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
There are 2 studies summarised in this briefing. Evidence published before 2010 was considered in the NICE interventional procedures guidance on electrotherapy for the treatment of haemorrhoids, and so was not included in this briefing. One fully published study and 1 abstract (total n=157) published since 2010 were selected for inclusion in this briefing. The included papers report on 2 non-comparative observational studies. Results show that eXroid effectively reduced haemorrhoids with no complications.
Evidence considered in the NICE guidance found that eXroid had mixed results regarding effectiveness and procedural pain.
Table 2 summarises the clinical evidence as well as its strengths and limitations.
Overall assessment of the evidence
There is limited published evidence regarding the safety and effectiveness of eXroid since 2010. Both studies included in this briefing use the previous version of the device, Ultroid. The company has stated that the 2 versions of the technology are similar.
The 2 studies were non-randomised, non-comparative observational studies, which limit the ability to assess the effectiveness of eXroid compared with alternative treatments. The studies did not report a sample size calculation and it is unclear whether they were adequately powered to detect differences in outcomes.
Confounding factors included previous treatments, anal fissures and haemorrhoid grade. Both studies stratified patients by haemorrhoid grade in terms of number of treatments needed to resolve haemorrhoid symptoms.
Follow up varied between the studies, from 1 to 6 months (Hudson-Peacock and Hudson-Peacock, 2014); and a mean of 16 months (Olatoke et al. 2014). However, it was unclear how long patient follow up was after their final direct current electrotherapy treatment. Additionally, attrition rates were not presented in the studies.
Olatoke et al. (2014) offered an option of operative treatment or eXroid to all patients who presented with haemorrhoids during the study period. This resulted in selection bias (for example, patients with more severe symptoms may have opted for surgery). Comparative treatment costs from other countries may not be generalisable to the UK and unit costs from older studies may not be representative of the current cost of treatment.
Table 2 Summary of selected studies
|
Study size, design and location |
100 people in a prospective, single-arm observational study abstract. Location: UK. |
|
Intervention and comparator(s) |
Ultroid 2.0. |
|
Key outcomes |
The study found no complications in treatment and all patients showed some reduction in haemorrhoids. |
|
Strengths and limitations |
This was an observational study and lacked comparison with alternative treatments. This evidence was submitted as an abstract to a scientific conference by the manufacturer. Manufacturer-sponsored studies may introduce bias into publication results and conclusions. |
|
Study size, design and location |
57 people in a prospective, single-arm observational study. Location: Nigeria. |
|
Intervention and comparator(s) |
Ultroid. |
|
Key outcomes |
The study found no complications. All patients had successful treatment and remained symptom free. |
|
Strengths and limitations |
This was an observational study and lacked comparison to alternative treatments. |