| 1. Research BackgroundDanish scholars Moller and Gudjonsson put forward Fluorosis for the first time in 1932. And it was a British missionary who first discovered and reported fluorotic cases in Southwest of China around 1930s and 1940s. He wrote a thesis on his discovery, which was published by Science magazine in New York, USA.Endemic Fluorosis, also known as Endemic Skeletal Fluorosis is a kind of chronic poisoning disease caused by an excessive intake of fluorine for a long time during people's lives. The disease that dues to superstandard rate of fluorine in drinking water sources from prevalent areas is called drinking water-born Endemic Skeletal Fluorosis, which is the research aim of our institute. From ancient time to date, Skeletal Fluorosis has been a threatening to people's health. As early as 1976, Chinese archaeologists found the fossil of typical skeletal fluorosis patients among ancient human fossil from 100,000 years ago at Xu Jiayao village of Gu Cheng in Yang Gao county, Shan Xi province. At present, this disease is pandemic and has different effects on about 35 countries and regions including Europe, Oceania, Americas, Asia and Africa. China is one of the worst epidemic areas. Except for Shanghai, the other cities, provinces and autonomous regions all have different level of localized outbreak. With a population of 1.3 billion, there is one fluoric patient in every 30 people averagely. By 2005, China has 1308 epidemic areas and 2.87 million of skeletal fluorosis patients, and affected population in these areas achieve 110 million.Skeletal fluorosis is the main manifestation of fluorine and caused by the attack of fluoride to skeletal system and related tissues. Its key symptoms include arthralgia, myalgia, tetany and numbness. There is no obvious sign for mild cases. But with patients'condition getting severe, the symptoms such as joints restriction or stiffness, deformity, hunch and paralysis will appear. It's not only harmful to patients'mind and body, but also affects the labor force, thus reduces the productivity of the disease areas.In general, modern medicine still lacks complete, systemic and fundamental knowledge on pathogenesis of skeletal fluorosis. Therefore, the therapeutics has limited effects. For effective treatment methods, we still have to further study its pathogenesis and get advanced. Lacking of unified and comprehensive standard for treatment results estimate is also a pending issue. For now, medications mainly focus on promoting fluoride excretion, reducing fluoride absorption, regularizing skeletal metabolism and relieving the symptoms. Traditional Chinese medicine, according to the theory of treatment based on syndrome differentiation and concept of holism, treat skeletal fluorosis as arthromyodynia depending on its clinic symptoms, characteristics, documents and records, and make clinic research through tonifying kidney, strengthening bones, dispelling wind, activating meridians to stop pain and promoting blood circulation by removing blood stasis. Its therapies have got positive results and include traditional Chinese drugs, fire needle (acupuncture with heated needles), acupuncture with time concerned, plaster and Chinese and Western integrative medicine etc. However, there are few research documents on fluorine cases China acupuncture applied to, thus an open area for researchers to explore.In view of positive clinic evaluation of acupuncture on painful disease and joint disease, and with the chief physician Wu Zhongchao's rich clinic experience in treatment of similar disease with acupuncture, our institute determines to use acupuncture to treat skeletal fluorosis and observe its results. We hope to provide new therapies for clinic treatment of skeletal fluorosis or acupuncture therapy and clinic proof, and complement the documents about how acupuncture can treat this disease. In addition, we also summarize the pathology rules of skeletal fluorosis in Chinese medicine, make further exploration and analysis on basis of results on pathology of this disease made by previous researchers. We commit ourselves to provide a new idea for syndrome differentiation in treating skeletal fluorosis.2. ObjectiveThis research adopted randomized controlled method based on clear diagnosis, unified curative effect indicators, following scientific research policy of randomization, blinding method and control group. Symptoms and curative indicators, syndrome of TCM, quality of life etc. were employed. The study aimed to comprehensively and objectively evaluate the therapeutic effects on treating skeletal fluorosis by acupuncture in line with differentiation as blood stasis and phlegm dampness.3. Materials and MethodsFrom May 2009 to June 2010,72 skeletal fluorosis patients from Qing Xian in HeBei Province(the water for drinking is not processed by reducing fluoride and contents fluoride about 2.67-7 mg/L) meeting the inclusion criteria were divided into the treatment group and control group by randomly stratified contrast. The treatment group received acupuncture therapy with treating principle of promoting blood circulation to remove blood stasis, dispersing phlegm and dampness, removing obstruction from meridians to stop pain. The control group(Caltrate D) had treating method for adjusting metabolic disorders between calcium and phosphorus and promoting excretion of flouride.①Treatment group:Filiform needle and electroacupucnture were applied, with fixed acupoints+local acupoints. Facedup and facedown position are changed, points which are difficult to maintain needles will be manipulated by quick acupuncture. Acupuncture therapy was employed every other day, with 30 minutes for each time, and 3 times a week. One month was a course for treatment, and totally two consecutive courses.Fixed acupionts:Dazhui (DU14), Geshu (BL17), Quchi (LI11), Hegu (LI4), Xuehai (SP10),Yinglingquan (SP9), Sanyinjiao (SP6), FengLong (ST40)Local acupoints:1 local acupoint was added for local pain (shoulder pain: Jianyu (LI15); elbow pain:Chize (LU5); wrist pain:Yangchi (SJ4); neck pain: Tianzhu(BL10); lower back pain:Yaoyangguan(DU3); hip pain:HuanTiao(GB30) or Juliao (GB29); knee pain:Dubi (ST35); ankle pain:Jiexi (ST41)) And as the same time, Ashi point in local part was coordinated with others. ②Control group:Intake of Caltrate D (600mg/pill,60 pill/bottle, TianJing Wyeth) The oral intake method:600mg each time, twice each day. The course of treatment was 1 month. And there came totally two consecutive courses.2 weeks,4 weeks,6 weeks during treatment and after treatment, symptoms of pain, the urine fluoride were evaluated in addition with the improvement of worst articular function disorder, as well as convulsion, numbness, stiffness, the function of looking after oneself in daily life, the TCM syndrome grading, improvement of daily life quality,etc. ACESS and SPSS 17 were adpoted for managing and analyzing data.4. Result4.1 PainIntra-group:VAS was significantly lower 2,4,6 weeks during treatment and after treatment than that of before treatment in both treatment and control group. Two groups both had benign function to alliviate pain from skeletal fluorosis. The mean value of VAS before treatment in treatment group was 7.156±1.1978. The mean value of VAS after treatment was 2.14±1.555, with P<0.01 tested by statitical analysis, which demonstrated that acupuncture had a remarkable effect to alliviate pain. The mean value of VAS before treatment in control group was 6.973±1.5319, and 4.257±1.8257 after treatment, with P<0.05 tested by statistical analysis, which showed that western medicine also had a remarkable effect to soothe pain.Inter-group:The remission rate of treatment group was higher than that of control group from 2 weeks after treatment to every time point after treatment. And it was significantly higher than that of control group after 6 weeks. The remission rate of acupuncture group was 70.76%, and 44.58% in western medicine group, with P< 0.01 tested by statisitical analysis. The remission rate of pain in acupuncture group was significantly higher than that of control group.4.2 Activity of Articular MovementIntra-group:The function disorder of worst articular could be improved in both of the treatment group and control group. The score of disorder was 2.55±0.759 before treatment in acupuncture group, and 0.45±0.759 after treatment, with statistically significant difference(P<0.01). The score lower after treatment than that before treatment illustrated distinct improvement of disorder of articular function. The score of disorder was 2.55±1.146 before treatment in western medicine group, and 1.3±0.923 after treatment, with statistically significant difference(P<0.05). The score lower after treatment than that before treatment explained that western medicine could distintly improved the disorder of articular function.Inter-group:The improving scale(therapeutic effect) of articular function disorder was superior to that of control group. The mean value of function improvement in acupuncture group(difference value of before treatment and after treatment) was 2.10±0.852, and 1.25±1.251 in western medicine group. Compared with western medicine group, the mean value of difference value was higher than that of acupuncture group, with a significant statistical difference(P<0.05).4.3 Convulsion, Numbness, StiffnessIntra-group:Convulsion could be improved in both of the treatment group and control group,. With the comparison between before and after treatment, the dissappearance rate was 82% in acupuncture group, showing a significant statistical difference(P<0.01).And the rate was 58.3% in western medicine group, with a significant statistical difference(P<0.05).Inter-group:There was no statistically significant difference(P>0.05) between two groups, so that the result could not be shown that the remission rate of convulsion was different with each other.There was no significant therapeutic effect for the concomitant symptoms as numbness and stiffness neither in acupuncture group nor in western medicine group.4.4 Fluorine in UrineIntra-group:Urine fluorine before treatment was higher than that of after 2nd,4th,6th weeks during the treatment course in acupuncuture group, with a significant statistical difference(P<0.01). Urine fluorine before treatment was 7.8413±3.6536, and 9.3245±4.07187 after treatment, which had a significant statistical difference(P <0.05) between before and after treatment.The comparison of urine fluorine before treatment to that of after 2nd,4th,6th weeks during treatment course in acupuncture group had no significant statistical difference(P>0.05).Inter-group:There was no statistically significant difference(P>0.05) of difference value of urine fluorine between before treatment and after 2nd,4th,6th weeks during the treatment course, so that the result could not be shown that the difference value of urine fluorine was different with each other.Urine fluorine before treatment was 1.8875+3.4889, and-0.4733±3.70806 after treatment, which had a significant statistical difference(P<0.05) between before and after treatment, which indicated after treatment, the discharge volumn of acupuncture group was higher than that of western medicine group.4.5 Activities of Daily LivingIntra-group:Activities of daily living in both groups could be improved. The score was 2.06±0.704 in acupuncture group before treatment and 1.33±0.854 after treatment, with a significant statistical difference(P<0.01). The score was 2.10±0.978 in acupuncture group before treatment and 1.39±0.882 after treatment, with a significant statistical difference(P<0.01).Inter-group:After treatment, difference value(before treatment-after treatment) of activities of daily living in bogh groups had no significant statistical difference(P>0.05), so that the result could not be shown that which was better in improvement of activities of daily living.4.6 Syndromes of TCMIntra-group:The blood stasis and phlegm dampness could be improved in acupuncture group. Before treatment, score of blood stasis was 7.79±2.446 before treament, and 4.7±1.944 after treatment, with P<0.01 tested by statistical analysis. It proved that there was a distinctive therapeutic effect of acupuncture treatment to improve the blood stasis. The score of phlegm and dampness before treatment was 9.15±4.494, and 3.45±2.306 after treatment, with significant statistical analysis(P <0.01).Before treatment, score of blood stasis was 8.13±1.959, and 7.60±1.639 after treatment, with no significant statistical analysis(P>0.05). As the same, the score of phlegm and dampness before treatment was 10.40±13.680 and 9.00±2.507 after treatment, with significant statistical analysis(P>0.05).Inter-group:The therapeutic effect in treatment group was suprior to that of control group. The difference value of score of blood stasis in acupuncture group(before treatment-after treatment) was 3.09±2.337, and 0.53±2.722 in western medicine group, with statistically significant different(P< 0.01).It indicated that the therapeutic effect on improving blood stasis in acupucnture group was remarkably suprior to that of control group.The difference value of score of was 5.70±3.405 in acupuncture group, and 1.40±2.874 in western medicine group, with statistically significant difference(P<0.01). It proved that the therapeutic effect on improving phlegm and dampness in in acupucnture group was remarkably suprior to that of control group.4.7 Quality of LifeIntra-group:The difference value of scores before and after treatment in improving General-Health(GH), ReportedHealth-Transition(HT), Physical Functioning (PF), Role-Physical (RP), Role-Emotional (RE), Social Functioning(SF), Bodily Pain(BP), Vitality (VT), Mental Health(MH) etc... before and after treatment had both statistically significant difference(P<0.01). Thus, it showed that there was distinct therapeutic effect on improving quality of life in both groups.Inter-group:The difference value of score of general health(GH) in acupuncture group(before treatment-after treatment) was 0.61±0.203, and 0.44±0.194 in western medicine group. The difference value of physical function in acupuncture group was 0.52±0.242, and 0.19±0.279 in western medicine group. For emotional function(EF) in acupuncture group, it was 0.67±0.344, and 0.18±0.296 in western medicine group. For social function(SF) in acupuncture group was 0.28±0.262, and 0.16±0.212 in western medicine group. For the items above, the difference value in acupuncture group was suprior to that in western medicine group, with a statistically significant difference(P<0.05). And for others, there were no statistically significant differences.4.8 Safety ReportsThere were no adverse reactions in both of acupuncture group and western medicine group.There was one case of needle sensing in acupuncture group.5. Conclusion①Acupuncture can effectively eliminate pain from skeletal flurosis, and remarkably improve activity disorder of the worst articular, with a significant statistical difference compared with those of Caltrate D group. And it can also relieve the convulsion symptom, with no significant statistical difference compared with that of Caltrate D group.②Acupuncture can increase the discharge volumn of patients with skeletal flurosis, with a significant statistical difference compared with that of Caltrate D group.③Acupuncture can enhance activities of daily living, but with no significant statistical difference compared with that of Caltrate D group. While it can effectively improve the syndromes as blood stasis or phlegm dampness with a significant statistical difference compared with those of Caltrate D group.④Acupuncture has both safety and non-toxic effect in treating skeletal flurosis. |
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