Table 1.
Summary of characteristics of the randomised controlled trials (RCTs) included in our analysis (n=119)
| RCT characteristic | No. of RCTs (%)* |
|---|---|
| Duration | |
| <6 months | 93 (78) |
| >6 months | 23 (19) |
| Not reported | 3 (3) |
| Year | |
| 2000–2007 (before CONSORT TCM)19 23 142 | 80 (67) |
| 2008–2014 | 39 (33) |
| Language | |
| English | 18 (15) |
| Chinese | 101 (85) |
| Country | |
| China | 117 (98) |
| Korea | 1 (1) |
| USA | 1 (1) |
| Scope | |
| Single centre | 108 (91) |
| Multicentre | 11 (9) |
| Impact factor 2013 | |
| Web of Science (score range from 0.59 to 2.711) | 13 (11) |
| Web of Science (score range from 7.871 to 16.104) | 4 (3) |
| Indexed in CNKI (score range from 0.031 to 1.068) | 101 (85) |
| Not indexed† | 1 (1) |
| Outcomes‡ | |
| Disease activity score | 15 (13) |
| ACR 20/30 | 28 (24) |
| Tender joint count | 72 (61) |
| Swollen joint count | 78 (66) |
| Health assessment questionnaire | 19 (16) |
| Pain | 53 (45) |
| Morning stiffness | 66 (55) |
| Laboratory outcomes (ESR, CRP, RF or anti-CCP) | 91 (76) |
| Radiographic outcomes | 3 (3) |
| Discontinuations | 51 (43) |
| Adverse events§ | 76 (64) |
| Funding | 27 (23) |
| CHM preparation (main intervention) | |
| Plant or extract (one herb) | 3 (3) |
| Decoction alone | 15 (13) |
| Decoction+patented | 2 (2) |
| Individualised (not following guidelines or with modifications) | 52 (44) |
| Patented | 43 (36) |
| Patented+individualised | 4 (3) |
| Most common CHM (>1 study) | |
| Tripterygium wilfordii/Tripterygium polyglycosides (alone or combined) | 15 (13) |
| Juanbi decoction/mixture or yishen juanbi capsule (including those with changes or combined) | 11 (9) |
| Feng shi decoction/granules/wine/injection (including those with changes or combined) | 10 (8) |
| Total glucosides of peony | 6 (5) |
| Xinfeng capsule | 4 (3) |
| Zhengqing fengtongning (alone or combined) | 4 (3) |
| Bi Qi capsule | 3 (3) |
| Lugua polypeptide injection | 3 (3) |
| Guizhi shaoyao zhimu decoction | 3 (3) |
| Tongbi (tablets or decoction) | 3 (3) |
| Xiatianwu | 3 (3) |
| Bizhongxiao | 2 (2) |
| Sanbi decoction | 2 (2) |
| Shi re bi granule/mixture | 2 (2) |
| Siwu wuteng decoction | 2 (2) |
| Unspecified (including decoctions without a name) | 11 (9) |
*Percentages have been rounded.
†Not indexed in Web of Science or CNKI.
‡RCTs can report on one or more outcomes.
§Including either clinical safety or laboratory parameters (alanine transaminase, aspartate transaminase, creatinine, white cell count, platelet count or haemoglobin).
ACR 20/30, American College of Rheumatology criteria for improvement at 20% or 30%; anti-CCP, anticyclic citrullinated peptide antibodies; CHM, Chinese herbal medicine; CNKI, China National Knowledge Infrastructure database; CONSORT TCM, Consolidated Standards of Reporting Trials statement for traditional Chinese medicine (including herbal interventions); CRP, C reactive protein; ESR, erythrocyte sedimentation rate; RCT, randomised controlled trial; RF, rheumatoid factor.