Context: Randomized controlled trials (RCTs) are among the cornerstones for generation of high-quality clinical evidence. However, incomplete or biased reporting of trials can hamper the process of review of trials and their results. Outcome switching, intentional, or otherwise leads to biased reporting and can result in false inferences. Aims: The aim of this study was to analyze the completeness of reporting Consolidated Standards of Reporting Trials (CONSORT) 2010 checklist items and detect if outcome switching had occurred. Settings and Design: This cross-sectional study was conducted in the department of pharmacology. Methods: Online editions of journals published by the Indian association of medical specialties from 2017 to 2019 were accessed, and the full-text versions of the published RCTs in them were downloaded. Reporting of each item in the CONSORT checklist was recorded. The effect of trial registration and CONSORT endorsement on reporting of key methodological parameters was also determined. Protocols of registered trials were accessed, and the outcome switching was assessed. Statistical Analysis Used: Descriptive statistics were used to summarize the data. Results: Average completeness of reporting has significantly improved from 2017 to 2019. Major areas of underreporting were generalizability, protocol availability, trial registration, date of recruitment, allocation concealment, and the patient flow diagram. CONSORT endorsing journals had worse, whereas registered trials had better reporting of key methodological indicators. No overt switching of outcomes was observed in 84 out of 86 registered trials where trial protocols were available online for comparison. Conclusions: Quality of clinical trial reporting in the Indian medical journals has improved but remains inadequate. CONSORT nonendorsement prevents completeness of trial reporting.

Background: Diabetes is a chronic disorder which requires long-term treatment. Non-adherence to treatment is a major factor responsible for morbidities and mortalities associated with diabetes. Complementary and alternative medicine (CAM) use has been one of the reasons for discontinuation of treatment. This study was conducted to assess the extent to which CAM and non-CAM users adhere to medical treatment. Methods: 200 patients attending the diabetic clinic over a period of 2 months participated in the study. After obtaining written informed consent, they were administered a CAM use and satisfaction questionnaire (TSQM) based on effectiveness, no side-effects, convenience and global satisfaction. Results: Out of 200 participants, 29% (58) used CAM. Naturopathy was the most commonly followed type of CAM (60 %; 35). Residing in the rural areas (OR-3.7), Socio-economic status above poverty line (OR-9), diabetics with comorbidities (OR-6) and microvascular complications (OR-6) and using insulin (OR-3) was found to be the predictors of CAM use. However, the incidence of hypoglycemic episodes was 52 times higher among CAM users. (91%; 52) of the CAM users did not reveal the use to their physicians, out of which (70%; 40) did not disclose due to the fear of discouragement by the doctor. CAM was found to be better in all aspects of patient satisfaction like effectiveness, noside-effects and global satisfaction than conventional medicine while conventional medicine users scored it to be more convenient to use than CAM. Conclusions: Doctors should enquire diabetics regarding CAM use since the voluntary disclosure is very less. Keeping lines of communication open for any discussions regarding pros and cons of CAM. Increasing patient awareness about potential drug interactions, when CAM is practised along with conventional medicine.

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Objective: The objective of the study was to evaluate the role of the herbal immunomodulators Immusante and Guduchi in boosting the immunity and overall health of healthcare workers assigned to coronavirus disease 2019 (COVID-19) wards. Methods: An open-label, randomized, prospective, and single center clinical study was conducted among 100 healthcare workers assigned to COVID-19 wards. Eligible subjects (50 in each arm) were randomly assigned to either arm I (Immusante+Guduchi tablets) or arm II (treatment as per the institutional policy). Assessments after 30 days of treatment included respiratory symptoms, Adapted Immune Status Questionnaire (ISQ), improvement in quality of life (Short form 12 [SF-12] Health Survey), and safety and tolerability. Results: All 100 subjects completed the study as per the protocol. There were no respiratory symptoms in the subjects in arm 1. However, four subjects (8%) in arm II reported cough during the study period. A better Immune status improvement was seen through the adapted ISQ in arm I as compared to arm II. In each of the 8 SF-12 Health Survey domains, a statistically significant difference was observed in arm I compared to arm II. A retrospective assessment of COVID-19 infection showed only 8% of subjects as COVID-19 positive in arm I compared with 26% of subjects in arm II. Conclusion: Considering the positive trend observed in this study in terms of ISQ, SF-12, and COVID-19 infection rates, the combination of Immusante and Guduchi in healthcare workers at a high risk of contracting COVID-19 infection had a beneficial effect in boosting immunity and overall health.