This 24-week prospective study (12-week intervention + 12-week follow-up) is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the therapeutic effects of YishenShujin Decoction, a clinically established herbal prescription, in patients with fibromyalgia (FM). The primary outcome is pain intensity measured by the Brief Pain Inventory (BPI). Secondary outcomes include improvements in the Fibromyalgia symptom scale(FS), revised Fibromyalgia Impact Questionnaire(FIQR), the Short Form-36 Health Status Questionnaire (SF-36), and FM-associated comorbidities. Safety profiles will be systematically monitored. In addition, brain structural and functional MRI will be used in this study to explore the underlying mechanisms.The findings aim to establish evidence for the formula's efficacy and provide insights into its role in FM management.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
100
Patients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks.
The placebo was contained one-tenth of the dose of the original recipe. It was packaged in the same granule bag as the YishenShujin Decoction, ensuring that the placebo exhibited the same color, texture, taste, and smell as the actual medicine. Patients in the placebo group received placebo granule at a dose of 2 bags each time, twice daily for 12 weeks.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing, Beijing Municipality, China
RECRUITINGThe change of the Brief Pain Inventory (BPI) from baseline.
The Brief Pain Inventory (BPI) evaluates the severity of pain and pain-related interference with daily functioning. The BPI total and subscale scores range from 0 to 10, with higher scores indicating greater pain intensity and more significant interference with daily activities.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline.
This scale consists of two subdomains to evaluate the overall severity of fibromyalgia according to the ACR fibromyalgia diagnostic criteria. The Widespread Pain Index (WPI) assesses the extent and diffuseness of body pain, with scores ranging from 0 to 19. Higher scores indicate more widespread, diffuse pain distribution across the body. The Symptom Severity Score (SSS) evaluates the severity of core accompanying fibromyalgia symptoms, with total scores ranging from 0 to 12. Higher scores represent greater severity of general somatic and associated symptomatic burden.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline.
A self-administered questionnaire with 10 subscales, measuring fibromyalgia symptoms and function domains. FIQR total score ranges from 0 to 100, with higher scores indicating more severe symptoms.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline.
The Multidimensional Fatigue Inventory-20 (MFI-20) measures fatigue severity. The MFI-20 total score ranges from 0 to 80, with higher scores indicate more severe fatigue.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Beck II Depression Inventory（BDI） from baseline.
The Beck II Depression Inventory (BDI) assesses the severity of depressive symptoms. Scores range from 0 to 39, with higher scores indicate a greater degree of depression severity.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Perceived Stress Scale (PSS) from baseline.
The Perceived Stress Scale (PSS) is for measuring the perception of stress and current levels of experienced stress. Scores range from 0 to 56, with higher total score indicating a greater degree of symptom severity.
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline.
The Short Form-36 Health Status Questionnaire (SF-36), which measured health-related quality of life (range, 0 to 100, with higher scores indicating better perceived health status).
Time frame: Baseline, week 2, week 4, week 8, week 12 and week 24
Global Impression of Change (PGIC) questionnaire evaluated at week 12.
A questionnaire determine any change in overall symptom status from the beginning of the study to its conclusion (score range, 1 \[very much improved\] to 7 \[very much worse).
Time frame: Week 12.
Brain morphology measured by structural MRI
To compare the changes in brain structure and morphology in patients with fibromyalgia before and after treatment by structural MRI. The images were acquired by a Siemens 3.0T Skyra scanner (Siemens; Munich, Germany) using fast spoiled gradient-echo sequence. Images contain whole brain, grey matter, white matter, atlas-based regions of interest for the patient group and healthy controls. The structural MRI images were processed with CAT 12 software (Version12.7, r1700). In detail, the voxel-based morphometry pipeline includes initial and refined voxel-based processing.
Time frame: Before and at the end of the study ( 0, 12 weeks ).
Brain functional connectivity measured by function MRI
To compare the changes in connectivity and metabolic function of the brain in patients with fibromyalgia before and after treatment by function MRI. The scanning sequence is set up under the guidance of an imaging professional, while ensuring that the participants undergo the MRI scans with their eyes closed but awake; head movements do not exceed 1.5 mm in translation in any direction and 1.5° in rotation in any direction.
Time frame: Before and at the end of the study ( 0, 12 weeks ).
Serum concentrations of inflammatory cytokines, oxidative stress biomarkers and circulating bile acids
Serum IL-6, TNF-α, HMGB1 were tested by ELISA; serum MDA, GSH were detected using biochemical colorimetric method; circulating bile acid components were quantified with liquid chromatography-mass spectrometry (LC-MS). All blood samples were collected at baseline (0 week) and study endpoint (12 weeks).
Time frame: Before and at the end of the study ( 0, 12 weeks ).
Fecal relative abundance of intestinal microbiota, fecal bile acid concentration and fecal short-chain fatty acid concentration
Intestinal flora composition was profiled by 16S rRNA high-throughput sequencing; fecal bile acids and short-chain fatty acids were both determined via LC-MS/MS technology. Fecal specimens were collected at baseline (0 week) and study endpoint (12 weeks).
Time frame: Before and at the end of the study ( 0, 12 weeks ).
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