| ObjectiveA randomized control trial was conducted in this research. Based on the comparison of symptoms, constitutions in Chinese medicine and life quality before and after the intervention of "spirit-regulation formula" with acupuncture to evaluate the short-tern and middle-tern effect on Sub-health state, as well as discover an effective way to improve the health state and discuss the mechanism of "spirit-regulation formula" with acupuncture on Sub-health state.MethodsSub-health state people was observed and an randomized and two-arm controlled design was used in this research, there were85cases in observation group and96cases in control group. Both of the two groups were receiving exercise, dietary, psychological guidance as the basic intervention, treatment of "spirit-regulation formula" with acupuncture, which includes Sishencong, Shenting, Yintang, double Neiguan, double Sanyinjiao was added in observation group for5weeks (10times). The total observation period is4months. The evaluating tools included Sub-health self assessment questionnaire, Sub-health state syndromes questionnaire, Constitution in Chinese medicine questionnaire, and the MOF SF-36questionnaire. All the above questionnaires were used before,5weeks and4months after the intervention to evaluate the clinical effect. Collected data were analyzed by SPSS18.0statistical software and analyzed with methods including descriptive statistics, t test, rank sum test, repeated measures analysis of variance.Results 1. There are no significant differences in the baseline level of gender, age and duration of disease(P>0.05).Total score of Sub-health self assessment questionnaire, Sub-health factors, Sub-health state syndromes questionnaire, area formed by all scores of Constitutions in Chinese medicine in questionnaire, cases of sub-health type and constitution in Chinese medicine type had no statistical significance (P>0.05).2. The main treatment effect analysis:rank sum test and chi-square test were used in this part.①On different observation time after the intervention, there are significant differences between the treatment effect of the two groups (P<0.01), as well as effective rate (P<0.01) and effectual (marked effective) rate(P<0.05).②5weeks after the intervention, health rate of the two groups had statistically significant differences(P<0.01);4months after the intervention, health rate of the two groups had statistically differences(P<0.05)3. The secondary outcome analysis:repeated measures analysis of variance and multivariate analysis of variance were used in this part.①On different observation time after the intervention, the total score of Sub-health self assessment checklist in the two group increased and the difference of both group had statistically significant differences(P<0.01). On the first observation time(5weeks after intervention), the two groups had significant differences(P<0.01); On the second one (4months after intervention), the two groups had no statistically differences(P>0.05).②On different observation time after the intervention, the total score of Sub-health state syndromes questionnaire were decreased in the two group and he difference of both group had statistically significance(P<0.01). And the two groups had significant differences (P<0.01).③On different observation time after the intervention, the total scores of the area formed by all scores of Constitutions in Chinese medicine in questionnaire were decreased in the two groups and the difference of both group had statistically significance (P<0.01). On the first observation time, the two groups had significant differences(P<0.01); On the second one, the scores of observation group increased, however, the two groups had statistically differences(P<0.05).④On different observation time after the intervention, the total scores of factors of sleep, fatigue, physical discomfort, digestive function, negative emotion, positive emotion and ability were increased in the two groups and the difference of both group had statistically significance (P<0.01); he total scores of skin factor, urine relation factor and social relationship factor had no improvement in the two groups (P>0.05). On the first observation time, the scores of sleep, fatigue, digestive function and negative emotion of the two groups had significant differences(P<0.05);the scores of physical discomfort, positive emotion, and ability factors of the two groups had no differences (P>0.05). On the second observation time, the scores of sleep, digestive function and negative emotion factors of the two groups had significant differences(P<0.05); the rest factor of the two groups had no differences(P>0.05).⑤On different observation time after the intervention, the TCM constitution type of the two groups had no differences(P>0.05).⑥On different observation time after the intervention, the total scores of Qi stagnation and Qi deficiency constitution in the two groups had significant differences(P<0.01); Comparing the two groups, the score of Qi stagnation constitution had significant differences(P<0.01); however, the score of Qi deficiency constitution had no differences(P>0.05).⑦On different observation time after the intervention, the dimension of physiological functions, general health, energy, social function, emotional function, mental health and the physical pain had improvement in the two groups and the difference of both group had statistically significance (P<0.05); the physiological function dimension in the two groups and body pain dimension in the control group had no differences(P>0.05). Comparing the two groups, On the first observation time, the scores of general health, energy dimension of the two groups had significant differences(P<0.05). On the second observation time, only the scores of energy dimension had significant differences(P<0.05); the rest dimension of the two groups had no differences(P>0.05).4. Analysis of adverse reaction:symptoms in headache and dizziness, syncope, mild injury of tendon.Conclusion1. Both basic guidance intervention and treatment of "spirit-regulation formula" with acupuncture all have clinical effects on improving the overall health status, symptoms and general physical condition. And the latter is obvious. The short-term efficacy of intervention of "Spirit-Regulating formula" with acupuncture on sub-health symptoms is significant, but medium-term efficacy decreased.2. Both basic guidance intervention and treatment of "spirit-regulation formula" with acupuncture all have clinical effects on sleep, fatigue, physical discomfort, digestive function, negative emotion, positive emotion, ability. Compared with basic guidance intervention,"Spirit-Regulating formula" with acupuncture had both significant short-term and middle-term effect on improving sleep, digestive function, negative emotion. And its short-term efficacy on fatigue symptoms is significant, but medium-term efficacy decreased.3. Both basic guidance intervention and treatment of "spirit-regulation formula" with acupuncture all have clinical effects on improving the Qi stagnation and Qi deficiency constitution. Compared with basic guidance intervention,"Spirit-Regulating formula" with acupuncture had better effect on Qi stagnation constitution than Qi deficiency one.4. Both basic guidance intervention and treatment of "spirit-regulation formula" with acupuncture all have significant clinical effects on improving the physiological functions, general health, energy, social function, emotional function and mental health aspect. The latter has significant effect on improving body pain aspect, but basic guidance had no effect on this aspect. Compared with the basic guidance intervention,"Spirit-Regulating formula" with acupuncture had both significant short-term and middle-term effect on improving energy dimension. And its short-term efficacy on general health dimension symptoms is obviously, but has poor medium-term efficacy.5. Both basic guidance intervention and treatment of "spirit-regulation formula" with acupuncture had poor effects on improving the TCM constitution type, skin factor, urine factor, social relationship factor and physiological function dimension. |
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