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16 november 2019: Bron: . 2019; 2019: 9492034. Published online 2019 Jun 19

Wanneer patienten met primaire leverkanker  zijn geopereerd of behandeld met TACE - Transarteriële Chemo Embolisatie en daarna 6 maanden lang de Ganji formule, een vorm van TCM - Traditionele Chinese kruiden krijgt dan is de sterfte op 1 jaar met de helft gereduceerd (10 vs 21 sterfgevallen) en de mediane overall overleving is beduidend beter in vergelijking met een placebo. Tussen TACE patienten was het verschil in 1-jaars overleving 20 procent (50 vs 70 procent)

De studie is een gerandomiseerde placebo gecontroleerde studie bij totaal 217 patienten met primaire leverkanker. 

Van september 2015 tot december 2017, werden 262 patienten opgenomen in de studie uit drie verschillende ziekenhuizen in Sjanghai. Na uitsluiting van 43 patienten op basis van de toelatingscriteria  bleven 217 patienten over die gerandomiseerd werden ingedeeld in een placebo controlegroep (N = 112) en Ganjigroep (N = 107).

Er waren geen verschillen bij de start van de studie tussen de patienten. Zie Table 1. of  Figure 1.

Tien patienten in de Ganji behandelingsgroep overleden binnen 1 jaar tegenover 21 patienten in de placebo controlegroep. Mediane overall overleving op 1 jaar was 88.9% in de Ganjigroep versus 76.7% in de controle groep (chi-square = 4.17, P = 0.030). Zie ook (Figure 2).

Bij de 108 patienten die een TACE behandeling hadden gehad werd progressie van de ziekte (recidief) gezien bij 26 van de 51 patienten uit de Ganjigroep en bij 40 van de 57 patienten uit de controlegroep.  (51.0% versus 70.2%; chi-square = 0.442; P = 0.041).

De mediane tijd tot zich een recidief / progressie van de ziekte voordeed ( TTP) was voor de Ganjigroep  10 maanden tegenover 5.2 maanden voor de controlegroep. (chi-square = 3.983; 95%CI = 0.352–0.991; P = 0.046) (Figure 3(b)).

Bijwerkingen waren min of meer gelijk voor beide groepen: (Table 2)

Als extra informatie:

De Ganji formule bestaat uit 14 verschillende kruiden: Dangshen (Codonopsis pilosula (Franch.) Nannf.), Baizhu (Atractylodes macrocephala), Baimaogen (Imperata cylindrica Beauv.var. major (Nees) C.E.Hubb.), Muli (Ostreagigastnunb), Biejia (concha testudo graeca), Zelan (Aconitum gymnandrum Maxim.), Chenpi (Citrus reticulata Blanco), Maozhuacao (Ranunculus ternatus Thunb.), Jigucao (Abrus cantoniensis Hance) Baihuasheshecao (Hedyotis diffusa Willd) Baiying, (Solanum lyratum Thunb.), Banzhilian (Scutellaria barbata D. Don), Biliguo (Ficus pumila Linn.), and Tengligen (Actinidia arguta (Sieb. & Zucc) Planch. ex Miq.).

Het volledige studierapport:  Ganji Formulation for Patients with Hepatocellular Carcinoma Who Have Undergone Surgery: A Multicenter, Randomized, Double-Blind, Controlled Trial is gratis in te zien.

Hier het abstract met referentielijst.

We showed that Ganji Formula combined with basic treatment could prolong OS and delay tumor progression for patients with primary liver cancer who had undergone surgery. Our study shows that Ganji Formula could be adjuvant therapy for HCC.

Published online 2019 Jun 19. doi: 10.1155/2019/9492034
PMCID: PMC6607716
PMID: 31320916

Ganji Formulation for Patients with Hepatocellular Carcinoma Who Have Undergone Surgery: A Multicenter, Randomized, Double-Blind, Controlled Trial

Jing-Hao Zhang, 1 , 2 Chao Zheng, 1 , 2 Xiao-Jun Zhu, 1 , 2 Xin Zhang, 3 Zhi-Jun Hou, 1 Zhen-Hua Zhou, 3 Yu-Qing Wang, 1 Kai-Xia Wang, 1 , 2 Zhuo Yu, 1 , 2 Man Li, 3 Yue-Qiu Gao, 1 , 2 , 3 and Xue-Hua Sun 1 , 2

Abstract

Objective. To ascertain the efficacy and safety of Ganji Formulation (GF) for patients with Hepatocellular carcinoma (HCC) who had undergone surgery. Materials and Methods. A total of 262 HCC patients who had undergone liver resection, local ablation, or transcatheter arterial chemoembolization (TACE) were divided randomly into the treatment group and control group. The former was treated with GF and the later with placebo, both for 6 months. The primary endpoint was overall survival (OS). Second endpoints were disease-free survival (DFS) or time to disease progression (TTP). Results. OS of the treatment group was significantly longer than that of the control group (P < 0.05). Subgroup analysis showed that, for patients who received TACE, the TTP was significantly longer in the treatment group than in the control group (P < 0.05). However, for patients who underwent liver resection or local ablation, there was no significant difference in DFS between the two groups (P > 0.05). Conclusion. GF could improve postoperative cumulative survival and prolong the TTP. This clinical trial number is registered with ChiCTR-IOR-15007349

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Articles from Evidence-based Complementary and Alternative Medicine : eCAM are provided here courtesy of Hindawi Limited

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