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Hv Worthington - One of the best experts on this subject based on the ideXlab platform.
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use of antimicrobial mouthwashes gargling and Nasal Sprays by healthcare workers to protect them when treating patients with suspected or confirmed covid 19 infection
Cochrane Database of Systematic Reviews, 2020Co-Authors: Martin J Burton, Janet E Clarkson, Beatriz Goulao, Annemarie Glenny, Andrew J Mcbain, Anne G M Schilder, Katie E Webster, Hv WorthingtonAbstract:Background COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well. Objectives To assess the benefits and harms of antimicrobial mouthwashes and Nasal Sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection. Search methods Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies. We sought studies comparing any antimicrobial mouthwash and/or Nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19. Data collection and analysis We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, Nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of Nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. Main results We found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature). AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and Nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.
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antimicrobial mouthwashes gargling and Nasal Sprays to protect healthcare workers when undertaking aerosol generating procedures agps on patients without suspected or confirmed covid 19 infection
Cochrane Database of Systematic Reviews, 2020Co-Authors: Martin J Burton, Janet E Clarkson, Beatriz Goulao, Annemarie Glenny, Andrew J Mcbain, Anne G M Schilder, Katie E Webster, Hv WorthingtonAbstract:BACKGROUND: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol-generating procedure (AGP). Not all those with COVID-19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID-19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them. If the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID-19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose. OBJECTIVES: To assess the benefits and harms of antimicrobial mouthwashes and Nasal Sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID-19 infection. SEARCH METHODS: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies. We sought studies comparing any antimicrobial mouthwash and/or Nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID-19 viral content of aerosol (when present); 4) change in COVID-19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, Nasal cavity, oro- or nasopharynx; 6) other adverse events: allergy, irritation/burning of Nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We found no completed studies to include in this review. AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID-19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies.
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antimicrobial mouthwashes gargling and Nasal Sprays administered to patients with suspected or confirmed covid 19 infection to improve patient outcomes and to protect healthcare workers treating them
Cochrane Database of Systematic Reviews, 2020Co-Authors: Martin J Burton, Janet E Clarkson, Beatriz Goulao, Annemarie Glenny, Andrew J Mcbain, Anne G M Schilder, Katie E Webster, Hv WorthingtonAbstract:Background COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of patients with infection are irrigated with antimicrobial solutions, this may help the patients by killing any coronavirus present at those sites. It may also reduce the risk of the active infection being passed to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose. Objectives To assess the benefits and harms of antimicrobial mouthwashes and Nasal Sprays administered to patients with suspected or confirmed COVID-19 infection to both the patients and the HCWs caring for them. Search methods Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies. We sought studies comparing antimicrobial mouthwash and/or Nasal spray (alone or in combination) at any concentration, delivered with any frequency or dosage to suspected/confirmed COVID-19 patients. Data collection and analysis We used standard Cochrane methodological procedures. Our primary outcomes were: 1) RECOVERY* (www.recoverytrial.net) outcomes in patients (mortality; hospitalisation status; use of ventilation; use of renal dialysis or haemofiltration); 2) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 3) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 4) change in COVID-19 viral load in patients; 5) COVID-19 viral content of aerosol (when present); 6) other adverse events: changes in microbiome in oral cavity, Nasal cavity, oro- or nasopharynx; 7) other adverse events: allergy, irritation/burning of Nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. Main results We found no completed studies to include in this review. We identified 16 ongoing studies (including 14 RCTs), which aim to enrol nearly 1250 participants. The interventions included in these trials are ArtemiC (artemisinin, curcumin, frankincense and vitamin C), Citrox (a bioflavonoid), cetylpyridinium chloride, chlorhexidine, chlorine dioxide, essential oils, hydrogen peroxide, hypertonic saline, Kerecis spray (omega 3 viruxide - containing neem oil and St John's wort), neem extract, nitric oxide releasing solution, povidone iodine and saline with baby shampoo. AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by a number of RCTs and other studies. We are concerned that few of the ongoing studies specifically state that they will evaluate adverse events such as changes in the sense of smell or to the oral and Nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.
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Antimicrobial mouthwashes (gargling) and Nasal Sprays to protect healthcare workers when undertaking aerosol‐generating procedures (AGPs) on patients without suspected or confirmed COVID‐19 infection
Cochrane Collaboration, 2020Co-Authors: Hv Worthington, Burton M, Je Clarkson, Ke Webster, Schilder Agm, Glenny A-m, Aj Mcbain, Goulao BAbstract:Background: COVID‐19 infection poses a serious risk to patients and – due to its contagious nature – to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol‐generating procedure (AGP). Not all those with COVID‐19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID‐19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them. If the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID‐19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose. Objectives: To assess the benefits and harms of antimicrobial mouthwashes and Nasal Sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID‐19 infection. Search Methods: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. Selection Criteria: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi‐RCTs; non‐randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross‐sectional studies; controlled before‐and‐after studies. We set no minimum duration for the studies. We sought studies comparing any antimicrobial mouthwash and/or Nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP. Data Collection and Analysis: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test‐positive COVID‐19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID‐19 viral content of aerosol (when present); 4) change in COVID‐19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, Nasal cavity, oro‐ or nasopharynx; 6) other adverse events: allergy, irritation/burning of Nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long‐term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. Main Results: We found no completed studies to include in this review. Authors' Conclusions: We identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID‐19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies.
S Callejas - One of the best experts on this subject based on the ideXlab platform.
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bioavailability of fluticasone propionate and mometasone furoate aqueous Nasal Sprays
European Journal of Clinical Pharmacology, 2004Co-Authors: Peter T Daleyyates, R L Kunka, Y Yin, S Andrews, S CallejasAbstract:Objectives To compare the systemic exposure for intraNasal mometasone furoate (MF) and fluticasone propionate (FP) aqueous Nasal Sprays (ANS) in terms of serum and urinary cortisol parameters and plasma pharmacokinetics.
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bioavailability of fluticasone propionate and mometasone furoate aqueous Nasal Sprays
European Journal of Clinical Pharmacology, 2004Co-Authors: Peter T Daleyyates, R L Kunka, Y Yin, S Andrews, S CallejasAbstract:To compare the systemic exposure for intraNasal mometasone furoate (MF) and fluticasone propionate (FP) aqueous Nasal Sprays (ANS) in terms of serum and urinary cortisol parameters and plasma pharmacokinetics. Twelve healthy subjects completed this three-way, cross-over study. They received FPANS (50 μg/spray), MFANS (50 μg/spray) or placebo ANS, eight Sprays per nostril every 8 h for 4 days. Cortisol measurements were made at baseline and day 4. FP and MF plasma concentrations were also measured on day 4. MFANS produced similar mean plasma AUC (123 pmol/l h) to FPANS (112 pmol/l h). Despite the use of high doses, necessary to generate adequate pharmacokinetic data, only minor reductions in cortisol parameters were found, with no difference between FPANS and MFANS. FP and MF have similar and very low systemic bioavailability when administered intraNasally using a high-dose regimen. It is therefore unlikely that therapeutic doses of intraNasal FP or MF will produce dissimilar or significant degrees of systemic exposure or systemic effects.
George Georges - One of the best experts on this subject based on the ideXlab platform.
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triamcinolone acetonide and fluticasone propionate Nasal Sprays provide comparable relief of seasonal allergic rhinitis symptoms regardless of disease severity
Allergy and asthma proceedings : the official journal of regional and state allergy societies, 2004Co-Authors: Harold Kaiser, Y Liao, Phyllis Diener, Michael Leahy, Jorge Garcia, George GeorgesAbstract:The aim of this study was to examine the effects of aqueous triamcinolone acetonide (TAA AQ) and fluticasone propionate (FP) Nasal Sprays on seasonal allergic rhinitis (SAR) symptoms and health-related quality of life (HRQL) in patients stratified into cohorts based on symptom severity. In a multicenter, investigator-blinded, parallel-group study, 295 patients with a ≥2-year history of SAR received once-daily TAA AQ, 220 leg, or FP, 200 μg, for 3 weeks. Median baseline total Nasal symptom score (TNSS; sum of Nasal congestion, rhinorrhea, sneezing, and Nasal itching scores) for all patients was 8.14 (range, 0-12). Patients were stratified by baseline TNSS into a moderate (<8.14) or severe (≥8.14) cohort. Changes from baseline TNSS, individual symptom scores, and HRQL were assessed. Sixty-nine TAA AQ and 76 FP patients were included in the moderate stratum (baseline mean TNSS = 6.14 and 6.22, respectively), and 79 (TAA AQ) and 71 (FP) patients were included in the severe stratum (TNSS = 10.03 and 9.47, respectively). At the study end, patients showed significant (p < 0.0001 all comparisons) and comparable improvements in TNSS in both the moderate (TAA AQ, -2.40 [95% confidence 'interval [CI}. -2.92, -1.87], 39% improvement; FP, -2.22 [95% Cl, -2.72, -1.73], 36% improvement) and the severe (TAA AQ, -3.85 [95% CI, -4.36, -3.33], 38% improvement; FP, -3.84 [95% CI, -4.43, -3.24], 41% improvement) strata. TAA AQ and FP significantly and comparably improved HRQL in both strata versus baseline. Once-daily TAA AQ and FP Nasal Sprays in patients with moderate or severe SAR provided significant and comparable symptom relief and improvements in HRQL.
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evaluation of patients preferences for triamcinolone acetonide aqueous fluticasone propionate and mometasone furoate Nasal Sprays in patients with allergic rhinitis
Otolaryngology-Head and Neck Surgery, 2004Co-Authors: Michael Stokes, Jorge Garcia, Stacey L Amorosi, David R Thompson, Leon Dupclay, George GeorgesAbstract:OBJECTIVE: To compare product attributes, preferences, and expected compliance associated with triamcinolone acetonide aqueous (TAA-AQ), fluticasone propionate (FP), and mometasone furoate (MF) Nasal Sprays in patients with allergic rhinitis.STUDY DESIGN AND SETTING: Data from 2 randomized, double-blind crossover studies with identical design were pooled (N = 215). Patients completed a 14-item sensory attributes questionnaire immediately after each product, and stated their preference and expected compliance with a prescription after receiving all products.RESULTS: Compared with FP and MF, TAA-AQ was associated with significantly less odor and greater liking of odor (P < 0.001); and less taste, less dryness of nose/throat, less aftertaste, and greater overall liking (P < 0.05). Significantly more patients preferred most a prescription of TAA-AQ (50.0%) versus FP (25.0%; P < 0.001) and MF (25.0%; P < 0.001), and would “definitely comply” with TAA-AQ (62.5%) versus FP (49.0%; P < 0.01) and MF (51.0%; P < 0....
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triamcinolone acetonide and fluticasone propionate aqueous Nasal Sprays significantly improve Nasal airflow in patients with seasonal allergic rhinitis
Allergy and asthma proceedings : the official journal of regional and state allergy societies, 2004Co-Authors: Eli O Meltzer, Y Liao, Phyllis Diener, Jorge Garcia, Carol L Gallet, Alfredo A Jalowayski, George GeorgesAbstract:Domiciliary measurement of Nasal peak inspiratory flow rate (nPIFR) provides a simple, noninvasive, objective assessment of Nasal patency and may be useful for determining the effectiveness of therapeutic interventions. This randomized, parallel-group, investigator-blind study compared the effects of triamcinolone acetonide aqueous Nasal spray (TAA AQ), 220 microg everyday (n = 19), and fluticasone propionate (FP AQ), 200 microg everyday (n = 20), for 21 days on Nasal airflow in patients with seasonal allergic rhinitis (SAR), using domiciliary nPIFR. Patients had a > or = 2-year history of springtime SAR and positive epicutaneous or intradermal test to grass, tree pollen, or outdoor molds. nPIFR was measured three times each morning (before dosing) and at bedtime using an In-Check nPIF meter. All measurements were recorded on diary cards, and the best of the three measurements was used for data analysis. There were no significant demographic differences between treatment groups at baseline. Baseline nPIFR (+/- SE) was 106.5 L/minute (+/- 51.2) and 97.7 L/minute (+/- 45.0) in the TAA AQ and FP AQ groups, respectively (p = 0.5733). Model-based estimation of mean change from baseline with TAA AQ and FP AQ at the end of the study were 21.72 (+/- 6.04) and 16.48 (+/- 5.73), respectively. Both treatment groups showed an approximately 20% improvement in nPIFR versus baseline (p = 0.0002 and p = 0.0069 for TAA AQ and FP AQ, respectively), with no statistical difference between treatments. Weekly mean nPIFR scores indicated progressive improvement in Nasal airflow with both treatments. Both TAA AQ and FP AQ were effective for improving Nasal airflow as indicated by increases in nPIFR in patients with SAR.
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comparative efficacy safety and effect on quality of life of triamcinolone acetonide and fluticasone propionate aqueous Nasal Sprays in patients with fall seasonal allergic rhinitis
Annals of Allergy Asthma & Immunology, 2002Co-Authors: Gary Gross, George Georges, Robert L Jacobs, Thomas H Woodworth, Janet LimAbstract:Background The topical potency of fluticasone propionate (FP) is known to be four times greater than that of triamcinolone acetonide (TAA). However, the significance of this difference has not been proven in the clinical treatment of seasonal allergic rhinitis (SAR). Objective To compare the efficacy, safety, and effect on health-related quality of life (HRQL) of FP and TAA aqueous Nasal Sprays in patients with SAR Methods Single-blind, parallel-group, active-controlled design. Patients were randomized to 3-week treatment with TAA 220 μg (n = 172) or FP 200 μg (n = 180) as two Sprays/nostril once daily AM. Twelve-hour reflective symptom evaluations (Nasal discharge, stuffiness, itching; sneezing; ocular itching/tearing/redness) were performed AM/PM, beginning at pretreatment baseline period. Incidences of specific treatment-related side effects were collected in daily questionnaires. HRQL was evaluated at baseline and end-of-treatment with a validated disease-specific, quality-of-life instrument. Results TAA and FP produced similar improvement in daily total Nasal symptom scores overall (49.4% and 52.7%, respectively; P = 0.332) and at every weekly time point ( P > 0.05). There were no significant differences between TAA and FP in any individual symptom score at any time point except week 2 (FP provided greater reduction in sneezing, P = 0.046). No significant difference was found between groups in overall occurrence of specific treatment-related side effects. Overall Rhinoconjunctivitis Quality of Life Questionnaire scores were similar for TAA and FP at end-of-treatment. Conclusions Despite differing molecular potencies, FP and TAA demonstrated comparable efficacy in the treatment of SAR, and produced similar occurrences of specific treatment-related side effects and similar improvements in overall patient HRQL.
Martin J Burton - One of the best experts on this subject based on the ideXlab platform.
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antimicrobial mouthwashes gargling and Nasal Sprays to protect healthcare workers when undertaking aerosol generating procedures agps on patients without suspected or confirmed covid 19 infection
Cochrane Database of Systematic Reviews, 2020Co-Authors: Martin J Burton, Janet E Clarkson, Beatriz Goulao, Annemarie Glenny, Andrew J Mcbain, Anne G M Schilder, Katie E Webster, Hv WorthingtonAbstract:BACKGROUND: COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. The risks of transmission of infection are greater when a patient is undergoing an aerosol-generating procedure (AGP). Not all those with COVID-19 infection are symptomatic, or suspected of harbouring the infection. If a patient who is not known to have or suspected of having COVID-19 infection is to undergo an AGP, it would nonetheless be sensible to minimise the risk to those HCWs treating them. If the mouth and nose of an individual undergoing an AGP are irrigated with antimicrobial solutions, this may be a simple and safe method of reducing the risk of any covert infection being passed to HCWs through droplet transmission or direct contact. Alternatively, the use of antimicrobial solutions by the HCW may decrease the chance of them acquiring COVID-19 infection. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose. OBJECTIVES: To assess the benefits and harms of antimicrobial mouthwashes and Nasal Sprays administered to HCWs and/or patients when undertaking AGPs on patients without suspected or confirmed COVID-19 infection. SEARCH METHODS: Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies. We sought studies comparing any antimicrobial mouthwash and/or Nasal spray (alone or in combination) at any concentration, delivered to the patient or HCW before and/or after an AGP. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs or patients; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) COVID-19 viral content of aerosol (when present); 4) change in COVID-19 viral load at site(s) of irrigation; 5) other adverse events: changes in microbiome in oral cavity, Nasal cavity, oro- or nasopharynx; 6) other adverse events: allergy, irritation/burning of Nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We found no completed studies to include in this review. AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review, nor any ongoing studies. The absence of completed studies is not surprising given the relatively recent emergence of COVID-19 infection. However, we are disappointed that this important clinical question is not being addressed by ongoing studies.
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use of antimicrobial mouthwashes gargling and Nasal Sprays by healthcare workers to protect them when treating patients with suspected or confirmed covid 19 infection
Cochrane Database of Systematic Reviews, 2020Co-Authors: Martin J Burton, Janet E Clarkson, Beatriz Goulao, Annemarie Glenny, Andrew J Mcbain, Anne G M Schilder, Katie E Webster, Hv WorthingtonAbstract:Background COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of HCWs are irrigated with antimicrobial solutions, this may help reduce the risk of active infection being passed from infected patients to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves, or alterations in the natural microbial flora of the mouth or nose. Understanding these possible side effects is particularly important when the HCWs are otherwise fit and well. Objectives To assess the benefits and harms of antimicrobial mouthwashes and Nasal Sprays used by healthcare workers (HCWs) to protect themselves when treating patients with suspected or confirmed COVID-19 infection. Search methods Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed randomised controlled trials (RCTs). We therefore planned to include the following types of studies: RCTs; quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies. We sought studies comparing any antimicrobial mouthwash and/or Nasal spray (alone or in combination) at any concentration, delivered to HCWs, with or without the same intervention being given to the patients with COVID-19. Data collection and analysis We used standard Cochrane methodological procedures. Our primary outcomes were: 1) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 2) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 3) viral content of aerosol, when present (if intervention administered to patients); 4) other adverse events: changes in microbiome in oral cavity, Nasal cavity, oro- or nasopharynx; 5) other adverse events: allergy, irritation/burning of Nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. Main results We found no completed studies to include in this review. We identified three ongoing studies (including two RCTs), which aim to enrol nearly 700 participants. The interventions included in these trials are povidone iodine, nitric oxide and GLS-1200 oral spray (the constituent of this spray is unclear and may not be antimicrobial in nature). AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by two RCTs and a non-randomised study. We are concerned that only one of the ongoing studies specifically states that it will evaluate adverse events and it is not clear if this will include changes in the sense of smell or to the oral and Nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular, where those receiving the intervention are otherwise fit and well, it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.
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antimicrobial mouthwashes gargling and Nasal Sprays administered to patients with suspected or confirmed covid 19 infection to improve patient outcomes and to protect healthcare workers treating them
Cochrane Database of Systematic Reviews, 2020Co-Authors: Martin J Burton, Janet E Clarkson, Beatriz Goulao, Annemarie Glenny, Andrew J Mcbain, Anne G M Schilder, Katie E Webster, Hv WorthingtonAbstract:Background COVID-19 infection poses a serious risk to patients and - due to its contagious nature - to those healthcare workers (HCWs) treating them. If the mouth and nose of patients with infection are irrigated with antimicrobial solutions, this may help the patients by killing any coronavirus present at those sites. It may also reduce the risk of the active infection being passed to HCWs through droplet transmission or direct contact. However, the use of such antimicrobial solutions may be associated with harms related to the toxicity of the solutions themselves or alterations in the natural microbial flora of the mouth or nose. Objectives To assess the benefits and harms of antimicrobial mouthwashes and Nasal Sprays administered to patients with suspected or confirmed COVID-19 infection to both the patients and the HCWs caring for them. Search methods Information Specialists from Cochrane ENT and Cochrane Oral Health searched the Central Register of Controlled Trials (CENTRAL 2020, Issue 6); Ovid MEDLINE; Ovid Embase and additional sources for published and unpublished trials. The date of the search was 1 June 2020. SELECTION CRITERIA: This is a question that urgently requires evidence, however at the present time we did not anticipate finding many completed RCTs. We therefore planned to include the following types of studies: randomised controlled trials (RCTs); quasi-RCTs; non-randomised controlled trials; prospective cohort studies; retrospective cohort studies; cross-sectional studies; controlled before-and-after studies. We set no minimum duration for the studies. We sought studies comparing antimicrobial mouthwash and/or Nasal spray (alone or in combination) at any concentration, delivered with any frequency or dosage to suspected/confirmed COVID-19 patients. Data collection and analysis We used standard Cochrane methodological procedures. Our primary outcomes were: 1) RECOVERY* (www.recoverytrial.net) outcomes in patients (mortality; hospitalisation status; use of ventilation; use of renal dialysis or haemofiltration); 2) incidence of symptomatic or test-positive COVID-19 infection in HCWs; 3) significant adverse event: anosmia (or disturbance in sense of smell). Our secondary outcomes were: 4) change in COVID-19 viral load in patients; 5) COVID-19 viral content of aerosol (when present); 6) other adverse events: changes in microbiome in oral cavity, Nasal cavity, oro- or nasopharynx; 7) other adverse events: allergy, irritation/burning of Nasal, oral or oropharyngeal mucosa (e.g. erosions, ulcers, bleeding), long-term staining of mucous membranes or teeth, accidental ingestion. We planned to use GRADE to assess the certainty of the evidence for each outcome. Main results We found no completed studies to include in this review. We identified 16 ongoing studies (including 14 RCTs), which aim to enrol nearly 1250 participants. The interventions included in these trials are ArtemiC (artemisinin, curcumin, frankincense and vitamin C), Citrox (a bioflavonoid), cetylpyridinium chloride, chlorhexidine, chlorine dioxide, essential oils, hydrogen peroxide, hypertonic saline, Kerecis spray (omega 3 viruxide - containing neem oil and St John's wort), neem extract, nitric oxide releasing solution, povidone iodine and saline with baby shampoo. AUTHORS' CONCLUSIONS: We identified no studies for inclusion in this review. This is not surprising given the relatively recent emergence of COVID-19 infection. It is promising that the question posed in this review is being addressed by a number of RCTs and other studies. We are concerned that few of the ongoing studies specifically state that they will evaluate adverse events such as changes in the sense of smell or to the oral and Nasal microbiota, and any consequences thereof. Very few interventions have large and dramatic effect sizes. If a positive treatment effect is demonstrated when studies are available for inclusion in this review, it may not be large. In these circumstances in particular it may be a challenge to weigh up the benefits against the harms if the latter are of uncertain frequency and severity.
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comparison of once daily mometasone furoate nasonex and fluticasone propionate aqueous Nasal Sprays for the treatment of perennial rhinitis
Annals of Allergy Asthma & Immunology, 1997Co-Authors: Michael Mandl, Keith B Nolop, Barry N. LutskyAbstract:Background Mometasone furoate (Nasonex), in a new once daily aqueous Nasal spray formulation, has been shown to be as effective and well tolerated as twice daily beclomethasone dipropionate aqueous Nasal spray in treating symptoms of seasonal allergic rhinitis and perennial rhinitis. Objective To compare the effectiveness and tolerability of mometasone furoate to placebo and to fluticasone propionate aqueous Nasal spray, all treatments administered once daily, in patients with perennial rhinitis. Methods This was a 3-month, randomized, double-blind, double dummy, parallel group study in 550 patients, aged 12 to 77 years, at 25 centers in Canada, Latin America, and Europe. Patients allergic to at least one perennial allergen, with confirmed allergy history, skin test positivity, and moderate to severe symptomatology, were eligible to receive one of the following treatments, once daily in the morning: mometasone furoate 200 micrograms, fluticasone propionate 200 micrograms, or placebo. The primary efficacy variable was the change from baseline in total am plus pm diary Nasal symptom score over the first 15 days of treatment. Results Four hundred fifty-nine patients were valid for efficacy. For the primary efficacy variable, mometasone furoate was significantly ( P .01) more effective than placebo and was not statistically different from fluticasone propionate (percent reductions from baseline were 37, 39, and 22 for mometasone furoate, fluticasone propionate, and placebo, respectively). Generally, similar trends were seen for physician-evaluated total Nasal symptoms, and patient-rated and physician-rated overall condition and response to therapy. Overall, mometasone furoate was at least as effective as fluticasone propionate at equivalent doses. There was no evidence of tachyphylaxis. All treatments were well tolerated. Conclusion Mometasone furoate and fluticasone propionate adequately controlled symptoms of perennial rhinitis and were well tolerated.
