Table 1

Characteristics of randomised controlled trials evaluating the effectiveness of inhaled disodium cromoglycate (DSCG) in children

StudySettingDesignDose DSCG and method of administrationAdditional study armInclusion criteriaAge
(years)
No of patients included/ analysedDuration of intervention period(s)Major effect parametersSide effectsAuthors'
conclusion
Methodological quality score
Smith et al(1968)42 School health serviceCrossover4 dd 20 mg SpinhalerNoneLongstanding perennial asthma5–1651/442 × 4 weeksDaily symptom scores, lung function, additional medication, laboratoryCoughPositiveChalmers: 44/91=0.48
Jadad: 4
Hyde et al (1970)38 Not specifiedCrossover4 dd 20 mg SpinhalerNoneDuration of asthma >1 year, definite symptoms before inclusion6–1660/572 × 3 weeksDaily symptom scores, clinical assessment, lung function, additional treatmentIrritated throat, headache, cough, wheezePositiveChalmers: 43/91=0.47
Jadad: 3
Shioda et al(1970)40 Hospital inpatients and outpatientsCrossover4 dd 20 mg SpinhalerNonePerennial asthma6–1534/332 × 4 weeksDaily symptom scores, lung function, clinical assessment, additional medication, school absenceContact dermatitis, headachePositiveChalmers: 45/90=0.50
Jadad: 3
Sly (1970)39 OutpatientsCrossover4 dd 20 mg SpinhalerNoneAsthmatic, responded on exercise with bronchospasm6–1221/162 × 4 weeksDaily symptom scores, clinical assessment, lung functionSore throatPositive/
equal
Chalmers: 38/94=0.40
Jadad: 4
Collins-
Williamset al(1971)36
Outpatients and inpatientsCrossover4 dd 20 mg TurbuhalerNoneSevere allergic asthma, wheezed at least once a week7–1763/632 × 4 weeksDaily symptom scores, clinical assessment, lung functionCough, dry mouth, dizziness, nausea, headachePositiveChalmers: 39/94=0.41
Jadad: 2
Limburg (1971)37 Inpatients Crossover4 dd 20 mg SpinhalerNoneIn asthma centre and regular asthma symptoms6–1630/292 × 4 weeksDaily symptom scores, lung function, additional treatmentCoughPositiveChalmers: 45/94=0.48
Jadad: 3
Fox et al(1972)34 HospitalCrossover4 dd 20 mg SpinhalerNoneChronic severe perennial bronchial asthma, a period of observation in the clinic for at least one year and pulmonary function impairment5–1628/232 × 12 weeks Daily symptom scores, clinical assessment, lung functionCoughPositiveChalmers: 32/91=0.35
Jadad: 4
Silverman et al (1972)35 OutpatientsParallel4 dd 20 mg capsulesNonePerennial asthma and disability exceeding 6–8 wks in preceding year, or 3–4 wks in preceding 3 months despite regular bronchodilator therapy, never use of corticosteroids or cromoglycate7–962/532 weeks baseline,
8 weeks treatment
Daily symptom scores, clinical assessment, lung functionCough, dry throatPositiveChalmers: 39/92=0.42
Jadad: 4
Hyde et al(1973)33 HospitalCrossover4 dd 20 mg SpinhalerNoneChronic disabling asthma5–1638/384 weeks baseline,
2 × 4 weeks treatment
Additional treatment, clinical assessment, lung functionCough, throat pain, dizzinessPositiveChalmers: 38/87=0.44
Jadad: 5
Crispet al(1974)32 UnspecifiedCrossover4 dd 20 mg small deviceNoneChronic asthma and 2 out of: nearly daily symptoms; nearly daily medication needed; intermittent or long term steroid usage5–1740/402 × 4 weeksDaily symptom scores, clinical assessment, lung function, additional medication Rash, wheezePositiveChalmers: 45/87=0.52
Jadad: 4
Hilleret al(1975)31 UnspecifiedCrossover factorial4 dd 20 mg SpinhalerBMV Chronic perennial asthma, symptoms inadequately controlled by DSCG and bronchodilators9–1311/94 × 1 monthDaily symptom scores, clinical assessment, additional medicationNonePositiveChalmers: 44/87=0.51
Jadad: 4
Hiller et al(1977)29 HospitalCrossover3 dd 20 mg nebulisedNoneFrequent troublesome asthma2–417/171 week baseline, 2 × 4 weeks treatmentDaily symptom scores, clinical assessment, lung functionUnspecifiedPositiveChalmers: 34/87=0.39
Jadad: 3
Matthew (1977)30 OutpatientsCrossover4 dd 20 mg nebulisedNoneSevere chronic perennial asthma + symptoms in baseline period3–610/98 weeks baseline,
2 × 4 weeks treatment
Daily symptom scores, additional treatment, lung functionUnspecifiedPositiveChalmers: 29/87=0.33
Jadad: 3
Edmunds et al(1980)28 UnspecifiedCrossover4 dd 1 capsuleSlow release aminophyllinePerennial asthma5–1530/303 × 4 weeksDaily symptom scores, lung function, additional medicationNausea, vomiting, abdominal pain, headachePositiveChalmers: 29/91=0.33
Jadad: 2
Glasset al(1981)27 HospitalCrossover4 dd 20 mg nebulisedTheophylline syrup Control of asthma poor under routine treatment1–416/164 weeks baseline,
3 × 8 weeks treatment
Daily symptom scores, additional treatmentMinorEqualChalmers: 29/94=0.31
Jadad: 2
Geller-
Bernstein et al(1982)26
HospitalCrossover4 dd 2 ml nebulisedNoneFrequent troublesome wheezy bronchitis despite regular bronchodilator therapy + symptoms in baseline period0–249/442 weeks baseline,
2 × 4 weeks treatment
Daily symptom scores, clinical assessmentUnspecifiedEqual/ positiveChalmers:
34/94= 0.36
Jadad: 4
Miraglia del Giudice et al (1982)41 HospitalCrossover3 dd 20 mg nebulisedNonePerennial asthma and symptoms despite bronchodilator therapy 0–531/312 weeks baseline,
2 × 4 weeks treatment
Daily symptom scores, additional treatment, clinical assessmentCough, sneezePositiveChalmers: 35/91=0.38
Jadad: 4
Geller-
Bernstein et al(1983)45
UnspecifiedCrossover4 dd 2 mg pressurised aerosolNoneModerately severe or severe extrinsic asthma at least 12 months, not taken DSCG or steroids for at least 6 months before trial 4–1348/432 weeks baseline,
2 × 6 weeks treatment
Daily symptom scores, asthma severity score, lung function, patients', parents' and physicians' preferencesThroat irritationPositive/
equal
Chalmers: 42/90=0.47
Jadad: 4
Henry et al(1984)25 HospitalCrossover3 dd 20 mg nebulisedIpratropium bromide 3 dd 250 μgSuffered from recurrent attacks of wheezing and considered troublesome asthma by paediatrician and parents<2 23/202 weeks baseline,
3 × 8 weeks treatment
Daily symptom scores, additional treatment, lung functionUnspecifiedEqualChalmers: 23/94=0.24
Jadad: 2
Cogswell et al(1985)24 HospitalCrossover4 dd 20 mg nebulisedNoneRegular attacks of asthma that required at least one admission to hospital1–427/244 weeks baseline,
2 × 26 weeks treatment
Daily symptom scores, additional treatmentUnspecifiedPositiveChalmers: 43/91=0.47
Jadad: 4
Bertelsen et al(1986)44 HospitalParallel 3 dd 20 mg nebulisedNoneRecurrent wheezy bronchitis demanding treatment at least once a month during preceding winter or later1–459/544–8 weeks baseline, 10 weeks treatmentDaily symptom scores, additional treatmentCough, wheeze
and eczema
EqualChalmers: 31/95=0.33
Jadad: 3
Yuksel et al(1992)43 HospitalCrossover4 dd 5 mg coffeecupNonePreterm born, wheeze and/or cough 3–4 days/week for the previous 4 weeks + symptoms for at least 3 days following all respiratory tract infections0–216/162–3 weeks treatmentDaily symptom scores, additional treatment, lung functionUnspecifiedPositiveChalmers: 32/91=0.35
Jadad: 2
Furfaro et al(1994)23 OutpatientsParallel 3 dd 40 mg nebulisedNonePresence of chronic pulmonary symptoms for at least one month and wheezing documented by a physician + symptoms in baseline period0–1 37/313 weeks baseline,
6 weeks treatment
Daily symptom scores, lung functionUnspecifiedEqualChalmers: 56/95=0.59
Jadad: 4
Tasche et al(1997)16 General practice settingParallel3 dd 10 mg spacer device, facemaskNonePreviously been prescribed anti-asthma medication and meeting formulated criteria for moderate asthma 1–4232/2184 weeks baseline, 22 weeks treatmentDaily symptom scores, loss of participants, additional medicationEczema in mask area, coughEqualChalmers: 75/95=0.79
Jadad: 3
  • BMV = beclomethasone-17-valerate.