Objective evaluation of the alleviating effects of Goshajinkigan on peripheral neuropathy induced by paclitaxel/carboplatin therapy: A multicenter collaborative study

Abstract

Abstract. Paclitaxel/carboplatin chemotherapy for cancer (TC therapy) exhibits neurotoxicity and causes peripheral neuropathy at a high frequency, which is difficult to cope with. In this study, we investigated the efficacy of Goshajinkigan, a traditional Japanese herbal medicine, for TC therapy-induced peripheral neuropathy. The subjects included in our study were patients with ovarian or endometrial cancer who underwent TC therapy and developed peripheral neuropathy. The patients were randomly divided into Group A, comprising of 14 patients (vitamin B12 treatment), and Group B, comprising of 15 patients (vitamin B12 + Goshajinkigan treatment). The observation period was 6 weeks following treatment initiation, and the evaluation items were as follows: i) the current perception threshold (CPT value) of the peripheral nerve, ii) visual analogue scale for numbness, iii) National Cancer Institute Common Terminology Criteria for Adverse Events v3.0 grade of neurotoxicity, and iv) a questionnaire on the subjective symptoms of peripheral neuropathy (functional assessment of cancer therapy-taxane). These were compared between the groups and no significant differences were noted in any item. However, CTCAE grade 3 neurotoxicity developed in 2 patients (14.3%) after 6 weeks of administration in Group A, whereas no neurotoxicity was observed in Group B. When the change in the frequency of abnormal CPT ratio at 6 weeks of administration from that before treatment was compared between the groups, the frequency of abnormal value was significantly lower in Group B than in Group A (p<0.05). This suggests that Goshajinkigan inhibits the progression of peripheral neuropathy.

A case of unresectable pancreatic cancer successfully treated with Gosha-jinki-gan for muscle cramps related to administration of S-1

“…Recently, preventive effects of oral GJG on chronic oxaliplatin-induced hypoesthesia 10) and paclitaxel induced allodynia 11) in animal models were reported. Clinically, GJG could show the preventive effect of paclitaxel induced peripheral neuropathy for patients with ovarian or endometrial cancer who underwent chemotherapy by a multicenter study 12) . Additionally, retrospective study showed the preventive effect of GJG on oxaliplatin induced peripheral neuropathy 13) .…”

Prophylactic Administration of Aucubin Inhibits Paclitaxel-Induced Mechanical Allodynia <i>via</i> the Inhibition of Endoplasmic Reticulum Stress in Peripheral Schwann Cells

“…It has been shown to attenuate the progression of peripheral neuropathy induced by docetaxel and paclitaxel/carboplatin treatments in cancer patients. 7,8) Our previous study has been shown that repetitive administration of goshajinkigan extract as a prophylactic inhibits the exacerbation of paclitaxel-induced mechanical allodynia in mice. 9) We also showed that aucubin, which is an iridoid glycoside and the main component of Plantaginis Semen, plays an important role in the anti-allodynic action of goshajinkigan.…”

A pilot clinical trial assessing the efficacy and safety of supplementation with a B complex vitamin to reduce the incidence of chemotherapy induced peripheral neuropathy in patients diagnosed with a malignancy

“…These results found 6 single herbs [238,245,[287][288][289][290][291][292][293][294][295][296], one extract [297], one 2-107 receptor agonist [298,299] and 8 combinations of herbs [300][301][302][303][304][305][306][307][308][309][310][311][312][313][314][315][316][317][318]. All studies were analysed for common scientific characteristics however lower levels of evidence was used as rigorous randomised clinical trials were limited.…”

“…Grade 3 CIPN was observed in 2/14 patients receiving vitamin B12 compared to 0/15 receiving vitamin B12/GJG. It was concluded that GJG inhibits the progression of CIPN but further trials are warranted [307].…”

“…From these Asian herbal combinations, Goshajinkigan (GJG) is the herbal medicine 2-117 that has been trialled extensively through animal and human clinical trials [300, 303, 304, 307-310, 312, 316, 318]. Of the clinical trials, three were retrospective studies using controls for Folfox and paclitaxel administration [308,310,318], one RCT [307] comparing vitamin B12 administration with the herbal combination and a recent phase II multi-centre, randomised, double-blind, placebocontrolled trial conducted as an adjuvant treatment with FOLFOX [309]. All studies concluded that this herbal combination may provide neuroprotection however, as this is a Japanese combination and has been trialled in Japan, it may be difficult to transfer into other countries depending on their National regulatory body.…”