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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.
Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].
Show detailsAuthors' objectives
To evaluate the efficacy of pentoxifylline therapy in improving the walking capacity of patients with moderate intermittent claudication.
Searching
MEDLINE was searched for trials published in any language between 1976 and 1994 inclusive, using the MeSH terms 'peripheral vascular disease', 'pentoxifylline' and 'intermittent claudication'. In addition, the bibliographic reviews of all the articles retrieved were examined, and experts in the field were consulted for information on unpublished or current pentoxifylline trials.
Study selection
Study designs of evaluations included in the review
Randomised, placebo-controlled, double-blind clinical trials evaluating pain-free walking distance and absolute claudication distance were eligible for inclusion. The first phase of crossover trials was also included. Single-blind and open studies were excluded.
Specific interventions included in the review
Therapy with pentoxifylline, 600 to 1,800 mg/day, lasting from 2 to 26 weeks.
Participants included in the review
Patients with moderate intermittent claudication due to peripheral vascular disease at stage II or III, according to Fontaine's classification (a pain-free walking distance of 50 to 200 m or less than 50 m, respectively). The duration of the intermittent claudication had to range from more than 3 months to less than 5 years.
Outcomes assessed in the review
The pain-free walking distance (the distance walked on a treadmill before the onset of calf pain) and absolute claudication distance (the maximum distance walked on a treadmill) were measured.
How were decisions on the relevance of primary studies made?
The authors do not state how the papers were selected for the review, or how many of the reviewers performed the selection.
Assessment of study quality
The quality of the reporting of each trial was assessed using a validated 3-item scale (see Other Publications of Related Interest). This assessed the trials on the basis of randomisation, double-blinding, and data relating to drop-outs and withdrawals. The authors do not state how the papers were assessed for validity, or how many of the reviewers performed the validity assessement. However, it was stated that the reviewers were blinded to the source, and any disagreements were resolved through group consensus.
Data extraction
The authors do not state how the data were extracted for the review, or how many of the reviewers performed the data extraction. Data were extracted on the trial design, the patients' characteristics, dosages and treatment periods.
Methods of synthesis
How were the studies combined?
Data on the pain-free walking distances and on the absolute claudication distances were pooled and presented as a weighted mean difference and an effect size. The 95% confidence intervals (CIs) were also calculated.
How were differences between studies investigated?
Between-trial heterogeneity was evaluated using Cochran's Q-test, and a sensitivity analysis of trial quality, dosages, treatment duration and disease severity was performed.
Results of the review
Eleven trials including 12 study groups were included (699 patients in total). There wer 10 trials (612 patients: 308 in the treatment group and 304 in the control group) of pain-free walking and 7 trials (511 patients: 258 in the treatment group and 253 in the control group) of absolute claudication.
The overall weighted mean difference was 29.4 m for pain-free walking distance. This was statistically significant (95% CI: 13.0, 45.9) and indicated that the participants in the treatment group walked on average about 30 m further than those not taking the drug.
The overall weighted mean difference was 48.4 m for absolute claudication distance, which was statistically significant (95% CI: 18.3, 78.6).
Between-trial heterogeneity was statistically significant when all of the trials were included in the analysis. In a sensitivity analysis of the pain-free walking distance, significant treatment effects and no statistically-significant heterogeneity were only found when trials were included that were 'medically eligible', i.e. they involved patients with stage II disease and a pain-free walking distance of 50 to 200 m. In a similar sensitivity analysis of the absolute claudication distance, the two conditions resulting in a significant treatment effect and no significant heterogeneity were the inclusion of 'medically eligible' trials and those with a shorter treatment duration (13 weeks or less).
Cost information
One study reported that, on average, pentoxifylline accounted for almost 10% of the total cost of care among patients using the drug on a continuous basis.
Authors' conclusions
Pentoxifylline therapy may be efficacious in improving the walking capacity of patients with moderate intermittent claudication. However, properly conducted clinical trials are required to provide a true estimate of the benefit.
CRD commentary
This review adequately stated its objectives, interventions, participants, outcomes, search strategy, inclusion and validity criteria, methods of analysis, and results. More details on the processes by which the inclusion and validity criteria were applied, and the methods used to extract the data, would have ben beneficial. The results appear to accurately reflect the evidence presented.
Bibliographic details
Hood S C, Moher D, Barber G G. Management of intermittent claudication with pentoxifylline: meta-analysis of randomized controlled trials. CMAJ: Canadian Medical Association Journal 1996; 155(8): 1053-1059. [PMC free article: PMC1335354] [PubMed: 8873633]
Other publications of related interest
Jadad AR, Moore RA, Carroll D, Jenkinson C, Reynolds DJ, Gavaghan DJ, et al. Assessing the quality of reports of randomized clinical trials: is blinding necessary? Control Clin Trials 1996;17:1-12.
This additional published commentary may also be of interest. Michaels J. Meta-analysis: pentoxifylline improves walking in intermittent claudication. ACP J Club 1997;126:37.
Indexing Status
Subject indexing assigned by NLM
MeSH
Chi-Square Distribution; Confidence Intervals; Humans; Intermittent Claudication /drug therapy; Pentoxifylline /therapeutic use; Randomized Controlled Trials as Topic; Research Design; Walking
AccessionNumber
Database entry date
31/08/1999
Record Status
This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.
- Authors' objectives
- Searching
- Study selection
- Assessment of study quality
- Data extraction
- Methods of synthesis
- Results of the review
- Cost information
- Authors' conclusions
- CRD commentary
- Bibliographic details
- Other publications of related interest
- Indexing Status
- MeSH
- AccessionNumber
- Database entry date
- Record Status
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- Review Cilostazol for intermittent claudication.[Cochrane Database Syst Rev. 2014]Review Cilostazol for intermittent claudication.Bedenis R, Stewart M, Cleanthis M, Robless P, Mikhailidis DP, Stansby G. Cochrane Database Syst Rev. 2014 Oct 31; 2014(10):CD003748. Epub 2014 Oct 31.
- Review Pentoxifylline and intermittent claudication: review of clinical trials and cost-effectiveness analyses.[J Cardiovasc Pharmacol. 1995]Review Pentoxifylline and intermittent claudication: review of clinical trials and cost-effectiveness analyses.Gillings DB. J Cardiovasc Pharmacol. 1995; 25 Suppl 2:S44-50.
- Management of intermittent claudication with pentoxifylline: meta-analysis of ra...Management of intermittent claudication with pentoxifylline: meta-analysis of randomized controlled trials - Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews
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