Low-dose amitriptyline combined with proton pump inhibitor for functional chest pain

Table 1 Baseline characteristics of the intention to treat population

Variables	Group		P value
	A (n = 20)	B (n = 20)
Age (yr)	51.1 ± 8.5	49.7 ± 9.59	0.628
Gender (female)	11 (55)	12 (60)	0.749
Alcohol	3 (15)	4 (20)	0.677
Smoking	4 (20)	9 (45)	0.091
BMI (kg/m2)	21.56 ± 1.74	21.79 ± 2.2	0.716
Region (rural)	9 (52.94)	7 (36.84)	0.332
Symptom index1	5 (25)	5 (25)	-
Acid exposure time	0.52% ± 0.68%	0.44% ± 0.8%	0.719
Baseline BDI	6.9 ± 2.22	7.35 ± 1.93	0.498

Data are expressed as absolute numbers (percentage) or mean ± SD.

¹Symptom index indicated number of patients who has score of symptom index by > 50% on 24-h esophageal pH monitoring. BMI: Body mass index; BDI: Beck Depression Inventory.

Table 2 Global symptom scores by follow-up time

Time	Group A	Group B	P value1
Week 0	5.85 (5.09-6.61)	6.10 (5.34-6.86)	0.642
Week 1	4.90 (4.14-5.66)	5.10 (4.34-5.86)	0.709
Week 2	3.94 (3.08-4.80)	3.90 (3.06-4.74)	0.948
Week 3	3.76 (2.86-4.66)	3.95 (3.10-4.80)	0.755
Week 4	3.82 (2.96-4.68)	3.90 (3.10-4.70)	0.889
Week 5	3.18 (2.38-3.98)	3.80 (3.05-4.55)	0.259
Week 6	3.00 (2.21-3.79)	3.95 (3.21-4.69)	0.084
Week 7	2.89 (2.12-3.65)	4.05 (3.33-4.77)	0.031
Week 8	2.47 (1.68-3.27)	4.37 (3.63-5.11)	0.001

Data are least square means (95%CI). Group A: rabeprazole + amitriptyline group vs Group B: double dose of proton pump inhibitor group.

¹P value < 0.006 is considered statistically significant after adjusting the significance level of 0.05 using Bonferroni correction method for multiple comparisons. The significant difference between two groups was found at week 8 only (P < 0.006).

Table 3 Treatment effect on the health-related quality of life assessed with Short-Form 36

Variables	Group		P value
	A (n = 20)	B (n = 20)
Physical functioning
Baseline	42.01 ± 13.47	32.83 ± 17.06	0.211
End of treatment	37.28 ± 12.76	38.42 ± 7.83	0.753
Role -physical
Baseline	31.51 ± 14.9	29.45 ± 15.51	0.670
End of treatment	37.88 ± 10.16	39.02 ± 12.49	0.768
Role-emotional
Baseline	32.01 ± 12.12	38.39 ± 12.68	0.112
End of treatment	36.99 ± 12.62	30.14 ± 16.95	0.182
Social functioning
Baseline	37.95 ± 14.06	33.82 ± 13.90	0.356
End of treatment	36.41 ± 13.03	30.07 ± 12.83	0.151
Body pain
Baseline	34.94 ± 14.39	30.13 ± 12.09	0.260
End of treatment	52.37 ± 17.00	41.32 ± 12.34	0.031
General health perceptions
Baseline	38.63 ± 11.66	31.82 ± 12.94	0.088
End of treatment	47.95 ± 18.58	31.84 ± 16.84	0.010
Mental health
Baseline	38.82 ± 14.72	39.20 ± 10.67	0.927
End of treatment	44.69 ± 10.79	38.88 ± 10.50	0.111
Energy/vitality
Baseline	38.08 ± 12.50	34.39 ± 12.64	0.360
End of treatment	42.95 ± 15.32	35.14 ± 10.87	0.084

All results are expressed as mean ± SD. Group A received amitriptyline and rabeprazole and group B received double dose of rabeprazole. P values are for the comparison of amitriptyline and rabeprazole vs double dose of rabeprazole at baseline and end of the treatment. Patients who received amitriptyline and rabeprazole treatment had a significantly greater improvement in the domains of body pain and general health perception than those who received a double dose of rabeprazole treatment (P = 0.031 and P = 0.01, respectively). The majority of the other domains of the Short-Form 36 (SF-36) did not reach statistical significance.