NATAP Reports

Highlights from Digestive Disease Week

May 20-23, 2001 Atlanta, Georgia

Herb Reports at DDW (CH100)*

If a person has HIV and HCV there is a risk that some herbs can interact with HIV medications. It has been reported that some herbs may be harmful to the liver. If you only have HCV milk thistle is commonly used. There is a little data suggesting it may improve liver condition, and at the IAS Conference in July 2001 Steve Piscitelli reported preliminary results from a study at the NIH showing Milk thistle did not appear to have clinically significant interaction with Crixivan. At this DDW conference there is data suggesting another herb may be helpful (CH100). Consulting with a knowledgeable professional about which herbs you may be taking and their potential for harm. Here are several herb studies at DDW.

A RANDOMIZED DOUBLE BLIND, PLACEBO CONTROLLED TRIAL OF A CHINESE HERBAL PREPARATION (CH100) IN CHRONIC HEPATITIS C.
      Lindsay C. Mollison, Leanne Totten, Chris Hovell, Kirrille Thayne, Crystal Connelly, Lyn Booth, Juliet 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 Hepatitis 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 thoughout 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 Twenty (20) subjects have withdrawn.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 treatment phase. Subjects reported improved symptoms during treatment.

Conclusions: These preliminary data suggest that the combination of herbs contained in CH100 may be beneficial in lowering ALT and in improving 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.

A TRIAL OF A CHINESE HERBAL MEDICINE FOR CHRONIC HEPATITIS C
     Tim J. Sladden, Northern Rivers Area Health Service, Lismore Australia; Robert G. Batey, John Hunter Hosp, Newcastle Australia; Nikki Keefe, Northern Rivers Area Health Service, Lismore Australia

BACKGROUND: Complementary therapies for hepatitis C virus (HCV) are popular in Australia. Following a phase II trial we examined the impact of a Chinese herbal medicine (CH100) on liver function, symptoms and health status in chronic HCV patients.

METHODS: Subjects with ALT>40U/L were recruited. Exclusions included interferon use, other liver disease, injecting drug use and alcohol >150g/week. Subjects were randomised double-blind (2 active: 1 placebo) with tablets taken 3 times/day for 6 months. Outcomes were examined at 0, 1, 3, 6 and 9 months.

RESULTS: 191/204 subjects completed baseline measures (51% male, 49% female; ages 27-56, mean 41 years). 128 subjects (85 active, 43 placebo) completed treatment. Common symptoms were fatigue, psychological symptoms, digestive symptoms, liver pain, headache, arthralgia, itchy eyes, rash, sore throat and menstrual symptoms in female subjects. Psychological symptoms were similar to side-effects attributed to interferon use: fatigue (47%), somatic effects (18%), depression (15%), irritability (10%), mood swings (8%), sleep disturbances (7%), other (12%) (Australian Hepatitis C National Database). Fatty foods, caffeine and alcohol made many subjects feel unwell. CH100 was mainly well tolerated by subjects. Mild, resolving gastrointestinal effects were common. Fatigue and headache were also reported (5%) and individuals noted dizziness, sweating, irregular heartbeat, rash and insomnia. The impact of CH100 on symptoms was inconclusive. There were reductions in liver pain (c2=8.9; p=0.03), bleeding gums (c2=14.1; p<0.01), vision problems (c2=7.8; p=0.049) and mood disorders (c2=8.6.; p=0.03). Symptom severity was reduced for liver pain, indigestion, mood swings and depression but no consistent pattern emerged with most symptoms not affected by therapy. Slight non-significant improvements were observed in health status and certain LFTs (ALP, ALT, AST).

CONCLUSION: The trial confirmed that symptoms such as fatigue, nausea and mood disorders are common in HCV. Some symptoms attributed to interferon therapy may be due to underlying infection. The trial did not illustrate definitive benefits of CH100 for treatment of HCV in this group of patients. Modest changes in hepatic biochemistry, symptoms and health status were observed. Certain individuals appeared to respond better with dramatic reductions in LFT levels. Studies of the impact of herbal treatments on different HCV genotypes, hepatic histology and viral load would further evaluate the purported benefits of these popular remedies.

HERBAL MEDICINES CONSUMPTION FOR CHRONIC LIVER DISEASE AND FUNCTIONAL INTESTINAL DISORDERS: PROSPECTIVE STUDY IN 526 OUTPATIENTS.
      Zuzana Detkova, Armelle Lefebvre, Dept of Hepatogastroenterology, Montpellier France; Cecile Bastide, Nathalie Peladan, Faculty of Pharmacy, Montpellier France; George Pageaux, Pierre Blanc, Dominique Larrey, Dept of Hepatogastroenterology, Montpellier France

The phytomedicine seems to become increasingly popular, particularly in functional disorders and liver disease. However, only limited data are available about the frequency of herbal medicine consumption.

Aim of the study: to analyse prospectively the frequency and the type of herbal medicines intake in outpatients consecutively seen in our department of hepato-gastroenterology.

Patients and Methods: Patients (pts) with chronic liver disease defined by abnormal liver tests for more than 6 months and confirmation of the disease by liver biopsy as well as pts with functional intestinal disorders were included. Enquiry on herbal medicine consumption was achieved directly by the consulting physician in all outpatients seen during an 8 months period. Type of consumed herbal medicine and duration of treatment were noted. Characteristics of pts population were age, sex, respective diseases, type and severity of liver disease if any.

Results: from April to November 2000, 526 pts were included: 251 males and 275 females, mean age 51 yrs (range: 15 - 94). There were 356 pts with chronic hepatitis C, 18 pts with chronic hepatitis B, 77 pts with other liver diseases (autoimmune hepatitis, primary biliary cirrhosis, alcoholic liver disease, NASH syndrome, focal nodular hyperplasia) and 75 pts with functional intestinal disorders. Patients consuming herbal medicines represented 30% of studied population, with mean age 52 yrs, 60% of consumers were women. There were 77% of pts with hepatitis C, representing 34% of all hepatitis C pts included; 11% of pts with other liver diseases; 9% of pts with functional intestinal disorders; 3% of pts with hepatitis B. The most frequently used products contained silymarin (27%), valerian and ballota (21%), desmodium ascendens (14%), millepertuis (7%).

Conclusion: Herbal medicines are frequently used in functional intestinal disorders and in chronic liver disease. There is no specific group of pts consuming herbal medicines regarding age, sex and type of disease. The most widespread products are those containing silymarin, valerian and ballota, desmodium ascendens and millepertuis. In the era of new therapeutic approaches for liver diseases, and especially for viral hepatitis, the unconvential medicine is still frequently used. The fact of herbal medicines increasing popularity together with the lack of evidence for its efficiency and safety should be kept in mind in approaching pts with liver disease.