Clinical and biochemical effects of a combination botanical product (ClearGuard) for allergy: a pilot randomized double-blind placebo-controlled trial.
BACKGROUND
Botanical products are frequently used for treatment of nasal allergy. Three of these substances, Cinnamomum zeylanicum, Malpighia glabra, and Bidens pilosa, have been shown to have a number of anti-allergic properties in-vitro. The current study was conducted to determine the effects of these combined ingredients upon the nasal response to allergen challenge in patients with seasonal allergic rhinitis.


METHODS
Twenty subjects were randomized to receive the combination botanical product, (CBP) 2 tablets three times a day, loratadine, 10 mg once a day in the morning, or placebo, using a randomized, double-blinded crossover design. Following 2 days of each treatment and during the third day of treatment, subjects underwent a nasal allergen challenge (NAC), in which nasal symptoms were assessed after each challenge dose and every 2 hours for 8 hours. Nasal lavage fluid was assessed for tryptase, prostaglandin D2, and leukotriene E4 concentrations and inflammatory cells.


RESULTS
Loratadine significantly reduced the total nasal symptom score during the NAC compared with placebo (P = 0.04) while the CBP did not. During the 8 hour period following NAC, loratadine and the CBP both reduced NSS compared with placebo (P = 0.034 and P = 0.029, respectively). Analysis of nasal lavage fluid demonstrated that the CBP prevented the increase in prostaglandin D2 release following NAC, while neither loratadine nor placebo had this effect. None of the treatments significantly affected tryptase or leukotriene E4 release or inflammatory cell infiltration.


CONCLUSIONS
The CBP significantly reduced NSS during the 8 hours following NAC and marginally inhibited the release of prostaglandin D2 into nasal lavage fluid, suggesting potential clinical utility in patients with allergic rhinitis.
Corren
Jonathan
J
Allergy Research Foundation, Los Angeles, USA. jcorren@ucla.edu
Lemay
Marc
M
Lin
Yumei
Y
Rozga
Lisa
L
Randolph
R Keith
RK
D000293:Adolescent; D000328:Adult; D000368:Aged; D018926:Anti-Allergic Agents / Q000627:therapeutic use*; D031176:Bidens / Q000737:chemistry*; D002935:Cinnamomum zeylanicum / Q000737:chemistry*; D018592:Cross-Over Studies; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000494:pharmacology; D005260:Female; D006801:Humans; D017336:Loratadine / Q000627:therapeutic use; D008297:Male; D029581:Malpighiaceae / Q000737:chemistry*; D008875:Middle Aged; D009297:Nasal Mucosa / Q000378:metabolism; D009299:Nasal Provocation Tests; D008517:Phytotherapy; D010865:Pilot Projects; D015230:Prostaglandin D2 / Q000032:analysis; D006255:Rhinitis, Allergic, Seasonal / Q000188:drug therapy*; D016896:Treatment Outcome
D018926:Anti-Allergic Agents; D004365:Drugs, Chinese Herbal; C442780:plant extract, Bidens pilosa; D017336:Loratadine; D015230:Prostaglandin D2