Effectiveness and Safety of Oral Emulsion of Liquid Paraffin, Milk of Magnesia, and Sodium Picosulfate in the Management of Constipation Symptoms in Postanorectal Surgical Patients: A Prospective, Single-arm, Multi-center, Open-label Study

A BSTRACT Background: This study aimed to evaluate the effectiveness and safety of oral emulsion containing milk of magnesia, liquid paraffin, and sodium picosulphate in treating constipation in Indian patients postanorectal surgery. Methods: This was a prospective, multicenter, single-arm, open-label, observational study among patients who underwent surgery for anal fissures, anal fistulas, or hemorrhoids, and were diagnosed with constipation for at least 3 days before the day of surgery. Patients were prescribed oral emulsion of liquid paraffin, milk of magnesia, and sodium picosulfate at a dose of 7.5 mL at bedtime, preferably with water, for 15 days. If the response was found unsatisfactory, the dose was increased to 15 mL. Patients were followed up on day 4 (±2 days) and 15 (±1-day). Results: A total of 80 (male: female, 57:23) patients with a mean ([standard deviation SD]) age of 42.9 (10.1) years were enrolled. Hemorrhoids (42.5%) were the most common diagnosis for which anorectal surgery was performed. The mean (SD) Patient Assessment of Constipation (PAC) Symptoms score declined significantly by −11.0 (5.4) ( P < 0.001) at day 4 and by −22.3 (11.5) ( P < 0.001) at day 15, compared to baseline. Similarly, for PAC quality of life mean (SD) Score declined significantly by −31.6 (23.5) ( P < 0.001) at day 15. The mean (SD) of frequency of spontaneous bowel movements/week increased by 0.4 ± 0.7 ( P < 0.001) at day 4 and by 0.6 (0.8) ( P < 0.001) at day 15 compared to the baseline mean (SD) score of 0.8 (0.7). No adverse events were reported during the study period. Conclusion: Oral Emulsion of Liquid Paraffin, Milk of Magnesia, and Sodium Picosulfate is an effective and well-tolerated treatment of symptoms of constipation in postanorectal surgery patients.