Curcumin maintenance therapy for ulcerative colitis: randomized, multicenter, double-blind, placebo-controlled trial.
OBJECTIVE
Curcumin is a biologically active phytochemical substance present in turmeric and has pharmacologic actions that might benefit patients with ulcerative colitis (UC). The aim in this trial was to assess the efficacy of curcumin as maintenance therapy in patients with quiescent ulcerative colitis (UC).


METHODS
Eighty-nine patients with quiescent UC were recruited for this randomized, double-blind, multicenter trial of curcumin in the prevention of relapse. Forty-five patients received curcumin, 1g after breakfast and 1g after the evening meal, plus sulfasalazine (SZ) or mesalamine, and 44 patients received placebo plus SZ or mesalamine for 6 months. Clinical activity index (CAI) and endoscopic index (EI) were determined at entry, every 2 months (CAI), at the conclusion of 6-month trial, and at the end of 6-month follow-up.


RESULTS
Seven patients were protocol violators. Of 43 patients who received curcumin, 2 relapsed during 6 months of therapy (4.65%), whereas 8 of 39 patients (20.51%) in the placebo group relapsed (P=.040). Recurrence rates evaluated on the basis of intention to treat showed significant difference between curcumin and placebo (P=.049). Furthermore, curcumin improved both CAI (P=.038) and EI (P=.0001), thus suppressing the morbidity associated with UC. A 6-month follow-up was done during which patients in both groups were on SZ or mesalamine. Eight additional patients in the curcumin group and 6 patients in the placebo group relapsed.


CONCLUSIONS
Curcumin seems to be a promising and safe medication for maintaining remission in patients with quiescent UC. Further studies on curcumin should strengthen our findings.
Hanai
Hiroyuki
H
Department of Endoscopic and Photodynamic Medicine, Hamamatsu University School of Medicine, and Center for Gastroenterology, Hamamatsu South Hospital, Hamamatsu, Japan.
Iida
Takayuki
T
Takeuchi
Ken
K
Watanabe
Fumitoshi
F
Maruyama
Yasuhiko
Y
Andoh
Akira
A
Tsujikawa
Tomoyuki
T
Fujiyama
Yosihihide
Y
Mitsuyama
Keiichi
K
Sata
Michio
M
Yamada
Masami
M
Iwaoka
Yasushi
Y
Kanke
Kazunari
K
Hiraishi
Hideyuki
H
Hirayama
Kazuhisa
K
Arai
Hajime
H
Yoshii
Shigehito
S
Uchijima
Masato
M
Nagata
Toshi
T
Koide
Yukio
Y
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000627:therapeutic use*; D003093:Colitis, Ulcerative / Q000188:drug therapy* / Q000473:pathology; D003113:Colonoscopy; D003474:Curcumin / Q000008:administration & dosage / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D019804:Mesalamine / Q000008:administration & dosage / Q000627:therapeutic use; D008875:Middle Aged; D012189:Retrospective Studies; D012460:Sulfasalazine / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; D012460:Sulfasalazine; D019804:Mesalamine; D003474:Curcumin