Fibromyalgia Syndrome
Conditions
Keywords
MRI, RCT, Chinese medicine
Brief summary
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.
Interventions
DRUGYishenShujin Decoction
Patients in the YishenShujin Decoction group received YishenShujin Decoction at a dose of 2 bags each time, twice daily for 12 weeks.
DRUGplacebo
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.
Sponsors
Juan Jiao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with primary fibromyalgia who met the FM classification criteria established by the American College of Rheumatology in 2016. * TCM syndromes of liver qi stagnation and yin blood insufficiency, or hepatic and renal yin deficiency. * aged 18 years old and above, 75 years old and below. * pain VAS score ≥ 4. * not taking the treatment of FM drugs or not using the treatment of FM program for more than 1 month. * Sign the informed consent.
Exclusion criteria
* Patients with severe depression or anxiety ; * patients with cardiovascular and cerebrovascular, liver, kidney and hematopoietic system and other serious primary diseases and thrombotic diseases ; * Lactating or pregnant women ; * patients with allergy to therapeutic ingredients ; * patients with severe pain caused by other diseases ( such as diabetic pain or postherpetic neuralgia ) ; * patients who have recently participated in clinical trials of the same indications ； * Patients who are male, right-handed, or have contraindications for MRI will not undergo MRI scanning. Contraindications include: History of neurological diseases: brain tumor, stroke, epilepsy, traumatic brain injury, multiple sclerosis, etc. Incompatible implants: cardiac pacemaker, defibrillator, certain types of aneurysm clips, cochlear implants, neurostimulators, etc. Presence of metallic foreign bodies in the body: dentures, intraorbital metallic fragments, shrapnel in certain body regions, etc. Claustrophobia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The change of the Brief Pain Inventory (BPI) from baseline. | Baseline, week 2, week 4, week 8, week 12 and week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The change of Fibromyalgia Symptom Scale scores (Widespread Pain Index [WPI] and Symptom Severity Score [SSS]) from baseline. | Baseline, week 2, week 4, week 8, week 12 and week 24 | 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. |
| The change of the revised Fibromyalgia Impact Questionnaire (FIQR) from baseline. | Baseline, week 2, week 4, week 8, week 12 and week 24 | 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. |
| The change of the Multidimensional Fatigue Inventory-20 (MFI-20) from baseline. | Baseline, week 2, week 4, week 8, week 12 and week 24 | 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. |
| The change of the Beck II Depression Inventory（BDI） from baseline. | Baseline, week 2, week 4, week 8, week 12 and week 24 | 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. |
| The change of the Perceived Stress Scale (PSS) from baseline. | Baseline, week 2, week 4, week 8, week 12 and week 24 | 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. |
| The change of the Short Form-36 Health Status Questionnaire (SF-36) from baseline. | Baseline, week 2, week 4, week 8, week 12 and week 24 | 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). |
| Global Impression of Change (PGIC) questionnaire evaluated at week 12. | 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). |
| Brain morphology measured by structural MRI | Before and at the end of the study ( 0, 12 weeks ). | 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. |
| Brain functional connectivity measured by function MRI | Before and at the end of the study ( 0, 12 weeks ). | 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. |
| Serum concentrations of inflammatory cytokines, oxidative stress biomarkers and circulating bile acids | Before and at the end of the study ( 0, 12 weeks ). | 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). |
| Fecal relative abundance of intestinal microbiota, fecal bile acid concentration and fecal short-chain fatty acid concentration | Before and at the end of the study ( 0, 12 weeks ). | 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). |
Countries
China
Contacts
CONTACTJuan Jiao
Outcome results
None listed