Dataset Information

Electroacupuncture plus moxibustion for major depressive disorder: A randomized, sham-controlled, pilot clinical trial.

ABSTRACT:

Background

The first treatment option for major depressive disorder (MDD) is antidepressants, however, there is substantial demand for alternative therapies due to its low compliance and remission rates. This study was aimed to explore the effectiveness, safety, and feasibility of electroacupuncture plus moxibustion therapy for MDD.

Methods

Thirty adults with MDD were randomly assigned to the treatment group (TG) or control group (CG). The TG was treated with electroacupuncture plus moxibustion, and the CG received sham interventions at non-acupoints for 8 weeks. The primary outcome measure was the intergroup difference of the mean change of total score of the Hamilton rating scale for depression (HRSD) between baseline and week 9. Secondary outcome measures were Beck's depression inventory, insomnia severity index, the state-trait anxiety inventory, the EuroQol-5 dimension index, the measure yourself medical outcome profile version 2, and frontal alpha asymmetry measured by electroencephalography. Adverse events (AEs) were monitored for safety assessment.

Results

The primary outcome measure was not significantly different between the two groups (p=0.2641), although the scores of HRSD in both groups improved significantly after treatment. No significant difference was identified between groups in secondary outcome measures. The incidence of AE was not significantly different between the two groups (p=0.1067).

Conclusion

A clinical trial using electroacupuncture plus moxibustion for MDD seems feasible. However, further studies with the larger size, adopting ideal controls are warranted to provide a confirmative conclusion to the efficacy and safety of electroacupuncture plus moxibustion for MDD.

Trial registration

The protocol was registered at Korean Clinical Trial Registry (CRIS-KCT0001810).

SUBMITTER: Kim M

PROVIDER: S-EPMC8605331 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Study objectivesTo evaluate the efficacy and safety of electroacupuncture as an additional treatment for residual insomnia associated with major depressive disorder (MDD).DesignRandomized, placebo-controlled.SettingA psychiatric outpatient clinic.Participants78 Chinese patients with DSM-IV-diagnosed MDD, insomnia complaint, a Hamilton Rating Scale for Depression (HDRS(17)) score ≤ 18, and fixed antidepressant dosage.InterventionElectroacupuncture, minimal acupuncture (superficial needling at non-acupuncture points), or noninvasive placebo acupuncture 3 sessions weekly for 3 weeks.Measurements and resultsInsomnia Severity Index (ISI), Pittsburgh Sleep Quality Index (PSQI), HDRS(17), 1 week sleep diaries, and 3 day actigraphy were administered at baseline, 1 week post-treatment, and 4 week post-treatment. There was significant group by time interaction in ISI, PSQI, and sleep diary-derived sleep efficiency (mixed-effects models, P = 0.04, P = 0.03, and P = 0.01, respectively). Post hoc pairwise comparisons revealed that electroacupuncture and minimal acupuncture were more efficacious than placebo acupuncture in ISI and PSQI at 1 week and 4 week post-treatment. Minimal acupuncture resulted in greater improvement in sleep diary-derived sleep efficiency than placebo acupuncture at 1 week post-treatment. There was no significant between-group difference in actigraphy measures, depressive symptoms, daily functioning, and hypnotic consumption, and no difference in any measures between electroacupuncture and minimal acupuncture.ConclusionCompared with placebo acupuncture, electroacupuncture and minimal acupuncture resulted in greater improvement in subjective sleep measures at 1 week and 4 week post-treatment. No significant difference was found between electroacupuncture and minimal acupuncture, suggesting that the observed differences could be due to nonspecific effects of needling, regardless of whether it is done according to traditional Chinese medicine theory.

Project description:Background: Major Depressive Disorder (MDD) is a moderately heritable disorder with a high lifetime prevalence. At present, laboratory blood tests to support MDD diagnosis are not available. Methods: We used a classifier approach on blood gene expression profiles of a unique set of non-medicated subjects (MDD patients and controls) to select genes of which expression is predictive for disease status. To reveal blood gene expression changes related to MDD disease, we applied a powerful ex vivo stimulus to the blood, i.e. incubation with lipopolysaccharide (LPS; 10 ng/ml blood). Results: Based on LPS-stimulated blood gene expression using whole-genome microarrays in 42 subjects (primary cohort; 21 MDD patients (mean age 42.3 years), 21 healthy controls (mean age 41.9 years)), we identified a set of genes (CAPRIN1, CLEC4A, KRT23, MLC1, PLSCR1, PROK2, ZBTB16) that serves as a molecular signature of MDD. These findings were validated for the primary cohort using an independent quantitative PCR method (P = 0.007). The difference between depressive patients and controls was confirmed (P = 0.019) in a replication cohort of 13 patients with MDD (mean age 42.8 years) and 14 controls (mean age 45.6 years). The MDD-signature score comprised of expression levels of 7 genes could discriminate depressive patients from controls with sensitivity of 76.9% and specificity of 71.8%. Conclusions: We show for the first time that molecular analysis of stimulated blood cells can be used as an endophenotype for MDD diagnosis, which is a milestone in establishing biomarkers for neuropsychiatric disorders with moderate heritability in general. Our results may provide a new entry point for following and predicting treatment outcome, as well as prediction of severity and recurrence of MDD. In total, 33 MDD patients and 34 healthy controls were analyzed using basal gene expression in whole blood, and gene expression from whole blood that was stimulated with LPS for 5-6 h, using microarrays. Patients were arbitrarily selected from all patients to serve as primary cohort (nMDD = 21 (MDD01-MDD21); nControls = 21 (Con01-Con21)), or replication cohort (nMDD = 12 (MDD22-MDD35); nControls = 13 (Con22-Con37)) using microarrays. This submission does not include Samples CON21_LPS or CON30_LPS.