Objective:

2

To evaluate the therapeutic effect of Yu Melody relaxation training (YMRT) combined with Jianpi Jieyu Decoction (JJD) in treating patients with insomnia disorders (ID).

Methods:

2

In this randomized controlled study

94 ID patients were included from Xiyuan Hospital

China Academy of Chinese Medical Sciences from September 2022 to January 2024. They were randomly assigned to the YMRT group (47 cases

YMRT plus JJD) and the control group (47 cases

oral JJD) using a random number table. Both treatment administrations lasted for 4 weeks

with a 2-week follow-up. The primary outcome was change in Insomnia Severity Index (ISI) scores from baseline to 4 weeks of intervention. Secondary outcomes included ISI response at week 4

as well as ISI

Patient Health Questionnaire-9 (PHQ-9)

and Generalized Anxiety Disorder 7-item (GAD-7) scores at baseline and weeks 1

2

3

4

and 6. Additionally

Pittsburgh Sleep Quality Index (PSQI) scores were evaluated at baseline and weeks 4 and 6. Adverse events (AEs) were recorded and compared between groups.

Results:

2

Five patients in each group did not complete the protocol requirements. The overall dropout rate was 10.64%.

The full analysis set included all 47 cases in each group. The ISI score decreased significantly at week 4 from baseline in the YMRT group compared with the control group

with a between-group difference of –3.2 points [95% confidence interval (CI): –5.08 to –1.34;

P

<

0.05

]

. The ISI response at week 4 in the YMRT group was significantly higher than that in the control group (85.11%

vs

. 51.06%)

with a between-group difference of 34.05% (95% CI: 13.77% to 50.97%;

P

<

0.05). At week 6

the YMRT group demonstrated greater reductions from baseline than the control group

with between-group differences of –2.1 points (–95% CI: –3.49 to –0.64;

P

<

0.05) for PHQ-9 scores

–3.5 points (95% CI: –5.21 to –1.85;

P

<

0.05) for PSQI scores

and –1.9 points (95% CI: –3.47 to –0.28;

P

<

0.05) for GAD-7 scores. Moreover

at weeks 4 and 6

the ISI and PSQI scores in the YMRT group were significantly lower than those in the control group (

P

<

0.05); and at week 6

the PHQ-9 score in the YMRT group was significantly lower (

P

<

0.05). There was no significant difference in the incidence rates of AEs between the two groups (8.51%

vs

. 4.26%

P

>

0.05).

Conclusions:

2

YMRT combined with oral JJD could improve sleep quality and alleviate depressive and anxiety symptoms in patients with ID. This combined therapy was effective and safe

and its effect was superior to oral JJD alone. (Registration No. ChiCTR2200063884)