Comparison of cinnarizine/dimenhydrinate fixed combination with the respective monotherapies for vertigo of various origins: a randomized, double-blind, active-controlled, multicentre study.

BACKGROUND AND OBJECTIVE: Vertigo may arise from dysfunction in the peripheral and/or the central vestibular system. Simultaneous activity of a medication at both sites will serve to improve the efficacy of antivertigo treatment. The aim of this study was to compare the efficacy and tolerability of a fixed combination of the peripherally acting cinnarizine (20 mg) plus the centrally acting dimenhydrinate (40 mg) with those of equally dosed monotherapies in the treatment of vertigo of various origins. METHODS: This prospective, randomized, double-blind, active-controlled, multicentre study included patients who assessed at least one vertigo symptom as being of at least medium intensity (≥2) on a 5-point visual analogue scale (VAS; ranging from 0 = not present to 4 = very strong) and who had pathological vestibulospinal movement patterns and/or nystagmus reactions. Patients were randomly assigned to receive either cinnarizine 20 mg/dimenhydrinate 40 mg as a fixed combination, cinnarizine 20 mg as monotherapy or dimenhydrinate 40 mg as monotherapy, each three times daily for 4 weeks. Patients were examined at baseline (t(0)), and after 1 week (t(1w)) and 4 weeks (t(4w)) of treatment. The primary efficacy endpoint was the decrease in mean vertigo score (MVS) at t(4w), which was calculated by averaging the total score for 12 individual vertigo symptoms, each assessed using the 5-point VAS. RESULTS: The study included 182 patients, of whom 177 were evaluable for efficacy. The mean ± SD reduction in MVS after 4 weeks of treatment with the fixed combination (-1.44 ± 0.56) was significantly greater than the reductions with each of the active treatments alone (cinnarizine -1.04 ± 0.53; dimenhydrinate -1.06 ± 0.56; p = 0.0001, both comparisons). Cinnarizine 20 mg/dimenhydrinate 40 mg as a fixed combination was associated with a significantly higher responder rate (78% of patients with MVS ≤0.5 at t(4w)) than the monotherapies. The odds ratios for MVS ≤0.5 at t(4w) in the cinnarizine or dimenhydrinate groups versus the fixed combination group were 0.345 and 0.214, respectively. The fixed combination reduced concomitant vegetative symptoms significantly more effectively than cinnarizine at both t(1w) (p < 0.05) and t(4w) (p < 0.01). Nine patients reported 15 adverse events (AEs) [three AEs for the fixed combination, six AEs each for cinnarizine and dimenhydrinate]. At t(4w) the tolerability of the treatments was rated as very good or good by almost all patients in all groups (fixed combination and dimenhydrinate 96.6% each; cinnarizine 98.3%). CONCLUSION: The fixed combination of cinnarizine 20 mg/dimenhydrinate 40 mg was an effective and well tolerated treatment for patients with vestibular vertigo of central and/or peripheral origin. The efficacy of the fixed combination exceeded that of each of the equally dosed active substances given as monotherapy, leading to higher responder rates, and showed a very good and comparable tolerability with a similar or even smaller rate of adverse events than the active substances given alone.

Primary spinal melanoma with bilateral papilledema.

A case of primary leptomeningeal malignant melanoma localized in the cervical region in a 41-year-old woman is presented. The only clinical finding was intracranial hypertension with papilledema. A diagnosis of primary CNS melanoma was made after dermatological and ophthalmological consultations, ruled out a metastatic lesion. Primary leptomeningeal melanoma is an extremely rare spinal tumor. Its clinical presentation with signs of increased intracranial pressure but without cord symptoms is unusual. Clinical features of this case including the radiological and histologic findings are described. Diagnosis as well as management are discussed.

Telemedicine diagnosis for fetal alcohol syndrome - The Manitoba experience.

The diagnosis of fetal alcohol syndrome has been possible, with increasing precision, since the original descriptions in the 1970s. Multidisciplinary diagnostic approaches have been recognized as most appropriate, although they are often not available. Telemedicine has been used in Canada over the same time period for a variety of diagnositc applications.Since 1999, funding by the Manitoba government has allowed the consolidation of services for children with prenatal alcohol exposure in Manitoba, and has allowed the development of a format for diagnosis using telemedicine.This paper describes the authors' experience with the above and offers observations that may be helpful to other programs that are focused on developing this format for the diagnosis of fetal alcohol syndrome.

Speech outcome after closure of oronasal fistulas with bone grafts.

PURPOSE: The purpose of this prospective study was to evaluate the outcome of speech after complete closure of oronasal fistulas with bone grafts and to determine the possible relationship between outcome of speech and the size and location of the oronasal fistulas. PATIENTS AND METHODS: Ten unilateral cleft lip and palate patients with postoperative oronasal fistulas, ranging in age from 7 to 14 years, underwent secondary alveolar cleft repair and closure of the oronasal fistulas with an iliac bone graft. All patients underwent videofluoroscopic evaluation of the velopharyngeal valve, audiologic assessment, and speech evaluation (resonance, nasal emission, articulation, intelligibility, and nasalance) preoperatively. The examinations were repeated 3 months postoperatively. RESULTS: Six patients had preoperative velopharyngeal competency (60%). Of the 4 patients with slight to mild velopharyngeal incompetency preoperatively, 2 developed velopharyngeal competency postoperatively. All patients had satisfactory audiologic function preoperatively. Every patient also was intelligible before and after surgery. Eight patients (80%) showed nasal emission before surgery and 7 of these patients improved postoperatively (P <.01). Nine patients had articulation errors before surgery, with no significant improvement postoperatively. Nasalance was significantly improved in selected sequences. All patients had variable levels of nasality preoperatively; 8 showed a significant decrease of nasality postoperatively (P <.002). The results were not related to location or size of the oronasal fistulas. CONCLUSION: A significant improvement in speech is noticeable after closure of oronasal fistulas. Early oronasal fistula closure might prevent permanent speech distortions acquired by the cleft palate patients at an early age.

An overview of liver transplantation.

Liver transplantation has evolved into an accepted therapy for those with end-stage liver disease. Since the late 1960s when Dr. Thomas Starzl pioneered the first successful human liver transplantation, it has become a surgical specialty requiring a multidisciplinary approach. Currently, more than 11,000 patients are awaiting liver transplantation. The donor shortage has led to development of techniques for reduction in size of liver grafts, split liver grafts, and living related grafts. Despite these developments, more than 1,000 patients died in 1997 while awaiting transplantation. The increasing demand has led to maximal use of potential organ donors. The complexity of problems and complications that arise during the waiting period and after the transplantation require continued and diligent care. The nurse is an integral part of the transplantation team and can provide ongoing assessment and education throughout the transplantation process to facilitate the patient's return to an independent lifestyle.

Cognition, communication, and hearing in young children with cleft lip and palate and in control children: a longitudinal study.

OBJECTIVE: To compare a group of children with cleft lip and palate (CLP) with a group of noncleft, matched control children on measures of cognitive development, speech and language abilities, and audiologic status at 12 and 24 months of age. DESIGN: Using a prospective, longitudinal study design, a group of 16 children with CLP and a group of 16 noncleft control children matched for race, sex, birth order, and socioeconomic status were compared using the Bayley Scales of Infant Development, the Receptive-Expressive Emergent Language Scale, the Sequenced Inventory of Communication Development-Revised (SICD-R), the Preschool Language Scale-Revised (PLS-R), the mean length of utterance, audiometric evaluation, and impedance screening at 12 and 24 months of age. All were free of other congenital abnormalities or known causes of neurodevelopmental dysfunction. RESULTS: Children with CLP had lower mental developmental index (MDI) and psychomotor developmental index scores than control children. They had lower language comprehension scores on the SICD-R and PLS-R and lower expressive language scores on the Receptive-Expressive Emergent Language Scale, SICD-R, and PLS-R than control children. The group with CLP had a significantly higher number of children with abnormal tympanogram results or ventilation tubes at 12 and 24 months. There was a positive correlation between language test scores at 24 months and MDI scores at 24 months (r = .73 to .85). Seventy-five percent of children with CLP who had hearing loss at 12 months had MDI scores more than 1 SD below the mean versus 0% of children with normal hearing. There was a relationship between hearing status at 12 months and comprehension and expressive language scores at 24 months. CONCLUSIONS: Children with CLP had significantly lower scores on tests of cognition, comprehension, and expressive language abilities than matched control children at 12 and 24 months of age. They also had a higher frequency of middle-ear disease and ventilation tubes than control children, although no significant difference in hearing sensitivity was found between groups. Early identification and treatment of these delays may reduce subsequent verbal deficits, hearing loss, and academic difficulties.