Establishing Minimal Clinically Important Differences in Quality of Life Measures in Opioid-Induced Constipation

ImportanceOpioid-induced constipation (OIC) is prevalent among patients treated with opioids for cancer pain. Safe and effective therapies for OIC in patients with cancer remain an unmet need.ObjectiveTo determine the efficacy of electroacupuncture (EA) for OIC in patients with cancer.Design, Setting, and ParticipantsThis randomized clinical trial was conducted at 6 tertiary hospitals in China among 100 adult patients with cancer who were screened for OIC and enrolled between May 1, 2019, and December 11, 2021.InterventionsPatients were randomized to receive 24 sessions of EA or sham electroacupuncture (SA) over 8 weeks and then were followed up for 8 weeks after treatment.Main Outcomes and MeasuresThe primary outcome was the proportion of overall responders, defined as patients who had at least 3 spontaneous bowel movements (SBMs) per week and an increase of at least 1 SBM from baseline in the same week for at least 6 of the 8 weeks of the treatment period. All statistical analyses were based on the intention-to-treat principle.ResultsA total of 100 patients (mean [SD] age, 64.4 [10.5] years; 56 men [56.0%]) underwent randomization; 50 were randomly assigned to each group. Among them, 44 of 50 patients (88.0%) in the EA group and 42 of 50 patients (84.0%) in the SA group received at least 20 (≥83.3%) sessions of treatment. The proportion of overall responders at week 8 was 40.1% (95% CI, 26.1%-54.1%) in the EA group and 9.0% (95% CI, 0.5%-17.4%) in the SA group (difference between groups, 31.1 percentage points [95% CI, 14.8-47.6 percentage points]; P &lt; .001). Compared with SA, EA provided greater relief for most OIC symptoms and improved quality of life among patients with OIC. Electroacupuncture had no effects on cancer pain and its opioid treatment dosage. Electroacupuncture-related adverse events were rare, and, if any, all were mild and transient.Conclusions and RelevanceThis randomized clinical trial found that 8-week EA treatment could increase weekly SBMs with a good safety profile and improve quality of life for the treatment of OIC. Electroacupuncture thus provided an alternative option for OIC in adult patients with cancer.Trial RegistrationClinicalTrials.gov Identifier: NCT03797586

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“…Coincidentally, the proportions of sustained responders were essentially the same for the 2 groups as the primary outcome ( Table 2 ). 27 …”

Section: Resultsmentioning

confidence: 99%

“…Minimally clinically important difference: 1.0. 27 f PAC-QOL scores are based on a 5-point Likert scale from 0 to 4; lower scores indicate better quality of life. Minimally clinically important difference: 1.0.…”

Section: Resultsmentioning

confidence: 99%

Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China

et al. 2023

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“… 39 Essentially, the diagnosis is constipation after starting opioid therapy. 15 , 40 Up to 57% of patients on long-term opioids for CNCP report constipation as a side effect of opioids. 41 , 42 OIC may occur at any time after initiation of therapy 16 at any opioid dosage 43 and despite use of laxatives which are considered the first-line therapy for OIC.…”

Section: Opioid-induced Constipation (Oic)mentioning

confidence: 99%

“…Currently available approved treatment options for OIC in CNCP in the United States include lubiprostone, a type 2 chloride channel activator; combination of oxycodone (a semi-synthetic opioid agonist) with naloxone (a nonselective opioid antagonist with both central and peripheral actions); and naloxegol, methylnaltrexone, and naldemedine, which are all peripherally acting µ-opioid receptor antagonists (PAMORA). 10 , 15 Naldemedine [Symproic® (Japan, USA); Rizmoic® (EU)] is a semi-synthetic opiate receptor antagonist approved in 2017 in the United States for the treatment of OIC in patients with CNCP. It is available as tablets of 0.2 mg. 48…”

Section: Opioid-induced Constipation (Oic)mentioning

confidence: 99%

“…12 Up to 22.9% of patients on oral opioids discontinue long-term therapy due to adverse events. 13 In a systematic review with 18,679 participants with CNCP, opioid usage was associated with a 42% higher risk of any adverse effect and 175% higher risk of serious adverse events compared to controls, including constipation, dizziness, drowsiness, fatigue, hot flushes, sweating, nausea, pruritis, and vomiting.14 While long-term opioid therapy is associated with development of tolerance to the therapeutic effect of opioids, leading to increased doses over time to maintain adequate pain control, there is also tolerance to the majority of side effects with the notable exception of opioid-induced constipation (OIC) which tends to persist over time, 15 and the mechanism is outlined in the following.…”

Section: Introductionmentioning

confidence: 99%

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Update on the role of naldemedine in opioid-induced constipation in patients with chronic noncancer pain

BouSaba

Sannaa

Camilleri

2022

Therap Adv Gastroenterol

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Chronic noncancer pain (CNCP) affects up to 20% of adults and can interfere with activities of daily living. Up to 4% of adults in the United States receive chronic opioid therapy and up to 57% of patients on long-term opioids for CNCP report opioid-induced constipation (OIC). OIC is essentially constipation occurring after starting opioid treatment. While laxatives are traditionally the first-line therapy for OIC, 81% of patients taking daily laxatives and opioids still reported OIC and considered that it negatively affected their quality of life. Naldemedine is a peripherally acting µ-opioid receptor antagonists (PAMORA) approved for the treatment of OIC in patients with CNCP. This article reviews the mechanism of action, efficacy, and safety of naldemedine in CNCP patients. Naldemedine improves OIC in patients with CNCP by acting as an opioid receptor antagonist in the gastrointestinal tract. It does not interfere with the analgesic properties of opioids or cause withdrawal symptoms since these effects are centrally mediated, and naldemedine does not cross the blood brain barrier. Naldemedine showed significant and sustained improvement in frequency of bowel movements, quality of life, and constipation-related symptoms. It is generally well tolerated with a higher incidence of gastrointestinal adverse events of mild or moderate severity such as diarrhea, abdominal pain, or vomiting compared to placebo. While there are no randomized, controlled trials that compare head-to-head pharmacological therapies used for treatment of OIC, network meta-analysis shows that naldemedine has an overall good benefit-risk profile compared to the other approved medications.

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Estimating minimal clinically important difference (MCID) for gastrointestinal symptoms in cystic fibrosis

Lee,

Sathe,

Moshiree

et al. 2024

Journal of Cystic Fibrosis

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Establishing Minimal Clinically Important Differences in Quality of Life Measures in Opioid-Induced Constipation

Cited by 7 publications

References 37 publications

Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China

Effects of Electroacupuncture for Opioid-Induced Constipation in Patients With Cancer in China

Update on the role of naldemedine in opioid-induced constipation in patients with chronic noncancer pain

Estimating minimal clinically important difference (MCID) for gastrointestinal symptoms in cystic fibrosis

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