Efficacy of cola ingestion for oesophageal food bolus impaction: open label, multicentre, randomised controlled trial.
- 2023-12-11
- BMJ (Clinical research ed.) 383
- E G Tiebie
- E P Baerends
- T Boeije
- P G Frankenmolen
- H Lameijer
- W van den Berg
- K J van Stralen
- K J van Stralen
- M L Ridderikhof
- A J Bredenoord
- PubMed: 38081653
- DOI: 10.1136/bmj-2023-077294
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Sample size
- n = 51
- Population
- 51 adults presenting with complete oesophageal food bolus impaction, defined as a sudden inability to pass saliva after consumption of foods
- Methods
- Open label, multicentre, randomised controlled trial; 28 patients in the intervention group instructed to consume 25 mL cups of cola at intervals up to a maximum total volume of 200 mL; 23 patients in the control group awaited spontaneous passage
- Blinding
- Open-label
- Duration
- between 22 December 2019 and 16 June 2022
Objective
To determine the efficacy and safety of cola in resolving complete oesophageal food bolus impaction.Design
Open label, multicentre, randomised controlled trial.Setting
Emergency departments of five Dutch hospitals at the secondary and tertiary level, between 22 December 2019 and 16 June 2022.Participants
51 adults presenting with complete oesophageal food bolus impaction, defined as a sudden inability to pass saliva after consumption of foods. Patients who ingested meat that contained bones, and patients with an American Society of Anesthesiologists (ASA) physical status classification of IV or higher were excluded.Interventions
28 patients in the intervention group were instructed to consume 25 mL cups of cola at intervals up to a maximum total volume of 200 mL. 23 patients in the control group awaited spontaneous passage. In either group, if complete resolution of symptoms did not occur, endoscopic removal was performed following current guidelines: within 6 hours for patients with complete obstruction, and within 24 hours for partial obstruction. In case of complete resolution of symptoms, elective diagnostic endoscopy was required.Main outcome measures
Improvement of oesophageal food bolus obstruction as reported by patients (ie, aggregate of complete and partial passage), and evaluation of complete passage. The secondary outcome was any intervention related adverse event.Results
Cola did not have a meaningful effect on the improvement of food bolus obstruction (17/28 (61%) intervention v 14/23 (61%) control; odds ratio 1.00, 95% confidence interval 0.33 to 3.1; relative risk reduction 0.0, 95% confidence interval -0.55 to 0.36; P>0.99). Complete passage was reported more often in the intervention group but this difference was not significant (12/28 (43%) intervention v 8/23 (35%) control; odds ratio 1.4 (0.45 to 4.4); relative risk reduction -0.23 (-1.5 to 0.39); P=0.58). No severe adverse events occurred. However, six (21%) patients in the intervention group experienced temporary discomfort after drinking cola.Conclusions
In this study, cola consumption did not lead to a higher rate of improvement of complete oesophageal food bolus impaction. Given the lack of adverse events in the treatment group and some events of resolution after treatment, cola might be considered as a first line treatment, but should not delay any planning of endoscopic management.Trial registration
Netherlands Trial Register (currently International Clinical Trial Registry Platform) NL8312.Research Insights
Cola did not have a meaningful effect on the improvement of food bolus obstruction (17/28 (61%) intervention v 14/23 (61%) control; odds ratio 1.00, 95% confidence interval 0.33 to 3.1; relative risk reduction 0.0, 95% confidence interval -0.55 to 0.36; P>0.99).
- Effect
- Neutral
- Effect size
- Small
- Dose
- 25 mL cups at intervals up to a maximum total volume of 200 mL
Complete passage was reported more often in the intervention group but this difference was not significant (12/28 (43%) intervention v 8/23 (35%) control; odds ratio 1.4 (0.45 to 4.4); relative risk reduction -0.23 (-1.5 to 0.39); P=0.58).
- Effect
- Neutral
- Effect size
- Small
- Dose
- 25 mL cups at intervals up to a maximum total volume of 200 mL