Multicenter Clinical Study on the Combined Intervention with Appropriate TCM Techniques in the Treatment of Opioid-induced Constipation
Objective To evaluate the clinical efficacy of combined intervention with appropriate TCM techniques in the treatment of opioid-induced constipation through a multicenter clinical study.Methods From July 2021 to October 2022,patients were selected based on the following criteria:fulfilling the diagnostic criteria for opioid-induced constipation,fulfilling the differentiation criteria for constipation with the pattern of intestinal dryness and fluid consumption,and being hospitalized in either the oncology wards of Yueyang Hospital of Integrated Traditional Chinese and Western Medicine,Shanghai University of Traditional Chinese Medicine,the hospice wards of Shanghai Putuo Liqun Hospital,or the hospice wards of Shanghai Changzheng Community Health Service Center.Eligible patients were divided into the control group(n=164)and the observation group(n=164)by using a random number table.Both groups received routine care with reference to the Protocol of Combined Treatment of Traditional Chinese Medicine and Western Medicine for Opioid-induced Constipation.On this basis,the control group additionally received lactulose oral solution(10 mL under fasting conditions,TID)and corresponding medication guidance,while the observation group additionally received combined intervention with appropriate TCM techniques,comprising TCM application,TCM iontophoresis and auricular acupressure therapy.The duration of intervention was 14 days in both groups.The daily average defecation frequency and the average defecation interval after intervention were compared between the two groups;the constipation symptoms,constipation-related quality of life scores and pain scores were compared pre-and post-intervention and between the two groups.Results The markedly effective rate(31.71%)of the observation group was higher than that of the control group(8.54%)and there was a significant difference in the efficacy of constipation symptoms between the two groups(Z=-5.41,P<0.01).There was no significant difference in the average daily defecation frequency and the average defecation interval post-intervention between the two groups(P>0.05).The constipation symptoms and constipation-related quality of life scores were significantly improved post-intervention compared to pre-intervention in both groups,and more pronounced and significant improvements were observed in the observation group(P<0.01).The pain scores post-intervention were significantly lower than those pre-intervention in the two groups(P<0.01),but no significant difference was observed between the groups(P>0.05).Conclusion For patients with opioid-induced constipation,the combined intervention with appropriate TCM techniques can relieve their constipation and constipation-related discomforts and improve their quality of life.This approach aligns with the concept of hospice care for patients with advanced cancers and holds certain implications for promotion in clinical practice.
Cancer painOpioid-induced constipationAppropriate TCM techniqueHospice care