Fifteen RCTs (n=2,226) were included in the review. One RCT scored 8 points, two RCTs scored 7 points, five RCTs scored 6 points, five RCTs scored 5 points, one RCT scored 4 points and one RCT scored 3 points. All 15 studies received one point for random allocation. Only six studies provided a adequate concealment of allocation. Six studies reported blinding of outcome assessor. Subjects and outcome assessors were blinded in three pharmacological interventions. Three studies reported an intention to treat analysis. Sample sizes ranged from 17 to 859.
One RCT (n=321) reported that participants fed with a nasogastric tube were less likely to experience either death or poor functional status compared to patients fed with a percutaneous endoscopic gastrostomy (PEG) tube (p=0.05). There were no statistically significant differences between groups for the risk of developing pneumonia. Two RCTs (n=53) reported that nasogastric tubes were associated with a higher risk of death and worse outcomes (including malnourishment) and more feeding interruptions due to tube failures compared with PEG tubes (individual study data reported in supplementary table).
One RCT (n=114) that evaluated the effectiveness of general swallowing treatment programmes did not report any deaths. A second RCT (n=306) reported no significant differences between groups for rates of death. There was conflicting evidence for reductions in pneumonia: one RCT (n=306) reported that participants who received usual care had significantly higher incidence of chest infection than patients who received more intensive therapies (p=0.03); one RCT (n=114) reported no significant differences between groups for incidence of pneumonia.
One RCT (n=34) that compared subcutaneous hydration with intravenous hydration found no significant differences between groups for the maintenance of serum osmolality with a normal range for three days.
One RCT (n=203) found that topical use of an antimicrobial gel was associated with reductions in the incidence of pneumonia (in particular patients with an abnormal swallow) compared to use of a placebo gel (p=0.029). There were no statistically significant differences between groups for mortality.
Four RCTs (n=190) evaluated interventions to improve the physiological aspects of swallowing and four RCTs (n=146) evaluated the benefit of dietary texture modifications and/or alteration of fluid viscosity. Due to a high level of variation between these studies it was not possible to evaluate the overall effectiveness of these interventions.