PubTransformer

A site to transform Pubmed publications into these bibliographic reference formats: ADS, BibTeX, EndNote, ISI used by the Web of Knowledge, RIS, MEDLINE, Microsoft's Word 2007 XML.

Will Chinese external therapy with compound Tripterygium wilfordii hook F gel safely control disease activity in patients with rheumatoid arthritis: design of a double-blinded randomized controlled trial.

Abstract Chinese external therapy (CET) is a topical application with mainly Chinese herb medicine therapy with thousands of years of historical implications and is a clinical routine that is commonly used for relieving joint-related symptoms in patients with arthritis in Chinese hospitals. However, there is a paucity of modern medical evidence to support its effectiveness and safety. Thus, we propose to implement a randomized, double-blinded, placebo-controlled clinical trial in patients with rheumatoid arthritis (RA) using, as the experimental intervention, topical application of a hospital-compounded gel preparation of Tripterygium wilfordii Hook F (TwHF).
PMID
Related Publications

Comparison of Tripterygium wilfordii Hook F versus sulfasalazine in the treatment of rheumatoid arthritis: a randomized trial.

A phase I study of ethyl acetate extract of the chinese antirheumatic herb Tripterygium wilfordii hook F in rheumatoid arthritis.

External application of compound Tripterygium wilfordii decreased the activity of rheumatoid arthritis.

Effect of External Applying Compound Tripterygium wilfordii Hook F. on Joint Pain of Rheumatoid Arthritis Patients.

Comparison of Tripterygium wilfordii Hook F with methotrexate in the treatment of active rheumatoid arthritis (TRIFRA): a randomised, controlled clinical trial.

Authors

Mayor MeshTerms
Keywords

Chinese external therapy

Rheumatoid arthritis

Topical application

Tripterygium

Journal Title bmc complementary and alternative medicine
Publication Year Start




PMID- 28870177
OWN - NLM
STAT- MEDLINE
DA  - 20170905
DCOM- 20170908
LR  - 20170908
IS  - 1472-6882 (Electronic)
IS  - 1472-6882 (Linking)
VI  - 17
IP  - 1
DP  - 2017 Sep 05
TI  - Will Chinese external therapy with compound Tripterygium wilfordii hook F gel
      safely control disease activity in patients with rheumatoid arthritis: design of 
      a double-blinded randomized controlled trial.
PG  - 444
LID - 10.1186/s12906-017-1957-z [doi]
AB  - BACKGROUND: Chinese external therapy (CET) is a topical application with mainly
      Chinese herb medicine therapy with thousands of years of historical implications 
      and is a clinical routine that is commonly used for relieving joint-related
      symptoms in patients with arthritis in Chinese hospitals. However, there is a
      paucity of modern medical evidence to support its effectiveness and safety. Thus,
      we propose to implement a randomized, double-blinded, placebo-controlled clinical
      trial in patients with rheumatoid arthritis (RA) using, as the experimental
      intervention, topical application of a hospital-compounded gel preparation of
      Tripterygium wilfordii Hook F (TwHF). METHODS: This study will be an 8-week
      double-blinded, randomized, placebo-controlled clinical trial conducted at
      Guang'anmen Hospital in Beijing, China, and 168 patients with moderately active
      RA will be randomly assigned with a 1:1 ratio to apply a topical gel preparation 
      containing TwHF or placebo. The primary outcome variable will be the proportion
      of subjects, by study group, to achieve a 20% improvement in the American College
      of Rheumatology criteria (ACR20) by week 8. Secondary outcome measures to be
      assessed at weeks 4 or 8 will include: measurement of ACR20 response rate at week
      4, ACR50 response rate, the changes in DAS28 score, and joint synovitis
      classification assessment monitored by musculoskeletal ultrasound. Safety
      evaluations conducted at weeks 4, 8 and 12 will be based on spontaneous
      complaints by the study subjects, but special emphasis will be focused on
      cutaneous allergy and alterations of menstruation in premenopausal female
      participants. Statistical analyses will be performed using the intention to treat
      analysis data set. DISCUSSION: This proposed clinical trail is designed to
      evaluate the efficacy and safety of CET based on a single topically-applied agent
      in a relatively large patient population with RA. This study protocol gives a
      detailed description of the usage and dosage of the topical compound TwHF gel and
      the methodology of this study. In addition, it is hoped that the outcomes of this
      study will be viewed as supporting the generalizability of CET in the setting of 
      inflammatory rheumatic diseases. The results of this study are expected to have
      important public health implications for Asian RA patients that currently utilize
      CET as a complimentary treatment. TRIAL REGISTRATION: Clinical trial gov
      Identifier: NCT02818361 . Registrated on Jun. 15, 2016.
FAU - Jiang, Quan
AU  - Jiang Q
AD  - Rheumatism Department, Guang'anmen Hospital, China Academy of Chinese Medical
      Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, 100053, China.
FAU - Tang, Xiao-Po
AU  - Tang XP
AD  - Rheumatism Department, Guang'anmen Hospital, China Academy of Chinese Medical
      Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, 100053, China.
FAU - Chen, Xian-Chun
AU  - Chen XC
AD  - Pharmaceutical Department, Guang'anmen Hospital, China Academy of Chinese Medical
      Sciences, No. 12 Fuhai Street, Daxing District, Beijing, 102628, China.
FAU - Xiao, Hong
AU  - Xiao H
AD  - Rheumatism Department, Guang'anmen Hospital, China Academy of Chinese Medical
      Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, 100053, China.
FAU - Liu, Ping
AU  - Liu P
AD  - Clinical evaluation center, Guang'anmen Hospital, China Academy of Chinese
      Medical Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, 100053,
      China.
FAU - Jiao, Juan
AU  - Jiao J
AUID- ORCID: http://orcid.org/0000-0002-4370-5137
AD  - Rheumatism Department, Guang'anmen Hospital, China Academy of Chinese Medical
      Sciences, No. 5 Beixiange Street, Xicheng District, Beijing, 100053, China.
      [email protected]
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20170905
PL  - England
TA  - BMC Complement Altern Med
JT  - BMC complementary and alternative medicine
JID - 101088661
RN  - 0 (Antirheumatic Agents)
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Gels)
SB  - IM
MH  - Adolescent
MH  - Adult
MH  - Aged
MH  - Antirheumatic Agents/*administration & dosage
MH  - Arthritis, Rheumatoid/*drug therapy
MH  - China
MH  - Drugs, Chinese Herbal/*administration & dosage
MH  - Female
MH  - Gels/administration & dosage
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Phytotherapy
MH  - Treatment Outcome
MH  - Tripterygium/*chemistry
MH  - Young Adult
PMC - PMC5584045
OTO - NOTNLM
OT  - Chinese external therapy
OT  - Rheumatoid arthritis
OT  - Topical application
OT  - Tripterygium
EDAT- 2017/09/06 06:00
MHDA- 2017/09/09 06:00
CRDT- 2017/09/06 06:00
PHST- 2017/08/08 [received]
PHST- 2017/08/30 [accepted]
AID - 10.1186/s12906-017-1957-z [doi]
AID - 10.1186/s12906-017-1957-z [pii]
PST - epublish
SO  - BMC Complement Altern Med. 2017 Sep 5;17(1):444. doi: 10.1186/s12906-017-1957-z.