摘要
目的：
采用多中心随机对照试验,观察针刺大肠俞募配穴、合穴下合穴配穴、合募俞配穴治疗功能性便秘的临床疗效,以及生存质量、精神心理状态改善程度,为针刺不同腧穴配伍治疗功能性便秘提供高质量的临床证据。
方法：
受试者来源于中国中医科学院广安门医院、成都中医药大学、湖南中医药大学、陕西中医学院等4个临床中心的校园招募、附属医院住院或门诊患者,采用多中心随机对照试验设计,纳入符合标准的247例功能性便秘患者,通过中央随机系统,将患者随机分为大肠俞募配穴组(试验A组)、合穴下合穴配穴组(试验B组)、合募俞配穴组(试验C组)和阳性药物对照组莫沙必利组(试验D组)。
A组针刺天枢、大肠俞；B组针刺曲池、上巨虚；C组针刺天枢、大肠俞、曲池、上巨虚;A组、B组所有穴位均取双侧,C组取单侧,左右两侧交替使用。针刺得气后,用20Hz电流刺激30分钟,电针强度以患者耐受为度。D组口服阳性对照药物：枸橼酸莫沙必利片,5删次,每日3次,连续服用4周。
研究周期为9周,基线期为1周,治疗期为4周,治疗完成4周后随访。A、B、C组采用针刺治疗,从入组后第1、2周每周连续治疗5天,1天1次,休息2天后再继续下一周治疗；第3、4周每周治疗3天,2天1次,休息2天后再继续下一周治疗,患者一共治疗16次。D组采用口服枸橼酸莫沙必利片,5mg/次,每日3次,连续服用4周。指标观察在入组时、入组后第2周、第4周和第8周时分别进行检测。
研究评价指标包括周排便次数、粪便质量、排便困难程度、健康相关生活质量评分一一健康调查简表(the MOS item Short From health survey,SF-36)、焦虑自评量表(Self-Rating Anxiety Scale,SAS)、抑郁自评量表(Self-rating Depression Scale,SDS)、针灸期待值评价等。针灸期待值于入组时评价一次；周排便次数、粪便性状、排便困难程度于试验入组时、入组第2周、第4周和第8周时各评价一÷仁：SF-36于入组时和入组第4周各评价一次SAS、SDS于入组时、入组第2周和第4周各评价一次
结果：
1.四个组完成与未完成试验的病例数无显著性差异,组间均衡一致。四个组的研究对象的一般情况、理化检查、各项主要疗效指标等基线比较组间均衡一致,各组间具有可比性(P>0.05)。
2.研究初步表明,四个组周排便次数四次评估组间比较无统计学意义(P>0.05),但是各组四次评估前后组内比较均具有显著性差异(P<0.01)。四个组粪便性状改善值四次评估组间比较无统计学意义(P>0.05),但是各组四次评估前后组内比较均具有显著性差异(P<0.01)。在排便困难程度的比较中,A、B组与D组四次评估差别组间比较无统计学意义(P>0.05),C组与D组比较有统计学意义(P<0.05),C组得分更低。各组四次评估前后组内比较均具有显著性差异(P<0.01)。
3.研究初步表明,四个组SF-36量表的各维度得分没有统计学差异(P>0.05)，各组治疗前后SF-36量表的各维度得分改善值的组间比较也没有统计学差异(P>0.05)。然而,各组治疗前后组内比较在部分维度上有统计学差异,各组有统计学差异的维度中有部分重合。
4.研究初步表明,四个组第一次到第三次评估SAS、SDS评分组间比较,差别无统计学意义(P>0.05)。各组SAS评分三次评估组内比较中,A组、C组三次评分比较有统计学意义(P<0.05),B组、D组三次评分比较没有统计学意义(P>0.05)。各组SDS评分三次评估组内比较中,A组三次评分比较有统计学意义(P<0.05),B组、C组、D组三次评分比较没有统计学意义(P>0.05)。针刺前后临床症状改善值与SAS、SDS评分改变有统计相关性,从相关系数可知周排便次数增加,SAS、SDS评分下降。
5.研究初步表明,四个组的研究对象的针灸期待值得分没有统计学差异(P>0.05)。在相关性分析中,针灸期待值评分与周排便次数改善、SAS评分改变没有统计相关性(P>0.05)；与SDS评分改变有统计相关性,针灸期待值升高,SDS评分下降。
结论：
1.研究结果初步表明,针刺可以有效治疗功能性便秘,其疗效与常规药物治疗效果相当。随着治疗时间的增加,其治疗效果呈增长的趋势,并具有一定的续效应。其治疗效果与受试者对于针灸的期待值尚无相关。
2.研究结果初步表明,针刺对功能性便秘患者的生存质量改善程度有限,针刺不同穴位配伍对精神心理状态的改善程度不同。
Objective:
This research was a multi-center randomized controlled trail of acupuncture for treating functional constipation.In order to get the clinical efficacy,the change of quality of life and mental state in this trail, we punctured the body at different compatibility of acupoints such as compatibility of Tianshu(ST25) and Dachangshu(BL25), compatibility of Quchi(LIll) and Shangjuxu(ST37), compatibility of those four acupoints. The results of effect assessment would be helpful to preliminarily clarify the efficacy of acupuncture for treating functional constipation.
Methods:
In this trial,247patients of functional constipation were randomly assigned to four groups using central randomization:compatibility of back-shu point and front-mu piont group (group A), compatibility of He-sea point and lower He-sea piont group (group B), compatibility of back-shu point, front-mu point, He-sea point and lower He-sea piont group (group C) and control group (group D). Tianshu(ST25) and Dachangshu(BL25), were punctured in group A; Quchi(LI11) and Shangjuxu(ST37) were punctured in group B; Tianshu(ST25), Dachangshu(BL25), Quchi(LI11) and Shangjuxu(ST37) were punctured in group C; pillars of mosapride were taken orally in group D.
Group A, group B all points were bilateral, group C were unilateral, the left and right sides were used interchangeably. After getting needle response, the stimulate of acupuncture would last30minutes by electric acupuncture apparatus at frequencies of20Hz. Each acupuncture session lasted for30minutes.The intensity was lower the degree of patients' tolerance. Group D took pillars of mosapride citrate,5milligram per time,3times a day and continuously for4weeks.
The research period had nine weeks. The treatment period was4weeks. Patients of group A, B and C were punctured in5times in first2weeks, and were punctured3times in last2weeks. There had16times in treatment period totally.
The outcome included the times of defecation per week, stool quality, the degree of difficulty in defecation, health-related quality of life score(SF-36), self-rating anxiety scale (SAS), self-rating depression scale (SDS), value of acupuncture expection appraisal,etc. The following outcome measurements were assessed at begining, the second, fourth and eighth week after randomization:value of acupuncture expection appraisal were assessed at begining after randomization; the times of defecation per week, stool'quality, the degree of difficulty in defecation were assessed at begining, the second, fourth and eighth week; health-related quality of life score were assessed at begining and the fourth week; SAS and SDS were assessed at begining, the second and fourth week.
Results:
1. This trial was well completed and the characteristics of four groups were comparable in baseline(P>0.05).
2. The results of study indicated preliminarily that the following outcomes among group A, B, C and D were not statistically significant (P>0.05). However, times of each group in four assessment compared before and after the therapy had a significant difference (P<0.01). The following outcomes among four groups were not statistically significant (P>0.05), but each group of four assessment compared before and after the therapy had a significant difference (P<0.01). In the comparison of the degree of difficulty in defecation, the differences among group A, B and D were not statistically significant(P>0.05),but the score of group C was lower than group D. Scores of each group in four assessment compared before and after the therapy had a significant difference (P<0.01).
3. The SF-36scale scores of four groups was not statistically significant (P>0.05). however, Scores of some dimensions in groups had a significant difference, and there was some overlap in these different dimensions.
4. There was no significant difference among four groups in three assessment of SAS and SDS(P>0.05).In the group self-comparisons. Scores of SAS in group A and C was statistically significant, but Scores of SAS in group B and D was not. In the group self-comparisons of SDS, Group A had a significant difference (P<0.01), but other three groups had none. There was statistical correlation between the improvement of clinical symptoms and changes of SAS and SDS. If frequency of defecation increase, scores of SAS and SDS will dropped.
5. There was no significant difference among four groups in value of acupuncture expection appraisal (P>0.05). In the correlation analysis, there was no statistical correlation between the acupuncture expection appraisal, improvement of clinical symptoms and changes of SAS.However, there was statistical correlation between value of acupuncture expection appraisal and changes of SDS. If value of acupuncture expection appraisal increase, scores of SDS will dropped.
Conclusions:
1. The results of study indicated preliminarily that the compatibility of points are effective treatment of functional constipation, its efficacy as the same as conventional drug treatment. Increasing trend with increasing treatment time, its therapeutic efficacy would increase and last in the follow-up period.But there was no statistical correlation between it and the acupuncture expection appraisal.
2. The results of study indicated preliminarily that the improvement of quality of life of patients with functional constipation treat by acupuncture was limited,and different compatibility of acupoints would have different changes of dimensions.
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