Background: Considering unique challenges with synthetic ACTH, a long treatment lag and preponderance of structural etiology of infantile epileptic spasms syndrome (IESS) in South Asia, there is conflict in literature regarding the first-choice hormonal therapy.

Methods: We searched on the PubMed, Embase, Scopus, and Web of Science databases for randomized clinical trials (RCTs) evaluating the efficacy and safety of hormonal therapies from the inception until November 2022. Complete cessation of spasms and electro-clinical response after two and six weeks of therapy were considered as efficacy outcomes, while the occurrence of clinically important adverse events as the safety outcomes. We performed the Frequentist approach for network meta-analysis.

Results: Of 650 citations screened, nine RCTs (n=566 children with IESS) were included. ACTH HD (high-dose) (OR: 7.60; 95%CI: 1.51, 38.17; p-score: 0.88) and prednisolone HD (OR: 2.90; 95%CI: 1.27, 6.63; p-score: 0.43) had significantly greater efficacy to achieve the complete cessation of spasms at six weeks as compared with ACTH LD (low dose). Dexamethasone 0.6 mg/kg (OR: 6.72; 95% CI:1.47, 30.72; p-Score: 0.86 and OR: 9.63; 95% CI: 1.99, 46.70; p-score: 0.90), had demonstrated a greater efficacy as compared to ACTH LD in achieving the complete cessation of spasms and electroclinical responses at two weeks of therapy, respectively.

Interpretation: Our network meta-analysis provides the highest quality evidence on preferred first-choice hormonal therapy in managing IESS in South Asia delineating the highest ranking of ACTH HD at six weeks and oral dexamethasone at 2 weeks therapy to achieve a complete cessation of epileptic spasms.

Nagita Devi
National Institute of Pharmaceutical Education and Research
India

Parth Lal
Postgraduate Institute of Medical Education and Research
India

Nidhun Kandoth
National Institute of Pharmaceutical Education and Research
India

Priyanka Madaan
Amrita School of Medical Sciences
India

Jitendra Kumar Sahu
Postgraduate Institute of Medical Education and Research
India

Dipika Bansal
National Institute of Pharmaceutical Education and Research
India