Genito Urinary Infection and Urinary Tract Infection in Patients with Type 2 Diabetes Mellitus Receiving SGLT2 Inhibitors: Evidence from a Systematic Literature Review of Landmark Randomized Clinical Trial.

BACKGROUND AND PURPOSE: SGLT2 inhibitors are class of drugs that are used in adults with type 2 diabetes through a novel mechanism of action by reducing renal tubular glucose reabsorption, leading to a reduction in blood glucose without stimulating insulin release. In this systematic review, we report the effects of treatment with SGLT2 inhibitors on urinary tract infection (UTI) and genitourinary infection (GUI). METHOD: The study integrated data from landmark trials of SGLT2 inhibitors (CANVAS, CREDENCE, DECLARE-TIMI 58, and EMPA-REG) to interpret the association of SGLT2 inhibitors with genital infection (GI) and UTI. We reported the review following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. The primary outcome was a composite of participants reporting UTI and GUI prescribed on SGLT2 inhibitors. RESULTS: The analysis of four studies involving 38,723 participants revealed incidences of both UTIs and GUI. In the SGLT2 inhibitor group, comprising 21,266 participants, 222 (1.04%) experienced UTIs, and 477 (2.24%) reported GUI. In contrast, among the placebo group consisting of 17,457 participants, 201 (1.15%) reported UTIs, and 70 (0.40%) reported genital infections. These findings underscore the elevated risk associated with SGLT2 inhibitor use, particularly regarding GUI, necessitating careful consideration in clinical practice and patient management strategies. CONCLUSION: The incidence of UTIs and particularly more pronounced GUI associated with SGLT2 inhibitors highlights the importance of careful risk assessment and monitoring in clinical decision-making, underscoring the need for patient management strategies.

Effect of Nigella Sativa in Improving Blood Glucose Level in T2DM: Systematic Literature Review of Randomized Control Trials.

BACKGROUND: Diabetes mellitus is a highly prevalent condition that affects people of all ages, races, and genders. Medicinal herbs have received a lot of attention from researchers, and they have suggested it to be a good adjuvant to oral diabetes medications because of their combined effects. OBJECTIVES: The purpose of this systematic review is to summarize the available evidences and literature of Randomized Control Trials (RCTs) on Nigella sativa (NS) in the management of Type 2 Diabetes Mellitus (T2DM). METHODS: A computerised database search was performed to obtain the relevant clinical trial studies. We searched the following PubMed and Google Scholar databases. Randomized controlled trials (RCTs) comparing NS versus any treatment for the management of T2DM in adults were eligible for inclusion. RESULTS: A total of 7 articles were retrieved for interpretation, complete assessment and data extraction in this systematic review. This systematic review seeks to give thorough information on the effects of NS on glucose and insulin profile status in patients with T2DM. INTERPRETATION & CONCLUSION: Different mechanisms are proposed which contribute to the anti-diabetic activity of NS. Various outcome parameters evaluated demonstrate a significant improvement in the management of T2DM and its complications upon intervention with NS.

Cannabis, a Miracle Drug with Polyvalent Therapeutic Utility: Preclinical and Clinical-Based Evidence.

Cannabis sativa L. is an annual herbaceous dioecious plant which was first cultivated by agricultural human societies in Asia. Over the period of time, various parts of the plant like leaf, flower, and seed were used for recreational as well as therapeutic purposes. The main chemical components of Cannabis sativa are termed as cannabinoids, among them the key psychoactive constituent is Δ-9-tetrahydrocannabinol and cannabidiol (CBD) as active nonpsychotic constituent. Upon doing extensive literature review, it was found that cannabis has been widely studied for a number of disorders. Very recently, a pure CBD formulation, named Epidiolex, got a green flag from both United States Food and Drug Administration and Drug Enforcement Administration for 2 rare types of epilepsies. This laid a milestone in medical cannabis research. This review intends to give a basic and extensive assessment, from past till present, of the ethnological, plant, chemical, pharmacological, and legal aspects of C. sativa. Further, this review contemplates the evidence the studies obtained of cannabis components on Alzheimer's, Parkinson's, amyotrophic lateral sclerosis, multiple sclerosis, emesis, epilepsy, chronic pain, and cancer as a cytotoxic agent as well as a palliative therapy. The assessment in this study was done by reviewing in extensive details from studies on historical importance, ethnopharmacological aspects, and legal grounds of C. sativa from extensive literature available on the scientific databases, with a vision for elevating further pharmaceutical research to investigate its total potential as a therapeutic agent.

Materiovigilance: Concept, Structure and Emerging Perspective for Patient's Safety in India.

There has been an escalation in the number, diversity, and complexity of medical devices. Regulation of these devices has also advanced due to the requirement of better regulatory perspective induced due to elevation in the number of adverse events associated with medical devices. All over the globe, various measures are undertaken to provide better safety to the patients along with attempts to improve the standard of medical devices. The initial and ultimate objective of the concept happens to be unfailingly to ensure patient safety as well as impart required guidance for both manufacturers and adept authorities enabling them to superintend cases coherently and appropriately. Materiovigilance programme of India (MvPI) was launched by the Drug Controller General of India at the Indian Pharmacopoeia commission (IPC) in Ghaziabad in 2015. The main purpose of this initiative is to monitor adverse events associated with medical devices in order to generate safety data, create awareness among the various stakeholders, and prescribe best practices for patient safety. Whilst the reforms in regulations have proposed policies and designs to elucidate, consolidate and accelerate the processes involved in manufacturing and importing medical devices to India, they consistently carry their challenges and limitations. To eliminate such complications the guidelines and regulations are anticipated to be implemented appropriately with the efficacious conclusion. India has been evident in matching with advancements in the World Medical Device regulation scenario, the current review at hand takes upon the question of 'how successful has it been so far'?