Ear, nose and throat (ENT)

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Research outputs from the ENT team at the RD&E.

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    Ginkgo biloba for tinnitus
    (Wiley, 2022-11-16) Sereda, M.; Xia, J.; Scutt, P.; Hilton, M. P.; El Refaie, A.; Hoare, D. J.
    BACKGROUND: Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression.  OBJECTIVES: To assess the effects of Ginkgo biloba for tinnitus in adults and children. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2022, Issue 6); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 June 2022. SELECTION CRITERIA: Randomised controlled trials (RCTs) recruiting adults and children with acute or chronic subjective tinnitus. We included studies where the intervention involved Ginkgo biloba and this was compared to placebo, no intervention, or education and information. Concurrent use of other medication or other treatment was acceptable if used equally in each group. Where an additional intervention was used equally in both groups, we analysed this as a separate comparison. The review included all courses of Ginkgo biloba, regardless of dose regimens or formulations, and for any duration of treatment. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were tinnitus symptom severity measured as a global score on a multi-item tinnitus questionnaire and serious adverse effects (bleeding, seizures). Our secondary outcomes were tinnitus loudness (change in subjective perception), tinnitus intrusiveness, generalised depression, generalised anxiety, health-related quality of life and other adverse effects (gastrointestinal upset, headache, allergic reaction). We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: This review included 12 studies (with a total of  1915 participants). Eleven studies compared the effects of Ginkgo biloba with placebo and one study compared the effects of Ginkgo biloba with hearing aids to hearing aids alone. All included studies were parallel-group RCTs. In general, risk of bias was high or unclear due to selection bias and poor reporting of allocation concealment and blinding of participants, personnel and outcome assessments. Due to heterogeneity in the outcomes measured and measurement methods used, only limited data pooling was possible.  Ginkgo biloba versus placebo When we pooled data from two studies for the primary outcome tinnitus symptom severity, we found that Ginkgo biloba may have little to no effect (Tinnitus Handicap Inventory scores) at three to six months compared to placebo, but the evidence is very uncertain (mean difference (MD) -1.35 (scale 0 to 100), 95% confidence interval (CI) -8.26 to 5.55; 2 studies; 85 participants) (very low-certainty). Ginkgo biloba may result in little to no difference in the risk of bleeding or seizures, with no serious adverse effects reported in either group (4 studies; 1154 participants; low-certainty). For the secondary outcomes, one study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on tinnitus loudness measured with audiometric loudness matching at 12 weeks, but the evidence is very uncertain (MD -4.00 (scale -10 to 140 dB), 95% CI -13.33 to 5.33; 1 study; 73 participants) (very low-certainty). One study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on health-related quality of life measured with the Glasgow Health Status Inventory at three months (MD -0.58 (scale 0 to 100), 95% CI -4.67 to 3.51; 1 study; 60 participants) (low-certainty). Ginkgo biloba may not increase the frequency of other adverse effects (gastrointestinal upset, headache, allergic reaction) at three months compared to placebo (risk ratio 0.91, 95% CI 0.52 to 1.60; 4 studies; 1175 participants) (low-certainty). None of the studies reported the other secondary outcomes of tinnitus intrusiveness or changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety. Gingko biloba with concurrent intervention versus concurrent intervention only One study compared Ginkgo biloba with hearing aids to hearing aids only. It assessed the mean difference in the change in Tinnitus Handicap Inventory scores and tinnitus loudness using a 10-point visual analogue scale (VAS) at three months. The study did not report adverse effects, tinnitus intrusiveness, changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life. This was a single, very small study (22 participants) and for all outcomes the certainty of the evidence was very low. We were unable to draw meaningful conclusions from the numerical results. AUTHORS' CONCLUSIONS: There is uncertainty about the benefits and harms of Ginkgo biloba for the treatment of tinnitus when compared to placebo. We were unable to draw meaningful conclusions regarding the benefits and harms of Ginkgo biloba when used with concurrent intervention (hearing aids). The certainty of the evidence for the reported outcomes, assessed using GRADE, ranged from low to very low. Future research into the effectiveness of Ginkgo biloba in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.
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    Singing Exercises Improve Sleepiness and Frequency of Snoring among Snorers—A Randomised Controlled Trial
    (Scientific Research Publishing, 2013-05-24) Powell, M. P. Hilton; Savage, J. O.; Hunter, B.; McDonald, S.; Repanos, C.; R
    Objectives: To assess the effectiveness of regular singing exercises in reducing symptoms of snoring and sleep apnoea. Methods: A prospective single blinded randomised controlled trial was conducted in the otolaryngology department of a UK teaching hospital (Exeter). 127 adult patients with a history of simple snoring or sleep apnoea were recruited. 93 patients completed the study. Patients were excluded because of severe sleep apnoea (apnoea index > 40), or morbid obesity (BMI > 40). The study group completed a self-guided treatment programme of singing exercises contained on a 3CD box set, performed for 20 minutes daily. Outcome measures included the Epworth Sleepiness Scale, the SF-36 generic quality of life assessment tool, visual analogue scales (VAS range 0-10) of snoring loudness and frequency, and visual analogue scale of compliance (for intervention group). Results: The Epworth scale improved significantly in the experimental group compared to the control group (difference -2.5 units; 95% CI -3.8 to -1.1; p = 0.000). Frequency of snoring reduced significantly in the experimental group (difference -1.5; 95% CI -2.6 to -0.4; p = 0.01), and loudness of snoring showed a trend to improvement which was non-significant (difference -0.8; 95% CI -1.7 to 0.1; p = 0.08). Compliance with exercises was good; median 6.6 (quartiles = 4.1, 8.3). Conclusions: Improving the tone and strength of pharyngeal muscles with a 3 months programme of daily singing exercises reduces the severity, frequency and loudness of snoring, and improves symptoms of mild to moderate sleep apnoea.
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    A randomised controlled trial comparing Rapid Rhino Mannheim and Netcell series 5000 packs following routine nasal surgery
    (European Rhinologic Society, 2009-04-23) McDonald, S. E.; Slater, J.; Powell, R.; Khalil, H. S.; Garth, R. J.
    OBJECTIVES: To determine whether there is a difference in discomfort between Netcell Series 5000 and Rapid Rhino Mannheim 8.0 cm (Cat. No. 800) packs used after routine nasal surgery, whilst in situ and during removal. This was tested in a single blind, randomised controlled trial at the ENT Department, Royal Devon & Exeter Hospital. PARTICIPANTS: Adults aged 16-65 undergoing nasal septal surgery and trimming of inferior turbinates. Patients were excluded if they were undergoing revision surgery, taking anticoagulants, or had a history of sino-nasal disease or trauma. Thirty nine entered and 32 completed the study. The intervention was a different nasal pack in each side of the nose, removed the morning after surgery. MAIN OUTCOMES MEASURES: Pain experienced by patients while packs are in situ and on removal as recorded on a standard unmarked 100 mm visual analogue scale. RESULTS: There was no difference in the pain scores whilst in situ. Rapid Rhino Mannheim was more painful on removal (difference = 10.6 mm, p < 0.001, Wilcoxon signed ranks test). CONCLUSIONS: Rapid Rhino Mannheim packs do not confer a benefit over Netcell Series 5000 packs after routine nasal surgery.