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Effectiveness and safety of Glycyrrhizae Decoction for Purging Stomach-Fire in Behcet disease patients: Study protocol for a randomized controlled and double-blinding trail.

Abstract Behcet disease (BD) is a worldwide-occurred autoimmune disorder and currently lack of optional successful treatment. An ancient traditional Chinese medical formula called Glycyrrhizae Decoction for Purging Stomach-Fire (GDPSF) was recorded and nowadays has been observed to be effective for BD patients. However, the strict randomized controlled and double-blinding trail is needed to further assess this alternative medicine.
PMID
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Authors

Mayor MeshTerms

Glycyrrhiza

Keywords
Journal Title medicine
Publication Year Start




PMID- 29595687
OWN - NLM
STAT- MEDLINE
DCOM- 20180411
LR  - 20180411
IS  - 1536-5964 (Electronic)
IS  - 0025-7974 (Linking)
VI  - 97
IP  - 13
DP  - 2018 Mar
TI  - Effectiveness and safety of Glycyrrhizae Decoction for Purging Stomach-Fire in
      Behcet disease patients: Study protocol for a randomized controlled and
      double-blinding trail.
PG  - e0265
LID - 10.1097/MD.0000000000010265 [doi]
AB  - BACKGROUND: Behcet disease (BD) is a worldwide-occurred autoimmune disorder and
      currently lack of optional successful treatment. An ancient traditional Chinese
      medical formula called Glycyrrhizae Decoction for Purging Stomach-Fire (GDPSF)
      was recorded and nowadays has been observed to be effective for BD patients.
      However, the strict randomized controlled and double-blinding trail is needed to 
      further assess this alternative medicine. METHODS: To ascertain the potential
      effects and safety of GDPSF for BD patients and to determine whether combination 
      application of GDPSF and thalidomide could possibly reduce the side effects and
      increase effectiveness for BD management, we will conduct a randomized, double
      blind, controlled clinical trial. Patients enrolled will be randomly assigned
      into 3 groups: GDPSF group, thalidomide group, and integrative group (treated by 
      both GDPSF and thalidomide). Participants will receive treatment for 6 months and
      accept a 12 months follow-up. Before and after treatment, clinical
      manifestations, blood tests, thalidomide dosage, remission levels, quality of
      life, and satisfactory levels will be assessed. The data of assessments on each
      group before and after treatments will be collected and analyzed through
      historical control, while between groups through intergroup control. Then
      statistical analysis will be applied to assess the effects and safety.
      DISCUSSION: This study protocol will assess the effects and safety of GDPSF for
      BD patients GDPSF. Combination application of GDPSF and thalidomide might be a
      new integrative medical method for BD patients. TRIAL REGISTRATION: Chinese
      Clinical Registry (ChiCTR-ONC-16009621) on Oct. 2016
      http://www.chictr.org.cn/showproj.aspx?proj=16395.
FAU - Chen, Yong
AU  - Chen Y
AD  - Department of Rheumatology and Immunology, Huadong Hospital affiliated with Fudan
      University, Shanghai, P.R. China.
FAU - Luo, Dan
AU  - Luo D
FAU - Cai, Jian-Fei
AU  - Cai JF
FAU - Lin, Chen-Hong
AU  - Lin CH
FAU - Shen, Yan
AU  - Shen Y
FAU - Zou, Jun
AU  - Zou J
FAU - Guan, Jian-Long
AU  - Guan JL
LA  - eng
PT  - Journal Article
PT  - Randomized Controlled Trial
PL  - United States
TA  - Medicine (Baltimore)
JT  - Medicine
JID - 2985248R
RN  - 0 (Drugs, Chinese Herbal)
RN  - 0 (Inflammation Mediators)
RN  - 4Z8R6ORS6L (Thalidomide)
SB  - AIM
SB  - IM
MH  - Behcet Syndrome/*drug therapy
MH  - Dose-Response Relationship, Drug
MH  - Double-Blind Method
MH  - Drug Therapy, Combination
MH  - Drugs, Chinese Herbal/administration & dosage/adverse effects/*therapeutic use
MH  - Female
MH  - *Glycyrrhiza
MH  - Humans
MH  - Inflammation Mediators/blood
MH  - Male
MH  - Pain/drug therapy
MH  - Patient Satisfaction
MH  - Pilot Projects
MH  - Quality of Life
MH  - Research Design
MH  - Thalidomide/administration & dosage/adverse effects/*therapeutic use
EDAT- 2018/03/30 06:00
MHDA- 2018/04/12 06:00
CRDT- 2018/03/30 06:00
PHST- 2018/03/30 06:00 [entrez]
PHST- 2018/03/30 06:00 [pubmed]
PHST- 2018/04/12 06:00 [medline]
AID - 10.1097/MD.0000000000010265 [doi]
AID - 00005792-201803300-00060 [pii]
PST - ppublish
SO  - Medicine (Baltimore). 2018 Mar;97(13):e0265. doi: 10.1097/MD.0000000000010265.