Randomised Clinical Trial

Randomised Clinical Trial: The Effects of Pregabalin vs Placebo on Functional Dyspepsia

Isariyaphong Kotikula; Nithi Thinrungroj; Kanokwan Pinyopornpanish; Phuripong Kijdamrongthum; Apinya Leerapun; Taned Chitapanarux; Satawat Thongsawat; Ong-Ard Praisontarangkul

Disclosures

Aliment Pharmacol Ther. 2021;54(8):1026-1032. 

In This Article

Results

Baseline Characteristics

Between April 2020 and February 2021, 192 FD patients were assessed for eligibility and 72 subjects were enrolled and randomised (Figure 1). Thirty-four patients were in the pregabalin group, and 38 patients were in the placebo group. Two patients in the pregabalin group withdrew due to dizziness and one patient withdrew because the patient was diagnosed with ectopic pregnancy. Four patients in the placebo group withdrew due to intolerable epigastric discomfort. Therefore, 31 patients in the pregabalin group and 34 patients in the placebo group completed the 8-weeks of treatment. Over 90 per cent of the participants adhered to the treatment. Baseline characteristics of patients are shown in Table 1. There were no significant differences in the baseline characteristics in terms of gender, concurrent medical illness, types of FD, the short-form Nepean Dyspepsia Index, or 7-point Global Overall Symptom scale between the two groups, except that the median age in the pregabalin group was higher than that in the placebo group (47 vs 34, P = 0.04).

Figure 1.

Consort flow diaphragm of study protocol. ESRD, end-stage renal disease

Self-report Adequate Relief

Base on the ITT analysis, the rate of responders in the pregabalin group was significantly higher than in the placebo group after 4 weeks of treatment (24 [70.6%] vs 16 [42.1%], P = 0.02). Pregabalin treatment was also more effective than placebo at the end of the 8 weeks of the study (24 [70.6%] vs 17 [44.7%], P = 0.03) (Figure 2). Per-protocol analysis did not substantially change in comparison to the ITT analysis. Baseline HADS scores were not associated with differential treatment response (P = 0.79).

Figure 2.

Rate of responders (self-report of adequate relief, %) between groups by intention to treat analysis

Dyspepsia Symptom Score (7-point Global Overall Symptom Scale)

The mean Global Overall Symptom scale between the pregabalin group and placebo group were different by week 4 (21.6 ± 8.8 and 26.3 ± 10.0, P = 0.05) and week 8 (18.2 ± 7.7 and 22.0 ± 9.2, P = 0.08). Additionally, the improvement in Global Overall Symptom scale from baseline was also significantly better in the pregabalin group compared to placebo at week 4 (−11.7 ± 10.6 and −3.7 ± 8.9, P < 0.01) and week 8 (−15.1 ± 12.2 and −8.0 ± 10.2, P = 0.01) (Figure 3). The change in symptom scores for epigastric pain, epigastric burn, and sensation of reflux of gastric acid were significantly different with greater symptom improvement in the pregabalin group (P = 0.01, 0.03 and <0.01, respectively). However, there were no significant differences in the changes in postprandial fullness, early satiety, nausea, and abdominal bloating symptoms score (P = 0.08, 0.22, 0.95 and 0.32, respectively) (Table 2).

Figure 3.

Mean difference in Global Overall Symptom scale between groups

Quality of Life

Baseline short-form Nepean Dyspepsia Index scores for overall quality of life and the five subscales were similar between both arms (Table 3). After treatment, the pregabalin group had a greater decrease in the overall short-form Nepean Dyspepsia Index scores compared to placebo (−9.6 ± 12.6 and −2.9 ± 11.0, P = 0.03), these were in addition to differences in the subcategories scores evaluating interference with daily activities (P = 0.03) and eat/drink (P = 0.05). However, there were no significant differences between the pregabalin and placebo groups in improving tension, knowledge/control, and work/study (P = 0.31, 0.32 and 0.28, respectively).

Safety Profile

There were 20 adverse events reported in the study. Dizziness was the most common side effect reported in 16 of 31 patients (51.6%) in the pregabalin group and 8 of 34 patients (23.5%) in the placebo group (P = 0.02). Other frequent side effects reported including lethargy and dry lips were similar between groups. No serious adverse events were reported during the 8 weeks of study.

processing....