Research
Gastroenterology, ISSN 0016-5085, 04/2001, Volume 120, Issue 5,
p. A384
A Randomized Double Blind, Placebo Controlled Trial of a Chinese Herbal
Preparation (CH100) in Chronic Hepatitis C.
Lindsay C. Mollison, Lean Totten, Crhis Hovell, Kirrille Thayne, Crystal Connely,
Lyn Booth, Luiet Connor, Helen Van Gessell, Miles Beaman, James McCarthy, Lewis
Marshall, John Olynyk, Michelle Porter, Fremantle Hosp. Fremantle Australia.
Aims: To examine the effects of CH100* in patients with Hepatitis
C infection.
Methods: A randomized double blind placebo controlled trial
in volunteers with chronic Hepatits C. All subjects at enrolment had an elevated
ALT and positive HCV-RNA by PCR. Two thirds of participants received active
CH100 and one third received placebo. Treatment was for 6 months, with a 6 month
follow-up period. Subjects were reviewed regularly trhoughout the trial with
clinical examination, measurement of ALT and HCV titre. Quality of life was
studied using SF-36 and symptoms checklist.
Results: Ninety seven (97) subjects entered the trial. At the
present time unblinding has not occurred. Fifty three (53) subjects have completed
the program, 17 are in follow up, and 7 remain on therapy. Twenty (20) subjects
have withdrawn. Mean screening ALT was 103 IU/ml and mean last ALT of all subjects
whilst on treatment was 92 IU/ml (P=0.027, paired t-test). Twelve of 70 subjects
(17%) who have completed the 6 month period of treatment had a normal ALT at
the end of treatment (P= 0.02, Fisher's test compared with baseline). A further
4 subjects normalised ALT at some time during the the treatment phase. Subjects
reported symptoms during treatment.
Conclusions: These prelminary data suggest that the combination
of herbs contained in CH100 may be beneficial in lowering ALT and in imporving
symptoms and quality of life in patients with chronic Hepatitis C infection.
Footnote- CH100 is a Chinese herbal preparation from Cathay Herbal Laboratories,
PO Box 878 Haymarket Sydney 2000 Australia.