(226) Adrenocorticotropic hormone versus prednisolone for infantile spasms: a systematic review and economic evaluation

Background: The primary treatment for infantile spasms (IS) is hormonal medications. The efficacy and safety of different doses of adrenocorticotropic hormones and glucocorticoids are still not clear.

Objectives: To evaluate the effectiveness, safety and economy of adrenocorticotropic hormone (ACTH) and prednisolone in the treatment of infantile spasms.

Methods: Medline, Embase, CENTRAL, China National Knowledge Infrastructure (CNKI), Wanfang database, VIP database, China Biology Medicine Disc and two clinical trial registration platforms were searched. The literature was screened, extracted and evaluated for quality, the results were analyzed by Meta-analysis. From the perspective of the health care system, the two treatment regimens were economically evaluated over a period of 14 days. The rate of spasm cessation on 14th day was used as the effect index; if there was a statistically significant difference, cost-effectiveness analysis was used; otherwise, minimum cost analysis was used. The univariate sensitivity analysis was used to verify the robustness of the results.

Results: A total of 9 randomized controlled trials (RCTs) were included. Meta-analysis showed that there was no significant difference in the rate of spasm cessation on 14th day[RR=1.05,95%CI(0.86,1.27),P=0.64], other short-term outcomes (the rate of electroclinical response and electro-clinical response on 14th day, No. of days taken for control of spasms) and the incidence of adverse events between ACTH group and prednisolone group, the long-term outcomes (spasms relapse rate [RR=0.58,95%CI(0.37,0.93),P=0.02] and No. of months taken for relapse [MD=1.65,95%CI(1.01,2.29),P < 0.01]) were statistically significant between two groups. The cost-minimization analysis showed that the cost of ACTH and prednisolone was 5629.19 yuan and 5.56 yuan, respectively. Univariate sensitivity analysis showed that the most influential factor was the cost of ACTH.

Conclusions: Available clinical evidence showed that ACTH and prednisolone had no statistical difference in improving the short-term outcomes of IS, nor in the occurrence of adverse drug reactions. ACTH has more advantages in improving the long-term outcome of IS. Prednisolone is more economical to treat IS within 14 days in China.