Dr. Mohamed Alshekhani

Kurdistan Board GEH J Club 2015

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.

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.

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.

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..

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.

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).

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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.

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.

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.

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