Adverse events in India's Ayush interventions for cervical and lumbar spondylosis: a systematic review.

INTRODUCTION: Low back and neck pain are common musculoskeletal disorders with multiple treatment options. India's traditional medical systems, known as Ayush (Ayurveda, Yoga and Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy) offer range of interventions and are widely used. In view of limited documentation of adverse events following Ayush interventions for lumbar and cervical spondylosis, we synthesized evidence and estimated proportion of studies reporting adverse events. METHODS: We systematically searched all published documents from biomedical and multidisciplinary abstract and citation databases and Ayush-specific repositories from their inception to April 2021. We selected studies as per inclusion criteria and extracted information, adhering to PRISMA guidelines. We systematically reviewed the qualitative evidence form the selected studies. RESULTS: Majority (94%) of the selected 113 studies were interventional studies and included 77 (68.1%) journal articles and 35 (31%) academic dissertations. Among the Ayush systems, considerable proportion was from Ayurveda (32.7%), followed by Siddha (24.8%), Yoga (22.1%), Unani (15.9%) and Homoeopathy (4.4%). Almost three-fourths of the studies were on lumbar spondylosis (65%; n = 74), followed by cervical spondylosis (31%; n = 35), and the remaining four included both. Thirteen percent of the 113 studies described adverse events [Yoga = 9.7%; Unani = 1.8% and Homoeopathy = 1.8%]. More adverse events were reported among the studies on lumbar (9.7%) than cervical spondylosis (2.7%). The nature of interventions were non-pharmacological (10.6%; n = 12), pharmacological (n = 2; 1.8%) or combined (n = 1; 0.9%). CONCLUSIONS: Only one in eight studies reported any adverse event following Ayush interventions for cervical and lumbar spondylosis. There could be certain degree of underreporting of adverse events and requires further exploration. PROSPERO Registration ID CRD42020167433.

Process evaluation of a complex, multilevel, multicomponent scheme for the prevention and control of non-communicable diseases in Tamil Nadu, India: A mixed-methods protocol.

Background: Non-communicable diseases (NCDs) are the leading cause of morbidity and mortality in India, necessitating development of multilevel and multicomponent interventions. Makkalai Thedi Maruthuvam (MTM) is a complex multilevel, multicomponent intervention developed and implemented by the south Indian State of Tamil Nadu. The scheme aims to deliver services for preventing and controlling diabetes, and hypertension at doorstep. This paper describes the protocol for planning and conducting the process evaluation of the MTM scheme. Methods and analysis: The process evaluation uses mixed methods (secondary data analysis, key informant interviews, in-depth interviews, conceptual content analysis of documents, facility-based survey and non-participant observation) to evaluate the implementation of the MTM scheme. The broad evaluation questions addressed the fidelity, contexts, mechanisms of impact and challenges encountered by the scheme using the Consolidated Framework for Implementation Research (CFIR) framework. The specific evaluation questions addressed selected inputs and processes identified as critical to implementation by the stakeholders. The CFIR framework will guide the thematic analysis of the qualitative interviews to explore the adaptations and deviations introduced during implementation in various contexts. The quantitative data on the indicators developed for the specific evaluation questions will be cleaned and descriptively analysed.

Baseline findings of a multicentric ambispective cohort study (2021-2022) among hospitalised mucormycosis patients in India.

In India, the incidence of mucormycosis reached high levels during 2021-2022, coinciding with the COVID-19 pandemic. In response to this, we established a multicentric ambispective cohort of patients hospitalised with mucormycosis across India. In this paper, we report their baseline profile, clinical characteristics and outcomes at discharge. Patients hospitalized for mucormycosis during March-July 2021 were included. Mucormycosis was diagnosed based on mycological confirmation on direct microscopy (KOH/Calcofluor white stain), culture, histopathology, or supportive evidence from endoscopy or imaging. After consent, trained data collectors used medical records and telephonic interviews to capture data in a pre-tested structured questionnaire. At baseline, we recruited 686 patients from 26 study hospitals, of whom 72.3% were males, 78% had a prior history of diabetes, 53.2% had a history of corticosteroid treatment, and 80% were associated with COVID-19. Pain, numbness or swelling of the face were the commonest symptoms (73.3%). Liposomal Amphotericin B was the commonest drug formulation used (67.1%), and endoscopic sinus surgery was the most common surgical procedure (73.6%). At discharge, the disease was stable in 43.3%, in regression for 29.9% but 9.6% died during hospitalization. Among survivors, commonly reported disabilities included facial disfigurement (18.4%) and difficulties in chewing/swallowing (17.8%). Though the risk of mortality was only 1 in 10, the disability due to the disease was very high. This cohort study could enhance our understanding of the disease's clinical progression and help frame standard treatment guidelines.