| Methods |
101 patients were randomized into 3 groups: A (n = 30) with drug therapy alone, B (n = 35) with drug therapy plus training on the use of nasal spray, and C (n = 36) the same as B plus a lesson on rhinitis and asthma. All patients received mometasone furoate nasal spray for 8 weeks as regular therapy, plus rescue medications on demand. Symptoms and drug consumption were evaluated during the pollen season |
| Participants |
101 patients (62 male, 39 female, age range 12 to 60 years) had suffered for at least 2 years from seasonal asthma and rhinitis (SAR) solely due to pollens (grasses, birch, Parietaria, and Compositae). Patients with sensitization to multiple pollens were included, whereas sensitization to cat dander, mites, or mold was a reason for exclusion. Exclusion criteria were as follows: anatomical abnormalities of the upper respiratory airways (septal deviation, polyposis), previous or ongoing immunotherapy, pregnancy/lactation, chronic treatment with systemic corticosteroids, malignancies, and major psychiatric disorders |
| Interventions |
The first group of patients (group A = 30 patients) was given only the drug with the instructions provided by the manufacturer. The second group (group B = 35 patients) received a brief training on how to use the nasal spray and were given simplified written instructions on the use of the device. The third group (group C = 36 patients) also attended a 1‐hour informal lesson on the clinical and pathogenic aspects of SAR, the treatment strategy, the correct use of medications, and the possible side effects of drugs. A trained allergist (1 per clinic) gave the lesson to patients, and the set of slides used was the same in the 3 clinics |
| Outcomes |
All patients completed a symptom diary, recording the presence and severity of their symptoms (self reported). The compliance with therapy was evaluated on the basis of the returned diaries and canisters. Symptoms were subdivided as follows: nasal (itching, sneezing, rhinorrhea, and blockage), ocular (itching, redness, lacrimation, and swelling), and respiratory (cough, wheezing, and chest tightness). The severity of symptoms was graded on a 10 cm visual analog scale (0: no symptoms, 10: severe symptoms). Patients were also required to record carefully each dose of each drug taken, in addition to the nasal corticosteroid |
| Notes |
8‐week follow‐up during the whole pollen season is satisfactory for the seasonal disease |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Unclear risk |
Not stated ‐ no details given. The study was designed to use 3 randomized, open‐controlled parallel groups. "One hundred and one patients suffering from SAR were randomly allocated into three groups receiving a written prescription of drug therapy alone, or training on how to use the nasal spray, or a detailed lesson on the nature of their disease." The presence and severity of symptoms were assessed during the whole pollen season, as was the intake of drugs(pg 66) |
| Allocation concealment (selection bias) |
Unclear risk |
(pg 66) Allocation concealment technique not mentioned "One hundred and one patients suffering from SAR were randomly allocated into 3 groups receiving a written prescription of drug therapy alone, or training on how to use the nasal spray, or a detailed lesson on the nature of their disease." |
| Selective reporting (reporting bias) |
Unclear risk |
No information given, no protocol available |
| Other bias |
Unclear risk |
Nothing noted but insufficient data provided to make a judgment |
| Blinding of outcome assessment (detection bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ intervention does not mention blinding. (pg 66) "The first group of patients (group A = 30 patients) was given only the drug with the instructions provided by the manufacturer. The second group (group B = 35 patients) received a brief training on how to use the nasal spray and were given simplified written instructions on the use of the device. The third group (group C = 36 patients) also attended a 1‐h informal lesson on the clinical and pathogenic aspects of SAR, the treatment strategy, the correct use of medications, and the possible side‐effects of drugs. A trained allergist (one per clinic) gave the lesson to patients, and the set of slides used was the same in the three clinics". |
| Blinding of outcome assessment (detection bias)
Patient outcome |
Unclear risk |
(PRIMARY) SELF REPORTED SYMPTOMS ‐ Blinding not mentioned. (pg 66) "The first group of patients (group A = 30 patients) was given only the drug with the instructions provided by the manufacturer. The second group (group B = 35 patients) received a brief training on how to use the nasal spray and were given simplified written instructions on the use of the device. The third group (group C = 36 patients) also attended a 1‐h informal lesson on the clinical and pathogenic aspects of SAR, the treatment strategy, the correct use of medications, and the possible side‐effects of drugs. A trained allergist (one per clinic) gave the lesson to patients, and the set of slides used was the same in the three clinics." |
| Blinding of participants (performance bias)
Adherence measure |
High risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ Subjective measure and patients likely were not blind |
| Blinding of participants (performance bias)
Patient outcome |
High risk |
(PRIMARY) SELF REPORTED SYMPTOMS ‐ Subjective measure; patients likely were not blind |
| Blinding of personnel (performance bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ Intervention does not mention blinding. (pg 66) "The first group of patients (group A = 30 patients) was given only the drug with the instructions provided by the manufacturer. The second group (group B = 35 patients) received a brief training on how to use the nasal spray and were given simplified written instructions on the use of the device. The third group (group C = 36 patients) also attended a 1‐h informal lesson on the clinical and pathogenic aspects of SAR, the treatment strategy, the correct use of medications, and the possible side‐effects of drugs. A trained allergist (one per clinic) gave the lesson to patients, and the set of slides used was the same in the three clinics." |
| Blinding of personnel (performance bias)
Patient outcome |
Unclear risk |
(PRIMARY) SELF REPORTED SYMPTOMS ‐ Blinding not mentioned. (pg 66) "The first group of patients (group A = 30 patients) was given only the drug with the instructions provided by the manufacturer. The second group (group B = 35 patients) received a brief training on how to use the nasal spray and were given simplified written instructions on the use of the device. The third group (group C = 36 patients) also attended a 1‐h informal lesson on the clinical and pathogenic aspects of SAR, the treatment strategy, the correct use of medications, and the possible side‐effects of drugs. A trained allergist (one per clinic) gave the lesson to patients, and the set of slides used was the same in the three clinics." |
| Incomplete outcome data (attrition bias)
Adherence measure |
Unclear risk |
(PRIMARY) SELF REPORT ‐ DIARY ‐ Unclear if amount of missing data would alter event rates. 6 patients dropped out because they did not attend the final visit(pg 66) |
| Incomplete outcome data (attrition bias)
Patient outcome |
Unclear risk |
(PRIMARY) SELF REPORTED SYMPTOMS ‐ Unclear if missing data will impact the event rates |
