Adjunctive therapies for AIDS dementia complex: Cochrane systematic review
Assessed as up to date: 2007/02/11
AIDS dementia complex is a common complication of human immunodeficiency virus type 1 (HIV-1) that continues to exist despite the current use of potent antiretroviral therapy. It is a source of great morbidity and, when severe, is associated with limited survival.Objectives
To determine efficacy and safety of adjunctive therapies for AIDS dementia complexSearch strategy
We searched the Cochrane HIV/AIDS group trials Specialized Register (December 2006), the Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 1, 2007), MEDLINE (January 1980 to February 2007), EMBASE (January 1980 to February 2007), AIDSearch (January 1980 to February 2007), PsycINFO (January 1980 to February 2007), PSYCHLIT (January 1980 to February 2007), LILACS (January 1980 to February 2007), conference proceedings, trial registers, theses databases, and reference lists of the articles. We also contacted manufacturers and researchers in the field.Selection criteria
Randomized controlled trials, either published or published, that compared one type of adjunctive therapy to no therapy or placebo in adults with AIDS dementia complexData collection and analysis
Two authors independently assessed trials quality, extracted data and entered data into RevMan 4.2 software. Where possible intention-to-treat data were used and we contacted study authors for additional information. We collected neurocognitive performance, adverse effects, tolerability and all-cause mortality information from the trials.Main results
Ten trials involving 711 people were included. All the studies were phase 2 trials. Six studies used adequate methods for allocation of sequence generation and unclear in the remaining four trials. Allocation concealment was adequate in five trials and unclear in the remaining trials. The trials were heterogeneous in terms of types, dosages, routes and frequencies of administration of the adjunctive therapies. There were no significant differences between the treated and placebo groups on neuropsychological test scores, number of those that complete the assign dosage of experimental medication, adverse effects, and all-cause mortality.Authors' conclusions
This review confirms the absence of evidence that any of the adjunctive therapies improves cognitive performance or quality of life, or both for patients with ADC, though they were well tolerated and safe.
Uthman Olalekan A, Abdulmalik Jubril O
There is no evidence that adjunctive therapies for AIDS dementia are effective, though they are well-tolerated and safe.
The authors did a systematic review of ten studies, to see if adjunctive therapies (supplemental to the main treatment) for AIDS dementia were effective and safe. They found no evidence that adjunctive therapies had any effect on the patients They did find adjunctive therapies to be safe, and without any harmful effect on the patients.
Implications for practice
There is a lack of evidence that any of the adjunctive therapies improves cognitive performance or quality of life, or both for patients with ADC. The evidence of safety and tolerability of these drugs does not justify recommending its routine clinical use.
Implications for research
There is a need for well designed, adequately powered, phase III trials on adjunctive therapies for ADC, with main objective on cognitive performance and/or quality of life. In addition there is a need for more research in transitional and developing countries with high burden of HIV and ADC.
Future trials should address the following:
- Review, and refine, the methodology for trials of neuropsychological endpoints, in people with ADC;
- Recruit an adequate number of participants and provide treatment for a sufficient duration and follow up;
- Interventions need to be carefully specified and monitored; include careful assessment and complete reporting of adverse events; and
- Define a priori an unambiguous, measurable, primary endpoint; and report results for all outcomes using CONSORT statement.
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