Osteopathic treatment in addition to standard care in patients with Gastroesophageal Reflux Disease (GERD) - A pragmatic randomized controlled trial.

Background: Long-term Proton Pump Inhibitor use is associated with low response rates and the risk of adverse events.

Objective: The objective of this study was to assess the effectiveness of Osteopathic Treatment in patients with Gastroesophageal Reflux Disease (GERD).

Methods: This study was a randomized controlled trial with a series of osteopathic interventions and an untreated control group. Patients in the osteopathic group (OG) received 4 osteopathic treatments within a time of eight weeks. The control group (CG) did not receive any osteopathic treatment. Primary outcome parameters were gastrointestinal symptoms, assessed by means of the Reflux Disease Questionnaire (RDQ). Secondary outcome parameters were Quality of life with regards to GERD symptoms, assessed by means of the Quality of Life in Reflux and Dyspepsia (QUOLRAD) questionnaire, medication use and osteopathic dysfunctions.

Results: Seventy patients were randomized. RDQ mean scores decreased statistically significantly in the OG but did not change in the CG; however, these data cannot be interpreted due to a large number of incorrectly completed questionnaires. The between group difference of the changes for the QOLRAD score was statistically significant 0.69 [95%CI = 0.35 to 1.0]. At week 20, changes in the QOLRAD of the OG were sustainable. Medication use decreased substantially in the OG whilst it remained the same in the CG.

Conclusion: A series of osteopathic treatments might potentially be beneficial for patients suffering from GERD. Future studies should include longer follow-up times and establish the clinical significance of results by introducing a global rating of change measurement.