| Objective1. To observe the efficacy and safety of needling Baihui and acupoint injection with erigeron breviscapus (EB) concomitant with five-element music therapy on post-stroke depression (PSD) of patients with ischemic brain stroke (IBS), hoping to provide valuable clinical references for the application of "treatments for both mind and body" on IBS patients.2. To observe the expressions of serum interleukin-6 (IL-6), high-sensitive C-reactive protein (hs-CRP), tumor necrosis factor-α (TNF-α) and homocysteine (HCY) so as to explore their relationships with PSD severity.MethodsA total of 92 PSD patients admitted in Inpatient Department of Department of Neurology, Guangzhou Hospital of TCM from March,2014 to February,2015 were selected as study objects and randomly divided into three groups by Random Number Table, control group (32 cases), treatment group A (30 cases) and treatment group B (30 cases). On the basis of basic therapies for patients with cerebral infarction, control group was added with oral Sertraline Hydrochloride Tablets (50 mg/d) while treatment group A with needling Baihui (q. d.) and acupoint injection on Yanglingquan (EB 2 mL, q. d.) and treatment group B with needling Baihui (q.d.) and acupoint injection on Yanglingquan (EB 2 mL, q.d.) concomitant with five-element music therapy (bid.),5 d as a cycle with 1 d intermission, for totally 3 cycles. Hamilton depression scale (HAMD) (17 programs), clinical observation of traditional Chinese medicine (TCM) symptoms of PSD, nervous functional defects scale (1995) (NFDS) and activities of daily living (ADL) among 3 groups were compared so as to evaluate the clinical efficacy and Treatment Emergent Symptom Scales (TESS) of 3 groups were compared in order to evaluate the safety.Results1. Comparison of baseline among 3 groups before treatmentBefore treatment, there was no significant difference in the general data (including ages, genders, nidus numbers and depression severity) as well as HAMD (17 Programs), clinical observation table of TCM symptoms, NFDS (1995) and ADL among 3 groups (P>0.05) with balanced baseline and comparability.2. Comparison of HAMD scoresHAMD scores decreased to some extent in all groups after treatment and there were significant differences when compared before treatment (P<0.01). However, there was no significant difference among 3 groups (P>0.05). After treatment, treatment group B was evidently larger than treatment group A in HAMD score changes, and the difference was significant (P<0.01).The evaluation results of clinical efficacy of HAMD of 3 groups showed that the clinical efficacy of control group, treatment group A and treatment group B were 59.4%,63.3% and 80%, respectively, but there was no significant difference (P>0.05).3. Comparison of TCM symptom scoreTCM symptom scores decreased to some extent in all groups after treatment and there were significant differences when compared before treatment (P<0.01). However, there was no significant difference among 3 groups (P>0.05). After treatment, the TCM symptom score was markedly higher in treatment group B than in treatment group A, and the difference was significant (P<0.01), which was also higher in treatment group A than in control group, but the difference was not significant (P>0.05).The evaluation results of clinical efficacy of TCM symptoms of 3 groups showed that the clinical efficacy of control group, treatment group A and treatment group B were 59.4%,70% and 96.6%, respectively, and there were significant differences among 3 groups (P<0.01).4. Comparison of NFDS scoresNFDS scores decreased to some extent in all groups after treatment and there were significant differences when compared before treatment (P<0.01). However, there was no significant difference among 3 groups (P>0.05). After treatment, the NFDS score was markedly higher in treatment group B than in treatment group A, and the difference was significant (P<0.01), which was higher in treatment group A than in control group, but the difference was not significant (P>0.05).5. Comparison of ADL scoresADL scores increased to some extent in all groups after treatment and there were significant differences when compared before treatment (P<0.01). However, there was no significant difference among 3 groups (P>0.05). After treatment, the ADL score was markedly higher in treatment group B than in treatment group A, and the difference was significant (P<0.01), which was lower in treatment group A than in control group, but the difference was not significant (P>0.05).6. Comparison of TESS scoresThe results of TESS score evaluation of 3 groups demonstrated that the TESS score was the highest in control group and were evidently lower in treatment groups A and B than in control group, and was the lowest in treatment group B. There were significant differences in all groups after treatment and there were significant differences when compared before treatment (P<0.01) and among 3 groups (P<0.01).7. Relationship between IL-6 and PSDSerum IL-6 level was higher in mild, moderate and severe PSD patients than the normal level, and there were significant differences (P<0.01), in which it was the lowest in mild PSD patients and the highest in severe PSD patients, indicating that the IL-6 level increased along with the severity of depression. However, there was no significant difference among mild, moderate and severe PSD patients (P>0.05).8. Relationship between TNF-a and PSDSerum TNF-a level was higher in mild, moderate and severe PSD patients than the normal level, and there were significant differences (P<0.01), in which it was the lowest in mild PSD patients and the highest in severe PSD patients, indicating that the TNF-a level increased along with the severity of depression. However, there was no significant difference among mild, moderate and severe PSD patients (P>0.05).9. Relationship between hs-CRP and PSDSerum hs-CRP level was higher in mild, moderate and severe PSD patients than the normal level, and there were significant differences (P<0.01), in which it was the lowest in severe PSD patients and the highest in moderate PSD patients. However, there was no significant difference among mild, moderate and severe PSD patients (P>0.05).10. Relationship between HCY and PSDSerum HCY level was lower in mild, moderate and severe PSD patients than the normal level, and there were significant differences (P<0.01), in which it was the lowest in mild PSD patients and the highest in severe PSD patients, indicating that the HCY level increased along with the severity of depression and all were lower than normal the normal level. However, there was no significant difference among mild, moderate and severe PSD patients (P>0.05).Conclusions1. Needling Baihui and acupoint injection on Yanglingquan or needling Baihui and acupoint injection on Yanglingquan concomitant with five-element music therapy both can effectively improve the depression severity and the ADL of patients with PSD, which suggests similar clinical efficacy with western medicine and lower rate of adverse responses than western medicine. However, needling Baihui and acupoint injection on Yanglingquan combined with five-element music therapy are more superior to western medicines in improving the clinical efficacy and TCM symptom score as well as NFDS. Compared with needling Baihui and acupoint injection on Yanglingquan, needling Baihui and acupoint injection on Yanglingquan concomitant with five-element music therapy are more effective in improving the depression severity, TCM symptoms, NFDS and ADL, with better clinical efficacy and less adverse responses in patients with PSD.2. Needling Baihui and acupoint injection on Yanglingquan concomitant with five-element music therapy is better in clinical efficacy and less in adverse responses in patients with PSD, thus providing clinical evidences for the treatment of psychological and physical diseases with principle of "treatments for both mind and body"3. Treatments for both mind and body are more effective than those only for body in clinical efficacy in patients with PSD.4. Serum IL-6, hs-CRP and TNF-α are in close association with the development of PSD after IBS, whose increases are not significant with the PSD severity, though they all increase to some extent. HCY has no remarkable connection with PSD after IBS. |
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