Pinimenthol ointment in patients suffering from upper respiratory tract infections - a post-marketing observational study.
In order to gain further experience regarding the tolerability of Pinimenthol ointment(1) in adolescents (> or = 12 years) and adults suffering from upper respiratory tract infections, a post-marketing observational study was performed. In this study, data of 3060 patients were collected (64.9% prospectively over an individual observation period of 5-14 days, 35.1% retrospectively). The prospective documentation also comprised data concerning treatment effects. Sample size of the post-marketing observational study was calculated in the way that adverse drug reactions with an event probability of at least 1:1000 would occur within the study at least once with a probability of 95%. Most patients suffered from cold, acute or chronic bronchitis, bronchial catarrh or hoarseness. Pinimenthol ointment was prescribed to inunction (29.6%), inhalation (17.3%) or inunction and inhalation (53.1%), respectively. The mean duration of study participation was 8.0 +/- 3.4 days. The tolerability was rated as excellent or good by 96.7% of physicians and 95.7% of patients. A total of 22 patients (0.7%) reported adverse drug reactions which mostly affected the skin or mucus membrane and therefore correspond to the expected adverse effects profile of Pinimenthol ointment. The treatment effect was mostly judged as excellent or good (physicians: 88.3%; patients: 88.1%). In conclusion, the study confirms Pinimenthol ointment as a well tolerated therapy option for upper respiratory tract infections in both adolescents and adults.
Kamin
Wolfgang
W
Children's Hospital, University of Mainz, Langenbeckstr. 1, D-55101 Mainz, Germany. kamin@kinder.klinik.uni-mainz.de
Kieser
Meinhard
M
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009822:Oils, Volatile / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D009824:Ointments; D011358:Product Surveillance, Postmarketing; D011446:Prospective Studies; D012141:Respiratory Tract Infections / Q000188:drug therapy*; D012189:Retrospective Studies
D009822:Oils, Volatile; D009824:Ointments; C028990:Pinimenthol