Table 3 Clinical Trials in Chemoprevention with Chinese Herbs
From: Cancer chemoprevention and therapy using chinese herbal medicine
Reference | Chinese herbs | Tumor Types | Type of Study | Number.of Patients | Administration Methods | Result | Conclusion | Adverse Events |
|---|---|---|---|---|---|---|---|---|
Li N et a.l, (1999) [71] | Green tea | Oral leukoplakia | RCT double-blind | Tx = 29 Ctr = 30 | Tx: Tea 3 g/day/Tea capsule 760 mg q.i.d. | Response rate: 37.9% in treatment arm vs 10% in control arm | Results provide some direct evidence on the protective effects of tea on oral cancer. | NA |
Ahn WS et al. (2003) [138] | Green tea | High-risk (HPV infected) cervical lesions | Pilot study | Tx = 51 Ctr = 39 | Tx1: Poly E Ointment 200 mg twice weekly Tx2: Poly E capsules 200 mg orally daily Tx3: EGCG capsules 200 mg orally daily Tx4:Poly E Ointment +Poly E capsules Ctr: nontreated | Overall 69% (35/51) in treatment arm vs 10% (4/39) patients in nontreated control (P < 0.05) | Green tea extracts can be a potential therapy regimen for patients with HPV-infected cervical lesions. | Hematological and non-hematological toxicities as well as adverse side effects in patients treated locallyor systemically with poly E and EGCG were evaluated at 4-week intervals for 12 weeks. |
Tsao AS et al. (2009) [67] | Green tea | High-risk oral premalignant lesions (OPLs) | Phase II RCT | Tx1 = 11 Tx2 = 11 Tx3 = 9 Ctr = 10 | Tx1: GTE 500 mg/m2 Tx2: GTE 750 mg/m2 Tx3:1000 mg/m2 Ctr: placebo thrice daily for 12 weeks | Response rate: GTE arms (n = 28; 50%) vs placebo (n = 11; 18.2%; P = 0.09). Two higher-dose GTE arms 58.8% (750 and 1000 mg/m2), 36.4% (500 mg/m2), and 18.2% (placebo); P = 0.03 | The result suggested a dose-response effect; GTE may suppress OPLs, in part through reducing angiogenic stimulus (stromal VEGF). | Higher doses increased insomnia/nervousness but produced no grade IV toxicity |
Yun TK et al. (2010) [76] | Red Ginseng | Chronic atrophic gastritis | RCT double-blind | Tx = 325 Ctr = 318 | Tx: red ginseng (1 g) per week Ctr: placebo for 3 years | Male red Ginseng group showed a relative cancer risk of 0.35 (95% CI, 0.13–0.96; P = 0.03) compared to the male placebo | Administration of red ginseng extract powder for 3 years exerted significant preventive effects on the incidence of non–organ-specific human cancers in males. | Many subjects complained of gastroin- testinal symptoms: 55.0% in the placebo group and 57.3% in the red Ginseng group(P > 0.05) |
Rugo H et al. (2006) [130] | BZL101 | Advanced breast cancer | Phase I study | N = 21 | Tx: 350 ml per day | There were no grade III or IV adverse events (AEs). | BZL101 was safe and had a favorable toxicity profile. | Grade I and II AEs included: nausea (38%), diarrhea (24%), headache (19%) flatulence (14%), vomiting (10%), constipation (10%), and fatigue (10%). |
Robert E et al. (2011) | Curcumin | Aberrant crypt foci (ACF) in smoker | Phase IIa | N = 41 Tx1 = 22 Tx2 = 19 | Tx1:2 g Tx2: 4 g daily for 30 days | 40% reduction in the ACF number occurred with the 4 g dose (P < 0.005); while ACF was not reduced in the 2 g group in plasma curcumin/conjugate levels pre-and post-treatment (5-fold increase; P = 0.009) in the 4 g group. | Curcumin was well tolerated at both 2 g and 4 g, and it can decrease the ACF number. | 61% had grade- I /II toxicity, primarily gastrointestinal disturbances. The single grade-III toxicity was atypical chest pain. |
Lin PZ et al. (1990) [70] | ATB | Precancerous lesions of the esophagus | RCT Placebo | N = 2523 Tx1 = 841 Tx2 = 841 Ctr = 841 | Tx1: ATB 8 tablets q.d Tx2: retinamide 25 mg q.d (1–6 months) 50 mg q.d (7–12 months) 100 mg q.d (13 months) Ctr: placebo | 3 and 5 years after, the incidence of esophageal cancer in the ATB group was reduced by 52.2% and 47.3%, respectively. (P < 0.05) | This method needs further trial and study in high risk areas of esophageal cancer. The reliability of the experimental results is critically discussed. | 1.67% diarrhea 0.6% nausea, rash |
Wang J et al. (2000) [139] | ATB | Esophageal epithelial hyperplasia | Single-blind RCT placebo | Tx = 300 Ctr = 149 | Tx: ATB 8 tablets b.i.d Ctr: placebo 8 tablets b.i.d | 64.3% (193/300) response rate in treatment arm vs 22.8% (34/139) in control arm (P < 0.05) | ATB is an effective drug in treatment of esophageal epithelialhyperplasia. | Adverse effects are mild and well tolerated by patients. |
Sun Z et al. (2010) [33] | ATB | Esophageal SCC in human patients with dysplasia | RCT | N = 112 Tx = 59 Ctr = 53 | TX: ATB 4 tablets, 3 times per day for 8–12 months Ctr: placebo | Reduced the size of oral lesion in 67.8% (40/59) patients,whereas the placebo was effective in 17% (9/53) patients (P < 0.01). | ATB could prevent human patients with oral leukoplakia. | Drug toxicity was not monitored |