Review Article

A Neutraceutical by Design: The Clinical Application of Curcumin in Colonic Inflammation and Cancer

Table 2

Curcumin: a list of clinical studies in humans.

Author/yearPhaseNumber of patientsDosage regimenFindings

Trials to assess safety and pharmacokinetics

Shoba et al., 1998 [25]110Humans: 2 g/day
Mice: 2 g/kg
Piperine enhances the serum concentration, absorption, and bioavailability of curcumin in both rats and humans with no adverse effects

Chen et al., 2001 [26]125500–12,000 mg/day × 90 daysHistologic improvement of precancerous lesions; seen in 1 out of 2 patients with recently resected bladder cancer, 2 out of 7 patients with oral leukoplakia, 1 out of 6 patients with intestinal metaplasia of the stomach, 1 out of 4 patients with CIN, and 2 out of 6 patients with Bowen’s disease

Lao et al., 2006 [27]124500–12,000 mg/dayCurcumin is safe and well tolerated up to 12 g/day

Author/yearDisease Number of patientsDosage regimenFindings

Trials to assess efficacy in gastrointestinal disease (CRC and IBD)*

Sharma et al., 2001 [28]Colorectal cancer1536–180 mg/day × 120 daysDecrease in lymphocytic glutathione S-transferase activity
Radiologically stable disease in five patients for 2–4 months of treatment
Well tolerated, and dose-limiting toxicity was not observed

Sharma et al., 2004 [29]Colorectal cancer15450–3600 mg/day × 120 daysDecrease in inducible PGE(2) production
Daily oral dose of 3.6 g of curcumin is advocated for phase II evaluation in the prevention or treatment of cancers outside the gastrointestinal tract

Garcea et al., 2004 [30]Liver metastasis in CRC43450–3600 mg/day × 7 dayPoor bioavailability following oral administration

Garcea et al., 2005 [31]CRC12450–3600 mg/day × 7 daysDecreased M1G DNA adducts
COX-2 levels in malignant colorectal tissue not affected by curcumin

Holt et al.,
2005 [32]
IBD10550 mg; × 2-3/day
× 60 days
All proctitis patients improved
Reduced concomitant medications in four of five Crohn's disease patients
Lowered CDAI scores and sedimentation rates

Hanai et al., 2006 [33]Ulcerative colitis892000 mg/day × 180 daysMaintains remission
Improved both CAI (clinical activity index) and EI (endoscopic index) that is
Reduced morbidity associated with UC

Ongoing trials (http://www.clinicaltrials.gov/)

Medical University of Vienna, Department of Clinical Pharmacology [Est. date of completion N/A]Safety and PKN/ALiposomal curcumin;
single dose i.v infusion at 10, 20, 40, 80, 120, and 180 mg/m² over 120 minutes
Safety, tolerability, and pharmacokinetics of liposomal curcumin in phase I dose escalation study
(i) to evaluate the safety and tolerability of  increasing doses of intravenous liposomal  curcumin in healthy subjects by means of  adverse events, vital signs, and safety  laboratory assessments
(ii) to investigate the pharmacokinetics of  increasing doses of intravenous liposomal  curcumin in healthy subjects

James Graham Brown Cancer Center, US [Est. Date of completion: Jan, 2013]Colon cancerRecruitingCurcumin: 3.6 g/day × 7 days
Curcumin conjugated with plant exosomes tablets × 7 days
Phase I clinical trial investigating the ability of plant exosomes to deliver curcumin to normal and malignant colon tissue
(i) to estimate the effect of a fixed concentration of  curcumin when delivered by plant exosomes  compared to oral tablets of curcumin alone

University of Leicester/University Hospitals Leicester, United Kingdom [Est. date of completion date: Jan, 2019]Colon cancerRecruitingPhase I/II a study combining curcumin (curcumin C3-complex, sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer
(i) Will focus on safety and tolerability
(ii) Secondary measurements include efficacy  supported by biomarker analysis

University of California, Irvine, US [Est date of completion: Dec, 2012]Colon cancerEstimated: 48Phase II a trial of curcumin among patients with prevalent subclinical neoplastic lesions (aberrant crypt Foci):
(i) Will determine mean percentage change in  PGE2 within aberrant crypt foci (ACF) from  baseline to 30 days after treatment with  curcumin in current smokers.

University of North Carolina, Chapel Hill, US [Est. date of completion: March, 2012]4 grams curcumin C3 tablet daily × 30 daysChemoprevention of colorectal neoplasia:
(i) Use of microarray analysis to identify genes  that are modified by curcumin that could be  used as biomarkers in future chemoprevention  studies
(ii) Will also evaluate tolerability and toxicity

Patient trials have also demonstrated clinical benefit in: rheumatoid arthritis, psoriasis, postoperative inflammation, chronic anterior uveitis and orbital inflammatory pseudo-tumours, irritable bowel syndrome, tropical pancreatitis, gall bladder and biliary motility, gastric ulceration, and familial adenomatous polyposis coli.