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. 2006 Apr 19;2006(2):CD003490. doi: 10.1002/14651858.CD003490.pub2

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
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
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
  • Type of laser: semiconductor laser therapy; double channel laser equipment (gallium arsenide)

  • Power: wavelength of 890 nm, frequency of 1500 Hz, and output of 4 to 6 mW

  • Site of application: site of external laser irradiation guided by location of the radiological lesion on chest radiography; laser probe placed in intercostals space corresponding to site of lesion both anteriorly and posteriorly

  • Length of each application: each laser irradiation for 4 minutes; total duration did not exceed 12 minutes (eg 3 fields of 4 minutes) per day

  • Total number of applications: daily for 10 days

  • Note: patients admitted into hospital for the laser therapy; those patients who consented to come daily were treated from outpatient clinic


2. Sham irradiation (placebo effect) using same machine without switching it on
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)
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