Herbal traditional Chinese medicine and its evidence base in gastrointestinal disorders

Table 9 Clinical trials with herbal traditional Chinese medicine preparations for primary hepatocellular carcinoma

Ref.	Patients	Treatment	Control	Outcome	Remarks
Huang et al[154], 2013	68 pat.; HCC, stage IIIA, IIIB, palliative treatment	32 pat.; BST + Xiaoaiping inj., dose not given, 30 d	36 pat., BST	RECIST, immune function, QoL Karnofsky scale: significant for immune function, immediate therapeutic effect	China classification system. Kaplan-Meyer: First 20 wk no difference (-40%)
Zhai et al[159], 2013	379 pat.; HCC after hepatectomy	185 pat.; 50 mL/d Cinobufacini injection 10 d/mo, 12 mo + 4.5 g bid Jie Du granule, 6 mo	190 pat.; TACE pirarubicin, mitomycin C, once	Herbal TCM prolongs time to recurrence (P = 0.048)	5 dropouts for ITT in verum, 6 dropouts in control. After 14 mo, no further difference
Zhao et al[160], 2012	60 pat.; HCC, after microwave ablation therapy	30 pat.; Fuzheng Yiliu recipe, 6 mo, dose not given	30 pat.; additional treatment	Liver function, fibrosis, immune function improved	Data given only for lymphocytes
Tian et al[164], 2010	97 pat.; primary HCC or CCC	49 pat.; TACE + Ganji Decoction; dose not given, 4 wk; multiple cycles	48 pat.; TACE with mitomycin C, THP, 5-FU	Tumor regression in control better; survival better in test group	Intervention: no cytostatic agents in TACE. No Kaplan Meier shown
Yen et al[155], 2009	42 pat.; unresectable HCC	42 pat.; 750 mg capecitabine + PHY906	Dose escalation study	Improved survival to historical control (?)	No histology
Saif et al[158], 2010
Wang et al[165], 2009	77 pat.; advanced HCC	40 pat.; TACE + Ganji recipe, dose not given, 4 wk (1 course)	37 pat.; TACE	Survival not different at 3 mo, thereafter different; QoL improved
Hou and Lu[166], 2009	67 pat.; mid advanced HCC	35 pat.; TACE (gemcitabin, cisplatin) + TCM according to symptoms; 4 wk	32 pat.; TACE (gemcitabin, cisplatin)	QoL, CT/MRT, immune system. No differences described	Ambiguous data presentation
Chen et al[170], 2007	82 pat.; HCC, after TACE	45 pat.; complex prescription of Chinese crude drugs, 4 wk	37 pat.; routine liver protection, 4 wk	Symptoms improved in therapy group	No differentiation of drugs
Wu et al[171], 2005	61 pat.; HCC	33 pat.; local DDP application (TACE?) + Xiaoshui decoction, 2 mo	28 pat.; DDP application (TACE?)	Ascites, QoL, survival, symptoms: all significant, except QoL	Unclear basic treatment (DDP)
Lao[174], 2005	122 pat.; HCC, after TACE	62 pat.; 150 mg/d matrine injection, 2 wk	60 pat.; “some other hepatinica”, 2 wk	Enzyme levels are increased, no clear group allocation	TACE not speci-fied; effects between groups not clearly described
Lin et al[172], 2005	72 pat.; HCC II or III; with histology and microwave coagulation	36 pat.; 20 mL Shenqi mixture, 3 ×/wk, 1 mo	36 pat.; no additional treatment	Significant: cure rate, Karnofsky score, lymphocytes, AFP, Chinese symptom score	Microwave treatment: 2 times 60 W, 800 s 1/wk
Feng et al[161], 2005	80 pat.; HCC after TACE	20 pat.; dexamethasone + ginsenosides, dose, duration not given	20 pat.; each dexamethasone, ginsenosides or placebo; no dose, no duration	Treatment lowered nausea, vomiting, fever, pain, bone marrow inhibition	TACE not specified; no numbers given
Lin et al[167], 2005	85 pat.; middle advanced HCC	52 pat.; TACE with HCPT, + Shentao Ruangan pill	33 pat.; TACE with HCPT	No difference: tumor size; significant: survival, Chinese symptom score	HCPT: hydroxy- camptothecine
Zhang et al[175], 2004	65 pat.; ad vanced HCC	32 pat.; regular protective therapy + Jia Wei Si Jun Zi Tang; no dose or duration	33 pat.; regular protective therapy; no dose or duration	Sigificant improvement in treatment group; “superior in curative effect”	ICGR15: indocyanine green retention 15 min; intervention treatment mentioned, but not described
Chen et al[156], 2003	100 pat.; moderate and advanced HCC	50 pat.; Cino bufacini injection, no further information	50 pat.; no further information	Every parameter improved in Cinobufacini injection group	No individual parameter reported
Shao et al[176], 2001	60 pat.; middle advanced liver cancer; after TACE	30 pat.; Gan'ai No. I and No. II, no dose or duration given	30 pat.; no further details	Improved survival, recurrence rate, tumor shrinking, AFP, leukocytes	No treatment details
Xu et al[173], 2001	120 pat.; HCC, after resection	61 pat.; herbal TCM for Chinese symptoms, no type, dose, duration	59 pat.; no further treatment	ALT, AST, albumin, γ-GT, bilirubin improved	Unclear whether within or between group differences were reported
Wang[162], 1998	108 pat.; HCC embolism chemotherapy	40 pat.; each herbal TCM preparations, no type duration, dose	40 pat.; no further treatment	Survival rate, short term effects significant	No specific data, no treatment details
Zheng et al[163], 1998	106 pat.; HCC	56 pat.; embolization with Bletilla striata angioembolus, follow-up 4 yr	50 pat.; embolization with Gelfoam, follow-up 4 yr	All clinical parameters better than in control
Han et al[169], 1997	HCC with radiotherapy, no further data available	Xuefu Zhuyu decoction, no details on pat. number, dose, duration	No treatment	Survival significantly improved, metastasis not improved	“showed coordinate effect with radiotherapy”
Peng et al[157], 1993	Late stage HCC	4–8 mL Salvia miltiorrhizae composita; no pat. number given	No treatment description given	Sign. difference between groups	No description of treatment and results
Oka et al[152], 1995	260 pat.; HCC in cirrhosis	130 pat.; conventional drugs + 7.5 g/d Sho Saiko To (TJ-9), 5 yr	130 pat.; no treatment	Survival prolonged (n.s., P = 0.053), for HBs-negative pat. significant	Randomized, prospective, not blinded
Yamamoto et al[153], 1989	260 pat.; HCC in cirrhosis, matched pairs	130 pat.; 7.5 g/d of Sho Saiko To, 34 mo	130 pat.; conventional medicine, 34 mo	Sign. lower incidence of HCC (9 vs 17)

BST: Best supportive treatment; CCC: Cholangiolarcellular carcinoma; HCPT: Hydroxycamptothecine; HCC: Hepatocellular carcinoma; QoL: Quality of life; RECIST: Response Evaluation Criteria In Solid Tumors; TACE: Transarterial chemoembolization; THP: Tetrahydropyranyladriamycine.