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Peer-reviewedCC BY-NC-ND 4.0Trials

Indirect moxibustion therapy improves insomnia and associated symptoms in patients with schizophrenia

  1. 1Shanghai Mental Health Center, Shanghai Jiaotong University School of Medicine, Shanghai Institute of Traditional Chinese Medicine for Mental Health, Shanghai, People’s Republic of China

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.

Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09915-w.

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BibTeX
@article{cai2026indirect,
  title = {{Indirect moxibustion therapy improves insomnia and associated symptoms in patients with schizophrenia}},
  author = {Jing Cai and Mei Wu and Jianming Zhang},
  journal = {Trials},
  year = {2026},
  month = jul,
  doi = {10.1186/s13063-026-09915-w},
  url = {https://doi.org/10.1186/s13063-026-09915-w},
  note = {CC BY-NC-ND 4.0},
}
RIS
TY  - JOUR
TI  - Indirect moxibustion therapy improves insomnia and associated symptoms in patients with schizophrenia
AU  - Jing Cai
AU  - Mei Wu
AU  - Jianming Zhang
PY  - 2026
DA  - 2026/07/29
JO  - Trials
DO  - 10.1186/s13063-026-09915-w
UR  - https://doi.org/10.1186/s13063-026-09915-w
AB  - 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.  Supplementary Information: The online version contains supplementary material available at https://doi.org/10.1186/s13063-026-09915-w.
SN  - 1745-6215
ER  -