1.Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
Akhil Deepak VATVANI ; Pratik PATEL ; Timotius Ivan HARIYANTO ; Theo Audi YANTO
The Korean Journal of Pain 2024;37(4):367-378
Background:
Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient’s quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia.
Methods:
A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes.
Results:
A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: –0.86, 95% confidence interval [CI]: –1.20, –0.51, P < 0.001, I 2 = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P< 0.001, I 2 = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness.
Conclusions
This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.
2.Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
Akhil Deepak VATVANI ; Pratik PATEL ; Timotius Ivan HARIYANTO ; Theo Audi YANTO
The Korean Journal of Pain 2024;37(4):367-378
Background:
Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient’s quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia.
Methods:
A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes.
Results:
A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: –0.86, 95% confidence interval [CI]: –1.20, –0.51, P < 0.001, I 2 = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P< 0.001, I 2 = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness.
Conclusions
This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.
3.Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
Akhil Deepak VATVANI ; Pratik PATEL ; Timotius Ivan HARIYANTO ; Theo Audi YANTO
The Korean Journal of Pain 2024;37(4):367-378
Background:
Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient’s quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia.
Methods:
A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes.
Results:
A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: –0.86, 95% confidence interval [CI]: –1.20, –0.51, P < 0.001, I 2 = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P< 0.001, I 2 = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness.
Conclusions
This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.
4.Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
Akhil Deepak VATVANI ; Pratik PATEL ; Timotius Ivan HARIYANTO ; Theo Audi YANTO
The Korean Journal of Pain 2024;37(4):367-378
Background:
Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient’s quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia.
Methods:
A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes.
Results:
A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: –0.86, 95% confidence interval [CI]: –1.20, –0.51, P < 0.001, I 2 = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P< 0.001, I 2 = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness.
Conclusions
This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.
5.Efficacy and safety of low-dose naltrexone for the management of fibromyalgia: a systematic review and meta-analysis of randomized controlled trials with trial sequential analysis
Akhil Deepak VATVANI ; Pratik PATEL ; Timotius Ivan HARIYANTO ; Theo Audi YANTO
The Korean Journal of Pain 2024;37(4):367-378
Background:
Fibromyalgia is characterized by the presence of chronic widespread pain that may impair patient’s quality of life. Currently, the use of naltrexone as a therapeutic agent for fibromyalgia is not supported by enough evidence, especially from randomized controlled trials (RCTs). This study aims to analyze the efficacy and safety of low-dose naltrexone (LDN) for the management of fibromyalgia.
Methods:
A comprehensive search was conducted on the Scopus, Medline, ClinicalTrials.gov, and Cochrane Library databases up until May 20th, 2024. This review incorporates RCTs that examine the comparison between LDN and placebo in fibromyalgia patients. We employed random-effect models to analyze the odds ratio and mean difference (MD) for presentation of the outcomes.
Results:
A total of 4 RCTs with 222 fibromyalgia patients were incorporated. The results of our meta-analysis showed a significant reduction in pain scores (MD: –0.86, 95% confidence interval [CI]: –1.20, –0.51, P < 0.001, I 2 = 33%) and higher increment in pressure pain threshold (MD: 0.17, 95% CI: 0.08, 0.25, P< 0.001, I 2 = 0%) among fibromyalgia patients who received LDN than those who only received a placebo. The fibromyalgia impact questionnaire revised and pain catastrophizing scale did not differ significantly between the two groups. LDN was also associated with higher incidence of vivid dreams and nausea, but showed no significant difference with the placebo in terms of serious adverse events, headache, diarrhea, and dizziness.
Conclusions
This study suggests the efficacy of LDN in mitigating pain symptoms for fibromyalgia patients with a relatively good safety profile.
6.Efficacy and safety of Bromocriptine-QR as an adjunctive therapy on glycemic control in subjects with uncontrolled type 2 diabetes mellitus:A systematic review and meta-analysis
Theo Audi Yanto ; Charista Lydia Budiputri ; Michelle Patricia Muljono ; Shally Chandra
Journal of the ASEAN Federation of Endocrine Societies 2024;39(1):95-105
Introduction:
There has been an increasing awareness of the effects of combining bromocriptine-QR with other medications for diabetes mellitus type 2. This study aimed to assess the efficacy and safety of bromocriptine-QR as an adjunctive therapy for patients with uncontrolled type 2 diabetes mellitus.
Methodology:
This systematic review is registered at the International Prospective Register of Systematic Reviews (CRD42022360326). Literature search was done via MEDLINE, NCBI, Google Scholar, Science Direct, Europe PMC and Cochrane Library databases. We included randomized controlled trials with participants 18 years old and above with uncontrolled type 2 diabetes mellitus. The primary outcome of interest is the efficacy and safety of bromocriptine-QR as an adjunctive therapy for glycemic control. Case reports, case series, reviews and animal studies were excluded. The risk of bias was reviewed using the Cochrane Risk of Bias tool. Meta-analysis was performed using Review Manager 5.4 and presented as a weighted mean difference and 95% confidence interval for changes from the baseline level.
Results:
Nine studies were included in the systematic review with a total of 2709 participants. The baseline HbA1c in the bromocriptine-QR group was 7.42% and 7.51% in the control group. The bromocriptine-QR group was favoured, outperforming the control group in terms of reducing hemoglobin A1c(HbA1c), with a statistically significant difference (weighted mean difference -0.6%; 95% CI [-0.83,-0.36]; p<0.00001). The most common side effects were nausea (33.75% vs 6.92%), fatigue (13.11% vs 5.94%), and headache (11.17% vs 6.87%).
Conclusion
Administration of bromocriptine-QR at a dose range of 1.6 to 4.8 mg/day as an adjunctive therapy reduced HbA1c and FBG in patients with uncontrolled type 2 diabetes mellitus (T2DM). However, there were also statistically greater odds of the occurrence of adverse events such as nausea, vomiting, and headache compared to controls.
Diabetes Mellitus, Type 2