Characteristics of included studies [ordered by study ID]
Puri 2003
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| 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
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 |
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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 |
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Characteristics of excluded studies [ordered by study ID]
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| Study | Reason for exclusion |
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| | Abashev 1997 | Location: Russia
Excluded because we were unable to determine if this is a randomized controlled trial. The trial report says 5 study groups were formed using the results of the therapy, but continues to say that the 5 groups were different because they received different therapy: (1) antibacterial; (2) antibacterial plus LLLT of projections to surfaces of the body close to the internal organs affected by tuberculosis (ie, anatomical projections of affected areas); (3) antibacterial plus ultrasound therapy; (4) antibacterial plus LLLT on anatomical projections of affected organs plus ultrasound therapy; and (5) antibacterial plus LLLT on acupuncture points plus ultrasound therapy. In correspondence received from the author, the authors stated that the "groups were formed by the method of random sample". However, the trial author did not explicitly state that this was a prospective study, and if participants were randomly assigned to groups, what method was used for randomization; further attempts to contact the trial author were unsuccessful |
| | Agayev 2004 | Location: Azerbaijan
Study not randomized |
| | Lovacheva 2006 | Location: Russia
The method of randomization was not reported. After being contacted, the leading author explained that there was no systematic application of true randomization procedure for allocation of treatments. |
| | Maliev 1991a | Also see Shesterina 1991 and Maliev 2001b
Location: Russia
Excluded because we were unable to determine if this is a randomized controlled trial. This study was first published as a controlled trial or comparison of patients selected from the current practice. In Maliev 2001b, the same study was described as 'randomized'. The authors did not mention the method of randomization, concealment of allocation, or blinding |
| | Maliev 2001b | Also see Maliev 1991a and Shesterina 1991
Location: Russia
Excluded because there is a discrepancy in the number of participants included in the study. The same group of authors wrote this study report as for Maliev 1991a and Shesterina 1991. The study description is very similar to Maliev 1991a, although the immunoglobulin results are presented more extensively. While Maliev 1991a mentioned that two participants dropped out because of poor adherence, Shesterina 1991 reported one dropout and Maliev 2001b also reports one dropout. Despite the different number of participants in Maliev 1991a and Shesterina 1991, the results were described with identical numbers (see Shesterina 1991) |
| | Shesterina 1991 | Also see Maliev 1991a and Maliev 2001b
Location: Russia
Excluded because there is a discrepancy in the number of participants included in the study. The same group of authors wrote this study report as for Maliev 1991a. The study design was the same, but number of participants was only 56, not 102. While Maliev 1991a mentioned that 2 participants dropped out because of low adherence, this study (Shesterina 1991) did not report any dropouts. In a further publication of the data of the same 56 participants (Maliev 1991b - Additional references), 1 participant was reported to have dropped out. In the latest publication (Maliev 2001a), 5 participants in the intervention group and 5 participants in the control group are reported to have dropped out. Despite different number of participants in two reports (Maliev 1991a, Shesterina 1991), the outcomes were described with identical numbers as shown below:
Maliev 1991a:
1. Catarrhal endobronchitis "clinically cured" in 25/25 participants during 0.99+-0.1 months of treatment in the intervention group and in 18/28 participants during 2.58+-0.23 months in the control group.
2. Purulent endobronchitis relying on the bronchoscopy was cured in 25/26 participants (1 dropout/17 participants) during 1.13+-0.11 months in the intervention group and 13/22 participants during 3.43+-0.51 months in the control group
Shesterina 1991:
1. Catarrhal endobronchitis "clinically cured" in 13/13 participants during 0.99+-0.09 months of treatment in the intervention group and 9/14 participants during 2.58+-0.23 months in the control group.
2. Purulent endobronchitis relying on the bronchoscopy was cured in 15/16 participants (1 dropout/17 participants) during 1.13+-0.11 months in the intervention group and 7/12 participants during 3.43+-0.51 months in the control group
Repeated attempts to contact investigators to clear the problems with publications and study design were unsuccessful. In the light of these discrepancies we are unable to include this study |
| | Topolnitskii 1992 | Location: Russia
Excluded because the intervention and control groups did not receive the same baseline treatments: the control group received "pathogenetic" interventions (methyluracil, insulin, sodium thiosulphate) and no LLLT; the intervention group received no "pathogenetic" interventions, but did receive LLLT. The report in the full text dissertation says participants were distributed into two groups using a random numbers table. Concealment of allocation and blinding were not mentioned. Of the 25 participants in the intervention group, 6 were excluded because of poor adherence and discharged from the hospital between 1 to 3 months of therapy. No participants were excluded from the control group. The outcomes presented for the intervention group were calculated only for the participants that remained in the study. The trial author did not respond to our requests for further information |
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LLLT: low level laser therapy.
