Trial reportBMC pharmacology & toxicology2022
The effectiveness of pregabalin with or without agomelatine in the treatment of chronic low back pain: a double-blind, placebo-controlled, randomized clinical trial.
Trial report in BMC pharmacology & toxicology, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it, 6 citations in OpenAlex.
- Effects of Agomelatine on Sleep Across Populations: A Systematic Review and Meta-Analysis.Journal of sleep research · 2026Pooled it
- Agomelatine augmentation of sertraline in the treatment of moderate to severe obsessive-compulsive disorder: a randomized double-blinded placebo-controlled clinical trial.BMC psychiatry · 2023Trial
- Agomelatine improves symptom severity and quality of life in diarrhea-predominant irritable bowel syndrome: insights from a randomized controlled clinical trial.Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Effects of Tai Chi on insomnia in elderly people with chronic non-specific low back pain: A study protocol for a randomized controlled trial.Frontiers in psychology · 2023Article
- Short-term Complications of Open Latarjet Procedure for Recurrent Anterior Shoulder Dislocation.Medical journal of the Islamic Republic of Iran · 2023Article
- Spinopelvic Parameters as Risk Factors of Nonspecific Low Back Pain: A Case-Control Study.Medical journal of the Islamic Republic of Iran · 2023Article
Corrections and comments
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Authors and funding
7 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlthough various pharmacological and nonpharmacological treatments are available for the chronic low back pain (CLBP), there is no consensus on the best optimal treatment for this condition. This study aimed to investigate the efficacy of co-administration of pregabalin and agomelatine versus pregabalin with placebo to treat CLBP.
methodsForty-six CLBP patients without the surgical indication referred to the outpatient orthopedic clinic of Rasoul-e-Akram Hospital, Tehran, Iran, were randomly divided into two study groups: Group A [pregabalin (75 mg twice per day) + placebo] and Group B [pregabalin (75 mg twice per day) + agomelatine (25 mg per night)]. Patients were evaluated at weeks 0, 4, and 8. Outcome measures were the Persian versions of the Brief Pain Inventory (BPI) interference scale, Roland-Morris Disability Questionnaire (RMDQ), The Hospital Anxiety and Depression Scale (HADS), 36-Item Short Form Survey (SF-36), and General Health Questionnaire-28 (GHQ-28) were used.
resultsAt weeks 4 and 8 after the intervention, all evaluated measures showed significant improvement in both study groups (P < 0.01). The mean improvement of GHQ-28 was 3.7 ± 1.22 in group A and 13.1 ± 4.71 in group B. This difference was statistically significant (P = 0.003). Other outcomes did not vary substantially between the two research groups. Agomelatine treatment was well tolerated, with no significant adverse effects seen in patients. Liver tests of all patients were routine during the study period. Major adverse effect was not seen in any patient. The prevalence of Minor side effects was not significantly different between two study groups.
conclusionCompared with the pregabalin and placebo, co-administration of pregabalin and agomelatine had no added effect on improving pain scores in CLBP patients. However, the patients' general health was significantly improved after the combined administration of pregabalin and agomelatine.
trial registrationThe study protocol was registered in the Iranian Registry of Clinical Trials before starting the study (NO.IRCT20200620047852N1, Registration date: 23/06/2020).
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