Honey and Nigella sativa against COVID-19 in Pakistan (HNS-COVID-PK): A multicenter placebo-controlled randomized clinical trial.

Until now, no specific and effective treatment exists for coronavirus disease 2019 (COVID-19). Since honey and Nigella sativa (HNS) have established antiviral, antibacterial, antiinflammatory, antioxidant, and immunomodulatory properties, we tested their efficacy for this disease in a multicenter, placebo-controlled, and randomized clinical trial at four medical care facilities in Pakistan. RT-PCR confirmed COVID-19 adults showing moderate or severe disease were enrolled in the trial. Patients were randomly assigned in a 1:1 ratio to receive either honey (1 g kg-1 day-1 ) and Nigella sativa seeds (80 mg kg-1 day-1 ) or a placebo for up to 13 days along with standard care. The outcomes included symptoms' alleviation, viral clearance, and 30-day mortality in the intention-to-treat population. Three hundred and thirteen patients, 210 with moderate and 103 with severe disease, underwent randomization from April 30 to July 29, 2020. Among the moderate cases, 107 were assigned to HNS, whereas 103 were assigned to the placebo group. Among the severe cases, 50 were given HNS, and 53 were given the placebo. HNS resulted in ~50% reduction in time taken to alleviate symptoms as compared to placebo (moderate cases: 4 vs. 7 days, Hazard Ratio [HR]: 6.11; 95% Confidence Interval [CI]: 4.23-8.84, p < 0.0001 and for severe cases: 6 vs. 13 days, HR: 4.04; 95% CI: 2.46-6.64; p < 0.0001). HNS also cleared the virus earlier than placebo in both moderate cases (6 vs. 10 days, HR: 5.53; 95% CI: 3.76-8.14, p < 0.0001) and severe cases (8.5 vs. 12 days, HR: 4.32; 95% CI: 2.62-7.13, p < 0.0001). HNS further led to a better clinical score on day 6 with normal activity resumption in 63.6% vs. 10.9% among moderate cases (OR: 0.07; 95% CI: 0.03-0.13, p < 0.0001) and hospital discharge in 50% versus 2.8% in severe cases (OR: 0.03; 95% CI: 0.01-0.09, p < 0.0001). In severe cases, the mortality rate was less than 1/4th in the HNS group than in placebo (4% vs. 18.87%, OR: 0.18; 95% CI: 0.02-0.92, p = 0.029). No HNS-related adverse effects were observed. HNS, compared with placebo, significantly improved symptoms, expedited viral load clearance, and reduced mortality in COVID-19 patients. This trial was registered on April 15, 2020 with ClinicalTrials.gov Identifier: NCT04347382.

Clinical efficacy of iodine complex in SARS-CoV-2-infected patients with mild to moderate symptoms: study protocol for a randomized controlled trial.

BACKGROUND: Coronavirus disease 2019 (COVID-19) caused by the novel coronavirus-infected millions globally. Despite a wide range of advised options for the treatment of COVID-19, a single strategy to tackle this pandemic remains elusive, thus far. That is why we are conducting a clinical trial to find out the efficacy of iodine complex to clear a viral load of severe respiratory syndrome coronavirus-2 (SARS-CoV-2) along with a reduction in time taken to alleviate symptoms. METHOD: The proposed study is a placebo-controlled, add-on, randomized trial using parallel group designs. This is a closed-label and adaptive with sample size reassessment, multi-centered design with a 1:1:1:1 allocation ratio and superiority framework. It will be conducted in Shaikh Zayed Post-Graduate Medical Complex, Ali Clinic, and Doctors Lounge, Lahore, Pakistan. This study will have three arms of mild to moderately symptomatic COVID-19 patients (50 patients in each) which will receive ionic-iodine polymer complex with 200 mg of elemental iodine: interventional arm A will have encapsulated, arm B will receive suspension syrup form, arm C will get throat spray, while arm X will be standard care with placebo. Data will be collected on self-constructed, close-ended questionnaires after obtaining written consent. Data will be analyzed using SAS version 9.4. COVID-19 patients will be monitored by RT-PCR and HRCT (high-resolution computed tomography) chest. In addition to these, the duration of the symptomatic phase and mortality benefits will be analyzed in both groups. DISCUSSION: The study is designed to measure the superior efficacy of the iodine complex as an add-on in treating COVID-19-positive patients with mild to moderate symptoms. This combination is hypothesized to improve various parameters like rapid viral load reduction, clinical and radiological improvement, lower mortality, and reduction in hospitalization. The trial will aid in devising a better strategy to cope with COVID-19 in a relatively inexpensive and accessible way. The implications are global, and this could prove itself to be the most manageable intervention against COVID-19 especially for patients from limited-resource countries with deprived socioeconomic status. TRIAL REGISTRATION: ClinicalTrials.gov NCT04473261 . Registered on July 16, 2020.

Knowledge, attitude, and practice of clinicians about antimicrobial stewardship and resistance among hospitals of Pakistan: a multicenter cross-sectional study.

Considering that antimicrobial resistance (AMR) is a global challenge, there is a dire need to assess the knowledge, attitude, and practice (KAP) of clinicians in AMR endemic countries. The current multicenter, cross-sectional study aimed at highlighting gaps in antimicrobial (AM) stewardship and AMR among practicing doctors working in public tertiary care teaching hospitals of Lahore, Pakistan. A KAP survey, based on a self-administered questionnaire containing 45 questions, was distributed among 336 clinicians in 6 randomly selected hospitals. Overall, 92% of the clinicians considered AMR as a worldwide problem but only 66% disagreed that cold and flu symptoms require antibiotics. Moreover, around 68% of the doctors felt confident about their practice in AM but still, 96% felt the need to get more knowledge about AM drugs. The need for refresher courses on rational antibiotic use was expressed by 84% of the participants. The main contributing factors considered for AMR by the doctors included excessive AM usage in the medical profession (87.1%) and multiple antibiotics per prescription (76.4%). Pharmacologically, AM spectrum was accurately chosen by 1.4% for Ampicillin, 0.003% for Erythromycin and 0% for Levofloxacin. Clinically, more than 50% of the clinicians used miscellaneous AM for empirical therapy of respiratory tract infection and cholecystitis. The data was analyzed using Statistical Package for Social Sciences (SPSS) version 25. It is concluded that the knowledge of clinicians is relatively poor for AM spectrum and drugs of choice for certain infections. However, the clinicians are aware of their shortcomings and desire for improvement.

Prevalence of Panton Valentine Leucocidin gene containing Staphylococcus aureus in pus samples from Paediatric patients.

Staphylococcus (Staph) aureus containing Panton Valentine Leucocidin (PVL) gene are spreading in the whole world. This gene encodes PVL toxin that has lytic effect on WBCs contributing to the low immunity of the body. It also causes pus formation in various places of the body. This study was conducted to understand the effect of PVL positive Staph aureus in causing purulent infections in children between the age of one day to 15 years. Pus samples from various sites of the body from children between the age of one day to 15 years were taken. The number of pus samples containing Staph aureus was 45. These were collected over a period of one year, from October 2, 2017 to September 30, 2018, at the Shaikh Zayed Hospital, Lahore. A total of 27 (60%) PVL samples were positive Staph aureus. Prevalence of PVL gene was noted to be high in MSSA 9(64%), wound swabs 18(75%), in isolates from orthopaedic department 6(75%), indoor 21(63%), and in males 18(66%). Our study showed that most of the Staph aureus samples that were obtained from pus samples from children had PVL gene in their genome. This percentage is very high. To control its spread, we need to treat not only the patients but also their close contacts. The main objective to conduct this study was to assess the prevalence of PVL positive Staph aureus strain in our local setup. Paediatric age group was selected because it is the most vulnerable group and pus samples were chosen because this strain causes recurrent purulent infections.

Prophylactic potential of honey and Nigella sativa L. against hospital and community-based SARS-CoV-2 spread: a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: Considering the therapeutic potential of honey and Nigella sativa (HNS) in coronavirus disease 2019 (COVID-19) patients, the objective of the study is defined to evaluate the prophylactic role of HNS. TRIAL DESIGN: The study is a randomized, placebo-controlled, adaptive clinical trial with parallel group design, superiority framework with an allocation ratio of 1:1 among experimental (HNS) and placebo group. An interim analysis will be done when half of the patients have been recruited to evaluate the need to adapt sample size, efficacy, and futility of the trial. PARTICIPANTS: All asymptomatic patients with hospital or community based COVID-19 exposure will be screened if they have had 4 days exposure to a confirmed case. Non-pregnant adults with significant exposure level will be enrolled in the study High-risk exposure (<6 feet distance for >10min without face protection) Moderate exposure (<6 feet distance for >10min with face protection) Subjects with acute or chronic infection, COVID-19 vaccinated, and allergy to HNS will be excluded from the study. Recruitment will be done at Shaikh Zayed Post-Graduate Medical Institute, Ali Clinic and Doctors Lounge in Lahore (Pakistan). INTERVENTION AND COMPARATOR: In this clinical study, patients will receive either raw natural honey (0.5 g) and encapsulated organic Nigella sativa seeds (40 mg) per kg body weight per day or empty capsule with and 30 ml of 5% dextrose water as a placebo for 14 days. Both the natural products will be certified for standardization by Government College University (Botany department). Furthermore, each patient will be given standard care therapy according to version 3.0 of the COVID-19 clinical management guidelines by the Ministry of National Health Services of Pakistan. MAIN OUTCOMES: Primary outcome will be Incidence of COVID-19 cases within 14 days of randomisation. Secondary endpoints include incidence of COVID-19-related symptoms, hospitalizations, and deaths along with the severity of COVID-19-related symptoms till 14th day of randomization. RANDOMISATION: Participants will be randomized into experimental and control groups (1:1 allocation ratio) via the lottery method. There will be stratification based on high risk and moderate risk exposure. BLINDING (MASKING): Quadruple blinding will be ensured for the participants, care providers and outcome accessors. Data analysts will also be blinded to avoid conflict of interest. Site principal investigator will be responsible for ensuring masking. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 1000 participants will be enrolled in the study with 1:1 allocation. TRIAL STATUS: The final protocol version 1.4 was approved by institutional review board of Shaikh Zayed Post-Graduate Medical Complex on February 15, 2021. The trial recruitment was started on March 05, 2021, with a trial completion date of February 15, 2022. TRIAL REGISTRATION: Clinical trial was registered on February 23, 2021, www.clinicaltrials.gov with registration ID NCT04767087 . FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Anti-COVID property of subcutaneous ivermectin in synergy with zinc among midlife moderately symptomatic patients: a structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The study objective is to quantify the effectiveness of ivermectin (subcutaneous/oral IVM) in the presence or absence of zinc (Zn) for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients with moderate severity. TRIAL DESIGN: This quadruple-blinded, placebo-controlled randomized clinical trial will be a multiarmed multi-centered study with superiority framework. PARTICIPANTS: Quinquagenarian and sexagenarian patients with moderate COVID-19 symptoms and positive severe respiratory syndrome coronavirus -2 (SARS-CoV-2) PCR will be included. Participants with co-morbidities and pregnant women will be excluded. Patient recruitment will be done in Shaikh Zayed Medical Complex, Doctors Lounge and Ali Clinic in Lahore (Pakistan). INTERVENTION AND COMPARATOR: The registered patients will be allocated in 6 groups (30 participants each). Patients will be taking subcutaneous IVM at 200 µg/kg/48 h (Arm A) or subcutaneous IVM at 200 µg/kg/48 h and oral Zn 20mg/8 h (Arm B) or oral IVM at 0.2 mg/kg/day (Arm C) or oral IVM at 0.2 mg/kg/day and oral Zn 20mg/8 h (Arm D) or alone oral Zn 20mg/8 h (Arm E) or placebo alone (Arm X). Patients in all arms will receive standard care and respective placebo (empty capsule 8 hourly and/or subcutaneous normal saline 2ml/48 h). MAIN OUTCOMES: Primary endpoints will be duration of symptomatic phase and SARS-CoV-2 clearance along with high resolution CT (HRCT) chest score and clinical grade scale (CGS) on day 6. 30-day mortality will be documented as a secondary endpoint. SARS-CoV-2 clearance will be calculated by second PCR on day 7. HRCT chest score will be measured by the percentage and lung lobes involvement on day 6 with a maximum score of 25. CGS will be recorded on a seven-point scale; grade 1 (not hospitalized, no evidence of infection and resumption of normal activities), grade 2 (not hospitalized, but unable to resume normal activities), grade 3 (hospitalized, not requiring supplemental oxygen), grade 4 (hospitalized, requiring supplemental oxygen), grade 5 (hospitalized, requiring nasal high-flow oxygen therapy and/or noninvasive mechanical ventilation), grade 6 (hospitalized, requiring ECMO and/or invasive mechanical ventilation) and grade 7 (death). RANDOMISATION: A simple lottery method will be used to randomly allocate scrutinized patients in 1:1:1:1:1:1 ratio in 6 groups. BLINDING (MASKING): Patients, primary care physicians, outcome assessors and the data collection team will be blinded. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 180 participants will be randomized into six arms with five investigational and one placebo group. TRIAL STATUS: Institutional Review Board Shaikh Zayed Post-Graduate Medical Complex, Lahore, Pakistan has approved the protocol (version 2.3) with ID SZMC/IRB/Internal0056/2020. The trial was approved on July 14, 2020, and enrolment started on July 30, 2020. The estimated completion date is October 30, 2021. TRIAL REGISTRATION: Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04472585 dated July 16, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

COVID-19: A Potential Trigger for Thyroid Dysfunction.

Subacute thyroiditis (SAT) is a self-limiting thyroid dysfunction of viral origin. Relatively little is known about its occurrence in SARS CoV-2 infected COVID-19 patients. Herein, we report a case of SAT in a 58-year-old patient that was apparently triggered by infection with SARS CoV-2. Clinical, laboratory and imaging features of the patient are presented. The patient was vitally stable with a slightly tender and warm thyroid gland, which was painful on swallowing. His free thyroxine (FT4) was elevated, thyroid stimulating hormone (TSH) was below normal and free triiodothyronine (FT3) was in the physiological range. Previous thyroid exam conducted as a part of routine annual physical checkup was normal. The patient was put on prednisolone and recovered completely within three weeks.

A quadruple blinded placebo controlled randomised trial to evaluate the effectiveness of an Iodine complex for patients with mild to moderate COVID-19 in Pakistan (I-COVID-PK): A structured summary of a study protocol for a randomised controlled trial.

OBJECTIVES: The objective of the study is to measure the efficacy of ionic-iodine polymer complex [1] for clinical and radiological improvement in coronavirus disease 2019 (COVID-19) patients. TRIAL DESIGN: The trial will be closed label, randomized and placebo-controlled with a 1:1:1:1 allocation ratio and superiority framework. PARTICIPANTS: All PCR confirmed COVID-19 adult patients including non-pregnant females, with mild to moderate disease, will be enrolled from Shaikh Zayed Post-Graduate Medical Complex, Ali Clinic and Doctors Lounge in Lahore (Pakistan). Patients with any pre-existing chronic illness will be excluded from the study. INTERVENTION AND COMPARATOR: In this multi-armed study ionic-iodine polymer complex with 200 mg of elemental iodine will be given using three formulations to evaluate efficacy. Patients will be receiving either encapsulated iodine complex of 200 mg (arm A), iodine complex syrup form 40 ml (arm B), iodine complex throat spray of 2 puffs (arm C) or empty capsule (arm D) as placebo; all three times a day. All the 4 arms will be receiving standard care as per version 3.0 of the clinical management guidelines for COVID-19 established by the Ministry of National Health Services of Pakistan. MAIN OUTCOMES: Primary outcomes will be viral clearance with radiological and clinical improvement. SARS-CoV-2 RT-PCR and HRCT chest scans will be done on the admission day and then after every fourth day for 12 days or till the symptoms are resolved. RT-PCR will only be shown as positive or negative while HRCT chest scoring will be done depending on the area and severity of lung involvement [2]. Time taken for the alleviation of symptoms will be calculated by the number of days the patient remained symptomatic. 30-day mortality will be considered as a secondary outcome. RANDOMISATION: Stratification for initial COVID-19 status (or days from initial symptoms as a proxy), age groups, gender, baseline severity of symptoms and co-morbidities will be used to ensure that the study arms remain balanced in size for the 1:1:1:1 allocation ratio. Randomization will be done using the lottery method. As patients are being admitted at different times, they will be recruited after obtaining their voluntary written informed consent following all standard protocols of the infection, control and disinfection. BLINDING (MASKING): This is a quadruple (participants, care providers, investigators and outcomes assessors) blinded study where only the study's Primary Investigator will have information about the arms and their interventions. NUMBERS TO BE RANDOMISED (SAMPLE SIZE): 200 patients will be randomized into four groups with three experimental and one placebo arm. TRIAL STATUS: Protocol Version Number is 2.3 and it is approved from IRB Shaikh Zayed Hospital with ID SZMC/IRB/Internal0056/2020 on July 14th, 2020. The recruitment is in progress. It was started on July 30, 2020, and the estimated end date for the trial is August 15, 2021. TRIAL REGISTRATION: Clinical Trial has been retrospectively registered on www.clinicaltrials.gov with registration ID NCT04473261 dated July 16, 2020. FULL PROTOCOL: The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). With the intention of expediting dissemination of this trial, the conventional formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines.

Frequency Of Panton Valentine Leucocidin Gene In Staphylococcus Aureus From Skin And Soft Tissue Infections.

BACKGROUND: Staphylococcus aureus harbouring Panton Valentine Leucocidin gene are emerging and spreading worldwide. PVL gene was first identified by Noel Panton and Francis Valentine in 1932 who explained its ability to lyse leucocytes and its main relationship with skin and soft tissue infections. In Pakistan only limited data is available on the frequency and molecular analysis of PVL gene positive Staph aureus. Therefore, this study was conducted to understand the clinical epidemiology of PVL positive Staph aureus in our setup. Objectives of the study was aimed to determine the frequency of PVL gene in Staph aureus obtained from pus samples from skin and soft tissue infections from various departments; indoor and outdoor of a tertiary care hospital of Lahore. METHODS: 384 Staph aureus isolates from skin and soft tissue infections were selected from both indoor and outdoor departments of hospital. After identification by phenotypic methods, they were processed by PCR using luk-F and luk-S primers for the detection of PVL gene. RESULTS: 186 out of 384 Staph aureus isolates were positive for PVL gene. Overall frequency of PVL gene was 49%. Frequency of PVL gene in Staph aureus was 44.9% in males and 53.5% in females. The highest frequency of PVL gene was detected in paediatric age group. A large majority of positive isolates were from pus samples other than swabs and from the general surgery department. They mostly belong to indoor with indoor outdoor ratio of approximately 2:1. Frequencies of PVL gene in MRSA and MSSA were 51% and 44% respectively. Frequency of PVL gene was found to be high in Ciprofloxacin sensitive, Gentamicin sensitive, Erythromycin resistant and Fusidic acid resistant isolates. CONCLUSION: Almost half of Staph aureus isolates were found PVL positive. They were mostly multidrug resistant came from indoor setup. This situation is very alarming so, there is a need to adopt strict infection control policies in the hospitals to limit the widespread and injudicious use of antibiotics. There is also a need to apply PVL positive Staph aureus treatment to the effected individuals which involve not only antibiotics but also the decolonization of effected individuals and their close contacts.

New Delhi Metallo-Beta-Lactamase Producing Carbapenem-Resistant Gram-Negative Bacilli: Microbiological And Genotypic Analyses At A Tertiary Care Hospital In Pakistan.

BACKGROUND: Metallo-beta-lactamases (MBL) catalyze the hydrolysis of beta-lactam antibiotics including carbapenems. A novel MBL subtype, New Delhi MBL (NDM), poses a serious public health problem. The aims of this study were to determine the frequency of NDM producers among the Carbapenem-resistant gram-negative bacilli (GNB) in hospitalized patients and carrying out the molecular analysis of the NDM genes as reliable data on this is not available in Pakistan. METHODS: We carried out a cross-sectional study on prospectively collected clinical samples from 113 patients hospitalised at Shaikh Zayed Hospital Lahore, Pakistan. All the samples that were carbapenem-resistant on routine sensitivity testing were selected for this study. Various microbiological and genotypic analyses of the samples were performed. RESULTS: The mean age of the patients was 47.8±20.8 years. About a quarter (25.7%) of the samples was from the urology ward and 43% were urine samples. Around two-third of the samples (n=74, 65.5%) tested positive for Non-Enterobacteriaceae GNB. Pseudomonas spp was the most common isolate among the Non-Enterobacteriaceae and E-coli amongst the Enterobacteriaceae. NDM gene was detected in 22 patients (19.5%). We did not find any association of the NDM gene with the demographic and clinical characteristics.. CONCLUSION: NDMpositive GNB are present in our hospitalized patients, which is worrisome as these bacteria can disseminate globally and lead to an extensive and uncontrollable spread of pandemic clones for which efficient antibiotic therapy is currently not available. Systemic surveillance network and infection control strategies should be established to curtail dissemination of NDM-producing GNB in Pakistan.

Root cause analysis of methicillin resistant Staphylococcus aureus bacteraemia.

OBJECTIVE: To find the important risk factors and sources of bacteraemia in patients suffering from methicillin-resistant staphylococcus aureus bacteraemia. METHODS: The descriptive study was carried out at Shaikh Zayed Hospital, Lahore, from October 2010 to August 2011. Blood cultures were processed to isolate methicillin-resistant staphylococcus aureus. A questionnaire was completed by the participating patients suffering from bacteraemia. Information about risk factors present at the time and risk factors that served as the source of bacteraemia were noted. RESULTS: Total 4058 blood cultures were processed and 669(16.5%) were positive. Of them, 194(29%) cultures were found to be positive for staphylococci. Out of these 194 blood cultures, coagulase-negative staphylococci were isolated from 117(60%), and 77(40%) were positive for S. aureus. Out of these 77 samples, 26(34%) were found to be methicillin-sensitive staphylococcus aureus and 51(66%) were methicillin-resistant staphylococcus aureus. The overall frequency of methicillin-resistant staphylococcus aureus was 1.25%; 7.62% out of positive blood culture; 26.28% out of total staphylococci; and 66% out of total S. aureus. As for the source of infection, central venous pressure line 11(21.6%), post-influenza pneumonia 9(17.6%), peripheral intravenous line 8(15.7%) and dialysis line 7(13.7%) were major reasons. CONCLUSIONS: Taking care of aseptic measures while insertion, frequent change and early removal of the central venous and dialysis lines is of critical significance.

Antibiotic resistance of E. coli isolates from urine samples of Urinary Tract Infection (UTI) patients in Pakistan.

Drug resistance is becoming alarming with the passage of time worldwide in general and in third world countries in particular. Human urine specimens of patients of urinary tract infection at Sheikh Zayed hospital, Lahore, Pakistan were analyzed for drug resistance in Escherichia coli. A total of 69 Escherichia coli isolates from human urine specimens were obtained and screened for their antibiograms. A total of seven antibiotic resistance profiles were obtained with over 65% of the isolates showing multi-drug resistance. Very high resistance levels were detected against augmentin and gentamicin (87.5 &77.5 % respectively) while imipenem and tazocin recorded the least resistance levels (32.5% and 12.5% respectively) among the isolates.

Periodontitis in coronary heart disease patients: strong association between bleeding on probing and systemic biomarkers.

AIM: Few studies have examined the relationship of individual periodontal parameters with individual systemic biomarkers. This study assessed the possible association between specific clinical parameters of periodontitis and systemic biomarkers of coronary heart disease risk in coronary heart disease patients with periodontitis. MATERIALS AND METHODS: Angiographically proven coronary heart disease patients with periodontitis (n = 317), aged >30 years and without other systemic illness were examined. Periodontal clinical parameters of bleeding on probing (BOP), probing depth (PD), and clinical attachment level (CAL) and systemic levels of high-sensitivity C-reactive protein (CRP), fibrinogen (FIB) and white blood cells (WBC) were noted and analyzed to identify associations through linear and stepwise multiple regression analyses. RESULTS: Unadjusted linear regression showed significant associations between periodontal and systemic parameters; the strongest association (r = 0.629; p < 0.001) was found between BOP and CRP levels, the periodontal and systemic inflammation marker, respectively. Stepwise regression analysis models revealed that BOP was a predictor of systemic CRP levels (p < 0.0001). BOP was the only periodontal parameter significantly associated with each systemic parameter (CRP, FIB, and WBC). CONCLUSION: In coronary heart disease patients with periodontitis, BOP is strongly associated with systemic CRP levels; this association possibly reflects the potential significance of the local periodontal inflammatory burden for systemic inflammation.

Frequency of methicillin-resistant Staphylococcus aureus nasal colonization among patients suffering from methicillin resistant Staphylococcus aureus bacteraemia.

OBJECTIVE: To determine rate of nasal colonization in Patients suffering from bacteraemia caused by methicillin resistant Staphylococcus aureus. METHODS: This descriptive cross sectional study was carried out in a tertiary ca re, University Teaching Hospital (Shaikh Zayed Hospital, Lahore) from October 2010 to August 2011. Nasal swabs were taken from patients suffering from MRSA bacteraemia and were plated on mannitol salt agar plates to isolate Staphylococcus aureus (S. aureus) which were then tested for oxacillin susceptibility. RESULTS: Nasal colonization was present in 52.5% of patients suffering from MRSA bacteraemia. CONCLUSION: Nasal colonization rates with MRSA were high among patients suffering from MRSA bacteraemia especially in those undergoing dialysis or surgical procedures. Therefore, screening and nasal decolonization should be practiced in hospitals.

Non-surgical periodontal therapy reduces coronary heart disease risk markers: a randomized controlled trial.

AIM: Periodontal disease elevates systemic inflammatory markers strongly associated with coronary heart disease (CHD) risk. The aim of this randomized controlled trial was to investigate the effect of non-surgical periodontal therapy on systemic C-reactive protein (CRP), fibrinogen and white blood cells in CHD patients. MATERIALS AND METHODS: Angiographically proven CHD patients with periodontitis (n = 317) were randomized to intervention (n = 212) or control group (n = 105). Primary outcome was reduction in serum CRP levels; secondary outcomes were reductions in fibrinogen and white blood cells. Periodontal treatment included scaling, root planing and oral hygiene instructions. Periodontal and systemic parameters were assessed at baseline and at 2-month follow-up. Intent-to-treat (ITT) analysis was performed. RESULTS: Study was completed by 246 subjects (intervention group = 161; control group = 85). Significant improvements in periodontal and systemic parameters were observed in intervention group. The number of subjects with CRP > 3mg/L in intervention group decreased by 38% and in control group increased by 4%. ITT analysis gave a significant (χ(2) =4.381, p = 0.036) absolute risk reduction of 12.5%. CONCLUSION: In CHD patients with periodontitis, non-surgical mechanical periodontal therapy significantly reduced systemic levels of C-reactive protein, fibrinogen and white blood cells.

Helicobacter pylori in dental plaque; is it related to brushing frequency, plaque load and oral health status?

OBJECTIVE: To determine the relation between presence of H. pylori in supra-gingival dental plaque with oral hygiene habits and oral health status of patients suffering from symptomatic dyspepsia. STUDY DESIGN: Descriptive study. PLACE AND DURATION OF STUDY: The Department of Oral Health Sciences, Shaikh Zayed FPGMI, Lahore, from September 2008 to August 2009. METHODOLOGY: One hundred and fifty dyspeptic subjects with dental plaque were enrolled. After recording brushing frequency, oral health status and plaque load, the supra-gingival dental plaque samples were collected by sterile curettes. Helicobacter pylori were detected in dental plaque samples through PCR assay. RESULTS: Presence of H. pylori in dental plaque was found to be 37.5% in the sample. Most of the subjects brushed once daily, had plaque index score of 1 and had fair to poor oral hygiene status. Approximately 35% of the individuals who brushed once or twice a day harbored the bacterium in their dental plaque. There was no difference between bacterial detection rates among different categories of plaque index and oral health status of the study subjects. CONCLUSION: Presence of H. pylori in dental plaque was found to be associated with neither brushing frequency nor with the plaque load nor with the oral health status of individuals suffering from symptomatic dyspepsia.

Simultaneous amplification of two bacterial genes: more reliable method of Helicobacter pylori detection in microbial rich dental plaque samples.

Polymerase Chain reaction (PCR) assay is considered superior to other methods for detection of Helicobacter pylori (H. pylori) in oral cavity; however, it also has limitations when sample under study is microbial rich dental plaque. The type of gene targeted and number of primers used for bacterial detection in dental plaque samples can have a significant effect on the results obtained as there are a number of closely related bacterial species residing in plaque biofilm. Also due to high recombination rate of H. pylori some of the genes might be down regulated or absent. The present study was conducted to determine the frequency of H. pylori colonization of dental plaque by simultaneously amplifying two genes of the bacterium. One hundred dental plaque specimens were collected from dyspeptic patients before their upper gastrointestinal endoscopy and presence of H. pylori was determined through PCR assay using primers targeting two different genes of the bacterium. Eighty-nine of the 100 samples were included in final analysis. With simultaneous amplification of two bacterial genes 51.6% of the dental plaque samples were positive for H. pylori while this prevalence increased to 73% when only one gene amplification was used for bacterial identification. Detection of H. pylori in dental plaque samples is more reliable when two genes of the bacterium are simultaneously amplified as compared to one gene amplification only.

Non-surgical periodontal therapy lowers serum inflammatory markers: a pilot study.

BACKGROUND: Evidence suggests an association between periodontal disease and coronary heart disease (CHD). C-reactive protein (CRP), fibrinogen, and white blood cell (WBC) counts are markers of inflammation, and their systemic levels have been associated with CHD risk. This pilot study investigated the effect of non-surgical periodontal therapy on systemic levels of CRP, fibrinogen, and WBC counts in subjects with CHD or no CHD (NCHD). METHODS: Twenty-seven angiographically defined patients with CHD and 18 subjects with NCHD aged >or=40 years were recruited for the study. Periodontal disease was measured through the clinical parameters bleeding on probing (BOP) and probing depth (PD). All subjects received non-surgical periodontal therapy that included oral hygiene instructions and subgingival scaling and root planing. Systemic levels of inflammatory markers (CRP, fibrinogen, and WBC counts) were measured prior to and 1 month after periodontal therapy. RESULTS: Seventeen subjects with CHD and 11 subjects with NCHD completed the study. Subjects with CHD or NCHD experienced significant reductions in BOP (59% and 34%, respectively; P <0.05) and PD (41% and 35%, respectively; P <0.05), with non-significant intergroup differences (P >0.05). In all subjects, CRP, fibrinogen, and WBC counts were reduced significantly (21% to 40%) after periodontal therapy (P <0.05). CONCLUSIONS: Periodontal treatment resulted in significant decreases in BOP and PD and lowered serum inflammatory markers in patients with CHD or NCHD. This may result in a decreased risk for CHD in the treated patients. These findings will allow pursuit of a large-scale randomized intervention trial in this population.

Helicobacter pylori in dental plaque and gastric mucosa: correlation revisited.

Helicobacter pylori (H. pylori) related gastric infection is highly prevalent in developing countries. Prevalence of bacterium in dental plaque from these regions is also reported to be high, but association between simultaneous colonization of H. pylori in both these sites has not been established yet. Aim of this paper is to review possible association between simultaneous oral and gastric H. pylori colonization in dyspeptic patients. Pertinent literature was reviewed and all available evidence collected from Medline and PakMedinet. Studies conducted in the developing world show conflicting results. Some report a positive relation between oral and gastric H. pylori colonization while others deny any association. This may be due to the population sampled or methodology applied. Further studies are recommended to confirm the association between concurrent presence of H. pylori in dental plaque and gastric mucosa of dyspeptic patients using sensitive and specific tests for detection of bacterium in oral samples.

Bedside diagnosis of spontaneous bacterial peritonitis using reagent strips.

OBJECTIVE: To determine the efficacy of reagent strip for bedside diagnosis of spontaneous bacterial peritonitis (SBP). DESIGN: Cross-sectional analytical study. PLACE AND DURATION OF STUDY: Shaikh Zayed Postgraduate Medical Institute from November 2003 to August 2004. PATIENTS AND METHODS: Patients with cirrhosis and ascites underwent diagnostic paracentesis. Fluid was checked for leukocyte esterase released by PMN by using Combur 10 urine strip and graded for color change from 0-3. Fluid was also analyzed by cytology for PMN count. Results of both methods were compared to determine sensitivity, specificity and accuracy of strip for diagnosis of SBP. RESULTS: Of 214 paracentesis performed, SBP was diagnosed in 38 patients whereas 176 were negative for infection. Strip test was 97.7% sensitive and 89.4% specific with positive predictive value of 90%, negative predictive value of 97.7% and accuracy of 96.2%, when reagent strip grade 3 was considered as positive for diagnosis. CONCLUSION: Reagent strip is a quick bedside test, highly sensitive and specific for the diagnosis of SBP, based on polymorphonuclear count in ascitic fluid, to initiate early treatment, thus improving patient's outcome.