Therapeutic efficacy of traditional Chinese medicine, Shen-Mai San, in cancer patients undergoing chemotherapy or radiotherapy: study protocol for a randomized, double-blind, placebo-controlled trial

Abstract

BackgroundCancer is one of the major health issues worldwide. An increasing number of cancer patients are offered treatment with surgery, chemotherapy and radiotherapy. Traditional Chinese medicine (TCM) is one of the most common complementary therapies offered to cancer patients in Taiwan. We designed a randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy of TCM in patients with cancer.Methods/designIn this study, inclusion criteria are postoperative patients with histologically confirmed cancer within 3 years who are undergoing chemotherapy or radiotherapy, more than 18 years old, have given signed informed consent, have the ability to read Chinese, and the ability for oral intake.Exclusion criteria include being pregnant, breast feeding, having completed chemotherapy or radiotherapy, brain metastasis with Eastern Cooperative Oncology Group (ECOG) performance status of two to four, delusion or hallucinations, acute infection, and have received medications under other clinical trials.The patients were separated into an intervention group (Shen-Mai-San, SMS) and a placebo group for four weeks using a randomized, double-blind procedure. The European Organization for Research and Treatment of Cancer (EORTC) Quality of Life questionnaire (QOL-C30) was used to evaluate the quality of life. General data, hemoglobin (Hb), hematocrit (Hct), glutamic-oxalacetic transaminase (GOT), glutamic-pyruvic transaminase (GPT), blood urea nitrogen (BUN), creatinine, carcinoembryonic antigen (CEA), TCM diagnosis data and heart rate variability (HRV) were also recorded. These data were collected at baseline, two weeks and four weeks after receiving medication. The patients were prescribed granules which contained therapeutic medicines or placebo. Paired-T test was used for statistical analysis.DiscussionShen-Mai-San is composed of processed Ginseng radis, Liriope spicata, and Schizandrae fructus. It was found to be effective for treating cancer-related fatigue and had anti-fatigue activity. In TCM theory, SMS has a synergistic effect for qi and yin deficiency and has the ability to prevent fatigue. The symptoms of qi and yin deficiency are similar to chemotherapy- or radiotherapy-induced side effects. In order to evaluate the efficacy of SMS on cancer treatment, we designed a randomized, double-blind, placebo-controlled trial.Trial registrationThis study is registered to Clinical Trails.gov NCT01580358

The advantages of using traditional Chinese medicine as an adjunctive therapy in the whole course of cancer treatment instead of only terminal stage of cancer

“…The results showed that some TCMs such as TJ-41 used alone or in combination with chemotherapy or supportive care showed significant relief in cancer-related fatigue and improved quality of life compared to chemotherapy or supportive care based on single trials. In addition, a randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy of Shen-maisan (a famous Traditional Chinese herbal formulation composed of processed Ginseng, Liriope spicata, and Schizandrae fructus) in patients with cancer who were undergoing chemotherapy or radiotherapy (95). Shenmai-san was found to be effective for treating cancerrelated fatigue and had anti-fatigue activity.…”

Shenmai injection enhances the cytotoxicity of chemotherapeutic drugs against colorectal cancers via improving their subcellular distribution

“…Currently, SMI is a famous Chinese patent-protected injection that has been widely applied in clinical practice for treating shock with qi and yin deficiency, coronary heart disease, viral myocarditis and tumors [4] . Various pharmacodynamic studies have demonstrated that SMI is effective in cancer interventions as an adjunct agent to chemotherapy [4,8,16] . Shenmai was found to be effective in treating cancer-related fatigue and the side effects induced by chemotherapy or radiotherapy [16] , which can be explained by the synergistic effect of Shenmai for qi and yin.…”

“…Various pharmacodynamic studies have demonstrated that SMI is effective in cancer interventions as an adjunct agent to chemotherapy [4,8,16] . Shenmai was found to be effective in treating cancer-related fatigue and the side effects induced by chemotherapy or radiotherapy [16] , which can be explained by the synergistic effect of Shenmai for qi and yin. However, there is a lack of direct evidence to confirm the chemosensitization function of SMI or its underlying mechanisms.…”

Ren Shen Yangrong Tang for Fatigue in Cancer Survivors: A Phase I/II Open-Label Study

“…17 More significant synergistic effects on symptom control have been observed with all the ingredients combined. 18 TCM methods for managing chronic fatigue have been widely adopted for the treatment of cancer and other conditions in China and elsewhere. [19][20][21][22][23][24] In oncology care, the TCM method most often used in China is a mixture of herbal compounds and decoction.…”