ABSTRACT
Background:Spasmolytics and NSAIDs are a therapy of choice in colic pain. However, the tolerability and effectiveness of this combination remains unexplored. The aim of this prospective, single-arm, open label, multicenter study was to evaluate the safety and effectiveness of Anafortan-N�(fixed-dose combination of camylofin dihydrochloride 50 mg + nimesulide 100 mg) in patients with acute colicky abdominal pain.Methods: In all, 295 patients with acute colicky abdominal pain and at least one episode of colicky pain in the last 24 hours were enrolled in this study. None of the patients were hospitalized. All patients were advised Anafortan-N畉ablets twice daily orally for 5 days. The safety of Anafortan-N畐as assessed by number and percentage of patients with adverse events (AEs) and change in the severity and frequency of AEs by the end of treatment. The tolerability was determined by number and percentage of patients who hadto discontinue the treatment due to AEs. The effectiveness was evaluated as percentage change in the mean intensity of pain score (based on a 100-mm visual analog scale) from baseline to end of treatment.Results: Overall, 14 (4.7%) patients reported 14 AEs, all of which were treatment-emergent and non-serious. Of the 14 AEs, 7 AEs were mild, 6 AEs were moderate, and 1 AE was severe. No serious adverse events (SAEs) were reported. No adjustment of the study medication was required in response to any of the AEs, and none of the AEs led to discontinuation of the study treatment. At end of treatment(EOT), the pain intensity significantly (p<0.0001) reduced to 1.7�49 with a mean change of -69.9�.42 from baseline, and the daily pain intensity significantly (p<0.0001) reduced to 0.1�38 with a mean change of -3.5�77 from baseline.Conclusions: Among Indian patients presenting with acute abdominal colicky pain, twice daily treatment with a FDC of camylofin dihydrochloride 50 mg and nimesulide 100 mg (Anafortan-N�) showed significant reduction in pain intensity with very few side effects, thereby confirming its safety, tolerability, and effectiveness in acute colicky abdominal pain.
ABSTRACT
Background:Conventional haemorrhoidectomy is still considered as gold standard therapy for grade III &IV haemorrhoids. The conventional haemorrhoidectomy can be made easier with the help of harmonic scalpel with associated less post-operative complications.This study evaluated in a randomized prospective manner the differences in; duration of hospital stay, postoperative complications, symptomatic recurrence and cost effectiveness between conventional and harmonic scalpel assisted haemorrhoidectomy. Methods: The prospective study was carried out in 60 patients of symptomatic grade III & IV haemorrhoids, presented during August 2015 to August 2017. Each group of 30 patients treated with harmonic scalpel assisted haemorrhoidectomy and conventional haemorrhoidectomy; followed up for 6 months for complications. Results: In present study, the severity of pain was significantly more following conventional haemorrhoidectomy than harmonic scalpel assisted haemorrhoidectomy. Urinary retention was more common with conventional haemorrhoidectomy. Anal incontinence had similar incidence in both the groups of haemorrhoidectomy. Two patients had anal stenosis after conventional haemorrhoidectomy as compared to none in the harmonic scalpel group. No recurrence noted in both the groups. Cost effectiveness of the procedure is measured in form of hospital stay and return to daily activity and harmonic scalpel group have advantage over the conventional haemorrhoidectomy group in terms of less hospital stay and early return to daily activity. Conclusion: Harmonic scalpel assisted haemorrhoidectomy appears to be a better procedure compared with conventional haemorrhoidectomy in terms of less post-operative complications and decreased hospital stay in symptomatic patients with grade III & IV haemorrhoids.