Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Chinese Academy of Sciences

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Procedure: Acupuncture; Drug: non-steroidal anti-inflammatory drug (NSAID); Drug: leflunomide; Drug: methotrexate

Study type: Interventional

Funder types: Other

Identifiers

NCT01619176

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Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Acupuncture

Experimental group

Description:

Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)

Treatment:

Drug: non-steroidal anti-inflammatory drug (NSAID)

Drug: leflunomide

Drug: non-steroidal anti-inflammatory drug (NSAID)

Drug: methotrexate

Drug: methotrexate

Drug: leflunomide

Procedure: Acupuncture

Control

Active Comparator group

Description:

Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs)

Treatment:

Drug: non-steroidal anti-inflammatory drug (NSAID)

Drug: leflunomide

Drug: non-steroidal anti-inflammatory drug (NSAID)

Drug: methotrexate

Drug: methotrexate

Drug: leflunomide