Sajesh K. Veettil

Study of Drug Utilization Pattern for Acute Exacerbation of Chronic Obstructive Pulmonary Disease in Patients Attending a Government Hospital in Kerala, India

Objective: Drug utilization studies are powerful exploratory tools to ascertain the role of drugs in society. This study was conducted to establish the drug utilization pattern and the common adverse drug reactions for the treatment of acute exacerbation of chronic obstructive pulmonary disease (COPD) in one of the government hospitals in Kerala, India. Methods: This was a prospective observational study aimed at recognizing the drug utilization pattern for the treatment of acute exacerbation of COPD for 7-day under nonexperimental settings. All information significant to the study was collected from the case records and discussions conducted with the inpatients and bystanders during ward rounds, with the support of a physician. Moreover, daily follow-ups were conducted to assemble data on amendment in therapy, add-on therapy, and clinical improvement until the patient was discharged from the hospital or to an upper limit of 7-day, whichever is earlier. Results: All the patients in this study received combination therapy. Among the inhalational β-agonists, salbutamol accounted for 74% use. Parenteral steroids were used in 78% of the patients and all of them received hydrocortisone. Steroid inhalers were used only in 25% of the patients. Anticholinergics were used in 77.5% of patients. Antibiotics were used in 86.7% patients. The main adverse effects noted were dry mouth (15%) and bad taste (10%) and these adverse effects were highly correlated with the use of anticholinergics (P < 0.05). Conclusions: Despite the use of drugs according to the availability and physicians preference, it was found in the analysis that majority were in accordance with Global Initiative for Chronic Obstructive Lung Disease criteria recommendations.

Standard setting in OSCEs: a borderline approach.

The evaluation of clinical skills and competencies is a high‐stakes process carrying significant consequences for the candidate. Hence, it is mandatory to have a robust method to justify the pass score in order to maintain a valid and reliable objective structured clinical examination (OSCE). The aim was to trial the borderline approach using the two‐domain global rating scale for standard setting in the OSCE.

Comparative effectiveness of chemopreventive interventions for colorectal cancer: protocol for a systematic review and network meta-analysis of randomised controlled trials

BACKGROUND Colorectal cancer (CRC) is the third most common cancer worldwide and is associated with substantial socioeconomic burden. Despite considerable research, including numerous randomised controlled trials (RCTs) and systematic reviews assessed the effect of various chemopreventive interventions for CRC, there remains uncertainty regarding the comparative effectiveness of these agents. No network meta-analytic study has been published to evaluate the efficacies of these agents for CRC. Therefore, the aim of this study is to summarise the direct and indirect evidence for these interventions to prevent CRC in average-high risk individuals, and to rank these agents for practical consideration. METHODS We will acquire eligible studies through a systematic search of MEDLINE, EMBASE, the Cochrane Central Registry of Controlled Trials, CINAHL plus, IPA and clinicaltrials.gov website. The Cochrane Risk of Bias Tool will be used to assess the quality of included studies. The primary outcomes are the incidence of CRC, the incidence/recurrence of any adenoma or change in polyp burden (number or size). Quantitative synthesis or meta-analysis will be considered. We will also construct a network meta-analysis (NMA) to improve precision of the comparisons among chemo-preventive interventions by combining direct and indirect evidence. The probability of each treatment being the best and/or safest, the number-needed-to-treat [NNT; 95% credible interval (CrIs)], and the number-needed-to-harm (NNH; 95% CrIs) will be calculated to provide measures of treatment efficacy. The GRADE approach will be used to rate the quality of evidence of estimates derived from NMA. RESULTS This protocol has been registered (registration number: CRD42015025849) with the PROSPERO (International Prospective Register of Systematic Reviews). The procedures of this systematic review and NMA will be conducted in accordance with the PRISMA-compliant guideline. The results of this systematic review and NMA will be submitted to a peer-reviewed journal for publication. CONCLUSIONS To the best of our knowledge, this study will be the first NMA to identify the comparative effectiveness of interventions for the prevention of CRC. The results of our study will update evidence for chemoprevention of CRC, identify key areas for future research, and provide a framework for conducting large systematic reviews involving indirect comparisons.

Effects of chemopreventive agents on the incidence of recurrent colorectal adenomas: a systematic review with network meta-analysis of randomized controlled trials

Background Protective effects of several chemopreventive agents (CPAs) against colorectal adenomas have been well documented in randomized controlled trials (RCTs); however, there is uncertainty regarding which agents are the most effective. Methods We searched for RCTs published up until September 2016. Retrieved trials were evaluated using risk of bias. We performed both pairwise analysis and network meta-analysis (NMA) of RCTs to compare the effects of CPAs on the recurrence of colorectal adenomas (primary outcome). Using NMA, we ranked CPAs based on efficacy. Results We identified 20 eligible RCTs enrolling 12,625 participants with a history of colorectal cancer or adenomas who were randomly assigned to receive either a placebo or one of 12 interventions. NMA using all trials demonstrated that celecoxib 800 mg/day (relative risk [RR] 0.61, 95% confidence interval [CI] 0.45–0.83), celecoxib 400 mg/day (RR 0.70, 95% CI 0.55–0.87), low-dose aspirin (RR 0.75, 95% CI 0.59–0.96) and calcium (RR 0.81, 95% CI 0.69–0.96) were significantly associated with a reduction in the recurrence of any adenomas. NMA results were consistent with those from pairwise meta-analysis. The evidence indicated a high (celecoxib), moderate (low-dose aspirin) and low (calcium) Grading of Recommendations, Assessment, Development and Evaluation (GRADE) quality. NMA ranking showed that celecoxib 800 mg/day and celecoxib 400 mg/day were the best CPAs, followed by low-dose aspirin and calcium. Considering advanced adenoma recurrence, only celecoxib 800 mg/day and celecoxib 400 mg/day were demonstrated to have a protective effect (RR 0.37, 95% CI 0.27–0.52 vs RR 0.48, 95% CI 0.38–0.60, respectively). Conclusion The available evidence from NMA suggests that celecoxib is more effective in reducing the risk of recurrence of colorectal adenomas, followed by low-dose aspirin and calcium. Since cyclooxygenase-2 (COX-2) inhibitors (eg, celecoxib) are associated with important cardiovascular events and gastrointestinal harms, more attention is warranted toward CPAs with a favorable benefit-to-risk ratio, such as low-dose aspirin and calcium.

Efficacy of Biodentine and Mineral Trioxide Aggregate in Primary Molar Pulpotomies—A Systematic Review and Meta-Analysis With Trial Sequential Analysis of Randomized Clinical Trials

Objectives Pulpotomy is the favored treatment for pulp exposure in carious primary teeth. This review aimed to compare the success rates of biodentine (BD) and mineral trioxide aggregate (MTA) pulpotomies in primary molars using meta‐analysis (MA) and trial sequential analysis (TSA) and also to assess the quality of the results by Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Methods PubMed, EBSCOhost, and Scopus databases were searched. Additional searching was performed in clinical trial registry, reference lists of systematic reviews, and textbooks. Randomized clinical trials (RCTs) published in the English language through October 2017 comparing the success of pulpotomies in vital primary molars with a follow‐up of at least 6 months were selected. Study selection, data extraction, and risk of bias assessment were performed. MA by random effects model, TSA, and GRADE were performed. Results Eight RCTs (n = 474) were included. Two RCTs had low risk of bias. No significant difference was observed between MTA and BD in clinical success at 6 months (risk ratio [RR], 1.00; 95% confidence interval [95% CI], 0.97–1.02; I2 = 0%), 12 months (RR, 1.00; 95% CI, 0.96–1.05; I2 = 0%), and 18 months (RR, 1.00; 95% CI, 0.93–1.08; I2 = 0%). No difference was observed in radiographic success at follow‐up of 6 months (RR, 0.99; 95% CI, 0.96–1.02; I2 = 0%), 12 months (RR, 1.02; 95% CI, 0.47–2.21; I2 = 0%), and 18 months (RR, 1.02; 95% CI, 0.91–1.15; I2 = 0%). TSA indicated lack of firm evidence for the results of the meta‐analytic outcomes on clinical and radiographic success. GRADE assessed the evidence from the MA comparing the effect of MTA and BD in pulpotomy to be of low quality. Conclusion BD and MTA have similar clinical and radiographic success rates based on limited and low‐quality evidence. Future high‐quality RCTs between MTA and BD is required to confirm the evidence.

Effect of Nonsteroidal Anti-inflammatory Drug as an Oral Premedication on the Anesthetic Success of Inferior Alveolar Nerve Block in Treatment of Irreversible Pulpitis: A Systematic Review with Meta-analysis and Trial Sequential Analysis

Introduction: Successful anesthesia with an inferior alveolar nerve block (IANB) is imperative for treating patients with irreversible pulpitis in mandibular teeth. This systematic review assessed the efficacy of nonsteroidal anti‐inflammatory drugs (NSAIDs) as oral premedications on the success of IANBs in irreversible pulpitis. Methods: Three databases were searched to identify randomized clinical trials (RCTs) published up until September 2017. Retrieved RCTs were evaluated using the revised Cochrane Risk of Bias Tool. The primary efficacy outcome of interest was the success rate of IANB anesthesia. Meta‐analytic estimates (risk ratio [RR] with 95% confidence intervals [CIs]) performed using a random effects model and publication bias determined using funnel plot analysis were assessed. Random errors were evaluated with trial sequential analyses, and the quality of evidence was appraised using a Grading of Recommendations, Assessment, Development and Evaluation approach. Results: Thirteen RCTs (N = 1034) were included. Eight studies had low risk of bias. Statistical analysis of good‐quality RCTs showed a significant beneficial effect of any NSAID in increasing the anesthetic success of IANBs compared with placebo (RR = 1.92; 95% CI, 1.55–2.38). Subgroup analyses showed a similar beneficial effect for ibuprofen, diclofenac, and ketorolac (RR = 1.83 [95% CI, 1.43–2.35], RR = 2.56 [95% CI, 1.46–4.50], and RR = 2.07 [95% CI, 1.47–2.90], respectively). Dose‐dependent ibuprofen >400 mg/d (RR = 1.85; 95% CI, 1.39–2.45) was shown to be effective; however, ibuprofen ≤400 mg/d showed no association (RR = 1.78; 95% CI, 0.90–3.55). TSA confirmed conclusive evidence for a beneficial effect of NSAIDs for IANB premedication. The Grading of Recommendations, Assessment, Development and Evaluation approach did not reveal any concerns regarding the quality of the results. Conclusions: Oral premedication with NSAIDs and ibuprofen (>400 mg/d) increased the anesthetic success of IANBs in patients with irreversible pulpitis. HIGHLIGHTSA systematic review of the effects of oral premedication for inferior alveolar nerve block identified 13 RCTs.NSAIDs increase inferior alveolar nerve block success in irreversible pulpitis.Trial sequential analysis confirmed meta‐analytic results.

Efficacy and safety of chemopreventive agents on colorectal cancer incidence and mortality: systematic review and network meta-analysis.

Background Various interventions have been tested as primary prevention of colorectal cancers (CRC), but comprehensive evidence comparing them is absent. We examined the effects of various chemopreventive agents (CPAs) on CRC incidence and mortality. Methods We did a network meta-analysis based on a systematic review of randomized controlled trials (RCTs) that compared at least one CPA (aspirin, antioxidants, folic acid, vitamin B6, vitamin B12, calcium, vitamin D, alone or in combination) to placebo or other CPA in persons without history of CRC. Several databases were searched from inception up to March 2017. Primary outcomes were early and long-term CRC incidence and mortality. Results Twenty-one RCTs comprising 281,063 participants, 9 RCTS comprising 160,101 participants, and 7 RCTs comprising 24,001 participants were included in the network meta-analysis for early risk of CRC incidence, long-term risk of CRC incidence and mortality, respectively. For early CRC incidence, no CPAs were found to be effective. For long-term CRC incidence and mortality, aspirin was the only intervention that showed protective effects with potential dose-dependent effects (risk ratio [RR], 0.74 [95% CI, 0.57–0.97] for high-dose [≥325 mg/day] and RR, 0.81 [95% CI, 0.67–0.98] for very-low-dose [≤100 mg/day]). Similar trend was found for mortality (RR, 0.43 [95% CI, 0.23–0.81] for low-dose [>100–325 mg/day] and RR, 0.65 [95% CI, 0.45–0.94] for very-low-dose). However, in net clinical benefit analysis, when combining risk estimates on mortality from CRC, cardiovascular disease, and pooled risk estimates of major gastrointestinal bleeding, low-dose aspirin provided the highest net survival gain (%) of 1.736 [95% CI, 1.010–2.434]. Conclusion Aspirin at the dose range of 75–325 mg/day is a safe and effective primary prevention for long-term CRC among people at average risk. None of the other CPAs were found to be effective. There may potentially be differential effects among various doses of aspirin that needs further investigation.

Effects of calcium on the incidence of recurrent colorectal adenomas: A systematic review with meta-analysis and trial sequential analysis of randomized controlled trials.

Background: Protective effects of calcium supplementation against colorectal adenomas have been documented in systematic reviews; however, the results have not been conclusive. Our objective was to update and systematically evaluate the evidence for calcium supplementation taking into consideration the risks of systematic and random error and to GRADE the evidence. Methods: The study comprised a systematic review with meta-analysis and trial sequential analysis (TSA) of randomized controlled trials (RCTs). We searched for RCTs published up until September 2016. Retrieved trials were evaluated using risk of bias. Primary outcome measures were the incidences of any recurrent adenomas and of advanced adenomas. Meta-analytic estimates were calculated with the random-effects model and random errors were evaluated with trial sequential analyses (TSAs). Results: Five randomized trials (2234 patients with a history of adenomas) were included. Two of the 5 trials showed either unclear or high risks of bias in most criteria. Meta-analysis of good quality RCTs suggest a moderate protective effect of calcium supplementation on recurrence of adenomas (relative risk [RR], 0.88 [95% CI 0.79–0.99]); however, its effects on advanced adenomas did not show statistical significance (RR, 1.02 [95% CI 0.67–1.55]). Subgroup analyses demonstrated a greater protective effect on recurrence of adenomas with elemental calcium dose ≥1600 mg/day (RR, 0.74 [95% CI 0.56–0.97]) compared to ⩽1200 mg/day (RR, 0.84 [95% CI 0.73–0.97]). No major serious adverse events were associated with the use of calcium, but there was an increase in the incidence of hypercalcemia (P = .0095). TSA indicated a lack of firm evidence for a beneficial effect. Concerns with directness and imprecision rated down the quality of the evidence to “low.” Conclusion: The available good quality RCTs suggests a possible beneficial effect of calcium supplementation on the recurrence of adenomas; however, TSA indicated that the accumulated evidence is still inconclusive. Using GRADE-methodology, we conclude that the quality of evidence is low. Large well-designed randomized trials with low risk of bias are needed.

A cross-sectional study on knowledge and attitude toward Traditional Chinese Medicine (TCM) among adults in selected regions of Malaysia.

Abstract Background: The objectives of this study were to determine the knowledge and attitude of adult Malaysians about Traditional Chinese Medicine (TCM), to understand the variation in the knowledge and attitude toward TCM among different demographic groups of adult Malaysian population and to determine the pattern of TCM use among adult Malaysians. Methods: This study was a descriptive, cross-sectional survey using the convenience sampling method. A total of 400 adult Malaysians were recruited for this study. An interview-administered questionnaire was used. Descriptive statistics Mann-Whitney U Test and Kruskal–Wallis H test were used to analyze the data. The reliability of survey data in this study may affect since closed-ended questions are used. Results: The more commonly utilized therapy was herbal medicine (n=192, 82.1%), acupuncture (n=79, 33.8%) and oriental massage (n=58, 24.8%). The mean knowledge score and mean attitude score for the respondents were 5.00±1.71 and 7.17±2.10 respectively. There was a significant difference in the mean knowledge score between genders, among TCM users and non-TCM users, people of different education levels and ethnicity. Conclusions: There were more TCM users than non-TCM users and the use of TCM was higher in females than males. The most popularly used TCM modalities were herbal medicines and acupuncture. Gender, education, ethnicity and use of TCM had a significant effect on adults’ knowledge toward TCM.

Psychological impotence: Psychological erectile dysfunction and erectile dysfunction causes, diagnostic methods and management options

Psychological impotence or erectile dysfunction is nowadays a pretty common yet misunderstood disorder. People often cannot detect it properly and misunderstood it for physical impotence. Psychological impotence is basically caused by psychological problems. Most of the times, this kind of impotence are curable. Recent study has shown that most of the cases of impotence are basically of this nature. Numbers of sexual problems were found to be frequent. Physical, social/emotional, and relationship factors were all found to have a significant impact on the prevalence of one or more sexual problems. In addition, we observed an important gender difference: increasing age was more consistently associated with sexual problems among men. Thus, sexual problems among women and men appear to share similar correlates, but physical factors may play a larger role among men. However, as men age, there may be more psychological and relationship issues as well that influence their sexual satisfaction and performance.