Advice
Clinical and technical evidence
Clinical and technical evidence
A literature search was carried out for this briefing in accordance with the interim process and methods statement. This briefing includes the most relevant or best available published evidence relating to the clinical effectiveness of the technology. Further information about how the evidence for this briefing was selected is available on request by contacting mibs@nice.org.uk.
Published evidence
Three studies including 148 individual adults (21 were included in both of the Hägg 2015 studies) are summarised in this briefing. All of the studies are observational, before-and-after studies done in Sweden.
Table 1 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
All of the included studies were co-authored by the owner of the IQoro patent. All patients were referred from hospital ear, nose and throat departments, gastrointestinal surgeries and general practices to the specialist speech and swallowing centre at Hudiksvall hospital.
No power calculations were reported to assess for adequate sample size. Inclusion criteria varied between studies, and the company confirmed that 21 patients from the Hägg et al. (2015a) study were also included in the second Hägg et al. (2015b) study. All included patients had experienced symptoms for more than 1 year. Hägg et al. (2015a) included 21 hiatus hernia patients and 22 patients without a confirmed diagnosis, all of whom had been taking proton pump inhibitors (PPIs) for at least 1 year. These inclusion criteria should capture a population representative of the NHS. The total number of patients with a confirmed hiatus hernia in the 3 studies was 126.
No control group having standard care was present in the studies. It is possible that any effect seen in an uncontrolled design could be overestimated. All studies included long-term hiatus hernia sufferers. Each study compared subjective, self-reported measurements of symptoms related to hiatus hernia before and after a treatment period of 6 to 8 months training with IQoro. Self-reported outcomes can be subject to bias and while necessary, particularly in symptom-based conditions, may need to be supported by more detailed measures. The company confirmed that these assessments were blinded from the researchers. Objective measurements were also taken to rule out the presence of a central nervous lesion. Phone calls and interim swallowing capacity tests were made during the training period to attempt to ensure compliance to the regime. The Hägg et al. studies reported the results of pressure measurements in the hiatus canal and upper oesophageal sphincter for the same 12 patients, to investigate the physical effect of training. Patients were not followed up longer than the training period, so there is no confirmation of long-term benefit. The company confirmed that all patients were advised to continue with their PPI medication during the training period. No information was published on patient's adherence to PPI medication but the company have stated "all patients continued with their PPI medication as advised. As symptoms reduced, patients ceased to medicate. Use or cessation of PPIs was under the control of the patients' doctors. At end-of-training in the 3 studies quoted 93%, 58% and 61% ceased all PPI medication, the remainder mostly reduced dose and intake frequency".
Table 1 Summary of selected studies
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Study size, design and location |
A prospective, before-and-after, observational study on 86 consecutive adults (46 women) referred to a swallowing centre with sliding HH and enduring IED and GERD symptoms, despite PPI medication. The study was done in Sweden, with patients referred between 2014 and 2016. Patients were grouped by BMI:
All patients had received PPI medication for at least a median 3-year period and were still on this medication at the start of the study. |
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Intervention and comparator(s) |
All patients used IQoro for 6 months for neuromuscular training. The training consisted of pulling the device for 5 to 10 seconds with a gradually increasing strength and repeating this 3 times with 3 seconds of rest in between. The exercise was done 3 times a day, before eating. No comparator. |
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Key outcomes |
All patients did IED, GERD and swallowing self-assessments (VAS from 0 mm [normal] to 100 mm [total inability]) before and after training as well as a SCT and LFT. All IED and GERD symptom scores improved and there were no significant differences between BMI groups except for heartburn, cough and misdirected swallowing which were significantly (p<0.01) more reduced in severely obese patients. SCT, LFT and median VAS score was significantly improved (p<0.0001). There was no significant difference between the BMI groups except for the value of SCT, which was significantly (p<0.01) more improved in the severely obese group, and for the value of LFT, which was significantly (p<0.05) more improved in the moderately obese group. |
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Strengths and limitations |
Patients were recruited prospectively and consecutively. Compliance was also checked on 2 to 3 occasions by telephone throughout the study period. There was no group treated with standard care, so it is unclear if improvements were because of the treatment. No power calculation is reported. Follow up was only for the 6-month training period so any effect cannot be confirmed to continue after training has ceased. The inventor of the device is an author of this study. |
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Study size, design and location |
A prospective, before-and-after, observational study on 43 consecutive adults (21 women) referred to a swallowing centre with non-stenotic oesophageal dysphagia, who were taking PPIs for more than 1 year. The study was done in Sweden, with patients referred between 2012 and 2014. Of the patients, 21 were found to have a HH (median age 52 years, 13 women); the remaining patients were suffering from symptomatic reflux oesophagitis or dyspepsia but did not have a confirmed diagnosis of hiatus hernia. The patients had a median symptom duration of 4 years (range 1 to 28 years). A further 12 patients with HH had oesophageal high-resolution manometry to measure the pressure in the UES and hiatus canal, both while resting and while using the IQoro. |
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Intervention and comparator(s) |
All 43 patients had 6 to 8 months of training with IQoro and were split into group A (patients with HH) and group B (patients without a confirmed diagnosis of HH). The training consisted of pulling the device for 5 to 10 seconds with a gradually increasing strength and repeating this 3 times with 3 seconds of rest in between. The exercise was done 3 times a day, before eating. No comparator. |
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Key outcomes |
All 43 patients had a pathological VAS (0 to 100) at baseline and 100% had improved after training. Between baseline and end-of-training, LFT and VCT scores showed statistically significant improvements in both groups (p<0.001) and were taken as measures of good training compliance. OFMT and OST scores were all considered in the normal range at baseline. Self-reported measures of oesophageal dysphagia and reflux symptoms (from 0 to 3) improved in 98% and 86% of patients, respectively, between baseline and end-of-training. No statistically significant difference was found between group A and group B in any test either before or after the intervention. Pressure in the UES (68 to 95 mmHG) and hiatus canal (0 to 65 mmHG) increased when using the IQoro device. |
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Strengths and limitations |
Patients were recruited prospectively and consecutively. Compliance was also checked on 2 to 3 occasions by telephone throughout the study period. Measures of symptom severity were reported by patients on subjective scales. Although 2 groups are included, neither were treated with standard care, so it is unclear if improvements were because of the treatment. No power calculation is reported. Follow up was only for the 6 to 8-month training period so any effect cannot be confirmed to continue after training has ceased. The inventor of the device is lead author of this study. |
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Study size, design and location |
A prospective, before-and-after, observational study on 28 consecutive adult patients (14 women, median age 59 years) suffering from misdirected swallowing and oesophageal retention symptoms because of HH for more than 1 year. The patients were referred to a swallowing centre in Sweden between 2012 and 2014 and had a median symptom duration of 4 years (range 1 to 28 years). It is not reported if any of the 28 patients were also included in Hägg, Tibbling and Franzén (2015a) above. A further 12 patients with HH had oesophageal high-resolution manometry to measure the pressure in the UES and hiatus canal, both while resting and while using the IQoro. These were the same 12 patients reported in Hägg, Tibbling and Franzén (2015a) above. |
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Intervention and comparator(s) |
All 28 patients had 6 to 8 months of training with IQoro. The training consisted of pulling the device for 5 to 10 seconds with a gradually increasing strength and repeating this 3 times with 3 seconds of rest in between. The exercise was done 3 times a day, before eating. No comparator. |
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Key outcomes |
A statistically significant improvement was found in the self-reported measure of symptoms of misdirected swallowing, cough, hoarseness, oesophageal retention and globus (lump in throat; all p<0.001). Statistically significant improvement (p<0.001) in LFT, VCT and SCT results was considered a measure of good training compliance. OST and OFMT results confirmed that a central nervous lesion was not present in any patients. |
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Strengths and limitations |
Patients were recruited prospectively and consecutively. Compliance was also checked on 2 to 3 occasions by telephone throughout the study period. Measures of symptom severity are subjective. No comparator group treated with standard care was included, so it is not certain that improvements were because of the treatment. No power calculation is reported. Follow up was only for the 6‑ to 8-month training period so any effect cannot be confirmed to continue after training has ceased. The inventor of the device is lead author of this study. |
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Abbreviations: GERD, gastroesophageal reflux disease; HH, hiatal hernia; IED, intermittent oesophageal dysphagia; LFT, lip force test; OFMT, orofacial motor test; OST, oral sensory test; PPI, proton pump inhibitor; SCT, swallowing capacity test; UES, upper oesophageal sphincter; VAS, visual analogue score; VCT, velopharyngeal closure test. |
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Recent and ongoing studies
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Swallowing Function, Oral Health, and Food Intake in Old Age (SOFIA). ClinicalTrials.gov identifier NCT02825927. Completed November 2017, awaiting publication.