Larry Hand
June 13, 2012 — Supplementing the antihistamine
levocetirizine with the probiotic Lactobacillus johnsonii EM1 (Lj
EM1) effectively alleviated the symptoms of perennial allergic rhinitis (PAR)
in a group of Taiwanese children, according to a study published in the July issue of the International
Journal of Pediatric Otorhinolaryngology.
Ko-Huang Lue, MD, from the Division of Allergy, Asthma and
Rheumatology and Department of Pediatrics at Chung Shan Medical University
Hospital in Taichung, Taiwan, and colleagues conducted a 2-phase crossover
trial to compare treatment with levocetirizine alone or levocetirizine plus Lj
EM1 in 63 children aged 7 to 12 years with moderate to severe PAR for at least
1 year. The incidence of AR is 20% to 30% in general, but may be higher than 50%
in Taiwanese children, the researchers write.
In the open-label trial, the researchers randomly assigned
the children to receive either levocetirizine (5 mg) plus Lj EM1 (group
1: 32 children) or levocetirizine alone (group 2: 31 children) for 12 weeks,
following-up on patients every 4 weeks. After the first 12 weeks, the groups
switched treatments for another 12 weeks.
The children took the medication nightly at bedtime, and
children and guardians kept daily activity diaries and reported on 4 daily nasal
symptoms and 5 daily nonnasal symptoms. The symptoms were recorded on a 4-point
scale from 0 (no symptom) to 3 (severe). A total symptom score (TSS) was the
sum of all 9 symptoms. They also recorded sleep quality on a daily basis,
rating it from 0 (slept well) to 3 (slept poorly).
During the first 12-week period, TSS improved for each group
at weeks 4, 8, and 12 (P < .05) compared with baseline; and,
treatment was more effective in group 1 than group 2 at week 4 (P =
.014), week 8 (P = .011), and week 12 (P < .009). Group 2
improved "continually and progressively" during the second 12-week
period, and group 1 did not.
The 2 groups were also compared by using the Pediatric
Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), the score for which
decreased significantly in each group (P < .05); however, there was
no significant difference in PRQLQ score between the 2 groups (P =
.446). A decrease in the PRQLQ score represents an improvement in symptoms.
There were objective measures, too, including, but not
limited to, nasal peak expiratory flow rate (nPEFR), forced vital capacity
(FVC), forced expiratory volume in 1 second (FEV1), and percentage
of eosinophils in nasal smears. The nPEFR improved significantly for both
groups when measured at weeks 4, 8, 12, 16, and 24 (P < .01),
demonstrating more significant improvement for group 1 over group 2 at weeks
12, 16, and 20 (P < .05). The percentage of eosinophils in nasal
smears was reduced significantly in both groups compared with the run-in
period. In addition, although FEV1 and FVC improved significantly in
each group compared with baseline at weeks 8 through 24 (P < .05),
there was no statistically significant difference between the 2 treatment
regimens.
The researchers write that recent studies concluded that
probiotics may be beneficial for the treatment and prevention of early allergic
disease through modulation of the inflammatory response and immunity, although
controversy remains over whether benefits are derived for allergic airway
diseases, and more comprehensive clinical trials are needed.
"Our results demonstrate that levocetirizine plus Lj
EM1 is efficacious in the treatment of AR. However, there are several
limitations to this clinical trial," the researchers write. "The
open-label design makes it difficult to compare the clinical response between
the 2 treatment groups, but any bias may have been decreased by using the
crossover method. Another issue that remains unresolved is whether probiotics
provide long-term benefit (more than 12 weeks) in reducing AR and conferring
immunologic tolerance to allergens after the supplements have been
discontinued."
TTY Biopharm Co Ltd supplied the Lj EM1 for this study.
Int J Ped Otorhinolaryng.
2012;76:994-1001. Abstract
Medscape Medical News © 2012 WebMD,
LLC
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