针刺“调神方”干预亚健康状态的临床研究
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摘要
目的：
本研究为随机对照临床试验研究,通过对针刺“调神方”干预前后亚健康状态的症状、体质、生活质量等临床比较,旨在评价针刺“调神方”干预亚健康状态的短期疗效和中期疗效,期望能够探索出有效改善亚健康状态的干预方法和针刺处方并探讨针刺调神方防治亚健康状态的机理。
方法：
以亚健康状态患者作为研究对象,采用随机对照试验设计,共纳入观察组病例85例,对照组病例96例。观察组给予运动、饮食、心理指导等基线干预及针刺“调神方”(四神聪、神庭、印堂、内关双、三阴交双)干预,对照组仅给予基线干预,疗程为5周(10次),观察期为4个月。采用亚健康自评量表、亚健康状态观察表、中医体质量表、SF一36生活质量量表对受试者进行疗效评价,干预前、干预5周及干预4个月各1次。收集数据采用SPSS18.0统计软件分析,分析方法包括描述性统计、f检验、卡方检验、秩和检验、重复测量方差分析。
成果：
1.两组一般资料比较提示两组患者在性别、年龄、病程构成方面无统计学意义(P>0.05)。治疗前亚健康自评量表评分、亚健康类型、亚健康各因子评分、亚健康状态观察表总评分、中医体质量表总面积评分、体质类型均无统计学意义(P>0.05)。
2.主要疗效分析：经秩和检验和卡方检验,①干预后不同观测时点,两组疗效比较有显著差异(P<0.01)；有效率比较有显著差异(P<0.01)；显效率比较有明显差异(P<0.05)。②干预5周两组健康率有显著差异(P<0.01),干预4个月,两组健康率无差异(P>0.05)。
3.次要疗效分析：经重复测量的多因素方差分析与多变量方差分析,①干预后不同观测时点,两组亚健康状态观察表评分均有提高,其差异具有统计学意义(P<0.01),且干预5周,观察组疗效优于对照组(P<0.01)；干预4个月,两组疗效差别无统计学差异(P<0.05)。②干预后不同观测时点,两组亚健康症状观察表总评分均有降低,其差异具有统计学意义(P<0.01),观察组疗效优于对照组(P<0.01)。③不同观测时点,两组干预后中医体质量表评分总面积均有降低,其差异具有统计学意义(P〈0.01)。干预5周,两组评分有显著差异差异(P<0.01)；干预4个月,观察组评分有所升高,两组评分差别仍有统计学差异(P<0.05)。④干预后不同观测时点,两组睡眠、疲劳、躯体不适、消化功能、负性情绪、正性情绪及能力因子得分均有提高,其有显著统计学差异(P<0.01)；皮肤因子、小便因子与社会关系因子的评分改善无统计学差异(P>0.05)。组间比较,干预5周,两组睡眠、疲劳、消化功能、负性情绪因子评分比较差异有统计学意义(P<0.05)；躯体不适、正性情绪、能力因子差异无统计学意义(P>0.05)。干预4个月,两组睡眠、消化功能、负性情绪因子评分比较差异有统计学意义(P<0.05)；余因子差异无统计学意义(P>0.05)。⑤不同观察时点,两组中医体质类型的改变无统计学差异(P>0.05)。⑥不同观测时点,两组气郁、气虚体质评分有显著统计学差异(P<0.01)。组间比较,两组气郁体质评分均有显著统计学差异(P<0.01)；两组气虚体质评分均无显著统计学差异(P>0.05)。⑦两个不同观测时点,两组的生理职能、一般健康情况、精力、社会功能、情感职能、精神健康及观察组的躯体疼痛维度均有改善,其差异有统计学意义(P<0.05)；生理机能及对照组的躯体疼痛维度比较无统计学差异(P>0.05)。组间比较,干预5周,两组一般健康情况、精力维度差异具有统计学意义(P<0.05)；干预4个月,只有精力维度评分差异具有统计学意义(P<0.05)。
4.不良反应分析：表现在头痛头晕,晕针,肌腱轻度损伤。
结论：
1.针刺“调神方”及基线干预对于改善亚健康状态的整体健康情况、症状及总体体质情况均有效果,且针刺“调神方”明显优于基线干预。针刺“调神方”干预亚健康症状的短期疗效明显,中期疗效有所降低。
2.针刺“调神方”及基线干预对于改善亚健康状态的睡眠、疲劳、躯体不适、消化功能、负性情绪、正性情绪、能力情况均有效果。与基线干预比较,针刺“调神方”改善睡眠、消化功能、负性情绪情况短期及中期疗效均具有优势；改善疲劳情况的短期疗效优势明显,中期疗效欠佳。
3.针刺“调神方”及基线干预对于改善亚健康状态中的气虚、气郁体质均有效果。与基线干预比较,针刺“调神方”干预气郁体质比干预气虚体质更具优势。
4.针刺“调神方”及基线干预对于生理职能、一般健康情况、精力、社会功能、情感职能、精神健康方面的改善效果明显；针刺“调神方”改善躯体疼痛维度方面效果明显,而基线干预对此维度改善无效。与基线干预比较,针刺“调神方”改善精力维度情况短期及中期疗效优势明显；改善一般健康维度情况的短期疗效优势明显,中期疗效欠佳。
5.针刺“调神方”及基线干预对于改善亚健康状态的中医体质类型、皮肤因子、小便因子、社会关系因子及生理机能维度无效。
Objective
A 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.
Methods
Sub-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.
Conclusion
1. 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.
本研究为随机对照临床试验研究,通过对针刺“调神方”干预前后亚健康状态的症状、体质、生活质量等临床比较,旨在评价针刺“调神方”干预亚健康状态的短期疗效和中期疗效,期望能够探索出有效改善亚健康状态的干预方法和针刺处方并探讨针刺调神方防治亚健康状态的机理。
方法：
以亚健康状态患者作为研究对象,采用随机对照试验设计,共纳入观察组病例85例,对照组病例96例。观察组给予运动、饮食、心理指导等基线干预及针刺“调神方”(四神聪、神庭、印堂、内关双、三阴交双)干预,对照组仅给予基线干预,疗程为5周(10次),观察期为4个月。采用亚健康自评量表、亚健康状态观察表、中医体质量表、SF一36生活质量量表对受试者进行疗效评价,干预前、干预5周及干预4个月各1次。收集数据采用SPSS18.0统计软件分析,分析方法包括描述性统计、f检验、卡方检验、秩和检验、重复测量方差分析。
成果：
1.两组一般资料比较提示两组患者在性别、年龄、病程构成方面无统计学意义(P>0.05)。治疗前亚健康自评量表评分、亚健康类型、亚健康各因子评分、亚健康状态观察表总评分、中医体质量表总面积评分、体质类型均无统计学意义(P>0.05)。
2.主要疗效分析：经秩和检验和卡方检验,①干预后不同观测时点,两组疗效比较有显著差异(P<0.01)；有效率比较有显著差异(P<0.01)；显效率比较有明显差异(P<0.05)。②干预5周两组健康率有显著差异(P<0.01),干预4个月,两组健康率无差异(P>0.05)。
3.次要疗效分析：经重复测量的多因素方差分析与多变量方差分析,①干预后不同观测时点,两组亚健康状态观察表评分均有提高,其差异具有统计学意义(P<0.01),且干预5周,观察组疗效优于对照组(P<0.01)；干预4个月,两组疗效差别无统计学差异(P<0.05)。②干预后不同观测时点,两组亚健康症状观察表总评分均有降低,其差异具有统计学意义(P<0.01),观察组疗效优于对照组(P<0.01)。③不同观测时点,两组干预后中医体质量表评分总面积均有降低,其差异具有统计学意义(P〈0.01)。干预5周,两组评分有显著差异差异(P<0.01)；干预4个月,观察组评分有所升高,两组评分差别仍有统计学差异(P<0.05)。④干预后不同观测时点,两组睡眠、疲劳、躯体不适、消化功能、负性情绪、正性情绪及能力因子得分均有提高,其有显著统计学差异(P<0.01)；皮肤因子、小便因子与社会关系因子的评分改善无统计学差异(P>0.05)。组间比较,干预5周,两组睡眠、疲劳、消化功能、负性情绪因子评分比较差异有统计学意义(P<0.05)；躯体不适、正性情绪、能力因子差异无统计学意义(P>0.05)。干预4个月,两组睡眠、消化功能、负性情绪因子评分比较差异有统计学意义(P<0.05)；余因子差异无统计学意义(P>0.05)。⑤不同观察时点,两组中医体质类型的改变无统计学差异(P>0.05)。⑥不同观测时点,两组气郁、气虚体质评分有显著统计学差异(P<0.01)。组间比较,两组气郁体质评分均有显著统计学差异(P<0.01)；两组气虚体质评分均无显著统计学差异(P>0.05)。⑦两个不同观测时点,两组的生理职能、一般健康情况、精力、社会功能、情感职能、精神健康及观察组的躯体疼痛维度均有改善,其差异有统计学意义(P<0.05)；生理机能及对照组的躯体疼痛维度比较无统计学差异(P>0.05)。组间比较,干预5周,两组一般健康情况、精力维度差异具有统计学意义(P<0.05)；干预4个月,只有精力维度评分差异具有统计学意义(P<0.05)。
4.不良反应分析：表现在头痛头晕,晕针,肌腱轻度损伤。
结论：
1.针刺“调神方”及基线干预对于改善亚健康状态的整体健康情况、症状及总体体质情况均有效果,且针刺“调神方”明显优于基线干预。针刺“调神方”干预亚健康症状的短期疗效明显,中期疗效有所降低。
2.针刺“调神方”及基线干预对于改善亚健康状态的睡眠、疲劳、躯体不适、消化功能、负性情绪、正性情绪、能力情况均有效果。与基线干预比较,针刺“调神方”改善睡眠、消化功能、负性情绪情况短期及中期疗效均具有优势；改善疲劳情况的短期疗效优势明显,中期疗效欠佳。
3.针刺“调神方”及基线干预对于改善亚健康状态中的气虚、气郁体质均有效果。与基线干预比较,针刺“调神方”干预气郁体质比干预气虚体质更具优势。
4.针刺“调神方”及基线干预对于生理职能、一般健康情况、精力、社会功能、情感职能、精神健康方面的改善效果明显；针刺“调神方”改善躯体疼痛维度方面效果明显,而基线干预对此维度改善无效。与基线干预比较,针刺“调神方”改善精力维度情况短期及中期疗效优势明显；改善一般健康维度情况的短期疗效优势明显,中期疗效欠佳。
5.针刺“调神方”及基线干预对于改善亚健康状态的中医体质类型、皮肤因子、小便因子、社会关系因子及生理机能维度无效。
Objective
A 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.
Methods
Sub-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.
Conclusion
1. 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.
引文
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