Badesch 2000.
| Methods | Randomised open label controlled trial. Outcome assessor blinding: independent blinded observers assessed the primary efficacy measure which was exercise capacity. Withdrawals and drop outs were reported. Setting: 17 pulmonary hypertension referral centres. | |
| Participants | N =111. 56 were allocated to receive epoprostenol and 55 to conventional therapy. All had scleroderma spectrum of disease. Age: >16 years. Gender: Epoprostenol (5M and 51F). Conventional therapy group (10M and 45F). Diagnosis: NYHA functional class. Exclusions: Thrombo‐embolic disease/congenital heart disease. New therapies commenced in the last month or stopped within last week except anti‐coagulant agents. Current prostacyclin therapy. Patients with interstitial lung disease of more than a mild degree were not included as they were thought to be less likely to show benefit. | |
| Interventions | Epoprostenol via an indwelling central venous catheter and conventional treatment versus conventional treatment alone. Dosage was established according to signs and symptoms from an initial low dose. Trial for 12 weeks. Conventional therapy consisted of diuretics, calcium channel blockers and oral anti‐coagulants. 94 out of the 111 patients were on oral anticoagulants. |
|
| Outcomes | Exercise capacity, cardiopulmonary haemodynamics, NYHA functional class and Borg dyspnoea scores. | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Adequate sequence generation? | Low risk | Randomisation was conducted centrally according to a stratified randomised block design. |
| Allocation concealment? | Unclear risk | Information not specified |