1. Miracle Herb 2000: A Look at the Evidence Ann Zweber and Roberto Linares Oregon State University College of Pharmacy Introduction Miracle Herb 2000 has been used for weeks in several regions of Kentucky. Natives claim it cures warts and syphilis, as well as cause weight loss. Although many claims have been made, there is little evidence for safety and efficacy. Miracle Herb 2000 is a small shrub that grows on gravel roadsides. It is characterized by small pink leaves, and spikes on stems. Traditionally, the spikes are harvested in the fall and ground into a paste to apply to affected areas. Biochemistry Several studies of active constituents of Miracle Herb 2000 have been reported in the literature. MH 2000 contains a variety of flavones and terpenes which may contribute to its effects 1. One component, alpha hydroxy mega terpene has a unique, and highly unstable pyridine ring system which may disrupt sulfhydryl bonds in susceptible amino acids 2. Drug Action Absorption: Studies of the active components of MH 2000 have demonstrated that several of the are acid labile. Only one product currently available is an enteric coated tablet, possibly circumventing rapid inactivation by gastric acid. Distribution: No studies have been conducted to determine the distribution of MH 2000. xxxx is highly water soluble, indicating that if it is absorbed intact it would not likely distribute to fat tissues Metabolism and excretion: Urinalysis of patients using enteric coated MH 2000 found 15%, 25% and 25% of xxxx excreted unchanged at 4, 6 and 8 hours. Clinical Data Several small studies have been conducted to evaluate the efficacy of Miracle Herb 2000 for the treatment of warts. Results have been inconclusive Yoder, et al 5 conducted a randomized placebo controlled trial with 17 patients and found that Miracle Herb 2000 was no better than placebo for the elimination of warts on elbows. A summary chart would be nice here Wu, Smith, and Holler 6 conducted an open label trial with 23457 patients with chronic warts. After a six week treatment with a 10% solution of Miracle Herb 2000, 65% of the patients reported a reduced number and size of warts. Precautions and possible complications Because of the potential teratogenic effects, MH 2000 should not be used in pregnant of nursing women Animal studies in rats have shown an increase in tumor growth. Patients who are allergic to plants in the Family Micicaceae should not use Miracle Herb 2000. Unwanted effects of Miracle Herb 200 have been reported in some studies. These include: Excessive hair growth (35%) Constipation (14%) Insomnia(5%) Anhedonia (3%) Because Miracle Herb 2000 is metabolized by the cytochrome P450 3A4 enzyme, it may increase levels of the following medications: Yrgiptamine Somalopram Kegrololol MH 2000 may have an additive effect with: Jernilamine Pancreopril Comparison to Conventional Medicine The FDA has approved 3 other treatments for warts. Salicylic acid gel and patches are available without a prescription, and podophyllum toxin is used in a physician’s office. A comparison table of efficacy, treatment regimes, adverse effects, safety, and costs is provided below: MH 2000Salicylic acid gel Salicylic acid patches Podophyllu m toxin Efficacy20%60%63%70% TreatmentApply 6 times daily for 6 months Twice daily for 6 weeks Every 48 hours for 6 weeks Once with follow up in two weeks Adverse effects Excessive hair growth, hernias, cancer Local irritation Local irritation, toxic to … SafetyUnknownContraindi cated in diabetes Contraindic ated in children Costs$4000 for 6 month (full) treatment $15 for 6 weeks (full) treatment $20 for 6 weeks (full) treatment Office visit $75 plus treatment $25 Conclusion The safety and efficacy for Miracle Herb 2000 has not been established. Since herbal products are not regulated by the FDA, quality and standardization of products cannot be assured. Although Miracle Herb 2000 may be safe in small amounts for patients without contraindications, lack of support for its efficacy does not warrant recommendations for use at this time. Conventional treatments not only offer better data to support their use, but they may also be more cost effective and have less adverse effects. References 1 2 3