Treatment of functional dyspepsia with sertraline: A double-blind randomized placebo-controlled pilot study

Table 1 Demographics of study patients

	Sertraline	Placebo	P value
Number of patients	98	95
Age (yr)	43.0	41.6	0.515
Sex (male)	27	27	1.000
Current smokers (%)	3.2	7.3	0.122
Alcohol (%)	6.2	8.3	0.295
H. pylori positive (%)	8.4	7.3	0.843
NSAID use (%)	3.1	2.6	1.000
Predominant symptom n (%)
Ulcer like	17 (44.7)	21 (55.3)
Dysmotility like	60 (49.2)	62 (51.8)
Reflux like	8 (57.1)	6 (42.9)
Non-specific	13 (68.4)	6 (31.6)

H. pylori: Helicobacter pylori; NSAIDs: Non-steroidal anti-inflammatory drugs.

Table 2 Dyspepsia index, 36-item short-form score and hospital anxiety scale results

	Week 0	P value	Week 4	P value	Week 8	P value
Mean dyspepsia score
Sertraline	25.83	0.124	22.59	0.740	20.53	0.02
Placebo	27.19		22.94		23.34
SF36-physical functioning
Sertraline	81.79	0.585	79.30	0.39	75.61	0.15
Placebo	83.11		81.63		80.39
SF36-role physical
Sertraline	57.91	0.30	52.62	0.40	52.70	0.22
Placebo	52.11		57.87		62.17
SF36-bodily pain
Sertraline	49.10	0.002	54.22	0.89	53.97	0.50
Placebo	41.06		53.78		51.63
SF36-general health
Sertraline	33.76		39.06		35.39
Placebo	32.54	0.65	41.85	0.34	34.72	0.84
SF36-vitality
Sertraline	47.69	0.57	47.91	0.73	49.05	0.68
Placebo	46.76		48.88		50.33
SF36-social function
Sertraline	67.75		72.38		68.41
Placebo	67.68	0.98	72.19	0.96	69.74	0.73
SF36-role emotional
Sertraline	51.82		53.49		52.70
Placebo	50.75	0.85	54.19	0.90	51.32	0.85
SF36-mental health
Sertraline	58.12		54.89		65.24
Placebo	58.59	0.83	61.57	0.03	64.37	0.69
HAD scale
Anxiety score
Sertraline	14.27	0.52	13.58		14.29
Placebo	13.88		13.66	0.90	13.68	0.41
HAD scale
Depression score
Sertraline	15.51	0.14	15.50	0.88	14.27	0.45
Placebo	14.84		15.56		13.70

HAD: Hospital Anxiety and Depression Scale; SF36: 36-item short-form.

Table 3 Default patient profile n (%)

			Reason for default week 8
	Default week 4	Default week 8	No reason given1	Adverse effect of drug1	Other1
Sertraline	23	24	7 (16.3)	14 (32.6)	3 (7)
Placebo	11	19	11 (25.6)	8 (18.6)	0 (0)

¹Represents percentage of all default patients; P = 0.259 for drug adverse effect between sertraline and placebo groups.