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. 2017 Dec 13;2017(12):CD000467. doi: 10.1002/14651858.CD000467.pub2

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