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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
  1. Tx: Treatment group; Ctr: Control group; RCT: Randomized, placebo-controlled trial; NA: not applicable