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Natalie Lane is production editor, journals, with
the Pharmaceutical Press
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What is FACT?
Focus on Alternative and Complementary Therapies (FACT),
edited by Edzard Ernst (Laing Chair in Complementary Medicine,
Peninsula
Medical School, Universities of Exeter and Plymouth) is an evidence-based
journal that is a single point of reference for current information
on complementary and alternative medicine (CAM) from around the
world. Current literature is summarised and commented on by members
of the FACT international editorial board, reviewing topics
as diverse as herbal medicines, vitamins, minerals and supplements,
homoeopathy, acupuncture and manipulative therapies, and giving
readers a concise and objective view of the value of such therapies
currently available. FACT also contains news, short reports,
focus articles and debates on CAM. The full text of FACT is
available by subscription.
For further information visit www.pharmpress.com |
To compare Crocus sativus L. (saffron) with imipramine in mild to moderate
depression, a study of 30 adult outpatients was carried out in Tehran,
Iran. Assessment of the patients was by the Hamilton Rating Scale for
Depression (HAM-D) and either C sativus or imipramine was administered
but with no placebo control. The authors’ conclusion found that
C sativus 10mg demonstrated efficacy in patients with mild to moderate
depression, perhaps similar to imipramine 100mg. However, no HAM-D scores
were provided and results were displayed graphically.
FACT comments that this is possibly the first published study examining
efficacy of C sativus for depression but notes the need for well-designed
studies looking into effective safe agents. FACT highlights that this
study had many methodological flaws, primarily that it was conducted
over a short period with a small number of patients, no placebo controls
and no dose finding for either agent. There was particular concern about
this since the C sativus dose was based on animal studies. It was also
noted that the C sativus product was prepared in-house without verification
of its content. FACT suggests that, had the comparator been a first-line
antidepressant such as a selective serotonin reuptake inhibitor, there
would have been benefit. FACT comments that this study provides useful
data but its methodological flaws prevent widespread generalisation and
further research is required.
Ginseng and warfarin interaction?
A four-week study of 20 healthy subjects looked at interactions between
Panax quinquefolius L. (American ginseng) and warfarin. The subjects
received warfarin for three days during weeks 1 and 4. Beginning in
week 2, patients were randomly given P quinquefolius or placebo for
three weeks. The study monitored the change in peak international normalised
ratio (INR) and plasma warfarin levels, and noted that the peak INR
of those subjects taking P quinquefolius significantly decreased after
two weeks compared with those taking placebo. Also, the INR area under
the curve (AUC), peak plasma warfarin level and warfarin AUC were significantly
reduced. Although the authors acknowledged the limitations of using
healthy patients in this study, they concluded that P quinquefolius reduces the warfarin anticoagulant effect and that doctors should ask
their patients about ginseng use if prescribing warfarin.
FACT recognises that there are many concerns about the risks of herb
and drug interactions and little evidence to provide medical advice.
It highlights that this study carefully addresses the issues of the identification
and characteristics of P quinquefolius when other studies on ginseng
have had problems of poor identification. However, there are chemical
variations within a single species and between manufactured products
that can limit the transferability of results, and FACT queries the quality
of the P quinquefolius used compared with products available on the market.
Although the use of healthy patients and the accompanying limitations
of this are acknowledged, FACT comments that this does not detract from
the main message of the article — that doctors should ask patients
about their use of P quinquefolius when prescribing warfarin and should
discuss whether patients plan to start or stop P quinquefolius when warfarin
levels have stabilised. FACT also notes that although this study is relevant
solely to P quinquefolius, an overall message is that doctors should
discuss with their patients the use of any herbal products, especially
when drugs of a low therapeutic index are prescribed.
Can antioxidants prevent cancer?
To establish whether antioxidant supplements reduce the incidence of
gastrointestinal cancer and mortality researchers identified 14 high-quality
randomised trials. Neither the fixed-effect nor random-effect meta-analyses
showed any effects of supplementation with the stated antioxidants
compared with placebo. The researchers could
not find evidence that antioxidant supplements prevented gastrointestinal
cancers and supplements appeared to increase overall mortality. The exceptions
were four trials in which selenium showed a significant beneficial effect
and the researchers suggest that this should be studied further.
FACT observes that hypotheses and leads provided by associations of antioxidant
levels and outcomes cannot replace the data of prospective clinical trials.
The commentary discusses how the administration of antioxidants can have
effects on cell metabolism and proliferation, unrelated to their antioxidant
properties. In addition, the combinations of antioxidants are likely
to interact and counteract any beneficial effects. The administration
of an antioxidant in one individual may have a different biochemical
effect to supplementation in another. The use of individual studies — albeit
using the gold standard Cochrane analytical methodology and taking into
account selection or publication bias — is ultimately based on
the quality of data from the analysed studies. Such flaws prevent the
absolute conclusion that antioxidants have no role in preventing gastrointestinal
cancers. FACT says that the results of the meta-analysis provide a broad
perspective but, without detailed information, conclusions cannot be
drawn about whether specific antioxidants at determined
doses would benefit selected individuals. Until better evidence is received
concerning the role of supplementary antioxidants in select situations,
FACT proposes proven general lifestyle changes for the general population. |
The
Pharmaceutical Journal