Evidence inconclusive for sulpiride augmentation

Sulpiride plus clozapine is likely to be more effective than clozapine alone to treat patients with treatment-resistant schizophrenia, but evidence is weak and more research is needed, a Cochrane review concludes. Drawing from one long-term and three short-term randomised trials, the review analysed data of 221 patients with treatment-resistant schizophrenia who were treated with sulpiride as an augmentation treatment, or clozapine alone. Patients who received sulpiride plus clozapine tended to show more significant clinical improvement than those treated with clozapine alone (n=193). All short-term studies also found patients who received sulpiride plus clozapine had improved general mental state and less negative symptoms than those who received clozapine alone. However, patients who received sulpiride plus clozapine had more movement disorders (n=70) and an increase in serum prolactin, but less incidence of hypersalivation (n=162), weight gain (n=64), appetite loss and less abdominal distension (n=70). Long-term data showed no difference in significant clinical improvement or relapse between treatments. Despite the findings, the review authors noted that the quality of reporting in most studies was poor, the data was very limited, and all studies were prone to bias that could account for an overestimate of up to 30%. “More robust data are needed… and a large and high quality randomised trial is required to quantify both the benefits and risks of sulpiride plus clozapine for people whose schizophrenia is resistant to treatment,” they said. “Such a trial should measure global outcomes such as healthy days, social functioning, satisfaction with treatment, ability to live and work, and compliance,” they concluded. Full report released in first issue of Cochrane Systematic Reviews 2010...