[Summary text]
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Study design: Randomized controlled trial
Study grouping: Parallel group
Baseline Characteristics
Duloxetine
Control
Overall
Included criteria: The criteria used in a previous study of duloxetine [25]were adopted. Briefly, male and female outpatients agedbetween 20 and 75 years who met the ACR 1990 criteria for fibromyalgia [2] and had a Brief Pain Inventory (BPI)average pain score≥4 [26, 27] at visits 1 and 2 were included.
Excluded criteria: Exclusion criteria were as follows: past duloxe-tine treatment; serious or medically unstable disease,clinically significant abnormal laboratory values, or ab-normal electrocardiogram (ECG) findings; pain causedby non-fibromyalgia diseases; poorly controlled thyroid dysfunction; rheumatoid, inflammatory, or infectiousarthritis; autoimmune disorders other than thyroid dys-function; psychiatric disorders other than major de-pressive disorder within the past year; and suicidal tendencies as assessed using the Columbia-SuicideSeverity Rating Scale (C-SSRS).
Pretreatment: Both groups were balanced in terms of baseline demographic characteristics
Intervention Characteristics
Duloxetine
Control
Functioning. SF-36 (physical functioning), SEM. final
Quality of life SF-36 (total score) final. SEM
Functioning SF-36 (physical functioning) change. SE
Pain. BPI (BOCF) Change, SE
Pain BPI (pain on average). Final, SEM
Drowsiness, %
Nausea, %
Dry mouth, %
Constipation, %
Weight gain, %
Fatigue/somnolence, %
Dizziness, %
Dropout pga bivirkninger
Severe adverse events, n
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Selection bias (biased allocation to interventions) due to inadequate generation of a randomised sequence
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Quote: "After the screening phase, patients were assigned randomly to receive duloxetine or placebo in a 1:1 ratio, using a web-based patient regis- tration system (ACRONET Corp., Tokyo, Japan) with a stochastic minimization procedure. The following alloca- tion factors were used: (1) BPI average pain score at visit 2 (<6 vs. ≥6) and (2) presence or absence of concomitant major depressive disorder diagnosed on the basis of the M.I.N.I. International Neuropsychiatric Interview– Japanese version 5.0.0 [29]. It was ensured that the maxi- mum between-group difference in the number of subjects in each medical institution did not exceed two."
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Selection bias (biased allocation to interventions) due to inadequate concealment of allocations prior to assignment
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Quote: "The drug allocation con- troller confirmed the study drugs were undiscernible in terms of appearance, packaging, and labeling, and mock titration of placebo pills was also performed to maintain blinding. Only the drug allocation controller was aware of the type of drugs being dispensed."
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Performance bias due to knowledge of the allocated interventions by participants and personnel during the study
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Quote: "two. Blinding was maintained until the end of the study by the person responsible for the study drug assignment."
Quote: "The drug allocation con- troller confirmed the study drugs were undiscernible in terms of appearance, packaging, and labeling, and mock titration of placebo pills was also performed to maintain blinding. Only the drug allocation controller was aware of the type of drugs being dispensed."
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Detection bias due to knowledge of the allocated interventions by outcome assessors
Attrition bias due to amount, nature or handling of incomplete outcome data
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Judgement Comment: 76% of the patients in the placebo completed and 85% in the duloxetine group completed.
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Reporting bias due to selective outcome reporting
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Judgement Comment: Not all the primary oputcome mentioned in the protocol are reproted.
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Bias due to problems not covered elsewhere in the table
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014
Judgement Comment: No other apparent sources of bias
See Lunn et al "Duloxetine for treating painful neuropathy, chronic pain and fibromyalgia". Cochrane Library 2014