Characteristics of randomised controlled trials evaluating the effectiveness of inhaled disodium cromoglycate (DSCG) in children
Study | Setting | Design | Dose DSCG and method of administration | Additional study arm | Inclusion criteria | Age (years) | No of patients included/ analysed | Duration of intervention period(s) | Major effect parameters | Side effects | Authors' conclusion | Methodological quality score |
---|---|---|---|---|---|---|---|---|---|---|---|---|
Smith et al(1968)42 | School health service | Crossover | 4 dd 20 mg Spinhaler | None | Longstanding perennial asthma | 5–16 | 51/44 | 2 × 4 weeks | Daily symptom scores, lung function, additional medication, laboratory | Cough | Positive | Chalmers: 44/91=0.48 Jadad: 4 |
Hyde et al (1970)38 | Not specified | Crossover | 4 dd 20 mg Spinhaler | None | Duration of asthma >1 year, definite symptoms before inclusion | 6–16 | 60/57 | 2 × 3 weeks | Daily symptom scores, clinical assessment, lung function, additional treatment | Irritated throat, headache, cough, wheeze | Positive | Chalmers: 43/91=0.47 Jadad: 3 |
Shioda et al(1970)40 | Hospital inpatients and outpatients | Crossover | 4 dd 20 mg Spinhaler | None | Perennial asthma | 6–15 | 34/33 | 2 × 4 weeks | Daily symptom scores, lung function, clinical assessment, additional medication, school absence | Contact dermatitis, headache | Positive | Chalmers: 45/90=0.50 Jadad: 3 |
Sly (1970)39 | Outpatients | Crossover | 4 dd 20 mg Spinhaler | None | Asthmatic, responded on exercise with bronchospasm | 6–12 | 21/16 | 2 × 4 weeks | Daily symptom scores, clinical assessment, lung function | Sore throat | Positive/ equal | Chalmers: 38/94=0.40 Jadad: 4 |
Collins- Williamset al(1971)36 | Outpatients and inpatients | Crossover | 4 dd 20 mg Turbuhaler | None | Severe allergic asthma, wheezed at least once a week | 7–17 | 63/63 | 2 × 4 weeks | Daily symptom scores, clinical assessment, lung function | Cough, dry mouth, dizziness, nausea, headache | Positive | Chalmers: 39/94=0.41 Jadad: 2 |
Limburg (1971)37 | Inpatients | Crossover | 4 dd 20 mg Spinhaler | None | In asthma centre and regular asthma symptoms | 6–16 | 30/29 | 2 × 4 weeks | Daily symptom scores, lung function, additional treatment | Cough | Positive | Chalmers: 45/94=0.48 Jadad: 3 |
Fox et al(1972)34 | Hospital | Crossover | 4 dd 20 mg Spinhaler | None | Chronic severe perennial bronchial asthma, a period of observation in the clinic for at least one year and pulmonary function impairment | 5–16 | 28/23 | 2 × 12 weeks | Daily symptom scores, clinical assessment, lung function | Cough | Positive | Chalmers: 32/91=0.35 Jadad: 4 |
Silverman et al (1972)35 | Outpatients | Parallel | 4 dd 20 mg capsules | None | Perennial 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 cromoglycate | 7–9 | 62/53 | 2 weeks baseline, 8 weeks treatment | Daily symptom scores, clinical assessment, lung function | Cough, dry throat | Positive | Chalmers: 39/92=0.42 Jadad: 4 |
Hyde et al(1973)33 | Hospital | Crossover | 4 dd 20 mg Spinhaler | None | Chronic disabling asthma | 5–16 | 38/38 | 4 weeks baseline, 2 × 4 weeks treatment | Additional treatment, clinical assessment, lung function | Cough, throat pain, dizziness | Positive | Chalmers: 38/87=0.44 Jadad: 5 |
Crispet al(1974)32 | Unspecified | Crossover | 4 dd 20 mg small device | None | Chronic asthma and 2 out of: nearly daily symptoms; nearly daily medication needed; intermittent or long term steroid usage | 5–17 | 40/40 | 2 × 4 weeks | Daily symptom scores, clinical assessment, lung function, additional medication | Rash, wheeze | Positive | Chalmers: 45/87=0.52 Jadad: 4 |
Hilleret al(1975)31 | Unspecified | Crossover factorial | 4 dd 20 mg Spinhaler | BMV | Chronic perennial asthma, symptoms inadequately controlled by DSCG and bronchodilators | 9–13 | 11/9 | 4 × 1 month | Daily symptom scores, clinical assessment, additional medication | None | Positive | Chalmers: 44/87=0.51 Jadad: 4 |
Hiller et al(1977)29 | Hospital | Crossover | 3 dd 20 mg nebulised | None | Frequent troublesome asthma | 2–4 | 17/17 | 1 week baseline, 2 × 4 weeks treatment | Daily symptom scores, clinical assessment, lung function | Unspecified | Positive | Chalmers: 34/87=0.39 Jadad: 3 |
Matthew (1977)30 | Outpatients | Crossover | 4 dd 20 mg nebulised | None | Severe chronic perennial asthma + symptoms in baseline period | 3–6 | 10/9 | 8 weeks baseline, 2 × 4 weeks treatment | Daily symptom scores, additional treatment, lung function | Unspecified | Positive | Chalmers: 29/87=0.33 Jadad: 3 |
Edmunds et al(1980)28 | Unspecified | Crossover | 4 dd 1 capsule | Slow release aminophylline | Perennial asthma | 5–15 | 30/30 | 3 × 4 weeks | Daily symptom scores, lung function, additional medication | Nausea, vomiting, abdominal pain, headache | Positive | Chalmers: 29/91=0.33 Jadad: 2 |
Glasset al(1981)27 | Hospital | Crossover | 4 dd 20 mg nebulised | Theophylline syrup | Control of asthma poor under routine treatment | 1–4 | 16/16 | 4 weeks baseline, 3 × 8 weeks treatment | Daily symptom scores, additional treatment | Minor | Equal | Chalmers: 29/94=0.31 Jadad: 2 |
Geller- Bernstein et al(1982)26 | Hospital | Crossover | 4 dd 2 ml nebulised | None | Frequent troublesome wheezy bronchitis despite regular bronchodilator therapy + symptoms in baseline period | 0–2 | 49/44 | 2 weeks baseline, 2 × 4 weeks treatment | Daily symptom scores, clinical assessment | Unspecified | Equal/ positive | Chalmers: 34/94= 0.36 Jadad: 4 |
Miraglia del Giudice et al (1982)41 | Hospital | Crossover | 3 dd 20 mg nebulised | None | Perennial asthma and symptoms despite bronchodilator therapy | 0–5 | 31/31 | 2 weeks baseline, 2 × 4 weeks treatment | Daily symptom scores, additional treatment, clinical assessment | Cough, sneeze | Positive | Chalmers: 35/91=0.38 Jadad: 4 |
Geller- Bernstein et al(1983)45 | Unspecified | Crossover | 4 dd 2 mg pressurised aerosol | None | Moderately severe or severe extrinsic asthma at least 12 months, not taken DSCG or steroids for at least 6 months before trial | 4–13 | 48/43 | 2 weeks baseline, 2 × 6 weeks treatment | Daily symptom scores, asthma severity score, lung function, patients', parents' and physicians' preferences | Throat irritation | Positive/ equal | Chalmers: 42/90=0.47 Jadad: 4 |
Henry et al(1984)25 | Hospital | Crossover | 3 dd 20 mg nebulised | Ipratropium bromide 3 dd 250 μg | Suffered from recurrent attacks of wheezing and considered troublesome asthma by paediatrician and parents | <2 | 23/20 | 2 weeks baseline, 3 × 8 weeks treatment | Daily symptom scores, additional treatment, lung function | Unspecified | Equal | Chalmers: 23/94=0.24 Jadad: 2 |
Cogswell et al(1985)24 | Hospital | Crossover | 4 dd 20 mg nebulised | None | Regular attacks of asthma that required at least one admission to hospital | 1–4 | 27/24 | 4 weeks baseline, 2 × 26 weeks treatment | Daily symptom scores, additional treatment | Unspecified | Positive | Chalmers: 43/91=0.47 Jadad: 4 |
Bertelsen et al(1986)44 | Hospital | Parallel | 3 dd 20 mg nebulised | None | Recurrent wheezy bronchitis demanding treatment at least once a month during preceding winter or later | 1–4 | 59/54 | 4–8 weeks baseline, 10 weeks treatment | Daily symptom scores, additional treatment | Cough, wheeze and eczema | Equal | Chalmers: 31/95=0.33 Jadad: 3 |
Yuksel et al(1992)43 | Hospital | Crossover | 4 dd 5 mg coffeecup | None | Preterm born, wheeze and/or cough 3–4 days/week for the previous 4 weeks + symptoms for at least 3 days following all respiratory tract infections | 0–2 | 16/16 | 2–3 weeks treatment | Daily symptom scores, additional treatment, lung function | Unspecified | Positive | Chalmers: 32/91=0.35 Jadad: 2 |
Furfaro et al(1994)23 | Outpatients | Parallel | 3 dd 40 mg nebulised | None | Presence of chronic pulmonary symptoms for at least one month and wheezing documented by a physician + symptoms in baseline period | 0–1 | 37/31 | 3 weeks baseline, 6 weeks treatment | Daily symptom scores, lung function | Unspecified | Equal | Chalmers: 56/95=0.59 Jadad: 4 |
Tasche et al(1997)16 | General practice setting | Parallel | 3 dd 10 mg spacer device, facemask | None | Previously been prescribed anti-asthma medication and meeting formulated criteria for moderate asthma | 1–4 | 232/218 | 4 weeks baseline, 22 weeks treatment | Daily symptom scores, loss of participants, additional medication | Eczema in mask area, cough | Equal | Chalmers: 75/95=0.79 Jadad: 3 |
BMV = beclomethasone-17-valerate.