OBJECTIVE: The purpose of this study was to determine whether patients receiving a two-dose corticosteroid regimen before IV injection of nonionic contrast medium gain protection against adverse reactions to contrast material. SUBJECTS AND METHODS: A randomized, blinded study involving three institutions was initiated in 1988. Patients were divided into two groups. One group received a 32-mg oral dose of methylprednisolone administered 6-24 hr before and again 2 hr before injection of contrast material. The other group received placebo tablets administered in the same time periods. During a 3-year period, 1155 patients and control subjects successfully completed the protocol. Demographic characteristics, including histories of previous reactions and histories of asthma or allergy, did not differ in the two groups. All signs and symptoms that appeared after injection of contrast material were carefully recorded and graded according to an earlier scheme [1]. Patients, control subjects, and all attending personnel were blinded regarding the premedication. RESULTS:Corticosteroid pretreatment conferred protection for overall reactions (1.7% vs 4.9%, p = .005) and grade I (mild) reactions (0.2% vs 1.9%, p = .004). Subjects receiving corticosteroids also had fewer grade II (moderate) (p = .63) and grade III (severe) (p = .11) reactions, but the total numbers involved were small, and the differences were not significant. CONCLUSION: A rigidly controlled study of the potential protective effects of a two-dose oral corticosteroid regimen preceding IV injection of nonionic contrast medium indicates that corticosteroid pretreatment confers significant protection, at least for overall reactions and grade I reactions.
RCT Entities:
OBJECTIVE: The purpose of this study was to determine whether patients receiving a two-dose corticosteroid regimen before IV injection of nonionic contrast medium gain protection against adverse reactions to contrast material. SUBJECTS AND METHODS: A randomized, blinded study involving three institutions was initiated in 1988. Patients were divided into two groups. One group received a 32-mg oral dose of methylprednisolone administered 6-24 hr before and again 2 hr before injection of contrast material. The other group received placebo tablets administered in the same time periods. During a 3-year period, 1155 patients and control subjects successfully completed the protocol. Demographic characteristics, including histories of previous reactions and histories of asthma or allergy, did not differ in the two groups. All signs and symptoms that appeared after injection of contrast material were carefully recorded and graded according to an earlier scheme [1]. Patients, control subjects, and all attending personnel were blinded regarding the premedication. RESULTS: Corticosteroid pretreatment conferred protection for overall reactions (1.7% vs 4.9%, p = .005) and grade I (mild) reactions (0.2% vs 1.9%, p = .004). Subjects receiving corticosteroids also had fewer grade II (moderate) (p = .63) and grade III (severe) (p = .11) reactions, but the total numbers involved were small, and the differences were not significant. CONCLUSION: A rigidly controlled study of the potential protective effects of a two-dose oral corticosteroid regimen preceding IV injection of nonionic contrast medium indicates that corticosteroid pretreatment confers significant protection, at least for overall reactions and grade I reactions.