Africa Herbal Antimalaria MeetingNairobi, 20-22 March 2006

Research on Traditional Medicines used for the Treatment of Malaria in WHO African RegionTraditional Medicine Programme, WHO Regional Office for Africa, Brazzaville, Congo

Presented by Dr Mawuli W. Kofi-Tsekpo, PhDKenya Medical Research Institute (KEMRI)Member of WHO Regional Expert Committee on Traditional Medicine

Malaria Burden of Disease The prevalence of malaria has been escalating at an alarming rate and an estimated 300-500 million cases each year cause 1.5 to 2.7 million deaths.More than 90% of the deaths are in children under 5 years of age in Africa. Malaria (which accounts for 9% of global disease burden) ranks third among major infectious disease threats in Africa after pneumococcal acute respiratory infections (3.5%) and tuberculosis (TB) (2.8%).Malaria cases in Africa account for approximately 90% of malaria cases in the world.Between 1994 and 1996, malaria epidemics in 14 countries of Sub-Saharan Africa caused an unacceptably high number of deaths, many in areas previously free of the disease. Adolescents and young adults are now dying of severe forms of the disease.

Factors favouring the spread of malaria

Resistance of parasite to drugs is confounded by regional conflicts forcing mass migration of people to or from infected areas, and migration of non-immune people to infected areas for agricultural reasons

Changing rainfall patterns favouring mosquito breeding sites.

Adverse socioeconomic conditions leading to inadequate health budget to fight malaria

Policy orientations and Commitment of countries and WHOAdoption of Regional Strategy by RC50The April 2001-Abuja Declaration on research of traditional medicinesThe July 2001 - Lusaka Declaration on the decade of African TM (2001-2010)Adoption of global TRM Strategy 2002-2005Malaria, HIV/AIDS, TB and Other Infectious DiseasesAdoption of Plan of Action in 2003 in TripoliWHA56.13Ouagadougou, 2000Alma Ata Declaration, 1978

The Regional StrategyPromoting the Role of Traditional Medicine in Health Systems: A Strategy for the African Region.AFR/RC50/R3:- Resolution of the Regional Committee 31 August 2000

Priority Interventions of the Regional Strategy on Promoting the Role of TM in Health Systems

AFR/RC50/R3 Ouagadougou, Burkina Faso, 2000

CAPACITY BUILDING

POLICY FORMUALATION

RESEARCH PROMOTION

DEVELOPMENT OF LOCAL PRODUCTION

PROTECTIION OF INTELLECTUAL PROPERTY RIGHTS AND TRADITIONAL MEDICAL KNOWLEDGE

Research MethodologyGeneral Objective

Specific Objectives

Preclinical Evaluation/ Retrospective Study /Ethnomedical Evidence

MethodologyCriteria for patient selection (including Inclusion criteria and exclusion criteria)Sample sizeScreening PhaseSerum chemistriesHaematologyTreatment PhaseINFORMED CONSENT

Research MethodologyDrug AdministrationTraditional Herbal Remedy to be testedControl treatmentParasitaemiaSerum chemistriesHaematologyPhysical examination and vital signsElectrocardiogram (ECG) examinations Assessment of Efficacya) Primary outcome measuresb) Secondary outcome measures (optional)Assessment of SafetyDiscontinuation from the study

Countries that are conducting research of traditional medicines used for malaria Burkina FasoDRCGhanaKenyaMadagascarMozambiqueNigeriaSouth AfricaTanzaniaZambiaZimbabwe

The ability to conduct research and the tools and guidelines do exist. However, there is need to build the culture for research in the Region.

Role of TMs in the treatment of malaria

A survey conducted by RBM reported more than 60% of children with high fever due to malaria were successfully treated with herbal medicines in Ghana, Mali, Nigeria and Zambia, (WHO 1998)

Artemisia annua in China, Africa has to find other medicinal plants for malaria

Nascent pilot farms of Artemisia annua in Zimbabwe (Source: WHO/AFRO, 2006)

Nascent pilot farms of Artemisia annua in Zimbabwe (Source: WHO/AFRO, 2006)

Countries locally producing in small-scale traditional medicines for Malaria and HIV/AIDS in WHO African Region (Source: WHO/AFRO, 2006)

The Role of WHO in Research

To provide technical (and financial) support to research institutions and WHO Collaborating centres for research to produce evidence of TMs used for malaria and other priority diseases

To produce tools and guidelines on research methodology for adaptation by countries:

Clinical evaluation of traditional medicines in WHO African Region, Brazzaville, (AFR/EDM/ TRM/04.04)

WHO Guidelines on research methodologies and traditional medicine, Geneva, (WHO/EDM/TRM/2002.1).

Monograph on Artemisia Annua (of which I was chairperson during its review in China)

Guidelines on Good Agricultural and Collection practices of medicinal plants, 2004

Traditional Medicine is our own, if we Africans do not develop it, nobody else will

World Health Organization

* Swedish Parliament - Stockholm, 29-30 May 2002

Logo for African Traditional Medicine

A recent upsurge of malaria in endemic-disease areas with explosive epidemics in many parts of Africa is probably caused by many factors, including rapidly spreading resistance to antimalarial drugs, climatic changes, and population movements.

In the last decade, the prevalence of malaria has been escalating at an alarming rate, especially in Africa. An estimated 300-500 million cases each year cause 1.5 to 2.7 million deaths, more than 90% of the deaths are in children under 5 years of age in Africa.

Malaria (9% of global disease burden) ranks third among major infectious disease threats in Africa after pneumococcal acute respiratory infections (3.5%) and tuberculosis (TB) (2.8%). Malaria cases in Africa account for approximately 90% of malaria cases in the world.

Between 1994 and 1996, malaria epidemics in 14 countries of Sub-Saharan Africa caused an unacceptably high number of deaths, many in areas previously free of the disease. Adolescents and young adults are now dying of severe forms of the disease. Factors favouring the spread of malaria include:

Resistance of parasite to drugs conflicts forcing mass migration of people to or from infected areas migration of non-immune people to infected areas for agricultural reasons

Changing rainfall patterns favouring mosquito breeding sites

Adverse socioeconomic conditions leading to inadequate health budget to fight malaria In 1978, the Alma Ata declaration recognized the role of traditional medicine and its practitioners as important actors for achieving health for All. Since then the WHO Governing bodies at regional and global levels and partners have made recommendations and adopted various resolutions on traditional medicine. These include on: -Legislation-Use of pharmacopoeia-Research-Development of local production-Use of traditional medicinesIn 2000, the fiftieth session of the Regional Committee for Africa, in Ouagadougou, adopted a resolution on Promoting the role of traditional medicine in health systems. This is now the basis for supporting Member states to develop TM in terms of priority interventions. A year later, 2001 in Abuja, the African Union Heads of States and Government declared that research on TMs for Malaria, HIV/AIDS, TB and Other Priority Diseases should be made a priorityThe same year, 2001 in Lusaka, they declared the period 2001-2010 as the decade for African Traditional medicine.

The Fiftieth Session of the WHO Regional Committee for Africa adopted the Regional Strategy on Promoting the Role of Traditional Medicine in Health Systems which has for priority interventions:

Policy formulation where countries are urged to develop tools for institutionalizing TM in health systems

Capacity building Where countries are expected to build capacities in all aspects of TM

Research promotion Countries are urged to conduct relevant research to produce evidence on safety, efficacy and quality of TMs

Development of local production and conservation of medicinal plants Countries are urged to create an enabling political, regulatory and economic environment for LP of TMs and to cultivate large-scale of medicinal plants

Protection of intellectual property rights (IPRs) and traditional medical knowledge countries are encouraged to develop/update legislation for protection of IPRs and indigenous knowledge.

In order to implement the regional strategy component of research and capacity building in research, AFRO has developed guidelines on clinical evaluation of traditional medicines used for treatment of Malaria, HIV/AIDS, diabetes, sickle-cell Anaemia and hypertension. Research and development and local production for medicines used for these diseases should be accelerated.

A number of countries are at different stages of research and development using WHO Protocols. Here you can give an example of your own research.

The ability to conduct research and the tools and guidelines do exist. However, there is need to build the culture for research in the Region.

Apart from HIV/AIDS which is one of the priority diseases for whose treatment research and development must be accelerated, malaria is also one of the diseases with a high morbidity and mortality in the region. Apart from HIV/AIDS which is one of the priority diseases for whose treatment research and development must be accelerated, malaria is also one of the diseases with a high morbidity and mortality in the region.

This is an example of Artemisia annua farms new farms in Zimbabwe. There is a space between the plants because the country would like to alternate it with tea in order to see whether or not the yield is the same.

With WHO Support Kenya Tanzania, Uganda have increased hectares of cultivation of Artemisia annua, a medicinal plant, native in China.

A feasibility study undertaken by the National Institute for Medical Research in Tanzania which is conducting research on Artemisia annua and producing it locally (laboratory scale) revealed that the species grown in Tanzania is more commercially viable than the species in China.

More countries are increasingly requesting WHO to support them for the cultivation of Artemisia annua. However, countries need to:ensure that feasibility studies are conducted to determine the right environment/yield of Artemisia annua; Have a technical know-how for extraction of artemisinin; Extract artemisinin from leaves of Artemisia annua within six months of harvest for a good yield; 4. If Artemisia annua is boiled to 60 degrees the effect diminishes (China uses it as infusion, tea because it has its own traditional technique which maintains its potency)According to an Assessment carried out by Members of REC during 2004-2005, countries that are locally producing TMs used for malaria are: DRC, Mali, Burkina Faso, Ghana, Nigeria, South Africa, Tanzania from locally cultivated Artemisia annua (laboratory production of Dihyro-artemisinin).

In order to support countries to locally produce traditional medicines that are safety, effective and of good quality, WHO has developed a strategic framework on development of local production with support from REC. To provide technical (and financial) support to research institutions and WHO Collaborating centres for research to produce evidence of TMs used for malaria and other priority diseases

To produce tools and guidelines on research methodology for adaptation by countries

Clinical evaluation of traditional medicines in WHO African Region, Brazzaville, (AFR/EDM/ TRM/04.04). This publication includes guidelines on ethonomedical evidence of traditional medicines

WHO Guidelines on research methodologies and traditional medicine, Geneva, (WHO/EDM/TRM/2002.1).

The significance of the main features of the logo are:The map of Africa denotes African ownership of African Traditional Medicine. The medicinal plant, rose-colored pure flower represents the main raw materials used in traditional medicine. The green background of the map of Africa denotes the rich African biodiversity. The blue colour surrounding most of the African continent represents the bodies of water, which surround most of Africa, and are additional sources of some traditional medicines. The golden ring which houses all the other elements is a reflection of the golden competitive advantages that African Traditional Medicine offers with potential impact on the health, economy and development of African communities. The logo will now be used in advocacy materials on African Traditional Medicine.