RESUMO
Objective: Comprehensive evaluation of lisedexamfetamine dimesylate (LDX) alone and in combination with topiramate (TPM) was done for treatment of binge eating disorder (BED) in adults aged 18-55 years. Methods: In the present randomized clinical trial study, 93 patients were selected by convenience sampling method and were allocated to two groups of 48 and 45 using the permuted block randomization method. This study was conducted from January to September 2022 in Shiraz, Iran. Patients received LDX (n = 48) or LDX plus TPM. Average dose of LDX was 37.5 mg/day and 38 mg/day in the first and second group respectively. The second group (n = 45) also received TPM with average dose of 77.7 mg/day. Results: Twelve weeks treatment caused significant higher mean reduction in level of triglyceride (73.68 vs. 58.97 respectively, p = 0.024), low density lipo-protein (LDL) (9.66 vs. 5.16 respectively, p < 0.001) and body mass index (5.48 vs. 3.41 respectively, p < 0.001) with TPM plus LDX and also greater significant improvement (p < 0.001) in binge eating scale compared to use of LDX alone. Combination therapy with TPM and LDX had better tolerability and lower adverse events such as insomnia (p < 0.001), paresthesia (p = 0.001), confusion (p = 0.035) and ataxia (p = 0.009) compared to monotherapy in BED. Conclusion: The combinative treatment was more effective than single drug in terms of higher tolerability, safety and causing lesser adverse events for BED patients. However, more studies with larger samples are needed.
