Table 2

Treatment effects at 3 months

Variable	Endocinch		Sham		Observation		p Values*
Variable	Change	%	Change	%	Change	%	E–S	S–O
NS, not significant.
*Statistical tests analysed differences between the three groups, and, if significant, compared the Endocinch group with the sham group (E–S) and the sham group with the observation group (S–O).
†Frequency×severity (range 0–24), off antisecretory drugs.
‡p<0.05, within-group comparisons.
§Short-Form General Health Survey (higher scores for better function, except for bodily pain perception; range 0–100), off antisecretory drugs.
Heartburn score†	−8.6 (9.0)‡	−50	−0.9 (4.3)	−6	−3.1 (4.9)‡	−18	0.003	0.20
Heartburn frequency	−2.4 (2.4)‡	−47	−0.1 (0.8)	−1	−0.4 (1.1)	−7	0.002	0.68
Heartburn severity	−1.2 (1.6)‡	−34	−0.1 (0.6)	−4	−0.4 (0.5)‡	−13	NS
Regurgitation score†	−5.2 (8.3)‡	−32	−1.1 (4.2)	−7	−0.4 (5.5)	−2	NS
Regurgitation frequency	−1.6 (2.2)‡	−32	0 (1.0)	0	0 (1.3)	0	0.02	0.72
Regurgitation severity	−0.9 (1.4)‡	−27	−0.3 (0.6)	−9	−0.1 (0.6)	−2	NS

SF-20§
Physical function	19 (34)‡	+50	5 (24)	+10	10 (25)	+21	NS
Role function	25 (26)‡	+40	1 (22)	+2	2 (27)	+2	0.01	0.99
Social function	15 (31)	+23	0 (23)	0	5 (18)	+7	NS
Mental health	−2 (20)	−3	0 (8)	0	3 (14)	+6	NS
General health	14 (26)‡	+40	−1 (17)	+1	−2 (13)	−10	0.04	0.99
Bodily pain perception	−24 (39)‡	−34	2 (19)	+3	4 (18)	+8	0.02	0.78