Herbal Protocol Update

I have been on Dr. Zhang's herbal protocol for three and a half weeks now. So far the results have far exceeded anything I had hoped for. The fatigue and achiness has all but disappeared. The first week of the protocol was life as usual, extreme fatigue and achiness 2 or 3 days that week. Since then however, I have only experienced two days of extreme fatigue and achiness. Over the last year or so I was experiencing these days 2-4 times a week. I feel human again for the first time in years. The mild problems I reported the first week of treatment, feeling jittery, extreme intestinal gas and loose stools have abated as my body has adapted to the herbal formulas .Of course it's much too early to verify any results quantitatively by lab results or liver biopsy but judging by how I feel my life has greatly improved qualitatively and I'm very optimistic for the future. Dr. Zhang has scheduled the first lab tests for three months after beginning protocol.

While cruising the world wide web this morning I found yet another example of a Dr. agreeing that the toxicity of conventional interferon treatment is unacceptable. The article can be found here but I have reproduced it below:

Benefit vs. harm of treatment of chronic hepatitis C

TO THE EDITOR: I am quite apprehensive that your article (1) on hepatitis C by Dr. Ward and colleagues will cause misconceptions for family physicians and may cause harm to our patients.

The article (1) trumpets the efficaciousness of treatment of chronic hepatitis C. However, no justification for the repeated assertion of treatment effectiveness is offered. Treatment of hepatitis C does lower viral RNA loads, but I fear there is no evidence showing that treatment prevents cirrhosis, cancer, disability, and death. In lieu of outcomes evidence, what do experts say? The authors cited the consensus statement from the National Institutes of Health, (2) which discusses only disease-oriented evidence regarding the benefit of hepatitis C treatment. My local gastroenterology colleagues have no patient-oriented outcome evidence to report either. Real patient benefit, such as reduced incidence of cancer, cirrhosis, disability, and death remains speculative and the topic of ongoing research.

Yet, we have plenty of patient-oriented outcome evidence showing how this supposedly effective treatment is toxic. In my own practice, I have several patients who have been harmed significantly by treatment for hepatitis C, with outcomes such as chronic sprue-like enteropathy, myopathy, and depression.

No patient would tolerate cancer chemotherapy without the confidence that it improved their chance for better health. Yet, we are poisoning thousands of our patients who have hepatitis with just such a situation of known harm and uncertain benefits from treatment.

I have stopped referring my patients who have hepatitis C to gastroenterologists unless they enter a research protocol to help achieve patient-oriented outcome evidence. Until we have patient-oriented evidence that rates of cirrhosis and cancer are reduced with treatment, I do not feel that clear harm and no clear outcome benefit is acceptable.

JOSHUA STEINBERG, M.D.

State University of New York Upstate College of Medicine Department of Family

Medicine 475 Irving Ave., Suite 200

Syracuse, NY 13210

REFERENCES

(1.) Ward RP, Kugelmas M, Libsch KD. Management of hepatitis C: evaluating suitability for drug therapy. Am Fam Physician 2004;69:1429-38.

(2.) NIH consensus statement on management of hepatitis C: 2002. NIH Consens State Sci Statements 2002;19:1-46.

IN REPLY: While I agree with Dr. Steinberg that the pegylated interferon and ribavirin used in the treatment of patients with chronic hepatitis C are difficult agents to use, I disagree with his assertion that there is no evidence for improved patient outcomes with treatment.

Treatment not only "lowers viral RNA loads," but, when successful, appears to eliminate viral RNA entirely. The published treatment response rate of approximately 50 percent is not measured at the end of treatment, but represents the percentage of patients in whom hepatitis C viral RNA continues to be undetectable six months after finishing medication. Follow-up of patients who are RNA negative at six months shows that only 5 to 10 percent of them have had a virologic relapse at five years, with virtually none of those recurrences occurring after year 4. (1)

Other studies (2,3) have shown slowing and even regression of hepatic fibrosis, and a few of the patients in these studies actually regressed from cirrhosis to an earlier stage of fibrosis. Furthermore, among patients receiving treatment, even those who failed to achieve viral elimination showed a cessation of progression of fibrosis while being treated. Among patients who already have cirrhosis at the time of treatment initiation, therapy has been shown to improve survival (risk reduction [RR], 0.54; confidence interval [CI], 0.33 to 0.89) and to reduce the occurrence of hepatocellular carcinoma (RR, 0.65; CI, 0.43 to 0.97]). (4)

The National Institutes of Health consensus statement on the management of hepatitis C does not recommend that all patients with hepatitis C receive treatment, but rather states: "All patients with chronic hepatitis C are potential candidates for antiviral therapy. Treatment is recommended for patients with an increased risk of developing cirrhosis." (5) The decision to treat a patient with hepatitis C frequently is not an easy one and involves balancing the possibilities of cirrhosis, liver cancer, and death against the known side effects of the medications--side effects that, as Dr. Steinberg points out, occasionally may include serious toxicities. My own patient base includes those who have had substantial difficulties in tolerating pegylated interferon and ribavirin and those who have died from hepatitis C and its complications.

These medications are important advances in our ability to treat this illness, and I suspect that the data regarding their benefits are likely to continue to accumulate as longer-term outcome studies become available.

RAYMOND P. WARD, M.D., PH.D.

440 South Medical Drive Bountiful, UT 84010

REFERENCES

(1.) Veldt BJ, Saracco G, Boyer N, Camma C, Bellobuono A, Hopf U, et al. Long term clinical outcome of chronic hepatitis C patients with sustained virological response to interferon monotherapy. Gut 2004;53:1504-8.

(2.) Abergel A, Darcha C, Chevallier M, Ughetto S, Henquell C, Pol S, et al; French Multicentre Study Group. Histological response in patients treated by interferon plus ribavirin for hepatitis C virus-related severe fibrosis. Eur J Gastroenterol Hepatol 2004;16:1219-27.

(3.) Arif A, Levine RA, Sanderson SO, Bank L, Velu RP, Shah A, et al. Regression of fibrosis in chronic hepatitis C after therapy with interferon and ribavirin. Dig Dis Sci 2003;48:1425-30.

(4.) Shiratori Y, Ito Y, Yokosuka O, Imazeki F, Nakata R, Tanaka N, et al; Tokyo-Chiba Hepatitis Research Group. Antiviral therapy for cirrhotic hepatitis C: association with reduced hepatocellular carcinoma development and improved survival. Ann Intern Med 2005;142:105-14.

(5.) NIH consensus statement on management of hepatitis C: 2002. NIH Consens State Sci Statements 2002;19:1-46.

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