Asian ginseng (Panax ginseng, Araliaceae) root has been traditionally used for a variety of applications, including as a tonic to support and increase energy in debilitating conditions. The researchers in this trial have applied a particular type of ginseng called “Sun Ginseng” (SG)* (Ginseng Science, Inc., Seoul, Korea) to cancer patients to test its ability to improve various quality of life parameters.

This randomized, double-blind, placebo-controlled pilot study enrolled 53 cancer patients (15 male, 38 female) recruited from the Gynecologic Oncology Clinic and the Integrative Medicine Clinic of Gil Medical Center (Namdong-Gu, Incheon, South Korea) during May 2005 to January 2006. All of the patients were diagnosed with cancer, including 10 patients with stage I, 14 patients with stage II, and 29 patients with stage III cancer. The cancer diagnoses included hepatocellular carcinoma (n=11), cholangiocarcinoma (n=1), common bile duct cancer (n=1), uterine cervix cancer (n=16), ovarian cancer (n=8), uterine sarcoma (n=2), endometrial cancer (n=2), rectal cancer (n=3), stomach cancer (n=2), lung cancer (n=2), prostate cancer (n=1), pancreatic cancer (n=1), mesothelioma (n=1), breast cancer (n=1), and pseudomyxoma (n=1).

The authors note that the predominant cancers among the patients were gynecological and heaptobiliary cancers, which may have affected the results. (An HerbalGram peer reviewer notes that this is a fairly broad spectrum of tumors and that this trial would have had more statistical power if the cancers had been all of one type and if equal numbers of subjects with liver, uterine, and ovarian tumors had been distributed between both arms of the trial.)

The patients were randomly assigned to receive either SG (3,000 mg/day in 3 doses) (n=32) or a placebo (n=21). The treatment period was 12 weeks. The patients’ subjective quality of life was rated using 2 questionnaires: the World Health Organization Quality of Life Assessment-Bref (WHOQOL-BREF) and the General Health Questionnaire-12 (GHQ-12). The WHOQOLBREF consists of 26 questions in 4 areas: “physical health, psychological health, social relationships, and environment.” A higher score on the WHOQOL-BREF indicates a better quality of life. The GHQ-12 is a psychological self-rating tool that covers psychological symptoms, including anxiety, depression, somatic symptoms, and social dysfunction. A higher score indicates better mental health status and functioning.

The 2 groups were statistically similar in terms of cancer stage, age, and gender. At baseline, the “physical health” score on the WHOQOL-BREF was lower in the SG group than in the placebo group (P<0.05). In addition, the total GHQ-12 and the “psychological health” score of the WHOQOL-BREF trended towards lower scores in the SG group, but the differences were not statistically significant. The authors suggest that these score differences between the 2 groups may have affected the results of the study. After 12 weeks of treatment there were no patient drop-outs and no observed adverse effects in either group.

The “psychological health” score of the WHOQOL-BREF improved to a greater extent for the patients in the SG group, compared with the placebo group (P<0.02). There was also a statistically non-significant trend towards a greater improvement in the WHOQOL-BREF “environment” and “physical health” scores in the SG group, when compared with the placebo group. The GHQ-12 total score was more improved for the SG group, when compared with the placebo group (P<0.01). The average change in the “social relationships” section of the WHOQOL-BREF was not significantly different between the 2 groups. The authors speculate that effects seen in this study may be mediated by the biological effects of ginsenosides found in SG on neuroactive steroids and GABAA receptors and ligand binding.

The authors conclude that SG shows “some beneficial effect for improving subjective quality of life” in patients with cancer. Therefore, SG may help to improve aspects of the “mental and physical functioning in these cancer patients.” Future research is needed to confirm these results in a larger study population and in a trial with more well-reported details. The authors recommend that future studies be conducted to evaluate the effects of SG on the subjective quality of life in patients with different types of cancer. Future studies should also include phytochemical profiling of the SG product used. This trial, testing the biological activity of ginseng steam processed at 100, 110 and 120° C (autoclaved), noted that levels of ginsenosides F4, Rg3, and Rg5—which are absent from non-steam-processed ginseng—are progressively elevated with increasing temperature. Such treated ginseng was most potent of the 3 steamed products in the ability to induce endothelium-dependent relaxation. Also, Shibata¹ (as well as others) has demonstrated that partially deglycosylated saponins, produced by steaming as well as metabolic transformation by intestinal bacteria, have enhanced anti-carcinogenic activity, prominent among them, ginsenosides Rh1, Rh2, and Rg3. Other degraded ginsenosides in raw ginseng, produced by hydrolysis, isomerization at C-20, and dehydration, are present in only minute quantities.

The SG preparation is apparently manufactured by steaming raw Korean ginseng at 120° C (there does not appear to be any published confirmation of this statement available in the English scientific literature).² There is ample evidence that red ginseng is more biologically active than raw, unprocessed ginseng in some areas, including free radical scavenging,² antioxidant,^2,3 “anxiolytic-like,”⁴ and anti-tumor-promoting³ activities. In the present study, the authors have examined the effect of SG on the subjective quality of life in patients suffering mainly from gynecologic or hepatobiliary cancer.

This trial suffers from the following deficiencies in the reporting of the trial data, as noted by an HerbalGram peer reviewer. There is no mention of the method of randomization, no description of placebo product, and no indication if it was made to appear identical to the SG product. There is no discussion of what conventional medications the patients were taking, e.g., whether they were receiving cancer chemotherapy, radiation, surgery etc. Further, there is no assessment for compliance in taking pills or whether patients in either group may have been taking other ginseng products (or even if they were asked not to take other herbal products). Also, there was no apparent assessment for specific adverse events, if any were noted.

— Marissa Oppel, MS, Dennis V.C. Awang, PhD, FCIC

* Sun Ginseng and its manufacturer were not detailed in the “Materials and Methods” section of the trial publication, as is usually customary; however, it is apparent that Sun Ginseng is a trademarked brand name for this special, patented preparation and Ginseng Science Inc., its manufacturer, is mentioned in the acknowledgements as having funded this trial. More information is available at http://www.ginsengscience.com/english/product/sunsam.htm.