PMID- 23371457 OWN - NLM STAT- MEDLINE DCOM- 20130920 LR - 20211021 IS - 1993-0402 (Electronic) IS - 1672-0415 (Linking) VI - 19 IP - 2 DP - 2013 Feb TI - The efficacy and safety of Jitongning Capsule () in patients with ankylosing spondylitis. PG - 98-103 LID - 10.1007/s11655-012-1212-x [doi] AB - OBJECTIVE: To confirm the efficacy and safety of Jitongning Capsule in the treatment of ankylosing spondylitis (AS). METHODS: A total of 120 AS patients with early-intermediate were randomly and equally assigned to Jitongning Capsule group and sulfasalazine group. Jitongning Capsule was orally taken 4.5 g per day and sulfasalazine was orally taken 2 g daily for 12 months. The primary endpoint was the proportion of patients achieving the Assessment in Ankylosing Spondylitis 20 (ASAS 20), secondary end points included Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), Bath Ankylosing Spondylitis Metrology Index (BASMI), patient's global assessment by VAS rating, spinal pain, general pain and night pain, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP). Tumor necrosis factor-alpha (TNF-alpha), interferon-gamma (IFN-gamma) and interleukin-4 (IL-4) in the peripheral blood mononuclear cells (PBMC) of AS patients were measured. RESULTS: A total of 111 patients completed the study. There were 58 patients in Jitongning group and 53 patients in sulfasalazine group. Both drugs showed mild and occasional side effects. After treated by Jitongning Capsule and sulfasalazine, the proportion of ASAS20 responders at 12 month was 72.41% (42/58) and 67.92% (36/53) respectively. Both Jitongning Capsule and sulfasalazine treatment induced significant decrease in the proportion of CD4(+)T cell and CD8(+)T cell expressing TNF-alpha and IFN-gamma at 12-month of treatment compared with baseline values (P<0.05). CONCLUSION: Jitongning Capsule are effective in a setting close to real-life medical care with a sustained improvement in signs and symptoms of AS, and reduce cytokine levels in PBMC. It showed comparable effects to sulfasalazine. FAU - Wang, Yan-Yan AU - Wang YY AD - Department of Rheumatology, Chinese PLA General Hospital, Beijing, China. FAU - Lu, Hui AU - Lu H FAU - Zhao, Zheng AU - Zhao Z FAU - Huang, Feng AU - Huang F LA - eng PT - Journal Article PT - Randomized Controlled Trial DEP - 20130131 PL - China TA - Chin J Integr Med JT - Chinese journal of integrative medicine JID - 101181180 RN - 0 (Drugs, Chinese Herbal) RN - 0 (Tumor Necrosis Factor-alpha) RN - 0 (jitongning) RN - 207137-56-2 (Interleukin-4) RN - 82115-62-6 (Interferon-gamma) RN - 9007-41-4 (C-Reactive Protein) SB - IM MH - Adult MH - Blood Sedimentation MH - C-Reactive Protein/metabolism MH - CD4-Positive T-Lymphocytes/drug effects/metabolism MH - CD8-Positive T-Lymphocytes/drug effects/metabolism MH - Drugs, Chinese Herbal/*adverse effects/*therapeutic use MH - Endpoint Determination MH - Female MH - Flow Cytometry MH - Humans MH - Interferon-gamma/metabolism MH - Interleukin-4/metabolism MH - Male MH - Middle Aged MH - Spondylitis, Ankylosing/blood/*drug therapy/immunology MH - Treatment Outcome MH - Tumor Necrosis Factor-alpha/metabolism MH - Young Adult EDAT- 2013/02/02 06:00 MHDA- 2013/09/21 06:00 CRDT- 2013/02/02 06:00 PHST- 2011/04/03 00:00 [received] PHST- 2013/02/02 06:00 [entrez] PHST- 2013/02/02 06:00 [pubmed] PHST- 2013/09/21 06:00 [medline] AID - 10.1007/s11655-012-1212-x [doi] PST - ppublish SO - Chin J Integr Med. 2013 Feb;19(2):98-103. doi: 10.1007/s11655-012-1212-x. Epub 2013 Jan 31.