针刺特定穴治疗功能性消化不良多中心大样本随机对照研究
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摘要
目的：采用数据挖掘技术对针刺治疗功能性消化不良(Functional Dyspepsia, FD)的用穴规律进行挖掘,并在此基础上,按照CONSORT声明和STRICTA标准,通过规范的临床随机对照试验,以FD患者为研究对象,以非特定穴、非经非穴为对照,客观观察针刺特定穴治疗FD的临床疗效,拟初步阐明“经穴效应具有特异性,经气会聚是其关键”的研究假说。
方法：采用多中心、随机、对照的研究方法,通过中央随机系统将符合纳入标准的474名FD患者随机分为A组(胃经特定穴组),B组(俞募配穴组),C组(胃经非特定穴组)和D组(非经非穴组)进行针刺治疗。采用HANS电针仪,每天治疗1次,每次30 min,5次一个疗程,疗程期间休息2天,共治疗4个疗程,并于疗程结束后4周、12周各随访1次。以症状积分和尼平消化不良指数(Nepean DyspepsiaIndex,NDI)量表中生活质量部分为主要评价指标,评价每2个疗程结束后以及随访的疗效。
结果：
1、4组均对FD患者餐后饱胀不适、早饱感和上腹痛症状有明显改善。在生活质量方面,A组和B组对FD患者生活质量各领域有明显改善,但D组在各评价时间点对生活质量各领域的改善不明显,C组在各评价时间点对生活质量干扰领域,在治疗2周、治疗结束时对生活质量食物饮料领域以及治疗2周时对生活质量睡眠打扰领域的改善不明显。
2、A组在入组2周、治疗结束、治疗结束后4周及治疗结束后12周时的NDI量表各生活质量领域、餐后饱胀不适、早饱感症状的改善值,以及在入组2周、治疗结束、治疗结束后4周随访时的上腹痛症状改善值与D组比较均具有统计学差异(P<0.05)。
3、A组在入组2周、治疗结束、治疗结束后4周及治疗结束后12周时的NDI量表干扰、认识控制、食物饮料领域改善值,治疗结束时的NDI量表睡眠打扰领域改善值,以及在治疗结束、治疗结束后4周随访、治疗结束后12周随访时餐后饱胀不适的改善值与C组比较具有统计学差异(P<0.05)。
4、除在治疗结束时,A组在NDI量表认识控制领域,及治疗2周时的食物饮料领域的改善值与B组比较具有统计学差异(P<0.05)外,A组和B组在其余评价时间点的其余生活质量领域均无统计学差异(P>0.05)。A组在入组2周,治疗结束后4周随访及治疗结束后12周随访时的早饱感和上腹痛改善值,以及入组2周时的餐后饱胀不适改善值与B组无统计学差异(P>0.05)。
5、治疗结束时,A组的有效率与B、C、D组比较均具有统计学差异(P<0.05)。
结论：
1、针刺胃经特定穴及俞募配穴治疗对于提高FD患者的生活质量疗效显著,并能有效改善FD患者的3个主要临床症状：餐后饱胀不适、早饱感和上腹痛。
2、针刺特定穴较针刺非特定穴、非经非穴具有效应优势,具体体现为：特定穴针刺治疗在治疗期间和随访时共4个时间点对生活质量4个领域、PDS型餐后饱胀不适和早饱感症状以及在大部评价时间点对EPS型上腹痛症状的改善优于非经非穴；在4个时间点对生活质量3个领域(干扰、认识控制、食物饮料)、PDS型餐后饱胀不适症状以及在治疗结束时睡眠打扰领域的改善优于胃经非特定穴。
3、针刺特定穴较针刺非特定穴、非经非穴具有效应优势,为特定穴效应特异性的存在以及“经穴效应具有特异性,经气会聚是其关键”的课题假说提供了试验证据。
Objective:To explore the rule of acupoints selection for functional dyspepsia (FD) by data mining methods and to investigate the therapeutic efficacy of acupuncture on specific acupoints for FD by comparing non-specific acupoints with non-acupoints so as to preliminarily clarify the hypothesis of "acupoint has specificity in efficacy, which is closely related to the gathering of meridian qi"
Method:Multi-center, central-randomanization controlled trial was designed.474 patients meeting the inclusion criteria were randomly allocated to receive one of specific-point acupuncture treatments (Treatment Group A:ST34, ST36, ST40, ST42; Treatment Group B:UB21, REN12) or non-specific-point acupuncture (Group C:ST32, ST33, ST35, ST38) or non-acupoint puncture (Group D) treatment. The HAN's acupoint nerve stimulaor was used. The study consisted of a treatment period of 4 weeks (five sessions continuously per week, an interval two days between two courses), and a follow-up period of 12 weeks. Dyspepsic symptoms and the disease-specific quality of life (Nepean Dyspepsia Index,DNI) were evaluated to determine patients'therapeutic efficacy.
Results:
1. Each group had significant therapeutic effect in relieving three main symptoms as postprandial fullness, early satiation and pigastric pain. In the life quality improvement, A and B group significantly raised the quality of life in all subscales of NDI. Clinically differences were not deteted in four sunscales of life quality in D group at four assessment time. As for C group, clinically differences were not deteted in subscale of interference at four assessment time, in sunscale of eating/drinking in 2-week,4-week after treatment and in subscale of sleep in 2-week after treatment.
2. The changes in the score of NDI and Dyspeptic Symptom Score of postprandial fullness and early satiation were significant different between A and D groups in 2-week, 4-week after treatment as well as 4-week and 12-week follow-up period (P<0.05). The differences between A and D groups in 2-week,4-week after treatment as well as 1 month follow-up period were also significant in the change of Dyspeptic Symptom Score of pigastric pain.
3. The changes in the score of NDI subscales of interference, konwledge/control and eating/drinking were significantly different between A and C groups in 2-week,4-week after treatment as well as 4-week and 12-week follow-up period (P<0.05). The differences between A and C groups in 4-week after treatment as well as 4-week and 12-week follow-up period were also significant in the change of Dyspeptic Symptom Score of postprandial fullness. There was significant difference between A and C group in the change of NDI subscale of sleep at the end of treatment.
4. Except for significant difference between A and B group in the change of NDI subscale of interference at the end of treatment and the subscales of eating/drinking in 2-week after treatment, no significant differences were detected between the two groups in the other NDI subscales and at other assessment time. There were not significant differences between A and B group in the changes of Dyspeptic Symptom Score of early satiation and pigastric pain.in 2-week after treatment,4-week and 12-week follow-up as well as postprandial fullness in 2-week after treatment(P>0.05).
5. There was significant difference between A and other three groups in the overall efficacy at the end of treatment (P<0.05).
Conclusion:
1. Puncturing at specific acupoint on the stomach meridian and the combination of Back-shu and front-mu point of stomach have significant effect in improving quality of life on FD patients and relieving three main symptoms as postprandial fullness, early satiation and pigastric pain.
2. Puncturing at specific acupoint shows better effect in improving dyspepsia-related quality of life in four subscales of NDI, relieving postprandial fullness and early satiation in 2-week,4-week after treatment as well as 4-week and 12-week follow-up,and relieving pigastric pain in 2-week,4-week after treatment as well as 12-week follow-up than non-acupoint. The effect of puncturing at specific acupoint is also superior to non-specific acupoint in improving dyspepsia-related quality of life in three subscales of NDI (interference, konwledge/control and eating/drinking), relieving postprandial fullness in 2-week,4-week after treatment as well as 4-week and 12-week follow-up,and improving dyspepsia-related quality of life in subscale of sleep at the end of treatment.
3. The effect of puncturing at specific acupoint is superior to non-acupoint and non-specific acupoint, which provides the hypothesis of "acupoint has specificity in efficacy, which is closely related to the gathering of meridian qi" with primilary evidence.
方法：采用多中心、随机、对照的研究方法,通过中央随机系统将符合纳入标准的474名FD患者随机分为A组(胃经特定穴组),B组(俞募配穴组),C组(胃经非特定穴组)和D组(非经非穴组)进行针刺治疗。采用HANS电针仪,每天治疗1次,每次30 min,5次一个疗程,疗程期间休息2天,共治疗4个疗程,并于疗程结束后4周、12周各随访1次。以症状积分和尼平消化不良指数(Nepean DyspepsiaIndex,NDI)量表中生活质量部分为主要评价指标,评价每2个疗程结束后以及随访的疗效。
结果：
1、4组均对FD患者餐后饱胀不适、早饱感和上腹痛症状有明显改善。在生活质量方面,A组和B组对FD患者生活质量各领域有明显改善,但D组在各评价时间点对生活质量各领域的改善不明显,C组在各评价时间点对生活质量干扰领域,在治疗2周、治疗结束时对生活质量食物饮料领域以及治疗2周时对生活质量睡眠打扰领域的改善不明显。
2、A组在入组2周、治疗结束、治疗结束后4周及治疗结束后12周时的NDI量表各生活质量领域、餐后饱胀不适、早饱感症状的改善值,以及在入组2周、治疗结束、治疗结束后4周随访时的上腹痛症状改善值与D组比较均具有统计学差异(P<0.05)。
3、A组在入组2周、治疗结束、治疗结束后4周及治疗结束后12周时的NDI量表干扰、认识控制、食物饮料领域改善值,治疗结束时的NDI量表睡眠打扰领域改善值,以及在治疗结束、治疗结束后4周随访、治疗结束后12周随访时餐后饱胀不适的改善值与C组比较具有统计学差异(P<0.05)。
4、除在治疗结束时,A组在NDI量表认识控制领域,及治疗2周时的食物饮料领域的改善值与B组比较具有统计学差异(P<0.05)外,A组和B组在其余评价时间点的其余生活质量领域均无统计学差异(P>0.05)。A组在入组2周,治疗结束后4周随访及治疗结束后12周随访时的早饱感和上腹痛改善值,以及入组2周时的餐后饱胀不适改善值与B组无统计学差异(P>0.05)。
5、治疗结束时,A组的有效率与B、C、D组比较均具有统计学差异(P<0.05)。
结论：
1、针刺胃经特定穴及俞募配穴治疗对于提高FD患者的生活质量疗效显著,并能有效改善FD患者的3个主要临床症状：餐后饱胀不适、早饱感和上腹痛。
2、针刺特定穴较针刺非特定穴、非经非穴具有效应优势,具体体现为：特定穴针刺治疗在治疗期间和随访时共4个时间点对生活质量4个领域、PDS型餐后饱胀不适和早饱感症状以及在大部评价时间点对EPS型上腹痛症状的改善优于非经非穴；在4个时间点对生活质量3个领域(干扰、认识控制、食物饮料)、PDS型餐后饱胀不适症状以及在治疗结束时睡眠打扰领域的改善优于胃经非特定穴。
3、针刺特定穴较针刺非特定穴、非经非穴具有效应优势,为特定穴效应特异性的存在以及“经穴效应具有特异性,经气会聚是其关键”的课题假说提供了试验证据。
Objective:To explore the rule of acupoints selection for functional dyspepsia (FD) by data mining methods and to investigate the therapeutic efficacy of acupuncture on specific acupoints for FD by comparing non-specific acupoints with non-acupoints so as to preliminarily clarify the hypothesis of "acupoint has specificity in efficacy, which is closely related to the gathering of meridian qi"
Method:Multi-center, central-randomanization controlled trial was designed.474 patients meeting the inclusion criteria were randomly allocated to receive one of specific-point acupuncture treatments (Treatment Group A:ST34, ST36, ST40, ST42; Treatment Group B:UB21, REN12) or non-specific-point acupuncture (Group C:ST32, ST33, ST35, ST38) or non-acupoint puncture (Group D) treatment. The HAN's acupoint nerve stimulaor was used. The study consisted of a treatment period of 4 weeks (five sessions continuously per week, an interval two days between two courses), and a follow-up period of 12 weeks. Dyspepsic symptoms and the disease-specific quality of life (Nepean Dyspepsia Index,DNI) were evaluated to determine patients'therapeutic efficacy.
Results:
1. Each group had significant therapeutic effect in relieving three main symptoms as postprandial fullness, early satiation and pigastric pain. In the life quality improvement, A and B group significantly raised the quality of life in all subscales of NDI. Clinically differences were not deteted in four sunscales of life quality in D group at four assessment time. As for C group, clinically differences were not deteted in subscale of interference at four assessment time, in sunscale of eating/drinking in 2-week,4-week after treatment and in subscale of sleep in 2-week after treatment.
2. The changes in the score of NDI and Dyspeptic Symptom Score of postprandial fullness and early satiation were significant different between A and D groups in 2-week, 4-week after treatment as well as 4-week and 12-week follow-up period (P<0.05). The differences between A and D groups in 2-week,4-week after treatment as well as 1 month follow-up period were also significant in the change of Dyspeptic Symptom Score of pigastric pain.
3. The changes in the score of NDI subscales of interference, konwledge/control and eating/drinking were significantly different between A and C groups in 2-week,4-week after treatment as well as 4-week and 12-week follow-up period (P<0.05). The differences between A and C groups in 4-week after treatment as well as 4-week and 12-week follow-up period were also significant in the change of Dyspeptic Symptom Score of postprandial fullness. There was significant difference between A and C group in the change of NDI subscale of sleep at the end of treatment.
4. Except for significant difference between A and B group in the change of NDI subscale of interference at the end of treatment and the subscales of eating/drinking in 2-week after treatment, no significant differences were detected between the two groups in the other NDI subscales and at other assessment time. There were not significant differences between A and B group in the changes of Dyspeptic Symptom Score of early satiation and pigastric pain.in 2-week after treatment,4-week and 12-week follow-up as well as postprandial fullness in 2-week after treatment(P>0.05).
5. There was significant difference between A and other three groups in the overall efficacy at the end of treatment (P<0.05).
Conclusion:
1. Puncturing at specific acupoint on the stomach meridian and the combination of Back-shu and front-mu point of stomach have significant effect in improving quality of life on FD patients and relieving three main symptoms as postprandial fullness, early satiation and pigastric pain.
2. Puncturing at specific acupoint shows better effect in improving dyspepsia-related quality of life in four subscales of NDI, relieving postprandial fullness and early satiation in 2-week,4-week after treatment as well as 4-week and 12-week follow-up,and relieving pigastric pain in 2-week,4-week after treatment as well as 12-week follow-up than non-acupoint. The effect of puncturing at specific acupoint is also superior to non-specific acupoint in improving dyspepsia-related quality of life in three subscales of NDI (interference, konwledge/control and eating/drinking), relieving postprandial fullness in 2-week,4-week after treatment as well as 4-week and 12-week follow-up,and improving dyspepsia-related quality of life in subscale of sleep at the end of treatment.
3. The effect of puncturing at specific acupoint is superior to non-acupoint and non-specific acupoint, which provides the hypothesis of "acupoint has specificity in efficacy, which is closely related to the gathering of meridian qi" with primilary evidence.
引文
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