| BackgroundDepression is a common mental disorder which afflicts human beings physically and psychologically. With the rapid development of society and economy, and the acceleration of life paces, great changes have taken place in spectrum of diseases as people burden increasing mental pressure. Mental disorders gradually become a usual disease with its rising incidence recent years. The rate of diagnosis and treatment for depression is very low nowadays; and the conventional method is drug treatment.Because depression is the complicated mental disease, any single drug can not treat the multiple symptoms. Acupuncture therapy has the role of integrated and multiple targeted for depression, and has been paid great attention by many clinical researchers. Although many studies had been carried out, these studies still could not supply enough effective evidence based medicine for acupuncture treatment.In order to verify the curative effect of acupuncture treatment for depression, we searched and optimized many depression treatment protocols in recent years, confirm two protocols for treating depression by acupuncture. Based on the principles of evidence based medicine, we carried out a multi-center, large samples, randomized and controlled trial, to supply objective evidences for acupuncture treating depression and to promote the wide clinical application of acupuncture treatment for depression.Object1. To confirm the validity of different acupuncture therapeutic proposals for depression.2. To evaluate the effective time, features and advantages of the three different proposals based on the validity of acupuncture for depression.3. To discuss the influences different depression treatment protocols to patients' self-assessment of clinic results and health condition.4. To discuss the influences different protocols to TCM syndrome differentiation brief scales, expecting to offer ideas for curative effect assessment method of TCM clinics studies.MethodsIn order to evaluate the effective of acupuncture for depression, multi-center, large samples, randomized and controlled trial were carried out. Clinical cases were collected from four branch centers (The 6th Hospital of Peking University, The Sixth Hospital of Baotou City, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine and Affiliated Hospital of Southern Medical University) simultaneously.Clinic patients had been selected into the trial, according to the diagnosis standardization, eliminating standardization, grouping standardization and informed consensus principle, and been divided into three groups(electro-acupuncture group, manual acupuncture group, Paroxetine hydrochloride group) randomly. Electro-acupuncture group was intervened by electro-acupuncture, the main acupunctural acupoints were BAIHUI, YINTANG, the acupoints of differentiation of symptoms were FENGFU, FENGCHI, NEIGUAN, SANYINJIAO. Manual acupuncture group was acupunctured by manual operation, the main acupunctural acupoints were BAIHUI, YINTANG, the acupoints of differentiation of symptoms were FENGFU, NEIGUAN, SANYINJIAO. The clinical period of treatment were 6 weeks. Follow-up study was carried out on the fourth week after the clinical treatment. All the clinical cases in this study were collected from the 6th Hospital of Peking University and multiple center respectively.From November 2008 to July 2010,88 clinic outpatients have been selected into the trial in 6th hospital of Peking university according to the diagnosis standardization, eliminating standardization, grouping standardization and informed consensus principle. The participants are divided into three groups randomly,28 for electro-acupuncture with Paroxetine hydrochloride,25 for manual acupuncture with Paroxetine hydrochloride and 35 for Paroxetine hydrochloride merely.Total cases are collected from four clinical centers (the 6th hospital of Peking university, the Sixth Hospital of Baotou City, Affiliated Hospital of Nanjing University of Traditional Chinese Medicine and Affiliated Hospital of Southern Medical University Hospital), from June 2008 to December 2010,477 clinic outpatients have been selected into the trial according to the diagnosis standardization, eliminating standardization, grouping standardization and informed consensus principle. The participants are divided into three groups randomly,161 for electro-acupuncture with Paroxetine hydrochloride,162 for manual acupuncture with Paroxetine hydrochloride and 154 for Paroxetine hydrochloride merely.HAMD and SDS scales are applied in the assessment of curative effect at the 0,1,2,4,6 weeks, and at the 0,2,4,6 weeks, SERS scale is applied to assess the side effects. At the 0,6 weeks, CGI scale is applied to assess the global curative effect of each group, with WHOQOL-BREF scale for patients'life quality assessment, MYMOP scale for self-assessment of clinic syndromes and a TCM syndrome differentiation brief scale for the TCM syndrome changes.4 weeks after the treatment termination, the participants are reviewed with HAMD. Main effective outcome measures were analyzed by two methods of Intention To Treat analysis (ITT) and Pendence Proposal Single analysis(PPS).ResultsResults for branch center1. Curative effect:According to ITT and PPS analysis, statistical meaning are found in differences among the three groups (P<0.05), the total effect rate of both the two acupuncture group are higher than the medicine group, but no significant differences are found between two acupuncture groups(P>0.05).2. Recovery rate:According to ITT and PPS analysis, no statistical meaning are found in differences among the three groups (P>0.05).3. Effect time:According to ITT and PPS analysis, significant differences are found between 1 week after treatment HAMD scores and baseline scores in the two acupuncture group. In medicine group, significant differences are found between 2 weeks after treatment HAMD scores and the baseline scores.2,4,6 weeks after treatment, significant differences are found in HAMD scores among three groups(P<0.05), no significant differences are found in the improvement of depressive symptoms after treatment between the two acupuncture groups.Depressive Symptoms can be improved 1 week after treatment in the two acupuncture groups; while in medicine group is 2 weeks, which indicates that acupuncture has an early curative effect.4. HAMD factors scores:Significant differences are found at HAMD anxiety/somatization, sleep disorders factors scores after 1,2,4,6 weeks treatment among the three groups(P<0.05), the improvement of the two factors in two acupuncture groups is better than that of medicine group at each period.No significant differences are found at the improvement of HAMD retardation, cognition disorder, body weight factors scores at each period among three groups at each period(P>0.05).No significant differences are found at the improvement of HAMD anxiety/somatization, sleep disorders, retardation, cognition disorder, body weight factors scores at each period between two acupuncture groups at each period (P>0.05)5. SDS scores:Significant differences are found between 2 weeks after treatment scores and baseline scores in all three groups. Scores in two acupuncture groups are significantly lower than that of medicine group after 4,6 weeks treatment P<0.05), but no significant differences are found between two acupuncture scores at each period (P>0.05) 6. CGI scores:Significant differences are found at disease severity, total assessment of curative effect and curative effect index among all three groups after 6 weeks treatment(P<0.05), disease severity, total assessment of curative effect of the two acupuncture groups are significantly lower than that of the medicine group, while the curative effect index of the two groups is apparently higher than the medicine group.No significant differences are found at disease severity, total assessment of curative effect and curative effect index between the two acupuncture groups after 6 weeks treatment(P>0.05).7. Adverse events and side effects:Rates of bad events in the three groups are 14.29%, 12.0%,17.14%, without significant differences(P>0.05).Significant differences are found at SERS scores among three groups after 2,4,6 weeks treatment(P<0.05). SERS scores of two acupuncture groups are significantly lower than that of medicine group at each period, but no significant differences are found between two acupuncture groups at each period(P>0.05).8. WHOQOL-BREF scores:Significant differences are found at total subjective feeling of living quality, total subjective feeling of health condition, physical aspect and psychological aspect scores among the three groups after 6 weeks treatment(P<0.05), scores in the two acupuncture groups are significantly higher than that of medicine group, but no significant differences are found between the two acupuncture groups. No significant differences are found at social relationship aspect and environment aspect scores among all three groups after 6 weeks treatment.9. MYMOP scores:Significant differences are found at symptoml, symptom2, activity and global health condition scores among three groups after 6 weeks treatment(P<0.05), Scores in two acupuncture groups are significantly lower than the medicine group, but no significant differences are found between two acupuncture groups.10.TCM syndrome differentiation brief scale scores:Pretty significant differences are found at main complaints, combined symptoms and Eight-principles syndrome differentiation scores among three groups after 6 weeks treatment(P<0.01), Scores in two acupuncture groups are significantly lower than the medicine group, but no significant differences are found between two acupuncture groups.11. follow-up HAMD scores:Significant differences are found among three groups. Scores in two acupuncture groups are significantly lower than the medicine group, but no significant differences are found between two acupuncture groups(P>0.05).Results for total clinical cases of the four centers 1.According to HAMD scores, after the analysis of ITT and PPS, the three groups had the apparently differences (P<0.05) The electro-acupuncture group and manual acupuncture group was more better than Paroxetine hydrochloride group.2.When HAMD≤7, after the analysis of ITT and PPS, the full remission for three groups was significantly different (P<0.05) The electro-acupuncture group and manual acupuncture group was more better than Paroxetine hydrochloride group.3.To evaluate the effective time based on HAMD scores, by using the two analysis methods, each group has the anti-depression effect after 1 week treatment(P<0.01). There exist differences among the three groups after 2 weeks treatment(P<0.01), electro-acupuncture group, manual acupuncture group was more effective than Paroxetine hydrochloride group, electro-acupuncture was no differences with manual acupuncture group (P>0.05)4. SDS scores were analyzed by the two analysis methods, SDS scores for the three groups was significant different from baseline (P<0.01). There exist significant differences among the three groups(P<0.01). SDS scores for manual acupuncture group and electro-acupuncture group was more lower than Paroxetine hydrochloride group. There were no differences between the two acupuncture groups (P>0.05)5.SERS scores were analyzed by the two analysis methods, SERS scores for the three groups was significant different from baseline (P<0.01). There exist significant differences among the three groups(P<0.01). SERS scores for manual acupuncture group and electro-acupuncture group was more lower than Paroxetine hydrochloride group. There were no differences between the two acupuncture groups (P>0.05)6. By analysis of ITT and PPS, WHOQOL-BREF table scores for the three groups was significant different from baseline (P<0.01). There were no differences among the three groups for the scores of WHOQOL-BREF table (P>0.05)7.CGI table were analyzed by the two methods:SI scores for the three groups were different from the baseline (P<0.01), SI scores were different for the three groups (P<0.05), SI scores for electro-acupuncture group and manual acupuncture groups was lower than Paroxetine hydrochloride group, SI scores for the two acupuncture groups were no differences (P>0.05)GI were significant different among the three groups (P<0.01), GI for electro-acupuncture group and manual acupuncture group was better than Paroxetine hydrochloride group, GI for the two acupuncture groups were no differences (P>0.05) El were significant different among the three groups (P<0.01), El for electro-acupuncture group and manual acupuncture group was better than Paroxetine hydrochloride group, El for the two acupuncture groups were no differences (P>0.05)Comparison for the results of two classification casesThe results for multiple center, large samples,randomization study was almost the same as the results for branch centers, there still existed some differences for relative indexes:1.When evaluated the full remission of depression by using HAMD≤7, branch center results showed that there were no differences for the three groups; total clinical cases results showed that the two acupuncture groups were more effective than Paroxetine hydrochloride group.2.To effective time, branch center results showed that Paroxetine hydrochloride group had effective from the second week, total clinical cases results showed that Paroxetine hydrochloride group had effective from the first week. Scores for the three groups were almost the same for branch center and total clinical cases.3.To SDS scores, branch center results showed that SDS scores for the three groups were different from their baseline, there were differences for the three groups after 4 weeks treatment. Total clinical cases results showed that there were differences for the three groups during different periods, significant differences was more earlier than branch center.4.To SERS scores, the branch center results were almost the same as the total clinical cases results, there existed differences among the groups and during different periods.5.CGI for the three groups were almost the same between branch center results and total clinical cases results6. To WHOQOL-BREF table scores, total quality of life was almost the same for the branch center and total clinical cases. After treatment, branch center results showed that there were differences among the three groups; total clinical cases results showed that there were no differences among the three groups.Conclusions1.The effectiveness of combined acupuncture and Paroxetinehas hydrochloride is superior to the Paroxetinehas hydrochloride treatment, the combined treatment improves the recovery rate of depression.2.Acupuncture can shorten the effective time of Paroxetinehas hydrochloride and have an advantage of improve the patients'somatic symptoms such as the anxiety/somatization, sleep disorders factors as well.3.The combined treatment of acupuncture and medicine is superior to the medicine group in improving patients'self-assessment of symptoms of depression and health condition. 4.Acupuncture can improve patients'self-condition, activity and health assessment, and increase the self-awareness of the patients.5.Assessment for depression curative effect based on TCM syndrome differentiation can be in accordance with other assessment methods. |
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