The effectiveness of pregabalin with or without agomelatine in the treatment of chronic low back pain: a double-blind, placebo-controlled, randomized clinical trial Article Swipe
Seyed Mani Mahdavi
,
Behnam Shariati
,
Mohammadreza Shalbafan
,
Vahid Rashedi
,
Masoomeh Yarahmadi
,
Alireza Ghaznavi
,
Shayan Amiri
·
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1186/s40360-022-00612-3
YOU?
·
· 2022
· Open Access
·
· DOI: https://doi.org/10.1186/s40360-022-00612-3
Background Although 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. Methods Forty-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. Results At 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. Conclusion Compared 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 registration The 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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Metadata
- Type
- article
- Language
- en
- Landing Page
- https://doi.org/10.1186/s40360-022-00612-3
- https://bmcpharmacoltoxicol.biomedcentral.com/counter/pdf/10.1186/s40360-022-00612-3
- OA Status
- gold
- Cited By
- 6
- References
- 34
- Related Works
- 10
- OpenAlex ID
- https://openalex.org/W4295762985
All OpenAlex metadata
Raw OpenAlex JSON
- OpenAlex ID
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https://openalex.org/W4295762985Canonical identifier for this work in OpenAlex
- DOI
-
https://doi.org/10.1186/s40360-022-00612-3Digital Object Identifier
- Title
-
The effectiveness of pregabalin with or without agomelatine in the treatment of chronic low back pain: a double-blind, placebo-controlled, randomized clinical trialWork title
- Type
-
articleOpenAlex work type
- Language
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enPrimary language
- Publication year
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2022Year of publication
- Publication date
-
2022-09-14Full publication date if available
- Authors
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Seyed Mani Mahdavi, Behnam Shariati, Mohammadreza Shalbafan, Vahid Rashedi, Masoomeh Yarahmadi, Alireza Ghaznavi, Shayan AmiriList of authors in order
- Landing page
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https://doi.org/10.1186/s40360-022-00612-3Publisher landing page
- PDF URL
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https://bmcpharmacoltoxicol.biomedcentral.com/counter/pdf/10.1186/s40360-022-00612-3Direct link to full text PDF
- Open access
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YesWhether a free full text is available
- OA status
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goldOpen access status per OpenAlex
- OA URL
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https://bmcpharmacoltoxicol.biomedcentral.com/counter/pdf/10.1186/s40360-022-00612-3Direct OA link when available
- Concepts
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Pregabalin, Agomelatine, Medicine, Placebo, Double blind, Randomized controlled trial, Chronic pain, Clinical trial, Neuropathic pain, Anesthesia, Physical therapy, Internal medicine, Alternative medicine, Antidepressant, Pathology, HippocampusTop concepts (fields/topics) attached by OpenAlex
- Cited by
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6Total citation count in OpenAlex
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2023: 6Per-year citation counts (last 5 years)
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34Number of works referenced by this work
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10Other works algorithmically related by OpenAlex
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