2. Introduction:
•13% of a study participants suffering from hepatotoxicity owing to
non–body building HDS (Herbal dietary supplements) required
transplantation compared versus only 3% of those with
conventional medication–associated liver injury.
•The true incidence of liver injury in the United States owing to
herbal products is yet to be established.
•DILIN’s findings are particularly important against the backdrop of
the current regulatory environment for HDS, which neither
promotes nor mandates research on their safety or efficacy.
•A survey of the literature indicates that HDS-related hepatotoxicity
is indeed a worldwide problem.
•Spanish Liver Toxicity Registry showed that HDS products accounted
for 2% ,the 10th most common therapeutic group.
•Studies from Korea/Singapore reported HDS as being responsible
for for 73% &71%, respectively, of all identified cases of
hepatotoxicity.
3. Introduction:
•Herbal products used for centuries among to treat symptoms&dis.
•Recently, their use in the West has grown significantly, rivaling that
of prescription medications.
•Currently,theyare used mainly for weight loss& bodybuilding,
improve well-being& symptoms of chronic diseases.
•Many believe that because they are natural, they must be effective
& safe; however, these beliefs are erroneous.
•Few herbals studied in well-designed controlled trials of patients
with liver or other diseases, despite testimony to the contrary.
•Current highly effective antivirals make efforts to treat hepatitis C
with herbals redundant.
•Herbals are no safer than conventional drugs& have caused liver
injury severe enough to require transplantation or cause death.
•Their efficacy, safety& claims are not assessed by regulatory
agencies&there is uncertainty about their contents.
4. HDS: Classification
•Herbal products used as medicine of 3 broad categories:
•1.Individual crude herbals derived from plants (stems, roots, leaves,
berries, seeds,flowers) &barks of trees, used over centuries &
selected generally by traditional healers.
•Their chemical constituents are often unknown or not fully
characterized&may vary widely depending on weather conditions,
geographic location&elevation where grown.
•Most are given as a single product, although some, as traditional
Chinese medicines (TCMs) or Japanese Kampo medicines, may
include several herbals bundled together,selected by experienced
herbalists based on traditional values &long use.
•Herbal products are administered as infusions, decoctions, syrups,
poultices, lotions, or compresses.
•Most have not been evaluated for efficacy (or safety) by scientific
controlled trials&effective doses have rarely been established.
5. HDS: Classification
•2. Botanicals, the chemical constituents of which were used to
synthesize potent& effective conventional drugs& helped launch
the pharmaceutical industry.
•Through the mid-1980s, > 80% of drugs were derived from plants;
now 15%.
•Examples are willow bark containing acetylsalicylic acid, the
precursor of aspirin; china bark(cinchona), the original source for
quinine; poppies that yielded opioids and morphine; purple
foxglove, from which digitalis was extracted; deadly nightshades
(jimson weed,mandrake), the source for atropine&many others.
•Some anticancer drugs also originated from herbal products,
including alkaloids derived from berberine and piperine& vincristine
from Madagascar periwinkle..
6. HDS: Classification
•3. Encompasses the burgeoning commercial herbal industry that
creates &markets products under trade names, now the
predominant type used in Western countries, as much with the
hope of improving wellbeing as for treating illnesses.
•Products generally contain multiple constituents, ranging in number
from 2 to more than a doze&may include additional components
such as vitamins.
•Constituents are selected for their purported individual benefits,
not necessarily by an experienced herbalist&without evidence that
the combination is complementary.
•Like traditional herbal products, few if any have been evaluated for
true benefit using scientific methods.
•For some, there is concern about contamination and/or
adulteration.
7. Epidemiology and Expenditure
•In US 1990, 34% of respondents reported using CAMs during the
preceding year, with 2.5% using herbal products.
•On further analysis, 67.6% admitted using an alternative therapy
during their lifetime, a secular trend believed to have started half a
century earlier.
•When the investigators repeated the telephone survey in 1997,they
found that use of CAMs had increased to 42%, with 12.1% of
participants using herbal products.
•The same trend was reported in a series of National Health &
Nutrition Examination Surveys,conducted from 197- 1974, 23% of
the general population reported using vitamin supplements.
•From 1976-1980, 35% of the population reported using
supplements (predominantly older people with higher
education&incomes).
•
8. Epidemiology and Expenditure
•From 1988-1994, 35% of men and 44% of women took supplements;
increased to 52% between 1990 and 2000.
•A1999 National Health Interview Survey of non institutionalized
civilians found that 28.9% of adults used at least one CAM in the
preceding year, with 9.8% using herbal products.
•38.2 million US adults were estimated to have used CAMs during
2002, with women using CAMs more frequently than men.
•A telephone health &dietary survey among non institutionalized US
adults, sponsored by (FDA), found that 73% of respondents used
dietary supplements, with 4% attributing an adverse event to the
supplement.
9. Epidemiology and Expenditure
•These findings are similar in other Western countries.
•A survey from Europe involving 6 European countries (Finland,
Germany, Italy, Romania, Spain, and the United Kingdom) found
that among 2359 consumers, 18.8% admitted using one or more
plant food supplements.
•$13.2 billion was spent on CAMs in 1990,4 increasing to $27 billion
in 1997.
•The National Center for Complementary &Alternative Medicine
estimated an expenditure of $33.9 billion in 2007, equivalent to
approximately one-third of total out-of-pocket spending on
prescription drugs.
•Sales increased each year from$4110 million in 1999 to $5600
million in 2012.
10. Reasons for Using Herbal Products:
•Some people believe that pharmaceutical drugs are too costly,
cause adverse effects&conflict with their personal beliefs in natural
healing.
•Others regard general medical care as lacking compassion & time
restricted.
•Most, believe that because medicinal herbal products have been
used for centuries, they must be effective&safe; this view is
bolstered by positive feedback from the Internet & testimonials.
11. Reasons for Using Herbal Products:
•Unfortunately, many people who use herbal products are reluctant
to inform their physicians of their use for fear of reprimand.
•Herbal products are used to complement conventional medications
or as an alternative to pharmaceuticals, hence the term CAM.
•Using unproven herbal products alone to treat serious diseases such
as cancer, (HIV), diabetes,cardiovascular and liver diseases, among
others, obviously carries great risk.
•Those who use herbal products also have other objectives; in a
recent questionnaire, their goals, in order of prevalence, were to
influence the natural history of the disease, promote wellbeing,
reduce adverse effects, take control of their lives,relieve symptoms,
provide emotional support, improve quality of life, cope better with
illness&support natural healing