Comparative Effects Of Integrative Acupuncture Therapy And Paroxetine In Patients With Mild-to-moderate Depressive Disorder And Insomnia

ObjectiveThis study aims at comparing the effect of integrative acupuncture therapy with paroxetine in patients with mild-to-moderate depressive disorder and insomnia.MethodsThis was a randomized controlled trial. Recruited 60 patients with mild-to-moderate depressive disorder and insomnia from acupuncture and psychological department from Guangdong Provincial Hospital of TCM,1:1 randomized into two groups,30 cases in each group. The treatment group(group 1) was treated with acupuncture, moxibustion and intradermal needling, while the control group (group 2) was treated with paroxetine.①In group 1:Acupuncture points included Hegu (LI14), Taichong (LR30), Baihui (DU20), Yintang (EX-HN3), Zhongwan (CV12), Xiawan (CV10), Qihai (CV6), Guanyuan (CV4), Huaroumen (ST24), moxibustion points included Geshu (BL17), Danshu (BL19), and intradermal needling points included Xinshu (BL15), Ganshu (BL18).Manipulated the needles until de-qi, retained the needles for 30 minutes, and at the same time asked patients to take deep breath. After pulling out the needles, asked patients to turn to prone position or sitting position. Dipped medicinal paraffin oil onto acupoints, sticked minimal moxa cones onto skin and lit them with joss stick. Removed the burnt moxa cones when skin turned red and patients felt painful. Inserted intradermal needle into acupoint, put 1 square centimeters of surgical tape under the needle and 4 squre centimeters of surgical tape above it.Retained the needles for 3 days. Administrated intervention twice a week and the duration was 8 weeks.②In group 2:Seroxat produced by SK&F Pharmaceutical Corpotation was used in this study. The initial dose of Seroxat was 20mg and adjusted dose if necessary. The max dose could not exceed 50mg daily. Took Seroxat 30 minutes before sleep every day for eight weeks. Administered interventions every day and the duration was 8 weeks.The primary outcome measures was Pittsburgh Sleep Quality Index (PSQI). The secondary outcomes were Hamilton Rating Scale for Depression(HAM-D), Insomnia Severity Index(ISI) and Self-reporting Inventory(SCL-90). Outcomeswere evaluated at baseline,4 weeks and 8 weeks during treatment. Safety assessments included Treatment Emergent Symptom Scale(TESS), treatment-emergent adverse events(AEs), reasons for discontinuation, and AEs leading to discontinuation.Statistical analysis was carried out using SPSS software (version 19; IBM Corporation, Armonk, NY, USA). Means and standard deviations were used for continuous data and frequencies and percentages for categorical data. For the normally distributed continuous data, t-tests were conducted to compare means. For categorical data, chi-square analyses were conducted. Any significant imbalances among the groups were reported using student t-tests or chi-squares when appropriate.Results1. A total of 60 patients were recruited in the study, however,2 cases of control group dropped out.58 patients were included in statistical analysis.2. No significant difference was found at baseline regard to age, gender,course of depression, course of insomnia, score of PSQI, score of HAM-D24, score of ISI, score of SCL-90 (P>0.05).3. Pittsburgh Sleep Quality Index①total scoreThe total score of PSQI were reduced in two groups. Compared to baseline, significant differences were found at 4 weeks and 8 weeks separately within the two group (P=0.000). At 4 weeks and 8 weeks, no significant differences were found between groups (P=0.356, P=0.493).②factor scoreSix factor score including sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances and daytime dysfunction, were reduced in the treatment group, and significant differences were found at 8 weeks compared to baseline(P<0.05). Seven factor score including sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication and daytime dysfunction, were reduced in the control group, and significant differences were found at 8 weeks compared to baseline (P<0.05). At 4 weeks, no significant differences were found between seven factor of two groups(P>0.05).At 8 weeks, significant differences were found between sleep quality, sleep latency of two groups(P=0.002, P=0.019).4. Hamilton Rating Scale for DepressionThe score of HAMD-24 were reduced in two groups. Compared to baseline, significant differences were found at 4 weeks and 8 weeks separately within the two group (P=0.000).At 4 weeks and 8 weeks, no significant differences were found between groups (P=0.888, P=0.270).5. Insomnia Severity IndexThe score of ISI were reduced in two groups. Compared to baseline, significant differences were found at 4 weeks and 8 weeks separately within the two group(P<0.05). At 4 weeks and 8 weeks, no significant differences were found between groups (P=0.060, P=0.126).6. Self-reporting Inventory①total scoreThe total score of SCL-90 were reduced in two groups. Compared to baseline, significant differences were found at 4 weeks and 8 weeks separately within the two group (P=0.000). At 4 weeks and 8 weeks, no significant differences were found between groups (P=0.293, P=0.715).②depression factor scoreThe depression factor score were reduced in two groups. Compared to baseline, significant differences were found at 4 weeks and 8 weeks separately within the two group (P=0.000). At 4 weeks and 8 weeks,no significant differences were found between groups (P=0.904, P=0.785).③somatization factor scoreThe somatization factor score were reduced in two groups. Compared to baseline, significant differences were found at 4 weeks and 8 weeks separately within the two group (P=0.000). At 4 weeks, no significant difference was found between groups (P=0.364).At 8 weeks, significant difference was found between groups (P=0.043).7. Effective RateAt 8 weeks, the effective rate of treatment group was 86.67%, and the effective rate of control group was 82.14%. No significant difference was found (χ2=0.226, P=0.634).8. Safety EvaluationThree cases in treatment group reported subcutaneous hematoma after pulling out the needles. The hematoma faded after hot compress therapy and potato slice application, and the patients continued the study. In control group, fifteen case reported nausea and vomiting, ten cases reported loss of appetite, eight cases reported somnolence, five cases reported constipation, three cases reported diarrhea, and and one case was found tachycardia and T wave high peak by electrocardiogram in 8 weeks.ConclusionIntegrative acupuncture therapy can improve the mood and sleep quality of patients with mild-to-moderate depressive disorder and insomnia, and integrative acupuncture therapy may be as effective as paroxetine. In the aspect of improving sleep quality and reducing sleep latency, integrative acupuncture therapy may be more effective than paroxetine. The adverse reaction of integrated acupuncture therapy is less than paroxetine.