| Background:Cancer pain is one of the most common symptoms experienced by colorectal cancer patients.Meanwhile,it is a widespread problem around the world.Effective pain control,especially for advanced cancer patients,is one of the four priorities on Integrated Cancer Stragegies of the World Health Organization.Cancer pain is the most complicated,most comprehensive,and most diverse among pains,and it will change along with the progress of the tumor.About 69%of the patients who suffer from pain will affect the normal function of the body.Despite there are many resources among modern medicine,patients with various cancers have not received adequate management on cancer pain,and it diminishes their quality of life.Therefore,we should seek more and appropriate cancer pain management to improve their quality of life.Many patients suffering from colorectal cancer seek supplemental and alternative treatments,such as moxibustion.Moxibustion with seed-sized moxa is one of the Traditional Chinese Medicinal therapies in China.It is utilized not only to treat and prevent various diseases but also manage signs and symptoms including pain.Recent studies have shown that moxibustion can effectively relieve cancer pain.The adpotion of Acupuncture and Moxibustion,a kind of non-medicine method including moxibustion with seed-sized moxa cone,has become the highlight for humans to manage cancer pain.Renowed Chinese medicine practitioners Professor LIN Guohua has rich clinical experience and obtained satisfactory results especially in treating pain.In this thesis,we adpoted moxibustion with seed-sized moxa cone applied at acupoints of combination of the Four flowers and Alarm&Sea(Prof LIN Guohua’s experience in the acupoint selection for colorectal cancer pain)in treating colorectal cancer pain.It is of great significance for the enrichment of traditional Chinese medicine In managing cancer pain.Objective:A prospective randomized controlled clinical trial was conducted to observe the clinical efficacy,feasibility and safety of the treatment of colorectal cancer pain by utilizing moxibustion with seed-sized moxa cone applied at Four Flowers and Sea&Alarm(Prof LIN Guohua’s experience in the acupoint selection for colorectal cancer pain).To understand the impact of moxibustion with seed-sized moxa cone applied on Four Flowers and Sea&Alarm on the quality of life of patients with colorectal cancer.And to explore the possible mechanism of Four Flowers and Sea&Alarm in treating colorectal cancer pain.Method:A randomized controlled trial was conducted.Sixty patients with colon cancer were recruited.They were randomly allocated to two groups in 1:1 ratio.The control group would only receive the first and second steps of oral medication according to the administration principle of World Health Organization ’ s(WHO’s)Pain Relief Ladder.The moxibustion with seed-sized moxa cone group would receive moxibustion with seed-sized moxa cone at acupoints of combination of the Four flowers and Alarm&Sea plus taking the first and second steps of oral medication according to the administration principle of WHO’s Pain Relief Ladder.During treatment,a thin layer of diedawanhuaoil would be applied at the acupoints(combination of the Four flowers and Alarm&Sea)of participants in the moxibustion with seed-sized moxa cone group at first,and then 1:35 refined moxa size like grain(about 2 mg)were placed on the top.After that,incense was utilized to ignite the granules and burned it to about 3/4.When the patient felt pain for 2 to 3 seconds,took away the granules with forceps.Repeated the above steps 7 times in each vist andremoved the residue with cotton swab at last.All participants would receive the treatment every other day,for 10 days as one course of treatment.And the treatment lasted for 2 courses.The primary outcome measure would be the mean change in the average scores of the Visual Analog Scale.The secondary outcome measures would be the mean difference in changes from the baseline of the Quality of Life Instruments for Cancer Patients-Colorectal Cancer(QLICP-CR).In order to evaluate the clinical efficacy of the moxibusion treatment in pain control and the impact on the quality of life,each outcome measure would be analyzed before,after the first course and after the second course between groups.Safety would also be assessed by monitoring adverse events at each visit.All data were analyzed by SPSS 19.0.This research project had been approved by the Ethics Committee of the First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine(Guanzhou,China)prior the study.Results:There was no significant difference in VAS scores between both groups before treatment(moxibustion with seed-sized moxa cone group:7.457±0.158 vs control group:7.520±0.155)(P>0.05).The VAS scores of both groups were improved each course of the treatment.The VAS scores of moxibustion with seed-sized moxa cone(4.307±0.073)were significantly lower than those of the control group(4.740±0.188)(P<0.05).There was no significant difference between moxibustion with seed-sized moxa cone and control groups in the physical domain indexes before treatment(55.500±1.863 vs 54.067±1.746)(P>0.05).The physical domain indexes of both groups were improved after treatment.The moxibustion with seed-sized moxa cone group(72.200±1.760)was significantly better than the control group(62.433±1.808)(P<0.05).The psychological domain index of the moxibustion with seed-sized moxa cone and control groups before treatment(66.200±1.313 vs 68.800±1.401)had no significant difference(P>0.05).The Psychological domain indexes of both groups were improved after each course of the treatment.And the moxibustion with seed-sized moxa cone group(48.700±1.294)was significantly better than the control group(61.733±1.190)(P<0.05);There was no significant difference in Social domain indexes between the the moxibustion with seed-sized moxa cone and control groups before treatment(P>0.05).Both groups reported that there was no improvement in the aspect of social domain indexes after each course of the treatment(75.667±1.201 VS 72.000 ±1.826)(P>0.05).There were no significant differences between the moxibustion with seed-sized moxa cone and control groups in the aspect of Common symptoms and side effect domain(54.933±1.130 vs.55.933±1.466)(P>0.05)before treatment.Both groups were improved after each course of the treatment.The moxibustion with seed-sized moxa cone group(40.567±1.044)was significantly better than the control group(48.767±1.168)(P<0.05).There was no significant difference between the the moxibustion with seed-sized moxa cone and control groups in the Special domain index before treatment(65.767±1.602 vs.67.600±1.396)(P>0.05).Both groups were improved in the aspect of Specific domain after each course of the treatment.The moxibustion with seed-sized moxa cone group(44.100±1.272)was significantly better than the control group(57.033±1.247)(P<0.05).In summary,the quality of life of the moxibustion with seed-sized moxa cone and control groups was not significantly different(61.533±0.567 vs.61.833±0.426)(P>0.05)before treatment.The quality of life of both groups was improved after each course of the treatment.And the moxibustion with seed-sized moxa cone group(56.267±0.631)was significantly betters than the control group(60.500±0.481)(P<0.05).In addition,during the study,only 2 participants in the moxibustion with seed-sized moxa cone group developed mild dizziness after treatment,and they were recovered after being treated by the doctor.Three participants complained of blisters noted after moxibustion with seed-sized moxa cone.The blisters were small and reabsorbed spontaneously without any other special treatment.Other symptoms were also noted but were not related to the integration treatment of the moxibustion with seed-sized moxa cone and oral medication according to the administration principle of WHO’ s Pain Relief Ladder.In the moxibustion with seed-sized moxa cone group,there were 3 participants complained of loss of appetite,2 participants complained of dry mouth and 2 participants complained of constipation.Whereas there were complaints noted in the control group including one palpitation,3 dry mouth,2 loss of appetite,4 dizziness and 2 constipation.Even though there were side effects reported as mentioned,but thosed were mild and participants were recovered without any special treatments,which may also be caused by side effects of medications regarding to the oral medication of WHO’s Pain Relief Ladder.In summary,the integration treatment of moxibustion with seed-sized moxa cone and oral medication according to the administration principle of WHO’s Pain Relief Ladder is safe,so it should be promoted.Conclusion:Moxibustion with seed-sized moxa cone applied at acupoint combination of Four Flowers and Sea&Alarm can alleviate pain for colon cancer patient.On the other hand,in addition to social functions,this study found that moxibustion with seed-sized moxa cone applied at acupoint combination of Four Flowers and Sea&Alarm have a certain improvement effect on the physical function,psychological function,specific modules,common symptoms and side effects pf the quality of life of colorectal cancer patients.Larger studies,multi-centers,and randomized controlled trials peculiar to various types of cancer are warranted to confirm its treatment effects in more details,and to further improve the protocol of acupuncture treatment in the future. |
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