Gastroenterol Res

Gastroenterology Research, ISSN 1918-2805 print, 1918-2813 online, Open Access

Article copyright, the authors; Journal compilation copyright, Gastroenterol Res and Elmer Press Inc

Journal website https://gr.elmerpub.com

Original Article

Volume 19, Number 4, August 2026, pages 190-203

Real-World Patient-Reported Outcomes With Piromal in Gastroesophageal Reflux Symptoms

↓ Figure 1. Change in symptom severity score from baseline to T3 (25 days). ***P < 0.0001; hoarseness **P = 0.0004.

↓ Figure 4. Change in VNRS quality-of-life scores from baseline to T3 (25 days). ***P < 0.0001. VNRS: Verbal Numeric Rating Scale.

↓ Figure 5. Change in symptom severity score at T1 (7 days) and T2 (15 days). *P < 0.05. **P < 0.01. ***P < 0.0001.

↓ Figure 6. Change in symptom frequency score at T1 (7 days) and T2 (15 days). *P < 0.05. **P < 0.01. ***P < 0.0001.

↓ Figure 7. Change in nocturnal symptom scores at T1 (7 days) and T2 (15 days). *P < 0.05. **P < 0.01. ***P < 0.0001.

↓ **Table 1.** Participant Demographics and Clinical Characteristics (N = 155)
Characteristic	N (%)
SD: standard deviation; GERD: gastroesophageal reflux disease; PPIs: proton pump inhibitors.
Gender
Male	69 (44.5%)
Female	86 (55.5%)
Age (years)
Mean (SD)	53.24 (16.69)
Median (minimum–maximum)	55 (19.00–93.00)
Diagnosis of GERD (symptoms)
Typical (gastro-esophageal)	129 (83.2%)
Typical/atypical (gastro-esophageal/laryngo-pharyngeal)	26 (16.8%)
Concomitant use of PPI
No	133 (85.8%)
Yes	22 (14.2%)

↓ Table 1. Participant Demographics and Clinical Characteristics (N = 155)

Characteristic

N (%)

SD: standard deviation; GERD: gastroesophageal reflux disease; PPIs: proton pump inhibitors.

Gender

Male

69 (44.5%)

Female

86 (55.5%)

Age (years)

Mean (SD)

53.24 (16.69)

Median (minimum–maximum)

55 (19.00–93.00)

Diagnosis of GERD (symptoms)

Typical (gastro-esophageal)

129 (83.2%)

Typical/atypical (gastro-esophageal/laryngo-pharyngeal)

26 (16.8%)

Concomitant use of PPI

133 (85.8%)

Yes

22 (14.2%)

↓ **Table 2.** Change in Severity Score of Symptoms From Baseline to T3 (25 Days)
Symptom	Value at baseline (mean ± SD)	Value at T3 (mean ± SD)	Mean difference ± SD	P value
SD: standard deviation.
Pyrosis	3.33 ± 0.72	1.41 ± 0.67	–1.92 ± 0.78	< 0.0001
Acid regurgitation	2.54 ± 0.90	0.24 ± 0.50	–2.30 ± 0.85	< 0.0001
Epigastric pain	2.52 ± 0.88	0.35 ± 0.53	–2.17 ± 0.79	< 0.0001
Sore throat	0.36 ± 0.67	0.17 ± 0.39	–0.19 ± 0.47	< 0.0001
Hoarseness	0.18 ± 0.46	0.07 ± 0.28	–0.11 ± 0.39	0.004
Feeling of a “knot” in the throat	1.37 ± 1.24	0.41 ± 0.61	–0.97 ± 0.98	< 0.0001
Desire to clear the voice	0.17 ± 0.47	0.03 ± 0.21	–0.14 ± 0.45	< 0.0001
Persistent cough that worsens with the supine position	0.43 ± 0.72	0.15 ± 0.40	–0.28 ± 0.56	< 0.0001
Early satiety	2.88 ± 0.75	1.37 ± 0.76	–1.51 ± 0.66	< 0.0001
Feeling of fullness after meals	3.50 ± 0.77	1.32 ± 0.76	–2.19 ± 0.72	< 0.0001
Burning/epigastric pain	2.93 ± 0.83	0.66 ± 0.66	–2.26 ± 0.69	< 0.0001

↓ Table 2. Change in Severity Score of Symptoms From Baseline to T3 (25 Days)

Symptom

Value at baseline (mean ± SD)

Value at T3 (mean ± SD)

Mean difference ± SD

P value

SD: standard deviation.

Pyrosis

3.33 ± 0.72

1.41 ± 0.67

–1.92 ± 0.78

< 0.0001

Acid regurgitation

2.54 ± 0.90

0.24 ± 0.50

–2.30 ± 0.85

< 0.0001

Epigastric pain

2.52 ± 0.88

0.35 ± 0.53

–2.17 ± 0.79

< 0.0001

Sore throat

0.36 ± 0.67

0.17 ± 0.39

–0.19 ± 0.47

< 0.0001

Hoarseness

0.18 ± 0.46

0.07 ± 0.28

–0.11 ± 0.39

0.004

Feeling of a “knot” in the throat

1.37 ± 1.24

0.41 ± 0.61

–0.97 ± 0.98

< 0.0001

Desire to clear the voice

0.17 ± 0.47

0.03 ± 0.21

–0.14 ± 0.45

< 0.0001

Persistent cough that worsens with the supine position

0.43 ± 0.72

0.15 ± 0.40

–0.28 ± 0.56

< 0.0001

Early satiety

2.88 ± 0.75

1.37 ± 0.76

–1.51 ± 0.66

< 0.0001

Feeling of fullness after meals

3.50 ± 0.77

1.32 ± 0.76

–2.19 ± 0.72

< 0.0001

Burning/epigastric pain

2.93 ± 0.83

0.66 ± 0.66

–2.26 ± 0.69

< 0.0001

↓ **Table 3.** Change in Frequency Score of Symptoms From Baseline to T3 (25 Days)
Symptom	Value at baseline (mean ± SD)	Value at T3 (mean ± SD)	Mean difference ± SD	P value
SD: standard deviation.
Pyrosis	3.41 ± 0.72	1.89 ± 0.83	–1.52 ± 0.79	< 0.0001
Acid regurgitation	2.49 ± 0.92	0.27 ± 0.54	–2.22 ± 0.85	< 0.0001
Epigastric pain	2.59 ± 0.86	0.40 ± 0.62	–2.19 ± 0.78	< 0.0001
Sore throat	0.43 ± 0.88	0.18 ± 0.42	–0.25 ± 0.66	< 0.0001
Hoarseness	0.24 ± 0.59	0.06 ± 0.27	–0.17 ± 0.54	< 0.0001
Feeling of a “knot” in the throat	1.45 ± 1.34	0.42 ± 0.64	–1.03 ± 1.10	< 0.0001
Desire to clear the voice	0.20 ± 0.53	0.04 ± 0.22	–0.16 ± 0.55	< 0.0001
Persistent cough that worsens with the supine position	0.48 ± 0.84	0.20 ± 0.50	–0.28 ± 0.60	< 0.0001
Early satiety	2.81 ± 0.77	1.35 ± 0.76	–1.46 ± 0.79	< 0.0001
Feeling of fullness after meals	3.34 ± 0.82	1.33 ± 0.88	–2.01 ± 0.82	< 0.0001
Burning/epigastric pain	2.86 ± 0.89	0.74 ± 0.75	–2.13 ± 0.81	< 0.0001

↓ Table 3. Change in Frequency Score of Symptoms From Baseline to T3 (25 Days)

Symptom

Value at baseline (mean ± SD)

Value at T3 (mean ± SD)

Mean difference ± SD

P value

SD: standard deviation.

Pyrosis

3.41 ± 0.72

1.89 ± 0.83

–1.52 ± 0.79

< 0.0001

Acid regurgitation

2.49 ± 0.92

0.27 ± 0.54

–2.22 ± 0.85

< 0.0001

Epigastric pain

2.59 ± 0.86

0.40 ± 0.62

–2.19 ± 0.78

< 0.0001

Sore throat

0.43 ± 0.88

0.18 ± 0.42

–0.25 ± 0.66

< 0.0001

Hoarseness

0.24 ± 0.59

0.06 ± 0.27

–0.17 ± 0.54

< 0.0001

Feeling of a “knot” in the throat

1.45 ± 1.34

0.42 ± 0.64

–1.03 ± 1.10

< 0.0001

Desire to clear the voice

0.20 ± 0.53

0.04 ± 0.22

–0.16 ± 0.55

< 0.0001

Persistent cough that worsens with the supine position

0.48 ± 0.84

0.20 ± 0.50

–0.28 ± 0.60

< 0.0001

Early satiety

2.81 ± 0.77

1.35 ± 0.76

–1.46 ± 0.79

< 0.0001

Feeling of fullness after meals

3.34 ± 0.82

1.33 ± 0.88

–2.01 ± 0.82

< 0.0001

Burning/epigastric pain

2.86 ± 0.89

0.74 ± 0.75

–2.13 ± 0.81

< 0.0001

↓ **Table 4.** Change in Nocturnal Symptom Scores From Baseline to T3 (25 Days)
Symptom	Value at baseline (mean ± SD)	Value at T3 (mean ± SD)	Mean difference ± SD	P value
SD: standard deviation.
Pyrosis	3.37 ± 0.71	1.36 ± 0.64	–2.01 ± 0.74	< 0.0001
Acid regurgitation	2.13 ± 1.04	0.16 ± 0.89	–1.97 ± 0.89	< 0.0001
Epigastric pain	2.20 ± 0.98	0.19 ± 0.43	–2.01 ± 0.93	< 0.0001
Sore throat	0.32 ± 0.69	0.14 ± 0.43	–0.18 ± 0.53	< 0.0001
Hoarseness	0.22 ± 0.56	0.05 ± 0.21	–0.17 ± 0.50	< 0.0001
Feeling of a “knot” in the throat	1.21 ± 1.24	0.31 ± 0.56	–0.90 ± 0.98	< 0.0001
Desire to clear the voice	0.16 ± 0.45	0.02 ± 0.18	–0.14 ± 0.48	< 0.0001
Persistent cough that worsens with the supine position	0.39 ± 0.70	0.14 ± 0.38	–0.26 ± 0.52	< 0.0001
Early satiety	2.68 ± 0.82	1.10 ± 0.71	–1.59 ± 0.76	< 0.0001
Feeling of fullness after meals	3.17 ± 0.88	1.03 ± 0.74	–2.14 ± 0.85	< 0.0001
Burning/epigastric pain	2.66 ± 0.94	0.58 ± 0.62	–2.08 ± 0.88	< 0.0001

↓ Table 4. Change in Nocturnal Symptom Scores From Baseline to T3 (25 Days)

Symptom

Value at baseline (mean ± SD)

Value at T3 (mean ± SD)

Mean difference ± SD

P value

SD: standard deviation.

Pyrosis

3.37 ± 0.71

1.36 ± 0.64

–2.01 ± 0.74

< 0.0001

Acid regurgitation

2.13 ± 1.04

0.16 ± 0.89

–1.97 ± 0.89

< 0.0001

Epigastric pain

2.20 ± 0.98

0.19 ± 0.43

–2.01 ± 0.93

< 0.0001

Sore throat

0.32 ± 0.69

0.14 ± 0.43

–0.18 ± 0.53

< 0.0001

Hoarseness

0.22 ± 0.56

0.05 ± 0.21

–0.17 ± 0.50

< 0.0001

Feeling of a “knot” in the throat

1.21 ± 1.24

0.31 ± 0.56

–0.90 ± 0.98

< 0.0001

Desire to clear the voice

0.16 ± 0.45

0.02 ± 0.18

–0.14 ± 0.48

< 0.0001

Persistent cough that worsens with the supine position

0.39 ± 0.70

0.14 ± 0.38

–0.26 ± 0.52

< 0.0001

Early satiety

2.68 ± 0.82

1.10 ± 0.71

–1.59 ± 0.76

< 0.0001

Feeling of fullness after meals

3.17 ± 0.88

1.03 ± 0.74

–2.14 ± 0.85

< 0.0001

Burning/epigastric pain

2.66 ± 0.94

0.58 ± 0.62

–2.08 ± 0.88

< 0.0001

↓ **Table 5.** Change in Symptom Severity Score From Baseline to T3 in the MD Only and MD + PPI Groups
Symptom	Variations at T3 vs. baseline (mean ± SD)/MD ± PPI	Variations at T3 vs. baseline (mean ± SD)/MD only	P value
Mean change (T3 vs. baseline) severity scores. *P < 0.05, MD + PPI vs. MD alone (Wilcoxon rank-sum test); exploratory analysis (n = 22 vs. 133). No multiplicity adjustment. MD: medical device; PPI: proton pump inhibitor.
Pyrosis	–2.27 ± 0.63	–1.86 ± 0.79	0.0146*
Acid regurgitation	–2.14 ± 1.04	–2.32 ± 0.82	0.0266
Epigastric pain	–2.23 ± 0.81	–2.16 ± 0.79	0.6459
Sore throat	–0.32 ± 0.57	–0.17 ± 0.45	0.1333
Hoarseness	–0.23 ± 0.43	–0.09 ± 0.38	0.0314*
Feeling of a “knot” in the throat	–1.50 ± 0.91	–0.88 ± 0.97	0.00053*
Desire to clear the voice	–0.27 ± 0.55	–0.12 ± 0.43	0.0974
Persistent cough that worsens with the supine position	–0.50 ± 0.67	0.24 ± 0.54	0.0340*
Early satiety	–1.82 ± 0.66	–1.46 ± 0.65	0.0258*
Feeling of fullness after meals	–2.09 ± 0.81	–2.20 ± 0.70	0.7453
Burning/epigastric pain	–2.18 ± 0.66	–2.28 ± 0.70	0.5759

↓ Table 5. Change in Symptom Severity Score From Baseline to T3 in the MD Only and MD + PPI Groups

Symptom

Variations at T3 vs. baseline (mean ± SD)/MD ± PPI

Variations at T3 vs. baseline (mean ± SD)/MD only

P value

Mean change (T3 vs. baseline) severity scores. *P < 0.05, MD + PPI vs. MD alone (Wilcoxon rank-sum test); exploratory analysis (n = 22 vs. 133). No multiplicity adjustment. MD: medical device; PPI: proton pump inhibitor.

Pyrosis

–2.27 ± 0.63

–1.86 ± 0.79

0.0146*

Acid regurgitation

–2.14 ± 1.04

–2.32 ± 0.82

0.0266

Epigastric pain

–2.23 ± 0.81

–2.16 ± 0.79

0.6459

Sore throat

–0.32 ± 0.57

–0.17 ± 0.45

0.1333

Hoarseness

–0.23 ± 0.43

–0.09 ± 0.38

0.0314*

Feeling of a “knot” in the throat

–1.50 ± 0.91

–0.88 ± 0.97

0.00053*

Desire to clear the voice

–0.27 ± 0.55

–0.12 ± 0.43

0.0974

Persistent cough that worsens with the supine position

–0.50 ± 0.67

0.24 ± 0.54

0.0340*

Early satiety

–1.82 ± 0.66

–1.46 ± 0.65

0.0258*

Feeling of fullness after meals

–2.09 ± 0.81

–2.20 ± 0.70

0.7453

Burning/epigastric pain

–2.18 ± 0.66

–2.28 ± 0.70

0.5759

↓ **Table 6.** Change in Symptom Frequency Score From Baseline to T3 in the MD Only and MD + PPI Groups
Symptom	Variations at T3 vs. baseline (mean ± SD)/MD ± PPI	Variations at T3 vs. baseline (mean ± SD)/MD only	P value
Mean change (T3 vs. baseline) frequency scores. *P < 0.05, MD + PPI vs. MD alone (Wilcoxon rank-sum test); exploratory analysis (n = 22 vs. 133). No multiplicity adjustment. MD: medical device; PPI: proton pump inhibitor.
Pyrosis	–1.82 ± 0.91	–1.47 ± 0.76	0.1431
Acid regurgitation	–2.23 ± 0.92	–2.22 ± 0.85	0.8634
Epigastric pain	–2.23 ± 0.81	–2.18 ± 0.78	0.5846
Sore throat	–0.64 ± 0.85	–0.19 ± 0.60	0.0014*
Hoarseness	–0.32 ± 0.57	–0.15 ± 0.53	0.0804
Feeling of a “knot” in the throat	–1.50 ± 1.01	–0.95 ± 1.10	0.0239*
Desire to clear the voice	–0.14 ± 0.35	–0.17 ± 0.58	0.8624
Persistent cough that worsens with the supine position	–0.55 ± 0.67	–0.23 ± 0.58	0.0085*
Early satiety	–1.73 ± 0.94	–1.41 ± 0.76	0.0695
Feeling of fullness after meals	–1.86 ± 0.71	–2.03 ± 0.83	0.3726
Burning/epigastric pain	–2.23 ± 0.87	–2.11 ± 0.80	0.4760

↓ Table 6. Change in Symptom Frequency Score From Baseline to T3 in the MD Only and MD + PPI Groups

Symptom

Variations at T3 vs. baseline (mean ± SD)/MD ± PPI

Variations at T3 vs. baseline (mean ± SD)/MD only

P value

Mean change (T3 vs. baseline) frequency scores. *P < 0.05, MD + PPI vs. MD alone (Wilcoxon rank-sum test); exploratory analysis (n = 22 vs. 133). No multiplicity adjustment. MD: medical device; PPI: proton pump inhibitor.

Pyrosis

–1.82 ± 0.91

–1.47 ± 0.76

0.1431

Acid regurgitation

–2.23 ± 0.92

–2.22 ± 0.85

0.8634

Epigastric pain

–2.23 ± 0.81

–2.18 ± 0.78

0.5846

Sore throat

–0.64 ± 0.85

–0.19 ± 0.60

0.0014*

Hoarseness

–0.32 ± 0.57

–0.15 ± 0.53

0.0804

Feeling of a “knot” in the throat

–1.50 ± 1.01

–0.95 ± 1.10

0.0239*

Desire to clear the voice

–0.14 ± 0.35

–0.17 ± 0.58

0.8624

Persistent cough that worsens with the supine position

–0.55 ± 0.67

–0.23 ± 0.58

0.0085*

Early satiety

–1.73 ± 0.94

–1.41 ± 0.76

0.0695

Feeling of fullness after meals

–1.86 ± 0.71

–2.03 ± 0.83

0.3726

Burning/epigastric pain

–2.23 ± 0.87

–2.11 ± 0.80

0.4760