Nishioka, M., Shimada, M., Kurita, N., Iwata, T., Morimoto, S., Yoshikawa, K., . . . Kono, T. (2011). The Kampo medicine, Goshajinkigan, prevents neuropathy in patients treated by FOLFOX regimen. International Journal of Clinical Oncology, 16, 322-327.

To clarify the efficacy of Goshajinkigan (GJG) for peripheral neuropathy associated with oxaliplatin

Intervention Studies: From January 2007 through December 2009, 45 patients with advanced or recurrent colorectal cancer who were being treated with 5-fluorouracil, oxaliplatin, and leucovorin (FOLFOX) every two weeks participated in the study. Patients were randomized to receive either oral GJG (7.5 g/daily) or no drug. The median number of cycles was 13 for the patients in the GJG group and 12 for the control group. Neuropathy was evaluated during every course according to the Neurotoxicity Criteria of Debiopharm. Other neuromodulatory agents such as calcium and magnesium infusions were not allowed during the study. Oxaliplatin dose was reduced in the event of grade 3 neuropathy.

• N = 21      
• MEDIAN AGE = 67 years
• MALES = 51%,  FEMALES = 49%
• KEY DISEASE CHARACTERISTICS: The GJG group included 15 patients with colon cancer and 7 patients with rectal cancer. The control group included 16 patients with colon cancer and 7 patients with rectal cancer.
• OTHER KEY SAMPLE CHARACTERISTICS: 82% had received no previous treatment. The median cumulative dose of oxaliplatin was 1112.5 mg/m², with a range of 340–2720.

• SITE: Single site
• SETTING TYPE: Outpatient
• LOCATION: Tokushima University Hospital in Tokushima, Japan

• PHASE OF CARE: Active treatment
• APPLICATIONS: Late effects and survivorship

Prospective, randomized, controlled trial

Patients were evaluated at baseline and during their every-two-weeks treatment course according to the Neurotoxicity Criteria of Debiopharm.

The incidence of grade 3 peripheral neuropathy in the GJG group was significantly lower than in the control group (p < 0.01, log-rank test). The incidence of grade 3 peripheral neuropathy after 10 courses was 0% in the GJG group and 12% in the control group. After 20 courses, it was 33% in the GJG group and 75% in the control group. The only differences in adverse effects between the two groups were peripheral neuropathy and influence on tumor response.

A randomized, double-blind, placebo-controlled trial would be needed to determine efficacy of this oriental herbal medication. No trials with GJG have been conducted in the United States, so no history exists of it being used as an intervention for chemotherapy-induced peripheral neuropathy. These preliminary findings suggest that further research in use of GJG may be warranted.

• Small sample < 30
• Not placebo-controlled
• Not double-blind
• The Neurotoxicity Criteria of Debiopharm was not described. Several other neurotoxicity scales, even a specific oxaliplatin scale, exist. No explanation was provided for why this scale was chosen.
• Sample characteristics of those randomized are provided; however, characteristics of only those who actually completed the study are not described.
• GJG is an oriental herb and would need further testing to be used in the United States in a clinical trial.

Although it has shown some positive results in reducing neuropathy in a clinical trial in Japan, GJG can not be recommended for treating chemotherapy-induced peripheral neuropathy in the United States until further testing occurs in a large, randomized, double-blind study.