A comparative study: The efficacy of liquid paraffin and lactulose in management of chronic functional constipation

Abstract Objectives : To determine and compare efficacy, safety and optimal dose of two laxatives, liquid paraffin and lactulose, in 40 children with chronic functional constipation.
Methods : A total of 20 children were treated with liquid paraffin and 20 with lactulose for 8 weeks and at an initial dose of 1 mL/kg per day for both drugs. The dose was adjusted every 3 days as required and a diary was kept to monitor dose, side-effects, stool frequency and consistency, and other symptoms.
Results : During first 4 weeks, improvement in stool consistency and frequency was significantly higher in liquid the paraffin group ( P <  0.01 and P  < 0.05, respectively). Improvement in the number of stools per week was also significantly higher in the liquid paraffin group during the last 4 weeks of therapy ( P <  0.05).
Compliance rates averaged 95% in the liquid paraffin group and 90% in the lactulose group during the first 4 weeks of therapy and 90% in the liquid paraffin group and 60% in the lactulose group during the last 4 weeks of therapy (χ² = 4.8, SD = 1, P  = 0.02). During the first 4 weeks of therapy and during the last 4 weeks of therapy, mostly side-effects and poor symptom control, respectively, influenced the compliance in the liquid paraffin group.
Conclusions : Liquid paraffin is more effective in the treatment of children with constipation. Patients treated with liquid paraffin responded more rapidly than patients responding to lactulose and showed fewer side-effect. It is considered that late response and side-effects in conjunction with poor symptom control influence the patient compliance and the successful treatment of childhood constipation.