Efficacy and tolerability of borage oil in adults and children with atopic eczema: randomised, double blind, placebo controlled, parallel group trial
BMJ 2003; 327 doi: https://doi.org/10.1136/bmj.327.7428.1385 (Published 11 December 2003) Cite this as: BMJ 2003;327:1385All rapid responses
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It is not difficult to measure essential fatty acids in red cells and
I have requested this test routinely for many years for my patients. The
commonest deficiencies, as David Horrobin was the first to teach me, are
due to delta desaturase blocks in the omega-6 and omega-3 pathways because
of deficiencies of the co-factors zinc, magnesium and vitamin B6.
I quickly discovered that, even when these cofactors were replete, if
I only prescribed omega-6 EFAs, a shortage of omega-3 EFAs would be caused
and vice versa. No one, who thoroughly investigates their patients, would
expect a single nutritional supplement to prevent a complex condition like
atopic dermatitis. It is also known that immunogolbulin E levels increase
as Vitamin E levels decline making atopy more likely.
The treatment or avoidance of dermatitis needs many possible
precipitants, such as foods and chemicals, including toxic metals, to be
considered.
Nutritional therapy is not the same as single drug therapy which, as
highlighted in the accompanying editorial, may work only for the few, or,
as in the case of HRT, cause more real risks than illusory benefits.
Competing interests:
None declared
Competing interests: No competing interests
Given the reasonable complexity and layered expression that
eczema is it seems quite unreasonable to imagine or expect a
relatively benign nutritional therapeutic element to
indicate observable curative effect especially within the
time frame and unrewarding larger theapeutic matrix as
written. While not a totally mindless question it remains a
poorly asked one in this instance.
Competing interests:
None declared
Competing interests: No competing interests
Efficacy and tolerability of borage oil in adults and children with atopic eczema
Dear Sir,
I read with interest the article published by Takwale et al.
investigating the effect of borage oil on atopic eczema treatment.
The authors have concluded that the borage oil treatment does not
offer any advantage over placebo. This study has some limitations in
experimental design that can affect the results.
In this study two different placebos were used: Liquid paraffin for
adults and olive oil for children. Liquid paraffin is an inert material
for its effect on atopic dermatitis whereas; olive oil is not as inert as
it can modify cellular fatty acid profile. It has been reported to
increase tissue levels of dihomogammalinolenic acid (DGLA) (1;2), a
metabolite of gamma linolenic acid (GLA). By increasing tissue levels of
DGLA, it may also increase the dermal levels of lipoxygenase and
cyclooxygenase metabolites of DGLA that are reported to exert anti-
inflammatory actions.(3;4) Therefore, olive oil can show some beneficial
effects due to above mentioned biochemical pathways. As the placebo group
is also showing the reduction in eczema scores, it appears that these
positive action are contributed by olive oil and placebo effect. For
accurate analysis of placebo effect and potential superiority of
intervention, investigators should have done the separate analysis in
adult and children to avoid the potential variations in outcome induced by
different placebo.
The study does not mention how the compliance was monitored. In this
study, blood/tissue levels of GLA or metabolites were not measured. In
absence of such data, it is very difficult to ascertain actual compliance
with the study protocol. Lack of compliance with the protocol can
contribute to failure of treatment in 50% of times (5). In a multicentre
trial by Henz et al. (6), it was observed that the subjects with moderate
atopic eczema, who showed an increase in erythrocyte DGLA levels, showed
significant improvement. In the same study, inclusion of data from
patients who did not follow the protocol and did not show an increase in
the tissue DGLA levels, resulted in no effect of treatment. This further
confirms that monitoring for compliance is most essential part of the
clinical study to truly determine the effect of treatment.
The other major limitation of the study is the inclusion of data from
the patients who did not complete the trial but had at least one
observation after randomization. Therefore, they included non compliant
patients, who violated the protocol and should not have been included in
the analysis. This would have modified the outcome of the study, as was
demonstrated in the study by Henz et al. (6).
Investigators used Six Area, Six Sign Atopic Dermatitis severity
(SASSAD) score. They did not mention if one investigator evaluated the
patients or more than one investigators evaluated the patients. Assuming
more than one investigator evaluated the patients, one has to look into
the reliability of this scoring system as this scoring system is reported
to have a very high inter-observer variation (7 – 30, median 15.5, out
of a possible score of 108)(7).
Based on these limitations, it is premature to conclude that the
treatment with borage oil or another source of GLA is no better than
placebo. This study definitely indicates requirement for further research
with better control and analysis.
Reference List
1. Giron MD, Mataix FJ, Suarez MD. Changes in lipid composition and
desaturase activities of duodenal mucosa induced by dietary fat.
Biochim.Biophys.Acta 1990;1045:69-73.
2. Campbell KL, Dorn GP. Effects of oral sunflower oil and olive oil
on serum and cutaneous fatty acid concentrations in dogs. Res.Vet.Sci.
1992;53:172-8.
3. Miller CC, Ziboh VA. Gammalinolenic Acid-enriched Diet Alters
Cutaneous Eicosanoids. Biochemical and Biophysical Research Communications
1988;154:967-74.
4. Ziboh VA, Miller CC, Choi Y. Metabolism of Polyunsaturated Fatty
Acids by Skin Epidermal Enzymes: Generation of Antiinflammatory and
Antiproliferative Metabolites. American Journal of Clinical Nutrition
2000;71:361S-6S.
5. Cork MJ, Britton J, Butler L, Young S, Murphy R, Keohane SG.
Comparison of parent knowledge, therapy utilization and severity of atopic
eczema before and after explanation and demonstration of topical therapies
by a specialist dermatology nurse. Br J Dermatol 2003;149:582-9.
6. Henz BM, Jablonska S, van de Kerkhof P, Stingl G, Blaszczyk M,
Vandervalk P. Double-Blind, Multicentre Analysis of the Efficacy of Borage
Oil in Patients with Atopic Eczema. Br J Dermatol 1999;140:685-8.
7. Charman CR, Venn AJ, Williams HC. Reliability testing of the Six
Area, Six Sign Atopic Dermatitis severity score. Br J Dermatol
2002;146:1057-60.
Competing interests:
Work for Company manufacturing and selling oils rich in Essential fatty acids including Borage oil
Competing interests: No competing interests