| ObjectiveThis subject intends to use a small randomized controlled clinical study.Through comparison with the control group--the routine acupuncture therapy, to observe the clinical effect of fang’s scalp acupuncture and body acupuncture in treating insomnia of incoordination between heart and kidney. The paper preliminarily explores the experimental therapy’s clinical effectiveness and its possible mechanism of this study from a traditional Chinese medicine perspective. We would like to show a new kind of clinical acupuncture treatment and rigorous scientific data in treating insomnia of incoordination between heart and kidney. In order to extending significance about using fang’s scalp acupuncture to treating the disease in the depth and breadth.MethodMost cases in the research are from outpatients and inpatients who visited the Traditional Chinese Medicine Hospital of Guangdong Province and outpatients from the first affiliated hospital of Guangzhou University of TCM during December 2014 and December 2015. In accordance with the standard the research set to select cases,60 cases were equally randomized into treatment group (the group using fang’s scalp acupuncture and body acupuncture) and control group (the group using routine acupuncture therapy), with 30 cases each. The routine acupuncture treatment method in Wang Qicai’s Study of Acupuncture Moxibustion Treatment is referenced by the control group to select relevant acupuncture points for routine acupuncture treatment. The fang’s scalp acupuncture and body acupuncture treatment method in Fang YunPeng’s Scalp Acupuncture is referenced by the treatment group to select relevant acupuncture points and the routine acupuncture treatment. Patients from both the treatment group and the routine group were required to receive acupuncture treatment every day, five times a week. As every ten treatments were counted as one course, the research required both groups’patients to complete two courses. The overall standard for clinical curative effect of the research refers to the relevant standard of insomnia in the "Pittsburgh Sleep Quality Index" (PSQI), and the Traditional Chinese Medicine Syndrome Score-heart and kidney disharmony syndrome scale. The overall clinical curative effect and TCM syndrome score were evaluated when two courses were completed. Cases from two groups were randomly visited in three different periods (these were period after the first treatment, period after the second treatment and one month after two courses), during which curative effect index was evaluated. The research’s data was analyzed with SPSS20.0.Results60 cases were recruited into the study, and all of them were treated completely. No one was dropped out of the study. Finally,60 cases were included in the statistical analysis. Sixty patients with insomnia are randomly classified into 30 cases of observation group and 30 cases of control group.1. Comparison of the baseline information between treatment group and control group before treatment:through statistical analysis and comparison, we can know that two groups’patients had no statistical significance in sex, age, course of disease, syndrome of TCM, total point in PSQI scale or ingredient and integral in PSQI scale, indicating that patients from two groups had the same baseline condition before treatment.2. The curative effect comparison of two clinic trial:the differences between the TCM syndrome effect of Fang’s scalp acupuncture-body acupuncture group and the one of routine acupuncture group are comparable, with statistical significance (P<0.05). Among the 30 cases of insomnia of incoordination between heart and kidney in treatment group, there are 9 clinical convalesces example,9 shows excellent examples and 10 valid examples, which means that it is only 2 invalid examples. Therefore, the total curative effect rate is 93.33%, while the control group is 86.67%. The control is including 4 clinical convalesces examples,5 shows markedly effect examples,17 effective examples and 4 invalid examples. The differences between the total clinical curative effect of Fang’s scalp acupuncture-body acupuncture group and the one of routine acupuncture group are comparable, with statistical significance (P<0.05). The 30 cases of the experiment group, 10 cases healed,13 cases effectual,4 cases effective,3 cases invalid, the total effective rate was 90.00%, while the control group is 76.67%. The control is including 5 clinical convalesces examples,6 effectual examples, 12 effective examples and 7 invalid examples. The result shows that the clinical efficacy of the treatment group was higher than the control group.3. The curative effect indicator compare of different time:the treatment group and the control group divided into 3 periods of time. The first is the period after first treatment, the second is the one after 2 courses of treatment, and the last one is a month follow-up study after the all treatment. Sum up the points of TCM syndromes accumulate scores (insomnia with dreamful sleep, vexation, forgrtfulness, dizziness and tinnitus, weak waist, five upset hot, dry mouth), the total scores of PSQI scale and the scores of every quantity component in the PSQI scale (including sleep quality, time to fall asleep, sleep efficiency, sleep time, sleep disturbance, hypnotic drugs, daytime dysfunction). According the result, it made conclusions by comparing the group comparison between the time after follow-up study and the two times before the follow-up. Then it used the data to do the Intra-group comparison of the 3 periods of every group. The intra-group comparison of the group of using fang’s scalp acupuncture and body acupuncture:statistics shows that the TCM syndromes accumulate scores, the total scores of PSQI scale and the scores of every quantity component in the PSQI scale of the period after treatment are higher than the period before treatment. Intra-group differences are statistical significance (P<0.05). The trial result suggests that the treatment group had advantage. Comparison within the routine acupuncture group:compared with before treatment, the TCM syndromes accumulate scores, the total scores of PSQI scale and the scores of every quantity component in the PSQI scale after treatment and 1 month after treatment are both significantly lower, with P<0.05. This result indicates that routine acupuncture to treat insomnia of incoordination between heart and kidney has efficacy in all aspects. Comparison between the experiment group and the control group:there’s no significant difference between the two groups while comparing the TCM syndromes accumulate scores, the total scores of PSQI scale and the scores of every quantity component in the PSQI scale before treatment. But after two courses treatment and 1 month after the treatment, the TCM syndromes accumulate scores and the total scores of PSQI scale are lower than before treatment, with P<0.05. There is no substantially difference between sleep disturbance and hypnotic drugs after the first treatment, with P>0.05. After two treatments and 1 month after the treatment, the scores of every quantity component in the PSQI scales have statistical significance (P<0.05). In the whole, the experiment group have a better effect than the control group in improving patients’sleep in the three periods after treatment. The efficacy of the experiment group is superior to the control group, while comparing the TCM syndromes accumulates scores, the total scores of PSQI scale and the scores of every quantity component in the PSQI scale in the three periods.ConclusionBoth the fang’s scalp acupuncture and body acupuncture therapy and the routine acupuncture therapy have clinical effectiveness on insomnia of incoordination between heart and kidney, and the former is superior to the latter in general. The experiment therapy shows more advantage in decreasing the TCM syndromes accumulate scores, the total scores of PSQI scale and the scores of every quantity component in the PSQI scale. With its obvious, steady and safe clinical effectiveness on treatment group, the fang’s scalp acupuncture and body acupuncture therapy is worthy of promotion and further study. |
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