Die Behandlung des M. Menière mit Betahistin: Kritische Anmerkungen zur BEMED-Studie.

The BEMED study (BMJ 2016; 352: DOI 10.1136) was designed as multi-centric, double-blind, plaebo-controlled study in patients with Menière's disease. It should compare a low-level (2 × 24 mg/d) vs. high-level (3 × 48 mg/d) betahstine intake vs. placebo. The primary endpoint was the "number of vertigo attacks lasting longer than 20 min as documented in a patient's diary". The main finding of the study was that betahistine did not significantly better reduced the number of vertigo attacks than placebo. Therefore, the BEMED study should be critically discussed in the present paper.

[Implementation of Study Results in Guidelines and Adherence to Guidelines in Clinical Practice]. / Implementierung von Studienergebnissen in Leitlinien und deren Umsetzung in die Klinik.

Guidelines were introduced in hospital and practice-based otorhinolaryngology in the 1990s, and have been undergoing further development ever since. There are currently 20 guidelines on file at the German Society of Oto-Rhino-Laryngology, Head and Neck Surgery. The Society has cooperated in a further 34 guidelines. The quality of the guidelines has been continually improved by concrete specifications put forward by the Association of the Scientific Medical Societies in Germany [Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e.V.]. Since increasing digitalisation has made access to scientific publications quicker and more simple, relevant study results can be incorporated in guidelines more easily today than in the analogue world. S2e and S3 guidelines must be based on a formal literature search with subsequent evaluation of the evidence. The consensus procedure for S2k guidelines is also regulated. However, the implementation of guidelines in routine medical practice must still be considered inadequate, and there is still a considerable need for improvement in adherence to these guidelines.

[Management of patients with risk factors]. / Management von Risikopatienten.

This review deals with concomitant diseases and risk factors in patients treated for otorhinolaryngologic disease in outpatient and hospital services. Besides heart disease, lung disease, liver disease and kidney disease this article also covers disorders of coagulation (including the therapy with new anticoagulant drugs) of electrolyte hemostasis. Special attention is paid to prophylaxis, diagnosis and treatment of delirium. Also information is provided to optimize preparation of surgical procedures and pharmacotherapy.

[Results of transoral laser resection in T1-2 oropharyngeal, hypopharyngeal and laryngeal carcinomas]. / Ergebnisse der transoralen Laserresektion bei T1-2 Karzinomen von Oropharynx, Hypopharynx und Larynx.

BACKGROUND: Transoral laser microsurgery (TLM) has led to an expansion of the therapeutic modalities for malignomas of head and neck. This study aims to assess the oncologic results and functional outcomes of TLM in early carcinomas. PATIENTS AND METHODS: This is a retrospective study of 947 cases with T1-2 carcinomas primarily managed with laser surgery between 1979 and 2007. All cases were assessed for survival, with respect to location, T and N classification and status of surgical margins. Cases were additionally evaluated for incidence of major complications and retention of laryngeal and pharyngeal function. RESULTS: Disease specific survival was 78.6% for oropharyngeal, 68.9% for hypopharyngeal, 82.3% for supraglottic und 95.2% for glottis carcinomas. Survival estimates were found to be significantly better for cases without cervical metastasis and with negative surgical margins. A low rate of major complications (4.7%) were noted. 1% of the patients had a permanent dysfunction of swallowing and 1.1 % needed a permanent tracheostomy. CONCLUSION: Laser surgery appears to be a very effective management modality for small carcinomas of the head and neck as long as clear surgical margins can be achieved. This technique offers acceptable oncologic results with a low incidence of complications and satisfactory retention of function.

Evaluation of the revised TNM classification in advanced laryngeal cancer.

The latest revision of the UICCs TNM classification in 2002 subdivided advanced laryngeal carcinoma into the subcategories T4a and T4b, in order to emphasise the poor prognosis and inoperability of the latter group. Our study aims at evaluating the prognostic relevance of this subclassification. This retrospective analysis includes 163 patients treated for advanced laryngeal carcinoma between 1980 and 2002. The disease-free 5-year-survival rates for patients suffering from T4a and T4b laryngeal carcinoma were 32.4 and 6.7%, respectively (P = 0.003). The T-category and free margins proved to be significant prognostic factors. The survival of patients suffering from T4a carcinoma proved to be independent of specific location and number of invaded structures. This study confirms the much poorer prognosis for patients suffering from T4b carcinoma and thus supports the modified TNM classification.

[Traffic medicine expert opinions in otorhinolaryngology: current aspects]. / Verkehrsmedizinische Begutachtung in der HNO-Heilkunde : Aktuelle Aspekte.

According to German law granting of driving licenses depends on the proof of an adequate driving capability. The corresponding guidelines are at present in the process of being revised. At the moment bilateral deafness and high-grade hearing loss (> or = 60% in pure tone audiometry) are not exclusion criteria for driving licenses grades A, B and C, while driving licenses grade D and licenses for public transport are generally excluded. In the forthcoming revised edition of the guidelines it has been suggested that the latter group will also not be excluded. The regulations concerning dizziness are wide-sweeping at the moment as no driving license will be granted if dizziness is present but will be more specific in the next issue. In particular a division will be made between single axle and two axle vehicles. An expert assessment about driving suitability can only be made by a certified specialist with qualifications in traffic medicine.

Transoral laser surgery of supraglottic cancer: follow-up of 141 patients.

OBJECTIVE: To determine the role of transoral laser resection of supraglottic carcinomas. DESIGN: Retrospective unicenter study of the oncologic results of transoral carbon dioxide laser microsurgery for supraglottic carcinomas performed between February 1979 and December 1993. Median follow-up was 37 months. SETTING: University hospital academic tertiary referral center. PATIENTS: We reviewed the medical records of 141 patients (a consecutive sample of 131 men and 10 women; mean age, 60 years) with histologically proven supraglottic carcinomas undergoing transoral laser surgery, possibly in combination with neck dissection or radiotherapy. Stage distribution of patients was as follows: stage I, 23.4%; stage II, 25.5%; stage III, 16.3%; and stage IV, 34.8% (according to the Union Internationale Contre le Cancer staging system). MAIN OUTCOME MEASURES: Recurrence-free survival rates and local and regional recurrence rates. RESULTS: Five-year recurrence-free survival rates were as follows: the whole case load, 65.7%; stage I, 85.0%; stage II, 62.6%; stage III, 74.2%; and stage IV, 45.3%, according to the Union Internationale Contre le Cancer staging system. The local and regional recurrence rates were 16.3% and 9.9%, respectively. CONCLUSIONS: The oncologic results of transoral carbon dioxide laser surgery are satisfying if clean surgical margins (R0 resection) can be reached. In patients in whom tumor-free margins are not achieved (R1 and R2 resection) and transoral revision is not possible, transcervical procedures (partial or total laryngectomy) should be performed. The indication for transoral supraglottic laryngectomy in T3 lesions should be considered with restraint.

Extracorporeal shock wave lithotripsy of parotid stones. Results of a prospective clinical trial.

The extracorporeal shock wave treatment of parotid stones is a rather new therapy. Its usefulness was determined in a prospective study. Seventy-six patients (36 female, 40 male, 2 to 80 years of age) with symptomatic, sonographically detectable solitary sialoliths of the parotid gland were treated with an extracorporeal piezoelectric shock wave therapy after unsuccessful conservative therapy (sialagogues, gland massage, bougienage of the secretory duct). At most, 3 treatments per patient were performed. Altogether, 38 of the 76 patients (50%) were free of stones and no longer suffered from complaints after completion of shock wave treatment and a mean follow-up period of 48 months (range 6 to 71 months). During the follow-up period, in no case could renewed stone formation be observed. Residual stone fragments were detectable in 20 patients (26%), but did not cause further symptoms. Thirteen patients (17%) with residual stone fragments stated a significant improvement of their complaints after therapy. Five patients (7%) did not observe any changes of their pretherapeutic complaints and underwent parotidectomy. The therapeutic success was not influenced by stone size or by stone localization within the gland. During the follow-up period, no side effects of the therapy were identified. With stones of the parotid gland, extracorporeal shock wave lithotripsy is -- after one has used conservative therapies (sialagogues, gland massage) -- the treatment of choice, avoiding in the majority of cases a parotidectomy with its operative risks (paresis of the facial nerve, Frey's syndrome).

[Lymph node metastasis of glottic laryngeal carcinoma]. / Die Halslymphknotenmetastasierung des glottischen Larynxkarzinoms.

UNLABELLED: The incidence of lymph node metastases in glottic cancer is assumed to be lower than in other head and neck cancers. In a retrospective study this statement was investigated. MATERIAL AND METHODS: This analysis was based on 910 consecutive patients with glottic carcinoma treated between 1970 and 1990 by means of surgery with special interest on regional lymph node metastases. RESULTS: 8.6 % patients had clinically positive necks (N+) and 5.9 % pathohistologically positive necks (pN+). The incidence of lymph node metastases showed correlation with pT category and vocal cord mobility. Lymph node metastases were found in 5 % of pT2, in 18 % of pT3 and in 32 % of pT4 tumors. Only one patient with pT1 cancer had metastatic lymph node involvement. The incidence of occult lymph node metastases was 18 %. Lymph node involvement, extracapsular spread and lymphangiosis carcinomatosa proved to be relevant prognostic factors. The 5 year recurrent free survival rate was 86.7 % for the whole group, 81.6 % for patients with negative nodes (pN0), and 61.8 % for patients with pN+ nodes (p < 0.001 according to logrank test). CONCLUSIONS: Clinical lymph node staging plays an important prognostic role in the staging procedure also in glottic carcinoma. At least in T3 carcinomas, elective treatment of the cervical lymph nodes seems to be necessary. T2 carcinomas with impaired cord mobility have a significant higher risk for metastatic spread; therefore neck dissection should be discussed also in these cases.

[Basic principles and concepts of enteral nutrition of ENT patients]. / Grundlagen und Konzepte zur enteralen Ernährung von HNO-Patienten.

Patients suffering from head and neck cancer often show malnutrition even at the time of diagnosis. Therapeutic measures as surgery, radiation and antineoplastic chemotherapy additionally decrease the nutritional status. Therefore, an early supportive intervention is necessary in accordance to prognosis and quality of life. For many reasons, enteral nutrition has advantages to total parenteral nutrition. Percutaneous endoscopically guided gastrostomy (PEG) is the method of choice, for the application of enteral nutrition in most cases; special situations can be covered by using nasogastral feeding tubes, jejunostomy techniques, open surgical approach or radiologically guided gastrostomy. The industry provides a lot of different products suitable for nearly all patients. Furthermore, PEG facilitates the application of pharmacological agents, e.g. analgetics. However, the patient must be integrated in a network of professional care to ensure a safe nutrition therapy also in an outpatient setting.

Evaluation of the newly updated TNM classification of head and neck carcinoma with data from 3247 patients.

BACKGROUND: The fifth edition of the TNM classification contains a number of changes concerning head and neck tumors. The division of Stage IV tumors into three subcategories marks a significant expansion of the stage grouping procedure. METHODS: In a retrospective study, the clinical courses of 3247 patients with carcinoma of the oral cavity, the oro- and hypopharynx, the larynx, the salivary glands, and the maxillary sinus were comparatively evaluated according to the fourth and fifth editions of the TNM classification agreed upon by the International Union Against Cancer and the American Joint Committee on Cancer. The particular aim of this study was to test the prognostic relevance of the subdivision of Stage IV, especially for mucosal carcinoma. RESULTS: In classifying the primary tumor, the most extensive changes were noted for supraglottic and salivary gland tumors. On the basis of the fourth edition of the TNM classification, the following recurrence free 5-year survival rates for 3033 cases of mucosal cancer were calculated: Stage I, 91.0%; Stage II, 78.6%; Stage III, 61.4%; Stage IV, 31.0%. The calculations based on the fifth edition yielded the following: Stage I, 91.0%; Stage II, 77.2%; Stage III, 61.2%; Stage IVA, 32.4%; Stage IVB, 25.3%; Stage IVC, 3.6%. CONCLUSIONS: The adequacy of the revised stage classification in establishing a prognostic hierarchy was confirmed. However, a significant prognostic distinction between N2 metastasis (Stage IVA) and N3 metastasis (Stage IVB) could not be found.

[Severe oropharyngeal angioedema caused by ACE inhibitor. A case report]. / Schweres oropharyngeales Angioödem durch ACE-Hemmer. Eine Fallbeobachtung.

Inhibitors of angiotensin converting enzyme (ACE) are suspected of inducing angioedemas in up to 0.2% of all patients. These angioedemas are mainly localized in the upper airways and therefore can cause severe airway obstruction and even death due to suffocation. We report the case of a 64-year-old man, who underwent emergency tracheotomy because of severe angioedema of the larynx, which was refractory to pharmacological treatment. We conclude that patients with ACE inhibitor-induced angioedemas should be observed by monitoring in an intensive care unit to ensure the possibility of early intubation, because conventional antiallergic-antiedematous therapy by histamine-receptor antagonists and corticosteroids is an insufficient, unreliable form of therapy in severe cases. Especially otolaryngologists should know about this uncommon potentially life-threatening side-effect of ACE inhibitors.

In vitro effects of high-energy pulsed ultrasound on human squamous cell carcinoma cells.

Human squamous cell carcinoma cells cloned from the hypopharynx (FaDu) and oral cavity (SCC-4) were exposed to high-energy pulsed ultrasound (HEPUS) in vitro to evaluate the effects of various physical parameters on cell viability. Such included the number of pulses, voltage applied, pulse repetition rate and cell density. The experimental piezoelectric ultrasound transducer used in the experiments generated pulses with a high negative pressure amplitude. By varying the repetition frequency from 0.6 to 8 Hz, cell viability was found to be least when pulse repetition was approximately 1 Hz. An increase in transducer voltage resulted in a linear decrease in cell viability. The cell survival rate dropped exponentially as a function of the number of pulses applied, reaching 4.2% after 2000 pulses. The cell survival rate exhibited no significant dependence on cell density when cells ranged from 1 to 3.5 x 10(6) cells ml-1. Data obtained with trypan blue dye exclusion were confirmed by measurements of intracellular lactate dehydrogenase released into an extracellular fluid supernatant. By applying HEPUS to tumor cells, almost complete destruction of the cells could be achieved in vitro. The degree of cell destruction achieved depended significantly on the number of pulses administered, the pulse repetition rate and the transducer voltage applied.

[Current status of minimally invasive treatment methods in sialolithiasis]. / Aktueller Stand minimal-invasiver Behandlungsverfahren bei der Sialolithiasis.

Newly available minimally invasive methods have changed established treatment of human sialolithiasis during the past several years. After basic in vitro and in vivo investigations, two systems of shockwave treatment proved to be useful for clinical application: extracorporeal shockwave lithotripsy (piezoelectric system) and intracorporeal laser lithotripsy (using a rhodamine-6G dye laser). Following our clinical experiences with these methods a differential scheme for managing sialolithiasis is recommended depending on localization of the calculi and their maximal diameters. Submandibular stones are best treated by extra-corporeal lithotripsy if the stone is located in intraglandular parts or in the gland hilum. Stones of the hilum can also be treated by laser lithotripsy. In the distal parts and near the duct orifice, papillotomy and stone extraction should be tried independent of the stone size. If the stone is located in the intraglandular parts of the duct system or in the hilum and its diameter is over 12 mm, submandibulectomy is necessary. Calculi of the parotid gland should only be treated by extracorporeal lithotripsy, regardless of size and location.

[Long-term experience with percutaneous endoscopic controlled gastrostomy (PEG) in ENT tumor patients]. / Langzeiterfahrung mit der perkutanen endoskopisch kontrollierten Gastrostomie (PEG) bei HNO-Tumorpatienten.

Percutaneous endoscopically controlled gastrostomy (PEG) enables patients suffering from a tumor of the upper aerodigestive tract to receive direct gastric feedings. The procedure also avoids the social stigma of a nasal feeding tube. The results of 630 PEG procedures used in 555 patients suffering from various head and neck cancers are reported. The mean age of the patients was 58.0 years with a range from 11 to 92 years. The PEG procedure was carried out under local anesthesia in 60% of the cases and with general anesthesia in 40%. In 512 patients the initial PEG procedure was successful while 43 of the patients require a second PEG procedure after loss of the PEG. In 19 patients the PEG procedure was not successful because of tumor obstruction or it was not possible to perform endoscopy. Twenty-four patients were successfully treated in a second or third session. Although 97% (n = 563) of all 555 patients and 92% (n = 579) of all PEG procedures were successful. The mean duration of PEG use was 243 (range: 0-2271 days). In 66 patients (10.5%) complications occurred but severe complications developed in only 8 patients (1.3%). Operative interventions were necessary in two cases. No deaths resulted from the PEG. These findings show that the PEG technique is safe to do with only few complications when performed by a skilled team.