Puri 2003.
Methods | Generation of allocation sequence: notes that "patients were randomly divided into two groups", but method unclear Allocation concealment: unclear Blinding: participants blinded, but unclear if provider and outcome assessor blinded Inclusion of all randomized participants in analysis: 53.85% (70/130) completed treatment and were available for analysis, but unclear which group all of these participants belonged to Length of follow up: 135 days |
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Participants | Number: 130 enrolled Inclusion criteria: new sputum smear positive pulmonary tuberculosis patients Exclusion criteria: history of frank haemoptysis, diabetes mellitus, liver disease and alcohol abuse |
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Interventions | Basic antituberculous regimen for both groups: 2 months daily intensive phase with isoniazid, rifampicin, ethambutol, and pyrazinamide, followed by 4 months of daily isoniazid and rifampicin; intensive phase extended for 1 more month in those participants whose sputum microscopy result was positive for acid fast bacilli at the end of 2 months 1. Low level laser therapy
2. Sham irradiation (placebo effect) using same machine without switching it on |
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Outcomes | 1. Clinical improvement in symptoms (not defined)
2. Sputum examination for acid‐fast bacilli by Ziehl‐Neelsen method: patient considered sputum negative when sputum microscopy results were negative for acid‐fast bacilli and remained negative on subsequent examination Other outcomes in trial report that are not used in review: 3. Weight gain (change in mean body mass index) 4. Haemoglobin (not defined) |
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Notes | Location: Department of Tuberculosis and Chest Diseases, LRS Institute of Tuberculosis and Allied Diseases, Sri Aurobindo Marg, New Delhi, India Date: unclear, pre‐2001 because paper received at journal office on 19 October, 2001 HIV status of participants: specifically states that HIV testing not done Consent: all participants gave informed consent Contacting trial authors: we attempted to contact the corresponding author on two occasions in 2005 for clarifications and further information, but we were unsuccessful |