Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Rheumatoid Arthritis Clinical Trial

Official title:

Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01619176
• Other study ID #: acumicro
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: December 2014

Study information

• Verified date: November 2023
• Source: Chinese Academy of Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acupuncture is used and recommended by the WHO for the treatment of Rheumatoid Arthritis. The molecular bases of this recommendation are not known, the investigators want to compare with the usage of high-throughput molecular technologies the variations occurring in patients treated with acupuncture and conventional treatment with the ones treated with conventional treatment only. The investigators observe the variations in blood and in the gut microbiome.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• The patient should be diagnosed as the first or second stage of rheumatoid Arthritis (RA) and checked with X ray for additional diagnose.
• diagnosed for RA according to ACR(1987)
• the patient should be in the active stage of the disease, defined as:

1. swollen joints >3

2. tender joints > 5

3. any one of the following: (c1.) morning stiffness lasting more than 45 minutes (c2.) Erythrocyte Sedimentation Rate (ESR) >= 28mm/h (c3.) C-reactive protein (CRP)>= 12mg/L

• Should not be resistant to MTX nor leflunomide
• Blood test should satisfy:

1. Hemoglobin (Hb)>=85g/L

2. White cell >=3.5 10+9/L

3. Platelets >= 100 10+9/L

4. Liver function: serum alanine aminotransaminase (ALT), aspartate transaminase (AST) and total bilirubin (TBil) should be less than 1.5 times the upper limit of normal (ULN)

5. Kidney function: Serum creatinine (Cr) level should be less than ULN.

6. Pregnancy test should be negative

• should be positive for anti-cyclic citrullinated protein antibodies (anti-CCP).
• should agree to sign the informed consent

Exclusion Criteria:

• Serious diseases affecting liver, kidney, heart and lung, or diseases related to hematologic,endocrine and nervous systems. .
• Be treated by MTX or Leflunomide in the last 3 months.
• Be treated with cortical hormone (could be intramuscular injection, intravenous injection or injection to articular cavity) in the last 4 weeks.
• Be treated with biological agents, such as antagonist of TNF-alpha,IL-6, and CD20 mono antibody in the last 3 months.
• Be treated by chronic medicine, such as immunosuppressive agent, Penicillamine, chloroquine and gold based Disease-modifying antirheumatic drugs (DMARDs) in the last 3 months.
• Pregnant and breast-feeding woman
• Having history of serious drug allergy
• In the acute or chronic phase of infection (such as lung diseases)
• Easy bleeding patients or patients with local skin infection (only for acupuncture)
• The patients cannot accept acupuncture (only for acupuncture)
• Be treated with acupuncture in the past 3 months(only for acupuncture).
• No pregnant and breast-feeding woman.
• No history of serious drug allergy.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Drug:
• methotrexate
methotrexate: 7.5mg/week to 15mg/week for 3 months
• non-steroidal anti-inflammatory drug (NSAID)
NSAID: 100mg twice a day for 3 months
• leflunomide
leflunomide: 20mg/day for 3 months
• methotrexate
methotrexate: 7.5mg/week to 15mg/week for 3 months
• non-steroidal anti-inflammatory drug (NSAID)
NSAID: 100mg twice a day for 3 months
• leflunomide
leflunomide: 20mg/day for 3 months

Procedure:
• Acupuncture
30 minutes acupuncture every other day for 3 months. Basic acupoints: Zusanli, st36; Taixi,KI3); Shenxu, BL23 Additional acupoints due to personal condition: Waiguan,SJ5; Baxie,Ex-UE9;Yinlingquan,(SP9); Quchi,LI11; Yanglingquan,GB34; Xuehai,SP10; Dazhu,BL11; Dazhui,DU14; Pixu,BL20.

Locations

Country	Name	City	State
China	Shanghai GuangHua Hospital of integrated traditional and western medicine	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Chinese Academy of Sciences	Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

Liu, Y. et al. (2023). Wound Healing from Bench to Bedside: A PPPM Bridge Between Physical Therapies and Chronic Inflammation. In: Podbielska, H., Kapalla, M. (eds) Predictive, Preventive, and Personalised Medicine: From Bench to Bedside. Advances in Pred

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ACR20 Response Rate at 3 Weeks	ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire; The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)	From baseline to 3 weeks
Primary	ACR20 Response Rate at 3 Months	ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire; The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)	From baseline to three months
Secondary	ACR50 Response Rate at 3 Weeks	ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire; The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)	From baseline to 3 weeks
Secondary	ACR50 Response Rate at 3 Months	ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire; The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)	From baseline to three months
Secondary	ACR70 Response Rate at 3 Weeks	ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire; The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)	From baseline to 3 weeks
Secondary	ACR70 Response Rate at 3 Months	ACR criteria stands for: American College of Rheumatology Criteria. ACR criteria measures improvement in tender or swollen joint counts and improvement in three of the following five parameters: acute phase reactant (such as sedimentation rate) patient assessment physician assessment pain scale disability/functional questionnaire; The number indicates the percentage of improvement in tender or swollen joint counts as well percentage improvement in three of the other five criteria (patient's assessment of pain, a physician's global assessment of disease, a patient's global assessment of disease, physical function as assessed by the Health Assessment Questionnaire-Disability Index (HAQ-DI), and the level of acute-phase reactant)	From baseline to three months
Secondary	DAS28 at Baseline	The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*v(TJC28) +0.28*v(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*v(TJC28)+0.28*v(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.; The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 2.6-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease	At baseline
Secondary	DAS28 at 3 Weeks	The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*v(TJC28) +0.28*v(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*v(TJC28)+0.28*v(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.; The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease	At 3 weeks
Secondary	DAS28 at 3 Months	The DAS28 (disease activity score) considers 28 tender and swollen joint counts, general health (GH; patient assessment of disease activity using a 100 mm visual analogue scale (VAS) with 0 = best, 100 = worst), plus levels of an acute phase reactant (either the level of erythrocyte sedimentation rate ESR (mm/h) or C-reactive protein CRP (mg/litre)). DAS28 values were calculated as follows: DAS28 (CRP) = 0.56*v(TJC28) +0.28*v(SJC28)+0.014*GH+0.36*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56*v(TJC28)+0.28*v(SJC28)+0.014*GH+0.70*ln(ESR), where TJC = tender joint count and SJC = swollen joint count.; The scale does not have bounds. DAS28 total score < 2,6 means remission DAS28 total score ranged between 0-3.2 means inactive disease; DAS28 total score ranged between 3.3-5.1 means moderate disease activity; DAS28 total score >5.1 means very active disease	At 3 months

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