randomized controlled trial of propranolol.pptx

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1. A Randomized Controlled Trial of Propranolol Use During Ligation Program for Secondary Prophylaxis of Esophageal Variceal Bleeding Wen-Chi Chen, Tsung Chieh yang, Pei Chang Lee, Yen po Wang, Ming Chih Hou, Fa Yauh Lee Taken from The American Journal of Gastroenterology Journal Reading

2. Introduction 2

3. GERD 3 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Gastroesophageal reflux disease (GERD) is one of the most and costliest common digestive disorders worldwide. The prevalence is estimated at 8%-33% in all age groups in both males and females Proton pump inhibitors (PPIs) are the most important group of drugs for reducing stomach acid secretion, exert the most significant therapeutic effects against GERD. In nearly 30% of patients with GERD, these drugs cannot improve their condition  failure of PPI treatment Challenge in the control and management of GERD

4. Melatonin is used to improve sleep disorders in many countries Secreted in the pineal gland to control sleep patterns and in the enterochromaffin cells to improve the digestive system motility. 4 In duodenal enterocyte, Melatonin Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Melatonin stimulation of melatonin type 2 (MT2) receptors increase of bicarbonate secretion protection of duodenal epithelium against stomach acids reduces stomach acid secretion Inhibit transient lower esophageal sphincter relaxation Inhibit biosynthetic nitric oxide Reduced GERD symptoms Antioxidant and free radical scavenger Gastroprotective effect

5. Introduction 5 Kandil et al indicated that oral melatonin alone could reduce GERD symptoms (heartburn and epigastric pain) Klupińsk et al melatonin administration improved the symptoms of functional dyspepsia Therefore, the present study aimed to investigate the efficacy, safety, and quality of life (QOL) of patients with GERD, who received sublingual Melatonin Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. In previous studies, the oral tablet form of melatonin was used for the treatment of upper gastrointestinal disorders, with low bioavailability (about 15%) in the gastrointestinal tract. Attempts to increase the bioavailability of melatonin seem rational to improve the management of different diseases.

6. Materials and Methods 6

7. Materials and Methods 7 Double-blind randomized clinical trial Initiated on May 1, 2022 and continued until October 1, 2022 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Inclusion criteria: diagnosis of GERD age above 18 years Having heartburn or regurgitation 2 days or more per week score ≤32 on the Frequency Scale for the Symptoms of GERD (FSSG) Exclusion criteria: history of sensitivity to omeprazole or melatonin patients with peptic ulcer and duodenal ulcer on endoscopy; pregnant or breastfeeding current use of drugs causing transient lower esophageal sphincter relaxation (e.g., CCB and nitrates) patients with Child-Pugh C cirrhosis; severe renal damage (AKIN stage 3); shift workers; using medications with major interactions with omeprazole or melatonin (e.g., fluvoxamine); using alt or traditional medicines concurrently severe symptoms (FSSG score >32).

8. Materials and Methods 8 Kawakubo H, et al. Upper gastrointestinal symptoms are more frequent in female than male young healthy Japanese volunteers as evaluated by questionnaire. Journal of neurogastroenterology and motility. 2016 Apr;22(2):248.

9. 9 Melatonin group Placebo group Omperazol Melatonin 20mg/day PO Before breakfast 3mg/day SL at night + Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Omperazol Placebo 20mg/day PO Before breakfast + Materials and Methods Figure 1. Flow diagram of the study for 4 weeks Evaluation: Heart burn, epigastric pain, FSSG, GERDQ

10. Results 10

11. Statistical Analysis FSSG was used as the main index Statistical analyses indicated no significant differences in terms of sex, BMI, and smoking habit. However, the mean age of the melatonin group was significantly lower than that of the placebo group. 11 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Table 1. Demographic characteristics of the patients in sublingual melatonin and placebo group

12. Statistical Analysis Table 2 outlines the number of patients with epigastric pain and heartburn in each group before and after the study. The number of patients with heartburn and epigastric pain reduced in the melatonin group compared to the placebo group, and statistically significant The scores of FSSG and GERQ questionnaires were determined and compared between the melatonin and placebo groups before and after the study. 12 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Table 2. Baseline and secondary outcomes in sublingual melatonin and placebo group (n=72)

13. The FSSG scores were not significantly different between the 2 groups before treatment after 4 weeks Post-treatment FSSG score reduced in both groups; this reduction was significant in both melatonin and placebo groups compared to the baseline (P = .001 and P = .0001). The FSSG score was lower in the melatonin group compared to the placebo group, and the difference was statistically significant (P = .0001). Melatonin group showed a greater FSSG score reduction compared to the placebo group. Additionally, the GERQ scores of the 2 groups were determined before and after the study, but was not significantly different After 4 weeks, the GERQ score increased more considerably in the melatonin group compared to the placebo group, and the difference was statistically significant (P = .0001). 13 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Statistical Analysis

14. The main ADR was drowsiness in the 2 groups (5 cases in melatonin and 3 cases in placebo group). Also nausea, vomiting, mouth dryness and headache have been reported (less than 3 cases in any side effects) Although the incidence of ADRs was higher in the melatonin group, no significant difference was found between the 2 groups (P = .55). 14 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Statistical Analysis

15. Discussion 15

16. Discussion The efficacy of omeprazole alone was greater than melatonin, and the concurrent use of melatonin and omeprazole was more effective than other groups. Due to the small sample size, further trials are recommended. 16 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Evaluating efficacy of melatonin in treatment of GERD, Efficacy of oral melatonin tablets in the management of GERD symptoms was reported. Low bioavailability of oral melatonin tablets (below 15%) in different studies  this trial used sublingual form. Melatonin level was sig lower in the group of H. pylori plus dyspepsia (P < .001) After 6 months of melatonin, improvement in dyspepsia symptoms was 47% in the placebo group and 84.3% in the treatment group. Kandil et al Bang et al, meta-analysis Chojnacki et al

17. Discussion 17 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. No clinical study has yet investigated the effects of sublingual melatonin on controlling GERD symptoms. Based on FSSG showed that melatonin significantly contributed to the alleviation of GERD symptoms compared to the placebo (P = .001) Nevertheless, in the placebo group, the symptoms diminished significantly compared to the baseline, which is most probably due to treatment with omeprazole.

18. Discussion 18 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Results of current study indicated the greater effect of melatonin plus omeprazole versus omeprazole alone in the management of GERD symptoms, greater improvements in the QOL of patients after 4 weeks. In a review study by Bang et al, the use of melatonin was associated with decreased sleep disorders, which would indirectly reduce the symptoms of GERD. Gurges et al reported that GERD is mostly associated with sleep disorders in patients.  consistent with the results of the present study. Additionally, the current study showed that sublingual melatonin was not associated with serious ADRs and was well-tolerated by the patients; the similar incidence rates of side effects in the 2 groups confirm this finding

19. Limitation 19 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206. Unlike some previous research, assessments in this study only included subjective parameters, while more objective parameters (such as manometry, pH monitoring, and measurement of melatonin concentration) were not examined In this trial, the age was different significantly between the 2 groups Randomization error (variability, imprecision) can be overcome by increasing the sample size. Although a positive effect of sublingual melatonin has been observed in our trial, more sample sizes recommend strongly in future trials. Future studies are highly recommended to address these shortcomings.

20. Conclusion 20

21. Conclusion 21 Malekpour H, et al. Is the Addition of Sublingual Melatonin to Omeprazole Superior to Omeprazole Alone in the Management of GERD Symptoms: A Clinical Trial. The Turkish Journal of Gastroenterology. 2023 Dec;34(12):1206.

22. Thank You 22

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