| Background:Previous study focused mostly on the cause,mechanism,methods and point selection when treating insomnia with acupuncture,however,few research has been conducted about the manipulation and stimulus of acupuncture.The concept of soft acupuncture which advocate pain free treatment is popular in foreign country,and thus,the manipulation and stimulus is usually neglected in most cases.Due to our clinical experience,applying different stimulus according to different patterns can improve the therapeutical effect of acupuncture.Therefore,this research is aimed to investigate the most appropriate stimulus when treating insomnia of heart and spleen deficiency pattern with acupuncture.Objective:To explore the effect of different acupuncture stimulus intensity on heart and spleen deficiency insomnia,and analyze the optimum stimulus intensity for such cases.Methods:This was a randomized,controlled,patient-assessor-blind,explorative clinical research.Insomnia patients with heart and spleen deficiency pattern were randomized with random number table into a strong stimulus group(SS)and a weak stimulus group(WS).1 AcupointsBoth of the two groups use the same acupoints like:DU-20,BL-15,BL-20,SP-6,HT-7,BL-62,KI-6.2 Acupuncture manipulationDeep penetration in SS:EX-HN1 was punctured to DU-20 for 0.8 cun,BL-15,BL-20 was punctured to spine for 1.2cun,SP-6 was punctured for 1.2 cun perpendicularly while HT-7,BL-62,KI-6 was punctured for 0.5 cun perpendicularly.After qi arrived,took twirling supplement method ranging from 90°-180°,60-90/min in frequency for 20s on each point,twirling manipulation was done every 10 min during needle retention.The needle was retained for 30min.Shallow penetration in WS:EX-HN1 was punctured to DU-20 for 0.5 cun,BL-15,BL-20 was punctured to spine for 0.5cun,SP-6 was punctured for 0.5 cun perpendicularly,while HT-7,BL-62,KI-6 was punctured for 0.2 cun perpendicularly.After qi arrived,took twirling supplement method ranging below 90°,within 60/min in frequency for 10s on each point,took no manipulation during needle retention.The needle was retained for 30min.3 Time and course of treatmentThe treatment was done in afternoon every other day for a succession of 4 weeks,2 months follow-up visit in both groups.4 Index and time points of evaluationThe primary evaluation index Sleep times and PSQI and the secondary evaluation index SAS,SDS,TCM Syndrome Scale,Sleep Rate and the dosage of medicine were assessed every week during treatment period and every month during follow-up period.Adverse event were recorded to assess safety.Results:1.Comparison during treatment period:(1)Strong stimulus group:The sleep time,sleep efficiency,PSQI,TCM Syndrome Scale,SAS and SDS were significantly different in 1th,2th,3th,4th week compared with that before treatment,P<0.05.The dosage of using sleep medicine in the first week had no significantly difference than before,P=0.066>0.05.While in 2th,3th,4th week,It was less than before treatment,which had significantly difference with P<0.05.The PSQI has seven 'component'score.Sleep quality,sleep latency,sleep duration,habitual sleep efficiency and daytime dysfunction in 1th,2th,3th,4th week had significantly difference than before with P<0.05,and all the scores were less than before.Sleep disturbances and use of sleeping medication in 1th,2th,3th week had no significantly difference than before,P>0.05.While in 4th week,they had significantly difference than before with P<0.05,and all the scores were less than that before treatment.(2)Weak stimulus group:Compared with that before treatment,in 1th,2th,3th,4th week the sleep time and sleep efficiency were increased,PSQI,TCM Syndrome Scale,SAS,SDS and the dosage of using sleep medicine were decreased.All the alternations had significantly different with P<0.05.The seven 'component' score of PSQI 1th,2th,3th,4th week were less than that before treatment.While sleep quality,sleep latency,sleep duration,habitual sleep efficiency and daytime dysfunction in 1th,2th,3th,4th week had significantly difference than before with P<0.05.Sleep disturbances and use of sleeping medication Only in 4th week had significantly difference than before with P<0.05.(3)The comparison between two groups:The total effective rate of SS was 76.7%,and that of WS was 86%,which was significantly higher than SS.During the treatment period the sleep time in the first three weeks there was no significantly different between two groups,in the 4th week WS was significantly longer than WS with P<0.05.The PSQI in WS was lower than SS,while in the first two weeks,the difference between the two groups had no statistically significant,in the 3th and 4th week the difference between the two groups had statistically significant with P<0.05.The sleep efficiency and TCM Syndrome Scale in 1th,2th,3th,4th week had significantly difference between two groups with P<0.05.The average sleep efficiency of WS in 1th,2th,3th,4th week was higher than SS,and the average score of TCM Syndrome Scale in WS was lower than SS.During the treatment period the dosage of using sleep medicine had no significantly difference between two groups with P<0.05.The average score of SAS and SDS of WS in 4th week was significantly lower than SS,P<0.05.2.Comparison during follow-up period:(1)During the follow-up period,the sleep efficiency and sleep time of the two groups were decreased compared with that in 4th week,but there was still a significant increase compared with that before treatment,the difference was statistically significant,P<0.05.The scores of TCM Syndrome Scale and PSQI of two groups were increased in 8th,12th week compared with 4th week,but there was still a significant decline compared with before treatment,which had statistical difference with P<0.05.Both of the two groups had a slight increase in the dosage of using sleep medicine during the follow-up period,but there was no significant difference compared with that in 4th week with P>0.05.The SAS and SDS scores of SS in 8th week and 12th week were significantly higher than those in 4th week,and lower than before treatment,all of which were statistically significant,P<0.05.The SAS and SDS scores of WS in 8th and 12th week were significantly higher than those in 4th week,but the difference between 8th week and 4th week has no statistically significant with P>0.05,the difference between 12th week and 4th week has statistically significant with P>0.05.(2)During the follow-up period,the difference of the sleep time,sleep efficiency,TCM syndrome scores,PSQI scores,SAS scores and SDS scores between the two groups had statistically significant,P<0.05.And each index of SS was better than that of WS.Conclusion:1.Both of strong stimulus acupuncture and week stimulus acupuncture were effective for PI with syndrome of heart and spleen deficiency.They can prolong the sleep time of participants,improve their sleep efficiency,reduce drug consumption,relieve symptoms and anxiety and depression associated with insomnia.Effect could last for at least 2month,although each index might have slight rebound after finishing the treatment.2.Effect of WS was better than SS.And the advantage was more obvious with the prolongation of treatment time. |
PDF Full Text Request