scholarly journals Use of proton pump inhibitors to treat persistent throat symptoms: multicentre, double blind, randomised, placebo controlled trial

BMJ ◽  
2021 ◽  
pp. m4903
Author(s):  
James O’Hara ◽  
Deborah D Stocken ◽  
Gillian C Watson ◽  
Tony Fouweather ◽  
Julian McGlashan ◽  
...  

Abstract Objective To assess the use of proton pump inhibitors (PPIs) to treat persistent throat symptoms. Design Pragmatic, double blind, placebo controlled, randomised trial. Setting Eight ear, nose, and throat outpatient clinics, United Kingdom. Participants 346 patients aged 18 years or older with persistent throat symptoms who were randomised according to recruiting centre and baseline severity of symptoms (mild or severe): 172 to lansoprazole and 174 to placebo. Intervention Random blinded allocation (1:1) to either 30 mg lansoprazole twice daily or matched placebo twice daily for 16 weeks. Main outcome measures Primary outcome was symptomatic response at 16 weeks measured using the total reflux symptom index (RSI) score. Secondary outcomes included symptom response at 12 months, quality of life, and throat appearances. Results Of 1427 patients initially screened for eligibility, 346 were recruited. The mean age of the study sample was 52.2 (SD 13.7) years, 196 (57%) were women, and 162 (47%) had severe symptoms at presentation; these characteristics were balanced across treatment arms. The primary analysis was performed on 220 patients who completed the primary outcome measure within a window of 14-20 weeks. Mean RSI scores were similar between treatment arms at baseline: lansoprazole 22.0 (95% confidence interval 20.4 to 23.6) and placebo 21.7 (20.5 to 23.0). Improvements (reduction in RSI score) were observed in both groups—score at 16 weeks: lansoprazole 17.4 (15.5 to19.4) and placebo 15.6 (13.8 to 17.3). No statistically significant difference was found between the treatment arms: estimated difference 1.9 points (95% confidence interval −0.3 to 4.2 points; P=0.096) adjusted for site and baseline symptom severity. Lansoprazole showed no benefits over placebo for any secondary outcome measure, including RSI scores at 12 months: lansoprazole 16.0 (13.6 to 18.4) and placebo 13.6 (11.7 to 15.5): estimated difference 2.4 points (−0.6 to 5.4 points). Conclusions No evidence was found of benefit from PPI treatment in patients with persistent throat symptoms. RSI scores were similar between the lansoprazole and placebo groups after 16 weeks of treatment and at the 12 month follow-up. Trial registration ISRCTN Registry ISRCTN38578686 and EudraCT 2013-004249-17.

2018 ◽  
Vol 103 (10) ◽  
pp. 1395-1400 ◽  
Author(s):  
Rashmi G Mathew ◽  
Sahar Parvizi ◽  
Ian E Murdoch

AimsTo compare success proportions at 5 years in three surgical groups: group 1, trabeculectomy alone; group 2, trabeculectomy followed by cataract surgery within 2 years; and group 3, trabeculectomy performed on a pseudophakic eye.MethodsA retrospective cohort study. 194 eyes of 194 patients were identified with at least 5 years’ follow-up post trabeculectomy (N=85, 60 and 49 in groups 1, 2 and 3, respectively).Main outcome measures1. Primary outcome measure: intraocular pressure (IOP) at 5 years post-trabeculectomy surgery, 2.Secondary outcome measure: change in visual acuity at 5 years.ResultsAt 5 years, the mean IOP (SD) was 12.9 (3.5), 12.5 (4.8) and 12.7 (4.8) mm Hg in groups 1, 2 and 3, respectively. Overall success was almost identical, 58%, 57% and 59% in groups 1, 2 and 3, respectively. There was no significant difference between the groups in terms of percentage IOP reduction, number of medications, proportion restarting medication and reoperation rates at 5 years. Logistic regression for an outcome of failure showed men to be at increased risk of failure OR 1.97 (95% CI 1.10 to 3.52, p=0.02). Nearly 80% of patients retained or improved their vision following their initial trabeculectomy.ConclusionsThe sequence in which surgery is carried out does not appear to affect trabeculectomy function at 5 years, success being similar to trabeculectomy alone. In our study, men may be at increased risk of failure.


2019 ◽  
Vol 6 (1) ◽  
pp. e000426
Author(s):  
Robert Slade ◽  
Raza Alikhan ◽  
Matt P Wise ◽  
Lam Germain ◽  
Simon Stanworth ◽  
...  

BackgroundPredicting patient outcomes following critical illness is challenging. Recent evidence has suggested that patients with blood group AB are more likely to survive following major cardiac surgery, and this is associated with a reduced number of blood transfusions. However, there are no current data to indicate whether a patient’s blood group affects general intensive care outcomes.ObjectiveThe objective of this study was to determine if ABO blood group affects survival in intensive care. The primary outcome measure was 90-day mortality with a secondary outcome measure of the percentage of patients receiving a blood transfusion.DesignRetrospective analysis of electronically collected intensive care data, blood group and transfusion data.SettingGeneral intensive care unit (ICU) of a major tertiary hospital with both medical and surgical patients.PatientsAll patients admitted to ICU between 2006 and 2016 who had blood group data available.InterventionNone.Measurements and main results7340 patients were included in the study, blood group AB accounted for 3% (221), A 41% (3008), B 10.6% (775) and O 45.4% (3336). These values are similar to UK averages. Baseline characteristics between the groups were similar. Blood group AB had the greatest survival benefit (blood group AB 90-day survival estimate 76.75, 95% CI 72.89 to 80.61 with the overall estimate 72.07, 95% CI 71.31 to 72.82) (log-rank χ2 16.128, p=0.001). Transfusion requirements were similar in all groups with no significant difference between the percentages of patients transfused (AB 23.1%, A 21.5%, B 18.7%, O 19.9%, Pearson χ2 5.060 p=0.167).ConclusionAlthough this is primarily a hypothesis generating study, intensive care patients with blood group AB appeared to have a higher 90-day survival compared with other blood groups. There was no correlation between blood group and percentage of patients receiving transfusion.


2019 ◽  
Vol 07 (11) ◽  
pp. E1522-E1527 ◽  
Author(s):  
Tilak Shah ◽  
Vladimir Kushnir ◽  
Pritesh Mutha ◽  
Mankanchan Majhail ◽  
Bhaumik Patel ◽  
...  

Abstract Background and study aims Liquid nitrogen spray cryotherapy (LNSC) can provide rapid dysphagia relief, and is postulated to stimulate a local antitumor immune response. The aim of this prospective pilot clinical trial was to evaluate the safety and efficacy of LNSC when administered prior to chemoradiotherapy. Patients and methods Treatment-naïve adult patients with dysphagia at the time of biopsy-proven squamous carcinoma or adenocarcinoma of the esophagus were prospectively enrolled at two tertiary medical centers. Patients underwent a single session of LNSC. The primary outcome measure was change in dysphagia at 1 and 2 weeks post-cryotherapy. A secondary outcome measure was clinical complete response rate (CR) following chemoradiotherapy. Results Twenty-five patients were screened, of whom 21 patients were eligible and enrolled. There were seven with metastatic and 14 with locally advanced cancer. The primary outcome of dysphagia improvement of ≥ 1 point occurred in 15/21 patients (71 %) at 1 week, and 10/20 patients (50 %) at 2 weeks. The median dysphagia score improved by 1 at 1 week (P = 0.0003), and 0.5 at 2 weeks (P = 0.02). Six of nine patients (67 %) with locally advanced cancer who completed chemoradiation did not have residual tumor cells on mucosal biopsy, and five of nine patients (56 %) had a clinical CR. There were no serious cryotherapy-related complications. Conclusions LNSC provided safe and effective palliation for esophageal cancer patients who presented with dysphagia at index diagnosis. Its combination with chemoradiotherapy did not lead to any serious toxicity. Our study provides a scientific rationale for pursuing larger clinical trials addressing synergistic effects of combining LNSC with chemoradiation.


2012 ◽  
Vol 47 (3) ◽  
pp. 271-275 ◽  
Author(s):  
Nayereh Khoraminya ◽  
Mehdi Tehrani-Doost ◽  
Shima Jazayeri ◽  
Aghafateme Hosseini ◽  
Abolghassem Djazayery

Objective: To compare the therapeutic effects of vitamin D3 plus fluoxetine and fluoxetine alone in patients with major depressive disorder. Methods: In the present double-blind, randomized, placebo-controlled trial, 42 patients with a diagnosis of major depressive disorder based on DSM-IV criteria were randomly assigned into two groups to receive daily either 1500 IU vitamin D3 plus 20 mg fluoxetine or fluoxetine alone for 8 weeks. Depression severity was assessed at 2-week intervals using the 24-item Hamilton Depression Rating Scale (HDRS) as a primary outcome measure and the 21-item Beck Depression Inventory (BDI) as a secondary outcome measure. Serum 25(OH) vitamin D was measured at baseline and after intervention. Results: Forty patients completed the trial. A two-way repeated-measures analysis of variance showed that depression severity based on HDRS and BDI decreased significantly after intervention, with a significant difference between the two groups. The vitamin D + fluoxetine combination was significantly better than fluoxetine alone from the fourth week of treatment. Conclusions: In the present 8-week trial, the vitamin D + fluoxetine combination was superior to fluoxetine alone in controlling depressive symptoms.


BJGP Open ◽  
2021 ◽  
pp. BJGPO.2021.0132
Author(s):  
Nasir Wabe ◽  
Judith Thomas ◽  
Gorkem Sezgin ◽  
Muhammad Kashif Sheikh ◽  
Emma Gault ◽  
...  

BackgroundThere has been a precipitous rise telehealth use in general practice during the COVID-19 pandemic. Understanding differences between face-to-face and telehealth consulting is an important component for planning the future use of telehealth services beyond the pandemic. However, there is limited evidence on whether telehealth consulting impacts medication prescribing under pandemic circumstances.AimTo compare medication prescribing in face-to-face versus telehealth consultations during the COVID-19 pandemic in Australian general practice.Design and SettingThis multisite, retrospective observational study used de-identified routinely collected electronic health data extracted from 806 general practices in Victoria and New South Wales (NSW), Australia between April-December 2020.MethodThe primary outcome measure was whether at least one medication was prescribed following a telehealth or face-to-face consultation. Data are reported by medication and for each of the Anatomical Therapeutic Chemical (ATC) Classification System level one groups. The secondary outcome measure was first-time prescribing. Telehealth included both telephone and video consultations.ResultsA total of 13,608,216 consultations satisfied the inclusion criteria (61% face-to-face and 39% telehealth). Most telehealth consultations were conducted via telephone (97.8%). Overall, 39.3% of face-to-face and 33.0% of telehealth consultations prescribed at least one medication– a statistically significant difference (adjusted OR 1.38; 95% CI 1.379–1.381). The prescribing rate was greater for face-to-face vs telehealth consultations for all drug groups except ATC level 1N (nervous system).ConclusionUnder COVID-19 restrictions in the states of Victoria and NSW, Australia, medication prescribing was higher in face-to-face consultations when compared to telehealth consultations in the study population.


2018 ◽  
Author(s):  
Jacqueline Burgess ◽  
Kerrianne Watt ◽  
Roy M Kimble ◽  
Cate M Cameron

BACKGROUND New technologies, widespread availability of the internet, the rise of social media and increased ownership of smartphones provide new opportunities for health researchers to communicate and engage with target audiences. OBJECTIVE This new technology was used to recruit mothers of young children to a smartphone application (app) to increase their knowledge about childhood burns (specifically hot beverage scalds) and correct burn first-aid. This six-month intervention deployed on the Cool Runnings app, used gamification techniques to reinforce intervention messages and engage participants. METHODS A two-group, parallel, single blinded, randomized controlled trial (RCT) to evaluate the efficacy of a smartphone app-based burn prevention intervention. Participants were women aged 18+, living in Queensland, Australia, with at least one child aged 5-12 months at the time of enrolment. The primary outcome measure was change in knowledge around burn risk and correct burn first-aid assessed via two methods: overall score; and categorised as adequate (score =4) vs inadequate (score less than 4). The secondary outcome measure was the efficacy of gamification techniques (measured by: app opens, photo uploads, pop quiz completions and content views). RESULTS In total, 498 participants were recruited via social media and enrolled. At 6-month follow-up, 244 participants completed the post-test questionnaire. Attrition rates in both groups were similar. Participants who remained in the study did not differ from those who were lost to follow up on any characteristics except for education level. Although similar at baseline, intervention group participants achieved significantly greater improvement in overall knowledge post-test than control group participants on both primary outcome measures (overall knowledge intervention: mean=2.68± 1.00 vs control mean:2.13±1.03; intervention: 20.47% adequate vs control: 7.3%). Consequently, the NNT was 7.46. Logistic regression showed participants exposed to the highest level of disadvantage were 7.3 times more likely to improve overall knowledge scores than participants in other levels of disadvantage. There were also significant correlations between each of the four gamification techniques and knowledge change (p<0.001). In addition, participants with low/moderate ‘app activity’ were 8.59 times more likely to have improved knowledge between baseline and 6-month follow-up than those who had no app activity (95%CI=2.9-25.02); participants with high app activity were 18.26 times more likely to have improved knowledge (95%CI=7.1-46.8). CONCLUSIONS Despite substantial loss to follow-up, this RCT demonstrates the Cool Runnings app was an effective intervention for improving knowledge about hot beverage scald risks and burn first-aid in mothers of young children. The benefits of combining gamification elements in the intervention were also highlighted. Given the low cost and large reach of smartphone apps to deliver content to, and engage with targeted populations, results from this RCT provides important information on how smartphone applications can be used for widespread injury prevention campaigns, and public health campaigns generally. CLINICALTRIAL This trial was registered with the Australian New Zealand Clinical Trials Registry (ACTRN12616000019404)


Author(s):  
Courtney Cox ◽  
Krishna Patel ◽  
Rebecca Cantu ◽  
Chary Akmyradov ◽  
Katherine Irby

OBJECTIVE: Status asthmaticus is commonly treated in pediatric patients by using continuous albuterol, which can cause hypokalemia. The primary aim of this study was to determine if serial potassium monitoring is necessary by examining treatment frequency of hypokalemia. METHODS: This retrospective analysis was performed in 185 pediatric patients admitted with status asthmaticus requiring continuous albuterol between 2017 and 2019. All patients were placed on intravenous fluids containing potassium. The primary outcome measure was the treatment of hypokalemia in relation to the number of laboratory draws for potassium levels. The secondary outcome measure was hypokalemia frequency and relation to the duration and initial dose of continuous albuterol. RESULTS: Included were 156 patients with 420 laboratory draws (average, 2.7 per patient) for potassium levels. The median lowest potassium level was 3.40 mmol/L (interquartile range, 3.2–3.7). No correlation was found between initial albuterol dose and lowest potassium level (P = .52). Patients with hypokalemia had a mean albuterol time of 12.32 (SD, 15.76) hours, whereas patients without hypokalemia had a mean albuterol time of 11.50 (SD, 12.53) hours (P = .29). Potassium levels were treated 13 separate times. CONCLUSIONS: The number of laboratory draws for potassium levels was high in our cohort, with few patients receiving treatment for hypokalemia beyond the potassium routinely added to maintenance fluids. Length of time on albuterol and dose of albuterol were not shown to increase the risk of hypokalemia. Serial laboratory measurements may be decreased to potentially reduce health care costs, pain, and anxiety surrounding needlesticks.


2016 ◽  
Vol 96 (8) ◽  
pp. 1170-1178 ◽  
Author(s):  
Esther E. Fox ◽  
Alan D. Hough ◽  
Siobhan Creanor ◽  
Margaret Gear ◽  
Jennifer A. Freeman

Abstract Background Pilates exercise is often undertaken by people with multiple sclerosis (MS) who have balance and mobility difficulties. Objectives The primary aim of the study was to compare the effects of 12 weeks of Pilates exercises with relaxation on balance and mobility. Secondary aims were: (1) to compare standardized exercises with relaxation and (2) to compare Pilates exercises with standardized exercises. Methods A multicenter, assessor-blinded, randomized controlled trial was conducted. Participants with Expanded Disability Status Scale scores of 4.0 to 6.5 were randomly allocated to groups receiving 12 weeks of Pilates exercises, standardized exercises, or relaxation. Assessments were undertaken at baseline and weeks 12 and 16 (primary outcome measure: 10-Meter Timed Walk Test [10MTW]). Results One hundred participants (mean age=54 years, 74% female) were randomized to study groups. Six participants relapsed (withdrew from the study), leaving 94 participants for intention-to-treat analysis. There was no significant difference in mean 10MTW measurements between the Pilates and relaxation groups. At 12 weeks, there was a mean reduction of 4.2 seconds for the standardized exercise group compared with the relaxation group (95% confidence interval [relaxation group minus standardized exercise group measurements]=0.0, 8.4) and a mean reduction of 3.7 seconds for the Pilates group compared with the standardized exercise group (95% confidence interval [Pilates group minus standardized exercise group measurements]=−0.4 to 7.8). At 16 weeks, mean 10MTW times for the standardized exercise group remained quicker than those for the Pilates and relaxation groups, although the differences were nonsignificant. There were no significant differences between the Pilates and relaxation groups for any secondary outcome measure. Limitations In this study, therapists were limited to a standardized basket of exercises that may have affected the study outcomes. Furthermore, choosing measures such as posturography to assess balance, accelerometry to assess walking, or a specific trunk assessment scale might have been more responsive in detecting changes in outcome. Conclusion Participants did not improve significantly, either in the short term or at the 4-week follow-up, on the 10MTW after 12 weeks of Pilates exercises compared with 12 weeks of relaxation.


2011 ◽  
Vol 125 (6) ◽  
pp. 585-589 ◽  
Author(s):  
J M Fishman ◽  
S Sood ◽  
M Chaudhari ◽  
P Martinez-Devesa ◽  
L Orr ◽  
...  

AbstractObjective:There is currently no standardised management protocol following functional endoscopic sinus surgery. This study assessed frequent endoscopic cleaning versus minimal intervention in the early post-operative period following such surgery.Study design:Prospective, randomised controlled, single-blinded, within-subject trial involving 24 patients with bilateral chronic rhinosinusitis undergoing bilateral functional endoscopic sinus surgery.Main outcome measure:The primary outcome measure was ethmoid cavity healing, based on endoscopic appearance, graded using a modified Lund–MacKay endoscopic score.Secondary outcome measure:Lund–MacKay symptom score before and after surgery.Results:There was no overall statistically significant difference between the two groups (p = 0.37). Subgroup analysis revealed a significant effect of regular suction clearance on adhesions at three months (p = 0.048), but not on oedema, polyps, granulation, discharge or crusting.Conclusion:There is no evidence from this study to support frequent endoscopic cleaning in the early post-operative period after functional endoscopic sinus surgery. Less intensive post-operative management is recommended, resulting in decreased patient morbidity and fewer post-operative follow-up appointments.


2017 ◽  
Vol 18 (1) ◽  
pp. 10-16
Author(s):  
Prawesh Singh Bhandari ◽  
G. KC ◽  
S. Uprety

Introduction: Amongst musculoskeletal injuries, ankle ligament sprains are the single most common  sports injury. However, there often appears to be no common regimen for their management, with a wide spectrum of treatment options available. The purpose of this study is to determine the functional outcome of the ankle joint after a moderate or severe inversion injury, comparing standard treatment with a Below Knee Slab Splint against a Stirrup ankle brace.Method: Prospective study conducted at the emergency department at Tribhuvan University Teaching Hospital. Fifty patients presenting consecutively were randomized into two equal groups: one group was treated with Below Knee Slab Splint and the other with an Stirrup ankle brace. All patients were given a standardized advice sheet referring to rest, ice, compression, and elevation, NSAIDS and support. Patients were reviewed after 48–72 hours, 14 days, and 3 week. Primary outcome measure: Ankle joint function assessed at 3 week using the modified Karlsson scoring method (maximum score 90). Secondary outcome measure: The difference in ankle girth (swelling) at 3 weeks. Results: Twenty-five patients in Below Knee Slab Splint group and twenty-five patients in the stirrup ankle brace group. The age of the patients ranged from 16 to 55 years with the mean of 30.68±9.33 years.The difference in mean age in years was not different in both groups (P>0.05).The distribution of gender and occupation in both groups were homogeneous (P>0.05). The karlsson’s score mean for brace group is 79.8±5.3 and for other group is 72.0±10.3 (p-value: 0.002). Thus there was a significant difference in Karlssons score between the two groups showing better functional improvement in patients receiving Stirrup ankle brace. There is significant difference in the swelling of clients in between application of the brace (1.00±0.48 and slab (1.70±0.50) the at end of the third week with p value 0.000.Conclusion: The use of Stirrup ankle brace for the treatment of lateral ligament ankle sprains produces a significant improvement in ankle joint function at three weeks compared with standard management with aimmobilization in below knee posterior slab splint.JSSN 2015; 18 (1), Page: 10-16


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