Quality of Life (QOL) Changes At 2 Weeks and At the End of Treatment with Topical 0.4% Glyceryl Trinitrate (GTN) in Patients with Chronic Anal Fissure (CAF); Results from a Prospective Randomized Trial Assessing Optimal Treatment Duration.

Background: CAF has a negative impact on QoL but little is known on the effect of nonsurgical treatment on QoL in patients with CAF. There is no data on short term changes in QoL for any CAF treatment. The aim of the study was to assess if fissure healing and absence of pain at defecation following treatment with topical GTN had any effect on QoL in the short term and by the end of treatment. Methods: Within a prospective randomized trial comparing 40 days vs. 80 days treatment with twice daily 0.4% GTN (Rectogesic®, Prostrakan Group), QoL was assessed using the descriptive system and the VAS part of the EQ5D. The descriptive EQ5D is organized into 5 scales (mobility, self care, usual activities, pain/ discomfort and anxiety/depression). Each scale is scored and evaluated independently. In the VAS part the patient answers the question “what is your health status today?” by choosing a point on a visual scale of 1 (worse) to 100 (best). The EQ5D was administered at baseline, after 2 weeks and at the end of treatment. For the descriptive system each scale and VAS score were analyzed with non-parametric repeated measures ANOVA. When comparing groups, changes in each scale and in the mean VAS between beginning and end of treatment were analyzed by Mann Whitney test. Results: Of 188 patients with chronic fissure 96 were randomized to 40 days and 92 to the 80 days treatment. Of 151 patients who completed the assigned treatment 79 (52%) had their fissures healed and 92 (61%) were pain free. There was a significant improvement of mobility, self care, usual activities, pain/discomfort, anxiety/depression and VAS score (p<0.0001). All improvements, except self care, were already significant at 2 weeks. The improvement in usual activity was higher in the 80 days group (p<0.05). Healed fissure at the end of treatment was correlated with greater improvement in self care and usual activities (p<0.05). Absence of pain at defecation at the end of treatment was correlated with a greater improvement in usual activities (p<0.0001), pain/ discomfort (p<0.0001) and anxiety/depression (p=0.001). Conclusion: There is a marked improvement in QoL after treatment with twice daily 0.4% GTN which is already significant after 2 weeks. Of the different EQ5D scales better self care correlated with fissure healing, improvement in usual activities correlated with fissure healing, absence of pain and longer treatment duration, improvement in pain/discomfort and anxiety/depression correlated with absence of pain.