Is Tab lesuride (generic name: not specified, possibly a brand name for a medication like Levosulpiride) 25 mg three times a day (tds) an effective treatment for dyspepsia?

Levosulpiride 25 mg Three Times Daily for Dyspepsia

Levosulpiride 25 mg three times daily is a reasonable treatment option for functional dyspepsia, particularly for patients with dysmotility-like symptoms (postprandial distress syndrome), but it is not recommended as first-line therapy according to current guidelines.

First-Line Treatment Should Be Prioritized

Before considering levosulpiride, the following evidence-based first-line approaches must be implemented:

• All patients with dyspepsia should undergo H. pylori testing (stool antigen or breath test) and receive eradication therapy if positive 1, 2
• Proton pump inhibitors (PPIs) are the recommended first-line pharmacotherapy, especially for epigastric pain syndrome subtype 2
• Regular aerobic exercise should be recommended for all patients with functional dyspepsia 2

The most recent British Society of Gastroenterology guidelines (2022) and American Gastroenterological Association recommendations establish a clear treatment hierarchy that does not include levosulpiride as first-line therapy 1, 2.

Evidence for Levosulpiride

While levosulpiride is not mentioned in major international guidelines, there is research evidence supporting its use:

• Levosulpiride 25 mg three times daily has demonstrated efficacy in multiple randomized controlled trials for functional dyspepsia 3, 4, 5
• A large multicenter trial of 1,298 patients showed levosulpiride was significantly superior to domperidone, metoclopramide, and placebo for overall symptom improvement, particularly for postprandial bloating, epigastric pain, and heartburn 4
• Levosulpiride works through dual mechanisms: D2 dopamine receptor antagonism and 5HT4 serotonin receptor agonism, which accelerates gastric and gallbladder emptying 3
• A 2023 comprehensive review noted that levosulpiride might be beneficial but conclusive evidence is lacking compared to tricyclic antidepressants 6

When Levosulpiride May Be Appropriate

Levosulpiride could be considered in the following clinical scenarios:

• After H. pylori eradication (if positive) and PPI trial have failed to provide adequate symptom relief 1, 2
• For patients with predominant dysmotility-like symptoms (fullness, bloating, early satiety) rather than epigastric pain 1, 5
• As an alternative prokinetic agent in regions where it is available and other prokinetics are contraindicated 3

Second-Line Treatment Hierarchy

According to current guidelines, if first-line therapy fails:

• Tricyclic antidepressants at low doses (e.g., amitriptyline 10 mg once daily) are the recommended second-line therapy, particularly for epigastric pain syndrome 2, 7, 6
• TCAs have the strongest evidence among neuromodulators for functional dyspepsia 6

Safety Considerations

• Levosulpiride has a similar adverse event profile to other D2 dopamine antagonists, including galactorrhea, breast tenderness, and menstrual changes 4
• The frequency of side effects ranges from 12-20% in clinical trials 4
• Avoid combining with medications that prolong the QT interval 2, 7
• Dropout rates due to side effects may be lower than with cisapride 5

Common Pitfalls to Avoid

• Do not use levosulpiride as first-line therapy without first attempting H. pylori eradication (if positive) and PPI therapy 1, 2
• Do not prescribe overly restrictive diets that may lead to malnutrition while managing dyspepsia 1, 2
• Do not routinely perform gastric emptying studies before initiating prokinetic therapy in typical functional dyspepsia 2
• Recognize that cisapride is no longer recommended due to cardiac toxicity 1

Clinical Algorithm

1. Test for H. pylori and eradicate if positive 1, 2
2. If H. pylori negative or symptoms persist after eradication: Trial of PPI therapy 2
3. If PPI fails and dysmotility symptoms predominate: Consider prokinetic agent (levosulpiride 25 mg three times daily could be used here) 1, 3, 5
4. If symptoms persist: Low-dose tricyclic antidepressant 2, 7, 6
5. Refractory cases: Multidisciplinary team management 1, 2