Placebos used in clinical trails for Chinese herbal medicine

Recent Patents on Inflammation and Allergy Drug Discovery

Volumn 2, Issue 2, 2008, Pages 123-127

  Qi, Guan D ^a   We, Ding A ^b   Chung, Leung P ^c,d   Fai, Cheng K ^c  

^a HONG KONG INSTITUTE OF VOCATIONAL EDUCATION   (Hong Kong)

^b NANJING UNIVERSITY OF CHINESE MEDICINE   (China)

^c CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

^d CHINESE UNIVERSITY OF HONG KONG   (Hong Kong)

Author keywords

Chinese herbal medicine (CHM); Clinical trial; Placebo

Indexed keywords

CHINESE DRUG; CINNAMON EXTRACT; HERBACEOUS AGENT; PHARMACEUTICAL VEHICLES AND ADDITIVES; PLACEBO; STARCH;

AWARENESS; CHINESE MEDICINE; CHOLELITHIASIS; CHRONIC PROSTATITIS; CLINICAL TRIAL; COGNITIVE DEFECT; CONGESTIVE HEART FAILURE; DATA BASE; DRUG CAPSULE; FOOD COLOR; HEART FAILURE; HERBAL MEDICINE; HUMAN; MAIZE; METHODOLOGY; MOMORDICA CHARANTIA; NON INSULIN DEPENDENT DIABETES MELLITUS; PEPTIC ULCER; PHARMACY; POSTMENOPAUSE OSTEOPOROSIS; POWDER; PRIORITY JOURNAL; REVIEW; STANDARD; VALIDATION PROCESS; PATENT; RANDOMIZED CONTROLLED TRIAL; VALIDATION STUDY;

CLINICAL TRIALS AS TOPIC; DRUGS, CHINESE HERBAL; HUMANS; PATENTS AS TOPIC; PLACEBOS; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RESEARCH DESIGN; VALIDATION STUDIES AS TOPIC;

EID: 55849135582     PISSN: 1872213X     EISSN: None     Source Type: Journal    
DOI: 10.2174/187221308784543700     Document Type: Review

References (88)

1. Lai S-L. Methodology of clinical trial in integrated medicine. Science Press, 2003.
2. Wen Z-H, Lai S-l, Liang W-X, Guo X-F, Wang Q. Further improving the quality of clinical trial report of TCM. Chin J Integrated Tradit West Med 2004; 24 (11): 1022-1025.
3. Lai S-L. Key points about clinical effectiveness assessment of traditional chinese medicine. J Guangzhou university of TCM 2002; 19 (4): 245-250.
4. Tang J-L, Zhan S-Y, Edzard E. Review of randomised controlled trials of traditional chinese medicine. Br Med J 1999; 319: 160-161.
5. David P. Understanding the placebo effect in complementary medicine: theory, practice, and research. Churchill Livingstone 2001; 1-238.
6. Alain S, Therese D-S. Good Practice of Clinical Drug Trials. 3rd ed., Karger, 1992; 1-260.
7. International Ethical Guidelines for Biomedical Research Involving Human Subjects. The Council for International Organizations of Medical Sciences (CIOMS). 2002.
8. The Chinese Medicine Council of Hong Kong, Good Clinical Practice for Proprietary Chinese Medicines, 2001.
9. Zhong, S., Yu, H.: GB2428974 (2007).
10. Lai, Z., Huang, X.: US20070202201 (2007).
11. Collaborative Group for China Coronary. China coronary secondary prevention study (CCSPS) Chin J Cardiol 2005; 33 (2): 109-115.
12. Zhu J, Jiang M, Zou J-D, Xu L-H, Xiong N-N. Exploratory clinical study of antitussive effects of total alkaloid agent extracted from Papaver somniferum L. in patients with acute tracheitis and bronchitis. Chin J Clin Pharmacol Ther 2004; 9(12): 1365-1368.
13. Liang C-Q, Guo Y-Q. Clinical observation of Wanshuanli for stable anginapectoris. J Shanxi Medical University 2004; 35(6): 580-581.
14. Cui Y, Liang X-Q, Yue H-F, et al. Influence of eong-term intake of GTP on T lymphocyte subgroups and NK cell activity in high risk subjects of developing liver cancer. Chin J Cancer Prevention & Ttreatment 2005; 12(2): 92-94.
15. Cui Y, Li D-R, Ye S-Y, et al. Research of immune function and anti-oxidation for human with longterm taking green tea polyphenols. Tumor 2004; 24(5): 427-428,432.
16. Liu Y-J, Weng F-Q, Li Q, et al. Effect of Huo Xue Bo Gu Pill on immanent basic fibroblast growth factor (bfgf) and quality of the primary callus after fracture. Chin J Traditional Medical Traumatology & Orthopedics 2004; 12 (6): 11-14.
17. Li S-Z, Zheng B-H, Wang H-B, Li S-S, Yao W-X, Wang L. The effect and significance Gao Yuan Kang capsules on lung function changes of people swiftly enter plateau. J High Altitude Med 2004; 14(3): 1-3.
18. Lelia D. Pre-eclampsia and hypertension. Chin J Evid Based Med 2004; 4(10): 716-729.
19. Lu JM, Wang LH, Li LJ, et al. Concurrent radiotherapy and "San-Yang-Xue-Dai" for local advanced non-small cell lung cancer. Bull Chin Can 2004; 13(11): 743-746.
20. Liu HR, Liu SB, Yuang R, et al. Clinical study of Yangxinkang and Baoxinkang on congestive heart failure. Clin Med J China 2001; 8(3): 253-254.
21. Zhang F, Zhang Z-F, Shen Q, Ni L-Q. Clinical observation of "Zaocys Hydrolytic Liquid" in 120 cases of rheumatoid arthritis. ACTA Universitatis Traditionis Medicalis Sinensis Pharmacologiaeque Shanghai 2001; 15(2): 22-24.
22. Du BJ, Tu XH, Li LZ. The clinical study of zhikeping capsule on hyperlipidemia. J Tradit Chin Med 2004; 11(9): 757-759.
23. Zhang RH, Chen KJ, Lu DX, et al. clinical study on treatment of postmenopausal osteoporosis by yigu capsule. Chin J Integr Tradit West Med 2004; 24(8): 680-684.
24. Cui JH, Zhang XZ, Wang YH, et al. When exercises at highland the Rhodioladumulosa contained formula affect on the levels of lactic acid, myoglobin and blood ammonia of human body. J Preventive Medicine of Chinese People's Liberation Army 2001; 19(6): 426-428.
25. Xu Y-L, Qu N-N. Clinical trial of Shaorilao cleaning lung and controlling cough capsule for the treatment of acute tracheabronchitis. Liaoning J Trad Chin Med 2004; 31(7): 587-588.
26. Guo J-S, Li M, Shen Z-L, et al. Effect of nutrients- herbs mixture on military fatigue. J Preventive Med Chin Peoples Liberation Army 2003; 21(1): 5-7.
27. Baoru Y, Kirsti OK, Raija LT, Leena MM, Heikki PK. Dietary supplementation with seabuckthorn (hippophae rhamnoides) oils and skin surface roughness of patients with atopic dermatitis. The Global Seabuckthorn Res Develop 2004; 2(1): 44-47.
28. Mao YM, Zeng MD, Lu L-G, et al. Capsule oxymatrine in the treatment of liver fibrosis in patients with chronic virus hepatitis: A randomized, double blind, placebo-controlled, multicenter clinical study. Chin J Hepatol 2002; 7(4): 222-225.
29. Wang W, He HX, Hu WL, Zhang XM, Wang YL. Efficacy and safety of intraprostatic injection of chuanshentong for chronic abacterial prostatitis/chronic pelvic pain syndrome. Natl J Androl 2004; 10 (3): 182-187.
30. Chen JC, Gu DF, Wu XG, et al. Effects of soy protein supplement on blood pressure. Chin J Hypertens 2004; 12(2): 172-175.
31. Han JQ, Wang XW, Wang Yu, et al. A clinical prospective study of radiosensitization on lung adenocarcinoma by agrimophol. Chinese J Radiological Medicine Protection 2003; 23(5): 355-357.
32. Ye YB, Su YX. The attenuating effect of soy isoflavones extract on bone loss in postmenopausal women. ACTA Nutrimenta Sinica 2004; 26 (1): 49-53.
33. Bai LL, Wang FC, Tan B. Secondary prevention of sanjiang capsule in treating coronary heart disease. Shandong J Tradit Chin Med 2002; 21(8): 461-463.
34. Li SM, Leng JY, Xiao ZQ, et al. The effect of Panax Notoginseng Saponins on QT dispersiohs of patients after intracoronary stent implantation. Chin J Gerontol 2002; 22(2): 115-116.
35. Xu G, Lu J, Tang X-D, et al. The efficacy and safety of Prostant TM in the treatment of chronic prostatitis:a multi center, randomized, double blinded, placebo controlled trial. Chin J Urol 2002; 23(5): 296-298.
36. Su Y-C, Lin C-J, Chen K-T, et al. Effects of Huangqi Jianzhong Tang on hematological and biochemical parameters in judo athletes. ACTA Pharmacologica sinica 2001; 22(12): 1154-1158.
37. Zhao H-X. Assessment of the therapeutical effect of antiosteoporosis capsule treating post-menopause osteoporosis. J Tradit Chin Med Pharmacy 2001; 16(2): 31-33.
38. Dai L-M. Study of the modulating effect of Yunnanbaiyao on inflammatory cells in sputum from patients with chronic obstructive pulmonary disease in stable phase. Chin J New Drugs 2001; 10(4): 282-284.
39. Fang Z-L, Xie M-H, Deng J, et al. Silkworm powder anti-fatigue study. Chin J Sports Med 2001; 20 (1): 81-82.
40. Su X-Y, Xu M, Xu W-N, et al. Influence of Huangqijing oral liquor on the left ventricular function and exercise tolerance in patients with alcoholic myocardiopathy. Chinese J Integrated Traditional and Western Medicine in Intensive and Critical and Critical Care 2001; 8(4): 241-242.
41. Li Y-M, Zhang C-Y, Wang J, et al. The effects of heart-benefiting recipe on the intellects of Alzheimer' s disease patients whose state of illness were middle and serious. Modern Rehabilitation 2000; 4(7): 996-997.
42. Deng S-M, Wan B, Wang J-Y, et al. The efficacy of Menglong capsules in treatment of 61 patients with impotence. Chin J New Drugs 2000; 9(7): 484-486.
43. Xu G-Z, Duan L-X, Wang Z-F, Liu R-K, Lu X-X, Cai Z-J. A double, blind clinical trial of jitai tablets vs lofexidine in the treatment of heroin withdrawal symptoms. Chinese J Drug Dependence 2000; 9(4): 273-277.
44. Yao X-X, Feng L-Y, Bai W-Y, Wang L-H, Zhang H, Qi, F-C. Effects of anti-Hp capsule multitherapy in peptic ulcer. World Chin J Gastroenterol 1999; 7(9): 766-769.
45. Wang N-l, Sun X-H, Li J-Z, et al. Neuroprotective effects of erigeron breviscapus (vant) hand-mass on glaucoma-A multi-center clinical trial. Int J Ophthalmol 2004; 4(4): 587-592.
46. Pan W-N, Liu Y-G, Li R-X, Li J. Perspective study of TCM used peri-operatively for the patients with cholelithiasis. Sichuan J Tradit Chin Med 2005; 23(2): 77-78.
47. Shen Q, Zhou E-Y, Chen Y-M, Song Y, Luo Y-P. Treatment of Incomplete Spinal Cord Injury by "Jietankang Pill". Shanghai J Tradit Chin Med 2004; 38(12): 17-19.
48. Zhang F-R. Efficacy and safety of lizhi soft capsule in treatment of patients with benign prostatic hyperplasia. Chin J Clin Pharmacol Ther 2004; 9(12): 1424-1427.
49. Li Y-M, Xie S-Z, Wang J, Pan Y-F, Lin S-M. To study and compare the effects on memory function letdown in middle-aged and aged patients by tiao xin and bushen prescriptions. Geriatrics Health Care 2004; 10(4): 224-226.
50. Feng L-Y, Zhang Y-M, Peng Z-X. Combined therapy of duodenal ulcer with TCM and western medicine: arandomized double blind controlled study. Chin J Celiopathy 2003; 3(3): 164-166.
51. Qin X-J, Hai C-X, He W, Liang X, Chen H-L, Liu R. Studies on supplementation with nutrients-compound to improve cognitive function. ACTA Nutrimenta sinica 2004; 26(5): 341-343,347.
52. Jia H-X, Tang Y-Y, Jiang Z-K, et al. Clinical observation of the treatment of cognitive impairment in schizophrenia by the TCM therapy of enforcing spleen and nourishing kidney. J Beijing Uni Tradit Chin Med 2004; 27(5): 80-83.
53. Lu L-G, Zeng M-D, Mao Y-M, et al. Oxymatrine in the treatment of chronic hepatitis B for one year: a multicenter random double-blind placebo-controlled trial. Chin J Hepatol 2004; 12(10): 597-600.
54. Wang Y-G, Jin S-L, Yan M, et al. Effect of yinxing leaf and clozapine in the treatment of first onset schizophrenia. Shandong Archives of Psychiatry 2004; 17(4): 213-214.
55. Li J, Mi M, Zhong W-J, Dong M-Z. A study on the blood- sugar regulation function of enriched - chromium tea. Shanghai J Prev Med 2001; 13(2): 56-57.
56. Wang Y-F, Li H-F, Xu Y-F, et al. Clinical confirmation of preparation from the branch and leaf of peanut in treating insomnia. Shanghai J Tradit Chin Med 2001; 35(5): 11-14.
57. Quan Y-P. Clinical investigation on treatment of migraine with tianning liquid. Jiangsu J Tradit Chin Med 2004; 25(9): 20-21.
58. Wang Q, Yang J-X, Li G-X, et al. Multi-center and randomly controlled trial of Shuganyiyang Capsules for the treatment of erectile dysfunction. J Beijing Uni Tradit Chin Med 2004; 27(4): 72-75.
59. Yin S-S, Wang B-E, Wang T-L, Jia J-D, Qian L-X. The effect of Cpd 861 on chronic hepatitis B related fibrosis and early cirrhosis: a randomized, double blind, placebo controlled clinical trial. Chin J Hepatol 2004; 12(8): 467-470.
60. Wang J, Jing L, Zhong J-B, Wang Y-Y, Ma L-H, Liu J-G. Clinical study on compatibility and dismantlement of Xuefu Zhuyu decoction. Chin J Mater Med 2004; 29(8): 803-807.
61. Xu G-Z, Duan L-X, Liu C, et al. A double-blinded controlled clinical trial to evaluate the detoxicated effect of Fuzhengkang in heroin dependent subjects. Chin J Drug Abuse Prev Treat 2002; 4: 2-7.
62. Wang X-X, Li T-Q, Xiao H-X, et al. Clinical study of weinikang capsule (weinikang capsule) in the treatment of reflux esophagitis. Shanxi J Tradit Chin Med 2004; 20(1): 10-12.
63. Bo S-N, Liang Q, Zhang S-W, Wang B-E. The effect of chinese herbal 912 capsule and it's different ingredients to the nail microcirculation in the patients with acute infectious disease. J Exp Clin Med 2002; 1(2): 73-76.
64. Huang L-Z, Zhang X-M, He X. Clinical observation on analgesic effects of Wenyangzhitong Capsule to bony metastatic carcinoma. Chin J Information On Tradit Chin Med 2004; 11(3): 197-198.
65. Li Su-Y, Li J-S, Ma Li-J, et al. Effect of Bufeiyishen Grain of TCM on extracellular matrix in patients with chronic obstructive pulmonary disease. Chin J Information On Tradit Chin Med 2003; 10(9): 13-15.
66. Liu J-H, Wang Y-H, Lou L-H, Zhu X-C, Li J. Clinical and experimental study on the intervenient effect of Tiangu Granule on deafness caused by the aminoglycoside antibiotics. Chin J Tradit Med Sci Technol 2002; 9(3): 131-132.
67. Xiao N-L, Yang W-R. Treating 35 cases of lumbar disc protrusion with Yaotuiling Capsule. Hunan Guiding J TCMP 2002; 8(4): 185-186.
68. Mao Y-M, Zeng M-D, Lu L-G, et al. Capsule oxymatrine in the treatment of liver fibrosis in patients with chronic virus hepatitis: A randomized, double blind, placebo-controlled, multicenter clinical study. Chin J Hepatol 2002; 7(4): 218-221.
69. Liu Z-L, Wu S-X, Gao G-D. Clinical assessment on treatment of hyperlipidemia with Pushen Capsule. Chin J Integr Tradit West Med 2004; 24(3): 227-229.
70. Zhang B-L, Wang Y-Y, Chen R-X, et al. Clinical randomized double-blinded study on treatment of vascular dementia by Jiannao Yizhi Granule. Chin J Integrated Tradit West Med 2002; 22(8): 577-580.
71. Zhang H, Li X, He W-Y, Wang H-X, Yu F-E. Clinical trial of Wuling Capsule plus Nimodipime for treatment migraine. Chin J Clin Med 2002; 18(9): 791-792.
72. Yang Y-D, Liu Z, Xu X-R. Clinical study of multiple-effect decoction beneficial to brain in the treatment of cerebral infarction. J Shandong Uni Tradit Chin Med 2002; 26(3): 187-190.
73. Li J, Kang L, Zhang S-S, et al. Double blind and randomized clinical trail on the effect of shenfutuodu capsule compared with clonidine on withdrawal syndrome of heroin addicts. Chin J Drug Dependence 2002; 11(2): 125-128.
74. Shen Z-Y, Guo W-M, Chen Y. Study of kidney-tonifying recipe on transcriptional regulating pattern of the expression of T lymphocytes apoptosis related genes in aging subjects. Chin J Gerontol 2002; 22(4): 241-243.
75. Deng Y-P, Xu G-Z, Wang W, et al. Clinical evaluation of analgesic effect and safety of scorpion venom injection. Chin Pharm J 2002; 37(6): 459-462.
76. Li X-W, Dai L-M, Huang W-L, Fang L-Z, Yang Y-P, Zhang J-Q. Study on regulating cytokines in induced sputum of patients in stable obstructive pulmonary disease with oral yunnan baiyao. Academic Journal of Kunming Medical College 2001; 22(2): 29-31.
77. Du G-Z, Li Q, Zhao Q-M, Wu X-C. A randomized controlled clinical trial of Niuxijing capsule in prevent and treatment of leukopenia after chemotherapy. China Pharmacist 2000; 3(2): 106-108.
78. Guo S, Jiang Z, Sheng L-X. A double blind study on tolerability of herbal compound zhengtongning in healthy volunteers. Chin J Drug Dependence 2000; 9(4): 278-282.
79. Liu T-L. Experimental study on polyphenol anti-plaque effect in human. Chin J Stomatol 2000; 35(5): 383-384.
80. Wu H, Chen Y-P, Lu L-P, Ding Y-G, Xian S-X, Huang Y-S. A clinical study of Zushima Injection in the treatment of bi-syndrome. Tradit Chin Drug Res Clin Pharmacol 2000; 11(5): 261-265.
81. Liu X-S, Liu C-J, Meng S-F, et al. The curative effects of PUYUAN WEI KANG on chronic gastritis and peptic ulcer. Med J Qilu 1999; 14(3): 176-177.
82. Xu D-S, Shen Z-Y, Wang W-J, et al. Immunoregulation of youguiyin, sijunzitang, taohong siwutang in treating patients with deficiency of kidney, spleen and bloodstasis syndrome. Chin J Integrated Tradit West Med 1999; 19(12): 712-714.
83. Hu H-Q, Jiang Z-L, Zou G-G, et al. Observation of the seasickness prophylactic effect of pulvis zingiber siccus. Chin J Nautical Med 1999; 6(1): 23-25.
84. Luo X-M, Wang H, Ding Y-H, et al. Effects of tea polyphenols on bulbar conjunctiva microcirculation in aircrew. Chin J Aerospace Med 1999; 10(1): 21-23.
85. Chen W-W, Li R-L, Ye Fu-Q, et al. Clinical and Pharmacological Studies of Lianxiang Capsule for Epigastralgia. Tradit Chin Drug Res Clin Pharmacol 1999; 10(5): 268-271.
86. Wang X-F, Dong D, Liu F, Li J, Lu Y. Preliminary exploration of Placebo preparation in TCM clinical trial. Liaoning J Tradit Chin Med 2003; 30(12): 966-967.
87. Wen Z-H, Wang Q, Lang W-X, Lai S-L. Application of blind method in double-blind randomized controlled trial of Shengmai Capsule for chronic heart failure. J Guangzhou Uni Tradit Chin Med 2004; 21(4): 315-322.
88. Xie Z-F, Li N. Evidence of efficacy of integrative medicine and CJIM. Chin J Integr Med 2004; 10(4): 300-302.