Acupuncture combined with cranial electrotherapy stimulation on generalized anxiety disorder: A randomized controlled trial
Liu, E., Zhang, W., Wang, J., Zhao, F., & Bai, Y.
Chinese Acupuncture & Moxibustion. 2020; 40(11).
Device Used
Alpha-Stim® SCS
Key Variables
Anxiety and Quality of Life
Funding Source / Location
Department of TCM, First Hospital of Hebei Medical University, Shijiazhuang, China
Objective & Design
Objective: To observe the therapeutic effect of acupuncture combined with cranial electrotherapy stimulation (CES) on generalized anxiety disorder (GAD).
Design: A randomized controlled study comparing the effectiveness of four (K=4) different treatment groups (1) medication only (MED), (2) acupuncture only (ACU), (3) cranial electrotherapy stimulation only (CES), and (4) acupuncture plus CES (ACU + CES) for the treatment of generalized anxiety disorder (GAD). The medication only (MED) group was considered the control group as it received treatment-as-usual (TAU), and the acupuncture only (ACU) and CES only (CES) and acupuncture plus CES (ACU+CES) are the experimental groups.
Baseline and post-treatment anxiety scores were measured using the Hamilton Anxiety Rating (HAM-A) scale. Similarly, baseline and end of treatment quality of life were assessed using the World Health Organization Quality of Life Questionnaire-Brief Version (WHOQOL-BREF). Adverse events were measured using the Treatment Emergent Symptom Scale (TESS). Patients were assessed at the end of the study and relapse rates reassessed 12 months after the end of treatment.
Outcome Measures
Primary Outcome Measure
- Anxiety: Assessed using the Hamilton Anxiety Rating Scale (HAM-A). Scores range from 0–56 with <17 indicating "Mild severity".
- Quality of Life: Measured by the World Health Organization's Quality of Life Questionnaire Brief Version (WHOQOL-BREF).
Secondary Outcome Measure
- Side Effects: Measured by the Treatment Emergent Symptom Scale (TESS).
- Assesses adverse events that first occurred or worsened in severity after initiation of treatment or therapy.
Key Inclusion Criteria
- Met criteria for Generalized Anxiety Disorder (GAD)
- Diagnosis of GAD ≥6 months
- Hamilton Anxiety Rating (HAM-A) scale ≥14
- Age <80 years
- Provide informed consent
Key Exclusion Criteria
- Chronic medical conditions (severe heart, brain, liver, kidney)
- Not a good candidate or unfit for CES or acupuncture
- Use of anxiolytic medication in the last two weeks
- Other psychiatric disorders
Protocol Summary
Patients in all four groups (K=4) received treatment for sixty (60) days irrespective of group assignment.
- Medication only (MED): treated with oral tandospirone citrate (brand name Sediel) an anxiolytic and antidepressant drug used in China and Japan. Dosage was 10mg after breakfast, lunch, and dinner.
- CES only (CES): received treatment using the Alpha-Stim® SCS device daily for 60 minutes each time.
- Acupuncture only (ACU): received traditional acupuncture applied daily for 30 minutes.
- Acupuncture plus CES (ACU+CES): received CES treatment before acupuncture.
Results
Subjects: A total of 200 patients with GAD were randomly allocated into four groups (K=4) using a random number table, with 50 cases per group (n=50). Comparison of subjects' general characteristics at baseline across all groups were not statistically significant (p>.05). The groups can be considered comparable.
Data Analysis: Across all four groups, patients reported benefitting from the treatment they received. The level of anxiety was significantly reduced as evidenced by the lower HAM-A scores (p<.05). Furthermore, quality of life as measured by the WHOQOL-BREF significantly improved following treatment (p<.05).
Adverse Events: A comparison of adverse events across the four groups as measured by the TESS scores indicates that patients in the medication only (MED) group reported significantly higher side effects than the other treatment conditions (p<.05). In addition, the relapse rate at follow-up, 1-year post-treatment was significantly higher in the medication only (MED) group than those of the other three groups (p<.05).
Effectiveness: The total effective rate of the medication only (MED) group was 80%, for the CES only group (CES) 80%, and for the acupuncture only (ACU) group 84%. Although the improvements to patients' life following treatment are substantial, all the treatment conditions were significantly lower than the 96% effective rate reported by the acupuncture plus CES group (ACU+CES) (p<.05).
Conclusion
Overall, the total effective rate in the acupuncture plus CES group was significantly better than the other three groups (p<.05). Noticeably, the reduction in anxiety and improvements to the quality of life reported by patients in the acupuncture plus CES (ACU+CES) group was significantly greater than the other three groups (p<.05).
The authors conclude acupuncture combined with CES can effectively relieve symptoms in patients with GAD, improve their quality of life, reduce the occurrence of adverse reactions, and the relapse rate. The authors support the mechanism of action proposed in the literature that CES therapy stimulates the secretion and release of a range of neurotransmitters... In this study, the CES group and the MED group had similar reductions in anxiety symptoms and improvements in quality of life. However, the CES group experienced significantly fewer and less severe side effects than the medication group. Additionally, the rates of relapse were over three times more in the medication group than in the CES at one-year follow-up. Thus, the clinical effectiveness of CES is superior to that of medication.
Limitations & Study Quality
Limitations: This was a strong RCT with one-year follow up that measured both anxiety and quality of life. However, the randomization was not blinded and both participants and investigators were aware of group assignments. Additionally, the authors did not discuss an a priori plan for missing data in this article.
Study Quality: GOOD
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