Goshajinkigan

Goshajinkigan

PEP Topic 
Peripheral Neuropathy
Description 

Goshajinkigan is a Japanese herbal medicine composed of 10 ingredients that is reported to affect sensory nerves. This preparation was studied for its effectiveness in preventing and managing chemotherapy-induced peripheral neuropathy.

Effectiveness Not Established

Research Evidence Summaries

Kono, T., Hata, T., Morita, S., Munemoto, Y., Matsui, T., Kojima, H., . . . Mishima, H. (2013). Goshajinkigan oxaliplatin neurotoxicity evaluation (GONE): A phase 2, multicenter, randomized, double-blind, placebo-controlled trial of goshajinkigan to prevent oxaliplatin-induced neuropathy. Cancer Chemotherapy and Pharmacology, 72, 1283–1290.

doi: 10.1007/s00280-013-2306-7
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Study Purpose:

To evaluate the efficacy of a Japanese medicine called goshajinkigan (TJ-107) for preventing oxaliplatin-induced neuropathy, compared to placebo controls, and also to evaluate its safety

Intervention Characteristics/Basic Study Process:

Patients were randomized to receive goshajinkigan ( TJ-107) 7.5 mg per day day, a mix of extracts of 10 crude herbs, or placebo for 26 weeks starting on the first day of chemotherapy. Neuropathy was measured before each chemotherapy cycle every two weeks until the eighth chemotherapy cycle and every four weeks thereafter until 26 weeks. Patients randomly were assigned to the intervention or control group.

Sample Characteristics:

  • N = 89
  • MEDIAN AGE = 64 years
  • AGE RANGE = 36–88 years
  • MALES: 53.9%, FEMALES: 41.6%
  • KEY DISEASE CHARACTERISTICS: To be included in the study, patients had to be undergoing oxaliplatin-based chemotherapy for colorectal cancer.
  • OTHER KEY SAMPLE CHARACTERISTICS: Primarily Eastern Cooperative Oncology Group score of 0 upon enrollment

Setting:

  • SITE: Multi-site   
  • SETTING TYPE: Outpatient    
  • LOCATION: Japan

Phase of Care and Clinical Applications:

  • PHASE OF CARE: Active treatment
  • APPLICATIONS: Palliative and supportive care

Study Design:

  • Double-blinded, randomized, placebo-controlled trial

Measurement Instruments/Methods:

  • Neuropathy was measured by National Cancer Institute Common Terminology Criteria for Adverse Events (version 3) sensory items at baseline and every two weeks until the eighth cycle of chemotherapy and monthly until the 26th week.
  • The FACT/GOG-NTX-12 also was completed by patients at baseline and before every chemotherapy cycle.

Results:

Although there was a trend toward lower neuropathy scores as measured by the FACT/GOG-NTX in the intervention group at eight weeks (p = .421) and 26 weeks (p = .151), the differences were not statistically significant. The incidence of grade 2 peripheral neuropathy or greater until the eighth cycle was 39% in the experimental group and 51% in the control group (RR = 0.76, 95% CI 0.47–1.21), and the incidence of grade 3 or greater neurotoxicity was 7% in the treatment group and 13% in the placebo group (RR = 0.51, 95% CI 0.14–1.92). The time to development of grade 2 or greater toxicity was 5.5 months in the experimental group and 3.9 months in the placebo group (RR = 0.65, 95% CI 0.36–1.17). No differences were observed between those getting the different FOLFOX regimens. The goshajinkigan was tolerated well. Adverse effects were similar between study groups and most likely caused by the chemotherapy, but vomiting was significantly less prevalent in the treatment group (p = .029).

Conclusions:

Goshajinkigan may delay development of grade 2 or greater oxaliplatin-induced peripheral neuropathy, and there was a trend toward less severe chemotherapy-induced peripheral neuropathy in the intervention group at 8 and 26 weeks as compared to the control group.

Limitations:

  • Small sample (less than 100)
  • Findings not generalizable
  • Other limitations/explanation: Not generalizable to people with neuropathy caused by any other drug than oxaliplatin

Nursing Implications:

This study showed that administration of goshajinkigan, a traditional Japanese kampo medicine, was associated with reduced prevalence and severity of neurotoxicity among patients receiving oxaliplatin and was tolerated well by patients. Further study is needed to support the use of goshajinkigan for oxaliplatin-induced peripheral neuropathy. Goshajinkigan may not be widely available in the United States or outside of Japan.

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.

doi: 10.1007/s10147-010-0183-1
Print

Study Purpose:

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

Intervention Characteristics/Basic Study Process:

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.

Sample Characteristics:

  • 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.

Setting:

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

Phase of Care and Clinical Applications:

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

Study Design:

Prospective, randomized, controlled trial

Measurement Instruments/Methods:

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

Results:

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.

Conclusions:

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.

Limitations:

  • 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.

Nursing Implications:

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.


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