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Acupuncture Study on Rheumatoid Arthritis, Monitoring Microbiome and Blood

Non Inferiority Trial for the Study of Acupuncture on Rheumatoid Arthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01619176
Enrollment
10
Registered
2012-06-14
Start date
2012-10-31
Completion date
2014-12-31
Last updated
2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, blood, gut intestinal microbiome

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.

Interventions

DRUGmethotrexate

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

DRUGnon-steroidal anti-inflammatory drug (NSAID)

NSAID: 100mg twice a day for 3 months

DRUGleflunomide

leflunomide: 20mg/day for 3 months

PROCEDUREAcupuncture

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.

Sponsors

Shanghai Guanghua Hospital of Integrated Traditional Chinese and Western Medicine
CollaboratorOTHER
Chinese Academy of Sciences
Lead SponsorOTHER_GOV

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
ACR20 Response Rate at 3 WeeksFrom baseline to 3 weeksACR 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 MonthsFrom baseline to three monthsACR 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

MeasureTime frameDescription
ACR70 Response Rate at 3 WeeksFrom baseline to 3 weeksACR 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 MonthsFrom baseline to three monthsACR 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 WeeksFrom baseline to 3 weeksACR 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 3 WeeksAt 3 weeksThe 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 MonthsAt 3 monthsThe 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 BaselineAt baselineThe 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
ACR50 Response Rate at 3 MonthsFrom baseline to three monthsACR 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)

Countries

China

Participant flow

Pre-assignment details

Quality of biological sampling was not good enough to grant production of quality omic data

Participants by arm

ArmCount
Acupuncture
Acupuncture plus conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) 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 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.
6
Control
Conventional treatment (methotrexate+leflunomide+non-steroid anti-inflammatory drugs) 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
4
Total10

Baseline characteristics

CharacteristicAcupunctureControlTotal
Age, Continuous48.7 years
STANDARD_DEVIATION 13.08
48.0 years
STANDARD_DEVIATION 10.3
48.4 years
STANDARD_DEVIATION 12.4
CRP(mg/L)9.8 mg/L
STANDARD_DEVIATION 5.3
24.6 mg/L
STANDARD_DEVIATION 22.3
18.27 mg/L
STANDARD_DEVIATION 17.9
ESR（mm/h)53.2 mm/h
STANDARD_DEVIATION 45.5
71.2 mm/h
STANDARD_DEVIATION 60.2
60.4 mm/h
STANDARD_DEVIATION 49.4
hemoglobin(g/L)119.5 g/L
STANDARD_DEVIATION 13.1
113.5 g/L
STANDARD_DEVIATION 24.1
117.1 g/L
STANDARD_DEVIATION 16.4
Lymphocyte(%)30.3 % of cells
STANDARD_DEVIATION 6.6
21.0 % of cells
STANDARD_DEVIATION 3.2
26.6 % of cells
STANDARD_DEVIATION 7.1
neutrophile granulocyte(%)61 % of cells
STANDARD_DEVIATION 6.5
69.0 % of cells
STANDARD_DEVIATION 6.1
64.2 % of cells
STANDARD_DEVIATION 6.9
Region of Enrollment
China
6 Participants4 Participants10 Participants
RF(IU/mL)246.25 IU/mL
STANDARD_DEVIATION 235.3
382.4 IU/mL
STANDARD_DEVIATION 409.1
314.3 IU/mL
STANDARD_DEVIATION 317.4
Sex: Female, Male
Female
6 Participants4 Participants10 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants
White cell number(10^9 cells/L)6.0 10^9 cells/L
STANDARD_DEVIATION 1.8
5.2 10^9 cells/L
STANDARD_DEVIATION 3.6
5.7 10^9 cells/L
STANDARD_DEVIATION 2.4

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 60 / 4
serious
Total, serious adverse events
0 / 60 / 4

Outcome results

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)

Time frame: From baseline to three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AcupunctureACR20 Response Rate at 3 Months5 Participants
ControlACR20 Response Rate at 3 Months3 Participants
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)

Time frame: From baseline to 3 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AcupunctureACR20 Response Rate at 3 Weeks0 Participants
ControlACR20 Response Rate at 3 Weeks1 Participants
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)

Time frame: From baseline to three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AcupunctureACR50 Response Rate at 3 Months2 Participants
ControlACR50 Response Rate at 3 Months1 Participants
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)

Time frame: From baseline to 3 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AcupunctureACR50 Response Rate at 3 Weeks0 Participants
ControlACR50 Response Rate at 3 Weeks1 Participants
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)

Time frame: From baseline to three months

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AcupunctureACR70 Response Rate at 3 Months0 Participants
ControlACR70 Response Rate at 3 Months1 Participants
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)

Time frame: From baseline to 3 weeks

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
AcupunctureACR70 Response Rate at 3 Weeks0 Participants
ControlACR70 Response Rate at 3 Weeks0 Participants
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\*√(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

Time frame: At 3 months

ArmMeasureValue (MEAN)Dispersion
AcupunctureDAS28 at 3 Months3.85 units on a scaleStandard Deviation 0.59
ControlDAS28 at 3 Months4.5 units on a scaleStandard Deviation 0.6
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\*√(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

Time frame: At 3 weeks

ArmMeasureValue (MEAN)Dispersion
AcupunctureDAS28 at 3 Weeks5 units on a scaleStandard Deviation 0.14
ControlDAS28 at 3 Weeks5.27 units on a scaleStandard Deviation 1.15
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\*√(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

Time frame: At baseline

ArmMeasureValue (MEAN)Dispersion
AcupunctureDAS28 at Baseline4.98 units on a scaleStandard Deviation 1.13
ControlDAS28 at Baseline6.8 units on a scaleStandard Deviation 1.97

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026