A randomized study on comparing effect and safety of wuling capsule and deanxit in patients with anxiety or depression status

Objective To evaluate the efficacy and safety of wuling capsule compared with deanxit in treatment of patients with depression or anxiety status. Methods A total of 139 patients with depression or anxiety status were enrolled in a multi-center double blind clinical trial. All patients were randomized into two groups, 67 patients in wuling capsule group and 73 patients in deanxit group. Efficacy and adverse effects were evaluated with Hamilton Anxiety Scale (HAMA), Hamilton Depression Scale (HAMD),Pittsburgh Sleep Quality Index (PSQI) and Treatment Emergent Symptoms Scale (TESS) before treatment and 1, 2, 4, 6 weeks after treatment to verify the noninferiority of wuling capsule. Results There was no significant difference in score decline of HAMA and HAMD between the two groups (HAMA: wuling vs deanxit group: 9.0 ± 5.4 vs 10.3 ± 5.4, F = 2.11, P =0.148 ; HAMD: wuling vs deanxit: 9.1±5.6 vs 10.5±5.7, F = 1.61, P=0.207). There was no significant difference in response rate and remission rate between the two groups. No significant difference was found in score decline of PSQI between the two groups (wuling vs deanxit group: 4.1±4.5 vs 5.0 ± 4.2, F = 0.72, P=0.192). The incidence of adverse events was 41% in the wuling group and 55% in the deanxit group respectively. The main adverse effects were symptoms of gastrointestinal and neurology system. Conclusion Safe and well tolerated, wuling capsule improves the anxiety, depression and insomnia symptoms of patients with depression or anxiety status. Key words: Anxiety;  Depression ;  Flupenthixol;  Randomized controlled trial