Reduction of Postoperative Adhesions after Laparoscopic Surgery for Endometriosis by Using a Novel Anti-Fibrotic Drug Pirfenidone: A Randomized Double Blind Study

Introduction: This study was done to insight the effect of the novel anti-fibrotic drug Pirfenidone in the prevention of postoperative endometriosis induced adhesions. Patients and methods: 210 patients were enrolled and randomly allocated into 2 groups according to sequence of computer-generated block-random numbers. Each group included 105 patients. This prospective randomized double blind controlled study was conducted at Tanta University Hospital between August 2013 and May 2016. In group A (study group) the patients after the initial laparoscopic management received Pirfenidone 200 mg (pirfinex) tablets in a dose of 3 tablets tds i.e. 1800 mg daily for 6 months while in group B (control group) the patients after the initial laparoscopy received placebo starch tablets 3 tablets tds also for 6 months. The patients in both study groups were subjected to 2nd look laparoscopy after 6 months from the initial procedure. The primary outcome measure of the study was the difference in the AFS scoring between the study groups during the second look laparoscopies. Secondary outcome measure was the difference between both groups regarding the rate of pregnancy before the second look. Results: On comparing the American Fertility Society score on 2nd look laparoscopy between both groups a statistically significant lower score was found in the study group A when compared to the control group B (P=0.019). 95% CI for difference: (-8.00; -0.73). The pregnancy rate before the 2nd look laparoscopy was 39.3% in group A and 31% in group B and this difference is statistically non-significant (P=0.215). Conclusion: Although that from the results of this study we can conclude that Pirfenidone (Pirfenix) is an effective drug to be used in reduction of the postoperative endometriosis provoked adhesions, the actual benefit of pirfenidone is very moderate (no difference in pregnancy rates). Pirfenidone provides minor clinical added value. The use of pirfenidone should not be recommended since its use is associated with potential adverse events (side effects). Use of pirfenidone necessitates regular monitoring of tolerability and liver enzymes. The most commonly reported adverse events were gastrointestinal disorders (nausea, dyspepsia and diarrhoea), rash, photosensitivity and fatigue. Pirfenidone is an immunosuppressant. Therefore, its use should be limited to proven indications.