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Clinical Epidemiology 2018Various interventions have been tested as primary prevention of colorectal cancers (CRC), but comprehensive evidence comparing them is absent. We examined the effects of...
BACKGROUND
Various interventions have been tested as primary prevention of colorectal cancers (CRC), but comprehensive evidence comparing them is absent. We examined the effects of various chemopreventive agents (CPAs) on CRC incidence and mortality.
METHODS
We did a network meta-analysis based on a systematic review of randomized controlled trials (RCTs) that compared at least one CPA (aspirin, antioxidants, folic acid, vitamin B6, vitamin B12, calcium, vitamin D, alone or in combination) to placebo or other CPA in persons without history of CRC. Several databases were searched from inception up to March 2017. Primary outcomes were early and long-term CRC incidence and mortality.
RESULTS
Twenty-one RCTs comprising 281,063 participants, 9 RCTS comprising 160,101 participants, and 7 RCTs comprising 24,001 participants were included in the network meta-analysis for early risk of CRC incidence, long-term risk of CRC incidence and mortality, respectively. For early CRC incidence, no CPAs were found to be effective. For long-term CRC incidence and mortality, aspirin was the only intervention that showed protective effects with potential dose-dependent effects (risk ratio [RR], 0.74 [95% CI, 0.57-0.97] for high-dose [≥325 mg/day] and RR, 0.81 [95% CI, 0.67-0.98] for very-low-dose [≤100 mg/day]). Similar trend was found for mortality (RR, 0.43 [95% CI, 0.23-0.81] for low-dose [>100-325 mg/day] and RR, 0.65 [95% CI, 0.45-0.94] for very-low-dose). However, in net clinical benefit analysis, when combining risk estimates on mortality from CRC, cardiovascular disease, and pooled risk estimates of major gastrointestinal bleeding, low-dose aspirin provided the highest net survival gain (%) of 1.736 [95% CI, 1.010-2.434].
CONCLUSION
Aspirin at the dose range of 75-325 mg/day is a safe and effective primary prevention for long-term CRC among people at average risk. None of the other CPAs were found to be effective. There may potentially be differential effects among various doses of aspirin that needs further investigation.
PubMed: 30349391
DOI: 10.2147/CLEP.S174120 -
IUBMB Life Jan 2022Hyperhomocysteinemia is an independent predictor of the risk for cognitive decline and may be a result of low levels of vitamins B , B , and folate. Previous findings...
Hyperhomocysteinemia is an independent predictor of the risk for cognitive decline and may be a result of low levels of vitamins B , B , and folate. Previous findings suggest that adequate intake of these vitamins may reduce homocysteine levels. This review aimed to assess the effects of treatment with vitamins B B , and/or folic acid in the homocysteine levels in patients with mild cognitive impairment (MCI). A systematic literature review was conducted in EMBASE, MEDLINE®, PsycINFO, and Cochrane Central Register of Controlled Trials. The research question was formulated using the Population, Intervention, Comparison, and Outcome (PICO) framework: in patients with MCI (P); what is the efficacy of vitamins B , B , and/or folic acid intake (I); compared with baseline values, and/or compared with controls (C); in reducing homocysteine levels from baseline (O). A total of eight primary studies with a total of 1,140 participants were included in the review. Four were randomized controlled trials, one was a quasi-controlled trial, and three were observational studies. All studies included folic acid in their intervention, seven vitamin B , and four vitamin B . Mean (SD) length of the intervention period was 18.8 (19.3) months, ranging from 1 to 60 months. All studies showed a statistically significant decrease in homocysteine levels in groups treated with vitamins B B , and/or folic acid compared to controls, with a mean decline of homocysteine concentration of 31.9% in the intervention arms whereas it increased by 0.7% in the control arm. This review identified evidence of a reduction of plasma homocysteine levels in MCI patients taking vitamins B B , and/or folic acid supplements, with statistically significant declines being observed after 1 month of supplementation. Findings support that supplementation with these vitamins might be an option to reduce homocysteine levels in people with MCI and elevated plasma homocysteine.
Topics: Cognitive Dysfunction; Dietary Supplements; Folic Acid; Homocysteine; Humans; Randomized Controlled Trials as Topic; Vitamin B 12; Vitamin B 6; Vitamins
PubMed: 34058062
DOI: 10.1002/iub.2507 -
PloS One 2013Hand-foot syndrome (HFS) is a relatively frequent dermatologic toxic reaction to certain anti-cancer chemotherapies. The syndrome can evolve into a distressing condition... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Hand-foot syndrome (HFS) is a relatively frequent dermatologic toxic reaction to certain anti-cancer chemotherapies. The syndrome can evolve into a distressing condition that limits function and affects quality of life. Pyridoxine (vitamin B6) has been used empirically for the prevention of HFS caused by anti-cancer therapy. However, evidence of its efficacy remains controversial.
METHODOLOGY//PRINCIPAL FINDINGS
Systematic literature searches were conducted on the Cochrane Library, PUBMED, EMBASE, LILACS, CBM, CNKI, VIP, WANFANG and the U.S. ClinicalTrials.gov website. We included all related randomized controlled trials (RCTs) irrespective of language. Reviewers from different professions independently assessed all potential studies and extracted data. Subgroup analysis was planned according to dose of pyridoxine. 5 RCTs involving 607 patients were contributed to the meta-analysis. No significant differences were found between patients receiving pyridoxine and placebo for prevention of incidence of HFS and grade 2 or worse HFS (relative risk (RR) 0.96, 95%confidence interval (CI) 0.86-1.06; RR0.95, 95%CI 0.73-1.24, respectively). Similarly, no significant improvement in quality of life was detected among patients. However, significant difference was found for prevention of grade 2 or worse HFS with pyridoxine 400 mg daily compared to 200 mg (RR0.55, 95%CI 0.33-0.92).
CONCLUSIONS/SIGNIFICANCE
There is inadequate evidence to make any recommendation about using pyridoxine for prevention of HFS caused by chemotherapy. However, pyridoxine 400 mg may have some efficacy. Further studies of large sample sizes are needed to evaluate the efficacy and safety of pyridoxine, especially at high dose, in comparison with placebo.
Topics: Antineoplastic Agents; Drug Administration Schedule; Female; Hand-Foot Syndrome; Humans; Male; Neoplasms; Quality of Life; Randomized Controlled Trials as Topic; Severity of Illness Index; Treatment Outcome; Vitamin B 6
PubMed: 23977264
DOI: 10.1371/journal.pone.0072245 -
BMJ (Clinical Research Ed.) May 1999To evaluate the efficacy of vitamin B-6 in the treatment of premenstrual syndrome. (Review)
Review
OBJECTIVE
To evaluate the efficacy of vitamin B-6 in the treatment of premenstrual syndrome.
DESIGN
Systematic review of published and unpublished randomised placebo controlled trials of the effectiveness of vitamin B-6 in the management of premenstrual syndrome.
SUBJECTS
Nine published trials representing 940 patients with premenstrual syndrome.
MAIN OUTCOME MEASURES
Proportion of women whose overall premenstrual symptoms showed an improvement over placebo. A secondary analysis was performed on the proportion of women whose premenstrual depressive symptoms showed an improvement over placebo.
RESULTS
Odds ratio relative to placebo for an improvement in overall premenstrual symptoms was 2.32 (95% confidence interval 1.95 to 2.54). Odds ratio relative to placebo for an improvement in depressive symptoms was 1.69 (1.39 to 2.06) from four trials representing 541 patients.
CONCLUSION
Conclusions are limited by the low quality of most of the trials included. Results suggest that doses of vitamin B-6 up to 100 mg/day are likely to be of benefit in treating premenstrual symptoms and premenstrual depression.
Topics: Female; Humans; Premenstrual Syndrome; Pyridoxine; Randomized Controlled Trials as Topic; Treatment Outcome
PubMed: 10334745
DOI: 10.1136/bmj.318.7195.1375 -
Nutrients Apr 2020Previous evidence has suggested that vitamins might be beneficial for cognition. This systematic review aimed to investigate the efficacy of B vitamins, antioxidant... (Meta-Analysis)
Meta-Analysis
Previous evidence has suggested that vitamins might be beneficial for cognition. This systematic review aimed to investigate the efficacy of B vitamins, antioxidant vitamins, and vitamin D on the cognitive function of non-demented middle-aged or older people. Randomized or quasi-randomized controlled trials of individuals aged 40 years or older were included. PubMed/MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Library databases, and other grey literature sources were searched up to November 2019. Their methodological quality was evaluated using the Cochrane Risk of Bias tool. Twenty-three studies on B vitamins ( 22-1053; comprising folate, B6, and B12), nine on antioxidant vitamins ( 185-20,469), and six on vitamin D ( 55-4122) were included. Taking B vitamins for over 3 months was beneficial for global cognition (standardized mean difference (SMD) -0.18, 95% CI -0.30 to -0.06) and episodic memory (SMD -0.09, 95% CI -0.15 to -0.04). However, antioxidant vitamins (SMD -0.02, 95% CI -0.08 to 0.03) and vitamin D (SMD -0.06, 95% CI -0.36 to 0.23) were not. Antioxidant vitamins were beneficial for global cognition in sensitivity analyses using final measurement data as mean difference estimates (SMD, -0.04, 95% CI -0.08 to -0.01). Taking B vitamins and possibly antioxidant vitamins may be beneficial for the cognitive function of non-demented people.
Topics: Adult; Age Factors; Aged; Aged, 80 and over; Antioxidants; Cognition; Female; Healthy Aging; Humans; Male; Memory, Episodic; Middle Aged; Randomized Controlled Trials as Topic; Vitamin B Complex; Vitamin D
PubMed: 32331312
DOI: 10.3390/nu12041168 -
Annals of Family Medicine 2004We undertook a literature review to produce evidence-based recommendations for nonsurgical family physician management of carpal tunnel syndrome (CTS). (Review)
Review
BACKGROUND
We undertook a literature review to produce evidence-based recommendations for nonsurgical family physician management of carpal tunnel syndrome (CTS).
METHODS
Study design was systematic review of randomized controlled trials (RCTs) on CTS treatment. Data sources were English publications from all relevant databases, hand searches, and guidelines. Outcomes measured were nonsurgical management options for CTS.
RESULTS
We assessed 2 systematic reviews, 16 RCTs, and 1 before-and-after study using historical controls. A considerable percentage of CTS resolves spontaneously. There is strong evidence that local corticosteroid injections, and to a lesser extent oral corticosteroids, give short-term relief for CTS sufferers. There is limited evidence to indicate that splinting, laser-acupuncture, yoga, and therapeutic ultrasound may be effective in the short to medium term (up to 6 months). The evidence for nerve and tendon gliding exercises is even more tentative. The evidence does not support the use of nonsteroidal anti-inflammatory drugs, diuretics, pyridoxine (vitamin B6), chiropractic treatment, or magnet treatment.
CONCLUSIONS
For those who are not able to get surgery or for those who do not want surgery, there are some conservative modalities that can be tried. These modalities include ones for which there is good evidence. It would be reasonable to try some of the techniques with less evidence if the better ones are not successful. Reconsideration of surgery must always be kept in mind to avoid permanent nerve damage.
Topics: Adult; Aged; Carpal Tunnel Syndrome; Family Practice; Female; Humans; Male; Middle Aged
PubMed: 15209206
DOI: 10.1370/afm.21 -
The Cochrane Database of Systematic... 2003Non-surgical treatment for carpal tunnel syndrome is frequently offered to those with mild to moderate symptoms. The effectiveness and duration of benefit from... (Review)
Review
BACKGROUND
Non-surgical treatment for carpal tunnel syndrome is frequently offered to those with mild to moderate symptoms. The effectiveness and duration of benefit from non-surgical treatment for carpal tunnel syndrome remain unknown.
OBJECTIVES
To evaluate the effectiveness of non-surgical treatment (other than steroid injection) for carpal tunnel syndrome versus a placebo or other non-surgical, control interventions in improving clinical outcome.
SEARCH STRATEGY
We searched the Cochrane Neuromuscular Disease Group specialised register (searched March 2002), MEDLINE (searched January 1966 to February 7 2001), EMBASE (searched January 1980 to March 2002), CINAHL (searched January 1983 to December 2001), AMED (searched 1984 to January 2002), Current Contents (January 1993 to March 2002), PEDro and reference lists of articles.
SELECTION CRITERIA
Randomised or quasi-randomised studies in any language of participants with the diagnosis of carpal tunnel syndrome who had not previously undergone surgical release. We considered all non-surgical treatments apart from local steroid injection. The primary outcome measure was improvement in clinical symptoms after at least three months following the end of treatment.
DATA COLLECTION AND ANALYSIS
Three reviewers independently selected the trials to be included. Two reviewers independently extracted data. Studies were rated for their overall quality. Relative risks and weighted mean differences with 95% confidence intervals were calculated for the primary and secondary outcomes in each trial. Results of clinically and statistically homogeneous trials were pooled to provide estimates of the efficacy of non-surgical treatments.
MAIN RESULTS
Twenty-one trials involving 884 people were included. A hand brace significantly improved symptoms after four weeks (weighted mean difference (WMD) -1.07; 95% confidence interval (CI) -1.29 to -0.85) and function (WMD -0.55; 95% CI -0.82 to -0.28). In an analysis of pooled data from two trials (63 participants) ultrasound treatment for two weeks was not significantly beneficial. However one trial showed significant symptom improvement after seven weeks of ultrasound (WMD -0.99; 95% CI -1.77 to - 0.21) which was maintained at six months (WMD -1.86; 95% CI -2.67 to -1.05). Four trials involving 193 people examined various oral medications (steroids, diuretics, nonsteroidal anti-inflammatory drugs) versus placebo. Compared to placebo, pooled data for two-week oral steroid treatment demonstrated a significant improvement in symptoms (WMD -7.23; 95% CI -10.31 to -4.14). One trial also showed improvement after four weeks (WMD -10.8; 95% CI -15.26 to -6.34). Compared to placebo, diuretics or nonsteroidal anti-inflammatory drugs did not demonstrate significant benefit. In two trials involving 50 people, vitamin B6 did not significantly improve overall symptoms. In one trial involving 51 people yoga significantly reduced pain after eight weeks (WMD -1.40; 95% CI -2.73 to -0.07) compared with wrist splinting. In one trial involving 21 people carpal bone mobilisation significantly improved symptoms after three weeks (WMD -1.43; 95% CI -2.19 to -0.67) compared to no treatment. In one trial involving 50 people with diabetes, steroid and insulin injections significantly improved symptoms over eight weeks compared with steroid and placebo injections. Two trials involving 105 people compared ergonomic keyboards versus control and demonstrated equivocal results for pain and function. Trials of magnet therapy, laser acupuncture, exercise or chiropractic care did not demonstrate symptom benefit when compared to placebo or control.
REVIEWER'S CONCLUSIONS
Current evidence shows significant short-term benefit from oral steroids, splinting, ultrasound, yoga and carpal bone mobilisation. Other non-surgical treatments do not produce significant benefit. More trials are needed to compare treatments and ascertain the duration of benefit.
Topics: Administration, Oral; Carpal Tunnel Syndrome; Humans; Randomized Controlled Trials as Topic; Splints; Steroids; Treatment Outcome; Ultrasonic Therapy; Yoga
PubMed: 12535461
DOI: 10.1002/14651858.CD003219 -
Journal of Gynecology Obstetrics and... Jun 2024This systematic review aims to evaluate the efficacy and safety of Pyridoxine compared to Dopaminergic agonists (cabergoline and bromocriptine) in post-partum lactation... (Comparative Study)
Comparative Study Review
This systematic review aims to evaluate the efficacy and safety of Pyridoxine compared to Dopaminergic agonists (cabergoline and bromocriptine) in post-partum lactation inhibition. Cochrane Central, PubMed/MEDLINE, Cochrane Central, ScienceDirect, ClinicalTrials.gov, Web of Science, CINAHL and Google Scholar, covering the period from inception to November 2023. Additionally, the bibliographies of included articles and previous meta-analyses were screened for any relevant articles. The systematic review was conducted according to the Cochrane Handbook for Systematic Reviews of Interventions. The outcomes of interest encompassed inhibition of lactation, breast pain/tenderness, breast engorgement, milk secretion, fever, mastitis, prolactin level and adverse events related to pyridoxine, cabergoline and bromocriptine. Methodological quality assessment was conducted using the Cochrane risk of bias assessment tool for rigorous evaluation. Three clinical trials assessed the effectiveness of pyridoxine and dopaminergic agents (cabergoline and bromocriptine) for lactation inhibition. It was assessed by using different assessment methods such as a scale for milk secretion, serum prolactin levels, and questionnaires for assessing breast engorgement, breast pain, and milk leakage. On the global assessment of the therapeutic efficacy of dopaminergic agents, it was found that there was significant inhibition of lactation as compared to pyridoxine (p < 0.001). In conclusion, this systematic review contributes significant insights into lactation inhibition interventions. Dopaminergic agonists, specifically cabergoline and bromocriptine, stand out as more effective and tolerable choices compared to Pyridoxine. These findings provide a foundation for informed clinical decisions and underscore the need for careful consideration of lactation inhibition strategies in diverse clinical contexts.
Topics: Humans; Bromocriptine; Female; Pyridoxine; Cabergoline; Dopamine Agonists; Lactation; Lactation Disorders; Clinical Trials as Topic
PubMed: 38554942
DOI: 10.1016/j.jogoh.2024.102783 -
The Cochrane Database of Systematic... Dec 2019Vitamins and minerals are essential for growth and maintenance of a healthy body, and have a role in the functioning of almost every organ. Multiple interventions have... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Vitamins and minerals are essential for growth and maintenance of a healthy body, and have a role in the functioning of almost every organ. Multiple interventions have been designed to improve micronutrient deficiency, and food fortification is one of them.
OBJECTIVES
To assess the impact of food fortification with multiple micronutrients on health outcomes in the general population, including men, women and children.
SEARCH METHODS
We searched electronic databases up to 29 August 2018, including the Cochrane Central Register of Controlled Trial (CENTRAL), the Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register and Cochrane Public Health Specialised Register; MEDLINE; Embase, and 20 other databases, including clinical trial registries. There were no date or language restrictions. We checked reference lists of included studies and relevant systematic reviews for additional papers to be considered for inclusion.
SELECTION CRITERIA
We included randomised controlled trials (RCTs), cluster-RCTs, quasi-randomised trials, controlled before-after (CBA) studies and interrupted time series (ITS) studies that assessed the impact of food fortification with multiple micronutrients (MMNs). Primary outcomes included anaemia, micronutrient deficiencies, anthropometric measures, morbidity, all-cause mortality and cause-specific mortality. Secondary outcomes included potential adverse outcomes, serum concentration of specific micronutrients, serum haemoglobin levels and neurodevelopmental and cognitive outcomes. We included food fortification studies from both high-income and low- and middle-income countries (LMICs).
DATA COLLECTION AND ANALYSIS
Two review authors independently screened, extracted and quality-appraised the data from eligible studies. We carried out statistical analysis using Review Manager 5 software. We used random-effects meta-analysis for combining data, as the characteristics of study participants and interventions differed significantly. We set out the main findings of the review in 'Summary of findings' tables, using the GRADE approach.
MAIN RESULTS
We identified 127 studies as relevant through title/abstract screening, and included 43 studies (48 papers) with 19,585 participants (17,878 children) in the review. All the included studies except three compared MMN fortification with placebo/no intervention. Two studies compared MMN fortification versus iodised salt and one study compared MMN fortification versus calcium fortification alone. Thirty-six studies targeted children; 20 studies were conducted in LMICs. Food vehicles used included staple foods, such as rice and flour; dairy products, including milk and yogurt; non-dairy beverages; biscuits; spreads; and salt. Fourteen of the studies were fully commercially funded, 13 had partial-commercial funding, 14 had non-commercial funding and two studies did not specify the source of funding. We rated all the evidence as of low to very low quality due to study limitations, imprecision, high heterogeneity and small sample size. When compared with placebo/no intervention, MMN fortification may reduce anaemia by 32% (risk ratio (RR) 0.68, 95% confidence interval (CI) 0.56 to 0.84; 11 studies, 3746 participants; low-quality evidence), iron deficiency anaemia by 72% (RR 0.28, 95% CI 0.19 to 0.39; 6 studies, 2189 participants; low-quality evidence), iron deficiency by 56% (RR 0.44, 95% CI 0.32 to 0.60; 11 studies, 3289 participants; low-quality evidence); vitamin A deficiency by 58% (RR 0.42, 95% CI 0.28 to 0.62; 6 studies, 1482 participants; low-quality evidence), vitamin B2 deficiency by 64% (RR 0.36, 95% CI 0.19 to 0.68; 1 study, 296 participants; low-quality evidence), vitamin B6 deficiency by 91% (RR 0.09, 95% CI 0.02 to 0.38; 2 studies, 301 participants; low-quality evidence), vitamin B12 deficiency by 58% (RR 0.42, 95% CI 0.25 to 0.71; 3 studies, 728 participants; low-quality evidence), weight-for-age z-scores (WAZ) (mean difference (MD) 0.1, 95% CI 0.02 to 0.17; 8 studies, 2889 participants; low-quality evidence) and weight-for-height/length z-score (WHZ/WLZ) (MD 0.1, 95% CI 0.02 to 0.18; 6 studies, 1758 participants; low-quality evidence). We are uncertain about the effect of MMN fortification on zinc deficiency (RR 0.84, 95% CI 0.65 to 1.08; 5 studies, 1490 participants; low-quality evidence) and height/length-for-age z-score (HAZ/LAZ) (MD 0.09, 95% CI 0.01 to 0.18; 8 studies, 2889 participants; low-quality evidence). Most of the studies in this comparison were conducted in children. Subgroup analyses of funding sources (commercial versus non-commercial) and duration of intervention did not demonstrate any difference in effects, although this was a relatively small number of studies and the possible association between commercial funding and increased effect estimates has been demonstrated in the wider health literature. We could not conduct subgroup analysis by food vehicle and funding; since there were too few studies in each subgroup to draw any meaningful conclusions. When we compared MMNs versus iodised salt, we are uncertain about the effect of MMN fortification on anaemia (R 0.86, 95% CI 0.37 to 2.01; 1 study, 88 participants; very low-quality evidence), iron deficiency anaemia (RR 0.40, 95% CI 0.09 to 1.83; 2 studies, 245 participants; very low-quality evidence), iron deficiency (RR 0.98, 95% CI 0.82 to 1.17; 1 study, 88 participants; very low-quality evidence) and vitamin A deficiency (RR 0.19, 95% CI 0.07 to 0.55; 2 studies, 363 participants; very low-quality evidence). Both of the studies were conducted in children. Only one study conducted in children compared MMN fortification versus calcium fortification. None of the primary outcomes were reported in the study. None of the included studies reported on morbidity, adverse events, all-cause or cause-specific mortality.
AUTHORS' CONCLUSIONS
The evidence from this review suggests that MMN fortification when compared to placebo/no intervention may reduce anaemia, iron deficiency anaemia and micronutrient deficiencies (iron, vitamin A, vitamin B2 and vitamin B6). We are uncertain of the effect of MMN fortification on anthropometric measures (HAZ/LAZ, WAZ and WHZ/WLZ). There are no data to suggest possible adverse effects of MMN fortification, and we could not draw reliable conclusions from various subgroup analyses due to a limited number of studies in each subgroup. We remain cautious about the level of commercial funding in this field, and the possibility that this may be associated with higher effect estimates, although subgroup analysis in this review did not demonstrate any impact of commercial funding. These findings are subject to study limitations, imprecision, high heterogeneity and small sample sizes, and we rated most of the evidence low to very low quality. and hence no concrete conclusions could be drawn from the findings of this review.
Topics: Anemia, Iron-Deficiency; Food, Fortified; Health Status; Humans; Iodine; Micronutrients; Minerals; Nutrition Disorders; Randomized Controlled Trials as Topic; Sodium Chloride, Dietary; Vitamin A Deficiency; Vitamins
PubMed: 31849042
DOI: 10.1002/14651858.CD011400.pub2 -
Pain Medicine (Malden, Mass.) Apr 2020Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, and cyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidal... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, and cyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), particularly diclofenac, in a synergistic manner. The aim of this review was to determine the effects of diclofenac combined with TPC compared with diclofenac monotherapy for low back pain (LBP) management.
METHODS
We searched for randomized clinical trials on the MEDLINE, EMBASE, LILACS, and Cochrane databases of records of clinical trials, among other sources. We evaluated the risk of bias regarding randomization, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. A random-effects meta-analysis to examine patients with acute LBP (N = 1,108 adults) was performed, along with a subsequent sensitivity analysis.
RESULTS
Five studies in patients with LBP were included in the qualitative synthesis. Four of these studies in acute LBP were included in the first meta-analysis. A sensitivity test based on risk of bias (three moderate- to high-quality studies) found that the combination therapy of diclofenac plus TPC was associated with a significant reduction in the duration of treatment (around 50%) compared with diclofenac monotherapy (odds ratio = 2.23, 95% confidence interval = 1.59 to 3.13, P < 0.00001). We found no differences in the safety profile and patient satisfaction.
CONCLUSIONS
This meta-analysis demonstrated that combination therapy of diclofenac with TPC might have an analgesic superiority compared with diclofenac monotherapy in acute LBP. However, there is not enough evidence to recommend this therapy in other types of pain due to the scarcity of high-quality studies.
Topics: Anti-Inflammatory Agents, Non-Steroidal; Diclofenac; Drug Therapy, Combination; Humans; Low Back Pain; Pain Measurement; Pyridoxine; Thiamine; Vitamin B 12; Vitamin B Complex
PubMed: 31529101
DOI: 10.1093/pm/pnz216