Effects of Low-Dose Amitriptyline on Epigastric Pain Syndrome in Functional Dyspepsia Patients

Abstract

Aim To observe the therapeutic effect of low-dose amitriptyline (AMT) on epigastric pain syndrome (EPS) in patients with functional dyspepsia. Methods Sixty patients with EPS were randomly divided into the following two groups for a four-week clinical trial: routine treatment with pantoprazole (RT group) and the AMT group. The RT group was treated with 40 mg of pantoprazole once daily. The AMT group received 25 mg of AMT once daily before bedtime. The Nepean Dyspepsia Index (NDI) checklist, Hamilton Rating Scale of Anxiety/Depression (HAMA/HAMD), and Pittsburgh Sleep Quality Index (PSQI) were employed to evaluate dyspepsia symptoms, psychological distress, and sleep, respectively. Results All items were similar between the two groups before treatment (0 week). After 4 weeks of treatment, the NDIsymptom checklist score as well as the severity and bothersomeness of EPS in the AMT group was significantly decreased compared with those in the RT group (p < 0.05). However, no differences were found in the frequency of NDI checklist, psychological status (HAMD/HAMA scores) of EPS, or sleep quality (PSQI score) between the two groups after treatment. In addition, the time to fall asleep was shorter in the AMT group compared with the RT group after 4 weeks of treatment (p < 0.05). Conclusion Low-dose AMT effectively improved the dyspepsia symptoms and the time to fall asleep in the EPS patients, compared with pantoprazole, although it did not reduce the psychological distress. Therefore, AMT could be considered as a good candidate for EPS treatment in the clinic.

Systematic review and network meta‐analysis: efficacy of drugs for functional dyspepsia

“…The search strategy generated 11 425 citations, 83 of which we retrieved for further assessment as they appeared to be relevant (Figure S2). Of these, 67 articles were eligible for inclusion, 31‐97 which reported on 71 separate RCTs comprising 19 243 participants. Of these, 12 535 received a drug for FD and 6708 a placebo, allocated as described in Table S2.…”

“…Detailed characteristics of individual RCTs, including the comparisons made, are provided in Table S4. Eleven RCTs compared H 2 RAs with placebo, 31‐41 six trials, reported in five articles, compared acotiamide with placebo, 42‐46 five RCTs, reported in four articles, compared itopride with placebo, 47‐49,94 six trials compared itopride with domperidone, 50‐55 four RCTs, reported in three articles, compared standard‐dose and low‐dose PPIs both with each other and with placebo, 56‐58 four trials compared high‐dose PPIs with placebo, 59‐62 three RCTs compared standard‐dose PPIs with placebo, 63‐65 three trials compared low‐dose PPIs with placebo, 66‐68 three RCTs compared TCAs with placebo, 69,70,96 three trials compared 5‐HT 1A ‐receptor agonists with placebo, 71‐73 three RCTs compared antipsychotic drugs with placebo, 74‐76 two trials, reported in one article, compared tegaserod with placebo, 77 two RCTs compared H 2 RAs and 5‐HT 1A ‐receptor agonists both with each other and with mosapride, 78,79 one trial compared SSRIs with placebo, 80 one RCT compared SNRIs with placebo, 81 one trial compared TCAs and SSRIs both with each other and with placebo, 82 one RCT compared mirtazapine with placebo, 83 one trial compared mosapride with placebo, 84 one trial compared high‐dose, standard‐dose and low‐dose PPIs with each other and with placebo, 85 one RCT compared standard‐dose and low‐dose PPIs, and H 2 RAs with each other and with placebo, 86 one trial compared standard‐dose PPIs with H 2 RAs, 87 one RCT compared TCAs with high‐dose PPIs, 97 one RCT compared high‐dose PPIs with mosapride, 88 one trial compared standard‐dose PPIs with mosapride, 89 one RCT compared low‐dose PPIs with itopride, 90 one trial compared H 2 RAs with mosapride, 91 one RCT compared itopride with mosapride, 92 one trial compared mosapride with domperidone 93 and...…”

“…There were 42 RCTs, reported in 41 separate articles, 31,32,34,36,37,39,43,46,47,51,54,55,57‐61,65,69‐77,79‐84,86,88,90‐93,96,97 reporting adverse events leading to withdrawal. The network plot is provided in Figure S5.…”

Functional dyspepsia symptom diary is correlated with other questionnaires and associated with severity in patients with functional dyspepsia: a multicenter, prospective observational study

“…Several patient‐reported outcome (PRO) questionnaires have been established to evaluate the severity of FD, including Dyspepsia Symptom Severity Index (DSSI), Gastrointestinal Symptom Rating Scale (GSRS), and Short‐Form Nepean Dyspepsia Index (SF‐NDI) 7–10 . Furthermore, Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) are also commonly used for evaluating the psychological status of FD patients 11 . However, none of the existing questionnaires can be considered sufficient as the primary outcome measure for FD trials according to the Rome criteria 5 …”

“…[7][8][9][10] Furthermore, Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD) are also commonly used for evaluating the psychological status of FD patients. 11 However, none of the existing questionnaires can be considered sufficient as the primary outcome measure for FD trials according to the Rome criteria. 5 Functional dyspepsia symptom diary (FDSD) is a newly symptom-focused PRO measure raised by the Patient-Reported Outcome Consortium's Functional Dyspepsia Working Group.…”