SPINE
Efficacy of duloxetine versus alternative oral therapies: an indirect comparison of randomised clinical trials in chronic low back pain
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original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2014;2(1):23 Eur Spine J. 2013 Sep;22(9):1996-2009Fifteen randomized clinical trials were included in this meta-analysis to compare duloxetine to a variety of other pain medications in the treatment of chronic low back pain. Comparisons between duloxetine and antidepressants, cox-2 inhibitors, non-scheduled opioids, scheduled opioids and other drugs suggested that scheduled opioids were more effective than duloxetine; however, the effect size was minimal and difference was lost when repeated using a random effects model. Before any definitive conclusions can be made regarding duloxetine as an alternative treatment for chronic low back pain, further clinical trials providing direct comparisons are required.
Were the search methods used to find evidence (original research) on the primary question or questions stated?
Was the search for evidence reasonably comprehensive?
Were the criteria used for deciding which studies to include in the overview reported?
Was the bias in the selection of studies avoided?
Were the criteria used for assessing the validity of the included studies reported?
Was the validity of all of the studies referred to in the text assessed with use of appropriate criteria (either in selecting the studies for inclusion or in analyzing the studies that were cited)?
Were the methods used to combine the findings of the relevant studies (to reach a conclusion) reported?
Were the findings of the relevant studies combined appropriately relative to the primary question that the overview addresses?
Were the conclusions made by the author or authors supported by the data and or analysis reported in the overview?
How would you rate the scientific quality of this evidence?
Ja = 1
Ungewiss = 0.5
Nicht relevant = 0
Nein = 0
Die Bewertung der Berichtskriterien bewertet die Transparenz, mit der die Autoren die methodischen und studienspezifischen Merkmale der Studie in der Veröffentlichung angeben. Die Bewertung ist in fünf Kategorien unterteilt, die im Folgenden vorgestellt werden.
4/4
Introduction
4/4
Accessing Data
3/4
Analysing Data
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Results
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Discussion
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Der Fragilitätsindex ist ein Instrument, das bei der Interpretation signifikanter Ergebnisse hilft und ein Maß für die Stärke eines Ergebnisses liefert. Der Fragilitätsindex gibt die Anzahl der aufeinanderfolgenden Ereignisse an, die zu einem dichotomen Ergebnis hinzugefügt werden müssen, damit das Ergebnis nicht mehr signifikant ist. Eine kleine Zahl steht für ein schwächeres Ergebnis und eine große Zahl für ein stärkeres Ergebnis.
Warum wurde diese Studie jetzt benötigt?
Chronic low back pain is a common musculoskeletal disorder that contributes to growing disability rates, and results in a substantial economic burden on the healthcare system. Back pain can be caused by a number of factors, making it very difficult to determine an appropriate course of treatment. The majority of treatment strategies revolve around symptom relief including opioids, nonsteroidal anti-inflammatory drugs, anticonvulsants and antidepressants. Duloxetine regulates the descending pain inhibitory pathways by inhibiting serotonin epinephrine reuptake. This meta-analysis was necessary to make an indirect comparison of duloxetine and oral pharmacological therapies in the treatment of low back pain.
Was war die wichtigste Forschungsfrage?
Is duloxetine effective in relieving chronic low back pain compared to opioids, antidepressants, cox-2 inhibitors, and other drugs?
Was waren die wichtigsten Ergebnisse?
- Standardized mean differences were highest in studies assessing scheduled opioid treatment and in a the meta-analysis of 15 studies, the fixed effects model found scheduled opioids to be more effective than duloxetine; however, the effect size presented a less than small magnitude of effect and the difference was not found when assessed under a random effects model. Heterogeneity comparing non-scheduled opioids was 75%, scheduled opioids had a heterogeneity of 79% and all other drug classes had low heterogeneity.
- Meta-analysis using a fixed effects model found that, with the exception of selective serotonin reuptake inhibitors and glucosamine, all drug classes were more effective than placebo.
- Meta-analysis using a random effects model for indirect comparison between drug treatments resulted in antidepressants (SMD=0.28, 95%CI -0.33, 0.89), cox-2 inhibitors (SMD=-0.05, 95%CI -0.40, 0.30), non-scheduled opioids (SMD=-0.13, 95%CI -0.47, 0.20), scheduled opioids (SMD=-0.24, 95%CI -0.55, 0.05) and other drugs (SMD=0.22, 95%CI -0.29, 0.74) being similar to duloxetine (Between study variance = 0.04).
- Pain duration was found to be a covariate according to a sensitivity analysis (SD=0.08, 95%CI 0.06, 0.38), with lower treatment differences observed for patients who had suffered pain for over 6 months.
Was sollte ich mir besonders merken?
Duloxetine was found to be comparable to antidepressants, Cox-2 inhibitors, non-scheduled opioids and other drugs. Scheduled opioids were found to be more effective in the fixed effects model, however this benefit was not observed in the random effects model.
Wie wird sich dies auf die Behandlung meiner Patienten auswirken?
Duloxentine did not prove to be more beneficial to patients with chronic low back than other drugs that are currently used. Limitations include a low number of studies for each comparison and a variety of outcome measures used in the studies. Also, these results are based on an indirect comparison, indicating the need for future research that make head-to-head comparisons of duloxetine with other drug treatments.
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