The Potential Therapeutic Effect of Melatonin in Gastro-esophageal Reflux Disease

Tharwat S Kandil; Amany A Mousa; Ahmed A El-Gendy; Amr M Abbas

BMC Gastroenterol. 2010;10:7

Results

Table 1 illustrates that pretreated Patients with GERD showed heartburn, epigastric pain, and significant decrease in LES pressure, residual pressure, relaxation percentage, pH, serum gastrin and mean melatonin level and a significant increase in relaxation duration and basal acid output (BAO) relative to control group.

Table 2 illustrates that treatment with melatonin for 4 and 8 weeks leads to marked improvement of GERD symptoms regarding heartburn and epigastric pain. There was also a significant increase in the tone of the LES in the form of increased LES pressure, a significant increase in the residual pressure, a significant decrease in the relaxation duration, a significant increase in the relaxation percentage, a significant increase in the pH with a significant decrease in BAO, and a significant increase in serum gastrin and mean melatonin levels relative to pretreated patients.

Table 3 illustrates that treatment with omeprazole for 4 and 8 weeks leads to marked improvement of GERD symptoms regarding heartburn and epigastric pain. There was also a non-significant change in the tone of the LES, a non-significant change in the residual pressure, relaxation duration, relaxation percentage, a significant increase in the pH with a significant decrease in BAO, a significant increase in serum gastrin and a non - significant increase in the melatonin level.

Table 4 illustrates that treatment with melatonin and omeprazole for 4 and 8 weeks leads to marked improvement of GERD symptoms regarding heartburn and epigastric pain. A significant increase in the tone of the LES in the form of increased LES pressure also noted. In addition, there is a significant increase in the residual pressure, a significant decrease in the relaxation duration, a significant increase in the relaxation percentage, a significant increase in the pH with a significant decreased in BAO and a significant increase in serum gastrin and melatonin levels.

Table 5 illustrates that treatment with melatonin alone or combined with omeprazole (Group II & IV) leads to a significant increase in the tone of the LES in the form of increased LES pressure. Also, there is a significant increase in the residual pressure, a significant decrease in the relaxation duration, a significant increase in the relaxation percentage compared with patients treated with omeprazole alone (group III), while patients treated with omeprazole alone or combined with melatonin (group III & IV) showed a significant increase in PH and serum gastrin level with a significant decrease in BAO than melatonin alone (group II)

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Table 1. Comparison of control subjects and patients pretreated with melatonin, omeprazole and both (n = 9)
	control	Pretreatment with melatonin	Pretreatment with omeprazole	Pretreatment with melatonin and omeprazole
Symptoms:
1-Heart burn:
Yes	0	7	7	8
Duration(months)		1.3 ± 0.4	1.2 ± 0.3	1.4 ± 0.4
2-Epigastric pain:
Yes	0	6	6	6
Duration(months)		1.4 ± 0.5	1.3 ± 0.4	1.3 ± 0.4
A)LES Study:
1-LES pressure(mmHg)	22.8 ± 1.3	10 ± 1.58^a	10.5 ± 2.86^a	10.3 ± 1.68^a
2-Residual pressure (mmHg)	0.4 ± 0.01	0.012 ± 0.52^a	0.1 ± 0.064^a	0.012 ± 0.44^a
3-Relaxation duration (seconds)	5.0 ± 0.1	6.8 ± 0.12^a	6.5 ± 2.74^a	6.8 ± 0.16^a
4-Relaxation %	100 ± 0.00	86 ± 0.87^a	87.2 ± 0.17^a	85 ± 1.58^a
C) PH (at 5 cm above the LES):	7.8 ± 0.4	2.3 ± 0.36^a	2.1 ± 0.38^a	1.98 ± 0.37^a
D) BAO (mmol/h)	2.6 ± 0.6	24.7 ± 0.5^a	25.1 ± 0.6^a	24.9 ± 0.7^a
E) Serum Gastrin(pg/ml)	41.8 ± 7.1	22.1 ± 4.2^a	21.5 ± 4.6^a	21.9 ± 4.7^a
D) Melatonin level at day time (pg/ml):	36.1 ± 2.3	18.2 ± 5.54^a	18.5 ± 3.75^a	18.3 ± 3.8^a

a: p < 0.05 relative to control

Table 2. Effects of melatonin on patients with GERD group II (n = 9)
	Pretreatment with melatonin	4 weeks Post treatment with melatonin	8 weeks Post treatment with melatonin
Symptoms:
1-Heart burn:
Yes	7	3 (57.1%)	0 (100%)
Duration(months)	1.3 ± 0.4
2-Epigastric pain:
Yes	6	3 (50%)	1 (83%)
Duration(months)	1.4 ± 0.5
B)LES Study:
1-LES pressure(mmHg)	10 ± 1.58	14.5 ± 1.58^a	20.2 ± 1.56 ^ab
2-Residual pressure (mmHg)	0.012 ± 0.52	0.2 ± 0.016	0.32 ± 0.013^a
3-Relaxation duration (seconds)	6.8 ± 0.12	5.9 ± 0.16 ^a	5.3 ± 0.12 ^a
4-Relaxation %	86 ± 0.87	90 ± 0.86 ^a	100 ± 0.00 ^ab
C) PH (at 5 cm above the LES):	2.3 ± 0.36	5.2 ± 0.5 ^a	6.7 ± 0.65 ^ab
D) BAO (mmol/h)	24.7 ± 0.5	20.1 ± 0.4 ^a	16.6 ± 0.6 ^ab
E) Serum Gastrin(pg/ml)	22.1 ± 3.2	27.2 ± 2.3 ^a	32.3 ± 2.1 ^ab
D) Melatonin level at day time (pg/ml):	18.2 ± 5.54	28.26 ± 2.26 ^a	34.5 ± 2.35 ^ab

a: p < 0.05 relative to pretreatment with melatonin
b: p < 0.05 relative to 4 weeks post treatment with melatonin

Table 3. Effects of omeprazole on patients with GERD Group III (n = 9)
	Pretreatment with omeprazole	4 weeks Post treatment with omeprazole	8 weeks Post treatment with omeprazole
A) Symptoms:
1-Heart burn:
Yes	7	2 (71.4%)	0 (100%)
Duration(months)	1.2 ± 0.3
2-Epigastric pain:
Yes	6	2	0
Duration(months)	1.3 ± 0.4	(66.7%)	(100%)
B)LES Study:
1-LES pressure(mmHg)	10.5 ± 2.86	10.4 ± 4.05	10.5 ± 2.85
2-Residual pressure (mmHg)	0.1 ± 0.064	0.2 ± 0.15	0.1 ± 0.07
3-Relaxation duration (seconds)	6.5 ± 2.74	6.3 ± 2.7	6.3 ± 2.65
4-Relaxation %	87.2 ± 0.17	87.3 ± 0.25	87.1 ± 0.1
C) PH (at 5 cm above the LES):	2.1 ± 0.38	5.9 ± 0.48^a	7.2 ± 0.32^ab
D) BAO (mmol/h)	25.1 ± 0.6	17.2 ± 0.7^a	11.5 ± 0.6^ab
E) Serum Gastrin (pg/ml)	21.5 ± 4.6	32.1 ± 2.1^a	35.9 ± 1.8^ab
D) Melatonin level at day time (pg/ml):	18.5 ± 3.75	19.2 ± 3.47	17.9 ± 3.72

a: p < 0.05 relative to pretreatment with melatonin
b: p < 0.05 relative to 4 weeks Post treatment with melatonin

Table 4. Effects of melatonin and omeprazole on patients with GERD group IV (n = 9)
	Pretreatment with melatonin and omeprazole	4 weeks Post treatment with melatonin and omeprazole	Post 8 weeks treatment with melatonin and omeprazole
A) Symptoms:
1-Heart burn:
Yes	8	1(87.5%)	0 (100%)
Duration(months)	1.4 ± 0.4
2-Epigastric pain:
Yes	6	1(83.3%)	0 (100%)
ration(months)	1.3 ± 0.4
B) LES Study:
1-LES pressure(mmHg)	10.3 ± 1.68	14.5 ± 1.26^a	20.5 ± 1.22^ab
2-Residual pressure (mmHg)	0.012 ± 0.44	0.21 ± 0.016	0.33 ± 0.016^a
3-Relaxation duration (seconds)	6.8 ± 0.16	5.8 ± 0.13^a	5.2 ± 0.12^a
4-Relaxation %	85 ± 1.58	90 ± 1.23^a	100 ± 0.00^ab
C) PH (at 5 cm above the LES):	1.98 ± 0.37	6.1 ± 0.55^a	7.5 ± 0.31^ab
D) BAO (mmol/h)	24.9 ± 0.7	15.8 ± 0.9^a	10.2 ± 0.9^ab
E) Serum Gastrin (pg/ml)	21.9 ± 4.7	33.6 ± 2.7^a	36.8 ± 2.1^ab
D) Melatonin level at day time (pg/ml):	18.3 ± 3.8	28.83 ± 1.82^a	34.5 ± 2.35^ab

a: p < 0.05 relative to pretreatment with melatonin
b: p < 0.05 relative to 4 weeks Post treatment with melatonin

Table 5. Comparison of the three treated groups with GERD
	Melatonin	Omeprazole	Melatonin and Omeprazole	P value
	Melatonin	Omeprazole	Melatonin and Omeprazole	P1	P2	P3
A)Symptoms:
Heart burn:
control	0	0	0
pretreatment:
yes	7	7	8
duration (months)	1.3 ± 0.4	1.2 ± 0.3	1.4 ± 0.4
4 weeks
8 weeks	3(57.1%)	2(71.4%)	1(87.5%)
	0(100%)	0(100%)	0(100%)
Epigastric pain:
-control	0	0	0
pretreatment:
yes	6	6	6
duration (months)	1.4 ± 0.5	1.3 ± 0.4	1.3 ± 0.4
4 weeks	3(50%)	2(66.7%)	1(83.3%)
8 weeks	1(83%)	0(100%)	0(100%)
B) LES Study:				P1	P2	P3
1-LES pressure(mmHg)
control	22.8 ± 1.3	22.8 ± 1.3	22.8 ± 1.3	0.9	0.9	0.9
pretreatment:	10 ± 1.58	10.5 ± 2.86	10.3 ± 1.68	0.65	0.7	0.86
4 weeks	14.5 ± 1.58	10.4 ± 4.05	14.5 ± 1.26	0.006	0.468	0.002
8 weeks	20.2 ± 1.56	10.5 ± 2.85	20.5 ± 1.22	0.000	0.68	0.000
2-Residual pressure (mmHg)				P1	P2	P3
- control	0.4 ± 0.01	0.4 ± 0.01	0.4 ± 0.01	1.0	1.0	1.0
pretreatment:	0.012 ± 0.52	0.1 ± 0.064	0.012 ± 0.44	0.578	1.00	0.556
4 weeks	0.2 ± 0.016	0.2 ± 0.15	0.21 ± 0.016	1.00	0.198	0.198
8 weeks	0.32 ± 0.013	0.1 ± 0.07	0.33 ± 0.016	0.000	0.08	0.000
3-Relaxation duration (seconds)				P1	P2	P3
control	5.0 ± 0.1	5.0 ± 0.1	5.0 ± 0.1	1.0	1.0	1.0
pretreatment::	6.8 ± 0.12	6.5 ± 2.74	6.8 ± 0.16	0.747	1.000	0.747
4 weeks	5.9 ± 0.16	6.3 ± 2.7	5.8 ± 0.13	0.662	0.153	0.585
8 weeks	5.3 ± 0.12	6.3 ± 2.65	5.2 ± 0.12	0.747	0.102	0.059
4-Relaxation %				P1	P2	P3
control	100 ± 0.00	100 ± 0.00	100 ± 0.00	1.0	1.0	1.0
pretreatment:	86 ± 0.87	87.2 ± 0.17	85 ± 1.58	0.12	0.116	0.14
4 weeks	90 ± 0.86	87.3 ± 0.25	90 ± 1.23	0.1	1.000	0.1
8 weeks	100 ± 0.00	87.1 ± 0.1	100 ± 0.00	0.01	1.00	0.01
C) PH (at 5 cm above the LES):				P1	P2	P3
control:	7.8 ± 0.4	7.8 ± 0.4	7.8 ± 0.4	1.0	1.0	1.0
pretreatment:	2.3 ± 0.36	2.1 ± 0.38	1.98 ± 0.37	0.1	0.1	0.1
4 weeks	5.2 ± 0.5	5.9 ± 0.48	6.1 ± 0.55	0.008	0.002	0.09
8 weeks	6.7 ± 0.65	7.2 ± 0.32	7.5 ± 0.31	0.01	0.008	0.1
D) BAO(mmol/h)				P1	P2	P3
- control:	2.6 ± 0.6	2.6 ± 0.6	2.6 ± 0.6	1.0	1.0	1.0
pretreatment:	24.7 ± 0.5	25.1 ± 0.6	24.9 ± 0.7	0.1	0.1	0.1
4 weeks	20.1 ± 0.4	17.2 ± 0.7	15.8 ± 0.9	0.008	0.002	0.09
- 8 weeks	16.6 ± 0.6	11.5 ± 0.6	10.2 ± 0.9	0.01	0.008	0.1
E) Serum Gastrin(pg/ml)				P1	P2	P3
control:	41.8 ± 7.1	41.8 ± 7.1	41.8 ± 7.1	1.0	1.0	1.0
pretreatment:	22.1 ± 4.2	21.5 ± 4.6	21.9 ± 4.7	0.1	0.1	0.1
4 weeks	27.2 ± 2.3	32.1 ± 2.1	33.6 ± 2.7	0.008	0.002	0.09
- 8 weeks	32.3 ± 2.1	35.9 ± 1.8	36.8 ± 2.1	0.01	0.008	0.1
D) Melatonin level at day time (pg/ml):				P1	P2	P3
control	36.1 ± 2.3	36.1 ± 2.3	36.1 ± 2.3	1.0	1.0	1.0
pretreatment:	18.2 ± 5.54	18.5 ± 3.75	18.3 ± 3.8	0.1	0.665	0.472
4 weeks	28.26 ± 2.26	19.2 ± 3.47	28.83 ± 1.82	0.000	0.55	0.000
8 weeks	34.5 ± .35	17.9 ± 3.72	34.5 ± 2.35	0.000	1.00	0.000

P1: group III versus group II
P2: group IV versus group II
P3: group IV versus group III

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