Neem (Azadirachta Indica A. Juss) Capsules for Prophylaxis of COVID-19 Infection: A Pilot, Double-Blind, Randomized Controlled Trial.

CONTEXT: SARS-CoV-2 is a global public-health concern. Interventions to prevent infection are urgently needed. The anti-inflammatory and antiviral effects of neem make it a potential agent for COVID-19 prophylaxis. OBJECTIVE: The study intended to evaluate the prophylactic effects of neem capsules for persons at high risk of COVID-19 infection due to contact with COVID-19 positive patients. DESIGN: The research team designed a prospective, randomized, double-blind, placebo-controlled, parallel-design study. SETTING: The study was conducted at a single center in India. PARTICIPANTS: Participants were 190 healthcare workers at the hospital or relatives of patients with COVID-19 infection. INTERVENTION: Of the 190 participants, 95 were in the intervention group and 95 in the control group. Participants received 50 mg of a proprietary, patent-pending, neem-leaf extract or a placebo orally in capsules, twice a day for 28 days. OUTCOME MEASURES: The number of individuals positive for COVID-19 between baseline and follow-up on day 56 was the primary outcome measure. Secondary measures included an evaluation of neem's safety and its effects on quality of life (QOL) and changes in biomarkers. RESULTS: The mean age of participants was 36.97 years, and 68.42% were male. Total 13 subjects tested positive during the study. All were asymptomatic. Of the 154 participants who completed the study per-protocol, 11 tested positive, 3 in the intervention group and 8 in the control group. The probability of COVID-19 infection in participants receiving the intervention was 0.45 times that of participants receiving the placebo, a relative risk of 0.45, with the effectiveness of the intervention being around 55%. Treatment-emergent adverse events (TEAEs) in both groups were minimal and were of grade 1 or 2 in severity. Biomarkers and QOL remained stable in both groups. CONCLUSIONS: The study found a reduced risk of COVID-19 infection in participants receiving neem capsules, which demonstrates its potential as a prophylactic treatment for the prevention of COVID-19 infection. The findings warrant further investigation in clinical trials.

Efficacy of an Ayurvedic Formulation for Mild-to-moderate Osteoarthritis: A Phase 3, Randomized Controlled Study.

Context • Current treatment options offer only symptomatic pain relief for patients with osteoarthritis (OA). Thus, a need exists for effective treatment of the disability-causing disease. The proprietary polyherbal formulation, Nartana, has been used for several years for OA. Objective • The study intended to compare the benefits of the herbal formulation with those of routinely used nonsteroidal anti-inflammatory drugs (NSAIDs) for patients with mild-to-moderate OA. Design • The research team designed a phase 3, double-blind, double-dummy, randomized controlled study. Setting • The study was conducted at 2 hospital sites in Pune, India. Participants • The participants were 80 outpatients with OA at the hospitals. Intervention • The participants were randomly assigned to receive either the intervention (herbal formulation) or the active control (diclofenac) for 12 wk. The herbal formulation group received 450 mg of Nartana capsule and diclofenac-matching placebo. Treatment was given 2 ×/d for first 15 d and then 1 ×/d until the end of the study. The control group received 50 mg of diclofenac tablet 2 ×/d for first 15 d and then 100 mg of diclofenac tablet 1 ×/d and a Nartana-matching placebo until end of the study. Outcome Measures • To measure efficacy, the study used the modified Center for Rheumatic Diseases Pune version of the Western Ontario and McMaster Universities OA index (WOMAC) and the Health Assessment Questionnaire (HAQ). The study also measured overall perceived pain relief. The primary outcome measure was the change in the combined WOMAC score from baseline to postintervention (12 wk). Safety and other efficacy measures were the secondary end points. Results • The herbal formulation and diclofenac groups matched well at baseline for demographic profile, disease status, and WOMAC scores. The combined WOMAC scores were significantly reduced from baseline to postintervention for both groups (P < .01). The earliest significant reduction was seen at week 4 (P < .01) and persisted at subsequent visits (P < .01). Similar changes were also seen in the WOMAC subscales-pain, stiffness, and physical function or difficulty in performing routine activities-and HAQ scores. Similar changes were also seen in the WOMAC subscales-pain, stiffness, and physical function or difficulty in performing routine activities-and HAQ scores. Improvement was also observed with perceived pain relief. Overall, the efficacy of the herbal formulation was not inferior to the diclofenac. Related adverse events were generally mild to moderate in nature and were resolved with or without symptomatic treatment. Conclusions • For patients with mild-to-moderate OA, Nartana significantly reduced joint pain, stiffness, and physical function; improved quality of life; and provided pain relief. The herbal formulation's efficacy was not inferior to routinely prescribed diclofenac. The drug should be explored further in large long-term comparative studies as an alternative to NSAIDs.

What to use to express the variability of data: Standard deviation or standard error of mean?

Statistics plays a vital role in biomedical research. It helps present data precisely and draws the meaningful conclusions. While presenting data, one should be aware of using adequate statistical measures. In biomedical journals, Standard Error of Mean (SEM) and Standard Deviation (SD) are used interchangeably to express the variability; though they measure different parameters. SEM quantifies uncertainty in estimate of the mean whereas SD indicates dispersion of the data from mean. As readers are generally interested in knowing the variability within sample, descriptive data should be precisely summarized with SD. Use of SEM should be limited to compute CI which measures the precision of population estimate. Journals can avoid such errors by requiring authors to adhere to their guidelines.