. 2005 Mar 24;7(3):R644–R665. doi: 10.1186/ar1704

Table 5b.

Gastrointestinal adverse events reported in studies of arthritis patients (part 2)

			Number of		Incidence of events (%)
Outcome/ comparisons	Celecoxib daily dose	Comparator and daily dose	Trials	Patients	Celecoxib	Comparator	Relative risk^a(95% CI)	NNTp^bor NNH^c(95% CI)

*Abdominal pain*

Celecoxib v placebo	Any	Placebo	19	9,919	3.6	2.9	1.2 (0.92–1.5)
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	0.9	2.0	0.45 (0.15–1.3)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	2.7	4.2	0.64 (0.42–0.97)^a	67 (35–920)^b
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,615	5.3	7.8	0.75 (0.68–0.83)^a	41 (32–57)^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	20	31,711	6.6	10.0	0.76 (0.70–0.82)^a	29 (25–36)^b
Celecoxib (any dose) v any active	Any	Any active comparator	26	35,302	6.2	9.2	0.75 (0.70–0.81)^a	33 (28–41)^b

*Dyspepsia*

Celecoxib v placebo	Any	Placebo	19	9,919	6.9	4.8	1.30 (1.08–1.6)^a	46 (32–84)^c
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	2.9	2.2	1.34 (0.63–2.9)
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	4.4	4.9	0.89 (0.63–1.3)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	19	22,615	5.7	7.3	0.79 (0.71–0.88)^a	61 (43–100)^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	20	31,711	8.1	10.7	0.84 (0.78–0.90)^a	39 (31–52)^b
Celecoxib (any dose) v any active	Any	Any active comparator	26	35,302	7.8	9.9	0.85 (0.79–0.91)^a	48 (37–68)^b

*Diarrhoea*

Celecoxib v placebo	Any	Placebo	17	9,510	5.1	3.5	1.45 (1.16–1.82)^a	53 (37–97)^c
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	2.2	4.6	0.48 (0.24–0.95)^a	41 (22–450)^b
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	5	2,671	4.1	4.4	0.93 (0.65–1.3)
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	17	22,071	4.3	4.9	0.96 (0.85–1.1)
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	18	31,167	5.8	6.9	0.96 (0.88–1.1)
Celecoxib (any dose) v any active	Any	Any active comparator	24	34,758	5.6	6.6	0.95 (0.87–1.03)

*Clinical ulcers and bleeds*

Celecoxib v placebo	Any	Placebo	16	9,321	0.03	0.05		3 events
Celecoxib v paracetamol	Any	Paracetamol 4,000 mg	2	1,056	0.0	0.0		0 events
Celecoxib v rofecoxib	Any	Rofecoxib 25 mg	3	897	0.3	0.0		1 event
Celecoxib (200/400) v NSAID	200–400 mg	NSAID to maximum daily	17	22,075	0.2	0.6	0.35 (0.22–0.56)^a	250 (170–450)^b
Celecoxib (any dose) v NSAID	Any	NSAID to maximum daily	18	31,171	0.4	0.9	0.61 (0.46–0.81)^a	200 (140–320)^b
Celecoxib (any dose) v any active	Any	Any active comparator	22	32,508	0.4	0.8	0.61 (0.46–0.81)^a	210 (150–350)^b

^aRelative risk: bold indicates statistically significant difference. ^bNNTp (number-needed-to-treat to prevent one event) is indicated by bold. ^cNNH (number-needed-to-treat to harm one patient). CI, confidence interval; NSAID, nonsteroidal anti-inflammatory drug.