Trials. 2026 Jul 29;27(1):626. doi: 10.1186/s13063-026-09915-w.
ABSTRACT
OBJECTIVE: To evaluate the efficacy of low-dose dexzopiclone combined with Indirect moxibustion (IM), compared with sham Indirect moxibustion (SIM), on sleep quality (PSQI) and quality of life (SQLS) in patients with schizophrenia and comorbid insomnia.
METHODS: This single-center randomized controlled trial (NCT06171308) obtained ethics approval from Shanghai Mental Health Center (SMHC-IRB-2023-08). A total of 120 participants were randomly assigned to the IM group (n = 60) or the SIM group (n = 60), receiving 8 weeks of standardized intervention.
RESULTS: Baseline PSQI and SQLS scores were comparable between the two groups. After 4 and 8 weeks, the IM group demonstrated significantly lower PSQI and SQLS scores than the SIM group (PSQI at week 4: 10.10 ± 1.76 vs. 13.50 ± 1.65, week 8: 10.65 ± 1.54 vs. 12.77 ± 2.05, SQLS at week 4: 28.78 ± 8.84 vs. 35.56 ± 3.38, week 8: 30.36 ± 10.63 vs. 38.07 ± 3.42). The improvement in the IM group was significantly greater than that in the SIM group in terms of change from baseline (PSQI: -3.399 [95% CI: -4.078 to -2.719] at week 4, -2.115 [95% CI: -2.795 to -1.435] at week 8, SQLS: -6.801 [95% CI: -9.104 to -4.462] at week 4, -7.732 [95% CI: -10.071 to -5.393] at week 8), with all adjusted intergroup differences being statistically significant (P < 0.001).
CONCLUSIONS: Adjunctive Indirect Moxibustion led to statistically significant and clinically meaningful improvements in sleep quality and quality of life compared to sham procedure in this patient population over an 8-week period. These preliminary findings suggest IM is a promising adjunctive therapy. Further multicenter, long-term trials with expanded outcome indicators are required to validate its generalizability and sustained efficacy.
PMID:42928360 | DOI:10.1186/s13063-026-09915-w
