Characteristics of included studies [ordered by study ID]
Bang 1997
|
| Methods | Generation of allocation sequence: not stated
Allocation concealment: not stated
Blinding: not stated
Inclusion of all randomized participants in the analysis: 98.8%
Mean duration of follow up: no fixed duration |
|
| | Participants | Number: 118 randomized; mean age 34 years; 59% men
Inclusion criteria: "Proper condition for tuberculous pleurisy after the pleura tissue test, positive for cultivation of tuberculous bacilli and anti-bacteria from pleura fluid, pleura tissue and etc."
Exclusion criteria: people with "diabetes, high blood pressure, digestive ulcer, pneumonia, malignant tumor, cardiac insufficiency and etc."; HIV-negative |
|
| | Interventions | 1. Prednisolone plus standard regimen
2. Standard regimen only
Prednisolone: single dose per injection of 1 mg/kg twice weekly (period not stated) thereafter tapered off by 10 mg/week
Standard regimen: isoniazid (400 mg/day), rifampicin (600 mg/day; 450 mg if < 50 kg), pyrazinamide (1500 mg/day), ethambutol (800 mg/day) for 2 months followed by same regimen minus pyrazinamide for 7 months |
|
| | Outcomes | 1. Mean duration to relief from symptoms
2. Rate of reabsorption of pleural fluid
3. Pleural adhesions and thickening
4. Adverse effects |
|
| | Notes | Location: Korea
Date: June 1991 to September 1994 |
|
|
Elliott 2004
|
| Methods | Generation of allocation sequence: computer-generated allocation sequence in block size of 20 participants
Allocation concealment: unclear
Blinding: providers, participants and assessors
Inclusion of all randomized participants in the analysis: 98.5
Mean duration of follow up: 1.65 years for intervention group; 1.48 years for control group |
|
| | Participants | Number: 197 randomized; mean age 34 years; 58% men
Inclusion criteria: HIV-positive; clinical features suggesting tuberculous pleurisy with pleural effusion > 1/3 of 1 hemithorax; age > 18 years; no previous treatment or prophylaxis for tuberculosis; no recent treatment with glucocorticoids; not pregnant or breastfeeding;
Exclusion criteria: HIV-negative failed to complete screening procedures; failure to obtain pleural fluid for diagnostic purposes; empyema; a second, major HIV-related disease; risk factors for serious steroid-related adverse events; standard doses of antituberculous drugs could not be used (as in participants with concurrent liver disease) |
|
| | Interventions | 1. Prednisolone plus standard regimen
2. Placebo plus standard regimen
Prednisolone: single oral dose of 50 mg/day for 14 days, 40 mg/day for 14 days, 25 mg/day for 14 days, 15 mg/day for 14 d
Standard regimen: isoniazid (5 mg/kg/day; max 300 mg/day); rifampicin (10 mg/kg/day; max 600 mg/day); pyrazinamide (18 to 26 mg/kg/day); ethambutol (14 to 21 mg/kg/day for 2 months); followed by 4 months of isoniazid and rifampicin |
|
| | Outcomes | 1. All-cause mortality
2. Adverse effects related to steroid use
3. Resolution of tuberculosis
4. HIV-related events |
|
| | Notes | Location: Uganda
Date: November 1998 with recruitment until January 2002
Pleural aspiration and, if possible, biopsy for all participants on admission |
|
|
Galarza 1995
|
| Methods | Generation of allocation sequence: unclear
Allocation concealment: unclear
Blinding: providers, participants, and assessors
Inclusion of all randomized participants in the analysis: 100%; intention-to-treat analysis done
Mean duration of follow up: 46 months |
|
| | Participants | Number: 117 randomized; mean age 27 years; 51% men
Inclusion criteria: admitted to hospital for a pleural effusion of tuberculous aetiology
Exclusion criteria: HIV-positive; other criteria not stated |
|
| | Interventions | 1. Prednisone plus standard regimen
2. Placebo plus standard regimen
Prednisone: single oral dose of 1 mg/kg/day for 15 d tapering off over the next 15 d
Standard regimen: isoniazid (5 mg/kg/day; max 300 mg/day); rifampicin (10 mg/kg/day; max 600 mg/day); once daily as a combination tablet for 6 months |
|
| | Outcomes | 1. Time to normal temperature
2. Lung function assessed by forced vital capacity (FVC) at end of treatment
3. Pleural thickening at baseline and at 1, 6, and 12 months after start of treatment
4. Rate of reabsorption of pleural fluid on chest x-ray at baseline and at 1, 6, and 12 months after start of treatment
5. Adverse effects |
|
| | Notes | Location: Spain
Date: January 1985 with recruitment until January 1992
Definite microbiological or pathological diagnosis in 63% of participants
Before discharge pleural fluid was drained to 1/3 of hemithorax in all participants |
|
|
Lee 1988
|
| Methods | Generation of allocation sequence: unclear
Allocation concealment: unclear
Blinding: participants only
Inclusion of all randomized participants in the analysis: 89%
Duration of follow up: up to 24 months |
|
| | Participants | Number: 45 randomized; mean age 29 years; 60% men
Inclusion criteria: age < 45 years with pleural effusion with no previous treatment; no past history of pulmonary tuberculosis
Exclusion criteria: congestive heart failure; pneumonia; malignancy; other pulmonary diseases and conditions that contraindicated the use of corticosteroids |
|
| | Interventions | 1. Prednisolone plus standard regimen
2. Placebo plus standard regimen
Prednisolone: initially given as a single oral dose (0.75 mg/kg/day), tapered gradually over 2 to 3 months once radiological improvement was seen
Standard regimen: isoniazid (300 mg/day); rifampicin (450 mg/day for 9 to 12 months); and ethambutol (20 mg/kg/day for 3 months) |
|
| | Outcomes | 1. Resolution of clinical symptoms and signs
2. Rate of reabsorption of pleural fluid on chest x-ray
3. Pleural adhesions and thickening
4. Adverse effects |
|
| | Notes | Location: Taiwan
Date: October 1983 with recruitment until June 1987
HIV status: not stated
Diagnostic thoracocentesis (< 50 mL) on first day for all participants |
|
|
Lee 1999
|
| Methods | Generation of allocation sequence: not stated
Allocation concealment: not stated
Blinding: not stated
Inclusion of all randomized participants in the analysis: 100%
Mean duration of follow up: 9 months for intervention group; 12 months for control group |
|
| | Participants | Number: 82 randomized; mean age of 32 years; 64% men
Inclusion criteria: "Proper condition for tuberculous pleurisy after the pleura tissue test, positive for cultivation of tuberculous bacilli and anti-bacteria from pleura fluid, pleura tissue and etc."
Exclusion criteria: "diabetes, high blood pressure, digestive ulcer, pneumonia, malignant tumor, cardiac insufficiency and etc."; HIV-negative |
|
| | Interventions | 1. Prednisolone plus standard regimen
2. Standard regimen only
Prednisolone: single dose per injection of 30 mg/day for 30 days, followed by a tapering off over a further 30 days
Standard regimen: isoniazid, rifampicin, pyrazinamide, ethambutol for 6 months OR isoniazid, rifampicin, pyrazinamide, and streptomycin for 2 months followed by same regimen minus streptomycin for 4 months; dosage not stated |
|
| | Outcomes | 1. Rate of reabsorption of pleural fluid
2. Pleural adhesions and thickening
3. Adverse effects |
|
| | Notes | Location: Korea
Date: February 1990 to February 1997 |
|
|
Wyser 1996
|
| Methods | Generation of allocation sequence: unclear
Allocation concealment: unclear
Blinding: participants and assessors
Inclusion of all randomized participants in the analysis: 95%
Duration of follow up: 6 months |
|
| | Participants | Number: 74 randomized; mean age of 33 years; 61% men
Inclusion criteria: exudative pleural effusions with biopsy specimen proven tuberculous pleurisy
Exclusion criteria: other causes of pleural exudates including pneumonia or malignancy; other diseases and conditions that contraindicated use of corticosteroids, including diabetes mellitus, uncontrolled hypertension, peptic ulcer disease, and empyema; neoplastic disease; HIV-positive |
|
| | Interventions | 1. Prednisone plus standard regimen
2. Placebo plus standard regimen
Prednisone: oral dose of 0.75 mg/kg/day for 2 to 4 weeks; dose tapered by 5 mg/day over 2 weeks after clinical and radiological improvement
Standard regimen: isoniazid (8 mg/kg/day), rifampicin (10 mg/kg/day), and pyrazinamide (25 mg/kg/day) as a fixed combination tablet (Rifater); and pyridoxine (25 mg/kg/day) for 6 months |
|
| | Outcomes | 1. Resolution of symptoms: dyspnoea, cough, night sweats, tiredness, appetite, pleuritic chest pain, and general well-being were each graded from 0 to 100 using a visual analogue scale and combined index with a maximum score of 700 was calculated
2. Lung function at end of treatment as assessed by total lung capacity and forced vital capacity (FVC)
3. Recurrence of effusion
4. Residual pleural thickening at 24 weeks
5. Adverse effects |
|
| | Notes | Location: South Africa
Date: April 1994 with recruitment until January 1995
Thoracoscopy, bronchoscopy, and complete aspiration of pleural fluid for all participants on admission |
|
|
HIV: human immunodeficiency virus.
Characteristics of excluded studies [ordered by study ID]
|
| Study | Reason for exclusion |
|---|
| | Aspin 1958 | No randomization |
| | Bilaceroglu 1999 | Participants did not have pleurisy - cases of pulmonary tuberculosis |
| | Cherednikova 1973 | Case series |
| | Cisneros 1996 | Review |
| | Damany 1968 | Numbers of participants in each arm not clearly stated |
| | Filler 1963 | No randomization |
| | Fleishman 1960 | Diagnosis of tuberculosis not confirmed |
| | Grewal 1969 | No randomization |
| | Khomenko 1990 | Participants did not have pleurisy - cases of pulmonary tuberculosis |
| | Manresa 1997 | Letter referring to included trial (Galarza 1995) |
| | Mathur 1960 | No randomization |
| | Mathur 1965 | No randomization |
| | Mayanja-Kizza 2005 | Participants did not have pleurisy - cases of pulmonary tuberculosis |
| | Menon 1964 | No randomization |
| | Paheco 1973 | Compared prednisolone to another steroid (cortivazol) |
| | Paley 1959 | No randomization |
| | Porsio 1966 | Participants did not have pleurisy - cases of pulmonary tuberculosis |
| | Singh 1965 | No randomization |
| | Starostenko 1989 | No randomization |
| | Tani 1964 | No randomization |
| | Tanzj 1965 | No randomization |
|
|
Comparison 1. Corticosteroids versus control (placebo or no steroids)
|
| Outcome or subgroup title | No. of studies | No. of participants | Statistical method | Effect size |
|---|
| | 1 Death from any cause | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Subtotals only |
| | 2 Residual fluid at 4 weeks | 3 | 394 | Risk Ratio (M-H, Fixed, 95% CI) | 0.76 [0.62, 0.94] |
| | 3 Residual fluid at 8 weeks | 4 | 399 | Risk Ratio (M-H, Random, 95% CI) | 0.72 [0.46, 1.12] |
| | 4 Presence of pleural thickening | 4 | 309 | Risk Ratio (M-H, Fixed, 95% CI) | 0.69 [0.51, 0.94] |
| | 5 Presence of pleural adhesions | 2 | 123 | Risk Ratio (M-H, Fixed, 95% CI) | 0.75 [0.51, 1.11] |
| | 6 Days to improvement in symptoms | 2 | 123 | Mean Difference (IV, Fixed, 95% CI) | -4.32 [-7.44, -1.20] |
| | 7 Clinical symptoms after 7 days | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | 8 Adverse events leading to treatment discontinuation | 6 | 586 | Risk Ratio (M-H, Fixed, 95% CI) | 2.80 [1.12, 6.98] |
| | 9 HIV-associated events | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Totals not selected |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
| | | 1 | | Risk Ratio (M-H, Fixed, 95% CI) | Not estimable |
|
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