Efficacy and Safety of Ciprofloxacin Plus Fluocinolone Acetonide Among Patients With Acute Otitis Externa: A Randomized Clinical Trial.

Importance: Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution seems to be efficacious and safe in treating acute otitis externa (AOE) compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone. Objective: To evaluate the superiority of ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution compared with ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solution alone in treating AOE. Design, Setting, and Participants: A phase 3 randomized, double-blind, active-controlled clinical trial was conducted between August 1, 2017, and September 14, 2018, at 36 centers in the US. The study population comprised 493 patients aged 6 months or older with AOE of less than 21 days' duration with otorrhea, moderate or severe otalgia, and edema, as well as a Brighton grading of II or III (tympanic membrane obscure but without systemic illness). Statistical analysis was performed from November 14, 2018, to February 14, 2019. Interventions: Participants were randomly assigned to receive ciprofloxacin plus fluocinolone, ciprofloxacin, or fluocinolone twice daily for 7 days and were evaluated on day 1 (visit 1; baseline), days 3 to 4 (visit 2; conducted via telephone), days 8 to 10 (visit 3; end of treatment), and days 15 to 17 (visit 4; test of cure). Main Outcomes and Measures: The primary outcome was therapeutic cure (clinical and microbiological) at the end of the treatment period. The principal secondary end point was the time to end of ear pain. Efficacy analyses were conducted in the microbiological intent-to-treat population, clinical intent-to-treat population, and microbiological intent-to-treat population with Pseudomonas aeruginosa and Staphylococcus aureus. Results: A total of 493 patients (254 female patients [51.5%]; mean [SD] age, 38.2 [23.1] years) were randomized (197 to receive ciprofloxacin plus fluocinolone, 196 to receive ciprofloxacin, and 100 to receive fluocinolone). Therapeutic cure in the modified intent-to-treat population with ciprofloxacin plus fluocinolone (63 of 103 [61.2%]) was statistically comparable to that of ciprofloxacin (49 of 91 [53.8%]; difference in response rate, 7.3%; 95% CI, -6.6% to 21.2%; P = .30) and fluocinolone (20 of 45 [44.4%]; difference in response rate, 16.7%; 95% CI, -0.6% to 34.0%; P = .06) at visit 3 and significantly superior to ciprofloxacin at visit 4 (90 of 103 [87.4%] vs 69 of 91 [75.8%]; difference in response rate, 11.6%; 95% CI, 0.7%-22.4%; P = .04). A statistically faster resolution of otalgia was achieved among patients treated with ciprofloxacin plus fluocinolone (median, 5.0 days [range, 4.2-6.3 days]) vs ciprofloxacin (median, 5.9 days [range, 4.3-7.3 days]; 95% CI, 4.3-7.3 days; P = .002) or fluocinolone (median, 7.7 days [range, 6.7-9.0 days]; 95% CI, 6.7-9.0 days; P < .001). Ciprofloxacin plus fluocinolone demonstrated statistical superiority in sustained microbiological response vs ciprofloxacin (94 of 103 [91.3%] vs 74 of 91 [81.3%]; difference in response rate, 9.9%; 95% CI, 0.3%-19.6%; P = .04) and fluocinolone (34 of 45 [75.6%]; difference in response rate, 15.7%; 95% CI, 2.0%-29.4%; P = .01) and in the microbiological outcome vs fluocinolone by visit 3 (99 of 103 [96.1%] vs 37 of 45 [82.2%]; difference in response rate, 13.9%; 95% CI, 2.1%-25.7%; P = .01) and ciprofloxacin by visit 4 (97 of 103 [94.2%] vs 77 of 91 [84.6%]; difference in response rate, 9.6%; 95% CI, 0.9%-18.2%; P = .02). Fifteen adverse events related to study medications were registered, all of which were mild or moderate. Conclusions and Relevance: Ciprofloxacin, 0.3%, plus fluocinolone acetonide, 0.025%, otic solution was efficacious and safe in treating AOE but did not demonstrate superiority vs ciprofloxacin, 0.3%, or fluocinolone acetonide, 0.025%, otic solutions alone in the main study end point of therapeutic cure. Trial Registration: ClinicalTrials.gov Identifier: NCT03196973.

The effectiveness of topical 1% lidocaine with systemic oral analgesics for ear pain with acute otitis media.

BACKGROUND: Acute otitis media (AOM) is one of the most common childhood infections. Ear pain, the main symptom of AOM, results in parents frequently seeking medical assistance for their children. The aim of this study was to compare the effectiveness of topical 1% lidocaine ear drops administered with oral analgesics with that of oral analgesics alone. METHODS: This multicenter randomized, open-labeled study was conducted at 15 centers with 184 pediatric AOM patients with bilateral ear pain (aged 1-5 years) between May 1, 2016, and June 31, 2018. All patients received oral paracetamol or ibuprofen and topical 1% lidocaine, which was administered to each ear according to the randomization list. The ear pain score was evaluated within 48 h using the Face, Legs, Activity, Cry, and Consolability (FLACC) scale, and the patients were followed up for 10 days. RESULTS: The median age was 31.8 months (min-max, 12-84.2 months). Of those patients enrolled, 22.3% received paracetamol, and 24.5% received paracetamol with lidocaine ear drops; 23.4% received ibuprofen, and 29.9% received ibuprofen with lidocaine ear drops. Lower pain scores were significantly measured at baseline and 10th minutes by a reduction 25% (RR 13.64, 95% CI 4.47-41.63, p = 0.001, RR 0.14, 95% CI 0.06-0.35, p = 0.001) and 50% (RR 4.76, 95% CI 1.63-13.87, p = 0.004, RR 0.14, 95% CI 0.05-0.4, p = 0.001) in the paracetamol and lidocaine versus paracetamol groups and the ibuprofen and lidocaine versus ibuprofen groups, respectively. No serious side effects were evident during follow-up. CONCLUSION: This randomized study suggests that topical 1% lidocaine ear drops with paracetamol or ibuprofen seems to provide effective and rapid relief for children presenting with ear pain attributed to AOM.

Evaluation of Clinical Graded Treatment of Acute Nonsuppurative Otitis Media in Children with Acute Upper Respiratory Tract Infection.

Objective: To treat children with acute nonsuppurative otitis media induced by acute upper respiratory tract infection of varying severity and evaluate its therapeutic effects. Materials and Methods: Patients from the emergency department with acute nonsuppurative otitis media were followed up between September 2015 and December 2018. A total of 420 patients were classified into grades I to III according to tympanic membrane intactness and systemic reactions and treated according to grading. Results: Grade I patients showed no significant difference in the recovery of acute symptoms whether antibiotics are used or not. Grade II patients, after 3 months of follow-up, showed no tympanic membrane perforation, and 9 cases of binaural B-type children did not improve but were cured by operation. In grade III patients, after treatment for 4 hours in the experimental group 3, the earache subsided, 1 case had tympanic membrane perforation, and the patients recovered after 2 weeks (64/92) and after 3 months (28/92) of drug treatment. After treatment for 4 h in the control group 3, the earache eased, and 3 patients developed tympanic membrane perforation and were treated for 3 months. 4 binaural B-type children did not improve but recovered after surgical treatment. Conclusion: Grade I patients could be closely followed up by clinical observation. For anti-inflammatory patients with grade II disease, treatment has therapeutic significance. For patients with grade III, some patients still have TMP, but the use of cephalosporin third-generation drugs plus an appropriate amount of hormone therapy is effective in reducing symptoms and tympanic local reactions.

Effective Inexpensive Management of Necrotizing Otitis Externa Is Possible in Resource-Poor Settings.

INTRODUCTION: Necrotizing otitis externa resolves best with antimicrobial treatment. How to care for these patients and monitor their resolution remains a problem. Our protocol in Bangalore can manage these patients inexpensively and well. MATERIALS AND METHODS: Patients who were referred to our patients became the subjects for this paper. They were managed through our protocol, which consists of IV ciprofloxacin and meropenem, weekly labs, weekly examinations, and photodocumention. RESULTS: Fifty-one people presented with necrotizing otitis externa (NOE) between October 2015 and November 2017 and completed our entire protocol. Forty-six had complete resolution of their disease, while 5 had to undergo surgical removal of necrotic bone. Six of 8 patients with facial weakness had improvement in their House-Brackmann scores. Reduction of self-reported nocturnal pain, dissolution of ear canal granulations, and normalization of the erythrocyte sedimentation rate (ESR) proved to be the most accurate indicators of disease regression. CONCLUSION: Patients are monitored closely with review of their otalgia, examination of their canal, repeated ESRs, effective control of their diabetes, and radiological imaging. All this can be done in a resource-poor country, which in turn serves as a model for the wealthier nations.

Pain management in acute otitis media: a qualitative study of parents' views and expectations.

BACKGROUND: For unclarified reasons, parents tend to be cautious about administering analgesics to their children, potentially leading to suboptimal management of AOM symptoms. We aim to understand parents' views and expectations of pain management in acute otitis media (AOM) in children. METHODS: Qualitative study alongside a cluster-randomised controlled trial (PIM-POM study) aimed at optimising pain management in childhood AOM. We purposefully sampled 14 parents of children diagnosed with AOM by their GP, who were recruited to the trial between November 2017 and May 2018. Semi-structured interviews were held at home in the first two weeks after trial enrollment. Interviews were audio-recorded, transcribed and analyzed thematically. RESULTS: Parents experienced difficulties in recognising earache and other symptoms of an ear infection. They consulted the GP for a diagnosis, for reassurance and for management advice. Parents shared that, prior to consultation, they had insufficient knowledge of the benefits of correctly dosed pain medication at regularly scheduled intervals. Parents valued the GP's advice on pain management, and were happy to accept pain medication as standalone therapy, provided that the GP explained why antibiotics would not be needed. Parents' views and expectations of pain management in AOM were shaped by previous experiences of AOM within their family; those with a positive experience of pain medication are more likely to use it in subsequent AOM episodes. CONCLUSIONS: Parents of children with AOM consult the GP to help cope with uncertainties in recognising symptoms of AOM, and to receive management advice. It is important that GPs are aware of parents' lack of understanding of the role of pain medication in managing AOM, and that they address this during the consultation. TRIAL REGISTRATION: Netherlands Trial Register, identifier NTR4920 (registration date: 19 December 2014).

Pediatricians' attitudes in management of acute otitis media and ear pain in Turkey.

OBJECTIVES: Acute otitis media (AOM) is predominantly a disease of childhood and one of the common reasons for prescribing antibiotics. Ear pain is the main symptom of AOM, with the result that parents frequently seek immediate medical assistance for their children. Antibiotic therapy for AOM does not provide symptomatic relief in the first 24 hours, and analgesics are commonly recommended for relieving the pain associated with AOM. The aims of the present study were to assess pediatricians' attitudes toward AOM and ear pain management in Turkey. METHODS: This multicenter descriptive questionnaire study was conducted in 20 centers from different geographic locations in Turkey, with 977 pediatricians, between June 2015 and December 2016. The questionnaire comprised 20 questions focusing on the pediatricians' sociodemographic variables, experiences, and treatment related to AOM and ear pain. RESULTS: Of the pediatricians, 58.2% were residents, 36.5% were specialists, and 4.3% were lecturers. Most participants were working in a university hospital (54.8%) or education and research hospital (32.2%). In general daily practice, the AOM diagnosis rates were between 6% and 20% in outpatient clinics, and 52.3% of the participants stated the patients complained about ear pain in pediatric clinics. The watchful waiting (WW) rate, as opposed to immediate antibiotic treatment, was 39.8% for all the pediatricians. The pediatric residents used the WW strategy less than the specialists and lecturers did (p = 0.004). The rates of the WW strategy were higher in outpatient clinics where AOM was commonly diagnosed (p < 0.001). The most common antibiotic prescribed for AOM was amoxicillin clavulanate (76.7%). The mean recommended treatment period for AOM was 9.3 ± 2.2 days. The choices for systemic ear pain treatment were acetaminophen (26.8%), ibuprofen (29.4%), and alternating between ibuprofen and acetaminophen (43.9%). Moreover, 34.6% of the participants recommended topical agents for otalgia. Topical agents were more commonly recommended by the pediatric residents than specialists or lecturers (p < 0.001). Finally, 58.3% of pediatricians had experiences of the parents' usage of a variety of herbal and folk remedies, such as breast milk or olive oil, for their children's ear pain. CONCLUSION: Amoxicillin clavulanate was the most frequently prescribed antibiotic for AOM. WW was approved by the pediatricians, and having more AOM patients was a significant factor in the physicians' choice of WW; nevertheless, the WW rate was poor. Implementation of educational intervention strategies will help pediatricians in improving their compliance with evidence-based guidelines for AOM treatment. Otalgia is taken seriously by parents and pediatricians, and otalgia treatment seems to be well accepted in Turkey for providing symptomatic relief and enhancing the patients' quality of life.

A Review of Medicinal Plants for the Treatment of Earache and Tinnitus in Iran.

BACKGROUND AND PURPOSE: Despite numerous trials, there has not yet been any definite strategy to reduce replicable long-term tinnitus and earache. Complementary and alternative medical approaches have been used to decrease the symptoms of tinnitus and earache. This study was conducted to report medicinal plants that are used to treat ear disorders, especially earache and tinnitus in different regions of Iran. EVIDENCE ACQUISITIONS: Directory of Open Access Journals (DOAJ), Google Scholar, PubMed, LISTA (EBSCO), Embase, and Web of Science were searched using relevant search terms to retrieve eligible publications. RESULTS: Twenty-three species from sixteen families were used for the treatment of earache and tinnitus in Iran. Plants from families Asteraceae and Lamiaceae were the most commonly used plants for the treatment of earache. Ginkgo biloba was frequently reported for the treatment of tinnitus. CONCLUSION: This study shows the important role of medicinal plants in the treatment of earache and tinnitus in some regions of Iran. The medicinal plants reported in this review can be considered in treatments for earache and tinnitus if examined more extensively in clinical trials.

Retroauricular pain caused by Eagle syndrome: A rare presentation due to compression by styloid process elongation.

Eagle syndrome is a rare condition presenting with retroauricular pain (usually as main symptom) associated with dysphagia, headache, neck pain on rotation and, much rarelier, stroke. This occurs due to styloid process elongation. Sometimes, there is also styloid ligament calcification, which can cause compression of nerves and arteries and the symptoms above. Treatment can be conservative with pain modulators (e.g. pregabalin) or infiltrations (steroids or anesthetics drugs). In refractory cases, surgical approach aiming to reduce the size of the styloid process can be performed. We present a rare case of Eagle syndrome (documented by computed tomography) with good response to clinical treatment.

Retroauricular pain caused by Eagle syndrome: A rare presentation due to compression by styloid process elongation / Dor retroauricular causada pela síndrome de Eagle: uma apresentação rara por compressão pelo alongamento do processo estiloide

Summary Eagle syndrome is a rare condition presenting with retroauricular pain (usually as main symptom) associated with dysphagia, headache, neck pain on rotation and, much rarelier, stroke. This occurs due to styloid process elongation. Sometimes, there is also styloid ligament calcification, which can cause compression of nerves and arteries and the symptoms above. Treatment can be conservative with pain modulators (e.g. pregabalin) or infiltrations (steroids or anesthetics drugs). In refractory cases, surgical approach aiming to reduce the size of the styloid process can be performed. We present a rare case of Eagle syndrome (documented by computed tomography) with good response to clinical treatment.

Resumo A síndrome de Eagle é uma condição rara na qual ocorre dor retroauricular (usualmente é o principal sintoma) associada a disfagia, cefaleia, cervicalgia durante a rotação da cabeça e, mais raramente, a AVC. Isso ocorre por conta do alongamento do processo estiloide e, às vezes, há também calcificação do ligamento estiloide. Essas estruturas podem comprimir nervos e artérias causando os sintomas citados. O tratamento pode ser conservador com moduladores da dor, como pregabalina, ou com infiltrações (corticoides ou drogas anestésicas). Em casos refratários, cirurgia para reduzir o tamanho do processo estiloide pode ser realizada. É apresentado um caso raro de síndrome de Eagle (documentado com tomografia computadorizada) com boa resposta ao tratamento clínico.

ED triage pain protocol reduces time to receiving analgesics in patients with painful conditions.

BACKGROUND: Studies suggest that collaborative nursing protocols initiated in triage improve emergency department (ED) throughput and decrease time to treatment. OBJECTIVE: The objective of the study is to determine if an ED triage pain protocol improves time to provision of analgesics. METHODS: Retrospective data abstracted via electronic medical record of patients at a safety net facility with 67 000 annual adult visits. Patients older than 18 years who presented to the ED between March 1, 2011, and May 31, 2013, with 1 of 6 conditions were included: back pain, dental pain, extremity trauma, sore throat, ear pain, or pain from an abscess. A 3-month orientation to an ED nurse-initiated pain protocol began on March 1, 2012. Nurses administered oral analgesics per protocol, beginning with acetaminophen or ibuprofen and progressing to oxycodone. Preimplementation and postimplementation analyses examined differences in time to analgesics. Multivariable analysis modeled time to analgesics as a function of patient factors. RESULTS: Over a 27-month period, 23 409 patients were included: 13 112 received pain medications and 10 297 did not. A total of 12 240 (52%) were male, 12 578 (54%) were African American, and 7953 (34%) were white, with a mean (SD) age of 39 years (13 years). The pain protocol was used in 1002 patients. There was a significant change in mean time (minutes) to provision of analgesics between preimplementation (238) and postimplementation (168) (P < .0001). Linear regression showed the protocol-delivered medications to younger patients and of lower acuity in a reduced time. Variables not related to time to provision of medication included sex, payer, and race. CONCLUSION: Emergency department triage pain protocol decreased time to provision of pain medications and did so without respect to payer category, sex, or race.

Síndrome de Ramsay Hunt. A propósito de un caso / Ramsay Hunt syndrome. A case report

Presentamos el caso de una paciente con parálisis facial periférica coincidente con lesiones vesiculosas herpéticas óticas. El síndrome de Ramsay Hunt es la segunda causa más frecuente de parálisis facial periférica atraumática, con una presentación clínica muy variada. La parálisis facial de este síndrome ocurre en el 60-90 % de los casos, es periférica y puede preceder o seguir a las lesiones cutáneas con un peor pronóstico que la parálisis idiopática de Bell (AU)

We present the case of a female patient with peripheral facial paralysis coinciding with vesicular herpetic otic lesions. Ramsay Hunt syndrome is the second most common cause of atraumatic peripheral facial paralysis, with a very varied clinical presentation. The facial paralysis in this syndrome occurs in 60-90 % of cases, is peripherical and can precede or follow the cutaneous lesions with a worse prognosis than idiopathic Bell paralysis (AU)

Antibiotics for acute otitis media in children.

BACKGROUND: Acute otitis media (AOM) is one of the most common diseases in early infancy and childhood. Antibiotic use for AOM varies from 56% in the Netherlands to 95% in the USA, Canada and Australia. This is an update of a Cochrane review first published in The Cochrane Library in Issue 1, 1997 and previously updated in 1999, 2005, 2009 and 2013. OBJECTIVES: To assess the effects of antibiotics for children with AOM. SEARCH METHODS: We searched CENTRAL (2015, Issue 3), MEDLINE (1966 to April week 3, 2015), OLDMEDLINE (1958 to 1965), EMBASE (January 1990 to April 2015), Current Contents (1966 to April 2015), CINAHL (2008 to April 2015) and LILACS (2008 to April 2015). SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing 1) antimicrobial drugs with placebo and 2) immediate antibiotic treatment with expectant observation (including delayed antibiotic prescribing) in children with AOM. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trial quality and extracted data. MAIN RESULTS: For the review of antibiotics against placebo, 13 RCTs (3401 children and 3938 AOM episodes) from high-income countries were eligible and had generally low risk of bias. The combined results of the trials revealed that by 24 hours from the start of treatment, 60% of the children had recovered whether or not they had placebo or antibiotics. Pain was not reduced by antibiotics at 24 hours (risk ratio (RR) 0.89, 95% confidence interval (CI) 0.78 to 1.01) but almost a third fewer had residual pain at two to three days (RR 0.70, 95% CI 0.57 to 0.86; number needed to treat for an additional beneficial outcome (NNTB) 20). A quarter fewer had pain at four to seven days (RR 0.76, 95% CI 0.63 to 0.91; NNTB 16) and two-thirds fewer had pain at 10 to 12 days (RR 0.33, 95% CI 0.17 to 0.66; NNTB 7) compared with placebo. Antibiotics did reduce the number of children with abnormal tympanometry findings at two to four weeks (RR 0.82, 95% CI 0.74 to 0.90; NNTB 11), at six to eight weeks (RR 0.88, 95% CI 0.78 to 1.00; NNTB 16) and the number of children with tympanic membrane perforations (RR 0.37, 95% CI 0.18 to 0.76; NNTB 33) and halved contralateral otitis episodes (RR 0.49, 95% CI 0.25 to 0.95; NNTB 11) compared with placebo. However, antibiotics neither reduced the number of children with abnormal tympanometry findings at three months (RR 0.97, 95% CI 0.76 to 1.24) nor the number of children with late AOM recurrences (RR 0.93, 95% CI 0.78 to 1.10) when compared with placebo. Severe complications were rare and did not differ between children treated with antibiotics and those treated with placebo. Adverse events (such as vomiting, diarrhoea or rash) occurred more often in children taking antibiotics (RR 1.38, 95% CI 1.19 to 1.59; number needed to treat for an additional harmful outcome (NNTH) 14). Funnel plots do not suggest publication bias. Individual patient data meta-analysis of a subset of included trials found antibiotics to be most beneficial in children aged less than two years with bilateral AOM, or with both AOM and otorrhoea.For the review of immediate antibiotics against expectant observation, five trials (1149 children) from high-income countries were eligible and had low to moderate risk of bias. Four trials (1007 children) reported outcome data that could be used for this review. From these trials, data from 959 children could be extracted for the meta-analysis of pain at three to seven days. No difference in pain was detectable at three to seven days (RR 0.75, 95% CI 0.50 to 1.12). One trial (247 children) reported data on pain at 11 to 14 days. Immediate antibiotics were not associated with a reduction in the number of children with pain (RR 0.91, 95% CI 0.75 to 1.10) compared with expectant observation. Additionally, no differences in the number of children with abnormal tympanometry findings at four weeks, tympanic membrane perforations and AOM recurrence were observed between groups. No serious complications occurred in either the antibiotic or the expectant observation group. Immediate antibiotics were associated with a substantial increased risk of vomiting, diarrhoea or rash compared with expectant observation (RR 1.71, 95% CI 1.24 to 2.36; NNTH 9).Results from an individual patient data meta-analysis including data from six high-quality trials (1643 children) that were also included as individual trials in our review showed that antibiotics seem to be most beneficial in children younger than two years of age with bilateral AOM (NNTB 4) and in children with both AOM and otorrhoea (NNTB 3). AUTHORS' CONCLUSIONS: This review reveals that antibiotics have no early effect on pain, a slight effect on pain in the days following and only a modest effect on the number of children with tympanic perforations, contralateral otitis episodes and abnormal tympanometry findings at two to four weeks and at six to eight weeks compared with placebo in children with AOM. In high-income countries, most cases of AOM spontaneously remit without complications. The benefits of antibiotics must be weighed against the possible harms: for every 14 children treated with antibiotics one child experienced an adverse event (such as vomiting, diarrhoea or rash) that would not have occurred if antibiotics were withheld. Therefore clinical management should emphasise advice about adequate analgesia and the limited role for antibiotics. Antibiotics are most useful in children under two years of age with bilateral AOM, or with both AOM and otorrhoea. For most other children with mild disease in high-income countries, an expectant observational approach seems justified.

Middle-ear pain and trauma during air travel.

INTRODUCTION: Changes in air pressure during flying can cause ear-drum pain and perforation, vertigo, and hearing loss. It has been estimated that 10% of adults and 22% of children might have changes to the ear drum after a flight, although perforation is rare. Symptoms usually resolve spontaneously. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of interventions to prevent middle-ear pain during air travel? We searched: Medline, Embase, The Cochrane Library and other important databases up to July 2014 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found three studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: nasal balloon inflation, nasal decongestants (topical), and oral pseudoephedrine.

Successful treatment of pituitary abscess with intravenous antibiotics: a case report and literature review.

Pituitary abscess is a rare intrasellar infectious disease. It is usually treated with a combination of surgical drainage and intravenous antibiotics. We describe the case of a 38-year-old man with headache, fever, left earache, subsequent diabetes insipidus, and anterior pituitary insufficiency due to pituitary abscess, which was confirmed on the basis of clinical symptoms, laboratory examination results, and magnetic resonance imaging features. He was treated nonsurgically with intravenous antibiotics, with complete resolution of the pituitary abscess and recovery of pituitary function. Nonsurgical treatment may be an option for pituitary abscess.

The importance of being specific--a meta-analysis evaluating the effect of antibiotics in acute otitis media.

BACKGROUND: Whether acute otitis media (AOM) should be the cause for antibiotic treatment has been a matter of debate during the last decades. Treatment guidelines are based on less than twenty trials that have found the effect of antibiotics on symptomatic outcomes in AOM, such as pain, to be very modest. Two recent trials found a more substantial effect of antibiotics when they looked at treatment failure as the outcome. That the effect varies with the chosen outcome may not only be because the true effect is different but also because different outcomes are more or less specific for the disease in question. OBJECTIVE: The purpose of this study was to perform a meta-analysis to calculate a composite risk ratio for treatment failure in AOM and also to investigate whether the specificity of treatment failure as an outcome differs from that of symptomatic outcomes, such as pain. METHODS: Trials evaluating the effect of antibiotics in AOM and reporting the number of treatment failures were identified and a fixed-effects meta-analysis was performed. In addition, the literature was searched for articles providing direct or indirect figures on the specificity of different outcomes in AOM trials. A hypothetical study was designed to show how differences in sensitivity/specificity of inclusion/outcome criteria affect the results of a trial. RESULTS: The meta-analysis yielded a composite risk ratio of 0.4 (95% CI 0.35-0.48), p<0.001 for the effect of antibiotics on treatment failure. Based on data from the literature, the specificity of treatment failure was estimated to 92-100%. The hypothetical study showed how a non-specific outcome biases the effect estimate towards the null, whereas other kinds of misclassification only decrease precision. CONCLUSION: Future trials should focus on improving diagnostic criteria to increase precision but primarily, they should focus on choosing a specific outcome in order not to get a biased effect estimate.

Otitis media: an update on current pharmacotherapy and future perspectives.

INTRODUCTION: Acute otitis media (AOM) is the most common childhood bacterial infection and also the leading cause of conductive hearing loss in children. Currently, there is an urgent need for developing novel therapeutic agents for treating AOM. AREAS COVERED: Structured search of current literature. PubMed was searched for published literature in areas of pharmacotherapeutics, preventive therapies and complementary treatments for OM. The intent of this review is to provide a comprehensive evaluation of therapeutics for AOM, including preventive modalities and complementary medicine. EXPERT OPINION: the management of AOM in young children is still evolving and depends on patterns of bacterial colonization and antimicrobial resistance in the community. The introduction of vaccinations against potential respiratory tract pathogens has altered the frequency of recovery of pathogens causing ear infections in children. Even though not all patients require antimicrobial therapy to overcome their infection, these agents improve symptoms faster and lead to fewer treatment failures. Further studies are warranted to evaluate which patients would best benefit from antimicrobial therapy.