Seven studies were included: one RCT and six case series.
Intrathecal opioids for the treatment of chronic pain (1 RCT and 2 case series).
When using the intention-to-treat analysis from the RCT of 202 patients there was no statistically significant difference between CMM and IDDS for pain relief measured on a VAS, although when using the less conservative 'as treated' data there was a statistically significant greater reduction in pain for the IDDS patients than for the CMM patients. There was also a greater reduction in the composite toxicity score for the IDDS group compared with the CMM group. Estimated cumulative survival was 53.9% with IDDS and 37.2% with CMM. One case series of 30 patients reported statistically significant improvements from baseline to follow-up in pain, while the other case series of 82 patients reported improvements in pain though this was not statistically significant.
The RCT reported no statistically significant differences between IDDS and CMM in the total number of complications. Mortalities were reported, but no deaths were attributed to the therapy. There were some commonly reported drug-related physical side-effects. Device-related complications were reported as occurring infrequently. Catheter complications were frequent, while wound complications occurred infrequently.
Intrathecal baclofen (2 case series).
One case series of 131 patients reported a statistically significant decrease in spasticity, while the other case series of 115 centres reported improvements on a range of functional and other outcomes.
The total number of complications was not reported by either of the two studies. Mortalities were reported but were not attributed to the therapy. There were some commonly reported drug-related physical side-effects. Device-related and catheter-related complications were reported as occurring infrequently.