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    Alpha-Stim AID for anxiety disorders

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    3 Evidence

    Clinical evidence

    The clinical evidence comprises 6 studies, of which 3 are randomised controlled trials

    3.1 Six studies provided evidence relevant to the decision problem in the scope, including 2 published randomised controlled trials, 1 unpublished randomised controlled trial and 3 non-comparative observational studies. The studies included between 12 and 197 people. Only 1 study used the current model of the device, the others used older models. One study was done in the UK.

    Evidence shows that using Alpha-Stim AID relieves anxiety symptoms

    3.2 The 3 randomised controlled trials showed a statistically significant improvement in patient-reported anxiety scores with Alpha-Stim AID compared with drugs alone, a sham device, or no treatment in people with anxiety disorders. The benefit of Alpha-Stim AID in relieving anxiety symptoms was also reported consistently in the observational studies.

    There is no evidence of the long-term effect of Alpha-Stim AID

    3.3 The studies were of short duration (usually 5 to 6 weeks) with only 1 observational study reporting longer-term outcomes at 24 weeks.

    The published evidence on the effect of Alpha-Stim AID on quality of life is limited

    3.4 Only 2 of the studies reported improvements in quality of life (Morriss et al. 2019, Lu and Hu 2014) using health questionnaire (EQ-5D-5L and WHOQOL BREF) scores. An improvement in quality of life was also reported with Alpha-Stim AID in a patient survey facilitated by NICE's public involvement programme. For details, see the assessment report overview in the supporting documents for this guidance.

    Alpha-Stim AID is considered a safe device

    3.5 Adverse events reported with Alpha-Stim AID in 2 studies included mild headache, dizziness, nausea and feeling strange. Similar symptoms were reported by people who used Alpha-Stim AID in the patient survey that was done as part of this assessment. Additional symptoms reported in this survey included ear discomfort and worsening of anxiety symptoms. All reported adverse events were mild. The clinical experts did not identify any specific safety concerns with Alpha-Stim AID.

    Cost evidence

    One UK study is included in the economic modelling

    3.6 The company identified 1 UK study (Morriss et al. 2019). This reported the cost impact of Alpha-Stim AID as a treatment option for people with anxiety disorders who were waiting for individual cognitive behavioural therapy (iCBT) delivered by Improving Access to Psychological Therapies (IAPT) services. No additional economic analyses were identified by the external assessment centre (EAC).

    The company's model shows cost savings in treating anxiety disorders

    3.7 The company developed a decision tree model with a time horizon of 6 months. The model compared the cost of using Alpha-Stim AID as an option for people waiting for iCBT in IAPT services with that of iCBT alone. The results showed that Alpha-Stim AID was cost saving by £817.68 per person.

    The EAC changes the company's model to reflect the evidence and expert opinion

    3.8 The EAC agreed with many of the assumptions in the company's model but found some limitations. In the UK observational study, a significant proportion of people who were offered Alpha-Stim AID chose not to use it and preferred to wait for iCBT (Morriss et al. 2019). The EAC therefore revised this parameter in the model to reflect the reduced uptake of Alpha-Stim AID. The EAC also modified the structure of the model to better reflect the current care pathway outlined to it by clinical experts. The EAC's base case included drug treatment as an option at the start of the pathway and also for people whose anxiety symptoms did not respond to Alpha-Stim AID or iCBT. The EAC excluded the second course of iCBT for people whose anxiety symptoms did not respond to an initial course of treatment.

    The EAC's updated analysis suggests that cost saving is influenced by response rate and assumptions about the treatment pathway

    3.9 The EAC's base case showed that using Alpha-Stim AID saved £80.79 per person compared with iCBT. This was based on a 47.2% response rate with Alpha-Stim AID (Morriss et al. 2019) and a 54.2% response rate with iCBT (Gyani et al. 2013). The reported response rate for Alpha-Stim AID included everyone who used it in the Morriss et al. study. However, many people may also have had iCBT alongside or after Alpha-Stim AID. The reported response rates for treatment combinations were more uncertain and varied. For instance, the response rate was 65% in people using Alpha-Stim AID alone and 13% in people having Alpha-Stim AID followed by iCBT (Morriss et al. 2019). The EAC explored the effect of different response rates and treatment regimens. For details, see the addendum to the EAC's assessment report in the supporting documents for this guidance.