A Randomized Controlled Trial On The Adjuvant Analgesic Therapy With HANS In Opioid Tolerant Cancer Pain Patients

Background：Cancer pain is one of the most common symptoms of patients with advancedcancer. Inadequate pain control is a widespread clinical problem. Difficulty in doseescalation after the formation of opioid tolerance and persistent constipation are mainfactors which affect analgesic effects. Poorly controlled cancer pain may lead to patient’sanxiety and depression which form a vicious circle and increase the difficulty of paintreatment. Therefore, explore effective non-medication ways is an important strategy toimprove analgesic efficacy.Objectives: To observe and evaluate adjuvant analgesic efficacy of Han’s Accupoint NerveStimulator (HANS) in opioid tolerant patients with cancer pain.Methods: A randomized controlled trial was conducted. Opioid tolerant cancer painpatients who were undergoing strong opioid treatment were enrolled and were randomlyassigned into two groups. Participants were treated with either HANS or Mock-HANSrespectively. The two types of treatment are merely different in the intensity of outputcurrent: HANS was adjusted to amaximal but comfortable level (<30mA), whileMock-HANS was fixed at5mA. One pair of skin electrodes were placed on Hegu (LI4)and Neiguan (PC6), and the other pair were placed on Zusanli (ST36) and Sanyinjiao(SP6);2/100Hz dense-and-disperse frequency was used for both HANS and Mock-HANSgroup; each participant was treated for30minutes per day,5days on and2days off for2weeks. All patients’ general information, the therapeutic frequency of breakthrough pain(BP), and daily dose of Oral Morphine Equivalent (OME) were carefully recorded.Patient-reported questionnaires were used to assess the baseline, the8th and15th day’spain, Quality of life (QOL), and anxiety and depression. Mean scores of the two groups ofthese measurements were compared accordingly. The Chinese version ofthe Brief Pain Inventory (BPI-C) was used to assess pain, European Organization for theResearch and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) wasused to evaluate QOL, and Self-Rating Anxiety Scale (SAS) and Self-Rating DepressionScale (SDS) were used respectively to assess anxiety and depression.Results:67patients meeting the inclusion criteria participated in this study (34in HANS group and33in Mock-HANS group).1patient in HANS group and2patients inMock-HANS group dropped out due to disease progression or reluctant to furtherparticipation.33patients in HANS group and31in Mock-HAN group completed the2weeks treatment and assessment. The general information, baseline level of pain control,OME, the frequency of BP treatment, QOL and anxiety and depression weren’tsignificantly different between the two groups. Under-treatment of pain and poor QOLwere common characteristics of the two groups. Compared with the Mock-HANS group,the HANS group had significantly lower mean scores of the "least" and "average" painintensity on Days8and15, and significantly lower man scores of the “worst” painintensity on day8; the mean scores of the interfered “daily life” and “sleep” were alsomuch lower; but the average daily dose of OME didn’t show any significantly differencebetween the2groups. For the9symptoms in EORTC QLQ-C30assessment, the meanscores of constipation, pain, fatigue, and insomnia of HANS group were significantlylower on Days8and15; the mean scores of the overall health status on day15of HANSgroup was much better than Mock-HANS group. The incidence rates of both anxiety anddepression of the two groups weren’t significantly different; however, the mean scores ofanxiety and depression of the HANS group were much lower on Days8and15.Conclusion: Most participants’ cancer pain was under-treated. To these patients withopioid tolerance, HANS as a convenient and safe non-medication method could effectivelyrelieve pain; decrease the severity of constipation, fatigue and insomnia, and it could alsoimprove QOL and alleviate anxiety and depression which deserves further study andapplication.