Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

NCT01619176 | Completed Results

• 1 other identifier: acumicro
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis; blood; gut intestinal microbiome

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (7)

• ACR50 Response Rate at 3 Weeks

  From baseline to 3 weeks

• ACR50 Response Rate at 3 Months

  From baseline to three months

• ACR70 Response Rate at 3 Weeks

  From baseline to 3 weeks

• ACR70 Response Rate at 3 Months

  From baseline to three months

• DAS28 at Baseline

  At baseline

Study Arms (2)

Acupuncture

EXPERIMENTAL

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

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

Control

ACTIVE COMPARATOR

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

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

Interventions

methotrexate DRUG

methotrexate: 7.5mg/week to 15mg/week for 3 months

Control

non-steroidal anti-inflammatory drug (NSAID) DRUG

NSAID: 100mg twice a day for 3 months

Control

leflunomide DRUG

leflunomide: 20mg/day for 3 months

Control

Acupuncture PROCEDURE

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.

Acupuncture

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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：
• swollen joints \>3
• tender joints \> 5
• 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:
• Hemoglobin (Hb)\>=85g/L
• White cell \>=3.5 10+9/L
• Platelets \>= 100 10+9/L
• 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)
• Kidney function: Serum creatinine (Cr) level should be less than ULN.
• Pregnancy test should be negative
• should be positive for anti-cyclic citrullinated protein antibodies (anti-CCP).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chinese Academy of Sciences: lead
• Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine: collaborator

Study Sites (1)

Shanghai GuangHua Hospital of integrated traditional and western medicine

Shanghai, Shanghai Municipality, 200052, China

Location

Related 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 Predictive, Preventive and Personalised Medicine, vol 17. Springer, Cham. https://doi.org/10.1007/978-3-031-34884-6_12

  RESULT

Related Links

• Book chapter

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Methotrexate; Anti-Inflammatory Agents, Non-Steroidal; Leflunomide; Acupuncture Therapy

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Analgesics, Non-Narcotic; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Anti-Inflammatory Agents; Therapeutic Uses; Antirheumatic Agents; Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Complementary Therapies; Therapeutics

Results Point of Contact

• Title: DR. Christine Nardini
• Organization: CNR IAC

christine.nardini.rsrc@gmail.com

+393386947833

Study Officials

• Christine Nardini, PhD

  Key laboratory of Computational Biology,Chines Academy of Sciences-Max Planck Institute-CAS MPG PICB

  STUDY CHAIR

• Christine Nardini, PhD

  Consiglio Nazionale delle Ricerche Istituto per le Applicazioni del Calcolo "Mauro Picone"

  STUDY CHAIR

• Yuanhua Liu

  Shanghai Institute of Biochemistry and Cell Biology, CAS, Shanghai, PRC

  PRINCIPAL INVESTIGATOR

• Yongying Liang

  Guanghua Hospital, Shanghai, PRC

  PRINCIPAL INVESTIGATOR

• Xiaoyuan Zhou

  Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China

  PRINCIPAL INVESTIGATOR

• Jennifer E. Dent

  Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China

  PRINCIPAL INVESTIGATOR

• Ting Jiang

  Department of Neurology, University of California, San Francisco, USA

  PRINCIPAL INVESTIGATOR

• Ding Qin

  Guanghua Hospital, Shanghai, PRC

  PRINCIPAL INVESTIGATOR

• Youtao Lu

  Group of Clinical Genomic Networks, Shanghai Institutes for Biological Sciences, CAS-MPG, China

  PRINCIPAL INVESTIGATOR

• Dongyi He

  Guanghua Hospital, Shanghai, PRC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: June 14, 2012
• Study Start: October 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 13, 2023
• Results First Posted: September 8, 2023

Record last verified: 2023-11

Locations

CN (1)