Quality of life of patients treated with opium tincture or methadone: A randomized controlled trial.

OBJECTIVE: Quality of life (QoL) is an increasingly recognized patient-centered treatment outcome in individuals with opioid use disorder. There is a gap in literature on the impact of opium tincture (OT) on patients' QoL compared to standard treatment options such as methadone. This study aimed to compare the QoL of participants with opioid use disorder receiving OAT using OT or methadone and identify the factors associated with their QoL during treatment. METHODS: The opium trial was a multicenter non-inferiority randomized clinical trial in four private OAT outpatient clinics in Iran. The study assigned patients to either OT (10 mg/ml) or methadone sirup (5 mg/ml) for a follow-up of 85 days. QoL was assessed using the brief version of the World Health Organization Quality of Life instrument (WHOQOL- BREF). RESULTS: A total of 83 participants, 35 (42.2%) in the OT arm and 48 (57.8%) in the methadone arm, completed the WHOQOL-BREF in full and were included in the primary analysis. The mean score of patients' QoL showed improvement compared to baseline, but differences were not statistically significant between OT and methadone arms (p = 0.786). Improvements were mainly observed within the first 30 days of receiving treatment. Being married and lower psychological distress were associated with an improved QoL. Within the social relationships domain, male gender showed significantly higher QoL compared to females. CONCLUSION: OT shows promise as an OAT medication, comparable to methadone in improving patients' QoL. There is a need to incorporate psychosocial interventions to further sustain and improve the QoL in this population. Identifying other social determinants of health which affect QoL and the cultural adaptation of assessments for individuals from various ethnocultural backgrounds are critical areas of inquiry.

Opium tincture versus methadone for opioid agonist treatment: a randomized controlled trial.

AIM: To test if opium tincture (OT) was non-inferior to methadone in retaining participants in opioid agonist treatment (OAT). DESIGN: A Phase III, multi-centre, parallel-group, non-inferiority, double-blind randomized controlled trial with an allocation ratio of 1:1. Participants were provided treatment and followed for a period of 85 days. SETTING: Four OAT clinics in Iran. PARTICIPANTS: Two hundred and four participants with opioid use disorder [mean age (standard deviation) = 37.4 (9.3); female 11.3%] recruited between July 2017 and January 2018. INTERVENTIONS: Participants were assigned to either OT (102) or methadone (102) using a patient-centred flexible dosing strategy. MEASUREMENTS: Treatment retention over 85 days was the primary outcome. Self-reported opioid use outside treatment and occurrence of adverse events (AEs) were the secondary outcomes. FINDINGS: Remaining in treatment at the end of the follow-up were 68.6% in the methadone arm and 59.8% in the OT arm. The relative retention rate of methadone to OT was 1.15 (0.97, 1.36) in both intent-to-treat and per-protocol analyses; non-inferiority was not supported statistically, as the upper bound of the confidence interval exceeded our pre-specified non-inferiority margin (1.25). Opioid use outside treatment was reported by 30.3% of OT (n = 152) and 49.4% of methadone (n = 168) patients, a difference in proportions of -19%: 90% confidence interval (-28%, -10%). The total count of AEs in the OT arm (22 among nine individuals) was significantly higher (P = 0.04) than that in the methadone arm (three among two individuals). Nausea was the most common side effect. CONCLUSION: While this study could not conclude the non-inferiority of opium tincture (OT) to methadone for retaining patients in opioid agonist treatment, OT retained 60% of participants to end of follow-up (85 days) and was superior to methadone in reducing self-reported opioid use outside treatment.

Substance of choice, impact of heroin or opium on treatment retention in a multicentre randomised controlled trial in Iran.

INTRODUCTION: In the Middle East and Asia, illicit opioid use exists across a spectrum between heroin and opium. The impact of primary opioid of choice on opioid agonist treatment retention has not been well evaluated previously, especially for opium tincture, an increasingly popular form of opioid agonist treatment in Iran. This study investigates the relationship between primary opioid of choice, namely heroin or opium, and retention in opium tincture and methadone treatment. METHODS: Participants with opioid use disorder (n = 204) were randomised to receive opium tincture or methadone. All participants were categorised as mainly using opium or heroin. Bivariate analyses between treatment retention and primary opioid of choice (P < 0.05) and logistic regression were conducted. RESULTS: Among the 191 participants included in this analysis, heroin was the primary substance of choice for 135 participants (70.7%) and opium for 56 (29.3%). Bivariate analysis showed that the opium group was more likely to be satisfied with family situation, employed and retained in treatment than the heroin group while less likely to experience incarceration and use multiple substances. When adjusting for covariates, primary opioid of choice was not significantly associated with retention in either methadone or opium tincture treatment arm. DISCUSSION AND CONCLUSIONS: Positive factors, such as employment, housing and family support, seem to collectively explain the higher retention in treatment among those who primarily use opium compared to those who use heroin. To optimise retention in opioid agonist treatment, biopsychosocial care models should be further evaluated to improve psychosocial functioning.

Comparing opium tincture and methadone for medication-assisted treatment of patients with opioid use disorder: Protocol for a multicenter parallel group noninferiority double-blind randomized controlled trial.

OBJECTIVES: This is the first study to compare the safety and efficacy of opium tincture (OT) with methadone for treatment of opioid use disorder. METHODS: In this multicenter, double-blind, noninferiority controlled trial, a stratified sample of 204 participants with opioid use disorder were recruited from community outreach, drop-in centers, and triangular clinics. Participants were excluded in case of active participation in another treatment program for opioid use disorder, hypersensitivity to trial medications, pregnancy, and certain serious medical conditions. They were randomized to receive either OT or methadone with an allocation ratio of 1:1 using a patient-centered flexible dosing strategy. Eligible participants were followed for a period of 12 weeks. Primary outcome is the difference in percentage of patients retained in the treatment. Secondary outcomes are craving, withdrawal symptoms, physical health, mental health, quality of life, and severity of substance use problems, cognitive function, safety profile, cost-effectiveness, and participants' satisfaction. Both intention-to-treat and per-protocol analyses will be conducted. The Ethics Board of the University of British Columbia and Tehran University of Medical Sciences approved the study. (clinicaltrials.gov; NCT02502175). RESULTS: To be reported after final analysis. CONCLUSIONS: If shown to be effective, OT will diversify the options for medication-assisted treatment of opioid use disorder.

[MINIMALLY INVASIVE PARATHYROIDECTOMY (MIP) UNDER LOCAL ANESTHESIA FOR TREATMENT OF PRIMARY HYPERPARATHYROIDISM (PHPT) CAUSED BY A SINGLE ADENOMA].

INTRODUCTION: Minimally Invasive Parathyroidectomy (MIP) has become the treatment of choice of Primary Hyperparathyroidism (PHPT) caused by an adenoma. In the present investigation we describe our experience with MIP performed under local anesthesia. METHODS: MIP was performed on 454 of 496 patients (91.5%) with PHPT. In 170 patients (37.4%), MIP was accomplished under local anesthesia. This procedure was elected when the medical condition prohibited general anesthesia, or in accordance with the patient's request. RESULTS: MIP under local anesthesia for PHPT was accomplished in 162 (95.3%) of the patients. In 8 patients the procedure was converted to general anesthesia, while the adenoma was located in 5 of these patients. In 3 patients (1.8%) the adenoma was not located even under general anesthesia and they awaited further investigations. Fifteen patients (8.2%) developed temporary hoarseness, and 20 patients (11.8%) developed temporary hypocalcemia postoperatively. CONCLUSIONS: MIP under local anesthesia for PHPT caused by an adenoma is feasible and safe, with a success rate of 95.3% similar to MIP performed under general anesthesia. MIP under local anesthesia has not yet become a prevalent procedure worldwide, as well as in our country. The results of the present study support our conclusions for utilizing this method under local anesthesia.

Tincture of opium for treating opioid dependence: a systematic review of safety and efficacy.

BACKGROUND AND AIMS: Recently, there has been a growing interest in using opium tincture (OT) for treating opioid dependence in certain regions. We aimed to assess the evidence on its safety and efficacy for this indication. METHODS: We searched several databases (CENTRAL, Medline, EMBASE, Web of Science, PsychINFO, ProQuest Dissertation and Theses Database, Iran Medex, clinicaltrials.gov and who.int/trialsearch) with no language or publication date limitations. Two reviewers selected randomized controlled trials (RCT), cohort/case-control/cross-sectional studies and case-series on safety or efficacy of OT for treating opioid dependence and then extracted reported measures of mentioned outcomes from selected studies. We used the Effective Public Health Practice Project (EPHPP) Quality Assessment tool for appraisal. RESULTS: From nine selected studies; in three RCTs and one cohort analytical analysis on detoxification, 110 patients were treated with 15-140 morphine equivalents/day (mEq/d) of OT; in four prospective and one retrospective uncontrolled case-series on long-term/maintenance treatment, 570 patients were treated with 100-400 mEq/d of OT. Only two studies on detoxification included a comparison: one concluded equal efficacy of OT and methadone in suppressing withdrawal symptoms (P = 0.32) and the other concluded OT to be less efficacious than buprenorphine/naloxone in suppressing withdrawal [OT = 12.20, 95% confidence interval (CI) = 11.00, 13.40]; control: 5.20 (95% CI = 4.69, 5.71) and craving (OT = 303.0, 95% CI = -144.664, 750.664; control: 0.0) but not significantly different (P = 0.26) in retaining participants in treatment. No major adverse events were reported. CONCLUSIONS: Conclusive recommendations about the safety and efficacy of opium tincture for treating opioid dependence are not possible at this time.

[Minimally invasive parathyroidectomy for treatment of primary hyperparathyroidism caused by parathyroid adenoma].

BACKGROUND: Minimally invasive parathyroidectomy (MIP) is frequently used for the treatment of primary hyperparathyroidism (PHPT) caused by a single adenoma. This method depends on preoperative localization of the tumor by a sestamibi scan, cervical ultrasound, and intraoperative parathyroid hormone (PTH) measurements. When the sestamibi scan is negative, the classical 4-gland exploration is used instead of MIP. AIMS: a. To evaluate the effectiveness of MIP for treatment of PHPT caused by adenoma. b. To evaluate the use of PTH selective venous sampling (PTH-SVS) in patients with negative sestamibi scintigraphy. METHODS: MIP was performed in all patients in whom an adenoma was diagnosed by sestamibi scan and US. When the sestamibi scan was negative, PTH-SVS was performed preoperatively for localization of the adenoma. RESULTS: Parathyroidectomy was performed in 541 patients, 458 with PHPT and 83 with secondary hyperparathyroidism. In 345 of 380 patients (90.8%) with an adenoma, MIP was performed, and in 92 of these patients the operation was performed under local anesthesia. A total of 444 (97.0%) of the patients with PHPT were cured by the surgery. In 56 patients with a negative sestamibi scan, PTH-SVS was used preoperatively for localization of an adenoma. In 30 of these cases (53%) MIP was successfully performed in spite of a negative sestamibi scan. CONCLUSIONS: MIP is the treatment of choice for PHPT caused by a single adenoma. When the preoperative sestamibi scan is negative, the authors recommend the use of PTH-SVS for preoperative localization. This resulted in 53% successful MIP in patients with a negative sestamibi scan.

Oral arginine reduces gut mucosal injury caused by lipopolysaccharide endotoxemia in rat.

BACKGROUND: The objective of this study was to evaluate the effects of lipopolysaccharide (LPS) endotoxemia and enteral arginine (ARG) supplementation on intestinal structural changes, enterocyte proliferation, and apoptosis in rat. METHODS: Male Sprague-Dawley rats, weighing 250-280 g, were divided into three experimental groups: control rats, LPS rats treated with lipopolysaccharide given ip at a dose of 10 mg/kg every 24 h (two injections), and LPS-ARG rats treated with enteral arginine given in drinking water (2%) 72 h before and following injection of LPS. Intestinal structural changes, enterocyte proliferation, and enterocyte apoptosis were determined on day 3 following the first LPS injection. RESULTS: LPS rats demonstrated a significant decrease in bowel weight in duodenum, mucosal weight in duodenum, jejunum, and ileum, mucosal DNA and protein in jejunum and ileum, and villus height in jejunum and ileum compared to control animals. LPS rats also had a significantly lower cell proliferation index in jejunum and ileum and a higher apoptotic index in jejunum and ileum compared to control rats. LPS-ARG animals demonstrated greater duodenal bowel weight, duodenal and ileal mucosal weight, ileal mucosal DNA and protein, ileal villus height, and jejunal and ileal cell proliferation index compared to LPS animals. CONCLUSIONS: LPS endotoxemia impairs the integrity of the gastrointestinal mucosa in rat. Decreased cell proliferation and increased apoptosis may be considered the main mechanisms responsible for the decreased cell mass. Enteral arginine administration decreases the mucosal injury caused by lipopolysaccharide.

Effects of enteral arginine supplementation on the structural intestinal adaptation in a rat model of short bowel syndrome.

The nitric oxide precursor L-arginine (ARG) has been shown to influence intestinal morphology and intestinal absorptive function. The purpose of the present study was to determine the effect of enteral ARG supplementation on structural intestinal adaptation, cell proliferation, and apoptosis in a rat model of short bowel syndrome (SBS). Thirty male Sprague-Dawley rats were divided into three experimental groups: Sham rats underwent bowel transection, SBS rats underwent 75% small bowel resection, and SBS-ARG rats underwent bowel resection and were treated with ARG given in the drinking water (2%). Parameters of intestinal adaptation, enterocyte proliferation and enterocyte apoptosis were determined on day 14 following operation. We have demonstrated that SBS-ARG animals had a lower jejunal and ileal mucosal weight, jejunal mucosal DNA and protein, ileal mucosal protein, jejunal villus height, jejunal and ileal crypt depth, and enterocyte proliferation index and a greater enterocyte apoptosis compared to SBS untreated animals. We conclude that in a rat model of SBS enteral L-arginine inhibits structural intestinal adaptation. Possible mechanism for this effect may be decreased cell proliferation and increased cell apoptosis.