The Effectiveness and Safety of Wu Tou Decoction on Rheumatoid Arthritis—A Systematic Review and Meta-Analysis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Ethics
2.2. Study Registration
2.3. Search Strategy
2.4. Inclusion and Exclusion Criteria
2.4.1. Inclusion Criteria
2.4.2. Exclusion Criteria
2.5. Study Selection and Data Extraction
2.5.1. The Characteristics of Study
2.5.2. Outcome Measures
2.6. Statistical Analysis
2.7. Quality Assessment
2.8. Publication Bias
3. Results
3.1. Study Selection
3.2. Characteristics of the Included Studies
3.3. Efficacy Assessment of WTD Monotherapy
3.3.1. Effective Rate
3.3.2. Blood Test Results
3.3.3. Other Outcome Measures of RA
3.4. Efficacy Assessment of WTD Combination Therapy
3.4.1. Effective Rate
3.4.2. Disease Activity Outcomes
3.4.3. Blood Test Results
3.4.4. Other Outcome Measures of RA
3.5. Safety Assessment
3.6. Risk of Bias Assessment
3.7. Sensitivity Analysis
3.8. Publication Bias Assessment
3.9. Evidence Evaluation
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Study (y) | Number of RA Patients (Male/Female) | Duration of RA | Treatment Details of WTD Group | Treatment Details of CTR Group | Duration of Treatment | Outcome Measures (Primary/Secondary/ Other Measures Used in Meta-Analysis) | ||||
---|---|---|---|---|---|---|---|---|---|---|
WTD | CTR | WTD | CTR | Name of Treatment | Frequency Sessions of Treatment | Name of Treatment Type of Administration (Oral or Injection) | Frequency Sessions of Treatment | |||
Li 2015 [40] | 49 (26/23) | 49 (24/25) | 2.23 ±1.34 (m) | 2.34 ±1.26 (m) | Modified WTD | BID | LEF (50 mg for first 3 d + 10~20 mg) by oral | QD | 30 d | ER/ESR, CRP, RF, AEs |
Liu 2013 [41] | 60 (35/25) | 60 (40/20) | 1 ± 2.1 (y) | 1 ±2.2 (y) | Modified WTD | QD | LEF (50 mg for first 3 d + 10 mg) by oral | QD | 30 d | ER/AEs |
Wei 2010 [42] | 70 (30/40) | 50 (24/26) | 2–8 (y) | 1–7(y) | Modified WTD | BID | MTX (15 mg), Prednisone (10 mg), Nimesulide (0.1 g), Glucosides capsule (2 cap) by oral | BID, TID, BID, TID | 4 w | ER/AEs |
Wang 2016(1) [43] | 33 (16/17) | 25 (12/13) | 11.94 ±8.02 (y) | 8.04 ±6.98 (y) | WTD | BID | MTX (15 mg) by oral | QW | 8 w | CRP, RF/DAS28/ Cyclic citrullinated peptide antibody |
Wang 2016(2) [44] | 15 (8/7) | 15 (7/8) | 7.67 ±3.12 (y) | 7.27 ±3.69 (y) | WTD | BID | MTX (15 mg) by oral | QW | 8 w | DAS28/TNF-a, IL-6, Vascular endothelial growth factor, IL-17, HGB, PLT |
Peng 2019 [45] | 67 (20/47) | 67 (19/48) | 7.28 ±3.65 (m) | 7.33 ±3.54 (m) | Modified WTD +CTR | BID | LEF (20 mg), MTX (10 mg) by oral | QD, QW | 3 m | ER, TJC, MS/ESR, CRP, RF, AEs/ DAS28, SJP |
Wang 2017 [46] | 52 (26/26) | 52 (28/24) | 4.4 ±2.1 (NR) | 4.7 ±2.2 (NR) | Modified WTD +CTR | QD | LEF (20 mg), MTX (10 mg) by oral | QD, QW | 3 m | ER, TJC, MS/ESR, CRP, RF/ DAS28, ACR20, ACR50, ACR70, HAQ, SJP |
Li 2018 [47] | 60 (24/36) | 60 (26/34) | 4.49 ±3.75 (y) | 4.37 ±3.42 (y) | Modified WTD + CTR | TID | Meloxicam Tab (7.5 mg), DCF (NR), Baishao GLS Cap (2 Cap) by oral | QD, TID, TID | 4 w | TJC/ESR, CRP, RF, AEs/ DAS28, ACR20, ACR50, ACR70, HAQ, SJP |
Chen 2015(2) [48] | 26 (19/7) | 26 (21/5) | 6.87 ±2.33 (y) | 7.57 ±1.98 (y) | Modified WTD +CTR | QD | MTX (10 mg), Tripterygium GLS (20 mg) by oral | QW | 6 m | ER/AEs |
Li 2022 [49] | 78 (33/45) | 78 (32/46) | 2.23 ±1.34 (m) | 2.34 ±1.26 (m) | Modified WTD +CTR | BID | DCF (25 mg), LEF (10 mg) by oral | TID, QD | 30 d | ER/ESR, CRP, AEs |
Zheng 2016 [50] | 50 (23/27) | 50 (22/28) | 6.5 ±5.4 (y) | 5.8 ±6.3 (y) | WTD +CTR | BID | LEF (20 mg) by oral | BID | 6 m | ER, TJC, MS/ESR, CRP |
Li 2016 [51] | 50 (29/21) | 50 (NR/NR) | 6.88 ±2.34 (y) | 7.56 ±1.97 (y) | Modified WTD +CTR | BID | MTX (10 mg), Tripterygium GLS (20 mg) by oral | QW, TID | 3 m | ER |
Liu 2015 [52] | 26 (NR/NR) | 26 (NR/NR) | NR | NR | Modified WTD +CTR | TID | LEF (20 mg) by oral | QD | 3 m | ER |
Li 2013 [53] | 23 (NR/NR) | 23 (NR/NR) | NR | NR | Modified WTD +CTR | BID | DCF (0.1 g), SSZ (0.75 g), Tripteryzgium GLS (0.02 g) by oral | QD, TID, TID | 1 m | ER/AEs |
Huang 2012 [54] | 28 (NR/NR) | 28 (NR/NR) | NR | NR | Modified WTD +CTR | BID | 99mTc-Methyl diphosphonate (5 mg) by injection | NR | 2 m | ER/ESR, RF, AEs |
Hu 2016 [55] | 30 (NR/NR) | 25 (NR/NR) | NR | NR | WTD +CTR | NR | DCF (50 mg), MTX (10 mg), LEF (20 mg) by oral | BID, QW, QD | 15 d | ER, TJC/ESR, CRP, AEs |
Zhou 2018 [56] | 50 (32/18) | 50 (28/22) | 39.20 ±11.38 (m) | 39.12 ±11.04 (m) | Modified WTD +CTR | BID | Igurtimod (25 mg) by oral | BID | 3 m | ER, MS/ESR, CRP, RF, AEs/ ACR 20, ACR 50, ACR70/ADL, QOL, SJP, Joint pain, Joint swelling, Joint heatness, Joint hardness/Lansbury Score |
Huang 2008 [57] | 35 (NR/NR) | 34 (NR/NR) | NR | NR | Modified WTD +CTR | BID | Ibuprofen (0.3 mg), MTX (15 mg) by oral | BID, QW | 6 w | ER |
Bai 2020 [58] | 131 (29/102) | 93 (17/76) | 1.0 ±0.5 (y) | 0.9 ±0.4 (y) | Modified WTD +CTR | QD | MTX (7.5–15 mg) by oral | QW | 12 w | ER/ESR, CRP/DAS28, HAQ/LDA |
Luo 2008 [59] | 36 (NR/NR) | 34 (NR/NR) | NR | NR | Modified WTD +CTR | BID | Celecoxib (0.2 g), MTX (15 mg) | BID, QW | 6 w | TJC, MS/ESR, CRP, RF, AEs/ GS, WT20, BPC |
Luo 2009 [60] | 32 (NR/NR) | 30 (NR/NR) | NR | NR | Modified WTD +CTR | BID | Celecoxib (0.2 g), MTX (15 mg) | BID, QW | 6 w | TJC, MS/ESR, CRP, RF, AEs/ GS, WT20 |
Mao 2013 [61] | 32 (NR/NR) | 30 (NR/NR) | NR | NR | Modified WTD +CTR | BID | Ibuprofen (0.3 g), MTX (15 mg) | BID, QW | 6 w | TJC, MS/ESR, CRP, RF, AEs/ SJP, GS, WT20, RBC, HGB |
Zheng 2008 [62] | 32 (NR/NR) | 30 (NR/NR) | NR | NR | Modified WTD +CTR | BID | Celecoxib (0.2 g), MTX (15 mg) | BID, QW | 6 w | TJC, MS/ESR, CRP, RF, AEs/ GS, WT20, PLT |
Zheng 2012 [63] | 32 (NR/NR) | 30 (NR/NR) | NR | NR | Modified WTD +CTR | BID | Ibuprofen (0.3 g), MTX (15 mg) | BID, QW | 6 w | TJC, MS/ESR, CRP, RF, AEs/Grip strength, 20-min walking time, TNF-a, IL-6, PAF |
Yue 2019 [34] | 40 (NR/NR) | 37 (NR/NR) | NR | NR | WTD +CTR | NR | MTX (10–15 mg) | QW | 12 w | CRP, ESR, AEs/DAS28, HAQ/LDA, Remission rate, Overall response rate |
Adverse Events | Total Number of Adverse Events | |
---|---|---|
Treatment Group | Control Group | |
Skin irritation | 6 [42,45,47,49,56] | 13 [42,45,47,49,56] |
Gastrointestinal problem (with nausea and vomiting) | 9 [42,48,49,53,55,56] | 18 [42,48,49,53,55,56] |
Diarrhea with vomiting | 8 [40,45] | 11 [40,45] |
Liver failure | 2 [45] | 3 [45] |
Decreased WBC | 0 [42] | 1 [42] |
Upper abdominal pain and reflux | 0 [54] | 2 [54] |
Outcome | Included RCTs (Participants) | Effect Estimate (95% CI) | I2 | Quality of Evidence | Reasons |
---|---|---|---|---|---|
ER (monotherapy) | 3 (338) | RR 1.25 (1.14, 1.37) | 48% | ⨁⨁◯◯ Low | Risk of bias, inconsistency |
ESR (monotherapy) | 1 (98) | MD 24.46 (20.72, 28.20) | Not applicable | ⨁⨁◯◯ Low | Serious imprecision |
CRP (monotherapy) | 2 (156) | MD 3.11 (0.66, 5.57) | 29% | ⨁⨁◯◯ Low | Serious imprecision |
RF (monotherapy) | 2 (156) | MD 75.35 (57.02, 93.67) | 88% | ⨁◯◯◯ Very Low | Serious imprecision, inconsistency |
ER (combination therapy | 13 (1248) | RR 1.25 (1.18, 1.33) | 0% | ⨁⨁⨁◯ Moderate | Risk of bias |
TJC (combination therapy) | 5 (513) | MD 2.29 (2.14, 2.45) | 96% | ⨁⨁◯◯ Low | Risk of bias, inconsistency |
MS (combination therapy) | 4 (438) | MD 17.98 (14.49, 21.47) | 77% | ⨁⨁◯◯ Low | Risk of bias, inconsistency |
ESR (combination therapy) | 9 (1049) | MD 9.66 (8.88, 10.43) | 88% | ⨁⨁⨁◯ Moderate | inconsistency |
CRP (combination therapy) | 8 (993) | MD 6.25 (5.75, 6.74) | 92% | ⨁⨁⨁◯ Moderate | inconsistency |
RF (combination therapy) | 5 (514) | MD 4.90 (3.67, 6.14) | 94% | ⨁⨁⨁◯ Moderate | inconsistency |
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Moon, J.-H.; Park, G.; Kwon, C.-Y.; Kim, J.-H.; Kim, E.-J.; Seo, B.-K.; Lee, S.-D.; Hong, S.-U.; Sung, W.-S. The Effectiveness and Safety of Wu Tou Decoction on Rheumatoid Arthritis—A Systematic Review and Meta-Analysis. Healthcare 2024, 12, 1739. https://doi.org/10.3390/healthcare12171739
Moon J-H, Park G, Kwon C-Y, Kim J-H, Kim E-J, Seo B-K, Lee S-D, Hong S-U, Sung W-S. The Effectiveness and Safety of Wu Tou Decoction on Rheumatoid Arthritis—A Systematic Review and Meta-Analysis. Healthcare. 2024; 12(17):1739. https://doi.org/10.3390/healthcare12171739
Chicago/Turabian StyleMoon, Jeong-Hyun, Gyoungeun Park, Chan-Young Kwon, Joo-Hee Kim, Eun-Jung Kim, Byung-Kwan Seo, Seung-Deok Lee, Seung-Ug Hong, and Won-Suk Sung. 2024. "The Effectiveness and Safety of Wu Tou Decoction on Rheumatoid Arthritis—A Systematic Review and Meta-Analysis" Healthcare 12, no. 17: 1739. https://doi.org/10.3390/healthcare12171739