Table 1.

Completed clinical trials using curcumin

TypeMaterials and methodsResults and conclusionsReferences
Phase IPatients: 10; 2,000 mg/d + piperine 20 mg/kgPiperine, a known inhibitor of hepatic and intestinal glucuronidation enhanced serum concentration, extent of absorption, and bioavailability.Shoba et al. 1998 (59)
Safety trialMuch higher concentration with piperine at 0.25 to 1 hour post drug (P < 0.01 at 0.25 and 0.5 hour; P < 0.001 at 1 hour).
Phase IPatients: 25; Oral 500–12,000 mg/d for 90 daysOral curcumin is not toxic to humans up to 8,000 mg/d for 3 months.Cheng et al. 2001 (60)
Safety trialBx done after treatmentHistologic improvement of precancerous lesions were observed in bladder cancer, oral leukoplakia, intestinal metaplasia of the stomach, CIN, and Bowen disease
Phase IPatients: 15, Oral curcumin extract of 440–2200 mg/d for 120 days.Safe administration of curcumin extract at doses up to 2.2 g daily, equivalent to 180 mg of curcumin.Sharma et al. 2001 (61)
Colon cancerActivity of GST and levels of M1G were measured.Curcumin has low oral bioavailability in humans and may undergo intestinal metabolism.
Lowered GST (Glutathione-S-transferase) with constant M1G.
Phase IPatients: 15, Oral 450–3,600 mg/d for 120 days.Lowered inducible serum PGE2 levels (P < 0.05).Sharma et al. 2004 (62)
Colorectal cancerDose-escalation study.No dose-limiting toxicity.
A daily oral dose of 3.6 g of curcumin is advocated for phase II evaluation in cancer prevention outside the gastrointestinal tract.
Levels of curcumin and its metabolites in plasma, urine, and feces were measured.Levels of curcumin and its metabolites in urine can be used to assess general compliance.
Phase IPatients: 12, Oral 450–3,600 mg/d for 7 days.M1G levels were 2.5-fold higher in malignant tissue as compared with normal tissue (P < 0.05 by ANOVA).Garcea et al. 2005 (63)
Colorectal cancerBx samples of normal and malignant colorectal tissue, at diagnosis and at 6–7 hours after the last dose of curcumin.The concentrations in normal and malignant colorectal tissue of patients receiving 3,600 mg of curcumin were 12.7±5.7 and 7.7±1.8 nmol/g, respectively.
The daily dose of 3.6 g curcumin achieves pharmacologic efficacy in the colorectum with negligible distribution of curcumin outside the gut.
Phase IPatients: 24, Oral 500–12,000 mg/day. Dose-escalation study for MTD and safetySeven of 24 subjects (30%) experienced only minimal toxicity.Lao et al. 2006 (64)
Safety trialSystemic bioavailability of curcumin or its metabolites may not be essential for CRC chemoprevention because CRC can still benefit from curcumin.
Phase IPatients: 14, Docetaxel (100 mg/m2) 1 hour i.v. every 3 weeks on day 1 × 6 cycles + Oral 500 mg/d for 7 consecutive days and escalated the dose until toxicity.MTD at 8,000 mg/dBayet-Robert et al. 2010 (65)
Open-labelVEGF, and tumor markers measured8/14 patients had measurable lesions, with 5 PR and 3 SD.
Advanced metastatic breast cancerSome biological and clinical responses were observed in most patients.
The recommended dose of curcumin was 6,000 mg/d for 7 consecutive days every 3 weeks in combination with a standard dose of docetaxel.
Phase IIPatients: 62, 1% ointment, several months for “External cancerous lesion”The first clinical study.Kuttan et al. 1987 (18)
Efficacy trialReduction in smell in 90% patients, reduction of itching in all cases, dry lesions in 70% patients, and reduction in lesion size and pain in 10% patients.
Skin lesion
Phase IIPatients: 5, Oral curcumin 480g + quercetin 20 mg t.i.d. for 180 days.Decrease in the number of polyps was seen in 60.4%.Cruz-Correa et al. 2006 (66)
FAPPolyps size and number assessedDecrease in the size of polyps was 50.9% in FAP patients
RCT in the future are necessary
Cohort studyPatients: 24Zyflamend, a novel herbal anti-inflammatory mixture, as a potential chemopreventive agent in a phase I trial for patients diagnosed with PIN.Rafailov et al. 2007 (67)
PIN
Phase IIaPatients: 4440% reduction in ACF numbers with 4-g doseCarroll et al. (68)