Mok, T.S., Yeo, W., Johnson, P.J., Hui, P., Ho, W.M., Lam, K.C., … Zee, B. (2007). A double-blind placebo-controlled randomized study of Chinese herbal medicine as complementary therapy for reduction of chemotherapy-induced toxicity. Annals of Oncology, 18, 768-774.

To evaluate the use of Chinese herbal medicine as a complementary therapy for the reducing chemotherapy-induced toxicity

Patients were randomly assigned to one of three Chinese herbalists who evaluated and prescribed combination, single-item, packaged, herbal extract granules. Herbalists completed university training and were licensed to practice Chinese herbal medicine (CHM) in Hong Kong and China. Patients were randomly assigned to each group and received either CHM or placebo packages with corresponding serial numbers in a 14-day supply at each clinic visit. The placebo package contained nontherapeutic herbs with an artificial smell and taste similar to typical herb tea. Each patient completed the log for each day’s consumption. On days 1 and 14, patients met with the herbalist in the clinic setting for evaluation and the herbalist documented the visit in case report form. A quality-of-life questionnaire was completed at baseline, day 1 of each cycle, and after four months.

The sample consisted of 120 patients with early-stage breast and colon cancer receiving adjuvant treatment in a university-based cancer center in Hong Kong.

Patients were included in the study if they

• Were 18 years or older
• Had an Eastern Cooperative Oncology Group (ECOG) performance status of less than 2
• Had no prior chemotherapy
• Had normal hematologic, liver, and renal function.

Patients were excluded from the study if they

• Required concurrent radiotherapy
• Were unable to take or follow directions for daily oral medications
• Had evidence of distant metastasis
• Had concurrent medical illness
• Had received prior chemotherapy
• Were pregnant or breast feeding.

The study was conducted at a university-based cancer center in Hong Kong.

This was a double-blind, placebo-controlled, randomized study.

The National Cancer Institute Common Toxicity Criteria (NCI-CTC) version 2.0 and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire 30 were used.

Patients recorded their daily intake of the herbal package contents on patient logs. Herbalists documented patient visits in case report form 

• CHM was not found to be efficacious for reducing hematologic toxicity associated with adjuvant chemotherapy for breast and colon cancer.
• CHM did reduce grade 2 nausea in the CHM group compared to the placebo group.
• Accrual to the study was slow because patients had a preference for receiving the true CHM rather than participating in a controlled, placebo trial. Therefore, a formal interim analysis was conducted with only half of the target accrual. The review committee eventually terminated the study. 

• Patient accrual was difficult because the population believed CHM to be effective.
• Cost and storage is a barrier with the herbal or natural product granules.
• More than 225 different types of preparations are available.
• CHM requires use of trained and certified herbalists.