Shuhe Granules （舒和颗粒） in Treating Rheumatoid Arthritis Comorbid with Insomnia with Kidney-Heart Deficiency and Qi-Blood Disharmony Syndrome：An Exploratory Single-Arm Clinical Trial
10.13288/j.11-2166/r.2026.16.010
- VernacularTitle:舒和颗粒治疗类风湿关节炎共病失眠心肾两虚、气血失和证的单臂探索性临床研究
- Author:
Yonghao PAN
1
;
Yuxi LI
1
;
Yu GAO
1
;
Xiangbin CHEN
1
;
Kaixin GAO
2
;
Runyue HUANG
2
;
Fei TAN
2
;
Jiamin YUAN
2
;
Biyun XU
2
;
Zhimin YANG
2
Author Information
1. The Second Clinical College of Guangzhou University of Chinese Medicine，Guangzhou，510105
2. The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
- Publication Type:Journal Article
- Keywords:
rheumatoid arthritis;
insomnia;
kidney-heart deficiency;
qi-blood disharmony;
Shuhe Granules （舒和颗粒）
- From:
Journal of Traditional Chinese Medicine
2026;67(16):1743-1751
- CountryChina
- Language:Chinese
-
Abstract:
ObjectiveTo investigate the clinical effects and safety of Shuhe Granules （舒和颗粒） in patients with rheumatoid arthritis （RA） comorbid with insomnia. MethodsA single-arm prospective exploratory design was adopted. Thirty RA patients comorbid with insomnia and diagnosed with the traditional Chinese medicine （TCM） syndrome of kidney-heart deficiency and qi-blood disharmony were enrolled. On the basis of maintaining their original RA treatment regimens， all patients received oral Shuhe Granules， one dose per day， for 12 consecutive weeks. The outcomes were assessed before treatment and at weeks 4， 8， and 12 after treatment. Sleep and related psychosomatic function were evaluated using the insomnia severity index （ISI）， Pittsburgh sleep quality index （PSQI）， fatigue severity scale （FSS）， patient health questionnaire-9 （PHQ-9）， generalized anxiety disorder-7 （GAD-7）， and Montreal cognitive assessment （MoCA） scores. RA-related assessments included the 28-joint disease activity score based on C-reactive protein （DAS28-CRP）， pain visual analog scale （VAS）， tender joint count （TJC28）， swollen joint count （SJC28）， morning stiffness duration， and health assessment questionnaire （HAQ） score. Laboratory parameters included erythrocyte sedimentation rate （ESR）， serum C-reactive protein （CRP）， anti-cyclic citrullinated peptide antibody （anti-CCP）， and rheumatoid factor （RF） levels. A literature-based historical control group was established through literature retrieval and meta-analysis. The ISI， PSQI， DAS28-CRP， and pain VAS scores were compared between the treatment group in the present study and the historical control group. Safety assessments were also performed. ResultsCompared with baseline before treatment， ISI and PSQI scores decreased at weeks 4， 8， and 12， while MoCA scores increased at weeks 4， 8， and 12. FSS scores decreased at weeks 4 and 12. At weeks 8 and 12， GAD-7 scores， DAS28-CRP scores， duration of morning stiffness， TJC28， and SJC28 were reduced. At week 12， PHQ-9， pain VAS， and HAQ scores significantly decreased （P＜0.05）. FSS and DAS28-CRP scores at week 12 were lower than those at week 4， and CRP levels at week 8 were lower than those at week 4 （P＜0.05）. Compared with the historical control group， the treatment group showed superior improvement in ISI and PSQI scores （P＜0.001）； however， no statistically significant differences were observed between the two groups in DAS28-CRP or pain VAS scores （P＞0.05）. No serious adverse events occurred during the study， and the 4 reported mild adverse events were all considered unrelated to the study medication. ConclusionShuhe Granules significantly improve sleep quality， fatigue， emotional status， cognitive function， RA-related symptoms， and joint function in patients with RA comorbid insomnia， with good safety and tolerability.
