Study of Complete Thymic Formula for HCV


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Supplement does not add to hepatitis C treatment

An over-the-counter dietary supplement touted as a remedy for hepatitis C does not appear to be effective in patients who have not responded to conventional treatment, according to a US study.

Nearly 4 million people in the US are infected with the hepatitis C virus (HCV), the leading cause of chronic liver disease in this country. Hepatitis C is usually treated with interferon, an immune system agent that inhibits viral growth. But this therapy has long-term efficacy in only 15% to 20% of cases.

``In addition, many persons cannot tolerate interferon therapy because of its numerous adverse effects,'' the researchers who conducted the new study, Dr. Gary A. Abrams, of the University of Alabama at Birmingham Liver Center, and colleagues, note. Consequently, many patients turn to untested over-the-counter remedies.

In their study, Abrams and colleagues tested one of these over-the-counter remedies, Complete Thymic Formula, among 38 hepatitis C patients who had not responded to or could not tolerate interferon. On the Internet, the manufacturer markets the product as a ``supplement,'' but other websites promote it as a hepatitis remedy.

In the study, roughly half of the patients took Complete Thymic Formula for 3 months, the other half took an inactive pill, or ``placebo.'' After 3 months, patients taking the formula had concentrations of virus in their blood that were just as high as those in patients who had been taking the placebo, the investigators found.

And a subgroup of patients who continued to take the formula for three additional months had the same levels of the virus in their blood at the end of the entire 6-month period as they had at the start of the study, according to the researchers. Moreover, one of the patients developed a condition called thrombocytopenia -- a decrease in the number of platelets, or blood clotting agents, in the blood -- ``that may have been due to use of Complete Thymic Formula,'' Abrams and colleagues report.

Since the study included only HCV patients who did not respond to interferon therapy, ``no conclusions can be drawn... about the use of Complete Thymic Formula therapy by HCV-infected patients who have never received interferon or who have predictors of better response to interferon therapy,'' Abrams and co-authors note.

Complete Thymic Formula contains extracts of thymosin and other thymus gland hormones from cows, and a variety of herbs, vitamins, enzymes, and minerals. Among other things, thymic hormones stimulate the production of interferon, and may enhance immune function.

Findings from one previous study suggest that a combination of interferon and a type of thymosin -- thymosin-alpha 1 -- may be effective among HCV patients never treated with interferon and those who have not responded to interferon, Abrams and colleagues note. ``Whether the combination of Complete Thymic Formula and interferon is beneficial is unknown,'' they write.

``Our results suggest that patients with HCV infection who have received interferon should be advised of the lack of efficacy and the potential risks of Complete Thymic Formula,'' they conclude.

SOURCE: Annals of Internal Medicine 1998;129:797-800.

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