Mats Engström

Prednisolone and valaciclovir in Bell's palsy: a randomised, double-blind, placebo-controlled, multicentre trial

BACKGROUND Previous trials of corticosteroid or antiviral treatments for Bells palsy have been underpowered or have had insufficient follow-up. The aim of this study was to compare the short-term and long-term effects of prednisolone and valaciclovir in the recovery of the affected facial nerve in a large number of patients. METHODS In this randomised, double-blind, placebo-controlled, multicentre trial, patients aged 18 to 75 years who sought care directly or were referred from emergency departments or general practitioners within 72 h of onset of acute, unilateral, peripheral facial palsy, between May, 2001, and September, 2006, were assessed. Patients were randomly assigned in permuted blocks of eight to receive placebo plus placebo; 60 mg prednisolone per day for 5 days then reduced by 10 mg per day (for a total treatment time of 10 days) plus placebo; 1000 mg valaciclovir three times per day for 7 days plus placebo; or prednisolone (10 days) plus valaciclovir (7 days). Follow-up was for 12 months. The primary outcome event was time to complete recovery of facial function, as assessed with a regional Sunnybrook scale score of 100 points. Analysis was by modified intention to treat. This study is registered with ClinicalTrials.gov, number NCT00510263. FINDINGS Of 839 patients who were randomly assigned, 829 were included in the modified intention-to-treat analysis: 206 received placebo plus placebo, 210 prednisolone plus placebo, 207 valaciclovir plus placebo, and 206 prednisolone plus valaciclovir. Time to recovery was significantly shorter in the 416 patients who received prednisolone compared with the 413 patients who did not (hazard ratio 1.40, 95% CI 1.18 to 1.64; p<0.0001). There was no difference in time to recovery between the 413 patients treated with valaciclovir and the 416 patients who did not receive valaciclovir (1.01, 0.85 to 1.19; p=0.90). The number of patients with adverse events was similar in all treatment arms. INTERPRETATION Prednisolone shortened the time to complete recovery in patients with Bells palsy, whereas valaciclovir did not affect facial recovery.

Agreement between the Sunnybrook, House-Brackmann, and Yanagihara facial nerve grading systems in Bell's palsy.

Objective: To assess the agreement between the Sunnybrook facial nerve grading system and the House-Brackmann and Yanagihara systems. Study Design: Prospective clinical facial nerve grading. Setting: Tertiary referral center. Patients: One-hundred assessments, 94 in patients with Bell’s palsy and 6 with herpes zoster. Intervention: Diagnostic. Main Outcome Measures: Evaluation according to the weighted regional Sunnybrook system, the gross House-Brackmann system, and the unweighted regional Yanagihara system. Weighted κ statistics was used to measure agreement between the grading systems. Results: The average weighted κ value between the Sunny-brook, House-Brackmann, and Yanagihara grading systems was 0.65; κ values increased temporally (but not statistically significantly) up to day 180. The highest agreement value, 0.72, was found between the Sunnybrook and Yanagihara grading systems. The weighted κ value between the Sunnybrook and House-Brackmann systems was 0.59. In Sunnybrook gradings less than 63, there was an overlap between House-Brackmann scores of III to VI. Reliable conversion tables between the gross House-Brackmann system and the regional Sunnybrook and Yanagihara systems could not be established. Conclusion: The Sunnybrook system scores at the same agreement level as the House-Brackmann and Yanagihara grading systems. There is an evaluative difference between the weighted regional Sunnybrook and the gross House-Brackmann systems. Substantial agreement was found between the regional Sunnybrook and Yanagihara scales. Sunnybrook grading is easy and quick. By adding objective measurements and additional secondary defects, the Sunnybrook system can be an alternative to the other predominating grading systems.

SERIAL GADOLINIUM-ENHANCED MAGNETIC RESONANCE IMAGING AND ASSESSMENT OF FACIAL NERVE FUNCTION IN BELL'S PALSY

Eleven patients with mild or moderate acute idiopathic peripheral facial palsy, so-called Bells palsy, were serially examined by gadolinium-DTPA-enhanced MRI on mean days 11, 40, and 97 (third examination, n = 10) after the onset of palsy. Results of the clinical and neurophysiologic assessment of facial nerve function were compared with the gadolinium-enhanced MRI findings. Eight of the 11 patients demonstrated contrast enhancement of the facial nerve at the initial examination, but in 7 of them, the enhancement had disappeared by the time of the serial follow-up gadolinium-enhanced MRI scans. The disappearance of facial nerve enhancement was found to be related to clinical and neurophysiologic improvements in facial nerve function during recovery from Bells palsy. The three patients whose scans were negative at the initial gadolinium-enhanced MRI examination had the same clinical severity of palsy, but initially they had milder neurophysiologic involvement than those who demonstrated enhancement; these three patients did not exhibit enhancement at serial follow-up scans. These findings indicate that the presence of enhancement at the initial MRI scan is not necessarily indicative of a poor prognosis for recovery.

Bell's palsy - the effect of prednisolone and/or valaciclovir versus placebo in relation to baseline severity in a randomised controlled trial.

Clin. Otolaryngol. 2012, 37, 283–290

Cancer of the parotid gland; long-term follow-up. A single centre experience on recurrence and survival

Background. The aim of the study was to investigate the results of treatment of malignant parotid gland tumours at a single centre during a 56 year period, focusing on tumour control and survival. Patients and methods. At Uppsala University Hospital, Sweden, 144 patients (73 male and 71 female) with parotid cancer were treated between 1948 and 2004. The mean and median ages were 62 and 65 years, respectively (range 16–89 years). Surgery was the primary treatment in 113 (78%) patients followed by radiotherapy in 81. Postoperative radiotherapy in doses of 64–66 Gy, where the intention was curative and delivered with either split course or not, was administered to a majority of patients after 1970. The split-course mode was practised between 1970 and 1989. The median follow-up time was 8.3 years for patients still alive. There were 57 (40%) relapses, of which 40 were local recurrences with 26 inside the treatment volume.Results. The overall 5-year survival was 53%. The majority of tumour-related deaths appeared in the first 3–5 years after diagnosis. Age, co-morbidity, the presence of lymph node metastases, adenoid cystic carcinoma and extent of disease were important for outcome; gender, however, was not. We found no difference in the survival between patients following split course therapy versus continuous fractionation. No difference could be seen in the survival of patients treated in the 1970s versus the 1990s. Conclusions. Age, nodal engagement, a higher T-stage, adenoid cystic carcinoma histopathology, facial palsy and intercurrent disease worsen the outcome of patients, whereas gender does not. Treatment principles at our hospital have been surgery followed by radiotherapy since the early 1970s even though a split course technique was practised during a part of this period. Survival has not improved markedly. Thus, there is scope for improvement for this group of patients.

The effect of study design and analysis methods on recovery rates in Bell's palsy.

We investigated how study design affects the rate of recovery in Bells palsy.

Prednisolone in Bell's Palsy Related to Treatment Start and Age.

Objective: To evaluate if treatment start and age are related to the outcome in Bells palsy patients treated with prednisolone. Study Design: Prospective, randomized, double-blind, placebo-controlled, multicenter trial. Setting: Sixteen otorhinolaryngologic centers in Sweden and 1 in Finland. Patients Data were collected from the Scandinavian Bells palsy study. A total of 829 patients were treated within 72 hours of onset of palsy. Follow-up was 12 months. Intervention: Patients were randomly assigned to treatment with placebo plus placebo (n = 206), prednisolone plus placebo (n = 210), valacyclovir plus placebo (n = 207), or prednisolone plus valacyclovir (n = 206). Main Outcome Measures: Facial function was assessed with the Sunnybrook grading system, and complete recovery was defined as Sunnybrook = 100. Time from onset of palsy to treatment start was registered. Results: Patients treated with prednisolone within 24 hours and 25 to 48 hours had significantly higher complete recovery rates, 66% (103/156) and 76% (128/168), than patients given no prednisolone, 51% (77/152) and 58% (102/177) (p = 0.008 and p = 0.0003, respectively). For patients treated within 49 to 72 hours of palsy onset, there were no significant differences. Patients aged 40 years or older had significantly higher complete recovery rates if treated with prednisolone, whereas patients aged younger than 40 years did not differ with respect to prednisolone treatment. However, synkinesis was significantly less in patients younger than 40 years given prednisolone (p = 0.002). Conclusion: Treatment with prednisolone within 48 hours of onset of palsy resulted in significantly higher complete recovery rates and less synkinesis compared with no prednisolone.

Validation of a Swedish version of the Facial Disability Index (FDI) and the Facial Clinimetric Evaluation (FaCE) scale.

Abstract Conclusion: Swedish versions of the Facial Disability Index (FDI) and Facial Clinimetric Evaluation (FaCE) scale are psychometrically valid. Both questionnaires can be used for clinical studies on peripheral facial palsy patients, and provide important information on quality of life. Objectives: To translate and validate Swedish versions of the FDI and FaCE scale in patients with peripheral facial palsy. Methods: Translation of the original questionnaires followed international guidelines. Internal consistency and test–retest stability were assessed in adult patients with stable peripheral facial palsy. Facial function was examined with the Sunnybrook and House-Brackmann scales. Subjects answered the questionnaires twice with a 2-week interval. Validity was assessed by comparing FDI and FaCE scale scores to SF-36 and Sunnybrook/House-Brackmann scores. Results: Ninety-three patients were included, 53% women and 47% men, mean age 56.9 years and mean duration of palsy 51.9 months. The questionnaires showed good/excellent psychometric properties with Cronbachs α scores between 0.76 and 0.92. In the test–retest analysis, intra-class correlation coefficients were very good for both questionnaires with scores of 0.83–0.97. Both questionnaires showed good sensitivity to discriminate between patients with varying degrees of facial dysfunction. Moderate to strong correlation was found between the social domains in the questionnaires when compared with the equivalent domains in SF-36.

The Effect of Prednisolone on Sequelae in Bell's Palsy

OBJECTIVE To study whether prednisolone reduces sequelae in Bells palsy. DESIGN Prospective, randomized, double-blind, placebo-controlled, multicenter trial with 12 months of follow-up. SETTING Seventeen referral centers. PATIENTS In all, 829 patients aged 18 to 75 years. INTERVENTIONS Randomization within 72 hours in a factorial fashion to placebo plus placebo (n = 206); prednisolone, 60 mg/d for 5 days, with the dosage then tapered for 5 days, plus placebo (n = 210); valacyclovir hydrochloride, 1000 mg 3 times daily for 7 days, plus placebo (n = 207); or prednisolone plus valacyclovir (n = 206). MAIN OUTCOME MEASURES Facial function at 12 months assessed with the Sunnybrook and House-Brackmann grading systems. RESULTS In 184 of the 829 patients, the Sunnybrook score was less than 90 at 12 months; 71 had been treated with prednisolone and 113 had not (P < .001). In 98 patients, the Sunnybrook score was less than 70; 33 had received prednisolone and 65 had not (P < .001). The difference between patients who received prednisolone and who did not in House-Brackmann gradings higher than I and higher than II was also significant (P < .001 and P = .01, respectively). No significant difference was found between patients who received prednisolone and those who did not in Sunnybrook scores less than 50 (P = .10) or House-Brackmann grades higher than III (P = .80). Synkinesis was assessed with the Sunnybrook score in 743 patients. Ninety-six patients had a synkinesis score more than 2, of whom 33 had received prednisolone and 63 had not (P = .001). Sixty patients had a synkinesis score more than 4, of whom 22 had received prednisolone and 38 had not (P = .005). CONCLUSION Prednisolone significantly reduces mild and moderate sequelae in Bells palsy. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00510263.

Sunnybrook and House-Brackmann Systems in 5397 Facial Gradings

Objectives. To study the correlation between Sunnybrook and House-Brackmann facial grading systems at different time points during the course of peripheral facial palsy. Study Design. Prospective multicenter trial. Setting. Seventeen otorhinolaryngological centers. Subjects and Methods. Data are part of the Scandinavian Bell’s palsy study. The facial function of 1920 patients with peripheral facial palsy was assessed 5397 times with both Sunnybrook and House-Brackmann (H-B) facial grading systems. Grading was done at initial visit, at days 11 to 17 of palsy onset, and at 1 month, 2 months, 3 months, 6 months, and 12 months. Statistical evaluation was by Spearman correlation coefficient and box plot analysis. Results. Spearman correlation coefficient varied from −0.81 to −0.96, with the weakest correlation found at initial visit. Box plot analysis for all assessments revealed that Sunnybrook scores were widely spread over different H-B grades. With 50% of the results closest to the median, Sunnybrook composite scores varied in H-B grades as follows: H-B I, 100; H-B II, 71 to 90; H-B III, 43 to 62; H-B IV, 26 to 43; H-B V, 13 to 25; and H-B VI, 5 to 14. Conclusion. Gradings correlated better in follow-up assessments than at initial visit. As shown by the wide overlap of the grading results, subjective grading systems are only approximate. However, a conversion table for Sunnybrook and H-B gradings was obtained and is included in the article. It can be used for further development of facial grading systems.