| Objective:To observe the efficacy and safety of Zhuyuzhitong formula and acupuncture as an adjuvant treatment for cancer pain,to provide an effective treatment method that is safe and easily administered.Methods:A total of 50 eligible patients were recruited for this study,and randomly allocated to either the treatment or the control group.26 patients were allocated to the treatment group and 24 patients were allocated to the control group.Both groups were given similar baseline treatment and analgesics based on their pain scores.Dosage alteration and titration were done according to NCCN guidelines for Adult Cancer Pain.The treatment group was further administered with a topical application of Zhuyuzhitong formula together with acupuncture treatment.Both groups were assessed daily for their NRS score,analgesics dosage and occurrence of breakthrough pain,while EORTC-QLQ C30 and SDS scores were assessed on day 1 and day 7.Statistical analysis was conducted using SPSS 23.0.Results:No significant difference was found between the baseline characteristics and scoring variables for both groups(P>O.05).Treatment outcomes:①NRS score:Both groups had statistically significant decreases in scores after 7 days of intervention(P<0.01).NRS score of the treatment group was lower than that of the control group,but no significance difference was observed(P>0.05).NRS score of the treatment group on day 5 was significantly lower than that of the control group(P<0.05).②Treatment response:Treatment response was higher in the treatment group than that of the control group,but no significant difference was observed(P>0.05).However,as the no response rate of the treatment group was lower than that of the control group,we conclude that the treatment group could potentially have a higher efficacy than that of the control group.③Occurrence of breakthrough pain:Throughout the course of treatment,there was a lower occurrence of breakthrough pain in the treatment group than in the control group,but no significant difference was observed(P>0.05).④Baseline morphine dose:Baseline morphine dose increased in both groups at the end of intervention,with a significant difference observed in the control group(P<0.05)but not in the treatment group(P>0.05).Baseline dose was lower in the treatment group that than in the control group,but no significant difference was observed(P>0.05).⑤Total dosage of morphine:Total morphine dosage was lower in the treatment group than that in the control group,but no significant difference was observed(P>0.05).⑥EORTC-QLQ C30 Functional scale:We mainly assessed the physical and emotional function for this study.Physical and emotional function scores significantly increased for both groups after treatment(P<0.05,P<0.01),but no significant difference was observed between both treatment and control groups(P>0.05).⑦EORTC-QLQ C30 Symptom scale:We assessed symptom scores for fatigue,nausea/vomiting,pain,sleeplessness,appetitelessness and constipation for this study.Symptom scores for fatigue,pain,sleeplessness and constipation decreased significantly in the treatment group(P<0.05,P<0.01),but no significant difference was observed for nausea/vomiting and appetitelessness(P>0.05).Symptom scores for fatigue and pain decreased significantly in the control group(P<0.05,P<0.01),but no significant difference was observed for nausea/vomiting,sleeplessness,appetitelessness and constipation(P>0.05).Symptom score for pain was significantly lower in the treatment group than that in the control group after intervention(P<0.05).⑧EORTC-QLQ C30 Global health status:Global health status scores increased significantly for both groups after treatment(P<0.05).Treatment group had a higher score than the control group,but significant difference was observed(P>0.05).⑨ SDS score:Both groups had significant decreases in SDS scores after intervention(P<0.01).SDS score in the treatment group was lower than that in the control group,but no significant difference was observed(P>0.05).⑩Safety assessment:No significant difference was observed for complete blood counts,liver function tests and renal function tests for both groups after treatment(P>0.05).One patient in the treatment group experienced a localised warm sensation,which was resolved upon removing the medication.No further treatment was required.No adverse effects were observed in the other patients,and no serious adverse effects occurred during this study.Conclusions:Zhuyuzhitong formula with acupuncture has a certain efficacy as an adjuvant treatment for cancer pain when used in conjunction with analgesics,and could possibly limit the increase in baseline morphine dosage.This treatment method is also effective in alleviating the symptoms of pain,sleeplessness and constipation,and is relatively safe for clinical administration. |
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