| ObjectiveComparing with Ling Nan traditional medicinal vesiculation and placebo control, to observe clinical effect and safety of No.2 Ling Nan traditional medicinal vesiculation therapy for insomnia caused by generalized anxiety disorder.Methods1. Randomizationg and blindness:Randomly divided 159 subjects of insomnia caused by generalized anxiety disorder into 3 groups-group 1, group 2, and group 3, according to the proportion of 1:1:1, with 53 subjects in each group. Used double blinded method to treat and follow up.2. Treating methods:(1) Group 1:① Medicine:Used No.2 Ling Nan traditional medicinal vesiculation therapy medicine, mainly contents were:Semen Brassicae Junceae, Rhizoma Coptidis, Cortex Cinnamomi Cassiae, Fructus Evodiae Rutaecarpae, and ect.② Medicine prepare:Weighed the medicine according to prescription. Used clear water to soak the medicine, then open-air dryed the medicine. Milled the medicine into powder, then sieved powder with siever of 80 Mu. Used proper amount of powder mixing with ginger juice in a ratio of 3:4 into lcmxlcmxlcm medicine cakes.③ Acupoints:There were two acupoints schemes:① Xinshu, Danshu, Shenshu, Sanyinjiao, Shuifen, Yinjiao; ② Zhongwan, Xiawan, Qihai, Guanyuan, Mingmen, Ganshu, Lingtai, Yongquan. If the acupoints were bilateral, both acupoints were used. Use acupoints schemes at every other time.④ Manipulation:Subjects were in a quiet inner room with temperature at least 25 degree centigrade, in either a sitting position or a lying position. Medicinal vesiculation were made according to the process of medicinal vesiculation therapy.(2) Group 2:① Medicine:Used Ling Nan traditional medicinal vesiculation medicine, mainly contents were:Semen Brassicae Junceae, Herba Asari Mandshurici, Radix Kansui, Rhizoma Corydalis Yanhusuo, and ect.② Medicine prepare, acupoints, and manipulation were the same with group 1.(3) Group 3:① Medicine:Used placebo medicine, mainly contents were:buckwheat powder, pigments, and ect.② Medicine prepare:Weighed the buckwheat powder. Used clear water to soak the medicine, then open-air dryed the buckwheat powder. Milled the buckwheat powder, then sieved it with siever of 80 Mu, mixing with 1:20 Ling Nan traditional medicinal vesiculation medicine, then using proper amount of powder mixing with ginger juice in a ratio of 3:4 into lcmxlcmxlcm medicine cakes.③ Acupoints, and manipulation were the same with group 1.3. Course of treatment and follow-up:Two times a week, for 8 times, and then with one month follow-up. Every treatment lasted for 1 hour. Valid cases at least finished 7 treatments.4. Outcomes:(1) Pittsburgh Sleep Quality Index (PSQI).(2) Zung`s Self-rating Anxiety Scale (SAS).(3) Short form 36 Health Survey (SF-36).(4) Genearal information:including sex, age, and ect.(5) Adverse effects.5. Time of outcome evaluation:before treatment, after treatment and after 1-month follow-up.6. Therapeutic effect standard:according to Diagnosis standard of Chinese Medicine Diseases, and Clinical Research Principles of New Herbal Medicine for Treating Insomnia.(1) Remitted:normal sleep time or more than 6 hours of sleep during night;(2) Particularly responded:better sleep more than 3 hours, sleep depth increased;(3) Responded:symptom reduced, sleep less than 3 hours;(4) Non-responded:no change.7. Statistic methods:Used SPSS16.0 software through chi-square test, F test, Wilcoxon signed rank test, Kruskal-Wallis test or Logistic Regression test.ResultsDuring the treatment,7 subjects dropped out-2 in group 1,3 in group 2, and 2 in group 3, total dropout rate was 4.4%. Data of all dropouts were excluded in statistic analysis.1. Baseline:Average age of three groups were 51.82±12.08,47.86±13.39, and 48.65±13.19 years,P=0.264.10 male and 41 female were in group 1,12 male and 38 female were in group 2,9 male and 42 female were in group 3, P=0.720. Disease length were 100.88±11.85,97.33±100.65, and 51.12±80.40 months in three groups separately, P=0.020. Treatment history were 32,28,28 in three groups separately, P=0.686. Treatment length were 19.16±49.04, 13.81 ±24.50, and 9.4±35.16 months,P=0.426. Besides disease history (P=0.020), all information in three groups were not significantly different at baseline (P>0.05).2. PSQI:(1) After 1 month treatment, there were significant differences among three groups (F=5.973,P=0.003<0.01). No difference between group 1 and group 2 (P=0.266). Both groups were better than group 3 (P=0.00<0.05, P=0.023<0.01). Comparing with baseline, group 1 and group 2 changed significantly (P=0.000<0.01), group 3 changed significantly (P=0.037<0.05).In 8 scales of PSQI, overall sleep quality and sleep efficiency were of significant differences (P<0.01) among three groups. Between groupl and group 3, overall sleep quality (P<0.01), duration of sleep, sleep efficency, and day dysfunctrion due to sleepiness (P<0.05) were of significant differences. Between group 2 and group 3, sleep efficency (P<0.01), overall sleep quality (P<0.05) were of significant differences. Comparing with baseline, overall sleep quality, sleep latency, duration of sleep, and sleep efficency were of significant differences (P<0.01) in both group 1 and group 2. Comparing with baseline, duration of sleep were of significant diffrence (P<0.05) in group 3.(2) After 1 month follow-up, there were significant differences among three groups (F=7.552, P=0.001<0.01). No difference between group 1 and group 2 (P=0.266). Both groups were better than group 3 (P=0.000<0.01, P=0.007<0.01). Comparing with baseline, group 1 and group 2 changed significantly (P<0.01), but no change in group 3 (P>0.05).In 8 scales of PSQI, overall sleep quality and sleep efficiency were of significant differences (P<0.01) among three groups. Between group 1 and group 3, overall sleep quality (P<0.01), duration of sleep, sleep efficency, and day dysfunctrion due to sleepiness (P<0.05) were of significant differences. Between group 2 and group 3, sleep efficency (P<0.01), overall sleep quality (P<0.05) were of significant differences. Comparing with baseline, overall sleep quality, sleep latency, duration of sleep, and sleep efficency (P<0.01) were of significant differences (P<0.01) in both group 1 and group 2.Comparing with baseline, duration of sleep were of significant diffrence (P<.05) in group 3.(3) Using reapeated measures, Mauchly’s Test of Sphericity (P=0.000), time factor (F=78.447, P=0.000), time factor*group (F=12.260, P=0.000), there were great differences among three groups and among different time.3. SAS:(1) After 1 month treatment, there were significant differences among three groups (P=7.361, P<0.01). No difference between group 1 and group 2. Both groups were better than group 3 (P<0.01). Comparing with baseline, group 1 and group 2 changed significantly (P<0.01), group 3 changed significantly (P<0.05).(2) After 1 month follow-up, there were significant differences among three groups (F=0.196, P<0.01). Both groups were better than group 3 (P<0.01). Comparing with baseline, group 1 and group 2 changed significantly (P<0.01), group 3 changed significantly(P>0.05).(3) Using reapeated measures, Mauchlys Test of Sphericity (P=0.000), time factor (F=59.831,P=0.000), time factor*group (F=4.451,P=0.013), there were great differences among three groups and among different time.4. SF36:(1) After 1 month treatment, there were significant differences among three groups (P<0.05) in Physical Functioning (PF), Vitality (VT), Role-Emotional (RE), and Mental Health (MH) scales of SF36. PF was siganifacantly different between group 1 and group 2 (P<0.05). Between group 1 and group 3, general Health (GH) and VT were of significant differences (P<0.05), and RE, MH were of significant differences (P<0.01). Between group 2 ang group 3, MH was significantly different (P<0.05). Comparing with baseline, VT was of significant difference (P<0.05) in group 1, and GH was of significant difference (P<0.05) in group 2.(2) After 1 month follow-up, there were significant differences among three groups in PF, GH, VT, and RE (P<0.05), MH (P<0.01). There was no difference between group 1 and group 2. PF, RP, VT and RE (P<0.05), GH, MH (P<0.01) were of significant diffrences between group 1 and group 3. VT (P<0.05), RP and MH (P<0.01) were of significant differences between group 2 and group 3. Comparing with baseline, VT in group 1 was significantly different (P<0.05), and RF in group 2 was significantly different (P<0.01).5. General Effacicy:After treatment,12 cases remitted,4 cases particularly responded,24 cases responded, and 10 cases non-responded in group 1.6 cases remitted, 11 cases prticularly responded,21 cases responded, and 12 cases non-responded in group 2. none cases remitted,3 cases particularly responded,26 cases responded, and 22 cases non-responded in group 3. Total efficacy rate was 80.39% in group 1,76% in group 2, and 56.86% in group 3. There was significant differences among three groups, P<0.01. There was no difference between group 1 and group 2 (P>0.05), but there were differences between group 1 and group 3, and between group 2 and group 3 (P<0.01).6. Medicine combined use:Patients in all three groups used less medicine during treatment and 1-month follow-up. No difference among three groups at baseline (P>0.05). After treatment, no difference among three groups (P>0.05), but patients in group 3 used more medicine than group 1 and group 2. After 1-month follow-up, there were differences among three groups (P<0.01). After 1-month follow-up, there were differences between group 1 and group 3 (P<0.05), between group 2 and group 3 (P<0.01) separately. In group 1, compared with baseline, there were differences after treatment and after 1-month follow-up separately (P<0.01). In group 2, compared with baseline, there were differences after treatment and after 1-month follow-up separately (P<0.01). In group 3, compared with baseline, there were differences after treatment and after 1-month follow-up separately (P<0.01); compared with after treatment, there was difference after 1-month follow-up (P<0.01).7. Adverse effect:No severe adverse effect was reported during the trial.5 cases of mild adverse effect in group 1,6 cases of mild adverse effect in group 2, while no adverse effect reported in group 3 (P>0.05).Gonclusion1. No.2 Ling Nan traditional medicinal vesiculation therapy significantly changes sleep condition, anxiety symptoms for better, improves life quality, and reduces medicine use in insomnia caused by generalized anxiety disorder.2. No.2 Ling Nan traditional medicinal vesiculation therapy and Ling Nan traditional medicinal vesiculation therapy have similar effect, but No. Ling Nan traditional medicinal vesiculation therapy significantly change duration of sleep scale and day dysfunctrion due to sleepiness sacle in PSQI and change PF, RE, GH, and VT scales in SF-36 better than Ling Nan traditional medicinal vesiculation therapy. And both No.2 Ling Nan traditional vesiculation therapy and Ling Nan traditional vesiculation therapy have few adverse reactions, have good application prospect, and have popularization value in future clinical research. |
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