Journal of pain research · 2025
Analgesic Efficacy and Tolerability of Amitriptyline versus Mianserin in Chronic Low Back Pain: A Randomised, Double-Blind, Controlled Pilot Trial.
Клинический случайКлиническое исследованиеСтатьяНазвание и аннотация: Перевод в очереди
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Wangnamthip Suratsawadee, Eiamtanasate Sarasate, Saisavoey Nattha, Sathienluckana Thanompong, Suthisiltham Lucksika, Panchoowong Skaorat, Tipapakoon Isaraporn, Euasobhon Pramote, Jensen Mark P, Srirojanakul Wanna
Аннотация
PURPOSE: Chronic low back pain (CLBP) is a complex, disabling condition that often necessitates multimodal treatment. Although tricyclic and tetracyclic antidepressants are recommended as adjunctive therapy, comparative efficacy data remain extremely limited.
PATIENTS AND METHODS: We conducted a randomised, double-blind, controlled trial in 24 individuals with CLBP to compare the efficacy and safety of amitriptyline with mianserin. Participants received amitriptyline (n = 15) or mianserin (n = 9) for 12 weeks with titrated dosing. Pain intensity (primary outcome), adverse effects, disability, health utility, quality of life, and psychological function were recorded at baseline and at each follow-up visit.
RESULTS: Participants in both groups reported significant within-group reductions in pain intensity from baseline to week 12. Mianserin was associated with a large effect size improvement (Cohen's d = -1.40; 95% CI -2.71 to -0.08), and amitriptyline was associated with a medium effect size improvement (d = -0.55; 95% CI -1.19 to 0.08). Amitriptyline significantly improved EQ-5D-5L utility scores (Δ=+0.116, p=0.008; d=0.61, 95% CI 0.14 to 1.09) but was associated with more anticholinergic effects than mianserin. Mianserin was better tolerated; only transient drowsiness was reported. Different benefits were noted in some outcome measures as a function of treatment condition: amitriptyline reduced stress by week 6, whereas mianserin lowered anxiety at weeks 6 and 12.
CONCLUSION: Both amitriptyline and mianserin appear to provide comparable adjunctive efficacy for CLBP. Mianserin may be more tolerable and cost-effective in resource-limited settings, although it is not yet approved for pain indications.
PATIENTS AND METHODS: We conducted a randomised, double-blind, controlled trial in 24 individuals with CLBP to compare the efficacy and safety of amitriptyline with mianserin. Participants received amitriptyline (n = 15) or mianserin (n = 9) for 12 weeks with titrated dosing. Pain intensity (primary outcome), adverse effects, disability, health utility, quality of life, and psychological function were recorded at baseline and at each follow-up visit.
RESULTS: Participants in both groups reported significant within-group reductions in pain intensity from baseline to week 12. Mianserin was associated with a large effect size improvement (Cohen's d = -1.40; 95% CI -2.71 to -0.08), and amitriptyline was associated with a medium effect size improvement (d = -0.55; 95% CI -1.19 to 0.08). Amitriptyline significantly improved EQ-5D-5L utility scores (Δ=+0.116, p=0.008; d=0.61, 95% CI 0.14 to 1.09) but was associated with more anticholinergic effects than mianserin. Mianserin was better tolerated; only transient drowsiness was reported. Different benefits were noted in some outcome measures as a function of treatment condition: amitriptyline reduced stress by week 6, whereas mianserin lowered anxiety at weeks 6 and 12.
CONCLUSION: Both amitriptyline and mianserin appear to provide comparable adjunctive efficacy for CLBP. Mianserin may be more tolerable and cost-effective in resource-limited settings, although it is not yet approved for pain indications.