47089
document
Glycerol lidocaine eardrops for the treatment of acute abacterial otitis externa . Inflammations of the external auditory canal number among the most frequently occurring ear-nose-throat diseases . For local treatment , substances from various groups of active ingredients are used as combinations and as single-agent drugs , e.g . antibiotics , glucocorticoids or analgesics [ 1 ] . In the case of acute otitis externa , treatment measures focus on the reduction of pain and swelling . The study described here investigates the efficacy and safety of glycerol lidocaine eardrops for the treatment of acute abacterial otitis externa ( CAS No . for glycerol : 56-81-5 , lidocaine-HCl : 73-78-9 ) . In this double-blind , three-arm study , 105 patients diagnosed with acute abacterial otitis externa were included and randomized to receive either glycerol eardrops , glycerol eardrops with 0.5 % lidocaine , or glycerol eardrops with 2 % lidocaine for seven days . The primary outcome parameter was the change of the five typical clinical symptoms , earache , itching , otorrhea , hearing impairment , and " clogged ear " at Visit 2 ( Day 7 ) based on the initial examination on Day 0 . Both therapy groups treated with a combination of glycerol and lidocaine exhibited definite improvement in overall symptoms after seven days . This improvement differed from the mild reduction of symptoms under treatment with glycerol eardrops alone . Overall improvement of symptoms , expressed by the area under the curve of the baseline-adjusted symptom sum score , yielded a mean value of 10.95 ( standard deviation 27.4 ) for the morning survey of the groups receiving eardrops containing only glycerol ; in comparison , for eardrops containing glycerol and 2 % lidocaine it was 15.71 ( +/- 23.6 ) and for glycerol with 0.5 % lidocaine , 23.16 ( +/- 19.4 ) . No severe adverse events occurred . Five adverse events were documented during the clinical investigation , none of which was considered by the investigators to be related to the study medication . Local therapy with glycerol lidocaine eardrops is a safe , and cost-effective treatment for the widely spread clinical picture of acute abacterial otitis externa . The advantage regarding efficacy of this combination compared with glycerol eardrops must be demonstrated in an adequately powered clinical trial .
47090
Intervention_Pharmacological
Glycerol lidocaine eardrops
47091
Intervention_Pharmacological
antibiotics
47092
Intervention_Pharmacological
glucocorticoids
47093
Intervention_Pharmacological
analgesics
47094
Intervention_Pharmacological
glycerol lidocaine eardrops
47095
Intervention_Pharmacological
glycerol
47096
Intervention_Pharmacological
lidocaine-HCl
47097
Intervention_Pharmacological
glycerol eardrops
47098
Intervention_Pharmacological
glycerol eardrops with 0.5 % lidocaine
47099
Intervention_Pharmacological
glycerol eardrops with 2 % lidocaine
47100
Intervention_Pharmacological
glycerol
47101
Intervention_Pharmacological
lidocaine
47102
Intervention_Pharmacological
glycerol
47103
Intervention_Pharmacological
lidocaine
47104
Intervention_Pharmacological
lidocaine
47105
Intervention_Pharmacological
therapy with glycerol lidocaine eardrops
47106
Intervention_Pharmacological
glycerol
47107
Outcome_Physical
acute abacterial otitis externa
47108
Outcome_Pain
reduction of pain
47109
Outcome_Adverse-effects
swelling
47110
Outcome_Physical
acute abacterial otitis externa
47111
Outcome_Physical
earache
47112
Outcome_Physical
itching
47113
Outcome_Physical
otorrhea
47114
Outcome_Physical
hearing impairment
47115
Outcome_Physical
clogged ear
47116
Outcome_Physical
overall symptoms
47117
Outcome_Other
mild reduction of symptoms
47118
Outcome_Physical
baseline-adjusted symptom sum score
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Outcome_Adverse-effects
No severe adverse events
47120
Outcome_Adverse-effects
adverse events
47121
Outcome_Other
safe
47122
Outcome_Other
cost-effective
47123
Participant_Condition
acute abacterial otitis externa
47124
Participant_Sample-size
105
47125
Participant_Condition
acute abacterial otitis externa