Pinto 1999.
| Methods | Double‐blind RCT. Duration of study: 1992 to 1994 Follow‐up: at 5 weeks |
|
| Participants | 19 people with Grade III CRP Pourquier classification, persistent symptoms for a minimum of 12 months Mean age 59 years (range 36 to 75), Sex (F/M): 18:1 Both groups had equivalent baseline characteristics 1 (SCFA arm) and 2 (placebo) arm dropped out due to heavy per rectum bleeds |
|
| Interventions | Intervention: SCFA enema (as per Harig preparation 60 ml bd, 5 wks) Comparator: placebo |
|
| Outcomes | No. of days of per rectum bleeding, colonoscopic scores, and DNA and protein content Reduction of days/week of bleeding in SCFA P = 0.001. Increased Hb in SCFA vs placebo P = 0.02. Colonoscopic scores reduced in both arms, but more in SCFA P = 0.02 | |
| Notes | Side effects were recorded and there were none. No QoL assessment either | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Participants were randomly allocated, but randomisation method not described |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to permit judgement |
| Blinding (performance bias and detection bias) | Low risk | Study was double blinded "allocated to receive either SCFA enemas or an indentically appearing saline isotonic solution..." |
| Blinding of outcome assessment subjective | Low risk | Participants were blinded to the treatment |
| Blinding of outcome assessment objective | Low risk | Outcome assessors were blinded to the treatment "...by two well‐trained physicians who were not aware of the study phase or the nature of the treatment administered." "All biopsy specimens were interpreted in a random and blinded manner by two pathologists." |
| Incomplete outcome data: subjective outcomes | Unclear risk | 3 drop outs: 1 in the intervention group and 2 in the placebo group. Reasons for dropouts not discussed |
| Incomplete outcome data: objective outcomes | Unclear risk | 3 drop outs; 1 in the intervention group and 2 in the placebo group. Reasons for dropouts not discussed |
| Selective reporting (reporting bias) | Unclear risk | Study was published in 1999, so no study protocol available. However, all outcomes prespecified in the methods section were reported in the results section |
| Other bias | Low risk | No indications of other bias |