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THERAPEUTIC MEDICINAL
PLANTS
From Lab to the Market
THERAPEUTIC MEDICINAL
PLANTS
From Lab to the Market

Editors
Marta Cristina Teixeira Duarte
CPQBA/UNICAMP – State University of Campinas
Paulinía, São Paulo
Brazil

Mahendra Rai
Department of Biotechnology
S.G.B. Amravati University
Amravati, Maharashtra
India

p,
A SCIENCE PUBLISHERS BOOK
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 Foreword

Traditional or ethno-medicine represents a series of empirical practices included in the knowledge of a

social group, frequently transmitted orally from one generation to another, with the intention of solving
health problems. It is often strongly connected to religious beliefs and practices of the respective culture.
The knowledge of medicinal or herbal plants is an important component of traditional medicine. Traditional
medicine is used globally and has rapidly growing economic importance. In developing countries, traditional
medicine is often the only accessible and affordable treatment available. In many Asian countries traditional
medicine is widely used, even though western medicine is often readily available. In our time of constantly
expanding pharmacological research it is easy to forget that medicinal plants still continue to play a leading
role in primary health care for 80% of the world’s population living in developing countries. Natural
products and medicinal products derived from them also constitute an essential element in the system of
health care for the remaining 20% of the world population.
In Japan, 60–70% of allopathic doctors prescribe traditional medicines for their patients. In the US
the number of visits to providers of Complementary Alternative Medicine (CAM) now exceeds by far the
number of visits to all primary care physicians. The expense for the use of Traditional and Complementary
Alternative Medicine is exponentially growing in many parts of the world. Traditional knowledge has
proven to be an important source for therapeutic drugs.
The global inventory of plant diversity consists currently of about 350,000 species, and most current
estimates expect about 420,000 plant species to exist. This tremendous diversity accounts for a wide
range of phytochemicals, and a high variation of compound composition even within one single species,
depending on growth conditions (soil, climate, nutrient status, etc.), and harvest practices and timing,
not even taking intraspecific variation into account. While traditional plant use and medicine preparation
normally take these details into account, they are often seen as of marginal importance in the herbal trade.
In the United States, botanical supplements are supposed to be labeled, with the requirement to include the
correct scientific name. However, in practice this does not prevent accidental or deliberate adulterations,
or can contain heavy-metal contaminations. The most problematic occurrence in herbal medicine trade
is, however, linked to the purchase and use, either in medication or research, of botanicals that are either
accidentally or purposefully wrongly identified, or are simply collected under a vernacular name without
any subsequent taxonomic treatment, and often without having any vouchered material that could later
be used for the verification of plant identity. A much more frequent occurrence is, however, the often
deliberate adulteration of botanicals with more common and cheaper species, which, although generally
not toxic, might completely lack efficacy. Bulk herbs are readily available unprocessed, which allows for
the retention of material for a botanical voucher. In contrast, raw botanicals are also often provided in
ground or powdered form, which makes morphological identification very difficult or virtually impossible.
In addition, little research has been done on the efficacy of traditionally made medicinal preparations,
because most efforts have focused on the elucidation of lead compounds and subsequent clinical trials,
with little regard to the correct harvesting or cultivation, and botanical identification of the source material.
One example of the problems of plant collections and markets was illustrated by recent studies in the
markets of La Paz, Bolivia, that focused on plants used for the treatment of urinary infections. One of
the most frequently mentioned herbs was ‘cola de caballo’, horsetail, which normally signifies species
of Equisetum. However, every single vendor in La Paz instead sold it as a species of Ephedra. Not only
does Ephedra not have any properties related to treating urinary infections or inflammations, but also its
main compounds can lead to serious side effects. Without the collection of botanical vouchers, this serious
vi Therapeutic Medicinal Plants: From Lab to the Market

health risk would not have been discovered. This clearly illustrates the great need of more studies that in
fact follow therapeutic medicinal plants from the source to the laboratory.
The present volume is indeed a very worthy effort to outline and address these issues on a global
scale. M.C. Texeira and M. Rai have done great job in bringing a broad field of accomplished contributors
together, who in 19 chapters, illuminate all aspects of medicinal plant use from local collectors and markets
to clinical trials in modern drug development.
Dominguez et al. provide an up to date view on traditional medicine in Mexico, and its translation into
a source for the medicines of tomorrow, while Noun Jihad et al. address the possibilities and limitations of
such an approach by using Lebanon as case study. In their contribution on Cuba, Escalona et al. highlight
the great efforts of this country to create an independent, high-class medicinal system that offers patients the
best of both traditional therapies and their applications in an allopathic setting. The chapter by Bussmann
and Sharon follows a similar trajectory in illustrating the long way from traditional plant collectors to
using medicinal plant extracts in bioassays.
A second set of contributions provides direct insights in applied research. Muñoz-Acevedo et al. review
species from Latin American that could be promising for the cosmetics industry, while Ilhan et al. look at
new remedies for hyperlipidemia, and Rojas and Buitrago as well as Teixeira Duarte and Teixeira Duarte
address the possibilities of finding new antibacterial agents derived from essential oils. This approach
culminates in a plethora of chapters focusing on individual species and the long way from traditional use
to lead compounds in drug discovery: Vinet et al. (Vitis vinifera polyphenols), Al-Nahain et al. (Centella
asiatica), Ríos and Andújar (Crocus sativus), Santana et al. (Euphorbia hirta and E. hyssopifolia), Patil and
Lade (Tribulus terrestris), Rai et al. (Vitex negundo) and Ortega Hernández-Agero (Melissa officinalis).
In a last group of contribution the focus lies on the problems of production, quality control, toxicity
and efficacy testing of herbal medicines. Melillo de Magalhães addresses the challenges in plant cultivation
as first step to provide standardized source material for drug development, while Araujo focuses on the
issue of toxicity in traditionally used medicinal plants. Rodrigues et al. take up the discussion on how to
actually improve the properties and quality of plant extracts, and Mootoosamy and Mahomoodally finally
review the current status of clinical trials of medicinal herbs, and highlight chances and challenges of
future development.
It is to hope that ‘Therapeutic Medicinal Plants: From lab to the market’ will be widely read, and will
become a standard reference for researchers in the whole chain of traditional medicines, from documentation
of traditional medicinal practices, to plant harvest, production and markets, extraction, clinical studies and
finally the elaboration of standardized herbal medicines for a global environment.

Professor Rainer W. Bussmann

William L. Brown Center
Missouri Botanical Garden, P.O. Box 299
St. Louis, MO 63166-0299, USA
phone: (314) 577-9503, facsimile: (314) 577-0800
Email: [email protected]
 Preface

Medicinal plants are known as a natural resource for the cure of different diseases since the dawn of
civilization. They have been used in the prevention, diagnosis and elimination of diseases, and solely
based on practical experience of thousands of years.
There are various reports of medicinal/ethnomedicinal plants by researchers all over the world.
Unfortunately, the research being carried out in laboratories are still restricted to the ‘four walls’ of the
laboratories. There is a greater need to initiate and transform these researches in fruitful formulations
leading to the development of newer products for the cure of diseases with special reference to new and
emerging diseases like AIDS, cancer, hepatitis and also for coping with multidrug resistance problems.
In 21st century, there is a greater need to validate the available knowledge of medicinal plants. World
Health Organization (WHO) emphasized on use of herbal medicines after its validation. The next steps
are formulation and finally the development of medicinal products.
The purpose behind editing a new book, is to gather recent developments in medicinal plant research
for different diseases, formulation of products and market strategy.
The book would be immensely useful for botanists, medicos, ayurvedic experts, traditional healers,
pharmacologists and common people who are interested in curative properties of medicinal plants.
MKR wishes to thank Dr. D.P. Rathod, and Dr. Shubhangi Ingole for their help in editing this work.
Marta Cristina Teixeira Duarte
Mahendra Rai
 Contents

Foreword v
Preface vii
1. Mexican Traditional Medicine: Traditions of Yesterday and 1
Phytomedicines of Tomorrow
Fabiola Domínguez, Angel Josabad Alonso-Castro, Maricruz Anaya,
Ma. Eva González-Trujano, Hermelinda Salgado-Ceballos and Sandra Orozco-Suárez
2. Centella asiatica: From Ethnomedicinal Uses to the Possibility of New Drug Discovery 38
Abdullah Al-Nahain, Rownak Jahan, Taufiq Rahman, Md Nurunnabi and
Mohammed Rahmatullah
3. Melissa officinalis L.: Overview of Pharmacological and Clinical Evidence of the 57
Plant and Marketed Products in Spain
M.T. Ortega Hernández-Agero, O.M. Palomino Ruiz-Poveda, M.P. Gómez-Serranillos
Cuadrado and M.E. Carretero Accame
4. Saffron crocus (Crocus sativus): From Kitchen to Clinic 77
José Luis Ríos and Isabel Andújar
5. Clinical Studies of Traditional Therapeutic Herbs before Marketing: Current 95
Status and Future Challenges
Anushka Mootoosamy and M. Fawzi Mahomoodally
6. Opportunities and Limitations in Medicinal and Aromatic Plants’ Markets and 107
Research in Developing Countries: Lebanon as a Case Study
Karam Nisrine, Noun Jihad, Yazbeck Mariana, Soubra Noura and Talhouk Rabih
7. Mutagenicity, Genotoxicity and Cytotoxicity Assays of Medicinal Plants: 130
First Step for Drug Development
Silvany de S. Araújo, Thaís C.C. Fernandes, Maria A. Marin-Morales,
Ana C. Brasileiro-Vidal and Ana M. Benko-Iseppon
8. The Medicinal Species Euphorbia hirta and E. hyssopifolia (Euphorbiaceae): 154
Uses, Phytochemical Data and Genetic Diversity
Karla C.B. Santana, Diego S.B. Pinangé, Karina P. Randau, Marccus Alves and
Ana M. Benko-Iseppon
9. Traditional Medicine in Cuba: Experience in Developing Products based on 174
Medicinal Plants
Julio C. Escalona, Renato Peres-Roses, Jesús R. Rodriguez, Claudio Laurido, Raúl Vinet,
Ariadna Lafourcade, Luisauris Jaimes and José L. Martinez
x Therapeutic Medicinal Plants: From Lab to the Market

10. Challenges for the Development of A Natural Antimicrobial from Essential Oils 188
Marta Cristina Teixeira Duarte and Renata Maria Teixeira Duarte
11. How to Improve Some Properties and Qualities of Plant Extracts and their 197
Derivatives using Pharmacotechnical Technology Approach
Rodney A.F. Rodrigues, Lais T. Yamane and Verônica S. de Freitas
12. Cultivation and Utilization of Medicinal Plants for Development of Products 217
Pedro Melillo de Magalhães
13. Essential Oils and their Products as Antimicrobial Agents: Progress and Prospects 253
Janne Rojas and Alexis Buitrago
14. Some Latin American Plants Promising for the Cosmetic, Perfume and 279
Flavor Industries
Amner Muñoz-Acevedo, Erika A. Torres, Ricardo G. Gutiérrez, Sandra B. Cotes,
Martha Cervantes-Díaz and Geovanna Tafurt-García
15. The Therapeutic Potential of Products based on Polyphenols from Wine Grapes in 331
Cardiovascular Diseases
Raúl Vinet, José Luis Martínez and Leda Guzmán
16. From Plant Collection to Lab and Market—Traditional Medicine in Northern Peru 343
Rainer W. Bussmann and Douglas Sharon
17. An Update on Plant Originated Remedies for the Medication of Hyperlipidemia 353
Mert Ilhan, Ipek Süntar and Esra Küpeli Akkol
18. Pharmacological Aspects of Tribulus terrestris Linn. (Goksura): Progress and Prospects 375
Anita Patil and Bipin D. Lade
19. Vitex negundo: Bioactivities and Products 392
Gauravi Agarkar, Priti Jogee, Priti Paralikar and Mahendra Rai
Index 407
 1
Mexican Traditional Medicine:
Traditions of Yesterday and
Phytomedicines of Tomorrow
Fabiola Domínguez,1 Angel Josabad Alonso-Castro,2
Maricruz Anaya,1 Ma. Eva González-Trujano,3
Hermelinda Salgado-Ceballos4 and Sandra Orozco-Suárez4,*

Introduction
The arrival of the Spaniards radically modified the native medicine practices of the Aztecs and the use of
medicinal plants. Diverse colonial documents, such as those of Martín de la Cruz, Juan Badiano, Bernardino
de Sahagún and Francisco Hernandez, provide examples of the use of medicinal plants from the viewpoint
of the Aztecs in works such as Libellus de Medicinalibus Indorum Herbis (Little Book of the Medicinal
Herbs of the Indians). Additional works describe the actions of Mexican medicinal plants and suggest
their usefulness, such as Historia de las cosas dela Nueva España (General History of the Things of the
New Spain) by Fray Bernardino de Sahagún (Viesca 1992, Viesca 1996).
Libellus de Medicinalibus is a manuscript completed in Mexico in 1552 which refers to native
medicinal plants, the curative effects of which were indicated in Latin texts. This medicinal ‘herbarium’
was written with the intention of showing the King of Spain the rich variety of medicinal plants that grew
in the New World. An elderly Indian physician and a native of Tlatelolco, Martín de la Cruz, described
the use of each of plant and provided drawings of them, and Juan Badiano (a young Indian) translated the
material from Nahuatl into Latin. This book was housed in the archives of the Vatican Library in Rome
and was rediscovered in the 20th century by U.S. historians, who confused it with a pre-Hispanic Aztec
codex and renamed it the Cruz-Badiano Codex or the Badiano Codex (Garibay 1964, De la Cruz 1964).
This codex is currently found at the National Museum of Anthropology in Mexico City.

1
Centro de Investigación Biomédica de Oriente, IMSS.
2
Departamento de Farmacia, División de Ciencias Naturales y Exactas, Universidad de Guanajuato.
3
Dirección de Investigaciones en Neurociencias, Instituto Nacional de Psiquiatría Ramón de la Fuente Muñiz.
4
Unidad de Investigación Médica en Enfermedades Neurológicas, Hospital de Especialidades Centro Médico Nacional Siglo
XXI, IMSS. Av. Cuauhtémoc 330 Col. Doctores, 06720, México DF. México.
* Corresponding author: [email protected]
2 Therapeutic Medicinal Plants: From Lab to the Market

In modern times, formal medical research of the codex and other texts began during the Porfirian
era, in the last two decades of the 19th century. A major progression in formal medical research occurred
in 1888, when the National Medical Institute in Mexico was created by the order of President Porfirio
Díaz. The objective of the Institute was to conduct studies of the Mexican medicinal flora with the goal of
incorporating medicinal plants into therapeutics at the national level. By 1915, the herbarium possessed
14,000 classified species and approximately 1,000 chemical compounds that were obtained from plants
(García 1981). However, the modern era of interest in the chemistry of natural products surged in Mexico
from 1940–1960 during the boom of steroidal sapogenins from inedible Mexican yams, which were used
as a source of progesterone (Gereffi 1978). Indeed, this became the cornerstone of the Syntex Company
that was founded in Mexico. Syntex initiated a true worldwide revolution in the organic synthesis of
steroidal hormones; it was the first to achieve the synthesis of progesterone and cortisone. Additionally, the
Syntex Company provided the basis for the first contraceptive, which was derived from the chemical and
ethnobotanical studies of Russell Earl Marker concerning the chemical diosgenin that was obtained from
the ‘cabeza de negro’ (black head) plant (Dioscorea mexicana) and later from the ‘barbasco’ (Dioscorea
composita) plant. The barbasco plant is an endemic species of Mexico (Soto 2005). In 1975, the Mexican
Institute for the Study of Medicinal Plants (IMEPLAM) was created. This institute was founded for the
multidisciplinary study of the plants most widely used in Mexico to treat common illnesses. The Institute
included historians, agronomical engineers, botanists, physicians, physiologists, chemists, and pharmacists
that were under the direction of Dr. Xavier Lozoya. During the existence of IMEPLAM (1975–1980),
numerous publications were produced, thus establishing the Institute as an icon in the research of medicinal
plants in Latin America and reactivating this type of research (Lozoya 1976). At the same time, the Institute
initiated the formation of the Medicinal Herbolarium, currently known as the Medicinal Herbolarium of
the Mexican Institute of Social Security (IMSS), which is located at the Twenty-First Century National
Medical Center in Mexico City. Its legacy comprises >120,000 specimens (Zolla 1980, Montes and Montes
2005). In 1980, the IMEPLAM became part of the IMSS Medical Research System.
The IMEPLAM embodied the tendencies of the 1960s with respect to the increased research interest in
natural plant drugs, including: a) the Indian Rauwolfia drugs and their derivatives, which were demonstrated
to successfully treat various mental disorders and other diseases; and b) the plant-derived drugs that induce
psychotic symptoms akin to symptoms of mental illnesses. Indeed, interest in such psychosis-inducing
drugs, which were traditionally used by healers and medicine men of ‘primitive’ cultures, resulted in an
extensive search for substances possessing hallucinogenic properties (Viesca et al. 2000).
At the end of the 20th century, a second stage of studies on medicinal plants and their therapeutic
potential ushered in a new era of phytopharmaceuticals. Currently, new mechanism actions are being
proposed to explain the pharmacological effects of these plant extracts on several activities and functions.
In recent years, there has been a rapid increase in global technological and economic potential that
has resulted in an increased ability to overcome problems related to poverty and poor health. However,
many developing countries have an impaired health status due to the resurgence of infectious diseases and
an increasing burden of noncommunicable diseases.
There are numerous methods to improve results in the healthcare sector including prevention, healing
with an existing treatment, and research into better methods of prevention, diagnosis or treatment. Research
results obtained for the prevention, diagnosis and treatment of diseases are reported to apply the gained
knowledge in solving health problems. Generally, research results are disclosed in articles published in
biomedical journals and/or theses.
However, commercially sponsored research results for drug, diagnostic and treatment techniques must
be intellectually protected to obtain a health registry for proper marketing. One or more patents are used
for the intellectual protection of research results. A patent has two important functions: protection, which
allows the patent owner to exclude others from commercially exploiting the invention for a period of 20
years; and disclosure, because the patent provides information that can stimulate technological innovation.
In Mexico, the Mexican Institute of Industrial Property grants government patents. This type of
intellectual protection is regulated by the Industrial Property Act and its rules. There have been no objections
to granting phytomedicine patents; however, the invention must meet three basic criteria for patentability:
novelty, inventive step, and industrial application.
 Mexican Traditional Medicine: Traditions of Yesterday and Phytomedicines of Tomorrow 3

The novelty criterion specifies that the invention is not derived from technical knowledge available to
the public worldwide prior to the first filing date of the relevant patent application. The inventive criterion
specifies that the invention would not have been obvious to a person skilled within the applicable field of
technology. The industrial application criterion specifies that the invention must be capable of being used
for industrial or business purposes.
In Mexico, there are few phytomedicine patents. As shown (Table 1.1), the first patent application
in this area was in 2005 and to date there have been a total of 27 patent applications. It should be noted
that 12 applications belong to the Mexican Social Security Institute. Medical applications of these patent
applications include substances that have anti-inflammatory, anti-microbial, anti-neoplastic, and anti-
hypertensive activity.
After scientists have identified specifically targeted new entities for disease diagnosis, treatment or
pharmaceutical purposes, preclinical studies are undertaken comprising in vitro studies, animal testing
and pharmacodynamic responses.

Table 1.1. Mexican patent applications of phytomedicines.

Phytomedicines Medical application Patent

Agave marmorata Treating chronic degenerative diseases MX2012010587
Tournefortia densiflora Treating microbial infections in skin MX2012007255
Buddleia cordata Treating the discomforts generated by any type of MX2012006934
gastritis
Salvia elegans Treating the comorbidity of high blood pressure MX2012006426
disorders with anxiety
Ageratina pichinchensis Treating chronic venous ulcers MX2012002783
Sechium chinantlense & Sechium Preventing and/or treating neoplasms MX2012002675
compositum
Cydonia oblonga Anti-inflammatory MX2012002190
Bougainvillea xbuttiana Anti-inflammatory MX2011013522
Matricaria recutita & Calendula officinalis Promoting the integrity of the corneal epithelium MX2011013407
Stevia rebaudiana Treating ocular diseases MX2011013620
Taxus globosa Treating anxiety MX2011010853
Capsicum annum Treating gastrointestinal problems MX2011009963
Loselia mexicana Treating anxiety MX2011009446
Hibiscus sabdariffa Anti-hypertensive MX2011006660
Ageratina pichinchensis Treating wound healing, and tinea MX2011005607
MX2007013011
Petiveria alliacea Treating of rheumatic diseases MX2011003459
Amphipterygium adstringens Treating skin lesions MX2010013512
Heteropterys brachiata Treating anxiety MX2010007355
Cladocolea loniceroides Treating breast cancer MX2010006779
Psittacanthus calyculatus Anti-hypertensive MX2010004628
Galphimia glauca Treating anxiety MX2009007792
Fluorensia cernua Anti-microbial agent against periodontopathogenic MX2009007244
bacteria
Psidium sartorianum Anti-parasitic MX2009004174
Allium spp. Treating diabetic foot MX2007016417
Echinacea angustifolia Treating gingivitis MX2005013173
Psidium guajava Treating gastrointestinal problems MX2005002081
4 Therapeutic Medicinal Plants: From Lab to the Market

It is necessary to have the proper authorization to market phytomedicines. In Mexico, the Federal
Commission against Health Risk (COFEPRIS, for its acronym in Spanish) is responsible for granting the
medical authorization for proper marketing. The COFEPRIS approval process begins when a manufacturer
requests permission, by submitting an investigational new drug application, to begin human testing. The
application must provide high quality preclinical data to justify the testing of the drug in humans.
The next stage is clinical trials, which use human subjects. Clinical trials include biopharmaceutical,
pharmacokinetic, pharmacodynamic, efficacy, safety and studies designed to demonstrate the proposed
therapeutic application. After application approval, the innovating company is allowed to distribute and
market the drug.
However, despite the existence of phytomedicine patent applications, there have not been any
clinical trials conducted that led to marketing authorization. There are various clinical trials of Mexican
phytomedicines (Table 1.2). However, these clinical trials were not registered with the COFEPRIS.
For example, a double-blinded randomized clinical trial was conducted in 197 women with primary
dysmenorrhea. Four intervention groups were defined: two extract doses of Psidium guajava (3 and 6 mg/
day), ibuprofen (1200 mg/day) and placebo (3 mg/day). Participants were individually followed up for
four months. The main outcome variable was abdominal pain intensity measured according to a visual
analogue scale. The standardized phytomedicine reduced menstrual pain significantly compared with
conventional treatment and placebo (Doubova et al. 2007). Currently, the patent for this phytomedicine
has been granted and the Mexican Social Security Institute (IMSS) has granted an operating license to the
company, Genomma Lab®. This phytomedicine is marketed under the name QG5®.

Table 1.2. Mexican clinical trials of phytomedicines.

Phytomedicines Clinical trial Reference

Solanum chrysotrichum Safety and effectiveness for the treatment of Tinea pedis Herrera-Arellano et al. 2003
Hibiscus sabdariffa Anti-hypertensive effectiveness and tolerability Herrera-Arellano et al. 2004
Galphimia glauca Efficacy and tolerability on generalized anxiety disorder Herrera-Arellano 2007
Ageratina pichinchensis Effectiveness and tolerability on patients with mild to mod- Romero-Cerecero et al. 2008
erate onychomycosis

Data on patent applications and registration of herbal medicines demonstrate that Mexico lacks an
adequate structure for phytomedicine development. This weakness is not due to Mexican scientific research,
because research on natural products in Mexico has flourished since 1960 and has resulted in extensive
literature concerning secondary metabolites in Mexican plants (Huerta-Reyes and Aguilar-Rojas 2009)
including anti-cancer (Alonso-Castro et al. 2011) not given in reference section and anti-diabetic agents
(Mata et al. 2013).
Despite the high scientific, technical level and experience of Mexican researchers, the low numbers
of phytomedicine patent applications may be attributed to several factors, such as: scientific evaluation
criteria, which are mainly based on recognition by the scientific community from publication within
indexed periodicals; lack of information about the patent database (both free access and private); and low
knowledge about patentability requirements, particularly the novelty criterion. Similarly, a strong policy
of disclosure in the drug registration system is required because regulatory constraints lead to high costs
for companies and there is a lack of information about the key steps required for medical authorization.
Finally, a policy allowing cohesion between university-business-government to foster phytomedicine
research, health registration and extensive marketing is necessary.

Herbalists Drugs (Phytomedicines)

Serenoa repens (W. Bartram) Small (Arecaeae) (001P2001, Tegrata; 044P2003, prostasan; oleomed p,
042P2003), a shrub-like species native to Mexico, the southeastern USA and West Indies, is used for the
treatment of prostatic hyperplasia (Capasso et al. 2003). This plant contains fatty acids and their glycerides
 Mexican Traditional Medicine: Traditions of Yesterday and Phytomedicines of Tomorrow 5

(oleic, caprylic, myristic, etc.), sterols (e.g., β–sitosterol, campesterol, and cycloartenol) and sitosterol
derivatives (Capasso et al. 2003). The therapeutic effects of this plant have been associated with the
down-regulation of inflammation-related genes and the activation of the nuclear factor-kappa B pathway
in prostate tissue (Silvestri et al. 2013). A clinical study indicated that this preparation improved physical
symptoms caused by prostatic hypertrophy (Coulson et al. 2013).

Hypericum perforatum L. (Hypericaceae) (005P2001, Conexit; 024P2003, Motivare), a plant native to

Europe, is used for the treatment of wounds, eczema, burns, trauma, rheumatism, neuralgia, gastroenteritis,
ulcers, hysteria, bedwetting and depression (Ghasemi-Pirbalouti et al. 2014). The chemical constituents
reported in this plant are α and β pinene, hypericin and hyperforin (Crupi et al. 2013). It has been
proposed that the pharmacological effects of this plant are involved in the regulation of genes that control
hypothalamic-pituitary-adrenal axis function and partially influence stress-induced effects on neuroplasticity
and neurogenesis (Crupi et al. 2013). A review indicated that Hypericum perforatum significantly decreased
depression when compared with placebo in 25 trials involving a total of 2129 patients (van der Watt et
al. 2008).

Valeriana officinalis L. (Caprifoliaceae) (006P2001, Tegrarina; 011P2001, Insocaps; 020P2003, Lerisor;

010P2005, Ansisom), native to Europe and Asia and commonly known as valerian, has been used for the
treatment of dysmenorrhea, anxiety, insomnia, seizures and migraine. Felgentreff et al. (2012) reported
the presence of valerenic acid and acetoxy valerenic acid in this plant. Fernández-San-Martín et al. (2010)
demonstrated that valerian extract increased subjective sleep quality compared with a placebo. However,
other reports indicate that valerian decreases fatigue in patients, but its efficacy to improve sleep needs
to be clarified (Barton et al. 2011). Furthermore, patients with generalized anxiety disorder who received
valerian during a four-week period had a significant improvement in the Hamilton Rating Scale for Anxiety,
but not in total anxiety scores (Andreatini et al. 2002). However, Valeriana officinalis is reported to induce
hepatotoxicity (Cohen and Del Toro 2008, Vassiliadis et al. 2009).

Piper methysticum G. Forst (Piperaceae), commonly known as kava, is distributed throughout the South
Pacific and is used for the treatment of anxiety and stress. Traditionally, kava extracts are prepared from
masticated rhizome roots that are combined with coconut milk or water (La Porte et al. 2011). The major
active constituents responsible for the pharmacological effects of kava are known as kavalactones or
kavapyrones (Bilia et al. 2002). The anxiolytic activity of kava is controversial. There are reports that kava
induces moderate anxiolytic effects (Sarris et al. 2012), whereas other reports indicate that kava lacks an
anxiolytic effect (Sarris et al. 2009, Sarris et al. 2012). Nevertheless, prolonged treatment with kava has
been demonstrated to induce hepatotoxicity (Teschke 2011).

Valeriana officinalis L. (Caprifoliaceae) and Melissa officinalis L. (Lamiaceae) (008P2001, Pokan;

003P2005, Isoren). Melissa officinalis L. (Lamiaceae), a perennial herb commonly known as lemon balm,
is native to South Central Europe and the Mediterranean region. Its potentially active components include
monoterpenoids and sesquiterpenes including geranial, neral, 6-methyl-5-hepten-2-one, citronellal, geranyl-
acetate, b-caryophyllene and b-caryophyllene-oxide, and 1, 8 cineole (Tittel et al. 1982). Clinical trials
have demonstrated that Melissa officinalis exerts an anxiolytic-like modulation of mood (Kennedy et al.
2002, Kennedy et al. 2004). The combination of Melissa officinalis and Valeriana officinalis reduced the
levels of sleep disorders in menopausal women compared with a placebo (Taavoni et al. 2013).

Gingko biloba L. (Gingkoaceae) (009P2001, Tegramen; 001P2003, Nemoril, 003P2003, Kolob; 022P2004,
Maxibiloba; Oleomed cer 014P2004; 013P2004, G-Kroll; 006P2004, Fylgoba) is used for failing memory,
age-related dementias and poor cerebral and ocular blood flow. However, this species is under threat of
extinction (IUCN 2012).

Tanacetum parthenium (L.) Sch. Bip., and Matricaria chamomilla L. (Asteraceae) (010P2001, Plusan).
Tanacetum parthenium is an aromatic herb, commonly known as feverfew, native to the Balkan Peninsula.
Tanacetum parthenium has been used as a folk remedy for fever, rheumatoid arthritis and migraines.
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