Efficacy of Clidinium and Chlordiadepoxide as Add-On Therapy in Gastric Disorders

Abstract

The treatment of Gastric disorders is a challenge. Clidinium/chlordiazepoxide is a combination of antispasmodic and anxiolytic drugs that has been used as an adjunct treatment for GERD, Functional Dyspepsia, and Organic dyspepsia in clinical practice with limited supporting evidence of efficacy. The study aims to assess the efficacy and safety of clidinium/chlordiazepoxide as an adjunct treatment to a proton pump inhibitor (PPI) in refractory dyspepsia. Materials and Methods: This prospective, observational, and comparative study was conducted in outpatient and inpatient units of the Gastroenterology Department at a tertiary care hospital. The study was carried out over 6 months, with a sample size of 82 subjects. Results and Discussions:A total of 82 patients were treated with Clidinium/Chlordiazepoxide out of which 42 and 40 were found to be female and male. among 32 patients, the condition after add-on therapy in functional dyspepsia 21(65.6%) improved, and 11(34.4%) remained unchanged. Among 39 patients, the condition after add-on therapy in GERD, 28(71.8%) was improved, 9(23.1%) remained unchanged, and 2(5.1%) was worsened. among 11 patients, the condition after add-on therapy in organic dyspepsia 8(72.7%) improved, and 3(27.3%) remained unchanged. Conclusion:The study revealed promising results for Functional Dyspepsia and Organic Dyspepsia, with a significant proportion of patients experiencing improvement. However, the outcomes for GERD were more varied, with a notable portion of patients showing no change or even worsening symptoms.

Introduction

A. Overview of Gastric Disorders

• GERD (Gastroesophageal Reflux Disorder): Caused by stomach acid flowing back into the esophagus due to factors like weak esophageal sphincter, hiatal hernia, obesity, smoking, and poor gastric motility.

• Dyspepsia:

  • Organic: Linked to underlying issues like ulcers or H. pylori.

  • Functional: No clear medical cause; associated with food sensitivity or delayed gastric emptying.

• Common Symptoms: Heartburn, bloating, nausea, abdominal pain.

B. Proton-Pump Inhibitors (PPIs)

• PPIs reduce stomach acid and are effective for GERD, ulcers, and H. pylori infections.

• Side Effects: Can include bone fractures, kidney issues, and infections.

• Limitations: Sometimes insufficient alone in treating symptoms.

C. Clidinium/Chlordiazepoxide Combination

• Brand Names: Librax, Spasrax, Gutrex, etc.

• Function: Used as an add-on therapy when PPIs are inadequate.

• Dosage: Clidinium (2.5 mg) + Chlordiazepoxide (5 mg)

• Benefits: Reduces gut movement, relaxes GI muscles, and reduces acid secretion.

• Risks: Overdose can be fatal; may cause drowsiness, confusion, allergic reactions, liver issues, and CNS effects.

• Contraindications: Liver impairment, porphyria, substance abuse.

II. Study Design

• Type: Prospective, observational, comparative study over 6 months with 4-week follow-up.

• Participants: 82 adults (both diabetic and non-diabetic), on clidinium/chlordiazepoxide as add-on therapy.

• Exclusions: Pregnant/lactating women, those not on the therapy, and non-consenting individuals.

III. Statistical Analysis

• Tools: Pearson Chi-square test, descriptive statistics, component bar diagram.

• Significance Level: p < 0.05

IV. Results

1. Demographics

• Age Range:

  • <30 years: 20.7%

  • 30–40 years: 22%

  • 41–50 years: 19.5%

  • 50 years: 37.8%

  • Mean Age: 43.52 years

• Gender: 51.2% male, 48.8% female

2. Effectiveness of Add-On Therapy

• Overall Outcome:

  • Improved: 69.5%

  • Unchanged: 28%

  • Worsened: 2.4%

3. By Gender

• Females showed slightly better improvement (73.8%) than males (65%)

• No significant difference (p = 0.296)

4. By Age

• Highest improvement in <30 group (88.2%)

• Least improvement in 30–40 age group (61.1%)

• No significant difference based on age

5. By Diagnosis

• GERD: 71.8% improved

• Functional dyspepsia: 65.6% improved

• Organic dyspepsia: 72.7% improved

• No significant difference in outcomes based on diagnosis (p > 0.05)

Conclusion

The study evaluated the efficacy and safety of clidinium/chlordiazepoxide as an adjunctive therapy for dyspepsia in 82 patients who did not respond well to PPIs. The results indicated that the drug was moderately effective, with 69.5% of patients experiencing improvement in their condition. However, 28% remained unchanged and 2.4% worsened. The study also analyzed the outcomes for different types of dyspepsia. Functional dyspepsia and organic dyspepsia showed improvement in 65.6% and 72.7% of patients, respectively. GERD, on the other hand, had a more varied response, with 71.8% improving, 23.1% remaining unchanged, and 5.1% worsening. While these findings suggest the potential benefit of clidinium/chlordiazepoxide as an adjunctive therapy, further research is necessary to better understand the underlying mechanisms of dyspepsia and develop more targeted treatments. This combination is used as an add-on therapy in different gastric disorders which significantly improves symptoms and quality of life.

References

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Copyright

Copyright © 2025 Dr. Nitesh Pratap, Ms. P. Twila Pushpa, D. Razak, E. Sahithi Reddy, G. Sathvika. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.