FWD 2
HerbClip: Standardized Bark Extract of French Maritime Pine (Pycnogenol®) Decreases Nasal and Ocular Symptoms in Allergic Rhinitis Patients in Pilot Study
Re: Standardized Bark Extract of French Maritime Pine (Pycnogenol®) Decreases Nasal and Ocular Symptoms in Allergic Rhinitis Patients in Pilot Study
Wilson D, Evans M, Guthrie N, et al. A randomized, double-blind, placebo-controlled exploratory study to evaluate the potential of Pycnogenol® for improving allergic rhinitis symptoms. Phytother Res. 2010 Aug;24(8): 1115-1119.
Allergic rhinitis is one of the
most frequent diseases encountered in clinical practice and, although not
life-threatening, it represents a dramatic impairment on quality of life. To
avoid adverse side effects related to continuous or on-demand medications for
seasonal allergic rhinitis, subjects are now seeking complementary and
alternative treatments. Pycnogenol® (Horphag Research; Geneva, Switzerland),
a standardized bark extract of the French maritime pine (Pinus pinaster) anecdotally considered beneficial in treating hay fever,
has been proven clinically effective in improving respiratory distress and
lowering leukotriene levels in asthma patients.1-3 This single-center,
randomized, double-blind, placebo-controlled pilot study evaluated its
effectiveness in improving the symptoms of allergic rhinitis in adults allergic
to birch pollen.
Otherwise healthy subjects
(18-65 years old) with a positive skin prick test response to birch pollen and
not affected by asthma, sinusitis, or
conditions other than allergies known to cause rhinitis were enrolled in the
study. Skin prick test results for other airborne allergens from trees such as
oak and grass pollens were also documented. Patients were randomized to
Pycnogenol (Manhattan Drug Company; Hillside,
New Jersey) or placebo and
instructed to take a 50 mg tablet in the morning and evening with meals. Nineteen
eligible subjects were randomized at baseline, beginning treatment 3-4 weeks
before the start of the birch pollen season in 2008, and 41 subjects began
treatment 5-6 weeks before the start of the season in 2009, as well as at trial
completion. Blood was collected at each of 5 screenings 2-4 weeks apart for the
measurement of total IgE and birch allergen specific IgE determination.
Subjects completed a daily
self-administered questionnaire to rate nasal (sneezing, stuffy nose, runny
nose, itchy nose) and eye (burning or itchy, watering or tearing eyes, redness)
symptoms. The local pollen forecast was checked daily and recorded for the
duration of the study. Changes of nasal and eye symptoms scores between groups
were compared using analysis of variance and unpaired t-tests. Comparisons of
frequencies were made using the Chi-square test. Birch allergen IgE comparisons
between groups were made with unpaired t-tests and analysis of covariance.
Results are presented as mean values and standard deviation. P < 0.05 was considered statistically
significant.
In 2008, no significant
difference was noted between groups for total eye (0.50 ± 0.58 versus 0.23 ± 0.29) and total nasal symptom
(0.62 ±
0.48 versus 0.54 ±
0.40) scores, Pycnogenol versus placebo, respectively. During the pollen
season, a more pronounced but non-statistically significant increase in birch
allergen IgE titer was recorded in the placebo group (n = 9; 7.8 ± 15.0 KU/L) compared to the
Pycnogenol group (n = 10; 5.0 ± 13.1 KU/L). In 2009, subjects were instructed to begin treatment at
least 5 weeks prior to the predicted birch allergy season, but its onset was
then delayed several weeks. Eight subjects started 6-7 weeks prior, and another
18 subjects 7-8 weeks prior to the start of the birch pollen season. The total
average nasal symptom score for the allergy season was lower in the Pycnogenol
group (n =
20; 0.31 ±
0.30) than in the placebo group (n = 21; 0.39 ±
0.33). A trend toward lower average total eye symptom scores was registered in
the Pycnogenol group (0.13 ± 0.18) versus placebo (0.20 ± 0.21). Comparison between trial start and end of the allergy season
showed an increase of 31.9% of birch specific IgE titer in the placebo group
compared to 19.4% in the Pycnogenol group.In spite of a much higher birch pollen count in the 2009 season compared
with 2008, the symptoms scores of groups in 2009 were significantly lower than
in 2008 (P =
0.028). There was no significant difference between groups in the number of
adverse events.
The proportion of subjects making
use of non-prescription antihistamines as rescue medication at least once
during the study was slightly lower in the Pycnogenol group (11/30; 36.7%)
compared to placebo (15/30; 50%), while a sub-analysis showed that the group
starting Pycnogenol over 7 weeks prior to the birch pollen appearance required very little
rescue medication (1/8; 12.5%) compared to placebo (5/10; 50%). The limited
number of subjects in this sub-analysis did not allow for statistical
evaluation, but it seems likely that the immune-modulating effect of Pycnogenol
may require the more extended time to manifest in noticeable symptom reduction.
This study indicates that
Pycnogenol may represent a promising therapeutic modality for subjects with
allergic rhinitis when taken in a timely manner: subjects treated with
Pycnogenol had better nasal and ocular symptoms and required less rescue
medication when treatment was started more than 5 weeks prior to the onset of
the allergy season. The interpretation of these results were made more
difficult by the concurrent seasonal exposure to birch and oak pollens, since
in 2009 75% of placebo users tested allergic to oak compared to 68% of Pycnogenol
users. The authors recommend additional studies with a bigger sample size
and/or higher dosages to provide statistical significance and clarify optimum
dosage and mechanisms of action.
—Silvia Giovanelli Ris
References
1Rohdewald P. A review
of the French maritime pine bark extract (Pycnogenol), a herbal medication with
a diverse clinical pharmacology. Int J Clin Pharmacol Ther. 2002;40:158-168.
2Hosseini S, Pishnamazi S, Sadrzadeh SM, Farid F, Farid R, Watson RR.
Pycnogenol® in the management of asthma. J
Med Food. 2001;4:201-209.
3Lau BH, Riesen SK,
Truong KP, Lau EW, Rohdewald P, Barreta RA. Pycnogenol as an adjunct in the
management of childhood asthma. J Asthma. 2004;41:825-832.