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JKM > Volume 40(1); 2019 > Article
Han, Cho, Park, Seong, Kim, Kim, Jung, Lee, and Leem: Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial with Herbal Medicinal Product for Lung Cancer]

Abstract

Objectives

This study aimed to ascertain what should be considered in the “Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer” by analyzing the existing guidelines and clinical trials.

Methods

The committee searched guidelines and clinical trials about herbal medicine for lung cancer. The searched trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparator, outcomes and trial design. Then, we compared the results of our analysis with the guidelines to identify the issues we will have to consider when making the “Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer”. Several guidelines for anti-tumor agents and clinical trials with herbal medicine were searched on the national institution homepage. The search terms were as follows: ‘lung neoplasm’, ‘herbal medicine’, ‘Medicine, Korean traditional’, ‘Medicine, Chinese Traditional’ etc.

Results

There was no guideline for clinical trial with herbal medicine for lung cancer. In addition, 7 articles were searched through database searching. All the participants had non-small cell lung cancer. The type of intervention was decoction. Comparators included conventional treatments such as chemotherapy. The outcome measurements used in the studies were quality of life, tumor response, and survival duration, etc. Safety was evaluated by recording adverse events and blood test.

Conclusions

Findings were made by reviewing existing guidelines and comparing them with clinical trials for lung cancer and herbal medicinal products. These results will be utilized in the development of “Guideline for Clinical Trials with Herbal Medicinal Products for Lung Cancer”.

Fig. 1
The flowchart of study selection
jkm-40-1-153f1.gif
Table 1
Search Strategy Used in PubMed
No. Search items
1 Lung Neoplasms”[MH]
2 Medicine, Korean Traditional[MH]
3 Medicine, Chinese Traditional[MH]
4 Medicine, East Asian Medicine[MH]
5 medicine, Kampo[MH]
6 integrative medicine[MH]
7 herbal medicine[MeSH Terms]
8 herb*[Text Words]
9 tang[Text Words]
10 san[Text Words]
11 dection[ALL]
12 tang[Text Words]
13 san[Text Words]
14 dection[ALL]
15 #2 OR #3 OR #4 OR #5 OR #6 OR #7 OR #8 OR #9 OR #10 OR #11 OR #12
16 #1 AND #15
Filter Text availability: full text, Publication dates: 10 years, Languages: English
Table 2
The List of Searched Guidelines Related to Lung Cancer and Clinical Trial for Herbal Medicinal Product
Publisher, Year Title Characteristics
Korean Association for the Study of Lung Cancer, 2010 Korean clinical practice guidelines for lung cancer13 1. clinical practice guideline of conventional medicine
2. related to lung cancer
3. multidisciplinary clinical guideline in Korea
SH Kim, 2006 Study on development of assessment guideline and endpoints for clinical trial with antitumor natural product14 1. specific to assessment tool for clinical trial
2. related to antitumor natural product
3. a research report
Korea Food & Drug Administration, 2006 Guideline for evaluation of clinical trial of anticancer drug15 1. related to anticancer agents which have toxicity against cancer cell or function of inhibition of cancer cell growth
Korea Food & Drug Administration, 2010 Guidelines for the review of nonclinical test data for approval of anti-cancer drug’s clinical trial plan and item authorization16 1. description of the minimum considerations for clinical testing of anticancer drugs aimed at treating progressive cancer patients based on the type and timing of nonclinical studies
National Institute of food and drug safety evaluation, 2015 Guidelines for clinical trial of anti-cancer drugs 17 1. related to anticancer agents which have toxicity against cancer cell or function of inhibition of cancer cell growth
National Institute of food and drug safety evaluation, 2015 Guidelines for non-clinical trial of anti-cancer drugs18 1. recommendations for nonclinical evaluation to support clinical trials in the development of anticancer drugs
National Institute of food and drug safety evaluation, 2015 Guidelines for exemption of anti-cancer drug data in Korean population19 1. guidelines for exemption from submission of clinical trial data about Koreans
Ministry of Food and Drug Safety, 2018 Guideline for the use of clinical trial medicines for therapeutic purposes20 1. guideline for the use of clinical trial medicines to patients with life-threatening conditions without other treatment
Lee HJ, 2012 Korean Society of Thoracic Radiology Guideline for Lung Cancer Screening with Low-Dose CT21 1. guideline for the use of screening with low-dose CT for lung cancer
Korea Institute of Oriental Medicine, 2005 A study on the clinical trial guidelines of herbal medicinal drug22 1. related to general herbal medicinal drug
2. a research report
Korea Institute of Oriental Medicine, 2005 A study on the clinical trial guideline of herbal medical drug(II)23 1. analysis of guidelines for clinical research of new medication in Chinese medicine
2. related to general herbal medicinal drug
Industry-Academia Collaboration Foundation, Kyung Hee University, 2006 Research on outcome indicators for clinical trials of herbal medicinal products 24 1. related to assessment tool
2. related to cough, phlegm, asthma
3. a research report
Korea Food & Drug Administration, 2007 General considerations for clinical trials in herbal medicine25 1. related to general herbal medicine
2. general principles and methods of clinical trials
3. a research report
National Institute of food and drug safety evaluation, 2017 Quality guidelines of herbal medicine for clinical trial26 1. recommendations for chemistry, manufacturing and control information on herbal medicines used in clinical trials
Table 3
The Characteristics of Included Study
Title Author Journal, Year Nation Design Group
Efficacy of auxiliary therapy with Danggui Buxue Decoction No.1 in treating patients of non-small cell lung cancer at peri-operational stage. Du QC Chin J Integr Med, 2009 China randomized controlled trial A: Conventional treatment +Danggui Buxue Decoction No.1(DB1)
B: Conventiona ltreatment
The study of early application with Dixiong Decoction (地芎汤) for non-small cell lung cancer to decrease the incidence and severity of radiation pneumonitis: A prospective, randomized clinical trial. Dou YQ Chin J Integr Med, 2010 China prospective, randomized clinical trial A: radiotherapy+ Dixiong Decoction
B: radiotherapy+ a decoction with the effects of supplementing qi and nourishing yin, clearing heat and detoxifying
Astragalus polysaccharide injection integrated with vinorelbine and cisplatin for patients with advanced non-small cell lung cancer: effects on quality of life and survival. Guo L Med Oncol, 2012 China open-label, prospective, randomizedcontrolled study A: vinorelbine and cisplatin + Astragalus polysaccharideinjection
B: vinorelbine and cisplatin
Traditional Chinese Medicine treatment as maintenance therapy in advanced non-small-cell lung cancer: A randomized controlled trial. Jiang Y Complement Ther Med, 2016 China randomized, controlled, open-label trial A: traditional Chinese medicine
B: chemotherapy (treated with pemetrexed (non-squamous NSCLC,500mg/m2, d1), docetaxel(75mg/m2, d1) orgemcitabine(1250mg/m2, d1 and d8)
Comprehensive geriatric assessment and traditional Chinese medicine intervention benefit symptom control in elderly patients with advanced non-small cell lung cancer. Xue D Med Oncol, 2015 China randomized controlled trial A: ST
B: ST+TCM
C: IT
D: IT+TCM
E: BSC+TCM
Treatment of advanced non-small-cell lung cancer with Chinese herbal medicine by stages combined with chemotherapy. Xu ZY J Cancer Res Clin Oncol, 2011 China prospective, randomized, controlled, multi-centered trial A: chemotherapy + CHM (Kangliuzengxiao decoction during chemotherapy and Feiyanning decoction after chemotherapy)
B: chemotherapy
Treatment of advanced non-small cell lung cancer with extracorporeal high frequency thermotherapy combined with Chinese medicine. Wu WY Chin J Integr Med, 2010 China a prospective, small sample and randomized controlled method A: the treatment of EHFT combined with Chinese medicine
B: only Chinese medicine

ST: standardized therapy, IT: individualized therapy, TCM: traditional Chinese medicine, BSC: best supportive care, CHM: Chinese herbal medicine, EHFT: extracorporeal high frequency thermotherapy

Table 4
The Characteristics of Participants and Inclusion/Exclusion Criteria of Included Studies
Study Age Sample size Patients Inclusion Criteria Exclusion Criteria
Du QC, 2009 A:54.02 B:52.56 82 The diagnosis of non-small-cell lung cancer (NSCLC) was confirmed After operation by pathological examination (1) patients of the thoracic department of the Wujing Shandong Zongdui Hospital
(2) who were hospitalized from2003to2007
(3) The diagnosis of NSCLC was confirmed after operation by pathological examination.
nonspecific
Dou YQ, 2010 A: 65.2±8.4
B: 61.8±13.5
46 NSCLC patients who were planning to receive radiotherapy (1) who were clearly diagnosed with non-small cell lung cancer and made the decision to receive radiotherapy
(2) Karnofsky Performance Status score>60 (KPS score, which measures the performance status of cancer patients with respect to activities of daily living and is used to measure quality of life),
(3) patients whose expected survival time was more than six months
(1) patients who were simultaneously Receiving chemotherapy, fasting, or opposed to taking Chinese herbal medicine
(2) subjects participating in other clinical trials
Guo L, 2012 A: 47–78
B: 47–77
136 NSCLC; measurable or assessable Stage IIIB or IV disease (1) histologically or cytologically confirmed NSCLC; measurable or assessable stage IIIB or IV disease
(2) Eastern Cooperative Oncology Group performance status score (ECOGPS) of 0–2
(3) No previous history of malignant disease
Patients were required to read without aid.
(1) Patients with active infections
(2) who had received previous chemotherapy
Jiang Y, 2016 A: 60.38±9.55
B: 58.41±10.36
64 advanced (stage IIIB/IV) NSCLC (1) diagnosis with primary bronchogenic carcinoma confirmed NSCLC via cytological or pathological examination who were at TNM stage IIIB/IV
(2) patients with postoperative recurrence and metastasis; patients who were atanage equal or older than 18 years old but equal or less than 80 years old
(3) TCM syndromes were Yin defiiency, Qi deficiency or Qi and Yin deficiency Who had completed four cycles of first-line chemotherapy
(4) achieving a maximum tumor response, including complete response (CR)/partial response (PR)/stable disease(SD)
(5) Eastern Cooperative Oncology Group(ECOG)PS of two or less; life expectancy of at least 6 months
(6) normal hematological function with total neutrophil count>1.5×109/Land platelets>80×109/L
(7) normal liver function and kidney function.
(1) disease progression after first-line chemotherapy
(2) received radiotherapy or targeted therapy
(3) allergy to the drug in the study
(4) participating other drug trials
(5) suffering from other primary malignant tumors
(6) serious problem of heart, liver or kidney with severe dysfunction pregnancy or breastfeeding
(7) existence of any severe unstable concurrent medical illness likely to interfere with the study protocol
Xue D, 2015 73.0 ± 5.3 (65–83) 33 elderly patients with advanced NSCLC (1) histopathologically confirmed advanced NSCLC
(2) American Joint Committee on Cancer (AJCC) stage IIIB, IV
(3) ≥65yearsold
(4) capable of reading
(5) understanding the questionnaires and ~informed consent”
(1) unable to understand the questionnaires
(2) unwilling to participate in this study
(3) unable to complete the research
Xu ZY, 2011 A: 60.0±8.24 (41–75)
B: 62.15±8.70 (45–76)
121 Patients with NSCLC of stage III or IV (1) aged from 18 to 78 years
(2) inoperable patients with stage IIIA, IIIB, or IV, histologically confirmed NSCLC, measurable disease either by computed tomography (CT) or magnetic resonance imaging (MRI)
(3) could complete 4 courses of chemotherapy
(4) predicted life expectancy>4months,
(5) Karnofsky performance status(PS)≥60
(6) provided signed informed consent
(1) Patients with serious heart, liver or kidney disease,
(2) hematopathy, unrespectable liver or brain metastases, serious infection
(3) rejecting to chemotherapy or whole chemotherapy courses uncompleted
Wu WY, 2010 44 – 84 66 advanced NSCLC (1) aged 30–85 years old
(2) pathological diagnosis of NSCLC at stages IIIB
(3) ECOG performance status (PS) of 0 to 3
(4) life expectancy of at least three months
(5) no prior radiotherapy or chemotherapy within two months
(6) normal liver, kidney and heart function
(7) signed informed consent forms prior to participating in this clinical trial
(1) patients had comorbid diseases such as active tuberculosis or severe infectious diseases, other active refractory tumors and severe cardiovascular disease or psychological disease.
(2) patients should not have had an artificial cardiac pace maker, metallic stent, metallic prosthesis implant, neurogenic bladder dysfunction, thermos regulation dysfunction or perceptions dysfunction.
(3) patients with severe chestwall skin damage
Table 5
The Interventions of Included Studies
Study Intervention Content & Dose Period
Du QC, 2009 Conventional treatment + Danggui Buxue Decoction No.1 (DB1) DB1: milkvetch root 30 g, Chinese angelica root 6 g, spatholobus stem 30 g, forsythia fruit 15 g, globe thistle root 10 g, chuanxiong 10 g and white-stiff silkworm 10 g, which was administered in a single dose every day, excepting the day of operation, from three days before operation to the end of the 4th week after operation, with the decoction taken orally in two parts in the morning and evening. 4 weeks
Dou YQ, 2010 1. radiotherapy+ Dixiong Decoction
2. radiotherapy+ decoction with the effects of supplementing qi and nourishing yin, clearing heat and detoxifying
A: Radix Rehmanniae 10g, Rhizoma Ligustici wallichii 15g, Cortex Moutan15g, Semen Juglandis12g, Flos Carthami 10g, Rhizoma Curcumae 10g, Fructus Forsythiae15g, and Radix Astragali 15g 8 weeks
Guo L, 2012 Astragalus polysaccharide(APS) injection A: received 250mg/days APS intravenously on day1 through day7 concurrently with a chemotherapy regimen identical to the vinorelbine and cisplatin arm. 28 days
Jiang Y, 2016 Maintenance therapy began from 21 days to 42 days since the last dose of first-line chemotherapy. Each therapy cycle was 21days. Maintenance therapy continued until disease progression, unacceptable toxicity, or until the patients requested therapy discontinuation. Each patient underwent a treatment and follow-up period. All patients were followed until death or study closure. TCM maintenance treatment included herbal injection (Cinobufacini, 20ml/d, d1–d10), herbal decoction (d1–d21) and Chinese acupoint application (d1–d21).
1) Herbal injection
Patients received Cinobufacini injection (20ml/d) for 10days in each 21-day cycle. 2) Herbal decoction
Patients with Qi deficiency syndrome were administered benefiting Qi and detoxication recipe; patients with Yin deficiency syndrome were administered benefiting Yin and detoxication recipe; patients with Qi and Yin deficiency syndrome were administered benefiting Qi and Yin and detoxication recipe. One decoction contained160ml of herbal preparation and each patient received two decoctions every day for 21 days in each 21-day cycle.
- Benefiting Qi and detoxication recipe consisted of: 15 g of Radix Astragali (sheng huangqi); 12g of Radix Codonopsis (dangshen); 9 g of Rhizoma Atractylodis Macrocephalae (baizhu); 15 g of Poria (fuling); 9 g of Pericarpium Citri Reticulatae(chenpi); 9 g of Rhizoma Pinelliae (banxia); 30 g of Semen Coicis (shengmiren); 15 g of Herba Epimedii (xianlingpi); 12 g of Fructus Psoraleae (buguzhi); 30 g of Selaginella doederleinii (shishangbai); 30 g of Salviachinensia Benth (shijianchuan); 30 g of Paris Polyphylla (qiyeyizhihua); 15 g of Spicaprunellae (xiakucao); 30 g of Concha Ostreae (shengmuli).
- Benefiting Yin and detoxication recipe consisted of: 30 g of Radix Adenophorae (nanshashen); 30 g of Radix Glehniae (beishashen); 15 g of Radix Ophiopogonis (maidong); 15g of Radix Asparagi (tiandong); 9 g of BulbusLilii (baihe); 9 g of Semen Armeniacae Amarum (kuxingren); 30 g of Herba Houttuyniae (yuxingcao); 30 g of Selaginella doederleinii (shishangbai); 30 g of Salviachinensia Benth shijianchuan); 30 g of Paris Polyphylla (qiyeyizhihua); 15 g of Spicaprunellae (xiakucao); 30 g of Concha Ostreae (shengmuli).
- Benefiting Qi and Yin and detoxication recipe consisted of: 15 g of Radix Astragali (shenghuangqi); 9 g of Rhizoma Atractylodis Macrocephalae (baizhu); 15 g of Radix Glehniae (beishashen); 12 g of Radix Asparagi (tiandong); 12 g of Fructus Ligustrilucidi (nvzhenzi); 30 g of Selaginelladoederleinii (shishangbai); 30 g of Salviachinensia Benth (shijianchuan); 30 g of Paris Polyphylla (qiyeyizhihua); 15 g of Spicaprunellae (xiakucao); 30 g of Concha Ostreae (shengmuli).
3) Chinese acupoint application
Chinese acupoint application included Mingmen point, Guan yuan point, Zusanli point and shenshu point. Acupoint sticking patches replaced every 24 h for 21 days in each 21-day cycle.
21-day cycle
Xue D, 2015 Chinese medicine Decoctions 150mL should be orally taken on an empty stomach twice daily (every 12 h), and the patent medicines should be taken according to the manufacturer’s package insert. Day 63 after chemotherapy.
Xu ZY, 2011 Kangliuzengxiao decoction during chemotherapy and Feiyanning decoction after chemotherapy Kangliuzengxiao (KLZX) decoction 150 ml twice a day during chemotherapy course (from the Wrstday of chemotherapy to the end of chemotherapy), then continued to have an oral intake of Feiyanning (FYN) decoction 150 ml twice a day after chemotherapy 3 – 39 months (15 months)
Wu WY, 2010 extracorporeal high frequency thermotherapy (EHFT) EHFT one hour once per day, together with Chinese medicine differentiation decoction, 250 mL orally taken, twice daily for 14 days as one cycle, and 3–4 cycles was performed. The patients in the control group were treated only with CM differentiation decoction using the same dose as the treatment group 14 days as one cycle, three to four cycles of treatment.
Table 6
The Comparator and Outcomes of Included Studies
Study Comparator Outcomes
Du QC, 2009 Conventional treatment: anti-inflammatory, Symptomatic and supportive therapies, 1. T-lymphocyte subsets
2. Natural Killer (NK) cell activity
3. serum levels of immunoglobulin (IgA, IgM, IgG)
4. interleukin-2 (IL-2)
5. tumor necrosis factor α (TNF-α)
6. cytokeratin fragment 19 (CYFRA21-1)
7. carcinoembryonic antigen(CEA)
Dou YQ, 2010 Radix Codonopsis 15 g, Radix Angelicae Sinensis 15 g, Semen Armeniacae Amarum 15 g, Herba Hedyotis Diffusae 15g, Rhizoma Atractylodis Macrocephalae 15 g, Raidix Ophiopogonis 15 g, Radix Sophorae Flavescentis 15 g, Radix Glehniae 10 g 1. incidence of radiation pneumonitis after radiotherapy
2. Watters clinical radiographic physiologic (CRP) dyspnea score
3. Radiation Therapy Oncology Group (RTOG) grading score
4. Karnofsky Performance Status (KPS) score
5. application of corticosteroids.
Guo L, 2012 vinorelbine (20mg/m2) on days 1, 8, and 15 while cisplatin (80mg/m2) was administered on day 15. 1. Response and survival
2. Toxicity and tolerability
3. QOL analysis
Jiang Y, 2016 treated with pemetrexed, 500 mg/m2, day1), docetaxel (75 mg/m2, d1) or gemcitabine (1250 mg/m2, day 1 and day 8), 1. TTP (the interval time from the first date of randomization to that of disease progression)
2. QOL
3. overall survival (OS)
4. 1-year survival rate
Xue D, 2015 without traditional Chinese medicine for symptom control 1. QoL
2. OS
3. median survival time (MST)
4. Comprehensive geriatric assessment (CGA)
5. WHO or Response Evaluation Criteria in Solid Tumors (RECIST).
Xu ZY, 2011 treated only with combination of Navelbine (Laboratories Pierre Fabre, France) 25–30 mg/m2 on days 1 and 8 and cisplatin (Qilu Pharmaceutical Factory, China) 70–80 mg/m2 on days 1, 2, and 3 (NP) given four weekly for four cycles 1. survival time,
2. Karnofsky score
3. main clinical symptoms
4. adverse reactions
Wu WY, 2010 Only with Chinese medicine differentiation decoction using the same dose as the treatment group. 1. RECIST
2. Progression free survival
3. OS, 1-year survival rate
4. Adverse event

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