Durante mucho tiempo no había principios uniformes para la Atribución de nombres a los antibióticos https://antibioticos-wiki.es . Más a menudo se les llama por el nombre genérico o especie del producto, con menos frecuencia-de acuerdo con la estructura química. Algunos antibióticos se nombran de acuerdo con el lugar donde se asignó el producto.
Obr_169.fm
Blackwell Science, LtdOxford, UKOBRobesity reviews1467-78812004 The International Association for the Study of Obesity. 693111Review ArticleAdverse events of herbal food supplements M. H. Pit-
obesity reviews Adverse events of herbal food supplements for body weight reduction: systematic review*
Complementary Medicine, Peninsula Medical
School, Universities of Exeter and Plymouth,
Herbal weight-loss supplements are marketed with claims of effectiveness. Our
earlier systematic review identified data from double-blind, randomized controlledtrials for a number of herbal supplements. The aim of this systematic review was
Received 25 May 2004; revised 1 October
to assess all clinical evidence of adverse events of herbal food supplements for
body weight reduction for which effectiveness data from rigorous clinical trialsexist. We assessed Ephedra sinica, Garcinia cambogia, Paullinia cupana, guar
Address reprint requests to: MH Pittler,
gum, Plantago psyllium, Ilex paraguariensis and Pausinystalia yohimbe. Litera-
Complementary Medicine, Peninsula Medical
ture searches were conducted on Medline, Embase, Amed and The Cochrane
School, Universities of Exeter and Plymouth, 25
Library. Data were also requested from the spontaneous reporting scheme of the
Victoria Park Road, Exeter, EX2 4NT, UK. E-
World Health Organization. We hand-searched relevant medical journals and our
own files. There were no restrictions regarding the language of publication. The
*See editorial, this issue pp. 89–92.
results show that adverse events including hepatic injury and death have beenreported with the use of some herbal food supplements. For herbal ephedra andephedrine-containing food supplements an increased risk of psychiatric, auto-nomic or gastrointestinal adverse events and heart palpitations has been reported. In conclusion, adverse events are reported for a number of herbal food supple-ments, which are used for reducing body weight. Although the quality of the datadoes not justify definitive attribution of causality in most cases, the reported risksare sufficient to shift the risk–benefit balance against the use of most of thereviewed herbal weight-loss supplements. Exceptions are Garcinia cambogia andyerba maté, which merit further investigation. Keywords: Adverse event, herbal supplement, safety, systematic review obesity reviews (2005) 6, 93–111
22.9% of the US adult population was considered obese,
Introduction
which increased to 30.5% in NHANES 1999–2000; 64.5%
The prevalence of overweight and obesity is increasing at
were classified as overweight (6). In the UK, the National
an alarming rate and obesity has become one of the most
Audit Office extrapolating prevalence data to the year 2005
important avoidable risk factors for morbidity and mortal-
suggests that levels of obesity in England could reach those
ity (1). The risk of developing, for instance, cancer, diabetes
now experienced in the USA. In 1980, 8% of women and
or heart disease increases with the degree of overweight in
6% of men were classified as obese; in 1998 the prevalence
both men and women (2–5). Based on a body mass index
had nearly trebled to 21% of women and 17% of men (7).
(BMI) in the healthy range – 18.5–24.9 kg m-2 – almost
The increase in obesity rates occurred more rapidly in
one-third of the US adult population must now be consid-
England than in other European countries (8). One of the
ered obese (BMI ≥ 30) and an additional third is over-
major factors responsible for the increase in prevalence
rates is a decrease in energy expenditure from physical
Nutrition Examination Survey (NHANES) III(1988–94),
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
These considerations and the notoriously poor compli-
herbal food supplements. Reports detailing adverse events
ance with conventional weight management programmes
after intake of single constituents of herbal extracts, cases
emphasize the importance of effective, safe and acceptable
of accidental poisoning, adverse events linked to occupa-
therapeutic options. It is therefore not surprising to see the
tional handling and studies assessing unconscious patients
plethora of herbal over-the-counter slimming aids on offer,
were excluded. Articles published in other languages than
which are marketed with claims of effectiveness. Our ear-
lier systematic review identified data from double-blind,randomized controlled trials (RCTs) for a number of herbal
food supplements (10). The weight of the evidence, how-ever, seems small for most supplements and therefore even
The searches identified largely anecdotal evidence. The
moderate adverse events may shift the risk–benefit balance
evidence relates to Ephedra sinica, Garcinia cambogia,
against their use. The aim of this systematic review was to
Paullinia cupana, guar gum, Plantago psyllium, Ilex
assess all clinical evidence of adverse events reported with
paraguariensis and Pausinystalia yohimbe. Herbal mono-
the use of herbal food supplements for reducing body
preparations and combination preparations were impli-
weight for which effectiveness data from rigorous clinical
cated. In many instances, the documentation of case reports
and clinical trials is insufficient. Little information existsfor a number of important issues such as main toxic con-stituents, mechanisms that caused the adverse events and
We conducted systematic literature searches on Medline,Embase, Amed and The Cochrane Library. Based on the
findings of our earlier review (10), we conducted searcheson the herbal food supplements for which data from ran-
Ephedra sinica or ma-huang is an evergreen shrub, which
domized, double-blind trials are available. Thus, the search
is native to central Asia and contains ephedrine as its pri-
terms were ephedra, Ephedra sinica, Garcinia cambogia,
mary active constituent (11). Food supplements containing
guar gum, Cyamopsis tetragonolobus, psyllium, Plantago
ephedra alkaloids have been linked to adverse central ner-
ovata, yerba maté, Ilex paraguariensis, guarana, Paullinia
vous system events and adverse cardiovascular events
cupana, yohimbe, Pausinystalia yohimbe, adverse event,
(12,13). Based on 50 randomized and non-randomized tri-
adverse effect, adverse drug reaction and side effect. Each
als, the most rigorous safety assessment to date concludes
database was searched from 1995 to January 2004. Data
that herbal ephedra and ephedrine-containing food supple-
were also requested from the spontaneous reporting
ments are associated with an increased risk of heart palpi-
scheme of the World Health Organization (WHO, Collab-
tation, psychiatric, autonomic and gastrointestinal adverse
orating Centre for International Drug Monitoring, Upp-
events (14). Since this assessment, additional reports of
adverse events have been published, which are listed in
accessed 14 January 2004). To identify additional pub-
lished or unpublished material, we conducted hand-searches in our own files and in a sample of relevant
medical journals (Erfahrungsheilkunde 1996–2004, For-schende Komplementärmedizin Klassische NaturheilkundeGarcinia cambogia, contains hydroxycitric acid, which has
1995–2004, Phytomedicine 1995–2004, Alternative and
been shown to inhibit citrate cleavage enzyme, suppresses
Complementary Therapies 1995–2004) and conference
de novo fatty acid synthesis and food intake, and conse-
proceedings (FACT – Focus on Alternative and Comple-
quently decreases body weight gain (52). Garcinia cambo-mentary Therapies 1996–2004). The bibliographies of all
gia extract has been tested in a number of trials. These trials
located papers were searched for further information.
and case reports detail few and mild adverse events for both
There were no restrictions regarding the language of pub-
Garcinia cambogia and hydroxycitric acid (Tables 1 and 2).
lication. The screening and selection of articles and theextraction of data were performed independently by two
reviewers (M.H.P., K.S.) and verified by a third (E.E.). Disagreements during this process were largely due to read-
Guarana is prepared from the seeds of Paullinia cupana
ing errors and were resolved through discussion between
and is indigenous to the Amazon basin (96). Guarana has
the coauthors. All data (e.g. clinical trials, post-marketing
been tested in a combination preparation with Ilex para-
surveillance studies, case reports) were considered for
guariensis (yerba maté, see below). It contains relatively
inclusion. To be included articles were required to report
large amounts of caffeine and is reported to prolong the
data on adverse events reported with the therapeutic use of
speed of gastric emptying (12). A number of adverse events
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111 obesity reviews
Adverse events of herbal food supplements
ts of adverse events associated with herbal weight-loss supplements
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111 obesity reviews
Adverse events of herbal food supplements
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111 obesity reviews
Adverse events of herbal food supplements
ting adverse events associated with herbal weight-loss supplements
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111 obesity reviews
Adverse events of herbal food supplements
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111 obesity reviews
Adverse events of herbal food supplements
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111 obesity reviews
Adverse events of herbal food supplements
pain, constipation, bloating (83 patients
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111 obesity reviews
Adverse events of herbal food supplements
are reported with the use of guarana and include irritability,
Discussion
heart palpitations, anxiety and other central nervous sys-tem events (Table 1).
The reviewed evidence indicates that a range of adverseevents has been reported with the use of herbal weight-losssupplements (Tables 1 and 2). Although the number of
cases and clinical trials may collectively look impressive,
Guar gum is a dietary fibre derived from the Indian cluster
the quality of the data does not. Frequently, the provided
bean (Cyamopsis tetragonolobus). An earlier review sug-
information is incomplete and important documentation is
gested predominately gastrointestinal adverse events (97).
lacking. In some instances the herbal ingredients are not
Most frequently, flatulence, diarrhoea and nausea were
sufficiently characterized and, in most, the mechanism of
reported by patients receiving guar gum. In 3% of the
action is not fully understood. Often, the information pro-
patients these were severe enough to necessitate the with-
vided is insufficient for making inferences about causality.
drawal from the trials. These findings are corroborated by
In fact, in many of the above reports and clinical trials, an
our present analysis of case reports and clinical trials
assumption of a causal relationship was made only because
other plausible reasons could not be identified. Therefore,in these cases, it may be unnecessarily alarmist to accept acause–effect relationship. On the other hand, the reported
risks imply the potential for harm and there is a possibility
Psyllium is a water-soluble fibre derived from the husks of
that they do signify causality even though they do not prove
ripe seeds of Plantago psyllium (12,96). Clinical trials and
it. In addition, the absence of convincing data of a cause–
case reports suggest adverse events for this food supple-
effect relationship cannot be taken as an indication of
ment. Particularly gastrointestinal complaints such as flat-
safety. Thus, considering firstly that the evidence of effec-
ulence, bloating, indigestion and nausea were reported. In
tiveness seems small for most herbal supplements (10), and
addition, a number of patients reported, vomiting and ret-
secondly considering the principle of ‘first do no harm’, the
rosternal pain after the use of psyllium. In many trials,
reported adverse events seem sufficient to shift the risk–
however, these adverse events are reported to have also
benefit balance against the use of most herbal weight-loss
occurred in the placebo group (Tables 1 and 2).
supplements. Exceptions are Garcinia cambogia and yerbamaté which, in our view, merit further investigation.
Patients frequently use food supplements in combination
with conventional medication. Therefore, a potential for
Yerba maté is prepared from Ilex paraguariensis, an ever-
herb–drug interactions exists. Perhaps ironically, for many
green tree native to South America. Few data are available
patients the motivation for using food supplements is that
on this herbal preparation. The only double-blind RCT
they are perceived as risk-free, a notion that – at least in
on the subject did not report on adverse events (98).
the UK – is heavily promoted by the media, which tend to
Epidemiological data suggest that the habit of ingesting hot
be biased in favour of alternative therapies (103). There is
maté drinks over long periods of time is linked to oesoph-
also evidence to suggest that adverse events experienced
ageal cancer (99). However, this seems to be related to
with the use of herbal food supplements are less likely to
chronic thermal injury rather than to a pharmacological
be reported to a healthcare professional than similar
adverse events experienced with conventional medicines(104). Collectively, these factors are likely to increase therisks of food supplements in clinical practice. In addition,
issues concerning the quality of herbal food supplements
Yohimbe (Pausinystalia yohimbe) is a tall evergreen tree,
such as adulteration with prescription drugs or other con-
which is native to Central Africa. Yohimbine, an alpha-2
taminants increase risks. Herbal medicines are marketed as
receptor antagonist, is the main active constituent of the
food supplements in many countries and therefore are sub-
ground bark of Pausinystalia yohimbe. Most clinical stud-
ject to less stringent controls. In the USA, for instance,
ies relate to the effects of this isolated constituent of
producers of food supplements do not have to demonstrate
yohimbe bark. It is often promoted for erectile dysfunction
efficacy, safety and quality similar to conventional drugs
and as a weight-loss supplement. The adverse events
(105). The effectiveness of any regulation that may exist in
reported with the use of yohimbine are well documented
this area is further diminished by the advent of internet
and include hypertension, anxiety and agitation (100–102).
For a herbal preparation of yohimbe, one case report of
Considering the present popularity of herbal food sup-
severe acute headache and hypertension is reported
plements (106–108), the number of identified adverse
events may seem small and their nature benign. This may
2005 The International Association for the Study of Obesity. obesity reviews 6, 93–111
Adverse events of herbal food supplements
obesity reviews
indicate that herbal food supplements are relatively (i.e.
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18 December 2006 Time ISCOC Registration Opening Ceremony ( Venue: GRAND BALLROOM 1) Signature Lecture 1 ( Venue: GRAND BALLROOM 1) HARNESSING A SINGLET OXENE FOR THE CONTROLLED OXIDATION OF ALKANES: A CATALYST FOR THE FACILE CONVERSION OF METHANE TO METHANOL UNDER AMBIENT CONDITIONS Chair: Thomas MAK Reception Plenary 1 ( Venue: GRAND BALLROOM 1) Plen
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