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07 Jun A pandemic influenza vaccine in India: from strain to sale within 12 months billion doses of vaccine to immunize its entire population

In the event of a highly pathogenic influenza pandemic, the Indian subcontinent would need 1.2 billion doses of vaccine to immunize its entire population, double if two doses were required to assure immunity. Serum Institute of India Limited (SII) thus became one of six initial grantees of the World Health Organization (WHO) technology transfer initiative to create capacity in developing countries to manufacture H5N1 pandemic influenza vaccine. At the outbreak of the A(H1N1) 2009 influenza pandemic, experience gained from the H5N1 project

was used to develop a live attenuated influenza vaccine (LAIV), since this was the only option for the level of surge capacity required for a large-scale immunization campaign in India. SII took <12 months to develop and market its LAIV intranasal vaccine from receipt of the seed strain from WHO. As of November 2010, over 2.5 million persons have been vaccinated with Nasovac(®) with no serious adverse reactions or vaccine failure after 3 months’ post-marketing surveillance. The product has been submitted for prequalification by WHO for purchase by United Nations agencies. In parallel, SII also developed an inactivated influenza vaccine, and is currently looking to ensure the sustainability of its influenza vaccine manufacturing capacity.

07 Jun Diphtheria, Tetanus, and Pertussis Immunity in Indian Adults and Immunogenicity of Td Vaccine

Rise of diphtheria cases in adults is a cause of concern worldwide. Pertussis is also now affecting adults. We assessed serum levels of tetanus, diphtheria and pertussis antibodies in 62 adults in Pune, India, who had missed their primary immunization. All adults were then given three doses of tetanus-diphtheria (Td) vaccine at 0, 1, and 6 months. All adults were immune to tetanus but 78% had long-term protection. For diphtheria, 88% were protected but only 9% had long term immunity. Only 60% were immune to pertussis. After three doses of the vaccine, long term immunity to both tetanus and diphtheria increased to 87% and 97%, respectively (P < 0.05). Geometric mean titres (GMT) of both antibodies also increased significantly. The vaccine caused minor local reactions and mild fever in a few subjects. There is need of three doses of Td vaccination in those Indian adults, who missed their primary immunization. Susceptibility to pertussis also needs to be further explored.

07 Jun 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.

07 Jun SSRI-induced coagulopathy: is it reality?

Selective serotonin reuptake inhibitors (SSRIs) are widely prescribed for the treatment of depres- sion, obsessive a compulsive disorders, bulimia, The generalized anxiety and phobic disorders. The majority of all antidepressants prescribed world- wide are from the SSRI family. Commonly pre- scribed SSRIs include fluoxetine, paroxetine, sertraline, citalopram, escitalopram and fluvox- amine. Unlike tricyclic antidepressants, SSRIs do not have anticholinergic side effects and are safe in overdose [Rang et al. 2007]. Common adverse events are gastrointestinal side effects, sexual dysfunction, headaches, anxiety, insomnia and sedation. There are reports of increased inci- dence of epistaxis and ecchymosis with SSRIs, which is probably due to impairment of platelet function. Gastric blood loss caused by nonsteroi- dal anti-inflammatory drugs (NSAIDs) may be increased by SSRIs. Bleeding events are rare but there may be potentially severe haematological complications following treatment with SSRIs. Fluoxetine, a commonly used SSRI, has been reported to cause ecchymosis, bleeding and other haematological complications. In a single case report, a 23-year-old woman treated with

07 Jun Progressive Muscle Relaxation in Hyperemesis Gravidarum

Aims: To assess the role of progressive muscle relaxation in the management of hyperemesis gravidarum.
Methods: This is a prospective, randomized, observer blind and comparative study. 30 pregnant women admitted for the treatment of hyperemesis gravidarum were enrolled and randomized into experimental and control groups. Each group was of 15 patients. Experimental group patients received pharmacotherapy with daily progressive muscle relaxation for 2 weeks, while patients in control group received only pharmacotherapy.
Results: (1) Significantly high number of patients required three or more drugs in control group as compared to experimental group, (2) experimental group patients achieved complete response within 2.73 days, while control group patients achieved complete response within 4 days, (3) none of the patients in experimental group had recurrence within 2 weeks of observation period, while 13% patients in control group had recurrence after complete response, (4) on clinical global improvement scale, patients in experimental group achieved better improvement.
Conclusions: Progressive muscle relaxation is effective in hyperemesis gravidarum and when combined with antiemetics, it reduces the number of antiemetics required to treat hyperemesis gravidarum. Patients also show early response to treatment, less recurrence and better improvement when combined with antiemetics.

07 Jun Diphtheria and Tetanus Antibody Persistence in Indian Pre-school Children and Response to a Booster dose of DT Vaccine

Despite effective vaccines, diphtheria (D) resurged recently in the former socialistic block, and tetanus (T) still occurs in less privileged countries. We studied the antibody persistence for D and T in Indian pre-school children who had received four doses of DTP vaccine and subsequently, the response to a booster dose. Anti-D and anti-T IgG antibodies prior to and one month after a DT vaccine were measured by ELISA in 223 healthy children of 4-6 years who had previously received four doses of the triple vaccine. Adverse reactions were monitored for one month. While 30% and 14% of subjects were susceptible to D and T, respectively, 98% and 100% of them attained seroprotection post-vaccination. Both responses were significant. Local, but not systemic reactions except fever were rather common. A high proportion of the Indian pre-school population is susceptible to D and T, despite of receiving four doses. The current policy of giving the fifth dose at this age is appropriate.

07 Jun 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 • A phase 3, doubleblind, double-dummy, randomized controlled study. 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. 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. (Altern Ther Health Med. 2017;23(1):26-33.)