Challenor 1989.
Methods | Double‐blind randomized placebo‐controlled (double‐dummy) trial Cross‐over design | |
Participants | N = 24 patients with primary Raynaud's phenomenon ‐ 22 female, 2 male Mean age 37.7 ± 2.9 years, range 17 to 61 Mean duration of disease 21.0 ± 3.3 years 3 smokers 4 dropouts | |
Interventions | Continuation of concurrent treatments unchanged Patients randomized to receive nifedipine or placebo Dose increased after 3 weeks After a further 3 weeks, patients crossed over to the opposite treatment for 6 weeks, with dose increasing as before | |
Outcomes | Subjective and objective assessments Daily participant record of episodes, number of attacks, duration, and severity, as well as number of visits outdoors, unwanted effects, and improvement Vibration perception, skin temperature, and blood plasma measurements | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Evidence insufficient for judgement of risk |
Allocation concealment (selection bias) | Unclear risk | Evidence insufficient for judgement of risk |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐dummy RCT: "Patients were randomized to receive either a 10‐mg sustained‐release formulation of nifedipine twice daily before food or a matching placebo." |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Participant diary used to record episodes of Raynaud’s phenomenon, noting number of attacks, duration, and severity |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Two participant withdrawals from the study for personal reasons unrelated to treatment Two participant treatment discontinuations after 5 and 7 days of 40 mg sustained‐release nifedipine due to unwanted effects ‐ the latter included in the analysis |
Selective reporting (reporting bias) | Low risk | No evidence of selective reporting |
Other bias | Unclear risk | Evidence insufficient for judgement of risk |