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

Participants

• Number: 70 people, of which only 41 (28 female and 13 male) were tested for all outcomes.

• Criteria of inclusion: age between 18 and 75 years; gastroesophageal reflux for a minimum of 6 months at least once or twice a week; a diagnosis of GERD issued by their general practitioner; an endoscopic test carried out over the last year with no serious pathological findings.
  • People were recruited from their general practitioner or from specialist clinics.

• Criteria of exclusion: cancer, Barrett’s syndrome, severe reflux symptoms (Savary/Miller grade II, III, IV), reflux in pregnancy, coronary heart disease, varicose veins in the oesophagus, neuropathies due to diabetes mellitus, alcoholism, gastrointestinal surgery over the last 6 months.
• Groups of study: 2 groups obtained by randomization
  • Group 1: OMT with standard care, 35 people
    • only 23 people (14 female and 9 male, mean age 48.8 years) filled out the RDQ questionnaire properly
  • Gruppo 2: standard of care, 35 people
    • only 18 people (14 female and 4 male, average age 50.5 years) filled out the RDQ questionnaire properly
    • after the study, people in this group had 2 sessions of OMT as a “payoff”

Interventions and evaluations

• Evaluation of frequency and severity of GERD symptoms (heartburn, regurgitation, digestive problems) by RDQ questionnaire at baseline, before each OMT session and at the follow-up after 20 weeks.
  • To ensure study blinding and reduce bias, the RDQ questionnaire was completed directly by the patients.
• Quality of life assessment for GERD using QOLRAD (emotional distress, vitality, problems with food or drinks, sleep, physical and social functioning).
  • Evaluation at baseline, after 4, 8 and 20 weeks for the OMT group.
  • Evaluation at baseline and after 8 weeks for the control group.
  • To ensure study blinding and reduce bias, the QOLRAD questionnaire was completed directly by the patients.
• Assessment of osteopathic dysfunctions at baseline and before each OMT session (at baseline and after 8 weeks for the Control group)
• Evaluation of the drugs taken through a drug diary filled in for 8 weeks
• Adverse effects’ evaluation
• 4 x 30-minute sessions of OMT over 6-8 weeks, with follow-up at 20 weeks.
• OMT: Personalized treatment based on clinical assessment with structural, visceral, and craniosacral techniques (including high-velocity low-amplitude, myofascial release, functional, balanced ligamentous tension techniques).
• Standard of care: administration of medications as needed.
• Visit, physical assessment and treatments performed by three osteopaths, graduated after 6 years of studies and with at least 1500 hours of experience with patients.
  • A standard evaluation form was used for the assessment

Results

• Primary outcomes: compared to the Control group, the OMT group showed a statistically significant improvement in the severity and frequency of symptoms of heartburn, regurgitation and digestive problems. In the OMT group these results were observed both at the end of the treatment and at the end of the follow-up, 8 weeks and 20 weeks from baseline respectively.
• Secondary outcomes: in the OMT group the QOLRAD questionnaire score increased, while it worsened in the Control group, with statistically significant differences. In the OMT group, all dimensions of the questionnaire improved and remained so until the end of the follow-up with the exception of physical/social functioning.

Although the dose taken remained the same, in the OMT group medication frequency decreased from 18 per day at baseline to 12 per day after 8 weeks. However, it remained constant in the control group (11 per day at baseline and 12 per day after 8 weeks). The most common osteopathic dysfunctions were observed at the level of the sacrum, C3-5, C0/1 and T1/T2, respiratory diaphragm and pylorus.

• Adverse events: no adverse effects were reported by the participants.

Discussion

OMT has been shown to reduce symptoms of gastroesophageal reflux, but the low number of completed RDQ questionnaires asks for caution in the interpretation of the results (as well as a new strategy to avoid similar situations in future studies also using RDQ questionnaires, especially in German, the language of the present study). Nevertheless, the quality of life results seem to confirm the utility of OMT in this pathological condition.

Although positive, the results of the RDQ remain doubtful also because they do not seem significant from a clinical point of view, as they are lower than the “minimum important difference” (MID) for the scales of the RDQ (the MID is that value which indicates the minimal change in an outcome that is linked to an actual clinical improvement in a person’s health). On the other hand, the improvements in the QOLRAD scales for the OMT group were all greater than 0.5, thus resulting significant also from a clinical point of view as the MID for the QOLRAD is precisely 0.5.

Future studies will need to better consider the most appropriate population of patients to recruit, even in the face of the population used in defining the MID for the rating scales used. Furthermore, it would be good to include an assessment of the patient’s overall change, in order to have a simpler and more immediate idea of the improvement or worsening obtained in relation to the interventions studied.

This study had the advantage of being a pragmatic study, ie, it remained as “realistic” as possible: for example, the treatments were customized to suit the patients’ individual needs. The use of the control group with standard care alone was chosen because GERD, without specific interventions, tends to remain stable over time: in this way, a good comparison was made with the OMT group.

With regard to the drugs taken, the low number of people recruited and the difference  between the two groups at baseline make it difficult to draw conclusions.

A limitation of the study is that it did not use a sham treatment in comparison to OMT, which might have favored a placebo or nocebo effect. On the other hand, performing a personalized treatment makes it more difficult to replicate the study. Future studies will therefore have to take these aspects into account and, for example, carry out a more in-depth analysis of the techniques used.

Given the low response rate to classic therapies such as proton pump inhibitors, the results that emerged lead us to consider OMT as a safe and effective support therapy, to be used according to the patients’ preferences.