| Methods |
Randomised double‐blind parallel group study. Method of randomisation not described. Patients were stratified into those recieving 2‐4 or 5‐10 daily doses of levodopa/ DDC inhibitor. They were then randomised in a 2:1 ratio, entacapone: placebo.
Intention‐to‐treat analysis.
Duration: 12 months |
| Participants |
326 patients, 37 withdrew from the entacapone group and 15 from the placebo group. 66% male, 34% female. Mean age 56.5 years old. Mean duration of PD 6.1 years. Mean levodopa dose 634 mg.
Inclusion criteria: Outpatients aged 30‐80 years, with levodopa‐responsive idiopathic PD, needing enhancement and/or smoothing of levodopa effects.
Exclusion criteria: Using apomorphine. Secondary parkinsonism, dementia or other significant neurological disease that could interfere with the evaluation. Patients with major psychiatric disorders, such as depression, or other clinically unstable major concurrent illnesses. Patients treated with neuroleptic agents in previous 6 months or with alpha‐methyldopa or reserpine within the previous month. |
| Interventions |
Patients received 200 mg entacapone (n=218) or placebo (n=108) with each levodopa dose.
The use of any levodopa preparation, and all other anti‐Parkinsonian treatments except apomorphine were allowed. Concurrent treatment with catechol‐structured drugs was prohibited. Treatment with MAO‐A inhibitors and/or non‐selective MAO inhibitors within one month prior to the initiation of the study medication was prohibited. |
| Outcomes |
Primary outcome: Safety i.e. Adverse events
Frequency of elevated liver transaminases.
Secondary outcomes: Levodopa dose
Interval between 1st 2 morning l‐dopa doses
UPDRS motor
UPDRS ADL
UPDRS mental
UPDRS total |
| Notes |
ENTACAPONE
Fluctuating and non‐fluctuating patients, fluctuation not defined, results not separated. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
Unclear risk |
B ‐ Unclear |
