Background
Low level laser therapy as a treatment for tuberculosis has been the subject of published studies since the early 1990s (Vlassov 2002). It has been used to treat pulmonary tuberculosis (Badalov 1990) and extrapulmonary tuberculosis (Iagafarova 1998) caused by drug sensitive and multiple-drug-resistant mycobacteria (Bhagwanani 1996; Lomachenkov 1998), and people who have tuberculosis in addition to an underlying medical condition such as endobronchitis (Shesterina 1991). The mechanism of action of low level laser therapy in treating tuberculosis is not known, but it has been hypothesized that it involves the modulation of "information exchange between the human body and universe" or have anti-inflammatory, immunomodulatory, and anaesthetizing action within the human body (Illarionov 1998).
A variety of different laser devices have been used for treating tuberculosis. They include gas lasers, such as the helium-neon laser and the nitrogen laser, and semiconductor lasers, such as the diode pulse beam arsenic-gallium laser. The devices typically deliver 2 mW to 200 mW, with the power density typically ranging from 0.05 W/cm
The main treatment for tuberculosis is a course of antituberculous drugs taken over a period of at least six months (WHO 1999). This lengthy treatment course can make it difficult for people to adhere to the full course and can increase the frequency of cases where the Mycobacterium tuberculosis bacteria, which cause tuberculosis, develop resistance to the antituberculous drugs (Yew 1999). Lasers seem to be mainly used for treating tuberculosis in countries of the former Soviet Union and India in the belief that they may reduce the length of the treatment or increase the frequency of cure (Vlassov 2002).
This Cochrane Review summarizes evaluates the available evidence on the role of low level laser therapy as an adjunct to antituberculous drugs for treating tuberculosis.
Objectives
To compare low level laser therapy plus antituberculous drugs with antituberculous drugs alone for treating tuberculosis.
Methods
Criteria for considering studies for this review
Types of studies
Randomized controlled trials.
Types of participants
People with tuberculosis affecting any organ. Diagnosis proven by a positive sputum smear or culture, or both, or through the examination of x-rays.
Types of interventions
Intervention
Low level laser therapy used specifically for treating tuberculosis plus antituberculous drugs.
Control
Antituberculous drugs.
Antituberculous drug regimens and other baseline treatments must be identical for both groups. We excluded laser therapy used for coagulation, evaporation of tissues, drying of wounds or surfaces of organs, and photoactivation of drugs.
Types of outcome measures
Primary
- All-cause death.
- Time to become sputum negative (smear or culture conversion, or both) for mycobacteria or frequency of conversion at two, five, six, or eight months.
Secondary
- Time to resolution of fever (or frequency of resolution of fever).
- Time to resolution of infiltration of lungs on x-ray* (or frequency of resolution).
- Time to lung cavity closure on x-ray* (or frequency of closure).
- Measure of lung function, such as forced vital capacity (FVC).
*X-rays must have been evaluated blindly and by no less than two specialists.
Adverse events
- Serious adverse events (leading to death, requiring hospitalization, or withdrawal from treatment).
- Other adverse events.
Search methods for identification of studies
We have attempted to identify all relevant trials regardless of language or publication status (published, unpublished, in press, and in progress).
Databases
We searched the following databases using the search terms and strategy described in Appendix 1: Cochrane Infectious Diseases Group Specialized Register (October 2009), CENTRAL (The Cochrane Library 2009, Issue 4), MEDLINE (1966 to October 2009), EMBASE (1974 to October 2009), CINAHL (1982 to October 2009), Science Citation Index (1945 to October 2009), PEDro (1929 to October 2009 ), LILACS (1982 to October 2009).
Other sources
We searched the electronic catalogue of the Central Medical Library in Moscow (1988 to April 2009) using the search terms tubercul* and laser*, the website of the National Centre for Science Information at the Indian Institute of Science (15 April 2002), handsearched the journal journal Probl. Tuberk. Bolezn. Legk. (2000 to April 2009), where most relevant articles were published in previous years. We used Google (July 2009) to search the Internet with the search terms tuberculosis and laser, and, for the Vlassov 2002 version, handsearched the proceedings of all relevant conferences available in the Central Medical Library and the private literature collections of two specialists in the field. We contacted relevant organizations and researchers for the original version.
Researchers and organizations: unpublished and ongoing trials
For the original version of the review (Vlassov 2002), we contacted individual researchers working in the field and organizations including the Centre of Advanced Technology (India), the International Union Against Tuberculosis and Lung Disease (IUATLD), and the Central Tuberculosis Research Institute (CTRI) of the Russian Academy of Medical Science.
Reference lists
We also checked the reference lists of all studies identified by the above methods.
Data collection and analysis
Selection of studies
Both authors independently screened the results of the literature search to identify potentially relevant studies, although only the first author screened the Russian language studies. We examined the full text of any potentially relevant articles before making a decision on their eligibility, and resolved differences in opinion through discussion. We attempted to contact the authors of studies where there was ambiguity.
Data extraction and management
Both authors independently extracted data from the included trial.
Assessment of risk of bias in included studies
Both authors independently assessed the risk of bias in trials. We assessed the generation of allocation sequence and concealment of allocation as adequate, inadequate, or unclear according to Juni 2001; described who was blinded to the intervention; and assessed the percentage of randomized participants included in the analysis of a primary outcome measure, with 90% or more considered as adequate. We resolved differences through discussion and attempted to contact the trial authors for clarification where needed.
Data synthesis
We were unable to do any data analyses. We will refer to the methods described in the protocol should we need to conduct analyses in future updates.
Results
Description of studies
See: Characteristics of included studies; Characteristics of excluded studies.
Of eight potentially relevant studies, we excluded seven studies, six conducted in Russia and one in Azerbaijan, for the reasons described in the 'Characteristics of excluded studies', and included one randomized controlled trial (Puri 2003).
Puri 2003 was conducted in New Delhi, India and enrolled 130 participants for an evaluation of the gallium-arsenide laser in the treatment of pulmonary tuberculosis. All participants received the same basic antituberculosis drug regimen in addition to either the laser treatment or sham laser treatment. Those receiving the laser had daily treatment for 10 days and were either admitted to hospital or attended the outpatient clinic. The treatment was external with the location guided by chest radiographs. Further details are provided in the 'Characteristics of included studies'. The participants in the sham irradiation control group used the same machine without switching it on.
The trial measured a number of outcomes of which the sputum conversion and clinical improvement are relevant to this review; however, no data are available for the latter outcome. Although the trialists did not report adverse events or death as outcome measures, some data were reported that relate to these. The trial report provided information on these outcome measures, but the data were insufficient for analysis. The attempts to contact the author for clarification were unsuccessful. The trial report did not provide details on the group that each of the participants were randomized into or which group those participants that left the trial were from; the only details on group allocation was for the 65 participants who were cured (see Figure 1).
![]() | Figure 1. Flow of participants as reported in Puri 2003 |
Risk of bias in included studies
Puri 2003 was described as a randomized controlled trial, but there is no information on how the allocation sequence was generated. It was also unclear how the allocation was concealed. The participants were blinded to the intervention, but it is unclear if this was the case also for the treatment providers and outcome assessors. In terms of the inclusion of the randomized participants available for the analysis of the time to sputum conversion (a primary outcome measure), the trialists have reported that 53.85% (70/130) of the enrolled participants completed treatment, but we are unsure to which treatment group five of these participants were allocated.
Effects of interventions
Death from any cause
The trialists reported one death, but it is not clear which treatment group the person was in. No further details were provided.
Time to become sputum negative
The trialists did not report the number of participants enrolled into each group, which meant that we do not have the denominators for this analysis. Although the trialists did provide details on the sputum conversion, it was only for the 65 participants reported as cured.
Discussion
The original version of this review included a search for and description of non-randomized studies on low level laser therapy for tuberculosis (Vlassov 2002). Over 3500 participants and 60 researchers from India and countries throughout the former Soviet Union were involved in the 29 studies, which tended to report promising results. Since this time we have continued our search of the literature and have been surprised to find that only one randomized controlled trial has since been conducted. It has been disappointing to find that the description of the methods and results in the trial report meant that we were unable to summarize the findings. Any further studies conducted in this area must be well-designed randomized controlled trials, which should be reported in full to allow the wider scientific community to gain a better understanding of the potential value of this intervention.
Authors' conclusions
Implications for practice The one small randomized controlled trial that evaluated low level laser therapy for treating tuberculosis was poorly reported and does not clarify the potential benefits or harms of this intervention. The use of this intervention is not supported by reliable evidence. |
Implications for research Researchers need to focus on conducting well-designed randomized controlled trials to assess low level laser therapy for treating tuberculosis. The trialists must ensure that all participants give their consent, use pragmatic outcome measures including adverse events, and provide a detailed description of any antituberculous drugs used concurrently with the laser therapy (these should be the same in both the intervention and control groups). The trials should be reported in full and preferably conform to the Consolidated Standards of Reporting Trials (CONSORT) statement (Moher 2001). |
Acknowledgements
We acknowledge the following support provided for the Vlassov 2002 version of the review: Leonid M Pechatnikov for independently checking the Russian language contributing articles, Carrol Gamble (née Preston) for statistical support, and Bertie Squire and Paul Garner for advice. Harriet G MacLehose contributed to and was an author on previous versions of this review.
Data and analyses
This review has no analyses.
Appendices
Appendix 1. Search methods: search strategies for databases
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What's new
Last assessed as up-to-date: 19 October 2009.
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History
Protocol first published: Issue 1, 2002
Review first published: Issue 3, 2002
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Contributions of authors
Vasiliy V Vlassov and Harriet G MacLehose contributed equally to the previous version of the review. Vasiliy V Vlassov and Andrey G. Reze contributed equally to the update of the review
Declarations of interest
Authors declare that they have no conflict of interest.
Sources of support
Internal sources
- Liverpool School of Tropical Medicine, UK.
External sources
- Department for International Development, UK.
Differences between protocol and review
2002, Issue 3: We added "drying of wounds or surfaces of organs" to the types of interventions that are excluded; removed "as an adjunct therapy" from the objective because this is more appropriate since it is not necessarily used in combination with other treatments; and moved the description of non-randomized studies has been moved from the 'Background' into the main review under a separate subheading.
Index terms
Medical Subject Headings (MeSH)
*Laser Therapy; Lasers [adverse effects]; Randomized Controlled Trials as Topic; Tuberculosis, Pulmonary [*radiotherapy]
MeSH check words
Humans

