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document
Equivalence study of a topical diclofenac solution ( pennsaid ) compared with oral diclofenac in symptomatic treatment of osteoarthritis of the knee : a randomized controlled trial . OBJECTIVE . To compare the safety and efficacy of a topical diclofenac solution versus oral diclofenac in relieving the symptoms of primary osteoarthritis ( OA ) of the knee , in a randomized , double-blind , double-dummy equivalence trial . METHODS A total of 622 men and women with radiological evidence of primary knee OA and mild to severe symptoms were randomly assigned to treatment with a topical diclofenac solution plus placebo oral capsules , or placebo topical solution plus oral diclofenac ( 50 mg ) capsules . Patients applied 50 drops of study solution and took 1 study capsule 3 times daily for 12 weeks . Efficacy variables were pain and physical function , measured by the Western Ontario and McMaster Universities ( WOMAC ) VA 3.1 OA Index , and patient global assessment ( PGA ) . Equivalence in the per-protocol group was based on previously defined ranges of clinically significant difference . Safety was assessed by evaluation of adverse events , vital signs , and laboratory data . RESULTS The difference in mean ( 95 % CI ) change scores ( final minus baseline ) between treatments was 13.3 mm ( -8.6 to 35.2 ) for pain ( total scale 500 mm ) , 71.0 mm ( -2.4 to 144.5 ) for physical function ( total scale 1700 mm ) , and 4.3 mm ( -1.2 to 9.8 ) for PGA ( total scale 100 mm ) . The CI for each efficacy variable fell within the predefined equivalence ranges ( pain , +/- 75 mm ; physical function , +/- 255 mm ; PGA , +/- 20 mm ) , indicating that no clinically relevant difference was found between the 2 treatment arms . Safety analyses of patients applying topical diclofenac solution revealed some minor skin irritation at the application site -- mostly skin dryness in 83/311 ( 27 % ) patients -- but a significantly reduced incidence , relative to oral diclofenac , of total and severe gastrointestinal ( GI ) adverse events , including dyspepsia , abdominal pain , diarrhea , and nausea . The number of patients developing abnormal liver function tests ( including clinically significant elevation ) , hemoglobin , and creatinine clearance was significantly higher in the oral diclofenac group . CONCLUSION Application of this topical diclofenac solution to the knee of patients with OA produced relief of symptoms equivalent to oral diclofenac , with minor local skin irritation , but significantly reduced incidence of diclofenac-related GI complaints and abnormal laboratory values .
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Intervention_Pharmacological
topical diclofenac solution ( pennsaid )
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Intervention_Pharmacological
oral diclofenac
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Intervention_Pharmacological
topical diclofenac solution
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Intervention_Pharmacological
oral diclofenac
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Intervention_Pharmacological
topical diclofenac solution
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Intervention_Control
placebo oral capsules
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Intervention_Control
placebo topical solution
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Intervention_Pharmacological
oral diclofenac
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Intervention_Pharmacological
diclofenac solution
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Intervention_Pharmacological
oral diclofenac
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Intervention_Pharmacological
topical diclofenac solution
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Intervention_Pharmacological
oral diclofenac
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Outcome_Other
safety and efficacy
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Outcome_Other
Safety analyses
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Outcome_Adverse-effects
minor skin irritation at the application site -- mostly
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Outcome_Adverse-effects
total and severe gastrointestinal ( GI ) adverse events
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Outcome_Adverse-effects
dyspepsia
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Outcome_Adverse-effects
abdominal pain
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Outcome_Adverse-effects
diarrhea
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Outcome_Adverse-effects
nausea
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Outcome_Physical
relief of symptoms
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Outcome_Adverse-effects
incidence of
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Outcome_Physical
diclofenac-related GI complaints
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Outcome_Physical
abnormal laboratory values
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Participant_Condition
osteoarthritis of the knee :
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Participant_Condition
patients with OA