To study the comparative effects of Cisapride and Levosulpiride orally used in patients suffering from non-ulcer dyspepsia

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  2. December 2022
Biswadeep Banerjee

To study the comparative effects of Cisapride and Levosulpiride orally used in patients suffering from non-ulcer dyspepsia

Keywords : Comparative Effects, Cisapride, Levosulpiride, Patients Suffering


Abstract

Aim

To compare efficacy, tolerability and safety profile of Cisapride & Levosulpiride orally used in patients of non-ulcer dyspepsia.

Material & Methods

This study has to conduct on patients with complains of non-ulcer dyspepsia attended Medical outdoor of Gouri Devi Institute of Medical Sciences, Durgapur. The total 60 patients have to include in the study, which have to randomly divide in two groups. Group A (Tiapride) comprising of 30 patients and Group B (Levosulpiride) comprising of 30 patients. Patients have to randomly allocate to receive one tablet of Cisapride hydrochloride, 5mg three times daily before meal and one tablet Levosulpiride of 75mg three times daily before meal. We have to enroll the patients at the interval of two weeks and continue it up to 3 months.

Study period

3 months.

Study design

Prospective and interventional study.

Inclusion criteria-

1. Patients presenting with complaints of non-ulcer dyspepsia like epigastric distention or pain nausea, heartburn.

2. Patients age 18-60 yrs. (male/female).

3. Informed consent.

Exclusion criteria-

  1. Patients with endoscopic evidence of ulcer disease and severe esophagitis.
  2. History of chronic intake of NSAIDS, Anti-coagulants and acid suppressants.
  3. Pregnant and lactating women.
  4. Patients suffering from any systemic disease.
  5. Patients not below than 18 years and above than 65 years. (male/female)

Initial investigations-

  1. Upper GI Endoscopy (one time, at the time or screening).
  2. Complete Hemogram
  3. Blood urea.
  4. Serum creatinine.
  5. Liver function tests
  6. 12 lead ECG.

Study outcome:

Patients’ symptoms were graded on a 4-point scale (0 to 3).

Grading of symptoms

0- No symptoms.

1- Mild symptoms.

2- Moderate symptoms.

3- Severe symptoms.

Symptoms were re-evaluated one and two weeks later. Following treatment, relief of symptom was assessed at the end of 2 weeks on a 5-points scale (1 to 5).

Grading of response (Based on subjective perception)

  1. 1.Marked or complete relief.
  2. 2.Moderate relief.
  3. Slight relief.
  4. No relief.
  5. Worsening of symptoms.

A 12 lead ECG was done on each patient at the screening visit to exclude QT prolongation, and at the end of 2 weeks to detect effects of Itopride and Levosulpiride on QT prolongation. Biochemical investigation like complete hemogram, blood urea, serum creatinine, liver function test, were done at the screening visit and at the end of treatment.

Statistical Analysis: Data derived from this study will be depicted in tabular form, mean ±SD. Score for the symptoms are presented as median (range). Stastical analysis was done using two-tailed paired t-test,Chi-square test.

Scope of the study: Beneficial effects of Itopride hydrochloride and Levosulpiride towards Non-ulcer dyspepsia and comparison of efficacy tolerability and safety profile between Cisapride hydrochloride and Levosulpiride.

Conclusion:

In present study, efficacy of Itopride was comparable to Levosulpiride in relieving the symptoms of non-ulcer dyspepsia. Both the drugs were clinically and biochemically well tolerated. QT prolongation changes were found in two patients but no serious cardiac toxicity was observed with patient receiving Cisapride. Levosulpiride does not show cardiac toxicity and any changes in ECG.

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