**5.3 Safety**

304 New Advances in the Basic and Clinical Gastroenterology

*Zingiber officinale* Pre-clinical Gingerols El-Abhar et al ;

*Cordia dichotoma* Pre-clinical Apigenin Ganjare et al

&

*Vitex negundo* Pre-clinical Unknown Zaware et al

Table 3. Plants and their active constituents for treatment of ulcerative colitis/IBD

regulatory agencies' strict guidelines on the quality and stability of herbal products has led to significant improvements in the quality control of herbal medicines. Recently the herbal manufacturing industry has focused on improving its quality assurance and quality control mechanisms to guard against the frequent episodes of substandard quality and possible adulterations. Use of high-performance liquid chromatograms, thin-layer chromatography, atomic absorption spectroscopy, gas chromatography and where necessary more sophisticated techniques such as NMR and LC/MS has now become common in complementary medicines manufacturing industries to ensure the quality of plant materials and final product (Rosenbloom et al., 2011). The emphasis on good manufacturing practice has steadily increased over years. In addition, new regulatory laws are now in place on product stability to support its shelf life. With the steady progress on different herbal quality control fronts, it is now possible to apply almost the same set of quality standards as for conventional medicines. As most of the traditional herbs listed in this chapter are not commercially manufactured, the data on the quality of these plant medicines is scarce.

Herbal medicines have a long history of traditional use. However, from today's stand point, traditional claims need to be verified. A well-designed randomized controlled trial is essential to determine the efficacy and safety of herbal medicines. The use of standardized herbal extracts in clinical trials is important to obtain reproducible data on the efficacy and safety of herbal medicines. Standardization of herbal extracts has become a common practice in phytomedicines. It allows the establishment of reproducible pharmaceutical quality by comparing a product with established reference substances and by defining the

ursolic acid

*Patrinia scabiosaefolia* Pre-clinical Oleanonic acid, oleanolic acid

**Evidence Chemical Constituents Reference** 

Minaiyan et al

al; Al-Habbal

et al ; Fernandez-Banares et al

Madisch et al ; Holtmeier et al

Cho et al

Oleanolic acid Kim et al; Kaliora et

Unknown Rodriguez-Cabezas

Boswellia acids Kiela et al ;

**Plant Scientific** 

*Pistacia lentiscus* Pre-clinical &

*Plantago ovata* Pre-clinical &

*Boswellia serrata* Pre-clinical &

**5.2 Efficacy** 

clinical

clinical

clinical

The positive attitude towards herbal medicines is based on the testimony that herbs have been used since antiquity and the belief that they have the advantage of being 'natural' rather than 'synthetic'. Traditional healing systems employed herbal medicines for the symptomatic management of diseases. However, these herbs are now being used extensively for health promotion and disease prevention not only in underdeveloped and developing nations, but also increasingly in developed nations. As little is known regarding adverse effects of herbal medicines and their frequencies, the chronic exposure of these herbal ingredients may pose health risks. In particular, when herbs are extracted and purified, their toxicity might be increased due to increased concentration of potential toxic compounds. Therefore, the common assumption that herbal medicines are by inference 'safe' may not be valid by today's health standards.

Generally, traditional herbal medicines lack the following pharmacological data in humans:


Phytochemical and pharmacological (preclinical and clinical) studies are important to address the above issues. The majority of the herbs mentioned in this chapter are tested only in animals. The main focus of these studies has been determining the efficacy of herbal extracts to support their traditional claims. However, it is a common procedure in these animal studies to measure toxic dose of herbal extracts. These toxicological studies are important to provide in vivo data in a whole animal situation on the dose and adverse effects of herbal extracts which may be relevant when tested in humans. None of these studies have reported any major adverse events in the experimental models of various GI disorders.
