Hepatitis C
Ergebnisse der Hepatitis C-Therapie am Gemeinschaftskrankenhaus Havelhöhe (Juli1999):
Viscum album and its immunomadulating activities
Survey of Unconventional Hepatitis C Therapy with an Aqueous Misteltoe
Extract and Lycopersicon esculentum
Harald Matthes, Burkhard Matthes, Silke Biesenthal.
Community Hospital Havelhöhe, Berlin
Academic Teaching Hospital of the Humboldt-University, Berlin
Introduction
Until now a satisfying therapy of chronic hepatitis C has not not been established. Success of conventional interferone monotherapy and interferone/ribavirin combined therapy lays in the range of 10-25% and 10-43% respectively, depending on the HCV genotype. Adverse effects of these therapies are usually high. Especially for patients who are non-responders or having contraindications to interferone, unconventional therapies with aqueous mistletoe extract (ABNOBAviscum® Quercus = AvQ) in combination with lycopersicon esculentum and Hepatodoron® may represent an alternative therapy. We investigated the course of therapy for 95 hepatitis C-patients. The aim of the therapy is to achieve an HCV-RNA-PCR negativity after 12 months of treatment and 6 months of follow up. Further criteria are the the quantitative course of transaminases, parameters of fibrosis (pro-collagen 3-peptid=PIIIP), possible adverse effects and quality of life.
Methods
Therapy trials were evaluated retrospectively for 95 patients. The therapy was conducted with AvQ dilution 6, 3 x /week and Hepatodoron® 3x2 tablets/day. After 14 days of therapy lycopersicon esc. (eth. dec. aquos. 3x 8-15 drops) was added. This regimen was continued for 12 months. HCV-RNA-PCR, transaminases and PIIIP were measured every 3 months. Sustained response is defined by HCV-RNA-PCR negativity after 12 months of therapy and 6 months of follow up. Partial response is defined by HCV-RNA-PCR reduction > 103 copies/ml and a decrease of transaminases of 50%. Patients were asked for aspects of quality of life like, fatigue and sensation of heaviness, physically unspecific symptoms like feeling of pressure and fullness, physical and psychological ability to take stress, depression, professional and social activities.
Results
HCV-genotypes 1 and 3 are mainly represented among the 95 patients (Fig. 1). 69 of 95 patients completed therapy, 47 of 69 were followed up over 6 months. 8 of 47 patients (17%) were HCV-RNA-PCR negative after 12 months of treatment and throughout the follow-up-period (Fig.2, 3). Distribution of genotype analysis demonstrates 4x genotype 3, 2x genotype 2 and 1 x genotype 1 (Fig. 3). Transaminase values normalized after 12 months but most of the sustained responders showed time courses of ALA with an initial increase (week 4-12) of about 3-5-fold higher than the initial value (Fig. 5B). 20 patients (42%) showed a significant decrease of HCV-RNA-PCR and transaminases (p<0,05) (Fig.2, 3,4, 5A). They were defined as partial responders and therapy was prolonged for further 6 -12 months (Fig. 3). After 30 months 8 of 20 partial responders showed a sustained response (Fig. 3). For 2 patients a so-called 'breakthrough' phenomena was observed. PIIIP-values were normal after 18 months for responders and non responders equally (Fig. 6). Significant adverse effects were not observed. Quality of life was improved in 54 cases (78%).
Discussion
The results of the follow-up study referring to the HCV-RNA-PCR state are nearly comparable to the interferone monotherapy but are clearly beneath the results of the combination interferone/ribavirin. The distribution of genotypes of the sustained responders is similar to that of the interferone therapy. The initial increase of transaminases for sustained responders seems to be a positive predictive parameter for complete recovery in these therapy regimens. Unlike to interferone, in the therapy with AvQ and lycopersicon no serious adverse effects had been observed. In contrast, quality of life was improved under the complementary therapy strategy. With about 800 $/year, costs of this therapy are relatively low. However further observations and prospective studies will be needed. In cases of interferone/ribavirine non responder or contraindications these developed complementary therapy may be an alternative or an attempt to decrease the liver fibrosis in chronic HCV infection.
Conclusion
8 of 47 patients (17%) were HCV-RNA-PCR negative after 12 months of treatment with normal transaminase and PIIIP values. 20 patients (42%) showed a significant decrease of HCV-RNA-PCR and transaminases. After continued treatment (further 6-12 months) 8 of these 20 partial responders showed a sustained response. Significant adverse effects were not observed. Quality of life was improved in 54 cases (78%). A carefully tailored administration of AvQ and lycopersicon esc. may represent a viable alternative to interferone/ribavirin therapy in cases of interferone non responder or contraindications of interferone.
