followed by online filling of SARF postpractical at 1 and 6 months. SARF was an 18-item form with a total score of 36. The module was implemented in the year 2012-2013. Feedback from students and faculty was taken using 15-item prevalidated feedback questionnaires. The module was modified based on the feedback and implemented for the subsequent batch in the year 2013-2014. The evaluation consisted of recording the number of students responding and the scores achieved. RESULTS: A total of 171 students in 2012-2013 batch and 179 in 2013-2014 batch participated. In the 2012-2013 batch, the number of students filling the SARF decreased from basal: 171; 1 month: 122; 6 months: 17. The average scores showed improvement from basal 16.2 (45%) to 26.4 (73%) at 1 month and to 27.3 (76%) at 6 months. For the 2013-2014 batch, the number (n = 179) remained constant throughout and the average score progressively increased from basal 10.5 (30%) to 27.8 (77%) at 1 month and 30.3 (84%) at 6 months. CONCLUSION: This module improved the accuracy of filling SARF by students and this subsequently will led to better ADR reporting. Hence, this module can be used to inculcate better ADR reporting practices in budding physicians.

Impact of recent regulatory notifications on an institutional ethics committee.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court's orders and a Parliamentary Standing Committee's report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee's (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants' safety and well-being.

Evaluation of antiepileptic effect of S-adenosyl methionine and its role in memory impairment in pentylenetetrazole-induced kindling model in rats.

BACKGROUND: Epilepsy is the third most common cause of neurological disability worldwide. Despite the introduction of antiepileptic drugs (AEDs) in the past 20years, the seizures of around 30% of patients with epilepsy remain refractory to available treatment. Also, available AEDs and the disease itself have the potential to exert detrimental effects on cognitive function and therefore compromise patient wellbeing. S-adenosyl methionine has potential antiepileptic and memory-enhancing properties because of its involvement in the transmethylation reaction. OBJECTIVES: The present study was designed to evaluate the antiepileptic effect of S-adenosyl methionine and its role in memory impairment in the pentylenetetrazole (PTZ)-induced kindling model in rats. MATERIALS AND METHODS: The antiepileptic effect of 2 doses of SAM (50 and 100mg/kg) was tested by evaluating seizure severity score and seizure latency in the pentylenetetrazole-induced kindling model in rats. At the end of the study, spatial memory was evaluated in an elevated plus maze (EPM) test, and animals were sacrificed for estimation of oxidative stress markers in brain tissue homogenate. RESULTS: A higher dose of SAM (100mg/kg) exhibited an increase in seizure latency and a decrease in seizure severity score, suggesting its antiepileptic activity in the PTZ-induced kindling model. Also, the administration of SAM (50 and 100mg/kg) showed a decrease in transfer latency in the EPM test compared to the disease control group (p<0.0001). Biochemical analysis of rat brain tissue revealed significantly decreased malondialdehyde (p<0.0001) and increased glutathione (GSH) (p<0.0001) in the SAM 100-mg/kg group compared with that in the disease control group. CONCLUSION: The results demonstrated that S-adenosyl methionine exerts antiepileptic, memory-enhancing, and antioxidant properties in a pentylenetetrazole-induced kindling model of epilepsy.

An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI) for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD) and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47). Maximum study procedure related PDs were due to patient visiting outside window period (126/304). Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447). The most common corrective actions stated by PI were participant counseling (85/323) and caution in future (70/323). The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.

Development of active learning modules in pharmacology for small group teaching.

BACKGROUND: Current teaching in pharmacology in undergraduate medical curriculum in India is primarily drug centered and stresses imparting factual knowledge rather than on pharmacotherapeutic skills. These skills would be better developed through active learning by the students. Hence modules that will encourage active learning were developed and compared with traditional methods within the Seth GS Medical College, Mumbai. METHODS: After Institutional Review Board approval, 90 second year undergraduate medical students who consented were randomized into six sub-groups, each with 15 students. Pre-test was administered. The three sub-groups were taught a topic using active learning modules (active learning groups), which included problems on case scenarios, critical appraisal of prescriptions and drug identification. The remaining three sub-groups were taught the same topic in a conventional tutorial mode (tutorial learning groups). There was crossover for the second topic. Performance was assessed using post-test. Questionnaires with Likert-scaled items were used to assess feedback on teaching technique, student interaction and group dynamics. RESULTS: The active and tutorial learning groups differed significantly in their post-test scores (11.3 ± 1.9 and 15.9 ± 2.7, respectively, P < 0.05). In students' feedback, 69/90 students had perceived the active learning session as interactive (vs. 37/90 students in tutorial group) and enhanced their understanding vs. 56/90 in tutorial group), aroused intellectual curiosity (47/90 students of active learning group vs. 30/90 in tutorial group) and provoked self-learning (41/90 active learning group vs. 14/90 in tutorial group). Sixty-four students in the active learning group felt that questioning each other helped in understanding the topic, which was the experience of 25/90 students in tutorial group. Nevertheless, students (55/90) preferred tutorial mode of learning to help them score better in their examinations. DISCUSSION: In this study, students preferred an active learning environment, though to pass examinations, they preferred the tutorial mode of teaching. Further efforts are required to explore the effects on learning of introducing similar modules for other topics.

Probiotics: current trends in the treatment of diarrhoea.

In recent years, research into and public interest in probiotics and probiotic foods have risen. Lactobacilli and bifidobacterium are the most commonly used probiotics while yoghurt and kefir are popular foods containing probiotics. Probiotics have been used to manage diarrhoea. Many things cause diarrhoea, including bacterial, viral and protozoal infections, radiation and antibiotic therapy. Different studies have found that probiotics may also enhance the immune response, reduce serum cholesterol, prevent colonic cancer, prevent dental caries, prevent ulcers due to Helicobacter pylori, maintain urogenital health, and ameliorate hepatic encephalopathy. Further studies are required to establish their role in these conditions.