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Clinical and Economic Evaluation of Acupuncture for Opioid-Dependent Patients Receiving Methadone Maintenance Treatment: The Integrative Clinical Trial and Evidence-Based Data.

ABSTRACT: Objective: From the health care and societal perspectives, this study aimed to evaluate the clinical and economic effects of acupuncture as an adjunctive therapy for patients receiving methadone maintenance treatment (MMT). Methods: We conducted a parallel-arm RCT in China in 2019. Patients were included who met the diagnostic criteria and receive MMT for more than 30 days. Patients were randomly assigned to the exposed group (acupuncture plus MMT) or control group (MMT) at a 1:1 ratio. Daily methadone dosage, drug cravings using the VAS score, and insomnia using the Pittsburgh Sleep Quality Index (PSQI) were chosen as the effectiveness indexes, and the quality-adjusted life years (QALYs) was chosen as the utility index. Results: Overall, 123 patients were included. The exposed group was significantly (P < 0.05) better than the control group in the improvement of daily methadone dosage (17.68 vs. 1.07), VAS (38.27 vs. 2.64), and PSQI (2.18 vs. 0.30). The QALY was 0.0784 (95%CI: 0.0761-0.0808) for the exposed group and 0.0762 (95%CI: 0.0738-0.0787) for the control group. The total cost of the exposed group (2869.50 CNY) was higher than the control group (2186.04 CNY). The ICER of daily methadone dosage (41.15), VAS (17.86), and PSQI (313.51) were shown to be economically efficient. While ICUR (310,663.64 CNY/QYLY) was higher than the cost suggested by WHO. Conclusion: Acupuncture as an adjuvant therapy for MMT patients realizes its cost-effectiveness by reducing the dosage of methadone, improving drug cravings, and alleviating insomnia. It helps to improve quality of life, but since its cost exceeds what society is willing to pay, further study is needed.

SUBMITTER: Wen H

PROVIDER: S-EPMC8415360 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Objectives: Opioid dependence has been a threat to public health for hundreds of years. With the increasing number of studies on acupuncture-related therapies for opioid dependence patients receiving methadone maintenance treatment (MMT), its effect of acupuncture therapy in treating MMT patients remains controversial. Therefore, we conducted a multiple-treatments meta-analysis, and incorporated both direct and indirect comparisons, in order to discover the most effective treatment for opioid dependence patients receiving MMT. Methods: Five English databases and three Chinese databases were searched from its inception to August 20, 2020, in order to compare the effects of acupuncture-related therapies and MMT, which was summarized as Western medicine (WM) in the following texts. The quality of studies was assessed according to Cochrane's risk of bias tool 5.1.0, and a pair-wise meta-analysis, cumulative meta-analysis, and the network meta-analysis was performed using the R software (Version 3.6.1) and STATA (Version 14.0). The primary outcome was the effective rate, which was calculated by the ratio of detoxifying patients to the total. The secondary outcome was the Modified Himmelsbach Opiate Withdrawal Scale (MHOWS). Results: A total of 20 trials were included, which consisted of comparisons among WM, traditional Chinese medicine (TCM), and the four types of acupuncture, namely, manual acupuncture (MA), electro-acupuncture (EA), auricular acupuncture (AA), and transcutaneous electrical acupoint stimulation (TEAS). Though none of the trials were at low risk of bias. In the pair-wise meta-analysis, no statistically significant differences were observed in terms of the effective rate. Furthermore, MA was more efficacious than WM, EA, and TEAS in MHOWS, with mean differences (MDs) of (-8.59, 95% CI: -15.96 to -1.23, P < 0.01), (-6.15, 95% CI: -9.45 to -2.85, P < 0.05), and (-10.44, 95% CI: -16.11 to -4.77, P < 0.05), respectively. In the network meta-analysis, MA was more effective than WM (RR: 1.40, 95% CI: 1.05 to 1.99) on the effective rate, and (MD: -5.74, 95% CI: -11.60 to -0.10) on MHOWS. TEAS was more effective than WM (MD: -15.34, 95% CI: -27.34 to -3.46) on MHOWS. Synthetically, MA had the highest probability to rank first in treating opioid dependence. Conclusions: The existing evidence shows that acupuncture related-therapies may effectively be used for treating patients receiving MMT, and that manual acupuncture may be the best choice for opioid dependence among all kinds of acupuncture-related therapies. Nevertheless, reducing the relapse and promoting the recovery of opioid dependence need more efforts from not only the medical industry but also government support, security system, and educational popularization. To strengthen the assurance of acupuncture-related therapies in the treatment of opioid dependence, we expected that clinical trials with high quality would be conducted, to provide more confident evidence.

Project description:BackgroundOpioid dependence is an increasing public health problem all over the world. Patients with opioid dependence have to receive methadone maintenance therapy (MMT) as replacement therapy for years or even for their entire life. Acupuncture as a kind of therapy has been used to treat substance dependence for many years. Jin's three-needle acupuncture (JTN), a type of acupuncture technique, has been applied to treat various diseases for several decades. However, JTN as an acupuncture technique has not been used to treat patients receiving MMT. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT.Methods/designThis study is a parallel-arm, randomized controlled trial that aims to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. A total of 140 eligible participants who range in age from 18 to 60 years and fulfil the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), for opiate dependence will be enrolled into this study. All eligible participants will be randomly assigned to the acupuncture group or routine group in a 1:1 allocation ratio. Participants who are enrolled in the acupuncture group will receive MMT and JTN treatment for 30 min per session. Meanwhile, those who are assigned to the routine arm will receive MMT only. All 18 sessions of JTN treatment will be delivered over 6 weeks (3 per week) and followed by a 4-week follow-up period. The primary outcome measure will be the visual analogue scale (VAS) for drug craving and the daily consumption of methadone (DCOM). Secondary outcome measures will include the urine test for opioid use, the 36-item Short Form Survey (SF-36), the Beck Anxiety Inventory (BAI), the Beck Depression Inventory II (BDI-II) and Pittsburgh sleep quality index (PSQI). VAS, DCOM, BAI, BDI-II and the urine test for opioid use will be evaluated at baseline, the second week, the fourth week, the sixth week and the tenth week. SF-36 and PSQI will be assessed at baseline, the fourth week, the sixth week and the tenth week.DiscussionThe results of this trial will provide evidence on the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT.Trial registrationChinese Clinical Trial Registry ChiCTR1900026357 . Registered on 2 October 2019.

Project description:Opioid analgesic use and disorders have dramatically increased among the general American population and those receiving methadone maintenance treatment (MMT). Most research among MMT patients focuses on opioid analgesics misuse or disorders; few studies focus on MMT patients prescribed opioid analgesics. We describe demographic, clinical, and substance use characteristics of MMT patients prescribed opioid analgesics and compare them with MMT patients not prescribed opioid analgesics.We conducted a cross-sectional secondary data analysis using screening interviews from a parent study. From 2012 to 2015, we recruited adults from 3 MMT Bronx clinics. Questionnaire data included patterns of opioid analgesic use, substance use, comorbid illnesses, and demographic characteristics. Our main dependent variable was patients' report of currently taking prescribed opioid analgesics. To compare characteristics between MMT patients prescribed and not prescribed opioid analgesics, we conducted chi-square tests, t tests, and Mann-Whitney U tests.Of 611 MMT patients, most reported chronic pain (62.0%), hepatitis C virus (HCV) infection (52.1%), and current use of illicit substances (64.2%). Of the 29.8% who reported currently taking prescribed opioid analgesics, most misused their opioid analgesics (57.5%). Patients prescribed (versus not prescribed) opioid analgesics were more likely to report human immunodeficiency virus (HIV) infection (adjusted odds ratio [aOR] = 1.6, 95% confidence interval [CI]: 1.1-2.3) and chronic pain (aOR = 7.6, 95% CI: 4.6-12.6).Among MMT patients primarily in 3 Bronx clinics, nearly one third reported taking prescribed opioid analgesics. Compared with patients not prescribed opioid analgesics, those prescribed opioid analgesics were more likely to report chronic pain and HIV infection. However, between these patients, there was no difference in illicit substance use. These findings highlight the complexity of addressing chronic pain in MMT patients.

Project description:Background and aimsPharmacy administration and dispensing of methadone for methadone maintenance treatment (MMT) can expand treatment access for opioid use disorder (OUD). This study investigated the feasibility and acceptability of a novel model permitting an opioid treatment program (OTP) physician to prescribe methadone for OUD treatment through collaboration with a partnered pharmacy.DesignNon-randomized, single-arm, open-label feasibility trial.SettingOne OTP and one community pharmacy in the United States.ParticipantsOne OTP physician, two pharmacists and 20 MMT patients receiving between six and 13 take-home methadone doses at 5-160 mg/day.InterventionPatients' methadone administration and dispensing of take-home doses was transferred from the OTP to the pharmacy for 3 months.MeasurementsPrimary outcome was medication adherence. Secondary outcomes were recruitment, treatment retention, substance use, counseling attendance at the OTP, pharmacist prescription drug monitoring program (PDMP) use, safety and satisfaction.FindingsOf 29 patients eligible at pre-screen, 20 patients (69%) enrolled into the study. Recruitment occurred from 6 August 2020 to 10 October 2020. Treatment retention rate at month 3 was 80% (16 of 20). Two participants returned early to the OTP because of a work/schedule change, one due to pregnancy and one following a non-study-related hospitalization. Medication adherence among 16 patients who were retained was 100%. Intervention fidelity was 100%. All participants attended random call-back visits. None showed evidence of tampering/diversion of methadone. Pharmacists checked the PDMP at all visits. All participants attended psychosocial counseling as planned. There were no positive urine screens for illicit opioid use and no study-related adverse events. All participants endorsed 'pharmacy is the right location for receiving methadone for MMT', 88% endorsed 'convenient or very convenient to receive methadone at the pharmacy' and 88% were satisfied or very satisfied with the quality of treatment offered.ConclusionsThis feasibility trial has found pharmacy administration and dispensing of physician-prescribed methadone for methadone maintenance treatment to be feasible and acceptable.

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Clinical and Economic Evaluation of Acupuncture for Opioid-Dependent Patients Receiving Methadone Maintenance Treatment: The Integrative Clinical Trial and Evidence-Based Data.

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