Pain
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Multicenter Study Observational Study
Opioid-induced constipation in cancer patients: a "real-world", multicentre, observational study of diagnostic criteria and clinical features.
The aim of this study was to investigate opioid-induced constipation (OIC) in a large cohort of "real-world" patients with cancer; the objectives were to determine the prevalence of OIC, the utility of a simple screening question, the accuracy of the Rome IV diagnostic criteria, the clinical features of OIC (physical and psychological), and the impact of OIC (quality of life). One thousand patients with cancer were enrolled in the study, which involved completion of the Rome IV diagnostic criteria for OIC, the Bowel Function Index, the Patient Assessment of Constipation Quality of Life questionnaire, and the Memorial Symptom Assessment Scale-Short Form. Participants also underwent a thorough clinical assessment by an experienced clinician (ie, "gold-standard" assessment of OIC). ⋯ Patients with OIC had more symptoms overall, higher Memorial Symptom Assessment Scale-Short Form subscale scores (and total score), and higher Patient Assessment of Constipation Quality of Life questionnaire subscale scores (and the overall score). Opioid-induced constipation was not associated with demographic factors, cancer diagnosis, performance status, or opioid equivalent dosage: OIC was associated with opioid analgesic, with patients receiving tramadol and transdermal buprenorphine having less constipation. The study confirms that OIC is common among patients with cancer pain and is associated with a spectrum of physical symptoms, a range of psychological symptoms, and an overall deterioration in the quality of life.
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Randomized Controlled Trial Multicenter Study
Does a screening trial for spinal cord stimulation in patients with chronic pain of neuropathic origin have clinical utility and cost-effectiveness (TRIAL-STIM)? a randomised controlled trial.
Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine whether a patient should receive permanent SCS implant, its evidence base is limited. We aimed to establish the clinical utility, diagnostic accuracy, and cost-effectiveness of an SCS screening trial. ⋯ Spinal cord stimulation screening trial had a sensitivity of 100% (95% CI: 78-100) and specificity of 8% (95% CI: 1-25). The mean incremental cost-effectiveness ratio of TG vs NTG was £78,895 per additional quality-adjusted life-year gained. In conclusion, although the SCS screening trial may have some diagnostic utility, there was no evidence that an SCS screening TG provides superior patient outcomes or is cost-effective compared to a no trial screening approach.
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Randomized Controlled Trial Multicenter Study
Intrathecal delivery of hydromorphone vs morphine for refractory cancer pain: a multicenter, randomized, single-blind, controlled noninferiority trial.
Hydromorphone is an alternative to morphine for intrathecal drug delivery system to treat refractory cancer pain; however, there is not enough clinical evidence to prove it. In our study, 233 patients from 12 different pain management centers across China were enrolled, 121 and 112 in the intrathecal hydromorphone (ITHM) and intrathecal morphine (ITMO) groups, respectively. The primary outcome was the clinical success rate, which was defined as ratio of patients achieving ≥50% pain relief. ⋯ The patient-controlled analgesia bolus change rate was lower in the ITHM group than in the ITMO group (ITHM -19.88% vs ITMO 7.79%, P < 0.01, t test) from first week. Our result shows that ITHM is noninferior to ITMO on pain relief to treat refractory cancer pain, however, at different doses and that the doses of morphine tended to increase, whereas those of hydromorphone decreased over time. Hydromorphone offers advantage over morphine in controlling BTP.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of propranolol for treatment of temporomandibular disorder pain: a randomized, placebo-controlled clinical trial.
Propranolol is a nonselective beta-adrenergic receptor antagonist. A multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2b trial enrolled participants aged 18 to 65 years with temporomandibular disorder myalgia to evaluate efficacy and safety of propranolol compared with placebo in reducing facial pain. Participants were randomized 1:1 to either extended-release propranolol hydrochloride (60 mg, BID) or placebo. ⋯ Propranolol was likewise efficacious for a ≥50% reduction in FPI (number-needed-to-treat = 6.1, P = 0.03). Adverse event rates were similar between treatment groups, except for more frequent fatigue, dizziness, and sleep disorder in the propranolol group. Propranolol was not different from placebo in reducing mean FPI but was efficacious in achieving ≥30% and ≥50% FPI reductions after 9 weeks of treatment among temporomandibular disorder participants.
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Randomized Controlled Trial Multicenter Study
Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study.
Constipation is the most common adverse event (AE) of opioid therapy. This multicenter, phase 2 study evaluated the efficacy and safety of linaclotide in treating opioid-induced constipation (OIC) in patients with chronic noncancer pain syndromes (NCT02270983). Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks. ⋯ No serious AEs related to diarrhea were reported in any treatment group. Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05). Linaclotide significantly improved OIC symptoms and was well tolerated in patients with chronic noncancer pain.