Double-blind, placebo-controlled study with a modified therapeutic vaccine of Salsola kali (Russian thistle) administered through use of a cluster schedule
Open accessAbstract
Background The inhalation of Salsola kali pollen is a common cause of respiratory diseases in Europe and North America.Objective To evaluate the efficacy and safety of a depigmented and glutaraldehyde-polymerized therapeutic vaccine of S kali.Methods The trial was randomized, double-blind, and placebo-controlled using a rush protocol in the build-up phase. Sixty patients with rhinoconjunctivitis (19 also had mild asthma) were randomly allocated to receive either active treatment (polymerized extract) or placebo. The final distribution was 41 patients in the active and 19 in the placebo group. Side effects were registered. Symptom and medication scores and the number of days free of symptoms during the pollen season were assessed to evaluate the clinical efficacy. A Rhinoconjunctivitis Quality of Life Questionnaire was completed in the previous pollen season (before treatment) and during the pollen season 1 year later (in the trial). Dose-response skin tests were performed at baseline and at the end of the trial.Results There was a significant difference (P < .05) in symptom and medication scores between both groups during the pollen season, with the active group the one that had fewer symptoms and lower intake of medication. The number of days without symptoms was higher in the active group (P < .05). This group also had a significant improvement in the Rhinoconjunctivitis Quality of Life Questionnaire and a reduction in skin sensitivity. No moderate or severe systemic reactions were registered.Conclusion Immunotherapy with this modified vaccine of S kali pollen is safe and efficacious to treat patients clinically sensitive to this pollen.Clinical implications Patients allergic to S kali (Russian thistle) can be successfully treated with immunotherapy to improve symptoms of allergic rhinitis and asthma, reduce medication use, and improve quality of life parameters.
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A large population-based survey of allergic rhinitis patients demonstrated a strong correlation between allergic rhinitis disease severity and sleep disturbance.
“A large population-based survey of AR patients demonstrated a strong correlation between AR disease severity and sleep disturbance.679”
From International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (2018) · cites this paper as [679]
The Patient population section describes 63 carefully selected patients randomly allocated to vaccine or placebo, not a large population-based survey. Table III in the Discussion compares sleep-domain scores between treatment groups; it does not report a correlation between allergic rhinitis severity and sleep disturbance. Page numbers are unavailable in our copy. (LLM, conf=0.86)
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Experimental — accuracy not yet measuredThe study showed that increasing severity of allergic rhinitis symptoms caused worse sleep quality.
“The study showed that increasing severity of AR symptoms caused worse sleep quality.”
From International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (2018) · cites this paper as [679]
Table III (Discussion; page unavailable) reports nasal-symptom and sleep-domain scores in both treatment groups. The treated group had lower scores on both, but the sleep difference was not statistically significant (P = .321). The paper does not show that increasing allergic-rhinitis severity caused worse sleep quality or establish a severity–sleep relationship. (LLM, conf=0.78)
Experimental — accuracy not yet measuredAllergen immunotherapy randomized controlled trials with 12 to 18 months of follow-up showed that placebo patients either stayed at their baseline quality-of-life impairment or improved to a lesser degree than treatment arms.
“The AIT RCTs have longer follow-up periods (12 to 18 months) and show similar results, with placebo patients either staying at their baseline QOL impairment, or improving to a lesser degree than the treatment arms.678,679”
From International Consensus Statement on Allergy and Rhinology: Allergic Rhinitis (2018) · cites this paper as [679]
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References 34 · Cited by 68
Research works printed but not linked: 6
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- Rafizadeh B. Demonstration of the blocking antibodies after immuno- therapy with Russian thistle. In: Csaba B, Leo ¨vey A, Szemere P, editors. Proceedings of the XIII Congress EAACI; 1986 May 4-10; Budapest, Hungary. Debrecen: Alfo ¨ldi Ny; 1986.
- Wurtzen PA, Nelson HS, Lowenstein H, Ipsen H. Characterization of Chenopodiales (Amaranthus retroflexus, Chenopodium album, Kochia scoparia, Salsola pestifer) pollen allergens. Allergy 1995;50:489-97.
- Authors
- Colás, C., Monzón, S., Venturini, M., & Lezaun, A.
- Affiliations
- Hospital Clínico Universitario Lozano Blesa (ES)
- Corresponding author
- Colás, Carlos
- ORCID
- Colás, Carlos
- Venue
- Journal of Allergy and Clinical Immunology
- Publisher
- Elsevier BV
- Published
- 2006-04
- Volume
- 117
- Issue
- 4
- Pages
- 810-816
- ISSN
- 0091-6749 (ISSN-L)
- OpenAlex
- W1981637609
- Cited by
- 68
- References
- 34
- Citations by year
- 2023: 2 · 2022: 2 · 2021: 4 · 2020: 3 · 2019: 2 · 2018: 3 · 2017: 4 · 2016: 4 · 2015: 3 · 2014: 3 · 2013: 6 · 2012: 3
- FWCI
- 4.00
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- Journal of Allergy and Clinical Immunology (publishedVersion)
- PubMed (publishedVersion)
- Topics
- Health Sciences › Medicine › Immunology and Allergy › Allergic Rhinitis and Sensitization
- Health Sciences › Medicine › Immunology and Allergy › Food Allergy and Anaphylaxis Research
- Health Sciences › Medicine › Physiology › Asthma and respiratory diseases
- Keywords
- Salsola kali, allergic rhinitis, allergen immunotherapy, therapeutic vaccines, rhinoconjunctivitis, asthma, quality of life, sensitive skin, vaccine safety
- MeSH terms
- Adolescent, Adult, Allergens, Asthma, Conjunctivitis, Allergic, Desensitization, Immunologic, Double-Blind Method, Female, Glutaral, Rhinitis, Allergic, Seasonal, Humans, Male, Middle Aged, Plant Extracts, Pollen, Safety, Salsola
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