title: Traditional herbal medicines (Kampo) for patients with rheumatoid arthritis receiving concomitant methotrexate: a preliminary study.
abstract: OBJECTIVE
  To assess the clinical effectiveness and safety of traditional herbal medicines (THM: Kampo) used in combination with oral methotrexate (MTX) in order to control the disease activity of rheumatoid arthritis (RA) in patients whose disease remains active despite treatment with MTX.
  
  
  METHODS
  Patients (n=13; male:female = l:12) with RA who achieved only a suboptimal response to MTX therapy (> or =6 mg/week and > or =6 months) were enrolled in this assessment. All patients were treated with Keishinieppiittokaryojutsubu (KER; decoction) according to the traditional diagnostic system. Every 3 months, joint symptoms were examined, and routine blood analysis and general serological tests including anticyclic citrullinated peptide antibody (aCCP) were performed, and then we calculated the disease activity score of 28 joints (DAS28).
  
  
  RESULTS
  One patient withdrew from the study after 4 weeks and discontinued consultations with our department for unknown reasons. Five (41.7%) of the twelve patients were defined as responders, and seven patients (58.3%) were classified as nonresponders based on DAS28-CRP findings. On comparison between responders and nonresponders, there was no significant difference with regard to age or disease duration and the dosages of concomitant prednisolone at baseline. KER responders had lower levels of aCCP at baseline than nonresponders (mean +/- standard deviation: 329.2 +/- 113.9 U/mL vs 623.8 +/- 242.8 U/mL, respectively) (P = .046, Mann-Whitney test). Furthermore, responders to KER showed a significant decrease in the serum levels of aCCP. The annual cost for KER treatment is much less than that for other new drugs.
  
  
  CONCLUSIONS
  In patients whose active RA persists despite treatment with MTX, KER in combination with MTX is safe and well tolerated and provides clinical and economic benefits. Furthermore, pretreatment serum levels of aCCP are a useful predictor of a good response to KER treatment, and a decrease in serum levels of aCCP may be an adjunctive indicator in predicting the efficacy of this kind oftreatment.
authors.affiliation: Department of Integrated Japanese Oriental Medicine, School of Medicine, Gunma University, Maebashi City, Japan. tkogure@showa.gunma-u.ac.jp
authors.forename: Toshiaki
authors.initials: T
authors.lastname: Kogure
authors.forename: Takeshi
authors.initials: T
authors.lastname: Tatsumi
authors.forename: Hiroko
authors.initials: H
authors.lastname: Sato
authors.forename: Yuko
authors.initials: Y
authors.lastname: Oku
authors.forename: Daijiro
authors.initials: D
authors.lastname: Kishi
authors.forename: Tomoyuki
authors.initials: T
authors.lastname: Ito
mesh_terms: D000328:Adult; D018501:Antirheumatic Agents / Q000008:administration & dosage*; D001172:Arthritis, Rheumatoid / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D004359:Drug Therapy, Combination; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D020835:Medicine, Kampo; D008727:Methotrexate / Q000008:administration & dosage*; D008875:Middle Aged; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D018501:Antirheumatic Agents; D004365:Drugs, Chinese Herbal; D008727:Methotrexate