| Objective:Taking chronic stable angina as the research vehicle, to compare the acupuncture with acupoints along meridian, acupuncture with acupoints on other meridian and waiting list treatments affects the quality of life on patients with chronic stable angina, and to explore the specific effect of acupoints along meridian.Methods:We recruited patients with chronic stable angina pectoris from large general hospitals of 5 different provinces into this multicenter randomized controlled clinical trial.245 subjects were randomly divided into the acupuncture with acupoints along meridian group, the acupuncture with acupoints on other meridian group and the waiting list group. On the same basic medicine treatment, patients of the acupuncture with acupoints along meridian group also took the electro acupuncture on both side NeiGuan (PC6) and TongLi (HT5); patients of the acupuncture with acupoints on other meridian group took the electro acupuncture on both TaiYuan (LU9) and KongZui (LU6), patients took the electro acupuncture 3 times a week, once every two days,30 minutes for each time,4 weeks for 12 times in total. The patients of waiting list group just took the basic medicine as treatment. This whole study last for 20weeks, include baseline period 4weeks, treatment period 4weeks and follow-up period 12weeks. Evaluating indicator contained the angina attack frequency, visual analogue score about pain intensity score (VAS score) and the standard score of the 5 different dimensions (physical activity limitation, steady state of angina, attack situation, treatment satisfaction, disease awareness)of the Seattle Angina Questionnaire (SAQ scale), also combined cardiovascular events safety index as the safety evaluating indicator to comprehensively assess the effects of acupuncture with acupoints along meridian on the quality of life of patients with chronic stable angina.Result:1. baseline comparision:with strict screening, there are 280 subjects enrolled in this study, expelled 15 cases in the follow-up period,20 cases dropt-out or expulsion, the last statistical analysis contained the 245 cases who finished the whole study.85 male and 160 female; 79 subjects in the acupoints along meridian group,84 subjects in the acupoints on other meridian and 82 in the waiting list group. Three groups are uniform consistency in gender, age, body mass index (BMI) and the patients’ condition (P>0.05)2. clinilc effects comparison:patients of these three groups during the 4th-16th weeks, the frequence of angina attack, VAS score and the SAQ score are different with baseline, the comparison within and between the groups are meaningful.(1) acupuncture with acupoints along meridian group VS waiting list group: during the 4th-16th weeks, the frequence of angina attack, VAS score, steady state of angina, and the treatment satisfaction of the patients in the group of acupuncture with acupoints along meridian were much better than waiting list group(P<0.05); the physical activity limitation was much better than waiting list group during the 8th-16thweeks(P<0.05). While there was no difference on the disease awareness between these two groups(P>0.05).(2) acupuncture with acupoints on other meridian group VS waiting list group:the frequence of angina attack of acupuncture with acupoints on other meridian group was much lower than waiting list group during the 4thweeks,8thweeks and the 16thweeks(P<0.05),and the mean of this indicator during the 12thweeks was lower than waiting list. In the SAQ scale, the attack situation and treatment satisfaction of the acupuncture with acupoints on other meridian group were much better than the other group(P<0.05). There was no difference of VAS score and disease awareness between these two groups(P>0.05).(3) acupuncture with acupoints along meridian group VS acupuncture with acupoints on other meridian group:angina attack frequency:during the 4th-16thweeks, acupuncture with acupoints along meridian group was much less than the other group. VAS score:there was no difference between these two groups during the 4th-8thweeks, while the score of the acupuncture with acupoints along meridian group was much lower than the acupuncture with acupoints on other meridian group during the following periods 12th-16thweeks(P<0.05).SAQ scale:within the 4th-16thweeks, acupuncture with acupoints along meridian group was much better than the group of acupuncture with acupoints on other meridian on the steady state of angina and attack situation dimensions (P<0.05); treatment satisfaction:patients of the both groups were satisfied with the treatments after the acupuncture(during the 4thweeks) (P<0.05); while during the 8th-16thweeks, this indicator of the acupuncture with acupoints along meridian group was much higher than the other group (P<0.05). There was no difference about the physical activity limitation and disease awareness between these two groups during the 4th-16thweeks.3. safety evaluation:no cardiovascular events occurred in the three groups, no adverse reactions, adverse events, serious adverse events in the three groups.Conclusion:1. based on the basic medicine treatment, combined the acupuncture with acupoints along meridian or the acupuncture with acupoints on other meridian could both improve the quality of life of patients with chronic stable angina better.2. from the present analysis, acupuncture with acupoints along meridian treatment is much better to improve the quality of life on patient with chronic stable angina than the acupuncture with acupoints on other meridian treatment, it’s preliminary proved that acupoints has the specific effects along the meridian. |
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