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Fulltext The Mechanisms of Probiotics, Prebiotics, Synbiotics, and Postbiotics in Oral Cancer Management

Mohd Fuad AS, Amran NA, Nasruddin NS, Burhanudin NA, Dashper S, Arzmi MH

Probiotics Antimicrob Proteins, 2023 Oct;15(5):1298-1311.
PMID: 36048406 DOI: 10.1007/s12602-022-09985-7

Oral carcinogenesis is preceded by oral diseases associated with inflammation such as periodontitis and oral candidiasis, which are contributed by chronic alcoholism, smoking, poor oral hygiene, and microbial infections. Dysbiosis is an imbalance of microbial composition due to oral infection, which has been reported to contribute to oral carcinogenesis. Therefore, in this review, we summarised the role of probiotics, prebiotics, synbiotics, and postbiotics in promoting a balanced oral microbiome, which may prevent oral carcinogenesis due to oral infections. Probiotics have been shown to produce biofilm, which possesses antibacterial activity against oral pathogens. Meanwhile, prebiotics can support growth and increase the benefit of probiotics. In addition, postbiotics possess antibacterial, anticariogenic, and anticancer properties that potentially aid in oral cancer prevention and treatment. The use of probiotics, prebiotics, synbiotics, and postbiotics for oral cancer management is still limited despite their vast potential, thus, discovering their prospects could herald a novel approach to disease prevention and treatment while participating in combating antimicrobial resistance.
Effective Modalities of Periodontitis Induction in Rat Model

Khuda F, Baharin B, Anuar NNM, Satimin BSF, Nasruddin NS

J Vet Dent, 2024 Jan;41(1):49-57.
PMID: 37259505 DOI: 10.1177/08987564231178459

Induction of periodontal disease using the rat model is the preferred model for human periodontal disease studies that are related to gene expression, mechanisms of inflammatory regulation, microbial and host responses, resolution, and the healing process. There are 3 methods that are frequently used to induce periodontal disease, which are: ligature application, oral bacterial inoculation, and the lipopolysaccharide injection technique. In the ligature model, sterile non-absorbable sutures or orthodontic wires are widely used to induce local irritation and bacterial plaque accumulation. Secondly, mono and mixed cultures of periodontal bacteria are inoculated orally by gavage or topical application. Lastly, lipopolysaccharide extracted from pathogenic bacteria can be directly injected into the gingival sulcus to induce inflammation and stimulate osteoclastogenesis and alveolar bone loss. Among these methods, ligature application induces inflammation and alveolar bone resorption more promptly compared to other methods. This review will provide an overview of the main induction methods in experimental periodontal disease, with their advantages and disadvantages.
Fulltext Malaysian Consensus Statement for the Diagnosis and Management of Acromegaly

Hussein Z, Bidin ML, Alias A, Thiagarajan M, Latif KA, Ratnasingam J, et al.

J ASEAN Fed Endocr Soc, 2019;34(1):8-14.
PMID: 33442131 DOI: 10.15605/jafes.034.01.03

In Malaysia, acromegaly is under-recognised with only 10-15% of the expected number of cases from prevalence estimates, having been diagnosed and managed in established endocrine centres with access to multidisciplinary care. This is mainly due to lack of awareness and standardised approach in diagnosing this disease resulting in delay in diagnosis and management with suboptimal treatment outcomes. This first Malaysian consensus statement on the diagnosis and management of acromegaly addresses these issues and is based on current best practices and latest available evidence so as to reduce the disease burden on acromegaly patients managed in the Malaysian healthcare system.
Fulltext Acute oral toxicity evaluation of synbiotic mixture containing Streptococcus salivarius K12 and Musa acuminata aqueous peel extract in Sprague-Dawley rats

Fuad ASM, Arzmi MH, Bakar ME, Taib IS, Khuda F, Nasruddin NS

J Ayurveda Integr Med, 2024 Dec 15;16(1):101037.
PMID: 39681048 DOI: 10.1016/j.jaim.2024.101037

BACKGROUND: The combination of S. salivarius K12 and M. acuminata are being used as synbiotic, but its safety evaulation is required.
OBJECTIVE: This study aimed to determine the LD50 of synbiotic containing probiotic Streptococcus salivarius K12 and prebiotic Musa acuminata peel extract.
MATERIALS AND METHODS: The determination of LD50 is done according to the Acute Oral Toxicity test No. 425 (AOT425). For limit test, five female Sprague Dawley rats were given a limit dose of 2000 mg/kg of the synbiotic mixture once orally, and observed for 12 days. For subacute toxicity test, twenty female Sprague Dawley rats were randomised into 4 groups (n = 5). Control group received saline, others received synbiotic mixture at doses 175 mg/kg, 550 mg/kg, and 2000 mg/kg, respectively, and observed for 14 days. Animals were euthanised on day-15, blood was collected, and subjected to haematological and biochemical analyses. Kidney and liver were preserved for histopathological examination.
RESULT: No significant changes on the average body weight of the animals throughout the study. Haematological parameters and biochemical analysis do not depict any changes related to acute toxicity. Histopathology analysis depicted mild changes on kidney and liver.
CONCLUSION: Based on the data, the LD50 of the synbiotic formulation is higher than 2000 mg/kb, with no sign of acute toxicity observed on all parameters.
Natural Concurrent Infection of Vibrio harveyi and V. alginolyticus in Cultured Hybrid Groupers in Malaysia

Mohamad N, Mohd Roseli FA, Azmai MNA, Saad MZ, Md Yasin IS, Zulkiply NA, et al.

J Aquat Anim Health, 2019 03;31(1):88-96.
PMID: 30536485 DOI: 10.1002/aah.10055

In September 2016, a marine fish farm operator in Selangor, Malaysia, reported a disease outbreak affecting juvenile hybrid groupers (Camouflage Grouper Epinephelus polyphekadion × Tiger Grouper E. fuscoguttatus). The average daily mortality was 120 fish, resulting in a cumulative mortality rate of 29% within 10 d. The affected hybrid groupers displayed lethargy, excessive mucus production, rotten fins, congestion of livers and kidneys, and enlargement of spleens. Microscopically, general congestion of the brains and internal organs was evident. Vibrio harveyi and V. alginolyticus were successfully isolated from the diseased fish. The isolated pathogens were found to be sensitive to oxytetracycline and tetracycline, but resistant towards ampicillin and vancomycin. Experimental infections using the isolated V. harveyi (108 CFU/mL), V. alginolyticus (108 CFU/mL), and concurrent infection by V. harveyi (108 CFU/mL) and V. alginolyticus (108 CFU/mL) in juvenile Asian Seabass Lates calcarifer resulted in 60, 100, and 100% mortality, respectively, within 240 h postinfection. The experimentally infected Asian Seabass demonstrated similar clinical signs and histopathological changes as the naturally infected hybrid groupers. However, concurrently infected fish demonstrated severe clinical signs and histopathological changes compared with single infections. These results suggest that both isolates of Vibrio are pathogenic to fish and responsible for the disease outbreak. However, concurrent infection involving V. alginolyticus and V. harveyi leads to a more devastating impact to the cultured fish. This is the first report of concurrent Vibrio infection in cultured marine fish in Malaysia.
Fulltext Antibiotic susceptibility and pathogenicity of Aeromonas hydrophila isolated from red hybrid tilapia (Oreochromis niloticus×Oreochromis mossambicus) in Malaysia

Pauzi NA, Mohamad N, Azzam-Sayuti M, Yasin ISM, Saad MZ, Nasruddin NS, et al.

Vet World, 2020 Oct;13(10):2166-2171.
PMID: 33281351 DOI: 10.14202/vetworld.2020.2166-2171

Background and Aim: Aeromonas hydrophila is a major cause of bacterial infections affecting a wide range of warm water fishes worldwide. In Malaysia, A. hydrophila isolations from diseased fishes were previously reported; however, with limited information. The present study investigates the antibiotic susceptibility and pathogenicity of A. hydrophila isolated from farmed red hybrid tilapia (Oreochromis spp.) in Malaysia.
Materials and Methods: A. hydrophila was biochemically identified and subjected to antibiotic susceptibility tests. The isolate was then intraperitoneally injected into red hybrid tilapia, and the mortality, clinicopathological changes, and LD50 were determined up to 240 h post-infection (hpi).
Results: The isolate demonstrated multiple antibiotic resistances (MAR) toward amikacin, ampicillin, cefotaxime, amoxicillin, trimethoprim-sulfamethoxazole, erythromycin, and streptomycin, with a MAR index of 0.5. The experimental infection of A. hydrophila at 105 CFU/mL in the red hybrid tilapia resulted in 100% mortality at 240 hpi. The LD50 was determined at 1.1×104 CFU/mL. Infected fish demonstrated occasional erratic swimming patterns, localized hemorrhages and depigmentation on the body and operculum areas, fin erosion, enlargement of the gall bladder, and hemorrhage in internal organs. Microscopic observation of infected fish revealed brain congestion, tubular necrosis, and glomerular shrinkage in the kidneys, necrosis of hepatocytes, and congestion of blood vessels in the liver.
Conclusion: The high virulence of A. hydrophila to the red hybrid tilapia emphasizes the importance of active, on-going monitoring of its prevalence in Malaysian tilapia farming.
Fulltext Xanthomatous Hypophysitis Presenting in an Adolescent Girl: A Long-Term Follow-Up of a Rare Case and Review of the Literature

Wong JSL, Nasruddin AB, Selveindran NM, Latif KA, Kassim F, Nair SB, et al.

AACE Clin Case Rep, 2021 02 01;7(3):220-225.
PMID: 34095493 DOI: 10.1016/j.aace.2021.01.008

Objective: Primary hypophysitis refers to the isolated inflammation of the pituitary gland not associated with other secondary causes. Among its histopathologic subtypes, xanthomatous is the rarest.
Methods: We describe a 22-year-old woman with xanthomatous hypophysitis (XH), its clinical progression over 8 years as well as the treatment effects of prednisolone and azathioprine. Our patient was first referred for severe short stature and delayed puberty at the age of 14 years.
Results: Investigations revealed multiple pituitary deficiencies. Magnetic resonance imaging showed a pituitary mass whereby a partial resection was performed. A full resection was not feasible due to the location of the mass. The histopathologic analysis of the tissue was consistent with XH. The results of secondary workout for neoplasm, infection, autoimmune, and inflammatory disorders were negative. After surgery, a progressive enlargement of the mass was observed. Two courses of prednisolone were administered with a significant reduction in the mass size. Azathioprine was added due to the unsustained effects of prednisolone when tapered off and the concern of steroid toxicity with continued use. No further increase in the mass size was noted after 6 months on azathioprine.
Conclusion: Glucocorticoid and immunotherapy are treatment options for XH; however, more cases are needed to better understand its pathogenesis and clinical progression.
Study on Streptococcus agalactiae infection in Javanese medaka (Oryzias javanicus Bleeker, 1854) model

Amal MNA, Ismail A, Saad MZ, Md Yasin IS, Nasruddin NS, Mastor SS, et al.

Microb Pathog, 2019 Jun;131:47-52.
PMID: 30940607 DOI: 10.1016/j.micpath.2019.03.034

This study determines the median lethal dose, and describes the clinico-pathological changes and disease development following Streptococcus agalactiae infection in Javanese medaka model. Javanese medakas were infected with S. agalactiae via intraperitoneal (IP) from 104 to 108 CFU/mL, and immersion (IM) route from 103 to 107 CFU/mL. The LD50-240h and clinico-pathological changes of the fish was determined until 240 h post infection (hpi). Next, the disease development was determined for 96 hpi in the fish following IP and IM infection at 103 CFU/mL and 104 CFU/mL, respectively. The LD50-240h of S. agalactiae in Javanese medaka was lower following IP injection (4.5 × 102 CFU/mL), compared to IM route (3.5 × 103 CFU/mL). The clinical signs included separating from the schooling group, swimming at the surface of water column, lethargy, erratic swimming pattern, corneal opacity and exophthalmia. Histopathological examinations revealed generalized congestion in almost all internal organs, particularly in liver and brain, while the kidney displayed tubular necrosis. Both IP and IM routes showed significant positive correlation (p 
Malaysian dental graduates' competence in holistic care: what do graduates and employers think?

Yusof ZY, Jaafar N, Jallaludin RL, Abu-Hassan MI, Razak IA

J Dent Educ, 2010 Dec;74(12):1380-7.
PMID: 21123505

The purpose of this study was to explore the University of Malaya (UM) dental graduates' competence in holistic care in real settings from the employers' and graduates' perspectives. A self-administered questionnaire consisting of ten domains was sent to thirty senior dental officers of the Ministry of Health (MOH) and 164 UM graduates. In this article, nineteen major competencies that best represent the graduates' competence in the provision of holistic care are discussed. Each competency was rated on a scale of 1 (very poor) to 4 (very good) and was categorized as "poor and of major concern" (if less than 60 percent of respondents scored good or very good), "satisfactory and of minor concern" (60-69 percent), or "excellent" (70 percent and above). One hundred and six out of 164 graduates (64.6 percent) and twenty-nine out of thirty employers (96.7 percent) responded. Overall, the employers rated the graduates lower than what the graduates rated themselves on all items. While the graduates felt they were excellent and satisfactory in sixteen out of nineteen items (84.2 percent), the employers felt they were poor in fourteen out of nineteen (73.7 percent). Both groups agreed that the graduates were excellent in communication, but poor in life-saving skills, obtaining patient's family and psychosocial histories, and recognizing signs and symptoms (not intraoral) indicating the presence of a systemic disease. In conclusion, although the graduates felt competent in the majority of the holistic care competencies, the employers had some reservations over such claims. Outcomes of the study led to recommendations to incorporate longer community-based learning hours, an improved behavioral science component, a module for special care patients, and multidepartmental collaborative teachings in the new integrated program aimed for implementation in 2011.
Assessing the competency of University of Malaya dental graduates: employers' and graduates' perceptions

Razak IA, Latifah RR, Jaafar N, Abu Hassan MI, Ab Murat N

J Dent Educ, 2008 Mar;72(3):364-9.
PMID: 18316541

A survey was conducted to assess competencies of dental graduates of the Faculty of Dentistry, University of Malaya, as perceived by the graduates and their employers, based on the five-year undergraduate curriculum introduced in 1995. All senior dental officers in the Ministry of Health (MOH), representing employers, and all 164 dental graduates of the years 2000, 2001, and 2002 were sent a self-administered questionnaire covering eight areas of competency. The respondents had to rate these areas on a scale of 1 (very poor) to 4 (very good). The responses for each area were then dichotomized into poor (1 and 2) and good (3 and 4). If less than 60 percent of the respondents rated an area as good, then it was categorized as needing attention; 60-69 percent as satisfactory; and 70 percent and above as excellent. One hundred and six graduates (64.6 percent) and twenty-nine employers (96.7 percent) responded; of the graduates, 73.6 percent were working in the MOH and 22.6 percent in private practice. About 57.1 percent of employers reported that at least five graduates have worked under them. Graduates (85.7 percent) and employers (83.3 percent) agreed that graduates have excellent skills in communication. Although all graduates perceived their competency to be excellent in the four areas (treatment planning; community-based skills; management, administrative skills, and personal management; and professional development skills), employers felt that these are the areas that are of concern and needed attention. In conclusion, whilst generally the graduates' level of competency in almost all areas is acceptable or good, there are areas of concern that need to be addressed to further improve the five-year curriculum at the University of Malaya.
Fulltext Validation of the Geriatric Oral Health Assessment Index (GOHAI) in the Malay language

Othman WN, Muttalib KA, Bakri R, Doss JG, Jaafar N, Salleh NC, et al.

J Public Health Dent, 2006;66(3):199-204.
PMID: 16913247 DOI: 10.1111/j.1752-7325.2006.tb02580.x

Objective: To translate and validate the Geriatric Oral Health Assessment Index (GOHAI into the Malay language for use in Malaysia.

Methodology: The 6-Likert scale GOHAI was translated into the Malay language and self-administered on 189 subjects aged 60+. All subjects underwent oral status assessment. The measure was assessed for construct and discriminant validity, for test-retest reliability and principal component factor.

Findings: Mean GOHAI score was 46.2 (SD 9.7, range 17-60). The Cronbach's alpha was 0.79. Mean GOHAI scores increased with more positive self-rated oral health and general health. The elderly with no perceived dental treatment need had higher mean GOHAI scores than those with perceived needs. There were slightly stronger inverse correlations between GOHAI scores and caries experience, number of teeth present, and number of pathologically mobile teeth. The measure demonstrated strong test-retest reliability. Eight of the 12 items had Spearman's r3 0.7. Only one principal factor was found at eigenvalue > 1. Using ANCOVA, self-rated perception of oral health and perceived need for dental treatment had the most significant impact on the GOHAI score.

Conclusion and recommendations: The Malay language version of the GOHAI demonstrated acceptable validity and reliability and will be an important instrument to measure oral health-related quality of life among Malay-speaking Malaysians. Use of the Malay language version GOHAI should also be pursued among diverse adult age groups.
Dental therapists: a global perspective

Nash DA, Friedman JW, Kardos TB, Kardos RL, Schwarz E, Satur J, et al.

Int Dent J, 2008 Apr;58(2):61-70.
PMID: 18478885

In 1921, New Zealand began training school dental nurses, subsequently deploying them throughout the country in school-based clinics providing basic dental care for children. The concept of training dental nurses, later to be designated dental therapists, was adopted by other countries as a means of improving access to care, particularly for children. This paper profiles six countries that utilise dental therapists, with a description of the training that therapists receive in these countries, and the context in which they practice. Based on available demographic information, it also updates the number of dental therapists practising globally, as well as the countries in which they practice. In several countries, dental therapy is now being integrated with dental hygiene in training and practice to create a new type of professional complementary to a dentist. Increasingly, dental therapists are permitted to treat adults as well as children. The paper also describes the status of a current initiative to introduce dental therapy to the United States. It concludes by suggesting that dental therapists can become valued members of the dental team throughout the world, helping to improve access to care and reducing existing disparities in oral health.
Three Taxa in One: Cryptic Diversity in the Black Fly Simulium nobile (Diptera: Simuliidae) in Southeast Asia

Low VL, Takaoka H, Pramual P, Adler PH, Ya'cob Z, Chen CD, et al.

J Med Entomol, 2016 07;53(4):972-976.
PMID: 27208009

We access the molecular diversity of the black fly Simulium nobile De Mejiere, using the universal cytochrome c oxidase subunit I (COI) barcoding gene, across its distributional range in Southeast Asia. Our phylogenetic analyses recovered three well-supported mitochondrial lineages of S. nobile, suggesting the presence of cryptic species. Lineage A is composed of a population from Sabah, East Malaysia (Borneo); lineage B represents the type population from Java, Indonesia; and lineage C includes populations from the mainland of Southeast Asia (Peninsular Malaysia and Thailand). The genetic variation of lineage C on the mainland is greater than that of lineages A and B on the islands of Borneo and Java. Our study highlights the value of a molecular approach in assessing species status of simuliids in geographically distinct regions.
Dietary Practices and Meal Patterns among Overweight and Obese School Children in Malaysia: Baseline Data from a School-Based Intervention Study

Selamat R, Raib J, Abdul Aziz NA, Zulkafly N, Ismail AN, W Mohamad WNA, et al.

Ecol Food Nutr, 2019 11 22;59(3):263-278.
PMID: 31755310 DOI: 10.1080/03670244.2019.1694922

This study aimed to determine dietary practices and meal patterns among Malaysian overweight and obese school children at baseline. This study was part of a school-based obesity intervention study, My Body is Fit and Fabulous at School (MyBFF@school). It involved 1045 primary and 1041 secondary overweight and obese school children from a randomly selected 23 out of 1196 primary and 15 out of 416 secondary government schools in central Peninsular Malaysia. The results showed a significantly higher of adequate intake (4-8 servings/day) of cereals and grains among primary (54.7%) than secondary school children (48.2%). About 28.2% of primary and 32.6% of secondary school children had consumed adequate fruit (2 servings/day), while a very low percentage of both primary (5.0%) and secondary (3.6%) school children consumed adequate vegetables (3 servings/day). As for the meal patterns, school children in both primary and secondary were not taking breakfast regularly (mean±SD for primary: 3.16 ± 2.61 days/week vs secondary: 2.97 ± 2.52 days/week). There was also a significantly higher mean frequency of primary school children brought plain water to school than the secondary school children. In conclusion, urgent actions to address improper dietary practices and meal patterns of overweight and obese school children in Malaysia are warranted.
Fulltext Embryonic mercury exposure in zebrafish: Alteration of metabolites and gene expression, related to visual and behavioral impairments

Abu Bakar N, Wan Ibrahim WN, Zulkiflli AR, Saleh Hodin NA, Kim TY, Ling YS, et al.

Ecotoxicol Environ Saf, 2023 May;256:114862.
PMID: 37004432 DOI: 10.1016/j.ecoenv.2023.114862

The widespread presence of mercury, a heavy metal found in the environment and used in numerous industries and domestic, raises concerns about its potential impact on human health. Nevertheless, the adverse effects of this environmental toxicant at low concentrations are often underestimated. There are emerging studies showing that accumulation of mercury in the eye may contribute to visual impairment and a comorbidity between autism spectrum disorders (ASD) trait and visual impairment. However, the underlying mechanism of visual impairment in humans and rodents is challenging. In response to this issue, zebrafish larvae with a cone-dominated retinal visual system were exposed to 100 nM mercury chloride (HgCl2), according to our previous study, followed by light-dark stimulation, a social assay, and color preference to examine the functionality of the visual system in relation to ASD-like behavior. Exposure of embryos to HgCl2 from gastrulation to hatching increased locomotor activity in the dark, reduced shoaling and exploratory behavior, and impaired color preference. Defects in microridges as the first barrier may serve as primary tools for HgCl2 toxicity affecting vision. Depletion of polyunsaturated fatty acids (PUFAs), linoleic acid, arachidonic acid (ARA), alpha-linoleic acid, docosahexaenoic acid (DHA), stearic acid, L-phenylalanine, isoleucine, L-lysine, and N-acetylputrescine, along with the increase of gamma-aminobutyric acid (GABA), sphingosine-1-phosphate, and citrulline assayed by liquid chromatography-mass spectrometry (LC-MS) suggest that these metabolites serve as biomarkers of retinal impairments that affect vision and behavior. Although suppression of adsl, shank3a, tsc1b, and nrxn1a gene expression was observed, among these tsc1b showed more positive correlation with ASD. Collectively, these results contribute new insights into the possible mechanism of mercury toxicity give rise to visual, cognitive, and social deficits in zebrafish.
Fulltext Is the burden of oral diseases higher in urban disadvantaged community compared to the national prevalence?

Jaafar N, Hakim H, Mohd Nor NA, Mohamed A, Saub R, Esa R, et al.

BMC Public Health, 2014;14 Suppl 3:S2.
PMID: 25438162 DOI: 10.1186/1471-2458-14-S3-S2

The urban low income has often been assumed to have the greatest dental treatment needs compared to the general population. However, no studies have been carried out to verify these assumptions. This study was conducted to assess whether there was any difference between the treatment needs of an urban poor population as compared to the general population in order to design an intervention programme for this community.
Fulltext Efficacy of Ivermectin Treatment on Disease Progression Among Adults With Mild to Moderate COVID-19 and Comorbidities: The I-TECH Randomized Clinical Trial

Lim SCL, Hor CP, Tay KH, Mat Jelani A, Tan WH, Ker HB, et al.

JAMA Intern Med, 2022 Apr 01;182(4):426-435.
PMID: 35179551 DOI: 10.1001/jamainternmed.2022.0189

IMPORTANCE: Ivermectin, an inexpensive and widely available antiparasitic drug, is prescribed to treat COVID-19. Evidence-based data to recommend either for or against the use of ivermectin are needed.
OBJECTIVE: To determine the efficacy of ivermectin in preventing progression to severe disease among high-risk patients with COVID-19.
DESIGN, SETTING, AND PARTICIPANTS: The Ivermectin Treatment Efficacy in COVID-19 High-Risk Patients (I-TECH) study was an open-label randomized clinical trial conducted at 20 public hospitals and a COVID-19 quarantine center in Malaysia between May 31 and October 25, 2021. Within the first week of patients' symptom onset, the study enrolled patients 50 years and older with laboratory-confirmed COVID-19, comorbidities, and mild to moderate disease.
INTERVENTIONS: Patients were randomized in a 1:1 ratio to receive either oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care (n = 241) or standard of care alone (n = 249). The standard of care consisted of symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.
MAIN OUTCOMES AND MEASURES: The primary outcome was the proportion of patients who progressed to severe disease, defined as the hypoxic stage requiring supplemental oxygen to maintain pulse oximetry oxygen saturation of 95% or higher. Secondary outcomes of the trial included the rates of mechanical ventilation, intensive care unit admission, 28-day in-hospital mortality, and adverse events.
RESULTS: Among 490 patients included in the primary analysis (mean [SD] age, 62.5 [8.7] years; 267 women [54.5%]), 52 of 241 patients (21.6%) in the ivermectin group and 43 of 249 patients (17.3%) in the control group progressed to severe disease (relative risk [RR], 1.25; 95% CI, 0.87-1.80; P = .25). For all prespecified secondary outcomes, there were no significant differences between groups. Mechanical ventilation occurred in 4 (1.7%) vs 10 (4.0%) (RR, 0.41; 95% CI, 0.13-1.30; P = .17), intensive care unit admission in 6 (2.4%) vs 8 (3.2%) (RR, 0.78; 95% CI, 0.27-2.20; P = .79), and 28-day in-hospital death in 3 (1.2%) vs 10 (4.0%) (RR, 0.31; 95% CI, 0.09-1.11; P = .09). The most common adverse event reported was diarrhea (14 [5.8%] in the ivermectin group and 4 [1.6%] in the control group).
CONCLUSIONS AND RELEVANCE: In this randomized clinical trial of high-risk patients with mild to moderate COVID-19, ivermectin treatment during early illness did not prevent progression to severe disease. The study findings do not support the use of ivermectin for patients with COVID-19.
TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT04920942.

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