Prevention of relapse in drug sensitive pulmonary tuberculosis patients with and without vitamin D3 supplementation: A double blinded randomized control clinical trial.

BACKGROUND: The immunomodulatory effects of vitamin D are widely recognized and a few studies have been conducted to determine its utility in the treatment of tuberculosis, with mixed results. This study was conducted to see if vitamin D supplementation in patients with active pulmonary tuberculosis (PTB) in the Indian population contributed to sputum smear and culture conversion as well as the prevention of relapse. METHODS: This randomized double-blind placebo-controlled trial was conducted in three sites in India. HIV negative participants aged 15-60 years with sputum smear positive PTB were recruited according to the Revised National Tuberculosis Control Program guidelines and were randomly assigned (1:1) to receive standard anti-tubercular treatment (ATT) with either supplemental dose of oral vitamin D3 (60,000 IU/sachet weekly for first two months, fortnightly for next four months followed by monthly for the next 18 months) or placebo with same schedule. The primary outcome was relapse of PTB and secondary outcomes were time to conversion of sputum smear and sputum culture. RESULTS: A total of 846 participants were enrolled between February 1, 2017 to February 27, 2021, and randomly assigned to receive either 60,000 IU vitamin D3 (n = 424) or placebo (n = 422) along with standard ATT. Among the 697 who were cured of PTB, relapse occurred in 14 participants from the vitamin D group and 19 participants from the placebo group (hazard risk ratio 0.68, 95%CI 0.34 to 1.37, log rank p value 0.29). Similarly, no statistically significant difference was seen in time to sputum smear and sputum culture conversion between both groups. Five patients died each in vitamin D and placebo groups, but none of the deaths were attributable to the study intervention. Serum levels of vitamin D were significantly raised in the vitamin D group as compared to the placebo group, with other blood parameters not showing any significant difference between groups. CONCLUSIONS: The study reveals that vitamin D supplementation does not seem to have any beneficial effect in the treatment of PTB in terms to the prevention of relapse and time to sputum smear and culture conversion. TRIAL REGISTRATION: CTRI/2021/02/030977 (ICMR, Clinical trial registry-India).

Efficacy of Bacillus Calmette-Guérin (BCG) Vaccination in Reducing the Incidence and Severity of COVID-19 in High-Risk Population (BRIC): a Phase III, Multi-centre, Quadruple-Blind Randomised Control Trial.

INTRODUCTION: Universal coverage of vaccines alone cannot be relied upon to protect at-risk populations in lower- and middle-income countries against the impact of the coronavirus disease 2019 (COVID-19) pandemic and newer variants. Live vaccines, including Bacillus Calmette-Guérin (BCG), are being studied for their effectiveness in reducing the incidence and severity of COVID-19 infection. METHODS: In this multi-centre quadruple-blind, parallel assignment randomised control trial, 495 high-risk group adults (aged 18-60 years) were randomised into BCG and placebo arms and followed up for 9 months from the date of vaccination. The primary outcome was the difference in the incidence of COVID-19 infection at the end of 9 months. Secondary outcomes included the difference in the incidence of severe COVID-19 infections, hospitalisation rates, intensive care unit stay, oxygen requirement and mortality at the end of 9 months. The primary analysis was done on an intention-to-treat basis, while safety analysis was done per protocol. RESULTS: There was no significant difference in the incidence rates of cartridge-based nucleic acid amplification test (CB-NAAT) positive COVID-19 infection [odds ratio (OR) 1.08, 95% confidence interval (CI) 0.54-2.14] in the two groups, but the BCG arm showed a statistically significant decrease in clinically diagnosed (symptomatic) probable COVID-19 infections (OR 0.38, 95% CI 0.20-0.72). Compared with the BCG arm, significantly more patients developed severe COVID-19 pneumonia (CB-NAAT positive) and required hospitalisation and oxygen in the placebo arm (six versus none; p = 0.03). One patient belonging to the placebo arm required intensive care unit (ICU) stay and died. BCG had a protective efficacy of 62% (95% CI 28-80%) for likely symptomatic COVID-19 infection. CONCLUSIONS: BCG is protective in reducing the incidence of acute respiratory illness (probable symptomatic COVID-19 infection) and severity of the disease, including hospitalisation, in patients belonging to the high-risk group of COVID-19 infection, and the antibody response persists for quite a long time. A multi-centre study with a larger sample size will help to confirm the findings in this study. CLINICAL TRIALS REGISTRY: Clinical Trials Registry India (CTRI/2020/07/026668).

The Bacillus Calmette­Guérin (BCG) vaccine has been studied previously in several settings, including reducing childhood mortalities due to viral infections and induction of trained immunity and reducing upper respiratory tract infections and pneumonia in older adults. This multi-centre trial has tried to evaluate the efficacy of BCG revaccination in reducing the incidence and severity of COVID-19 infections in adults between 18 and 60 years of age belonging to the high-risk group owing to the presence of comorbidities including diabetes, chronic kidney disease, chronic liver disease and chronic lung diseases. A single dose of BCG vaccine produced significantly high titres of BCG antibodies lasting for six months. While there was no significant reduction in the incidence of COVID-19 infection, there was an 8.4% reduction in the incidence of symptomatic COVID-19 disease at the end of 9 months of follow-up. In addition, there were significantly fewer severe COVID-19 infections requiring hospital stay and oxygen support. However, the overall numbers of severe COVID-19 infections were low. Thus, the study shows that BCG can protect against symptomatic and severe COVID-19 disease. However, it might not reduce the incidence of new infections. The study results are significant for low- and middle-income countries without adequate coverage of primary doses of COVID-19 vaccination, let alone the booster doses. Future studies should evaluate the BCG vaccine's efficacy as a booster compared with routine COVID-19 vaccine boosters.

Management of Life-Threatening Hemorrhage from Maxillofacial Firearm Injuries Using Foley Catheter Balloon Tamponade.

The aim of this study is to evaluate the efficacy of Foley catheter in the management of hemorrhage from penetrating maxillofacial injuries in austere environment. This retrospective cohort study evaluated all penetrating head and neck trauma caused by firearm injuries reported to a military hospital at a forward aid location during 2015-2017. Foley catheter was used in the emergency management of bleeding in 11 cases. The effectiveness of this technique in controlling hemorrhage, its indication, contraindications, and complications has been explained. Out of 26 penetrating injuries received during the time period, 11 patients underwent Foley catheter balloon tamponade for the control of hemorrhage. Ten out of 11 patients responded adequately to balloon tamponade. One patient with a bullet lodged inside the neck underwent immediate surgical exploration for its removal and repair of internal jugular vein. No neurological deficits or complications were noted in any of the patients. Foley catheter balloon tamponade is very effective in managing hemorrhage from head and neck penetrating injuries. It significantly reduces the mortality by controlling bleeding from the major vessels especially in a combat environment.

Indirect Sinus Floor Elevation Technique with Simultaneous Implant Placement without Using Bone Grafts.

CONTEXT: Maxillary posterior region is a problem area for the placement of implants. The advanced resorption of alveolar bone is combined with an increase in pneumatization of maxillary sinus because of higher intra-antral pressure, giving rise to severely atrophied alveolar ridges with reduced bone height. MATERIALS AND METHODS: A total of 26 implants were placed in 21 patients using indirect sinus lift with simultaneous implant placement without using bone grafts. Intra-oral periapical radiographs were taken to determine residual bone height, endosinus bone (ESB), and crestal bone level. RESULTS: All the implants were clinically and radiographically stable at the end of 6 months follow-up. All the implants showed ESB gain, with mean being 1.97 mm and 1.99 mm on mesial and distal sides, respectively. CONCLUSION: The findings of this study indicate that successful osseointegration is predictable using osteotome sinus floor elevation without bone graft. Spontaneous new bone formation seemed to be expected with implants placed using indirect sinus lift.

Pterygoid Hamulus Bursitis: A Rare Intra-Oral Pain Syndrome.

Pterygoid hamular bursitis is a rare craniofacial pain syndrome used to describe palatal and pharyngeal pain due to an enlarged pterygoid hamulus. The pterygoid hamulus is a hook-shaped bony process located bilaterally on each medial pterygoid plate of the sphenoid bone, posterior and medial to each maxillary tuberosity. These processes project downward and anterolaterally; serve as attachment for ligaments and a network of muscles. It can be palpated in patients with a finger palpating the posteromedial to maxillary tuberosity. The pathogenesis is elusive and varies from bursitis of tensor veli palatine, elongated pterygoid hamulus, persistent trauma to the mucosa overlying the pterygoid hamulus. The clinical features include strange chronic sensation, burning, swelling, and erythema of the pterygoid hamulus region. The pain often radiates to pharynx, ipsilateral face and sometimes radiating to temporal region making it difficult to diagnose from headache, temporomandibular disorders, and dental infections like pericoronitis. The anatomical neighboring structures in relation to oropharyngeal region may give a misleading diagnosis to dentist in case of pterygoid hamulus bursitis. The understanding of pterygoid hamulus anatomy and its relation to surrounding structures is necessary to get the correct diagnosis of the inflammatory or traumatic pain in oropharyngeal region.

Surgical management of oral submucous fibrosis using buccal fat pad: a retrospective study of 30 cases.

The aim of our study was to evaluate the effectiveness of buccal fat pad (BFP) in the management of oral submucous fibrosis (OSMF). Retrospective records of 30 patients of OSMF treated with BFP with atleast a year of follow-up were analyzed. Patients were divided into groups based on the stages of OSMF. Surgical management consisted of resection of fibrous bands, bilateral temporalis myotomy, and coronoidectomy followed by grafting with BFP. There were 17 patients of stage III (mouth opening 16-25 mm) and 13 patients of stage IV OSMF (mouth opening less than 16 mm). The mean mouth opening of stage III group pre-operatively was 19.94 ± 2.19 mm which increased to a mean of 35.12 ± 5.69 mm (p < 0.0001). For patients with stage IV OSMF, the mouth opening increased from a pre-operative of 10.23 ± 4.07 mm to a post-operative of 31.46 ± 6.78 mm (p < 0.0001). No intra-operative complications were noted in any patient. Relapse was seen in 1 patient (5.8%) of stage III while 3 patients (23.07%) had relapse in stage IV group. Our results indicate that BFP is a good flap owing to its benefits which are easy to harvest and entails minimal morbidity for management of OSMF.