dissertation on herbal medicine

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The growing use of herbal medicines: issues relating to adverse reactions and challenges in monitoring safety

The use of herbal medicinal products and supplements has increased tremendously over the past three decades with not less than 80% of people worldwide relying on them for some part of primary healthcare. Although therapies involving these agents have shown promising potential with the efficacy of a good number of herbal products clearly established, many of them remain untested and their use are either poorly monitored or not even monitored at all. The consequence of this is an inadequate knowledge of their mode of action, potential adverse reactions, contraindications, and interactions with existing orthodox pharmaceuticals and functional foods to promote both safe and rational use of these agents. Since safety continues to be a major issue with the use of herbal remedies, it becomes imperative, therefore, that relevant regulatory authorities put in place appropriate measures to protect public health by ensuring that all herbal medicines are safe and of suitable quality. This review discusses toxicity-related issues and major safety concerns arising from the use of herbal medicinal products and also highlights some important challenges associated with effective monitoring of their safety.

INTRODUCTION

The use of herbal medicines and phytonutrients or nutraceuticals continues to expand rapidly across the world with many people now resorting to these products for treatment of various health challenges in different national healthcare settings ( WHO, 2004 ). This past decade has obviously witnessed a tremendous surge in acceptance and public interest in natural therapies both in developing and developed countries, with these herbal remedies being available not only in drug stores, but now also in food stores and supermarkets. It is estimated that up to four billion people (representing 80% of the world’s population) living in the developing world rely on herbal medicinal products as a primary source of healthcare and traditional medical practice which involves the use of herbs is viewed as an integral part of the culture in those communities ( Mukherjee, 2002 ; Bodeker et al., 2005 ; Bandaranayake, 2006 ).

The use of herbal remedies has also been widely embraced in many developed countries with complementary and alternative medicines (CAMs) now becoming mainstream in the UK and the rest of Europe, as well as in North America and Australia ( Committee on the Use of Complementary, and Alternative Medicine by the American Public, Board on Health Promotion, and Disease Prevention, Institute of Medicine, 2005 ; Calapai, 2008 ; Braun et al., 2010 ; Anquez-Traxler, 2011 ). In fact, while places like the UK have a historical tradition of using herbal medicines ( Nissen, 2010 ), the use is also widespread and well established in some other European countries ( Calapai, 2008 ). In these developed countries, the most important among many other reasons for seeking herbal therapy is the belief that it will promote healthier living. Herbal medicines are, therefore, often viewed as a balanced and moderate approach to healing and individuals who use them as home remedies and over-the-counter drugs spend huge amount of money (in excess of billions of dollars) on herbal products. This explains in part the reason sales of herbal medicines are booming and represents a substantial proportion of the global drug market ( Roberts and Tyler, 1997 ; Blumenthal et al., 1998 ; WHO, 2002a ; Kong et al., 2003 ; Pal and Shukla, 2003 ; WHO, 2005a ; Bandaranayake, 2006 ).

As the global use of herbal medicinal products continues to grow and many more new products are introduced into the market, public health issues, and concerns surrounding their safety are also increasingly recognized. Although some herbal medicines have promising potential and are widely used, many of them remain untested and their use also not monitored. This makes knowledge of their potential adverse effects very limited and identification of the safest and most effective therapies as well as the promotion of their rational use more difficult ( WHO, 2002b ). It is also common knowledge that the safety of most herbal products is further compromised by lack of suitable quality controls, inadequate labeling, and the absence of appropriate patient information ( Raynor et al., 2011 ). It has become essential, therefore, to furnish the general public including healthcare professionals with adequate information to facilitate better understanding of the risks associated with the use of these products and to ensure that all medicines are safe and of suitable quality. Discussion in this review is limited to toxicity-related issues and major safety concerns arising from the use of herbal medicines as well as factors promoting them. Some important challenges associated with effective monitoring of safety of these herbal remedies are also highlighted with a view to helping refocus relevant regulatory agencies on the need for effectiveness and ensuring adequate protection of public health and promoting safety.

FACTORS RESPONSIBLE FOR INCREASED PATRONAGE AND SELF-MEDICATION WITH HERBAL MEDICINE

Essentially, herbal remedies consist of portions of plants or unpurified plant extracts containing several constituents which are often generally believed to work together synergistically. The recent resurgence of public interest in herbal remedies has been attributed to several factors some of which include (i) various claims on the efficacy or effectiveness of plant medicines, (ii) preference of consumers for natural therapies and a greater interest in alternative medicines, (iii) erroneous belief that herbal products are superior to manufactured products, (iv) dissatisfaction with the results from orthodox pharmaceuticals and the belief that herbal medicines might be effective in the treatment of certain diseases where conventional therapies and medicines have proven to be ineffective or inadequate, (v) high cost and side effects of most modern drugs, (vi) improvements in the quality, efficacy, and safety of herbal medicines with the development of science and technology, (vii) patients’ belief that their physicians have not properly identified the problem; hence the feeling that herbal remedies are another option, and (viii) a movement toward self-medication ( Bandaranayake, 2006 ).

The increasing utilization of herbs for self-medication by patients or individuals is also attributed to a number of other reasons such as (i) patients being uncomfortable about discussing their medical problems and fear lack of confidentiality in handling their health information, (ii) fear of possible misdiagnosis and wrong treatment by patients with non-specific symptoms or general malaise, and (iii) lack of time to see a physician; this is usually a reason where prior visit did not yield any positive experience ( Studdert et al., 1998 ). Furthermore, patients’ freedom of choice of a practitioner is also encouraging their utilization of alternative treatments and herbal remedies, although many select herbal medicines from a deductive approach based on anecdotal information, that is, “it worked for my friend or relative” ( Parle and Bansal, 2006 ). So also, because of the influence of religion and greater level of spiritual consciousness, many individuals tend to be increasingly disposed to accepting therapeutic value of a treatment based on faith or intuition rather than scientific reasoning ( Astin, 1998 ; Zeil, 1999 ). Herbal medicines, therefore, become particularly alluring when the body’s natural capacity for self-repair, given appropriate conditions, is emphasized ( Parle and Bansal, 2006 ).

In addition to all these above-mentioned factors, the marketing strategies and efforts by various manufacturers of herbal medicines and their sales representatives have seriously projected these products into greater limelight. Various advertisements in the mass media including television and radio programmes have significantly increased consumers’ awareness and given the herbal products undue respectability and credibility ( Brevort, 1998 ; Parle and Bansal, 2006 ). These advertisements are carefully presented to attract the different age groups of people that exist in the society. Children are encouraged to use herbs for their nutritional values to facilitate normal or healthy growth and development; young persons for their euphoric effects, supply essential ingredients to help them cope with daily stress and to prevent or slow the onset of aging; older persons for their anti-aging or rejuvenating effects and women for slimming and beauty enhancing effects ( Parle and Bansal, 2006 ).

INFLUENCE OF REGULATORY POLICIES ON SAFETY OF HERBAL MEDICINES

It has been observed that most of the problems associated with the use of traditional and herbal medicines arise mainly from the classification of many of these products as foods or dietary supplements in some countries. As such, evidence of quality, efficacy, and safety of these herbal medicines is not required before marketing. In the same vein, quality tests and production standards tend to be less rigorous or controlled and in some cases, traditional health practitioners may not be certified or licensed. The safety of traditional and herbal medicines has therefore become a major concern to both national health authorities and the general public ( Kasilo and Trapsida, 2011 ).

Until 2011, there were three possible regulatory routes by which an herbal product could reach a consumer in the UK. The unlicensed herbal remedy is the commonest route which does not have to meet specific standards of safety and quality neither is it required to be accompanied by safety information for the consumer ( Raynor et al., 2011 ). Recently, the European Union (EU) implemented a directive after a 7-year transition period to harmonize the regulation of traditional herbal medicine products across the EU and establish a simplified licensing system in order to help the public make informed choices about the use of herbal products. This requires that all manufactured herbal products either gain a product license of the type needed to manufacture “conventional” products or become registered as a “traditional herbal medicinal product” ( Routledge, 2008 ; Raynor et al., 2011 ).

Like conventional medicines, licensed herbal medicines hold a product license based on safety, quality, and efficacy. Hence, it is compulsory that they are accompanied by comprehensive information such as indications, precautions, how to use the product, side effects, how to store the product and regulatory information, for safe use. This information is usually provided on a leaflet inserted into the product package ( Raynor et al., 2011 ). On the other hand, due to insufficient evidence of reproducible efficacy to meet regulatory standards, license cannot be obtained for some herbal medicines to sell these products. This led to the creation of a new category of traditional herbal registration (THR) with a transition period of seven years ( European Union Herbal Medicines Directive, 2004 ). In line with this, the Traditional Herbal Medicines Registration Scheme, which is a “simplified registration scheme,” was introduced in the UK. In this scheme, herbal medicinal products are required to meet specific standards of safety and quality, agree upon indications for use based on their traditional use and also provide information in a leaflet to promote safe use of the product by the purchaser ( Raynor et al., 2011 ). However, this is not the case in many other parts of the world, especially in the developing countries where many unregistered and poorly regulated herbal products are sold freely on the market with little or no restraint. Furthermore, the common misconception that natural products are not toxic and are devoid of adverse effects often lead to improper use and unrestrained intake and this has also resulted in severe poisoning and acute health problems. This misconception is not limited to the developing countries. It also exists in highly developed countries, where the general public often resorts to “natural” products without any proper awareness or information on the associated risks, particularly in the event of excessive or chronic use ( UNESCO, 2013 ).

TOXICITY AND ADVERSE HEALTH EFFECTS OF SOME COMMON HERBAL MEDICINES

In most countries, herbal medicines and related products are introduced into the market without any mandatory safety or toxicological evaluation. Many of these countries also lack effective machinery to regulate manufacturing practices and quality standards. These herbal products are continuously made available to consumers without prescription in most cases and the potential hazards in an inferior product are hardly recognized ( Bandaranayake, 2006 ).

It is important to reiterate the staggering rate at which interest and use of herbal medicines is expanding. Over the past decade, the use of herbal medicines represents approximately 40% of all healthcare services delivered in China while the percentage of the population which has used herbal medicines at least once in Australia, Canada, USA, Belgium, and France is estimated at 48%, 70%, 42%, 38%, and 75%, respectively ( Foster et al., 2000 ; WHO, 2002b ). In spite of the positive perception of patients on the use of herbal medicines and alleged satisfaction with therapeutic outcomes coupled with their disappointment with conventional allopathic or orthodox medicines in terms of effectiveness and/or safety ( Huxtable, 1990 ; Abbot and Ernst, 1997 ), the problem of safety of herbal remedies continues to remain a major issue of concern.

The general perception that herbal remedies or drugs are very safe and devoid of adverse effects is not only untrue, but also misleading. Herbs have been shown to be capable of producing a wide range of undesirable or adverse reactions some of which are capable of causing serious injuries, life-threatening conditions, and even death. Numerous and irrefutable cases of poisoning have been reported in the literature ( Vanherweghem and Degaute, 1998 ; Cosyns et al., 1999 ; Ernst, 2002 ). The toxicity evaluation of the polyherbal formula, Yoyo “Cleanser” Bitters®, conducted recently in our laboratory ( Ekor et al., 2010 ), was prompted by an unpublished case report of a young male adult who had been on self-medication with this herbal product and was subsequently admitted to the hospital on account of liver failure. Yoyo “Cleanser” Bitters® is one of the herbal remedies that is widely advertised in the various Nigerian media and as such has gained so much public acceptance over time and continues to enjoy increased patronage among consumers, especially in the southwestern part of the country. Our study revealed that this herbal formula was capable of elevating plasma levels of liver enzymes and inducing hypokalemia following 30 days administration in rats. From our observation, the potassium loss (which is capable of predisposing to dangerous arrhythmias) was a greater risk associated with this herb during this sub-acute exposure or toxicity study. Prior to this study, we had evaluated the safety of “super B blood purifier” and “super B seven keys to power” mixtures in experimental model over a decade ago ( John et al., 1997 ). These herbal mixtures were marketed by a registered Nigerian company which cultivated medicinal plants and manufactured medicinal herbal preparations. The herbal blood tonics were well patronized by common folks who claim their efficacy according to the manufacturer’s stipulation that “they are safe, give strength and cleanse the blood and body of infection.” We obtained the herbal constituents ( Entandrophragma utile and Anacardium occidentalis ) and investigated the individual plant extract as well as the herbal tonics made from them. Although, all the extracts and tonics proved safe during acute toxicity study, chronic toxicity testing revealed splenic enlargement in 10% of mice that received E. utile or either of the two tonics and one case of lung tumor ( John et al., 1997 ). Recently, Auerbach et al. (2012) reported an association between traditional herbal medicine use and the development of liver fibrosis among study participants in Uganda. A number of Chinese herbal medicines and other herbal medicines from different parts of the world have also been implicated in cases of poisoning. Many of them have been shown to contain toxic compounds which are capable of reacting with cellular macromolecules including DNA, causing cellular toxicity, and/or genotoxicity ( Rietjens et al., 2005 ). For the purpose of brevity and other obvious constraints, adverse reactions of only a few commonly used herbal medicines are described below.

ARISTOLOCHIC ACIDS AND Aristolochia SPECIES

Following the discovery of the nephrotoxic and carcinogenic potentials of aristolochic acids ( Vanherweghem et al., 1993 ), several studies confirmed their genotoxic activity ( Kohara et al., 2002 ; Fang et al., 2011 ; Hwang et al., 2012 ). Schmeiser et al. (1996) demonstrated the presence of aristolochic acids-related DNA adducts in renal tissues of patients. These mutagenic adducts when formed are usually poorly repaired ( Sidorenko et al., 2012 ) and are capable of persisting for years in DNA ( Nortier et al., 2000 ). Aristolochic acids I and II have been identified in different Asian medicinal plants and also reported to be present in slimming products. This has led to the banning of medicinal products containing these acids in Belgium, UK, Canada, Australia, and Germany ( Hashimoto et al., 1999 ; Lee et al., 2002 ; Zhou et al., 2013 ).

Misidentification of medicinal plants and mislabeling herbal medicinal products are sometimes responsible for some of the observed adverse events or interaction and that is the reason it is important to assess herbal medicines for possible presence of adulterants. In the UK and many other countries Aristolochia fangchi was linked to the development of subacute interstitial fibrosis of the kidney referred to as “Chinese herbs nephropathy” ( Cosyns et al., 1994 ; Tanaka et al., 1997a , b ; Stengel and Jones, 1998 ; Lord et al., 1999 ). Also, recently a 75-year-old man was reported to have died in Australia from kidney failure associated with a toxic preparation containing the root of Aristolochia fangchi which he purchased over the internet for psoriasis ( Chau et al., 2011 ). This case report suggested the chronic use of aristolochic acid-containing herbal product as the most likely cause of the patient’s death. Similar cases had previously been reported in Taiwan and Japan ( Yang et al., 2002 ; Hong et al., 2006 ). Consumption of aristolochic acid-containing Chinese herbal products has also been demonstrated in several studies to be associated with increased risk of urothelial cancer ( Li et al., 2008 ; Yang et al., 2009 ; Lai et al., 2010 ; Chen et al., 2012 ).

A few years back, poisoning that was attributed to Fang-Ji ( Stephania tetrandra S. Moore) in a weight-loss preparation ( Cosyns et al., 1994 ; van Ypersele de Strihou, 1995 ; Reginster et al., 1997 ; Kessler, 2000 ) was actually caused by Guang-Fang-Ji ( Aristolochia fangchi ; Vanhaelen et al., 1994 ). The presence of aristolochic acids in the latter produced dramatic adverse reactions which led to nephrotoxic and carcinogenic events in more than 100 women using this weight-loss preparation ( Zhou et al., 2004 ). In this instance, the similarity in the names of the two herbal products was responsible for the confusion and the unfortunate events.

Ephedra sinica

Ephedra is a very popular herb with long history of traditional use in respiratory conditions ( Zhang et al., 1999 ; Bensky et al., 2004 ). This herb, whose efficacy has been demonstrated in a number of randomized double-blind clinical trials ( Boozer et al., 2002 ; Haller et al., 2005 ; Kim et al., 2008 ), is currently included in the Chinese Pharmacopoeia for therapeutic use and classified as non-toxic. It is an ingredient in commonly used formulary preparations such as Xiaoqinglong Heji for common cold and Zhisou Dingchuan Koufuye for asthma ( Chinese Pharmacopoeia Commission, 2010 ). Ephedra has been marketed in the US as a weight-loss dietary supplement and its use associated with a number of serious cardiovascular and central nervous systems (CNSs) adverse effects ( Verduin and Labbate, 2002 ; Hackman et al., 2006 ; Hallas et al., 2008 ; Chen et al., 2010 ). Several case reports have also linked the use of Ephedra sinica and Ephedra -containing dietary supplements to adverse events such as hepatotoxicity ( Skoulidis et al., 2005 ; Schoepfer et al., 2007 ), neurotoxicity ( Varlibas et al., 2009 ), and transient blindness ( Moawad et al., 2006 ).

Aconitum SPECIES

Aconitum carmichaeli and Aconitum kusnezoffii are used traditionally for pain relief ( Chinese Pharmacopoeia Commission, 2010 ). The toxicity of the medicinal plants derives primarily from the presence of diester diterpene alkaloids such as aconitine, mesaconitine, and hypaconitine in them ( Xu et al., 2005 ). These medicinal plants constitute important ingredients in some commonly used herbal preparations like Sini Tang, Fuzi Lizhong Wan, and Guifu Dihuang Wan for stroke and heart failure, diarrhea and diabetes, respectively ( Chinese Pharmacopoeia Commission, 2010 ). Poisoning due to homemade medicated liquor containing aconite and traditional medicine containing A. carmichaeli were reported in China between 1999 and 2008 ( Liu et al., 2011 ). Severe cases of cardiac toxicity from consumption of aconitine-containing herbal preparation manifesting as ventricular tachycardia and fibrillation and eventually leading to death have been reported ( Tai et al., 1992 ; Fujita et al., 2007 ; Dhesi et al., 2010 ; Lin et al., 2011 ). In other studies bradycardia and hypotension were observed ( Chan, 2009 ). Clinical cases of aconitine poisoning from A. kusnezoffii consumption have also been reported ( Chan and Critchley, 1994 ; Chan, 2002 ). Furthermore, the toxic effect of the combination of A. kusnezoffii and A. carmichaeli overdose which manifested as bradycardia and hypotension was also reported by Chan (2009) in a case study.

Tussilago farfara

Traditionally, Tussilago farfara has been used effectively for thousands of years for the treatment of acute and chronic cough and it is generally regarded as non-toxic ( Chinese Pharmacopoeia Commission, 2010 ). Total alkaloids and senkirkine isolated from this plant, on the other hand, have been demonstrated to be hepatotoxic ( Zhang et al., 2008 ). Recently, the potential health effects of the pyrrolizidine alkaloids found in T. farfara was reviewed and hepatic veno-occlusive disease and cirrhosis were suggested as the major potential disease outcome in human ( Edgar et al., 2011 ). However, restrictions in intake of pyrrolizidine-containing herbs and further investigations were recommended because of paucity of data on toxicity assessment in human ( Kim et al., 2013 ).

GARLIC ( Allium sativum )

Garlic has found relevance for management of hypertension and hypercholesterolemia besides its use as a food or food additive. It is known to contain alliin, which on crushing or chopping in the absence of heat or acid becomes activated by alliinase to allicin. Adverse effects associated with garlic extract including burning sensation in the gastrointestinal tract, nausea, diaphoresis, and lightheadedness have been reported. This extract may also cause contact dermatitis and morbid spontaneous spinal epidural hematoma has been attributed solely to excess garlic ingestion ( Rose et al., 1990 ).

Ginkgo biloba AND Ginseng

Ginkgo biloba has found widespread use in a variety of conditions and several products such as elixirs, extracts, tea, as well as capsules and tablets that may differ in terms of content, have been made from the dried root ( Sparreboom et al., 2004 ). The whole root which contains ginsenosides is usually used because these compounds possess specific pharmacologic effects that may oppose each other ( Chong and Oberholzer, 1988 ). Over 30 ginsenosides have been identified and these compounds are being investigated for their ability to inhibit cell proliferation, tumor cell invasion, and/or metastasis ( He et al., 2011 ; Kim et al., 2012 ). Recently, the ability of ginsenosides to modulate signaling pathways involving cell cycle, inflammatory, or growth factor pathways, was demonstrated ( Nag et al., 2012 ; Dunnick and Nyska, 2013 ). The leaf extracts of ginkgo had also been demonstrated to contain active compounds that had found usefulness in improving circulation and cognition ( Boullata and Nace, 2000 ).

The plant extracts appear to be relatively safe, although headache, dizziness, restlessness, nausea, vomiting, diarrhea, and dermal sensitivity are the most common side effects that have been observed. Ginkgo has been demonstrated to be capable of inhibiting platelet-activating factor and altering bleeding times. Therefore, cautious use had been advised in individuals or patients on anticoagulants therapy ( Boullata and Nace, 2000 ). The ability of ginkgo to induce liver cancer in experimental model was reported recently and genotoxic mechanisms were suggested to play some role in the carcinogenic process ( National Toxicology Program, 2012 ; Dunnick and Nyska, 2013 ). Similar observation was made in the thyroid gland and further studies are required to determine whether the mechanisms for the ginkgo-induced thyroid tumors are also found in humans ( National Toxicology Program, 2012 ; Dunnick and Nyska, 2013 ). In addition to the carcinogenic effects in the liver and thyroid, ginkgo has also been shown to be capable of inducing tumorigenesis in the nasal cavity. The pathogenesis of the nasal lesions was suggested to be related to toxic metabolites of ginkgo reaching the nasal cavity from the systemic circulation ( Reed, 1993 ; Sells et al., 2007 ). Some other authors, however, have attributed the nasal lesions to gastric reflux/post gavage reflux through the nasopharyngeal duct ( Damsch et al., 2011a , b ).

Although, Ginseng products as well as the published descriptions rarely report or specify the species, Ginseng used as herbal remedies has different botanical sources generally obtained from several Panax species including Panax quinquefolius, Panax Ginseng , and Panax pseudoginseng . In large or excessive doses, Ginseng has been reported to cause agitation, insomnia, and elevation of blood pressure while mastalgia and vaginal bleeding have been observed at recommended doses ( Baldwin et al., 1986 ; Dunnick and Nyska, 2013 ). Other adverse effects that have reported include transient nervousness, excitation, insomnia, inability to concentrate, headache, epistaxis, and allergies. A case of severe but non-fatal Stevens–Johnson syndrome was reported following a 3-day Ginseng administration ( Dega et al., 1996 ). Also, spontaneous bleeding from the iris into the anterior chamber of the eye was linked to the use of G. biloba extract ( Rosenblatt and Mindel, 1997 ).Separate case reports had also linked the use of G. biloba to the development of bilateral subdural hematomas and subarachnoid hemorrhage ( Rowin and Lewis, 1996 ; Vale, 1998 ).

KAVA ( Piper methysticum )

Kava is known for its CNS depressant activity and it is commonly used as an anxiolytic agent. Commonly reported side effects of this medicinal plant include headache, dizziness, gastrointestinal discomfort, and localized numbness after oral ingestion. Large dosages has been shown to be capable of giving rise to dry, scaly skin, and yellowish discoloration of the skin and nails, photosensitivity and redness of the eye. Excessive consumption of kava may also lead to photophobia and diplopia ( Boullata and Nace, 2000 ). The muscle relaxant and anticonvulsant effects of this plant have been attributed to its active pyrones constituent. Significant interaction of kava with other CNS depressants which may lead to a comatose state has been reported and as such concurrent use with these agents is usually not advised ( Almeida and Grimsley, 1996 ; Wong et al., 1998 ). In 2002, the US Food and Drug Administration received several reports of liver-related injuries alongside that of a previously healthy young female who eventually required liver transplantation following consumption of kava-containing products. This prompted the FDA to alert consumers on the potential risk of severe liver injury associated with the use of kava-containing dietary supplements. This liver-related risks also prompted regulatory agencies in other countries including Germany, Switzerland, France, Canada, and the UK to warn consumers about the potential risks of kava use and also went on to consider the withdrawal of kava-containing products from the market ( U.S. Food and Drug Administration, 2002 ). In over 25 reports of adverse events outside the US, kava-containing products were associated with liver-related injuries like hepatitis, cirrhosis, and liver failure with some of the affected patients eventually requiring liver transplants ( U.S. Food and Drug Administration, 2002 ).

ST. JOHN’S WORT

Hypericum perforatum, popularly known as St. John’s wort, contains active compounds, such as hypericin, hyperforin, and melatonin. It was once used against viral infections but has gained increased use for mild depressive symptoms ( Bennett et al., 1998 ; Rey and Walter, 1998 ). Adverse effects reportedly associated with its use include allergic reactions, headache, dizziness, restlessness, fatigue, dry mouth, nausea, vomiting, constipation, and photosensitivity. Hyperesthesia and a syndrome of dyspnea and hyperventilation with flushing headache, mydriasis, nausea, palpitations, and tremor, have been reported ( Rey and Walter, 1998 ). Schneck (1998) reported a hypomanic episode in a patient with a history of panic disorder who took St. John’s wort tincture for 10 days. The hypomanic episode, however, resolved within 2 days of discontinuing the herbal remedy. Interaction of St. John’s wort with antidepressants and anticoagulants has been demonstrated and the herbal remedy is usually not recommended in pregnancy because of its uterotonic activity ( Rey and Walter, 1998 ).

CHALLENGES ASSOCIATED WITH MONITORING SAFETY OF HERBAL MEDICINES

With the enormous global consumption of herbal products and medicines, it is high time they were included in pharmacovigilance systems. In terms of population exposure alone, it is essential to identify the risks associated with the use of herbal medicines, and in this regard, the safety of these products has become an issue of great public health importance ( WHO, 2004 , 2005b ). There is no doubt that the increasing cases of poisoning associated with the use herbal medicines in many parts of the world in recent times, is necessitating the need to ensure thorough toxicity assessment alongside active pharmacovigilance on these products in order to promote their safe use and protect public health ( Zhou et al., 2013 ).

The development as well as implementation of the regulation of traditional or herbal medicines in different parts of the world is often confronted with several challenges. Challenges often encountered and common to many countries are those related to regulatory status, assessment of safety and efficacy, quality control, safety monitoring and inadequate or poor knowledge about traditional, complementary/alternative, and herbal medicines within national drug regulatory authorities ( WHO, 2005b ).

CHALLENGES RELATED TO THE REGULATORY STATUS OF HERBAL MEDICINES

The definition and categorization of herbal medicines vary from one country to another. Depending on the regulations applying to foods and medicines, a single medicinal plant may be categorized as a food, a functional food, a dietary supplement, or a herbal medicine in different countries. This introduces serious difficulty in the definition of the concept of herbal medicines for the purposes of national drug regulation while at the same time also confusing patients and consumers ( WHO, 2005b ). In the United States, for example, natural products are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994 ( U.S. Food and Drug Administration, 2012 ). By definition, a dietary supplement is a product that is ingested and is intended to supplement the diet and contains a “dietary ingredient.” The dietary ingredients in these products may include vitamins, minerals, herbs, or other botanicals ( U.S. Food and Drug Administration, 2011 ). Under the DSHEA, additional toxicity studies are generally not required if the herb has been on the market prior to 1994 ( National Institute of Health (NIH) Office of Dietary Supplements, 2011 ). In this regard, the FDA bears the burden to prove that a herbal medicinal product or “dietary ingredient” is toxic or not safe for use. Additional major challenge in many countries is the fact that regulatory information on herbal medicines is often not shared between regulatory authorities and safety monitoring or pharmacovigilance centers ( WHO, 2004 ).

CHALLENGES RELATED TO THE ASSESSMENT OF SAFETY AND EFFICACY

There is no gainsaying the fact that the requirements as well as the research protocols, standards and methods needed for the evaluation of the safety and efficacy of herbal medicines are much more complex than those required for conventional or orthodox pharmaceuticals ( WHO, 2005b ; Zhou et al., 2013 ). A single herbal medicine or medicinal plant may contain hundreds of natural constituents, and a mixed herbal medicinal product may contain several times that number. Suppose every active ingredient were to be isolated from individual herb from which the herbal medicine is formulated or produced, the time and resources required would be tremendous. Such an analysis may practically be impossible especially where an herbal product is a mixture of two or more herbs ( WHO, 2005b ).

CHALLENGES RELATED TO QUALITY CONTROL OF HERBAL MEDICINES

The quality of the source materials used in the production of herbal medicines determines to a large extent the safety and efficacy of these herbal remedies. Generally, the quality of source materials is dependent not only on intrinsic (genetic) factors, but also on extrinsic factors like environmental conditions, good agricultural, and good collection practices (GACP) for medicinal plants, including plant selection and cultivation. It is the combination of these factors that makes it difficult to perform quality controls on the raw materials of herbal medicines ( WHO, 2004 , 2005b ). According to good manufacturing practice (GMP), correct identification of species of medicinal plants, special storage, and special sanitation and cleaning methods for various materials are important requirements for quality control of starting materials.

One of the major challenges often encountered in the quality control of finished herbal medicinal products, especially mixture herbal products, is the difficulty in ascertaining the inclusion of all the plants or starting materials ( WHO, 2005b ). Thus, the general requirements and methods for quality control of finished herbal products remain far more complex than for other pharmaceuticals ( WHO, 2003 , 2004 , 2005b ). To ensure safety and efficacy of herbal medicines, therefore, WHO continues to recommend the institution of quality assurance and control measures such as national quality specification and standards for herbal materials, GMP for herbal medicines, labeling, and licensing schemes for manufacturing, import and marketing, in countries where herbal medicines are regulated ( WHO, 2004 ).

CHALLENGES RELATED TO SAFETY MONITORING OF HERBAL MEDICINES

In recent years, issues relating to increasing use of herbal products in developed countries, dependence of many people living in developing countries on plants as a major source of medicines coupled with absence or weak regulation of herbal medicines in most countries and the occurrence of high-profile safety concerns, have increased awareness of the need to monitor safety and deepen understanding of possible harmful as well as potential benefits associated with the use of herbal medicines ( Rodrigues and Barnes, 2013 ). Adverse events arising from consumption of herbal medicines are attributable to several factors among which include the use of the wrong species of plant by mistake, adulteration of herbal products with other, undeclared medicines, contamination with toxic or hazardous substances, overdosage, misuse of herbal medicines by either healthcare providers or consumers and use of herbal medicines concomitantly with other medicines.

Although, the assessment of the safety of herbal medicines has become an important issue for consumers, regulatory authorities, and healthcare professionals, analysis of adverse events related to the use of these products is much more complex than in the case of conventional pharmaceuticals ( WHO, 2005b ; Zhou et al., 2013 ). It is also recognized that evaluation of safety is complicated by factors such as the geographical origin of plant material, different processing techniques, route of administration, and compatibility with other medicines ( Zhang et al., 2012 ). Furthermore, there is lack of the knowledge and/or poor emphasis on the importance of taxonomic botany and documentation by most manufacturers of herbal medicines and this poses peculiar challenges during identification and collection of medicinal plants used for herbal remedies ( Farah et al., 2000 ). In order to eliminate the confusion created by the common names, it is necessary to adopt the most commonly used binomial names (including their binomial synonyms) for medicinal plants. For example, Artemisia absinthium L., which contains an active narcotic derivative and capable causing CNS disorders and generalized mental deterioration, has at least 11 different common names. Seven of the common names bear no resemblance to its botanical name. Because common names are mainly used, Heliotropium europaeum (heliotrope), which contains potent hepatotoxic pyrrolidine alkaloids, is often confused with Valerian officinalis (garden heliotrope), known to contain valepotriates with sedative and muscle relaxant properties. This explains why it is important to provide the exact scientific name of the plant, the plant part used, and the name of the manufacturer when reporting adverse drug reactions of herbal medicines. Therefore, effective monitoring of safety of herbal medicine will require effective collaboration between botanists, phytochemists, pharmacologists, and other major stake-holders.

CONCLUSION AND RECOMMENDATIONS

The global acceptance and use of herbal medicines and related products continue to assume exponential increase. Issues relating to adverse reactions in recent times are also becoming more vivid, increasing in prevalence and no longer debatable because of previous misconception of regarding or categorizing herbal medicinal products as “safe” because they are derived from “natural” source. The reality is that “safety” and “natural” are not synonymous. Therefore, regulatory policies on herbal medicines need to be standardized and strengthened on a global scale. Relevant regulatory authorities in different countries of the world need to be proactive and continue to put in place appropriate measures to protect public health by ensuring that all herbal medicines approved for sale are safe and of suitable quality.

Providers of medicines, such as physicians, nurses, and pharmacists, often have little training in and understanding of how herbal medicines affect the health of their patients. Many of them are also poorly informed about these products and how they are being used. Adequate training is now very essential since most patients are almost often on other types of prescription or non-prescription medicines. In spite of the fact that the active involvement of orthodox healthcare professionals is continuously solicited and huge responsibility lies with them in terms of their valuable contributions to safety monitoring of medicinal products, it is also very important that all providers of herbal medicines are sufficiently empowered to play a role in monitoring safety of herbal medicines. This, however, should be in collaboration with the orthodox healthcare professionals. For this to be effective, it would be essential to create an atmosphere of trust to facilitate adequate sharing of knowledge about the use and safety of herbal medicines. In fact, the education of healthcare professionals, providers of herbal medicines, and patients/consumers is vital for the prevention of potentially serious risks from misuse of herbal medicines.

Of crucial importance also is an appropriate knowledge base relevant to diagnostic and treatment decision-making. Furthermore, individual healthcare provider should also show sufficient commitment toward understanding the use of herbal medicines. This can be by asking relevant questions about the use of these herbal remedies among others whenever they encounter patients who are taking these medications. Health professionals who work in poisons centers and health information services also need to be informed about herbal medicines. Finally, as with other medicines for human use, it has become mandatory that herbal medicines are covered in every country of the world by a drug regulatory framework to ensure that they conform with required standards of safety, quality, and efficacy.

Conflict of Interest Statement

The author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Acknowledgments

Martins Ekor gratefully acknowledges the support provided by Dr. Oluwayemisi E. Ekor during the course of preparation of this manuscript.

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Dissertations / Theses on the topic 'Traditional herbal medicine'

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Jordaan, Jacques R. "Mabopane herbal centre : healing misconceptions of traditional herbal medicine." Diss., University of Pretoria, 2014. http://hdl.handle.net/2263/45289.

Teng, Lida. "Pharmacovigilance of traditional Chinese herbal medicine in the UK." Thesis, University College London (University of London), 2007. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.499080.

Magora, Baboloki Helen. "Phytochemical and toxicological studies of some Botswanan plants used in traditional medicine." Thesis, University of Strathclyde, 2003. http://oleg.lib.strath.ac.uk:80/R/?func=dbin-jump-full&object_id=21197.

Thomsen, Michael, and n/a. "Immunomodulatory effects of traditional Chinese herbal formulation, ginseng and dang gui ten combination (PS10)." Swinburne University of Technology, 2006. http://adt.lib.swin.edu.au./public/adt-VSWT20061128.123722.

Sehume, Brian J. "Pharmaceutical evaluation of phela capsules Used as traditional medicine." Thesis, University of the Western Cape, 2010. http://etd.uwc.ac.za/index.php?module=etd&action=viewtitle&id=gen8Srv25Nme4_6049_1299482219.

In conclusion, the results obtained firstly indicated that the BP, EMEA and WHO were in fairly good agreement on the criteria and specifications that can be used to assesses the pharmaceutical quality of a traditional plant medicine such as Phela. Secondly, the Phela plant powders were found to have acceptable pharmaceutical properties that did not complicate or adversely affected the capsule manufacture. Thirdly, the Phela capsules produced were generally of acceptable pharmacopoeial standard. Fourthly, HPLC fingerprinting and pattern recognition analysis proved useful to examine the chemical stability of selected marker compounds of Phela and indicated that the capsules had no practical shelf life under elevated temperature and humid conditions. Overall, the Phela capsules should thus be suitable for use in a short time clinical trial, but for use in a long period trial the long term stability of the Phela capsules under ambient conditions must still be confirmed.

Niemeyer, Kathryn Jean. "Personalizing Western Herbal Medicine: Weaving a Tapestry of Right Relationships, a Grounded Theory Study." Diss., The University of Arizona, 2013. http://hdl.handle.net/10150/293447.

Popat, Alpa. "Investigating the hepatotoxicity of Callilepis laureola, Impila, a South African traditional herbal medicine." Thesis, National Library of Canada = Bibliothèque nationale du Canada, 2001. http://www.collectionscanada.ca/obj/s4/f2/dsk3/ftp05/MQ63176.pdf.

Blouws, Tarryn Alicia. "Garlic and African olive used as traditional herbs for hypertension in the Western Cape." Thesis, University of the Western Cape, 2012. http://hdl.handle.net/11394/4343.

O'Brien, David. "A phytochemical-bioactivity investigation of the South African traditional herbal medicine, Agathosma betulina (buchu)." Thesis, University of Reading, 2005. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.556106.

Iancu, Magdalena. "Local Use of Traditional and Modern Medicine : A case study in Babati District, Tanzania." Thesis, Södertörns högskola, Institutionen för livsvetenskaper, 2011. http://urn.kb.se/resolve?urn=urn:nbn:se:sh:diva-9453.

Chisaka, Joseph Wangisani. "The use of traditional herbal medicines among palliative care patients at Mulanje Mission Hospital, Malawi." Master's thesis, Faculty of Health Sciences, 2019. http://hdl.handle.net/11427/31511.

Thomsen, Michael. "Immunomodulatory effects of traditional Chinese herbal formulation, ginseng and dang gui ten combination (PS10)." Australasian Digital Thesis Program, 2006. http://adt.lib.swin.edu.au/public/adt-VSWT20061128.123722.

Hall, Braydon. "A Multivariate Approach to Integration of Ethnobotanical, Pharmacological, and Phytochemical Analyses of Cree and Squamish Traditional Herbal Medicines for Anti-Diabetes Use." Thesis, Université d'Ottawa / University of Ottawa, 2019. http://hdl.handle.net/10393/39248.

Huang, Tao. "Toward novel therapeutics for functional constipation: from traditional Chinese medicine herbal formula MaZiRenWan to cyclic spexin analogues." HKBU Institutional Repository, 2017. https://repository.hkbu.edu.hk/etd_oa/388.

Wong, Rosaline Christina. "The use of traditional medicines and rituals in the prevention and treatment of postnatal depression, among the Kadazan/Dusun and Bajau/Malay communities of East Malaysia." Thesis, University of Exeter, 1998. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.265275.

Lindh, Hanna. "Mothers, Markets and Medicine : The role of traditional herbal medicine in primary women and child health care in the Dar es Salaam region, Tanzania." Thesis, Uppsala universitet, Systematisk biologi, 2015. http://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-313345.

Matotoka, Mashilo Mash. "In vitro pharmacological and synergistic effects of herbal concoctions sold in Ga Maja, Limpopo Province." Thesis, University of Limpopo, 2019. http://hdl.handle.net/10386/2916.

Bhamra, Sukvinder. "Investigating the use and identity of traditional herbal remedies amongst South Asian communities using surveys and biomolecular techniques." Thesis, De Montfort University, 2016. http://hdl.handle.net/2086/12392.

Mathibela, Khomotso Malehu. "An investigation into aspects of medicinal plant use by traditional healers from Blouberg Mountain, Limpopo Province, South Africa." Thesis, University of Limpopo (Turfloop Campus), 2013. http://hdl.handle.net/10386/966.

Maxwell, Sheena, and sheenamax@optusnet com au. "An assesssment of non-conventional measures of lung function and the effedt of a herbal extract on mild-moderate childhood asthma." RMIT University. Health Sciences, 2007. http://adt.lib.rmit.edu.au/adt/public/adt-VIT20080507.150547.

Nuhu, Kaamel M. "DETERMINANTS OF HEALTH-SEEKING BEHAVIOR IN GHANA." OpenSIUC, 2018. https://opensiuc.lib.siu.edu/dissertations/1539.

Le, Thanh Tu. "L’étude comparative de l’encadrement juridique de la médecine traditionnelle au Vietnam, au Cambodge et au Laos." Thesis, Aix-Marseille, 2017. http://www.theses.fr/2017AIXM0119.

Liang, Jianguo, and 梁建国. "HIV-1 early diagnosis of men having sex with men in Hong Kong and discovery of novel agents for HIV-1 treatment from traditional Chinese herbal medicine." Thesis, The University of Hong Kong (Pokfulam, Hong Kong), 2013. http://hdl.handle.net/10722/196459.

Baidoo, Rhodaline. "Toward a Comprehensive Healthcare System in Ghana." Ohio University / OhioLINK, 2009. http://rave.ohiolink.edu/etdc/view?acc_num=ohiou1237304137.

Ford, Claudia Jeanne. "Weed Women, All Night Vigils, and the Secret Life of Plants: Negotiated Epistemologies of Ethnogynecological Plant Knowledge in American History." Antioch University / OhioLINK, 2015. http://rave.ohiolink.edu/etdc/view?acc_num=antioch1442086935.

Auditeau, Emilie. "Bases rationnelles de l’utilisation des plantes dans l’épilepsie : vers une amélioration de l’accessibilité au traitement dans les pays en développement." Thesis, Limoges, 2018. http://www.theses.fr/2018LIMO0053/document.

Mbikusita-Lewanika, Mbololwa. "The use of 'dry sex' traditional medicines by Zambian women." Thesis, King's College London (University of London), 2002. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.271329.

Ischkanian, Paula Cristina. "Promoção, comunicação e educação em saúde: a prática da acupuntura e da fitoterapia." Universidade de São Paulo, 2016. http://www.teses.usp.br/teses/disponiveis/6/6135/tde-04032016-143503/.

Awortwe, Charles. "Pharmacokinetic herb-drug interaction study of selected traditional medicines used as complementary and alternative medicine (CAM) for HIV/AIDS." Thesis, Stellenbosch : Stellenbosch University, 2015. http://hdl.handle.net/10019.1/96796.

Richey-Abbey, Laurel Rhea. "Bush Medicine in the Family Islands: The Medical Ethnobotany of Cat Island and Long Island, Bahamas." Miami University / OhioLINK, 2012. http://rave.ohiolink.edu/etdc/view?acc_num=miami1335445242.

Sagbo, Idowu Jonas. "Phytochemical analysis and antibacterial properties of aqueous and ethanol extracts of Brachylaena elliptica (Thurb.) dc. and Brachylaena ilicifolia (Lam.) Phill & Schweick." Thesis, University of Fort Hare, 2015. http://hdl.handle.net/10353/d1021289.

Jin, Ye. "Quality control of phytopharmaceuticals : assessment and quality control of traditional Chinese medicine." Thesis, Liverpool John Moores University, 2000. http://ethos.bl.uk/OrderDetails.do?uin=uk.bl.ethos.327675.

Feng, Huei-jiun, and 馮輝俊. "Success Factors for Traditional Chinese Herbal Medicine Retailer." Thesis, 2014. http://ndltd.ncl.edu.tw/handle/29716308559905835402.

CHEN, CHIA-HSUAN, and 陳佳璇. "Study on Whitening Properties of Traditional Taiwan Herbal Medicine Extract." Thesis, 2016. http://ndltd.ncl.edu.tw/handle/35ky4x.

"Adverse reaction of Chinese herbal medicines." 2003. http://library.cuhk.edu.hk/record=b5891440.

Chow, Jane. "Benefits of incorporating Chinese herbal medicine into current pharmaceutical regimens." Thesis, 2020. https://hdl.handle.net/2144/42089.

Chnag, Hung-Chou, and 張宏州. "The Effect of Intestinal Microflora on Traditional Chinese Medicine Diagnostic Pattern and Chinese Herbal Medicine." Thesis, 2004. http://ndltd.ncl.edu.tw/handle/33793782722085928871.

"Pharmacognostical studies on the Chinese medicinal herb: "Ku-Di-Dan"= [K‘u Ti Tan] (Herba Elephantopi)." Chinese University of Hong Kong, 1996. http://library.cuhk.edu.hk/record=b5895714.

Shu-Ching, Hsieh, and 謝淑卿. "Safety Surveillance on Traditional Chinese Herbal Medicine and the Related Empirical Studies." Thesis, 2008. http://ndltd.ncl.edu.tw/handle/50493509107280493765.

"Antiviral agents from selected Chinese herbal medicines." Thesis, 2004. http://library.cuhk.edu.hk/record=b6073972.

Wang, Ting. "EFFECTS OF TRADITIONAL CHINESE MEDICINAL HERBAL EXTRACTS ON HIV-1 REPLICATION." Thesis, 2011. http://hdl.handle.net/1805/2515.

"Immunomodulatory effects and toxicity of mimosa pudica, the sensitive plant." Chinese University of Hong Kong, 1993. http://library.cuhk.edu.hk/record=b5887741.

"Evaluation of the pharmacological effects and the underlying mechanisms of selected Chinese herbs on dementia." 2013. http://library.cuhk.edu.hk/record=b5884400.

Wright, Colin W., Peter A. Linley, R. Brun, S. Wittlin, and E. Hsu. "Can ancient texts assist in the development of herbal treatments for malaria?" 2014. http://hdl.handle.net/10454/7467.

"Effects of a kidney-tonifying herbal formula on Type I osteoporosis." Thesis, 2009. http://library.cuhk.edu.hk/record=b6075317.

"Application of library search techniques of FTIR fingerprint for the identification of traditional Chinese herbal medicine." 2003. http://library.cuhk.edu.hk/record=b5891453.

Pei-Hua and 蔡佩樺. "Establishment of screening platform of traditional Chinese herbal medicine against influenza virus by embryonated chicken egg." Thesis, 2011. http://ndltd.ncl.edu.tw/handle/58786261940314614030.

"Analytical and pharmacokinetic studies of the main chemical ingredients of rhizoma chuanxiong." Thesis, 2005. http://library.cuhk.edu.hk/record=b6074230.

"Effects of a chinese herbal medicine formula (SD) on a Drosophila sleep model." 2008. http://library.cuhk.edu.hk/record=b5893592.

"Chemical, molecular and pharmacological assessment of saussurea lappa clarke." 2004. http://library.cuhk.edu.hk/record=b6073678.

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• Research article
• Open access
• Published: 01 December 2017

Integrating herbal medicine into mainstream healthcare in Ghana: clients’ acceptability, perceptions and disclosure of use

• Peter Agyei-Baffour 1 ,
• Agnes Kudolo 2 ,
• Dan Yedu Quansah 3 &
• Daniel Boateng   ORCID: orcid.org/0000-0001-7568-7298 1  

BMC Complementary and Alternative Medicine volume  17 , Article number:  513 ( 2017 ) Cite this article

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Although there are current efforts to integrate herbal medicine (HM) into mainstream healthcare in Ghana, there is paucity of empirical evidence on the acceptability and concurrent use of HM, in the formal health facilities in Ghana. This study sought to determine client perception, disclosure and acceptability of integrating herbal medicine in mainstream healthcare in Kumasi, Ghana.

A cross-sectional study was conducted from May to August, 2015. Five hundred patients presenting at the outpatient departments of Kumasi South, Suntreso and Tafo Government Hospitals in Kumasi were randomly selected. Interviews were conducted with the use of structured questionnaires. A logistic regression analysis, using backward selection, was conducted to determine the influence of socio-demographic and facility related factors on the odds of using HM at the facility. All statistical tests were two-sided and considered significant at a p -value of <0.05.

Majority of the study respondents were females (64.8%) and the median age was 36 years. Less than half, 42.2%, of the respondents utilized HM services when they visited the health facility. Reasons for using HM at the facility level included ‘being effective’ (24.4%), ‘easy to access’ (25.3%) and ‘being comparatively cheaper’ (16%). About 86% never disclosed previous use of HM to their health care providers. Socio-economic status and perception of service provision influenced use of herbal medicines. Respondents who rated themselves wealthy had increased odds of using herbal medicines at the health facility as compared to those who rated themselves poor (OR = 4.9; 95%CI = 1.6–15.3).

This study shows that integration of herbal medicine is feasible and herbal medicines may be generally accepted as a formal source of healthcare in Ghana. The results of this study might serve as a basis for improvement and upscale of the herbal medicine integration programme in Ghana.

Peer Review reports

All over the world, different herbal plants, plant extracts, animal products and mineral substances have been used based on varying cultural backgrounds [ 1 ] as a way to manage and treat ill-health, prevent and promote health [ 2 ]. Herbal Medicine (HM), also known as Complementary Alternative Medicine (CAM) involves ways of treating and maintaining health that existed before the arrival of orthodox medicine [ 3 ]. Anthropologic and cross-cultural perspectives suggests that disease episodes that are recognisable are most likely to be treated outside the perimeter of a formal healthcare system [ 4 ].

HM is culturally acceptable and widely utilized in most parts of Africa for a wide spectrum of clinical illnesses [ 5 , 6 ]. In Ghana, knowledge of HM is almost universal in most homes with evidence of increasing usage, [ 7 ] and herbal medicines are used for the treatment and management of both acute (cuts, foot rots) and chronic ailments (stroke, fevers, and diabetes, cancer) [ 8 ]. In many parts of the country, herbal medicines are used to either treat malaria or compliment allopathic anti-malaria drugs [ 9 , 10 , 11 , 12 ]. Cryptolepis sanguinolenta, also known as ‘nibima’, have for instance been popularly mentioned and clinically shown to be efficacious against malaria, with its herbal tea formulations, trademarked as Phyto-Laria, being shown to offer 93.5% cure rate in vivo with no signs of toxicity [ 9 , 13 ]. Research on pregnant women visiting health facilities for anti-natal care also reported use of herbal medicines for the treatment of abdominal pains, constipation, to protect their pregnancies and for smooth delivery [ 14 ]. Users of HM are mostly initiated through convincing information from the media, families or friends about the efficacy of previously used herbal medicines [ 15 ].

Use of healthcare has been linked to the belief and perceptions about diseases and healthcare [ 16 ]. The use of herbs have been associated with common experience, perceptions that herbal medicines were effective, delayed medical care and sufficient knowledge of herbs [ 14 , 17 , 18 ]. Factors such as better efficacy, safe usage, easy access and affordability are also associated with the practice and utilization of herbal medicines over conventional medicines [ 5 , 7 , 14 , 19 , 20 ]. Other studies have revealed that the use of herbal medicines is independently associated with socio-demographic characteristics such as age, education level, and marital status [ 17 , 18 , 21 , 22 ].

In Ghana, efforts have been made to amend the National Health Policy to pave way for the integration of herbal medicine into mainstream healthcare, following the establishment of a policy of herbal medicine practice in 2005 [ 23 ]. In 2010, the Traditional Medicine Practice Council (TMPC) was set following the release of the 2nd edition of the Ghana Herbal Pharmacopoeia (GHP) in 2007 [ 24 ]. In 2012, HM practice was formally integrated into the main healthcare delivery system in Ghana, with a pilot of about 18 government facilities nationwide [ 24 ]. Trained Herbal Medical practitioners from the Kwame Nkrumah University of Science and Technology (KNUST), Centre for Research into Plant Medicine and Tetteh Quarshie Memorial Hospital in Ghana are licensed to consult and prescribe HM for clients both in the government and private hospitals in Ghana. Although the acceptance level of herbal medicines continues to increase, the fact still remains, that there is paucity of data on the acceptability and concurrent application of HM in Ghana. The incidence of combining CAM with allopathic medicines without the knowledge of health professionals may jeopardize therapy as well as cause many side effects or adverse events. This presents important implementation challenges and therefore needs to be assessed. A recent study that assessed the perception of trainers and stakeholders about the integration in one of the pilot facilities [ 25 ] revealed a lack of regulatory policy and protocol for integration, leading to different perceptions of the integration and called for multi-facility studies to further look into this. Using quantitative methods and representative samples from three implementing facilities, this study was conducted to determine the acceptability, client perceptions and disclosures related to herbal medicinal use in the public health facilities in the Kumasi metropolis.

Study design and setting

A cross-sectional design was utilized to collect data from May to August 2015. We selected the Kumasi metropolis for this study because the Metropolitan Health Directorate was piloting the concomitant use of herbal and orthodox medicine in some selected health facilities.

The population in Kumasi is heterogeneous as seen by the distinct cultural enclaves with representation of almost all the major ethnic groups in Ghana. The population is dominated by Akans, especially Asantes. According to the 2010 population census report, Kumasi had inter-censual growth rate of 5.4%. The total population of males and females in the metropolis is 972,258 residents and 1,062,806 residents respectively [ 26 ]. The metropolis is endowed with 189 health facilities out of which 91% are managed by private individuals. Doctor to patient and nurse to patient ratios are 1:41,606 and 1:7866 respectively and about 81% of the population are registered under the National Health Insurance Scheme (NHIS). Kumasi is the economic nerve of Ghana where people from all over the world converge to do business. Hence findings from studies conducted in Kumasi could be a fair representation of what pertains in Ghana.

Study population and sampling

The study population included patients who visited outpatient departments in public health facilities (Kumasi South, Suntreso, and Tafo Government hospitals) in Kumasi. Patients who voluntarily agreed and consented were enrolled.

Sample size was estimated using Cochran’s sample size formula [ 27 ], \( {n}_0=\frac{t{2}^{\ast }(p)(q)}{d2}. \) Where t = standard normal deviation = 1.96; p = prevalence rate (assumed to be 50%); q = proportion of target population estimated to access HM from the facility, i.e. 1 – p (50%); and d = degree of accuracy, 5%. This gives a total respondent, n, of 384. Making provision for 10% non-response (1.10 × 384 = 422), and design effect of (1.2 × 422 = 506), the total sample was approximated to 500. The sample drawn from each facility was calculated per their catchment sizes, resulting in 212, 112 and 174 participants from Kumasi South, Tafo and Suntreso Government Hospitals respectively, (See Additional file  1 : Table S1).

Study participants were recruited using a systematic random sampling technique, by defining a random starting point and a fixed sampling interval. Based on the number of expected attendance per facility and the period of data collection, we estimated the average respondents needed per day from each facility. On each day, per facility, the sampling interval, K , was calculated using the expected attendance and the average respondents needed. During the visit hours, the first participant identified and interviewed as the starting point and the Kth respondent is approached, starting the count at the selected starting participant. This was repeated until the required sample size was attained.

Data collection

Data were collected with the use of structured questionnaires (open ended and closed), which were structured based on the study variables including acceptability, use, and disclosure of use. The study instruments were pretested in a similar public facility, prior to the main data collection, to ascertain participants understanding of the questions before the actual field work started. In circumstances where it became obvious that the respondents found it difficult to answer the questions, the research team re-structured or reframed the questions to enhance clarity. The questionnaires were translated into the local language (Twi) and back translated into English and research assistance were trained to ensure consistency in questioning of participants to enhance uniformity and minimize bias.

Interviews were conducted in serene locations at the Out-Patience Departments (OPDs) of the various health facilities. The interviewers guided the respondents to clearly explain the questions to them where necessary, either in English language or Twi. Participants were assured of confidentiality of their information and were taken through the informed consent processes for approval before being interviewed. All study protocols were reviewed and approved by the Institutional Review Board of the Kwame Nkrumah University of Science and Technology - Committee for Human Research Publications and Ethics (CHRPE) and informed consents was sought from all participants.

Statistical analysis

All statistical analyses were carried out with Statistical Package for Social Sciences (SPSS) Version 22 [ 28 ]. Prior to data entry, any blank fields or inconsistencies in each questionnaire were resolved. General characteristics are summarized as proportions and mean ± standard deviation (SD). Bivariate associations were tested using Pearson and ordinal (linear) Chi-square for categorical and ordinal data respectively. Continuous variables were tested using one way analysis of variance (ANOVA). A logistic regression analysis, using backward selection, was also conducted to determine the influence of socio-demographic and facility related factors on the odds of using herbal medicine at the facility. Three models were fitted; model one tested the influence of socio-demographic variables, model two health facility variables and model 3 a combination of all covariates. All statistical tests were two-sided and were considered significant at a p -value of < 0.05.

Baseline characteristics of study participants

The median age (25th, 75th percentile) of the subjects was 36 years (28, 49 years) and majority, 64.8% were females, Table 1 . Most of the respondents had formal education (senior or middle schools). 56.6% of the respondents were married and 80% had either skilled or semi-skilled jobs. Majority were Christians (85%) and Akans (82.8%).

Herbal medicine utilization

About 98.4% of the participants had ever used HM and this was the usual treatment option for 46.2%, Table 2 . 42.2% of the respondents utilized herbal medicine when they visited health facilities and 85.8% of them were hoped to utilized this service in the future. Pharmaceutical pre-packaged dosage forms were the commonest (54.2%) source of herbal medicinal products followed by self-prepared formulations (33.8%). Pharmaceutical stores and market places constituted the most popular outlets from which herbal medicinal products were purchased. Majority of the respondents used herbal medicines once a week. The median cost of herbal medicine treatment was GHS 15.00 (USD 3.49) and majority perceived this cost as affordable. The median length of time spent to access herbal medicine in health facilities was 20 min.

Clients’ impression, satisfaction and reasons for use of integrated herbal medicine services at health facility

As shown in Fig.  1 , most of the respondents were satisfied with the integrated HM services at the health facility. Majority, 53% of the respondents indicated that preferences for HM would increase if herbal formulations are proven to be an effective treatment option whereas 13% believe positive recommendation of herbal medicines may increase usage. Others believed that people will opt for herbal medicine because of the high cost (11%) and exhaustive access associated with orthodox medicines (5%). 11% also stated that people would prefer to use herbal medicines because of its safety and natural propensity.

Client’s impression and satisfaction

The disclosure between patients and healthcare providers on use of herbal medicine

Most, 98.4% of respondents had never shared information on their use of herbal medicine with orthodox health care providers, although majority (56.9%) believed it was important to do so for treatment efficacy reasons, Table 3 . Reasons for non-disclosure of HM use included ‘being unnecessary’ (60.7%) and ‘will be insulted’ (7.8%). About 42.3% were not aware of availability of HM at the health facility, whiles 13.8% and 2.7% obtained information from health professionals and the media respectively. Some respondents disclosed that they struggled to obtain information on the dosage and when to take their medications.

Predictors of herbal medicine usage at the health facility

Employment status, self-rated socio-economic status and satisfaction with services were associated with use of HM at the health facility in the fully adjusted model (Table 4 ). The odds of using HM at the health facility was higher among respondents who rated themselves as wealthy or as compared to those who rated themselves poor. Respondents who believed the cost of HM were affordable had higher odds of using HM at the facility than those who believed otherwise (OR, 6.7; 95%CI, 2.1, 21.7). The model statistics shows that model 3 (full model) was much improved as compared to 1 and 2.

This study was conducted to explore the use, perceptions, acceptability and disclosures related to the integrated herbal medicine services in the mainstream healthcare in Ghana. We found a generally high level of herbal medicine usage among respondents. Almost all respondents in this study had ever used herbal medicines and most of these were pharmaceutical pre-packaged forms. Our results corroborates findings of increased use of herbal medicines in most parts of the world [ 29 , 30 , 31 ]. A study conducted in the Tanga District in Tanzania, also reported a 42% prevalence of use of herbal medicines [ 32 ]. Previous evidence from studies on specific populations have also shown high level of herbal medicine use. For example, study of pregnant women in Nigeria, reported a 67.5% prevalence of herbal medicine usage among pregnant women [ 33 ]. In Ghana, pregnant women are reported to use herbal medicines for the treatment of abdominal pains, constipation and to enhance smooth delivery [ 14 ]. These results were however dependent on the geographic area surveyed and the socio-cultural characteristics and ethnic background of the surveyed groups.

We further found that, although most patients at the public health facilities have ever used herbal medicines, not all of them were utilizing the integrated herbal medicine services at the health facility level. 42.2% of people, who patronize public health facilities, are currently utilizing the services of herbal medical practitioners at the health facility. This level of acceptability, 3 years into the integration program, however shows positive indications of possible integration of HM into mainstream healthcare. This suggest that, if HM is well integrated into mainstream healthcare, clients could assess both herbal and allopathic treatments in a formal setting for the treatment and management of both acute and chronic diseases. Previous evidence shows success from similar integration programs in other countries [ 3 ]. Countries like China and Sri Lanka have successfully integrated these two health systems. In China, 95% of general hospitals offering promotional and curative applications have traditional medicine departments and traditional Chinese medicine is used for the treatment of over 200 million outpatients and almost 3 million inpatients every year [ 3 ]. Sri Lanka has also evolved as one of the best health care systems in Asia and has attained health targets almost similar to standards in the Western world as a result of successful healthcare integration [ 3 ]. These indicate that with the availability of systematic knowledge, comprehensive methodology and rich clinical experiences, herbal medicines could be used as effective alternatives to complement healthcare provision in Ghana.

Disclosure of usage of HM

We found that, although most respondents believed that it is important to disclose the use of herbal medicine for efficacy reasons, majority had never done so. Evidence from a systematic review, also confirm a high rate of non-disclosure among users of herbal medicines [ 34 ]. Most of the non-disclosers in our study believed it were not necessary to do so whiles others felt they would be insulted by orthodox practitioners for disclosing their use of herbal medicines. In a similar study in the United States, patients reasons for nondisclosure of alternative medicine use included ‘doctors not enquiring of their use of alternative use’ and ‘beliefs that doctors need not know or would not understand’ [ 35 ]. A study by Braun et al. [ 36 ], also reported ‘concerns of undesirable response by the practitioners’, ‘the perception that the practitioner need not know about their alternative medicine use’, ‘and practitioners not asking about it’ as major reasons for patients lack of disclosure of herbal medicines. It is also believed that perceived legitimacy of alternative medicine treatments affects disclosure [ 37 ].

Client’s satisfaction and use of HM at the health facility

This study also found that satisfaction with services provided influenced the use of HM at the health facilities. Patient satisfaction has been suggested as a major quality outcome [ 38 , 39 ] and the extent to which they are satisfied with their health providers may be an important consideration in their health behaviour and health care utilization [ 40 , 41 ]. Our study found a high level of satisfaction with services provided to herbal medicines users at the health facilities. Majority of study subjects were impressed with the service provision of Herbal Medical practitioners.

Most of them also believed herbal medical services were affordable, although this could stem from a general perception in the Ghanaian community, that, herbal medicine is less expensive than orthodox medicines. In rural communities, herbal practitioners are even willing to accept delayed payment, payment in kind such as fowls, agricultural seeds, goats, palm oil, salt, or palm wine, or in some cases patients can negotiate the amount [ 42 ]. Buor [ 43 ] also argued that herbal medicines are relatively cheaper than modern medicines. This assumption could however hold at the community level, but at the health facility level, with the advent of NHIS, subscribers of the NHIS scheme will see the services of herbal medical practitioners as expensive. The current services at the health facilities are not covered by health insurance. More than 75% paid for the cost of HM by self-financing and the median cost of HM treatment at the facility among users in this study was GHS 15.00 (USD 3.49). It could therefore be postulated that the patronage of HM could increase if the services are covered by the health insurance scheme. As observed in this study, inactive NHIS members were more likely to utilize HM at the health facility as compared to active NHIS members and therefore the extent of utilization could improve if the services are covered by the NHIS [ 15 ].

Predictors of use of herbal medicines at the health facility

This study found that respondents who were semi-skilled had decreased odds of utilizing HM services as compared to those who were unemployed. The study also observed increased propensity of usage of HM among participants who rated themselves wealthy as compared to those who rated themselves poor. Employment and socio-economic status were also significantly associated with utilization of HM in the bivariate analysis (See Additional file 1 : Table S2). Evidence from some national surveys have also shown an association between higher socio-economic status and use of CAM, although this was not universal across all racial/ethnic groups [ 44 ]. The use of the integrated HM services among high socio-economic class in this setting, could however be due to their ability to pay for their services, which are not covered by the NHIS.

Strength and limitations

This study provides important quantitative data on the acceptability, use and perceptions of clients on the integrated herbal medicines services in public health facilities in Ghana. The availability of such finding is important to inform and guide the scale up of the programme. The use of participants from three facilities in the pilot programme enhances the generalizability of the study findings and strengthen the evidence for policy advice. Dwelling on previous experiences, this study might suffer some recall bias. We however ensured that appropriate questions were used to tease out responses, thereby ensuring that this bias is reduced to almost negligible. Also, important information on the point or state of disease condition (mild, serious or worse) where patients consider leaving herbal treatment was not assessed in this study. We recommend further studies to look at the point or state of diseases and the consideration of HM as well as expanding the study to cover other regions to gain broader insight into the subject matter.

We found that 42.2% of the study participants who patronized public health facilities, sort for the services of herbal medical practitioners at the health facility. Three years into the integration programme, this evidence shows a promising level of acceptability of use of HM at the health facility. However, it is an undeniable fact that there are gaps in awareness and reluctance in disclosure to allopathic health providers. Majority of the respondents did not disclose the use of herbal medicines. Whiles this study points towards a possible integration of herbal medicines with allopathic care, there is the need for general education and orientation of health service providers and clients on the availability of HM service in public health facilities. Findings from this study also suggest the need for further education of health providers on the legitimacy and acceptability of herbal medicine to run concurrently with orthodox medicine.

Abbreviations

Complementary Alternative Medicine

Foods and Drug Authority

Ghana Herbal Pharmacopoeia

Ghana Health Service

Ghana Standard Authority

Herbal Medicine

Kwame Nkrumah University of Science and Technology

Ministry of Health

National Health Insurance Scheme

Traditional Medicine Practice Council

World Health Organization

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Additional file

Additional file 1: table s1..

Estimated sample from each facility. Table S2. Bivariate analysis of Socio-demographic and healthcare related factors associated with herbal medicine use. (DOCX 74 kb)

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Agyei-Baffour, P., Kudolo, A., Quansah, D.Y. et al. Integrating herbal medicine into mainstream healthcare in Ghana: clients’ acceptability, perceptions and disclosure of use. BMC Complement Altern Med 17 , 513 (2017). https://doi.org/10.1186/s12906-017-2025-4

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A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines

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• Angela Caro-Rojas   ORCID: orcid.org/0000-0001-9773-7188 2 , 3 ,
• Hadir Rostom   ORCID: orcid.org/0000-0003-3872-0540 4 , 5 &
• Mohamed A. Elhawary   ORCID: orcid.org/0000-0002-4043-6867 6 , 7  

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1 Introduction

Herbal products are used globally for different purposes (e.g., therapeutic, cosmetic, etc.) and are easy to obtain as in most cases they do not require a prescription. Herbal and traditional medicines (H&TMs) have been used for generations and are part of the culture of many communities. Furthermore, in many countries, their introduction into the market is not yet fully regulated [ 1 ]. This calls for more safety monitoring for these products. In fact, there is a continuous progress in pharmacovigilance (PV) of herbal medicines (HMs) or “phytovigilance” in the context of regulations, terminologies for coding, etc. [ 2 ].

Hitherto, phytovigilance still faces many challenges, the most notable of which is underreporting of herbal medicines’ adverse reactions (ARs) [ 3 ]. There is a notion among the public that H&TMs are safe because of their natural origin [ 4 ]. Also, healthcare professionals (HCPs), in some cases, find complexity to distinguish between whether these ARs are caused by herbal products or whether these are consequence symptoms of the comorbid conditions or even interactions between HMs and conventional drugs [ 5 ]. Over and above that, sometimes they have no idea that H&TMs can cause unexpected and serious ARs (e.g., hepatic disorders, renal disorders, carcinogenic effects, etc.) [ 6 ]. This is due to the absence of a curriculum on PV in general and phytovigilance in particular within their undergraduate studies [ 7 , 8 ].

In addition, some may not realize that the origin of the herbal products, the way of extraction, their source, and the method of storage are aspects that must be considered, otherwise they will become contributing factors for the appearance of ARs or increase in severity and seriousness of these ARs [ 9 ]. Such perceptions hinder the spontaneous reporting of ARs and result in difficulty in the detection, assessment, and understanding processes [ 10 ]. Accordingly, it will be difficult to take the necessary measures to minimize the risks of H&TMs. Addressing these challenges that face the PV activities demands multidisciplinary collaborations between the different stakeholders of phytovigilance.

2 ISoP Special Interest Group on Herbal and Traditional Medicines (H&TMs SIG)

The International Society of Pharmacovigilance (ISoP) is a professional, independent, nonprofit society, open to anyone with an interest in the safe and effective use of medicinal products. The main goal is the better knowledge and understanding of the safe and effective use of medicines, pre- and postmarketing. Special interest groups (SIGs), which are considered a fundamental part of the ISoP operational strategy, are loops of ISoP members that cover several areas of interest on PV.

In that sense, ISoP has included in its scope the verification of best practices in the production, use, and follow-up effects of H&TMs.

2.1 Sharing Knowledge of Natural Health Products Around the Globe

The ISoP Special Interest Group on Herbal and Traditional Medicines (H&TMs SIG) was launched at the 17th Annual Meeting of ISoP in Liverpool in October 2017 [ 11 ].

Since 2022, the group has been under the leadership of Professor Souad Skalli from the Faculty of Science University Mohammed V in Rabat (Morocco), with a specific interest and expertise in the PV of H&TMs. The deputy Lead is Dr Florence van Hunsel from Netherlands Pharmacovigilance Centre “Lareb,” and the Project Manager is Professor Jia-bo Wang, School of Traditional Chinese Medicine, Capital Medical University, Beijing, China.

The H&TMs SIG objectives are aligned with and expand on the World Health Organization (WHO) Herbal and Traditional Medicines with the following goals [ 12 ]:

Address safety and PV issues in H&TMs.

Raise awareness among relevant organizations and patients about the safety of H&TMs and PV.

Support HCPs and organizations with scientific evaluation of ARs to HMs.

Promote and develop education on all aspects of phytovigilance.

Communicate activities and provide a forum for discussion and generation of new research and ideas, utilizing social media and other platforms.

Facilitate collaboration for ISoP members on H&TMs research and projects.

Advocate for the unique characteristics of H&TMs and the need for adapted PV tools.

Share news, research, regulatory actions, and other relevant information on HMs issues.

Expand membership in the H&TMs SIG.

Build relationships with other ISoP groups and chapters.

Collaborate with external organizations on phytovigilance initiatives.

The H&TMs SIG is made up of 31 members coming from various countries belonging to different partners of the HMs PV system as outlined in Table 1 . The year 2023 was particularly the year for new memberships with ten new members. This distribution of the different members of the group shows that most continents are represented as are all categories of countries both economically and in terms of the development and regulation of phytovigilance in these countries [ 13 , 14 ].

2.2 Communicating for the Safe Use of H&TMs

Unlike conventional medicines, PV of H&TMs s is not as developed, and this can be noticed at different levels in the WHO member countries for the international PV program. This ranges from the absence of PV of H&TMs s in the country to fairly even developed PV [ 13 , 14 ].

Phytovigilance must develop much further to ensure the safe use of H&TMs. In the daily healthcare sector, it remains a challenge and requires strong collaboration across regulatory agencies, pharmaceutical industries, HCPs, academics, traditional practitioners, herbalists, and patients who today expect to discuss with their HCPs and to participate in reporting, as well as to have their say in their treatment [ 15 ]. This collaboration must inevitably involve communication which may at times be challenging for phytovigilance specialists who are first of all dedicated to the collection and assessment of data on adverse reactions. Effective communication is required between all phytovigilance partners where H&TMs is concerned, and safety information must be shared and accessible to all [ 16 ].

The H&TMs SIG can leverage its members’ expertise by involving them in relevant lectures and communications at various meetings, including those organized or cosponsored by ISoP.

2.3 Promoting Phytovigilance to the Public

The H&TMs SIG continues to actively promote the exchange of safety information and science to enhance public awareness of phytovigilance. This is done through supporting the publication of phytovigilance related books and articles based on the translation of international educational phytovigilance textbooks and bibliographies. Such an example is Pharmacovigilance for Herbal and Traditional Medicines Advances—Challenges and International Perspective [ 17 ], a recently published book where the active members of the SIG were invited to write several of the chapters of which constitute the book. At the ISoP annual meeting 2023 in Bali, a proposal was put forward to use social media outlets for effective communication to disseminate information, real time warnings, and the latest news in relation to H&TMs.

2.4 Supporting Education and Research

Improvements in the education of all HCPs is required regarding the principles and practice of phytovigilance. The addition of such a subject to the curriculum of both conventional (medical) and alternative (naturopathic and chiropractic) schools and universities would inform these practitioners of the importance of discussing the use of H&TMs with their patients, as well as how to recognize and report ARs. The inclusion of information on H&TMs as a potential therapy should be included in academic programs. Pharmacological aspects of phytotherapy and phytovigilance should be included in the regular medical and pharmacy curriculum. This is already the case in Morocco, which, since 2017, has introduced a university curriculum for the pharmacovigilance of herbal medicines [ 18 ].

Phytovigilance training and education that involves national pharmacovigilance centers, national medicines regulatory affairs (NMRAs), as well as academia, is needed. The Moroccan experience may be replicated nationally and internationally. This experience and those of Switzerland were presented during ISoP 2023 in the preconference course dedicated to H&TMs. This half-day session was organized and conducted by the lead of the ISoP H&TMs SIG.

In the field of research, many members of the SIG have extensive experience in the field and participate in research projects of great scientific contribution. The results of these projects are published and even recognized and awarded by their peers.

We can mention the latest distinctions awarded to Souad Skalli from Morocco for her abstract: “Poster-300: DNA Barcoding as a Tool to Overcome the Challenges of phytovigilance of Natural Health Products Quality: The Example of Safran,” third poster prize during the twenty-first ISoP annual meeting in September 2022, Verona, Italy [ 19 ]. Of particular interest is the challenge of counterfeit natural products. The article by Jia-bo Wang et al. has been selected as one of the top ten advances in traditional Chinese medicine (TCM) research in China [ 20 ]. In addition, Kampadilemba Ouoba from Burkina Faso was awarded the 2023 International Prize for the proper use of medicines for his research into the PV of traditional medicines in West Africa. This prize was awarded by the French National Academy of Pharmacy, in partnership with Les Entreprises du Médicament (Leem).

2.5 Collaborating with Others for a Multidisciplinary Network

The H&TMs SIG, by devoting itself to building strong connections with other organizations (Regulatory, academic, researchers, HCPs, and public) in tackling challenges relating to the safety and effectiveness of HMs, promotes phytovigilance and H&TMs risk management knowledge during ISoP meetings and to provide a platform for researchers to interact and learn. In addition, the tradition is not only to organize meetings and to discuss with the participants but also to schedule exclusive meetings with the group members. This contributes to strengthening the ties between the participants and the group members. Moreover, exchanges of ideas and perspectives are better done face to face. Other external meetings may be organized in collaboration with the ISoP where the members of the group are actively involved in the discussion about H&TMs. An example of this was the conference held at the Royal Botanic Gardens at Kew, London, UK, from 13 to 14 April 2023, entitled Advances in Pharmacovigilance for HMs [ 21 ]. ISoP was a partner in arranging this conference, and several members of the ISoP H&TMs SIG gave invited presentations.

2.6 Boosting Active Dialogue Between ISoP Members Who are Interested in H&TMs

H&TMs SIG is a focal point for ISoP members who are interested in phytovigilance to share and provide information on relevant issues and developments and to support H&TMs pharmacovigilance. With its main mission to provide a forum for members to share experiences to suggest and discuss best practices and policy in the field of H&TMs monitoring and safety surveillance. Besides raising awareness of H&TMs pharmacovigilance issues among HCPs and the public, the ISoP H&TMs SIG is a valuable resource for anyone interested in the safe and effective use of H&TMs.

3 A Framework for Strengthen Phytovigilance and Boosting Patient Safety

Participation in domestic and international events concerned with patient safety issues is one of the ISoP’s strategies to foster PV worldwide [ 22 ]. These strategies are adopted through ISoP national and regional chapters along with ISoP SIGs or by individual members. Such events enhance the culture of medication safety in all aspects (e.g., World Patient Safety Day, MedSafetyWeek, etc.).

The Egyptian chapter of the ISoP received an invitation to participate in the tenth Volatile Oile Gallery (VOG). The VOG is an annual symposium that was established in 2014 by the pharmacognosy department of the Faculty of Pharmacy Ain Shams University (FOPASU), Cairo, Egypt [ 23 ]. It provides a scientific platform where students can present their work on the use of volatile oils in medicine. Every year, the students have the opportunity to show the importance of essential oils in the wellbeing of human life through transforming what they have learned in the lecture halls into life applications and present this information in a simplified way. There is a cultural character to the event where the international students attend in their folk costumes with the herbs for which their countries are famous.

It was an indispensable chance for the ISoP to highlight the importance of phytovigilance. Accordingly, a collaboration took place between the Egyptian Chapter and H&TMs SIG to develop a framework to promote the safety of HMs.

At the FOPASU campus, many stakeholders from different health sectors (e.g., NMRAs, nonprofit organizations, pharmaceutical companies, patients, hospitals, etc.) were invited to attend with their booths and the postgraduate students of the pharmacognosy department to present their scientific posters.

During the preparation for the event, the Egypt chapter provided a proposal to the organizers to be addendum to the VOG’s agenda. The proposal included several items, including:

Printing flyers with two different contents about the safety of HMs. One designated for medical students, HCPs. The second contains simplified content with visual graphics intended for patients and the public.

Providing scientific trainings before the event for students about PV and its broader scope, which includes not only medicines but also vaccines and HMs. The training consists of pivotal details about the safety of HMs. After these trainings, students will be able to give a focused message about phytovigilance while distributing the flyers.

The concept of these two points is to spread our message as widely as possible, by engaging the community in field activities through making the audience participate in disseminating information instead of being mere recipients. This strategy boosts deeper levels of community engagement.

The deliverables of adapting this approach are:

Debunking myths and infodemic about the unrealistic benefits of herbal products without considering their safety.

Giving an example of an executable framework for effective outreach.

Establishing a strong nexus between the different PV stakeholders to promote the safety monitoring of H&TMs.

Providing a forum to listen to the safety anecdotes about H&TMs from patients.

Increasing the awareness among the HCPs about other sources from which adverse effects may occur.

Engaging the community will allow PV stakeholders to recruit new allies and work under a common protocol.

Shedding light on the importance of updating the educational programs of undergraduate studies to integrate phytovigilance within the medical student curriculum.

Integrating the culture of safety of herbal products into the routine life of the community and creating a network between the PV stakeholders will help overcome all the barriers that face phytovigilance being consolidated within healthcare systems. It will facilitate the detection of new risks and the rapid development of phytovigilance to enable optimum measures to minimize these risks.

4 Conclusions

Adapting innovative approaches for opening new channels to the public to promote phytovigilance awareness is one of the strategies of the ISoP H&TMs SIG as a significant percentage of the community depends on H&TMs for many purposes, including healthcare. The public must be aware of the potential risks, just as it itself is aware of its benefits, to be able to evaluate all different treatment options, including H&TMs. Furthermore, PV stakeholders must develop communications tools for promoting the safer use of H&TMs. ISoP, as a nonprofit international professional organization, continues to provide support to all countries for fostering the science of PV to ensure the safe and proper use of medicines, and this includes H&TMs.

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Acknowledgements

The authors acknowledge the assistance of Francesco Salvo, ISoP Chapters Coordinator, Maribel Salas, ISoP Special Interest Groups Coordinator, and Brian Edwards, Vice President of ISoP, for reviewing the manuscript. The authors also wish to thank Heba Ibrahim, from the MedDRA MSSO, for her comments.

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Hadir Rostom

Faculty of Pharmacy, MSA University (President of ISoP Egypt Chapter), 6th of October City, Giza, Egypt

Egyptian Ministry of Health and Population, Central Administration for Pharmaceutical Affairs (Research Coordinator of ISoP Egypt Chapter), Cairo, Egypt

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Skalli, S., Caro-Rojas, A., Rostom, H. et al. A Framework for Promoting Safety Monitoring of Herbal Medicines: The International Society of Pharmacovigilance Special Interest Group on Herbal and Traditional Medicines. Drug Saf (2024). https://doi.org/10.1007/s40264-024-01440-6

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Facility for Rare Isotope Beams

At michigan state university, international research team uses wavefunction matching to solve quantum many-body problems, new approach makes calculations with realistic interactions possible.

FRIB researchers are part of an international research team solving challenging computational problems in quantum physics using a new method called wavefunction matching. The new approach has applications to fields such as nuclear physics, where it is enabling theoretical calculations of atomic nuclei that were previously not possible. The details are published in Nature (“Wavefunction matching for solving quantum many-body problems”) .

Ab initio methods and their computational challenges

An ab initio method describes a complex system by starting from a description of its elementary components and their interactions. For the case of nuclear physics, the elementary components are protons and neutrons. Some key questions that ab initio calculations can help address are the binding energies and properties of atomic nuclei not yet observed and linking nuclear structure to the underlying interactions among protons and neutrons.

Yet, some ab initio methods struggle to produce reliable calculations for systems with complex interactions. One such method is quantum Monte Carlo simulations. In quantum Monte Carlo simulations, quantities are computed using random or stochastic processes. While quantum Monte Carlo simulations can be efficient and powerful, they have a significant weakness: the sign problem. The sign problem develops when positive and negative weight contributions cancel each other out. This cancellation results in inaccurate final predictions. It is often the case that quantum Monte Carlo simulations can be performed for an approximate or simplified interaction, but the corresponding simulations for realistic interactions produce severe sign problems and are therefore not possible.

Using ‘plastic surgery’ to make calculations possible

The new wavefunction-matching approach is designed to solve such computational problems. The research team—from Gaziantep Islam Science and Technology University in Turkey; University of Bonn, Ruhr University Bochum, and Forschungszentrum Jülich in Germany; Institute for Basic Science in South Korea; South China Normal University, Sun Yat-Sen University, and Graduate School of China Academy of Engineering Physics in China; Tbilisi State University in Georgia; CEA Paris-Saclay and Université Paris-Saclay in France; and Mississippi State University and the Facility for Rare Isotope Beams (FRIB) at Michigan State University (MSU)—includes  Dean Lee , professor of physics at FRIB and in MSU’s Department of Physics and Astronomy and head of the Theoretical Nuclear Science department at FRIB, and  Yuan-Zhuo Ma , postdoctoral research associate at FRIB.

“We are often faced with the situation that we can perform calculations using a simple approximate interaction, but realistic high-fidelity interactions cause severe computational problems,” said Lee. “Wavefunction matching solves this problem by doing plastic surgery. It removes the short-distance part of the high-fidelity interaction, and replaces it with the short-distance part of an easily computable interaction.”

This transformation is done in a way that preserves all of the important properties of the original realistic interaction. Since the new wavefunctions look similar to that of the easily computable interaction, researchers can now perform calculations using the easily computable interaction and apply a standard procedure for handling small corrections called perturbation theory.  A team effort

The research team applied this new method to lattice quantum Monte Carlo simulations for light nuclei, medium-mass nuclei, neutron matter, and nuclear matter. Using precise ab initio calculations, the results closely matched real-world data on nuclear properties such as size, structure, and binding energies. Calculations that were once impossible due to the sign problem can now be performed using wavefunction matching.

“It is a fantastic project and an excellent opportunity to work with the brightest nuclear scientist s in FRIB and around the globe,” said Ma. “As a theorist , I'm also very excited about programming and conducting research on the world's most powerful exascale supercomputers, such as Frontier , which allows us to implement wavefunction matching to explore the mysteries of nuclear physics.”

While the research team focused solely on quantum Monte Carlo simulations, wavefunction matching should be useful for many different ab initio approaches, including both classical and  quantum computing calculations. The researchers at FRIB worked with collaborators at institutions in China, France, Germany, South Korea, Turkey, and United States.

“The work is the culmination of effort over many years to handle the computational problems associated with realistic high-fidelity nuclear interactions,” said Lee. “It is very satisfying to see that the computational problems are cleanly resolved with this new approach. We are grateful to all of the collaboration members who contributed to this project, in particular, the lead author, Serdar Elhatisari.”

This material is based upon work supported by the U.S. Department of Energy, the U.S. National Science Foundation, the German Research Foundation, the National Natural Science Foundation of China, the Chinese Academy of Sciences President’s International Fellowship Initiative, Volkswagen Stiftung, the European Research Council, the Scientific and Technological Research Council of Turkey, the National Natural Science Foundation of China, the National Security Academic Fund, the Rare Isotope Science Project of the Institute for Basic Science, the National Research Foundation of Korea, the Institute for Basic Science, and the Espace de Structure et de réactions Nucléaires Théorique.

Michigan State University operates the Facility for Rare Isotope Beams (FRIB) as a user facility for the U.S. Department of Energy Office of Science (DOE-SC), supporting the mission of the DOE-SC Office of Nuclear Physics. Hosting what is designed to be the most powerful heavy-ion accelerator, FRIB enables scientists to make discoveries about the properties of rare isotopes in order to better understand the physics of nuclei, nuclear astrophysics, fundamental interactions, and applications for society, including in medicine, homeland security, and industry.

The U.S. Department of Energy Office of Science is the single largest supporter of basic research in the physical sciences in the United States and is working to address some of today’s most pressing challenges. For more information, visit energy.gov/science.