Fernandez‐Rivas 2009.
Methods |
Design: Randomised controlled trial Participating centres: * Servicio de Alergia, Hospital Clinico San Carlos, Madrid, Spain. * Unidad de Alergia, Hospital de Fuenlabrada, Fuenlabrada, Spain. |
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Participants |
Inclusion criteria: * 18 to 65 years old, * Immediate reaction to peach ingestion: ‐ Specific IgE to peach proven by positive (≥ 3 mm) SPT either to a peach extract or fresh peach (prick–prick technique) and/or by a peach CAP ≥ 0.70 kU/l (Phadia, Uppsala, Sweden), and positive double‐blind, placebo‐controlled food challenge (DBPCFC) with peach. Exclusion criteria: * Placebo reaction in the DBPCFC with peach, previous history of food allergic reactions with hypotension, a case history of allergy to coconut, pollen immunotherapy within the previous 2 years and any clinical condition that contraindicates immunotherapy according to the European Academy of Allergy and Clinical Immunology (EAACI) guidelines or that the investigators judged that inclusion might hamper the patients safety or the study outcomes. No. of randomly assigned participants: 56 (37 SLIT and 19 placebo) Age [mean (SD)]: SLIT group: 29.1 (6.1); control group: 29.7 (7.8). Sex [Nº(% male)]: SLIT group: 15 (40.6%); control group: 9 (47.4%). |
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Interventions |
Intervention: SLIT treatment was administered sublingually (sublingual‐swallow technique) and comprised four vials containing 0.4, 2, 10 and 50 μg/ ml of Pru p 3. Control: Placebo administered in the same way to treatment. |
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Outcomes |
Primary outcome: Change in response to a double blind placebo controlled food challenge (DBPCFC) with peach. Secondary outcome: Changes in skin prick test (SPT), and in specific immunoglobulin E (IgE) and IgG4 to Pru p 3. Tolerance was assessed with a careful recording of adverse events. |
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Notes | The clinical trial was supported by ALK‐Abelló S.A. (Madrid, Spain). | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Patients were randomized to receive either active treatment or placebo in a 2:1 proportion, respectively, over 6 months. A stratified block randomization was carried out to ensure a similar distribution of patients presenting with systemic reactions. |
Allocation concealment (selection bias) | Unclear risk | Not specified |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not specified |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Only the "serum samples" outcome was described as blinded to investigator. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 4 intervention and 3 control participants lost to follow‐up (11% versus 16%) |
Selective reporting (reporting bias) | Low risk | All outcomes related to peach allergy treatment were measured and reported. |
Other bias | Low risk | The trial was not stopped early for benefit and no other bias appeared to be present in this study. |