Shugan Dingtong Decoction in the Treatment of Fibromyalgia

The Efficacy and Safety of the Shugan Dingtong Decoction in the Treatment of Fibromyalgia

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.

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Drug: Shugan Dingtong decoction; Drug: Duloxetine Hydrochloride

• Study Type: Interventional
• Enrollment (Actual): 72
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • China-Japan Friendship Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• patients aged 18-70 years old.
• patients who meet the diagnostic criteria of American College of Rheumatology in 2016.
• patients who meet the diagnostic criteria of Syndrome of stagnation of liver qi.
• pain scores between3 and 7 on visual analogue scale.
• patients sign the informed consent forms.

Exclusion Criteria:

• pregnant and lactating women.
• patients with serious primary diseases of respiratory, digestive, urinary, cardiovascular and immune system.
• patients with mental and psychological disorders including cognitive im-pairment, severe depression, somatoform disorders.
• patients with secondary fibromyalgia resulted from osteoarthritis, rheumatoid arthritis, trauma, hypothyroidism, malignant tumor.
• patients with severe pain resulted from diabetic and postherpetic neuralgia.
• patients who are allergic to the drugs used in this study.
• patients are participation in any other clinical trials or receive other drugs for the treatment of fibromyalgia.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Shugan Dingtong decoction; Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.	Drug: Shugan Dingtong decoction; Patients will accept Shugan Dingtong decoction 150ml (twice, per day) for 12 weeks.
Active Comparator: duloxetine hydrochloride; Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.	Drug: Duloxetine Hydrochloride; Patients will accept duloxetine hydrochloride 20mg (twice, per day) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2022
• Primary Completion (Actual): October 18, 2024
• Study Completion (Actual): October 18, 2024

Study Registration Dates

• First Submitted: August 18, 2022
• First Submitted That Met QC Criteria: August 18, 2022
• First Posted (Actual): August 19, 2022

Study Record Updates

• Last Update Posted (Estimated): November 19, 2024
• Last Update Submitted That Met QC Criteria: November 16, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Fibromyalgia; Myofascial Pain Syndromes; Serotonin and Noradrenaline Reuptake Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Sensory System Agents; Analgesics; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Antidepressive Agents; Duloxetine Hydrochloride
• Other Study ID Numbers: LZhang

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No