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Safety of Custom Traditional Chinese Herbal Medicine Practice at Cleveland Clinic


Galina V. Roofener LAc, LCH; Jamie Starkey LAc; Yanming Huang LAc, LCH; Susan Veleber LAc, LCH; Brenda Powell MD 

Cleveland Clinic Wellness Institute, Department of Integrative and Lifestyle Medicine


The goal of this study is to evaluate the safety of Traditional Chinese Herbal Medicine (TCHM) practice at CC CILM.

METHODS:

Patients >12 years old, with a variety of health complaints, not taking anticoagulants or receiving active chemotherapy, with normal liver enzymes and creatinine were qualified to receive TCHM. Patients’ electronic medical records (EMR) were reviewed. Under the supervision of a physician, a licensed Chinese Herbalist prescribed herbal formulas based on TCM diagnosis.
TCHM intake was separated by 2 hours from existing medications and supplements. Concurrent use of multiple supplements and < 5 pharmaceutical drugs was allowed.
Herbal granules manufactured by Kaiser Pharmaceutical Company (Taiwan) and compounded by Crane Herb Pharmacy (USA) were used.

RESULTS:

Over 24 months, 206 patients received 1245 prescriptions, totaling 68,379 doses and199,640 grams. Patients were re-evaluated in person on an as-needed basis. Detailed treatment progress, adverse event and hospitalizations were documented in the patient’s EMR. In the event of any unusual symptom or allergic reaction, patients were instructed to contact a provider.

A complete metabolic panel (CMP) collected at a baseline, 4-8 weeks and 6 months of herbal intake was used to evaluate safety.

CMP results did not detect changes that could be attributed to herbs. Patients reported three cases (1.5%) of mild adverse effects which includes anxiety. nausea and pruritus. All events were reported to The State of Ohio Medical Board according to Ohio law but none required FDA reporting.

CONCLUSION:

This study illustrates THCM as practiced at CC CILM is likely to be safe. This includes TCHM formulas compounded from concentrated 5:1 water-decocted extract granules manufactured according to ISO/IEC 17025:2005 testing lab international standards, compounded according to FDA regulation Title 21 CFR 111., and prescribed according to TCM principles by a licensed Chinese Herbalist.