Research Article
Comparison of safety and effectiveness of ondansetron and domperidone in patients with gastrointestinal problems N. Vetrivel1, D. Praveen2, P. Ranadheer Chowdary2, K. Elan Cheziyan3, M. Vijey Aanandhi3* ABSTRACT Objective: The objective of this study was to compare the safety and effectiveness of ondansetron and domperidone in patients with gastrointestinal (GI) problems. Materials and Methods: A prospective observational comparative study design was used with the help of data entry forms and regular ward round participation. The numeric scoring system was used to evaluate the efficacy assessment of ondansetron and domperidone in time interval 0–24 h. Results: The study was conducted in 100 patients. 50 patients were treated with ondansetron. 50 patients were treated with domperidone. 20% was suffering from peptic ulcer. 20% was suffering from GERD. 20% was suffering from duodenal ulcer. 30% was suffering from nonsteroidal anti-inflammatory drugs-induced ulcer. 10% was suffering from other GI problems. Conclusion: In the management of GI disturbance patients, ondansetron was found to be more effective than domperidone, and hence, it is considered better than domperidone as ondansetron shows better efficacy than domperidone. KEY WORDS: Domperidone, Gastrointestinal disturbances, Nonsteroidal anti-inflammatory drugs, Ondansetron, Ulcer
INTRODUCTION An antiemetic is a drug that is effective against vomiting and nausea. Antiemetics are typically used to treat motion sickness and the side effects of opioid analgesics, general anesthetics, and chemotherapy directed against cancer.[1] They may be used for severe cases of gastroenteritis, especially if the patient is dehydrated.[2] Antiemetics, though previously thought to cause birth defects, have been proven safe for use by pregnant women in the treatment of morning sickness and the more serious hyperemesis gravidarum.[3] Ondansetron, marketed under the brand name Zofran, is a medication used to prevent nausea and vomiting caused by cancer chemotherapy, radiation therapy, or surgery. It is also useful in gastroenteritis. It has little effect on vomiting caused by motion sickness.[4] It can be given by mouth or by injection into a muscle or into a vein.[5] Access this article online Website: jprsolutions.info
ISSN: 0975-7619
Common side effects include diarrhea, constipation, headache, sleepiness, and itchiness. Serious side effects include QT prolongation and severe allergic reaction. It appears to be safe during pregnancy but has not been well studied in this group. It is a serotonin 5-HT3 receptor antagonist. It does not have any effect on dopamine receptors or muscarinic receptors.[6-8] Ondansetron was first used medically in 1990. It is on the World Health Organization’s List of Essential Medicines, the most effective and safe medicines needed in a health system. It is available as a generic medication. The wholesale cost of the injectable form in the developing world is about 0.10–0.76 USD per dose. In the United States, it costs about 1.37 USD per tablet.[9] Domperidone, sold under the brand name Motilium among others, is a peripherally selective dopamine D2 receptor antagonist that was developed by Janssen Pharmaceutica and is used as an antiemetic, gastroprokinetic agent, and galactagogue. It may be administered orally or rectally and is available in the form of tablets, orally disintegrating tablets (based on Zydis technology), suspension, and suppositories. The drug is used to relieve nausea and vomiting, to increase
Department of Pharmacy Practice, School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies, Chennai, Tamil Nadu, India, 2School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies, Chennai, Tamil Nadu, India, 3Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies, Chennai, Tamil Nadu, India 1
*Corresponding author: Dr. M. Vijey Aanandhi, Department of Pharmaceutical Chemistry and Analysis, School of Pharmaceutical Sciences, Vels Institute of Science, Technology & Advanced Studies, Chennai, Tamil Nadu, India. E-mail:
[email protected] Received on: 15-10-2017; Revised on: 19-11-2017; Accepted on: 04-02-2018 Drug Invention Today | Vol 10 • Issue 3 • 2018
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the transit of food through the stomach (by increasing gastrointestinal [GI] peristalsis), and to promote lactation (breast milk production) by the release of prolactin.[10]
EMESIS AND ANTIEMESIS Vomiting occurs due to stimulation of the emetic (vomiting) center situated in the medulla oblongata.[11,12] Nausea is accompanied by reduced gastric tone and peristalsis. In the emetic response fundus and body of the stomach, esophageal sphincter and esophagus will relax, while duodenum and pyloric stomach contract in a retrograde manner. Rhythmic contractions of the diaphragm and abdominal muscles then compress the stomach and evacuate its contents through the mouth. Conditions that inhibit gastric emptying predispose to vomiting.[9]
MATERIALS AND METHODS Study Site The study entitled “comparison of safety and effectiveness of ondansetron and domperidone in patients with GI disturbances” was carried out in a tertiary care hospital located in Chennai. The hospital is unique and well known for its service to people who come from various areas of the state. The institution excels in diverse specialties such as general medicine, general surgery, obstetrics, gynecology, pediatrics, neonatology, orthopedics, psychiatry, geriatrics, cardiology, gastroenterology, ENT, ophthalmology, oncology, and dentistry. The hospital has well staff pharmacy and drug information center. Study Design This was a prospective observational comparative study. Study Duration The entire study was planned to be carried out for 6 months from November 2016 to April 2017. Study Criteria Inclusion criteria
The following criteria were included in the study: • Patients of either gender. • Patients of age above 18. • Patients willing to give informed consent. • Patients with GI disturbances. Exclusion criteria
The following criteria were excluded from the study: • Patients below 18 years of age. • Previous diagnosis of psychotic disorder. • Patients with severe illness and infection with HIV. • Pregnant and lactating women.
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Study Design Data entry form
A separate data entry form for incorporating patient details was also designed. The format contains name, date of admission, date of discharge diagnosis, name of unit, drug chart, length of stay, and sensitivity test. Ward round participation
A regular ward round into the study department was carried out. The medical charts of the patients were screened for appropriateness in all possible ways. Patient demographics such as age, weight, date of admission, length of stay, and medical histories including drug allergies were entered into the specially designed data entry form. Numeric scoring system
The numeric scoring system used to evaluate the efficacy assessment of ondansetron and domperidone in time interval 0–24 h. • • • •
0: No Nausea and vomiting 1: Nausea alone 2: Vomiting once 3: Vomiting two or more.
Data analysis
The obtained data were analyzed and were categorized based on the parameter. Patient medical history was also categorized.
RESULTS Efficacy assessment of ondansetron versus domperidone in patients with peptic ulcer is shown in Figures 1-5. • • • •
0: No nausea and/or vomiting 1: Nausea alone 2: Vomiting once 3: Vomiting two or more
DISCUSSION This study was designed to assess the comparison of safety and effectiveness of ondansetron and domperidone in patients with GI disturbances. The study was conducted in 100 patients. 50 patients were treated with ondansetron. 50 patients were treated with domperidone. 20% was suffering from peptic ulcer. 20% was suffering from GERD. 20% was suffering from duodenal ulcer. 30% was suffering from nonsteroidal anti-inflammatory drugs-induced ulcer. 10% was suffering from other GI problems. Treatment was given with ondansetron and domperidone. Scores were given using the numeric scoring system. Scores were given to access episodes of nausea and vomiting. The results of our study revealed Drug Invention Today | Vol 10 • Issue 3 • 2018
N. Vetrivel, et al.
Figure 1: Nausea and vomiting in two groups patients with peptic ulcer in 0–24 h time interval
Figure 2: Nausea and vomiting in two group patients with duodenal ulcer in 0–24 h time interval
Figure 4: Nausea and vomiting in two groups of patients with gastroesophageal reflux disease in time interval 0–24 h
Figure 5: Nausea and vomiting in patients with other GI disturbances in time interval 0–24 h
this study, ondansetron is found to be more potent when compared to domperidone.
ACKNOWLEDGMENT The authors are thankful to VISTAS and its management for providing research facilities and encouragement.
REFERENCES Figure 3: Nausea and vomiting in two groups patients with nonsteroidal anti-inflammatory drugs induced ulcer in time interval 0–24 h
that in the management of GI disturbance patients ondansetron was more effective than domperidone, which is considered better than domperidone. They ondansetron shows better efficacy than domperidone.
CONCLUSION The study was performed to compare safety and effectiveness of ondansetron and domperidone in patients with GI disturbances. The study revealed that in the management of nausea and vomiting in patients with GI disturbances. Ondansetron was effective than domperidone which shows better results than domperidone. Scores improved well with ondansetron and domperidone. Hence, according to
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Source of support: Nil; Conflict of interest: None Declared
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