Table 2.
Acceptability of Picolax and self administered enema as reported on an itemised questionnaire completed before screening. Values are numbers (percentages) of participants
| Total
|
Welwyn Garden City
|
Leicester
|
P value* | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Enema | Picolax | Difference in % (95% CI) | Enema | Picolax | Enema | Picolax | ||||
| Total using allocated preparation | 607 | 566 | 247 | 237 | 360 | 329 | ||||
| Ease of administration of enema: | ||||||||||
| Easy | 471 (78) | NA | 188 (76) | NA | 283 (79) | NA | ||||
| Quite difficult | 91 (15) | NA | 50 (20) | NA | 41 (11) | NA | ||||
| Very difficult | 7 (1) | NA | 4 (2) | NA | 3 (1) | NA | ||||
| Given by another person | 4 (1) | NA | 4 (2) | NA | 0 | NA | ||||
| Coping with no food: | ||||||||||
| No problem | NA | 356 (63) | NA | 160 (67) | NA | 196 (60) | ||||
| A bit difficult | NA | 142 (25) | NA | 53 (22) | NA | 89 (27) | ||||
| Very difficult | NA | 43 (8) | NA | 19 (8) | NA | 24 (7) | ||||
| Couldn't manage, had something | NA | 2 (0) | NA | 1 (1) | NA | 1 (0.3) | ||||
| Felt unwell | 88 (15) | 39 (7) | 8 (4 to 11) | 30 (12) | 17 (7) | 58 (16) | 22 (7) | 0.33 | ||
| Adverse effects rated as moderate or severe: | ||||||||||
| Abdominal pain or cramps | 56 (9) | 59 (10) | −1 (−5 to 2) | 23 (9) | 21 (9) | 33 (9) | 38 (12) | 0.44 | ||
| Nausea or vomiting | 16 (3) | 12 (2) | 1 (−1 to 2) | 7 (3) | 8 (3) | 9 (3) | 4 (1) | 0.25 | ||
| Faintness or dizziness | 22 (4) | 14 (3) | 1 (−1 to 3) | 10 (4) | 9 (4) | 12 (3) | 5 (2) | 0.30 | ||
| Wind | 24 (4) | 56 (10) | −6 (−9 to −3) | 13 (5) | 25 (11) | 11 (3) | 31 (9) | 0.38 | ||
| Bottom soreness† | 82 (14) | 50 (9) | 5 (1 to 8) | 27 (11) | 21 (9) | 55 (15) | 29 (9) | 0.32 | ||
| Incontinence | 8 (1) | 28 (5) | −4 (−6 to −2) | 6 (2) | 12 (5) | 2 (1) | 16 (5) | 0.10 | ||
| Sleep disturbance | 6 (1) | 74 (13) | −12 (−15 to −9) | 3 (1) | 36 (15) | 3 (1) | 38 (12) | 0.94 | ||
| Willing to use same preparation again | 543 (89) | 501 (89) | 0 (−3 to 5) | 227 (92) | 213 (90) | 316 (88) | 288 (88) | 0.57 | ||
*
Significance test for homogeneity of effect between Welwyn Garden City and Leicester.
†
Includes pain or irritation in any of the following areas: rectum, anal canal, anus, skin around anus or buttock.