Levosulpiride in somatoform disorders: A double-blind, placebo-controlled cross-over study

Area of Science:

• Psychiatry
• Pharmacology

Background:

• Psychopharmacotherapy for somatoform disorders (SDs) lacks robust data due to patient compliance and diagnostic challenges.
• Investigating effective and tolerable treatments for SDs is crucial.

Purpose of the Study:

• To evaluate the efficacy and tolerability of low-dose levosulpiride in treating somatoform disorders.
• To compare levosulpiride's effects against a placebo in a double-blind, cross-over design.

Main Methods:

• Seventy-four patients diagnosed with SDs received either levosulpiride (50 mg b.i.d.) or placebo for 4 weeks in a double-blind, cross-over trial.
• Clinical efficacy was assessed using the Comprehensive International Schedule for Somatoform Disorders-Somatoform Disorders Schedule (CISSD-SDS).
• Side effects were monitored using the Simpson and Angus Extrapyramidal Side Effects Scale (EPSE) and specific checklists.

Main Results:

• Levosulpiride significantly reduced the number of SD symptoms compared to placebo (P=0.007).
• A higher percentage of positive responses occurred during levosulpiride treatment, particularly in the placebo-levosulpiride sequence (80% vs. 44%, P<0.002).
• Extrapyramidal system side effects were more frequent in the levosulpiride group (13.4% vs. 2.8%, P=0.029), but endocrine and anticholinergic effects did not differ.

Conclusions:

• Low-dose levosulpiride demonstrates efficacy in treating somatoform disorders.
• Levosulpiride is generally well-tolerated, with extrapyramidal symptoms being the primary concern.
• Further research may explore optimizing levosulpiride dosage and management of side effects for SDs.