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Objective <p>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.</p> Methods <p>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 (<i>n</i> = 60) or the SIM group (<i>n</i> = 60), receiving 8 weeks of standardized intervention.</p> Results <p>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 (<i>P</i> &lt; 0.001).</p> Conclusions <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月29日

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  • Jing Cai,
  • Mei Wu,
  • Jianming Zhang

摘要

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.