Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: methotrexate; Drug: non-steroidal anti-inflammatory drug (NSAID); Drug: leflunomide; Procedure: Acupuncture

• Registration Number: NCT01619176
• Lead Sponsor: Chinese Academy of Sciences

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-05
• Study First Submitted QC: 2012-06-12
• Study First Posted: 2012-06-14
• Study Start: 2012-10
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Results First Submitted: 2022-09-15
• Results First Submitted QC: 2023-09-07
• Results First Posted: 2023-09-08
• Status Verified: 2023-11
• Last Update Submitted: 2023-11-08
• Last Update Posted: 2023-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acupuncture	non-steroidal anti-inflammatory drug (NSAID)	Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
Control	non-steroidal anti-inflammatory drug (NSAID)	Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
Acupuncture	Acupuncture	Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
Acupuncture	methotrexate	Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
Control	methotrexate	Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
Acupuncture	leflunomide	Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)
Control	leflunomide	Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)

Primary Outcome Measures

Name	Time	Method
ACR20 Response Rate at 3 Weeks	From baseline to 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)
ACR20 Response Rate at 3 Months	From baseline to three 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)

Secondary Outcome Measures

Name	Time	Method
DAS28 at 3 Weeks	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\*√(TJC28) +0.28\*√(SJC28)+0.014\*GH+0.36\*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56\*√(TJC28)+0.28\*√(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
DAS28 at 3 Months	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\*√(TJC28) +0.28\*√(SJC28)+0.014\*GH+0.36\*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56\*√(TJC28)+0.28\*√(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
ACR50 Response Rate at 3 Weeks	From baseline to 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)
ACR50 Response Rate at 3 Months	From baseline to three 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)
ACR70 Response Rate at 3 Weeks	From baseline to 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)
DAS28 at Baseline	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\*√(TJC28) +0.28\*√(SJC28)+0.014\*GH+0.36\*ln(CRP+1)+0.96; DAS28 (ESR) = 0.56\*√(TJC28)+0.28\*√(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
ACR70 Response Rate at 3 Months	From baseline to three 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)

Trial Locations

Locations (1)

Shanghai GuangHua Hospital of integrated traditional and western medicine; 🇨🇳 Shanghai, Shanghai, China