Ståle Nordgård

Ki‐67 As a Prognostic Marker in Adenoid Cystic Carcinoma Assessed With the Monoclonal Antibody MIB1 in Paraffin Sections

The monoclonal antibody MIB1 recognizing the Ki‐67 antigen in formalin‐fixed, paraffin‐embedded tissue was used to study the proliferative activity in 44 adenoid cystic carcinomas of the salivary glands. The antigen expression was compared with clinical factors, histopathological grading, and prognosis. The Ki‐67 value was significantly higher in tumors from patients suffering from treatment failure than in nonfailures (P < 0.001). The Ki‐67 expression was also higher in tumors exhibiting areas more than 30% of the solid growth pattern and higher in sinonasal tumors than in other locations. By Cox regression analysis, Ki‐67 more than 4% was the strongest prognostic indicator (P <0.005). Clinical stage and violation of surgical margins were also found to be independent significant prognostic indicators. We conclude that Ki‐67 expression estimated by the use of MIB1 is a powerful tool for predicting the short‐term prognosis for patients with adenoid cystic carcinoma.

Effects of Nonabsorbable Packing in Middle Meatus after Sinus Surgery

Objectives/Hypothesis: The aim of this study was to evaluate the effects of a nonabsorbable packing (NAP) in the middle meatus (MM) for 5 days after sinus surgery.

Soft palate implants for the treatment of mild to moderate obstructive sleep apnea.

OBJECTIVE: To evaluate the initial short-term effectiveness of palatal implants in treating patients with mild to moderate obstructive sleep apnea (OSA). Previous published studies have focused on snoring without OSA. STUDY DESIGN: A prospective, nonrandomized study of 25 previously untreated patients with an apnea-hypopnea index (AHI) of 10 to 30 and a body mass index (BMI) of ≤30. Three permanent implants (Pillar; Restore Medical, St Paul, MN) were placed in the soft palate of each patient with a specially designed delivery tool in an office setting under local anesthesia after a formal polysomnography. A repeat polysomnography was obtained after 90 days. RESULTS: The AHI was reduced from a mean of 16.2 to a mean of 12.1 (P < 0.05) for the study group. Twenty of 25 patients (80%) experienced a decrease in the AHI. Twelve of 25 patients (48%) showed a post-90-day implant AHI of 10 or less, a benchmark for the possible cessation of continuous positive airway pressure therapy. The Epworth Sleepiness Score decreased from 9.7 to 5.5 (P < 0.001) and the visual analog Scale of snoring intensity reported by bed partners decreased from 8.4 to 4.3 (P < 0.001). CONCLUSION: The palatal implant method can significantly improve AHI and other sleep-related parameters in patients with mild to moderate OSA and a BMI of ≤30. Short-term results are comparative to those reported for uvulopalatopharyngoplasty but achieved in a low-cost, single-stage, outpatient office setting with low morbidity.

The effects of debridement after endoscopic sinus surgery.

Objectives/Hypothesis: The aim of this randomized, partly blinded, controlled clinical trial was to evaluate the effects of debridement 6 and 12 days after endoscopic sinus surgery.

Palatal implants: a new method for the treatment of snoring

Objective—To evaluate the safety, feasibility and effectiveness of a treatment for snoring using permanent palatal implants. Material and Methods—This was a prospective, non-randomized study involving 35 healthy patients (26 males, 9 females) referred for treatment of habitual snoring. A baseline medical examination, an evaluation of snoring-related subjective symptoms and an overnight sleep analysis were performed. Three PET implants were placed in the palate of each patient using a new delivery device under local anaesthesia. The patients were followed by means of office visits at 2--3, 14, 30 and 90 days postoperatively, at which discomfort, pain, adverse events and changes in snoring-related parameters were recorded. Results—The average time required for the procedure was 8 min; 23% of the patients required no postoperative analgesia; the average consumption of analgesic was 125 mg of diclofenac and the average duration of analgesia was 1.5 days after the procedure. No bleeding, haematoma or infection were observed. Two of the implants were extruded; both of these patients experienced a satisfactory reduction in snoring intensity and no replacements were necessary. The mean reduction in snoring intensity was 51%, with the visual analogue scale score evaluated by the bed partner falling from 7.3 to 3.6 (p<0.001). The Epworth Sleepiness Score dropped from 9.3 to 4.6 (p<0.001). In total, 86% of the bed partners and 89% of the patients recommended the procedure. Conclusion—The new palatal implant system is safe and is associated with low morbidity. It is a fast, simple and effective treatment for snoring

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic cluster headache

Objective The main object of this pilot study was to investigate the safety of administering onabotulinumtoxinA (BTA) towards the sphenopalatine ganglion (SPG) in intractable chronic cluster headache. Efficacy data were also collected to provide indication on whether future placebo-controlled studies should be performed. Method In a prospective, open-label, uncontrolled study, we performed a single injection of 25 IU (n = 5) or 50 IU BTA (n = 5) towards the SPG in 10 patients with intractable chronic cluster headache with a follow-up of 24 weeks. The primary outcome was adverse events (AEs) and the main efficacy outcome was attack frequency in weeks 3 and 4 post-treatment. Results A total of 11 AEs were registered. There was one severe adverse event (SAE): posterior epistaxis. The number of cluster headache attacks (main efficacy outcome) was statistically significantly reduced in the intention-to-treat analysis from 18 ± 12 per week in baseline to 11 ± 14 (p = 0.038) in weeks 3 and 4, and five out of 10 patients had at least 50% reduction of attack frequency compared to baseline. The cluster attack frequency was significantly reduced for five out of six months post-treatment. Conclusion Randomised, placebo-controlled studies are warranted to establish the potential of this possible novel treatment of cluster headache.

Pilot study of sphenopalatine injection of onabotulinumtoxinA for the treatment of intractable chronic migraine

Objective The main objective of this pilot study was to investigate the safety of administering onabotulinumtoxinA towards the sphenopalatine ganglion in 10 patients with intractable chronic migraine with an open, uncontrolled design. We also collected efficacy data to provide an indication as to whether future placebo-controlled studies should be performed. Method In a prospective, open-label, uncontrolled study after one-month baseline, we performed bilateral injections of 25 IU onabotulinumtoxinA (total dose 50 IU) toward the sphenopalatine ganglion in a single outpatient session in 10 patients with intractable migraine with a follow-up of 12 weeks. The primary outcome was adverse events and the main efficacy outcome was frequency of moderate and severe headache days in month 2 post-treatment compared to baseline. Results All 10 patients experienced a total of 25 adverse events. The majority of these were different types of local discomfort in the face and jaw, and none were classified as serious. In an intention-to-treat analysis of the main efficacy outcome, a statistically significant reduction of moderate and severe headache days in baseline versus month 2 was observed (16.3 ± 6.2 days baseline versus 7.6 ± 7.6 days month 2, p = 0.009). Eight out of 10 patients experienced an at least 50% reduction of moderate and severe headache days compared to baseline. Conclusion The result warrants randomised, placebo-controlled studies to establish both safety and efficacy of this potential novel treatment of chronic migraine.

Three-year follow-up of palatal implants for the treatment of snoring.

Abstract Conclusions: The safety of treatment with palatal implants remains high 3 years after the procedure. The implant extrusion rate decreases over time. Additional surgery to the palate is safe. The presence of the implants seems important in sustaining efficacy past 1 year. Objectives: To investigate long-term safety and treatment results of palatal implants for treatment of snoring. Methods: A prospective clinical non-randomized trial of 55 patients with primary snoring followed over a period of 3 years. Results: No major adverse events were observed. Eleven of the 55 patients (20%) experienced implant extrusions, 8 during the first year, 3 in the second, and none in the third year. Twenty-six patients (47.3%) had additional procedures past 1 year. Only one post-implant surgery caused an extrusion. The success defined as no additional surgery followed by endpoint satisfaction rate was 34.6%. For patients with implants intact it was 41.5% (17/41) at 3 years, significantly better than for those who experienced loss of implants.CONCLUSIONS The safety of treatment with palatal implants remains high 3 years after the procedure. The implant extrusion rate decreases over time. Additional surgery to the palate is safe. The presence of the implants seems important in sustaining efficacy past 1 year. OBJECTIVES To investigate long-term safety and treatment results of palatal implants for treatment of snoring. METHODS A prospective clinical non-randomized trial of 55 patients with primary snoring followed over a period of 3 years. RESULTS No major adverse events were observed. Eleven of the 55 patients (20%) experienced implant extrusions, 8 during the first year, 3 in the second, and none in the third year. Twenty-six patients (47.3%) had additional procedures past 1 year. Only one post-implant surgery caused an extrusion. The success defined as no additional surgery followed by endpoint satisfaction rate was 34.6%. For patients with implants intact it was 41.5% (17/41) at 3 years, significantly better than for those who experienced loss of implants.

Normative data for diagnosing auditory processing disorder in Norwegian children aged 7-12 years

Abstract Objective: The main purpose of this research was to obtain normative data for auditory processing tests for Norwegian speaking children. Design: Participants were administered routine audiological tests and an auditory processing test-battery consisting of Filtered Words, Competing Words, Dichotic Digits, Gaps In Noise, Duration– and Frequency Pattern, Binaural Masking Level Difference and HIST Speech in Noise test. A group of 10-year-old children were retested after two weeks. The effects ear, age and gender and the test–retest reliability were investigated. Study sample: There were 268 normal hearing children aged 7–12 years who participated in the study. Results: Results revealed no differences between genders. The children showed improving performance by age on all tests, except from the Gaps In Noise and Binaural Masking Level Difference. As expected, the children showed a right ear advantage on dichotic speech tests that decreased with age. The test–retest reliability for the tests was good, with a small learning effect on the Filtered Words test. Conclusion: Normative data were established and the preferred tests for diagnosing Auditory Processing Disorder were suggested for Norwegian children aged 7–12 years.

Paranasal sinus opacification in headache sufferers: A population-based imaging study (the HUNT study-MRI).

Background The association between headache and paranasal sinus disease is still unclear. Because of symptom overlap, the two conditions are not easily studied on the basis of symptoms alone. The aim of the present study was to investigate whether paranasal sinus opacification on magnetic resonance imaging (MRI) was associated with migraine, tension-type headache (TTH) or unclassified headache. Methods This was a cross-sectional study of 844 randomly selected participants (442 women, age range 50–65 years, mean age 57.7 years). Based on 14 headache questions, participants were allocated to four mutually exclusive groups: migraine, TTH, unclassified headache or headache free. On MRI, opacifications as mucosal thickening, polyps/retention cysts and fluid in the five paired sinuses were measured and recorded if ≥1 mm. For each participant, opacification thickness was summed for each sinus and, in addition, a total sum of all sinuses was calculated. Opacification in each sinus was compared between headache-free participants and the headache groups using non-parametric tests, and the total sum was compared by logistical regression. Results No significant association was found between paranasal sinus opacification and headache in general, nor when headache was differentiated into migraine, TTH and unclassified headache. This was also true in separate analyses of mucosal thickening and fluid and of opacification from each paranasal sinus. Conclusion Migraine, TTH and unclassified headache were found not to be associated with an increased degree of paranasal sinus opacification at MRI.