Abstract | OBJECTIVE: The objective of the present study in 60 patients with chronic tinnitus aurium was to confirm the efficacy of oral treatment with 2 x 80 mg Ginkgo special extract EGb 761 per day subsequent to 10-day EGb 761 infusion treatment. METHODS: Patients with chronic tinnitus aurium underwent 10 days of in-patient infusion treatment with 200 mg/day EGb 761, after which they were randomized to double-blind, oral out-patient treatment with either 2 x 80 mg/day EGb 761 or placebo, given over a scheduled treatment period of 12 weeks. The primary outcome measure was the change in tinnitus volume in the more severely affected ear during randomized treatment. RESULTS: Fifty-two of 60 patients (89.7%) completed the infusion treatment; complete sets of data were available for 40 (66.7%), 30 (50.0%) and 22 (36.7%) patients after 4, 8 and 12 weeks of randomized treatment, respectively. For the primary outcome measure, significant superiority of EGb 761 over placebo was demonstrated in the intention-to-treat analysis data set after 4, 8 and 12 weeks of out-patient treatment (p < 0.05, 1-tailed), although the absolute treatment group difference was moderate. The results were supported by the secondary outcome measures for efficacy (e.g. decreased hearing loss, improved self-assessment of subjective impairment). During out-patient treatment, there were no attributable adverse events under EGb 761. CONCLUSIONS:
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Authors | C Morgenstern, E Biermann |
Journal | International journal of clinical pharmacology and therapeutics
(Int J Clin Pharmacol Ther)
Vol. 40
Issue 5
Pg. 188-97
(May 2002)
ISSN: 0946-1965 [Print] Germany |
PMID | 12051570
(Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial)
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Chemical References |
- Plant Extracts
- Ginkgo biloba extract
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Topics |
- Administration, Oral
- Biometry
- Chronic Disease
- Double-Blind Method
- Female
- Ginkgo biloba
- Humans
- Infusions, Intravenous
- Male
- Middle Aged
- Phytotherapy
- Plant Extracts
(administration & dosage, adverse effects, therapeutic use)
- Tinnitus
(drug therapy)
- Treatment Outcome
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