Are herbal remedies and dietary supplements safe and effective for breast cancer patients?

Abstract

There remains limited scientific evidence on the efficacy and safety of 'natural' therapies such as herbal remedies and dietary supplements. Nevertheless, breast cancer patients are particularly prone to purchasing such products because of the perception that 'natural' products are less toxic than conventional prescribed medicines. However, the potential for interactions of supplements with current medications, the potential for adverse effects from consumption at high levels, and the lack of disclosure of such treatments by the patient to their doctor are serious public health issues. Robust clinical trials are required to prove the efficacy and lack of adverse effects of such preparations, and communication between patients and doctors must be improved and doctors made more aware that their patients may be seeking advice and treatment from sources outside conventional medicine.

Introduction

Many women are keen to use herbal or 'natural' remedies, either to prevent breast cancer or to assist in treating the disease, but most remain unaware of the limited scientific evidence surrounding the efficacy of these remedies, and the potential drug interactions and adverse effects that may result from their consumption. In many instances these women rely on in-house sale staff of health food shops to provide sufficient and accurate advice. However, an article published in this issue of Breast Cancer Research [1] provides data on the heterogeneity of advice given by sales staff and the limited scientific evidence provided to purchasers of natural or herbal remedies. These data are consistent with previous studies [2-4] and highlight important issues regarding the misleading and potentially harmful nature of the advice provided to breast cancer patients by health food shops.

Risk versus benefit of 'natural' products

In the study published in this issue [1] a number of products were recommended, none of which are currently supported by scientific evidence to confer a health benefit. Indeed, in many instances the potential for adverse effects of the products were not discussed, or were drug interactions addressed. The study raises significant concerns, particularly following the recent publication of data from the Women's Health Initiative on the risk–benefit profile of hormone replacement therapy (HRT) [5] and the confirmation from the UK based Million Women Study that current and recent use of HRT increases the risk for breast cancer [6]. These data have been widely publicized in the press, and the headlines produced from such studies may lead women to seek dietary or herbal alternatives to drug therapies such as HRT, under the assumption that 'natural' products are safe and effective.

Women are high consumers of alternative or complementary therapies [7], and thus breast cancer patients are particularly prone to purchasing such remedies. Many of these remedies are based on folklore [8] and have not yet been scrutinized to the scientific rigor that is required for approval of drug therapies. In one study [9], conducted in the USA, the prevalence of use of alternative therapies by breast cancer patients was greatest in women with higher educational attainment and income. The key public health issues arising from consumption of such remedies relate to the potential for interactions of supplements with current drug therapy [10], the potential adverse effects associated with consumption, particularly at high doses [11], the concurrent use of several alternative therapies, the costs of such therapies, and the lack of disclosure of such treatments by the patient to their doctor [12].

Alarmingly, only half of the breast cancer patients in one USA-based study reported discussing their use of an alternative therapy with their doctor [9]. Doctors must be more aware that their breast cancer patients may be seeking advice and treatment from sources outside conventional medicine. Poor communication between patient and doctor is therefore a potential area for improvement, and doctors treating patients with breast cancer should initiate a dialogue on alternative therapies to ensure that optimal advice is given regarding treatment options.

Medical science continues to comb through nature's array of compounds for potential substances that may successfully prevent or treat breast cancer. To date, however, most of the herbal remedies or alternative 'natural' preparations on sale to breast cancer patients have either not been robustly tested in appropriately controlled clinical studies or lack clinical data to support their use in breast cancer [13,14]. Natural extracts are complex mixtures, and stringent regulations on quality assurance, which apply to drug therapies, are not currently enforced. Indeed, there is evidence to suggest wide variability in the quality of available dietary supplements and herbal remedies, one example of which is the poor correlation between actual and reported content of commercially available dietary phytoestrogen/isoflavone supplements [15].

Breast cancer patients are attracted to 'natural' or alternative therapies because of the perception that they are less toxic than conventional prescribed medicines. Although recent reports on the potential adverse effects and drug interactions resulting from consumption of some natural products [16-18] may have raised awareness within the medical community of the need for appropriate clinical trials to address the ratio of risk to benefit for these preparations, this information is unlikely to have filtered through to staff and purchasers from health food shops. In particular, risk assessment for dose and duration of exposure must be addressed to help define the 'efficacious' dose, if indeed there is any. Health food shops are and will probably remain a frequent source for such products and health advice, but to date they remain unregulated and their employees require no formal education in medical or nutritional science. Currently, the alternative therapy market is governed by marketing, with no regulation to ensure the efficacy or safety of the products on sale. In the future, more formal training of such staff on adverse effects, drug interactions and the limitations of the clinical data on the products sold would help consumers to make a more rational choice. From a manufacturing perspective, it would be ideal to introduce more stringent regulations to ensure that a health benefit can only be marketed following the completion and publication of clinical studies to define optimal dose and assure no potential adverse effects or drug interactions. Doctors must be aware of what products their patients are consuming, and instilling the importance of openness between manufacturers of alternative therapies and the medical community is important for future cooperation.

With the increasing availability of medical and nutritional information to consumers from the internet and other sources, doctors must remain up-to-date on the available complementary or alternative medicines their patients are consuming and offer cautious advice on their use. There is currently insufficient scientific evidence available to suggest that alternative therapies are safe and effective for either the prevention or treatment of breast cancer. Because of this lack of efficacy and potential for adverse effects, their use warrants caution, particularly in vulnerable breast cancer patients.

Conclusion

Breast cancer patients, along with the public in general, remain unaware that most of the herbal remedies and alternative natural preparations available have not been robustly tested in carefully designed clinical studies. Natural extracts are complex mixtures, and stringent regulations on quality assurance, which apply to drug therapies, are not currently enforced. For most of these products, we still do not know whether they work, and studies are required to define whether they are effective and safe and, if so, what dose is required for such an effect. Until such evidence-based data is available, their use merits caution, particularly in vulnerable breast cancer patients.

Competing interests

Abbreviations

HRT = hormone replacement therapy.

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Source : http://breast-cancer-research.com/content/5/6/300

Jamu for the ills of modernity?

Jamu is evolving to meet modern needs

Margot L. Lyon

Writings about Javanese herbal medicines (jamu) in Indonesia often emphasise their ancient origins and their status as traditional medicine. But the world of jamu has undergone many changes, and the market in jamu today reflects the complexities of contemporary life. An examination of how jamu are currently made, distributed, marketed and used provides a window into some of these issues.

Traditionally, jamu was prepared at home. But while few people today have the time, or the skills, for the lengthy process of preparing the various ingredients, traditional-style jamu are still readily available. In the early morning hours in almost any kampung in the cities and towns of Java, women peddle jamu door to door. Carrying a deep round basket heavy with bottles of reddish-brown or golden coloured liquid tied to her back, the jamu seller walks the narrow lanes of the kampung. These itinerate jamu sellers also service offices and factories, offering a pick-me-up for tired workers. Any traditional market, too, has permanent stalls selling jamu of various sorts that can be combined on the spot by the vendor depending on the client’s needs.

However, the majority of jamu sold today come in packaged form (jamu bungkus). These are most often in the form of small, brightly-coloured foil or plastic sachets of powder to brew with hot water or mix with other drinks. Jamu is also increasingly available in the form of tablets or capsules that look like conventional medicine.

Traditionally, jamu preparations were as much used to maintain good health and proper bodily functioning as for treating specific illnesses. Today, the taking of jamu as opposed to conventional pharmaceuticals, is still common for the many categories of ailments that don’t precisely correspond to biomedical categories of sickness. These are ailments such as masuk angin, similar to a cold or flu, and pegel linu, a term which refers to joint and muscular stiffness and rheumatic-type pain. Jamu­are also frequently used for women’s problems such as vaginal discharge, regulating the menses, and for conditions associated with pregnancy, birth, and postnatal health.

Today at least 50 per cent of all traditional medicines sold are for the enhancement of manliness, sexual performance, and sexual health. Increasingly common also is the marketing of jamu for problems such as high cholesterol, diabetes, and high blood pressure, as well as for conditions such as acne. Customers wanting to lose weight, enlarge their busts and so on, also turn to jamu.

The business of Jamu

The number of smaller businesses involved in the manufacture of jamu exploded in the late 1980s and through the 1990s. By 1998, nearly 700 firms making traditional medicines were registered with the Department of Health. Seventy nine of these were classed as industries proper, the remainder as small (often home) industries. This number does not include the many tiny household enterprises that operate without formal approval.

However, the commercial production of jamu is dominated by a few large companies. These firms generally began as family businesses but over time expanded into modern industries manufacturing jamu for both domestic and export markets. The earliest companies were Jamu Cap Jago founded in 1918 and Jamu Cap Potret Nyonya Meneer founded in 1919. Other main players in the jamu business have been Sido Muncul (1951), Air Mancur (1963), and more recent firms such as Mustika Ratu (1975), Sari Ayu (1979), as well as Deltomed and Borobodur.

In the 1960s and 1970s, the big jamu brands were still widely advertised at markets and fairs by teams of travelling salesmen. By the early 1980s, when the network of local distributors and agents was already well developed and the main brands were well known, the marketing strategies of the four biggest firms shifted to kiosks. Tens of thousands of kiosks were opened throughout Java and jamu companies ran training courses for their agents and sellers. The brand kiosks still exist, many in somewhat changed form, but many more kiosks of different sorts have opened over the last few years in both urban and rural areas. Kiosk owners often function as ‘consultant pharmacists’ giving advice on what jamu to take for specified ailments or needs. Local healers may write ‘prescriptions’ suggesting what jamu should be purchased at a brand kiosk.

Expanded markets

Jamu sales of all types have increased greatly since the beginning of the economic crisis in 1997. The price of conventional pharmaceuticals is very high, because even pharmaceuticals made in Indonesia use a high percentage of imported raw materials.

Part of this market expansion is demand, but the distribution and sale of packaged jamuxhas also provided income opportunities for many people. This has led to an ever expanding marketing chain for packaged jamu in rural and urban communities. Packaged jamu has moved into the supermarkets, pharmacies, beauty salons, and department stores, as well as the hundreds of thousands of small shops that sell tea, sugar or cigarettes. They are also available in a myriad of food stalls and small restaurants.

Some big jamu firms have moved toward products aimed at the middle class and wealthy, especially in the areas of natural skin care and cosmetics. More expensive brands are heavily promoted at special counters in exclusive shops or salons and upmarket jamu bars have joined Starbucks cafes opening in malls across the country. Middle and lower-priced brands are often marketed from temporary kiosks set up in market complexes or malls. Small, permanent shops also abound within shopping plazas or districts adjacent to bus terminals or other busy places. Even the old jamu gendong seller now usually carries packets of a selection of ready-made jamu, and women providing mixed jamu from their stalls in the markets, also have available a range of jamu bungkus.
Customer beware
Consumers of packaged jamu need to be both informed and cautious. They should buy from a reliable manufacturer and take note of warnings issued by government and non-governmental bodies that operate as watchdogs over the traditional medicine market as well as the food, cosmetic, and pharmaceutical industries.
Authenticity is also frequently a problem. The popularity of a jamu from a small firm, for example, may lead to counterfeiting. The name and packaging are duplicated almost exactly — but not necessarily its contents.
New ailments, new needs
There are other factors involved in the growing popularity of jamu. The profound economic crisis and growing political and social disorder, and the stresses these factors bring about in peoples’ everyday lives, has engendered a growing concern with health, stamina and wellbeing. In the context of these changing conditions, new demands for different sorts of medicines and tonics have emerged. The growth in demand for jamu has been accompanied by increased use of pharmaceuticals such as anti-depressants and anti-anxiety drugs, and an increase in prevalence of alcohol and illicit drug use.
Some of the most popular jamu today are those that meet the new demand for renewed energy, stamina, and alertness. Most of these energy drinks, tonics and supplements are manufactured by large drug or food manufacturers. Although they are considered jamu, they are not jamu proper, because they are not primarily herbal.
Best-selling bottled tonics like ‘Kratingdaeng’, ‘Fit-Up’, and ‘Hemaviton’ contain ingredients such as vitamin B, caffeine, and other substances associated with quick energy. One of the most successful energy drinks is ‘Extra-Joss’, manufactured by the firm Bintang Toedjoe. Though not a herbal preparation (except that it contains some ginseng), like some jamu it comes in the form of a small sachet of instant powder, and costs much less than the bottled energy drinks. Another product made by Bintang Toedjoe is a jamu for male potency, ‘Irex’. Extra-Joss and Irex, both already extremely popular, achieved even greater prominence when they were the featured advertised products during Indonesian TV broadcasts of World Cup Soccer. The images used to promote these and other energy drinks were ones of strength and anliness.
The promotion of manly qualities has always been an important function of jamu. Consequently, the category of energy drinks overlaps with the traditional category of obat kuat (literally medicine to make one strong, powerful). Obat kuat include medicines for enhancing male potency and aphrodisiacs, an increasing number of which are marketed as jamu in markets.
Obat kuat is primarily produced by small local manufacturers or imported from China. Few are actually purely herbal preparations; many contain testosterone or other steroids, and are marketed as the equivalent of Viagra at a fraction of the cost.

These new products, including new types of traditional medicines, sell a chemical sense of ‘power’. For their users, energy drinks and other stimulants create a sense of enhanced physical resources. Whatever their actual ingredients, they offer a sense of ready energy, of potential action, in the face of the daily grind of poorly-paid work or continuing poverty. But this strength is an illusion. It merely masks the effects of poor life conditions — lack of sleep, inadequate food intake, poor nutrition, pollution, chronic disease and parasites.

By Margot L. Lyon (margot.lyon@anu.edu.au) is an anthropologist in the School of Archaeology and Anthropology of the Australian National University in Canberra.

Source : http://insideindonesia.org/content/view/298/29/