Submited on: 26 Oct 2010 02:10:43 PM GMT
Published on: 26 Oct 2010 02:16:00 PM GMT
 
Review on Article ID WMC00993
Posted by Mr. Christof Jaenicke on 08 Dec 2010 09:50:04 AM GMT

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? No
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

    In the article „Efficacy Of Three Thixotropic Nasal Spray Preparations On Seasonal Allergic Rhinitis Assessed By Allergen Challenge In An Environmental Exposure Unit“ recently published by Luond-Valeskeviciute, Haenggi, and Gruenwald, in the online journal „Webmedcentral“ two human studies performed with three different thixotropic nasal sprays (IQM11,  IQM12, IQM13) for the treatment of seasonal allergic rhinitis were published.

    One of the two studies was designed as a prospective, randomized, cross-over pilot study with 16 patients and the other as a randomized single-blind, comparative cross-over study with 18 patients.

    In both studies patients with history of on seasonal allergic rhinitis (SAR) were exposed to grass pollen twice for 4 hours (respective 3h in the second study). During this time the SAR symptoms rhinorrhoea, nasal congestion, nasal pruritus, sneezing, eye itching, and eye tearing were rated every 15 min. The nasal spray was applied 5 min before allergic challenge.

    Even though the two studies used different rating scales (obviously the maximum values of comparable symptoms are different) the percentages of reduction are comparable (-16% to -18% for rhinorrhoea after treatment with IQM11 and IQM12, respectively). All the symptoms, except nasal congestion, showed treatment related statistically significant reduction of the symptom scores when compared to the control treatment.

    Both of the studies were only of short term, therefore they could only be considered as first hints for efficacy. Further clinical trials, with inclusion of a placebo-group will be necessary to demonstrate the effectiveness to prevent or reduce allergic reactions in long term application.

    The idea of a physical barrier to prevent allergens from interaction, is an interesting alternative to drug interventions, which are often associated with numerous adverse events.

     

  • Competing interests:
    No
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    Many years of experience in R&D of natural health products, among them products for allergy

  • How to cite:  Jaenicke C .Review on Article ID WMC00993[Review of the article 'Efficacy Of Three Thixotropic Nasal Spray Preparations On Seasonal Allergic Rhinitis Assessed By Allergen Challenge In An Environmental Exposure Unit ' by Gruenwald J].WebmedCentral 2010;1(12):WMCRW00207
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1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? Yes
7 Can you suggest any reductions in the paper, or deletions of parts? No
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

     

    The manuscript in general is an interesting and well written paper about the efficacy of three thixotropic nasal sprays on seasonal allergic rhinitis (SAR). The manuscript concerns two studies that have been performed: a prospective, randomized, cross-over pilot study (n=16) and a second semi-blind, comparative cross-over clinical trial (n=18) that followed the same study design. Both allergen challenge studies demonstrate that thixotropic nasal sprays are effective in reducing the main nasal symptoms in patients with seasonal allergic rhinitis (rhinorrea, nasal congestion, nasal pruritus, and sneezing.

     

    However, following comments should be taken into consideration:

    • It is unclear how subjects were recruited
    • Why was significance between IQM12 and IQM13 not tested?
    • The population size of both studies is quite small, the results can therefore be only regarded as preliminary results that need further verification. This issue should be addressed in the text
    • It is unclear why the study was not designed with a placebo group (i.e. water or saline spray)?
    • The authors should have indicated if all patients completed the entire study

     

    Nevertheless, it can be concluded, that the application of a physical barrier as a prophylactic to allergic response may be an interesting approach. Further research should be performed to confirm long-term health benefits of this particular application, since SAR normally lasts for a period of several weeks.

  • Competing interests:
    No
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    more than 20 years of experience in R&D including allergy products

  • How to cite:  Spiess S .Comments to the manuscript ?Efficacy of three thixotropic nasal spray preparations on sea-sonal allergic rhinitis assessed by allergen challenge in an environmental exposure unit?[Review of the article 'Efficacy Of Three Thixotropic Nasal Spray Preparations On Seasonal Allergic Rhinitis Assessed By Allergen Challenge In An Environmental Exposure Unit ' by Gruenwald J].WebmedCentral 2010;1(12):WMCRW00190
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Comments to the manuscript
Posted by Mr. Matthias Miller on 01 Dec 2010 11:43:50 AM GMT

1 Is the subject of the article within the scope of the subject category? Yes
2 Are the interpretations / conclusions sound and justified by the data? Yes
3 Is this a new and original contribution? Yes
4 Does this paper exemplify an awareness of other research on the topic? Yes
5 Are structure and length satisfactory? Yes
6 Can you suggest brief additions or amendments or an introductory statement that will increase the value of this paper for an international audience? Yes
7 Can you suggest any reductions in the paper, or deletions of parts? Yes
8 Is the quality of the diction satisfactory? Yes
9 Are the illustrations and tables necessary and acceptable? Yes
10 Are the references adequate and are they all necessary? Yes
11 Are the keywords and abstract or summary informative? Yes
  • Other Comments:

    1. Introduction: well-written and clear

     

    2. „For practical reasons, the study had no placebo

    control, as there is no conceivable placebo for a

    physical barrier.“: A placebo saline spray could have been used? Explain why patients would feel the difference.

     

    3. Please give information according to which standards the studies were performed.

     

    4. Discussion: „They are as effective as intranasal

    glucocorticosteroids but do not achieve their intended

    action through pharmacological, immunological or

    metabolic means.“ – This was not subject of any study. What data is the basis of this statement?

     

    5. Interesting application for the treatment of SAR, further investigations with prolonged study period and larger sample size would be desirable

  • Competing interests:
    No.
  • Invited by the author to review this article? :
    Yes
  • Have you previously published on this or a similar topic?:
    No
  • References:
    None
  • Experience and credentials in the specific area of science:

    Long-standing experience in R&D. among them products for treatment of allergy

  • How to cite:  Miller M .Comments to the manuscript[Review of the article 'Efficacy Of Three Thixotropic Nasal Spray Preparations On Seasonal Allergic Rhinitis Assessed By Allergen Challenge In An Environmental Exposure Unit ' by Gruenwald J].WebmedCentral 2010;1(12):WMCRW00186
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