Authors' objectives:

This review aims to answer the following questions about intrathecal pump systems, based on an analysis of the published literature. - Which drugs and dosages are commonly used in clinical practice? - How effective is this therapy compared with other treatments? - What are the risks? - What types of patients are suitable? - How costly is this type of treatment compared with other treatments? - What are the opinions of a group of UK pain specialists?

Authors' results and conclusions: - A total of 114 studies, containing information on over 2000 patients, were identified. - No randomised controlled studies or comparator studies were found. Data were extracted from case reports and case series-type information. - The most commonly used intrathecal drug was morphine, followed by morphine in combination with bupivacaine. Dose escalation is an issue with this therapy, with reported dose increases of between 1% and 160% per week. - A total of 53 studies were found that presented data on the effectiveness of pump systems. Sixteen of these reported visual analogue scores before and after pump usage. Average scores declined from 7.6/10 to 3/10 over a variable period of up to 2 years. All other measures of effectiveness, including various quality of life indicators, invariably reported positive effects. - Risks of the therapy include pharmacological side-effects attributable to the drugs used (incidence 3;26% of patients) and mechanical complications associated with the pump delivery systems (incidence up to 20%). - Patient selection criteria for this therapy are variously reported. The two main criteria are failure of or unacceptable side-effects from conventional therapy such as oral or subcutaneous opioids. A number of screening tests and trials of intrathecal therapy are used prior to actual pump implantation. - The patient population receiving pumps is varied; some have cancer pain and some have non-cancer pain. Many will have tried numerous conventional treatments prior to intrathecal therapy; for others, with limited life expectancy and intractable pain, this is a "last resort therapy". Two distinct patient types can therefore be identified: those with long life expectancy, but with resistant pain; and cancer patients with limited life expectancy and intractable pain that is resistant to all other treatments - Opinions sought from 18 UK pain specialists revealed a split in opinion over the use of these pumps in clinical practice, with one-third being in favour of their use, one-third against and one-third undecided. This non-random sample contrasted with the generally positive reports in the published literature.

Authors' recommendations: No randomised, controlled or comparator data were found while carrying out this review. All information is therefore suboptimal. Published reports frequently use non-standard outcome measures on a hetero-geneous patient population receiving different types of intrathecal pumps and drugs over varying periods. These variables make analysis very difficult. However, such data as are available indicate a generally positive effect of the therapy, with side-effects and complications occurring in about a quarter of the recipients, but it is difficult to draw definite conclusions because the quality of the data is so poor. Furthermore, the important clinical question: "Is this therapy any better than existing treatments?" is not answered by this review because of the lack of comparator data. The opinions from UK experts were not of such an overwhelmingly positive nature as the published reports.

Authors' methods: Systematic review

Project Status: Completed

URL for project: http://www.hta.ac.uk/1008

Year Published: 2000

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: England, United Kingdom

Organisation Name: NIHR Health Technology Assessment programme

Contact Address: NIHR Journals Library, National Institute for Health and Care Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK

Contact Name: journals.library@nihr.ac.uk

Contact Email: journals.library@nihr.ac.uk

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