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Fibromyalgia (FM) is a syndrome characterized by chronic and widespread musculoskeletal pain, fatigue sleep disturbances and cognitive and somatic symptoms. It is commonly conjectured that central sensitization is physiological hallmark of FM. Therefore, centrally acting medications including antidepressants and anticonvulsants are used to treat FM via downregulating dorsal horn sensitization and systemic hyperexcitability.However, those drugs are limited in clinical practice resulting from dose-limiting adverse effects and incomplete drug efficacy.Shugan Dingtong decoction(SGDTD) is a Chinese herbal formula and has been used for treatment of FM in clinical practice many years. However, few research can provide high-quality evidence on the efficacy and safety of SGDTD for the treatment of FM. Therefore, a parallel-group randomized controlled trial was designed to evaluate the efficacy and safety of SGDTD on FM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Shugan Dingtong decoction | Experimental | Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks. |
|
| duloxetine hydrochloride | Active Comparator | Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shugan Dingtong decoction | Drug | Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visual analogue scale pain scores | The primary outcome of this study is visual analogue scale(VAS) pain score used to evalu-ate pain intensity. VAS pain score ranges from 0 to 10, where 0 refers to no pain and 10 refers to unbearable pain. | 12 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fibromyalgia impact questionnaire | The fibromyalgia impact questionnaire will be used to measure physical functioning, work status, depression, anxiety, sleep, pain, stiffness, fatigue, and well being. This score ranges from 0 to 100 and high scores are related to greater impact on life quality. | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| China-Japan Friendship Hospital | Beijing | Beijing Municipality | 100029 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39906173 | Derived | Wang Z, Lan T, Zhang Y, Guo Z, Yu H, Sun G, Wang Z, Yan Z, Tao Q, Xu Y. Osteoarthritis and Degree of Fatigue are Associated with Pain Levels in Patients with Fibromyalgia Syndrome: A Cross-Sectional Study of 394 Patients. Int J Gen Med. 2025 Jan 31;18:497-507. doi: 10.2147/IJGM.S503902. eCollection 2025. |
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| ID | Term |
|---|---|
| D005356 | Fibromyalgia |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Duloxetine Hydrochloride | Drug | Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks. |
|
| Fatigue scale-14 |
The fatigue scale-14 will be used to evaluate physical and mental fatigue. The higher the score, the greater the fatigue. |
| 12 Weeks |
| Pittsburgh sleep quality index | Pittsburgh sleep quality index will be used to assess the sleep quality within the past month. The higher the score, the worse sleep quality. A total of PSQI score greater than five yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% | 12 Weeks |
| Traditional Chinses medicine symptom score | Traditional Chinses medicine symptom score is calculated based on the percentage of symptom score reduction | 12 Weeks |
| D009422 |
| Nervous System Diseases |
| D006571 |
| Heterocyclic Compounds |