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Advances in Nutrition (Bethesda, Md.) Nov 2023There is no comprehensive review of the evidence to support omega-3 polyunsaturated fatty acids (PUFAs) as a relatively safe and tolerable intervention. This study aimed... (Meta-Analysis)
Meta-Analysis Review
There is no comprehensive review of the evidence to support omega-3 polyunsaturated fatty acids (PUFAs) as a relatively safe and tolerable intervention. This study aimed to provide a meta-analytic and comprehensive review on the adverse effects of all kinds of ω-3 PUFA supplementation reported in randomized controlled trials (RCTs) in human subjects. A systematic review of RCTs published between 1987 and 2023 was carried out based on searches of 8 electronic databases. All RCTs that compared the adverse effects of ω-3 PUFAs containing eicosapentaenoic acid, docosahexaenoic acid, or both compared with controls (a placebo or a standard treatment) were included. The primary outcome was the adverse effects related to ω-3 PUFA prescription. A total of 90 RCTs showed that the ω-3 PUFA group, when compared with the placebo, had significantly higher odds of occurrence of diarrhea (odds ratio [OR] = 1.257, P = 0.010), dysgeusia (OR = 3.478, P < 0.001), and bleeding tendency (OR = 1.260, P = 0.025) but lower rates of back pain (OR = 0.727, P < 0.001). The subgroup analysis showed that the prescription ω-3 PUFA products (RxOME3FAs) had higher ω-3 PUFA dosages than generic ω-3 PUFAs (OME3FAs) (3056.38 ± 1113.28 mg/d compared with 2315.92 ± 1725.61 mg/d), and studies on RxOME3FAs performed more standard assessments than OME3FAs on adverse effects (63% compared with 36%). There was no report of definite ω-3 PUFA-related serious adverse events. The subjects taking ω-3 PUFAs were at higher odds of experiencing adverse effects; hence, comprehensive assessments of the adverse effects may help to detect minor/subtle adverse effects associated with ω-3 PUFAs. This study was registered at PROSPERO as CRD42023401169.
Topics: Humans; Randomized Controlled Trials as Topic; Fatty Acids, Omega-3; Eicosapentaenoic Acid; Fatty Acids, Unsaturated; Dietary Supplements
PubMed: 37567449
DOI: 10.1016/j.advnut.2023.08.003 -
The Cochrane Database of Systematic... Dec 2017The sense of taste is very much essential to the overall health of an individual. It is a necessary component to enjoy one's food, which in turn provides nutrition to an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The sense of taste is very much essential to the overall health of an individual. It is a necessary component to enjoy one's food, which in turn provides nutrition to an individual. Any disturbance in taste perception can hamper quality of life in such patients by influencing their appetite, body weight and psychological well-being. Taste disorders have been treated using different modalities of treatment and there is no consensus for the best intervention. Hence this Cochrane Review was undertaken. This is an update of the Cochrane Review first published in November 2014.
OBJECTIVES
To assess the effects of interventions for the management of patients with taste disturbances.
SEARCH METHODS
Cochrane Oral Health's Information Specialist searched the following databases: Cochrane Oral Health's Trials Register (to 4 July 2017); the Cochrane Central Register of Controlled Trials (CENTRAL; 2017 Issue 6) in the Cochrane Library (searched 4 July 2017); MEDLINE Ovid (1946 to 4 July 2017); Embase Ovid (1980 to 4 July 2017); CINAHL EBSCO (1937 to 4 July 2017); and AMED Ovid (1985 to 4 July 2017). The US National Institutes of Health Ongoing Trials Register ClinicalTrials.gov (www.clinicaltrials.gov) and the World Health Organization International Clinical Trials Registry Platform were searched for trials. Abstracts from scientific meetings and conferences were searched on 25 September 2017. No restrictions were placed on the language or date of publication when searching the electronic databases.
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) comparing any pharmacological agent with a control intervention or any non-pharmacological agent with a control intervention. We also included cross-over trials in the review.
DATA COLLECTION AND ANALYSIS
Two pairs of review authors independently, and in duplicate, assessed the quality of trials and extracted data. Wherever possible, we contacted trial authors for additional information. We collected adverse events information from the trials.
MAIN RESULTS
We included 10 trials (581 participants), nine of which we were able to include in the quantitative analyses (566 participants). We assessed three trials (30%) as having a low risk of bias, four trials (40%) at high risk of bias and three trials (30%) as having an unclear risk of bias. We only included studies on taste disorders in this review that were either idiopathic, or resulting from zinc deficiency or chronic renal failure.Of these, nine trials with 544 people compared zinc supplements to placebo for patients with taste disorders. The participants in two trials were children and adolescents with respective mean ages of 10 and 11.2 years and the other seven trials had adult participants. Out of these nine, two trials assessed the patient-reported outcome for improvement in taste acuity using zinc supplements (risk ratio (RR) 1.40, 95% confidence interval (CI) 0.94 to 2.09; 119 participants, very low-quality evidence). We meta-analysed for taste acuity improvement using objective outcome (continuous data) in idiopathic and zinc-deficient taste disorder patients (standardised mean difference (SMD) 0.44, 95% CI 0.23 to 0.65; 366 participants, three trials, very low-quality evidence). We also analysed one cross-over trial separately using the first half of the results for taste detection (mean difference (MD) 2.50, 95% CI 0.93 to 4.07; 14 participants, very low-quality evidence), and taste recognition (MD 3.00, 95% CI 0.66 to 5.34; 14 participants, very low-quality evidence). We meta-analysed taste acuity improvement using objective outcome (dichotomous data) in idiopathic and zinc-deficient taste disorder patients (RR 1.42, 95% 1.09 to 1.84; 292 participants, two trials, very low-quality evidence). Out of the nine trials using zinc supplementation, four reported adverse events like eczema, nausea, abdominal pain, diarrhoea, constipation, decrease in blood iron, increase in blood alkaline phosphatase, and minor increase in blood triglycerides.One trial tested taste discrimination using acupuncture (MD 2.80, 95% CI -1.18 to 6.78; 37 participants, very low-quality evidence). No adverse events were reported in the acupuncture trial.None of the included trials could be included in the meta-analysis for health-related quality of life in taste disorder patients.
AUTHORS' CONCLUSIONS
We found very low-quality evidence that was insufficient to conclude on the role of zinc supplements to improve taste acuity reported by patients and very low-quality evidence that zinc supplements improve taste acuity in patients with zinc deficiency/idiopathic taste disorders. We did not find any evidence to conclude the role of zinc supplements for improving taste discrimination, or any evidence addressing health-related quality of life due to taste disorders.We found very low-quality evidence that is not sufficient to conclude on the role of acupuncture for improving taste discrimination in cases of idiopathic dysgeusia (distortion of taste) and hypogeusia (reduced ability to taste). We were unable to draw any conclusions regarding the superiority of zinc supplements or acupuncture as none of the trials compared these interventions.
Topics: Acupuncture Therapy; Adolescent; Adult; Child; Humans; Quality of Life; Randomized Controlled Trials as Topic; Taste Disorders; Taste Perception; Zinc; Zinc Compounds
PubMed: 29260510
DOI: 10.1002/14651858.CD010470.pub3 -
Bulletin of the National Research Centre 2022In 2019, a viral and respiratory pathology called COVID-19 emerged in Wuhan, China, and spread to other continents. Its main symptoms include fever, cough, dyspnea,... (Review)
Review
BACKGROUND
In 2019, a viral and respiratory pathology called COVID-19 emerged in Wuhan, China, and spread to other continents. Its main symptoms include fever, cough, dyspnea, myalgia, anorexia and respiratory distress in the most severe cases, which can lead to death. Furthermore, manifestations in the oral cavity such as ageusia and dysgeusia, as well as lesions in other regions of the oral cavity, can be observed.
MAIN BODY
This systematic review and meta-analysis aimed to critically assess the clinical evidence on the use of photobiomodulation (PBMT) and antimicrobial photodynamic therapy (aPDT) for the treatment of oral lesions in patients infected with Sars-Cov-2. The literature extracted from electronic databases such as PubMed, Medline, CINAHL, and Google Scholar was screened for eligibility, and relevant articles were included. The review is limited to manuscripts published in English, Spanish and Portuguese language between December 2019 and October 2021. A total of 5 articles with 11 cases retracting PBMT and aPDT as therapeutic strategies for the regression of oral lesions and painful symptoms. The results show favoring the associated use of PBMT with aPDT ( = 0.004), and the isolated use of PBMT with the result of significant " = 0.005" and good confidence interval (7.18, 39.20) in ulcerative lesions, herpetic, aphthous, erythematous, petechiae and necrotic areas.
CONCLUSIONS
PBMT and aPDT could be effective in the treatment of oral lesions of patients infected with Sars-Cov-2 in a short period of time; however, more long-term randomized clinical trials studies are needed to define the therapeutic strategy.
PubMed: 35601476
DOI: 10.1186/s42269-022-00830-z -
The Cochrane Database of Systematic... Nov 2014The sense of taste is very much essential to the overall health of the individual. It is a necessary component to enjoying one's food, which in turn provides nutrition... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
The sense of taste is very much essential to the overall health of the individual. It is a necessary component to enjoying one's food, which in turn provides nutrition to an individual. Any disturbance in taste perception can hamper the quality of life in such patients by influencing their appetite, body weight and psychological well-being. Taste disorders have been treated using different modalities of treatment and there is no consensus for the best intervention. Hence this Cochrane systematic review was undertaken.
OBJECTIVES
To assess the effects of interventions for the management of patients with taste disturbances.
SEARCH METHODS
We searched the Cochrane Oral Health Group Trials Register (to 5 March 2014), the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library Issue 1, 2014), MEDLINE via OVID (1948 to 5 March 2014), EMBASE via OVID (1980 to 5 March 2014), CINAHL via EBSCO (1980 to 5 March 2014) and AMED via OVID (1985 to 5 March 2014). We also searched the relevant clinical trial registries and conference proceedings from the International Association of Dental Research/American Association of Dental Research (to 5 March 2014), Association for Research in Otolaryngology (to 5 March 2014), the US National Institutes of Health Trials Register (to 5 March 2014), metaRegister of Controlled Trials (mRCT) (to 5 March 2014), World Health Organization's International Clinical Trials Registry Platform (WHO ICTRP) (to 5 March 2014) and International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Clinical Trials Portal (to 5 March 2014).
SELECTION CRITERIA
We included all randomised controlled trials (RCTs) comparing any pharmacological agent with a control intervention or any non-pharmacological agent with a control intervention. We also included cross-over trials in the review.
DATA COLLECTION AND ANALYSIS
Two authors independently, and in duplicate, assessed the quality of trials and extracted data. Wherever possible, we contacted study authors for additional information. We collected adverse events information from the trials.
MAIN RESULTS
We included nine trials (seven parallel and two cross-over RCTs) with 566 participants. We assessed three trials (33.3%) as having a low risk of bias, four trials (44.5%) at high risk of bias and two trials (22.2%) as having an unclear risk of bias. We only included studies on taste disorders in this review that were either idiopathic, or resulting from zinc deficiency or chronic renal failure.Of these, eight trials with 529 people compared zinc supplements to placebo for patients with taste disorders. The participants in two trials were children and adolescents with respective mean ages of 10 and 11.2 years and the other six trials had adult participants. Out of these eight, two trials assessed the patient reported outcome for improvement in taste acuity using zinc supplements (RR 1.45, 95% CI 1.0 to 2.1; very low quality evidence). We included three trials in the meta-analysis for overall taste improvement (effect size 0.44, 95% CI 0.23 to 0.65; moderate quality evidence). Two other trials described the results as taste acuity improvement and we conducted subgroup analyses due to clinical heterogeneity. One trial described the results as taste recognition improvement for each taste sensation and we analysed this separately. We also analysed one cross-over trial separately using the first half of the results. None of the zinc trials tested taste discrimination. Only one trial tested taste discrimination using acupuncture (effect size 2.80, 95% CI -1.18 to 6.78; low quality evidence).Out of the eight trials using zinc supplementation, four reported adverse events like eczema, nausea, abdominal pain, diarrhoea, constipation, decrease in blood iron, increase in blood alkaline phosphatase, and minor increase in blood triglycerides. No adverse events were reported in the acupuncture trial.None of the included trials could be included in the meta-analysis for health-related quality of life in taste disorder patients.
AUTHORS' CONCLUSIONS
We found very low quality evidence that was insufficient to conclude on the role of zinc supplements to improve taste perception by patients, however we found moderate quality evidence that zinc supplements improve overall taste improvement in patients with zinc deficiency/idiopathic taste disorders. We also found low quality evidence that zinc supplements improve taste acuity in zinc deficient/idiopathic taste disorders and very low quality evidence for taste recognition improvement in children with taste disorders secondary to chronic renal failure. We did not find any evidence to conclude the role of zinc supplements for improving taste discrimination, or any evidence addressing health-related quality of life due to taste disorders.We found low quality evidence that is not sufficient to conclude on the role of acupuncture for improving taste discrimination in cases of idiopathic dysgeusia (distortion of taste) and hypogeusia (reduced ability to taste). We were unable to draw any conclusions regarding the superiority of zinc supplements or acupuncture as none of the trials compared these interventions.
Topics: Acupuncture Therapy; Adolescent; Adult; Child; Humans; Quality of Life; Randomized Controlled Trials as Topic; Taste Disorders; Taste Perception; Zinc Compounds
PubMed: 25425011
DOI: 10.1002/14651858.CD010470.pub2 -
Journal of Clinical Medicine Aug 2022Dry eye disease (DED) is a multifactorial disease that causes ocular discomfort and visual impairment on a damaged ocular surface. Lifitegrast, a novel T-cell integrin... (Review)
Review
Dry eye disease (DED) is a multifactorial disease that causes ocular discomfort and visual impairment on a damaged ocular surface. Lifitegrast, a novel T-cell integrin antagonist, was approved in the United States in July 2016 as a 5% (50 mg/mL) ophthalmic solution for DED management. Currently, no meta-analysis and systemic review based on relevant studies have been conducted. This study aimed to evaluate the efficacy and safety of lifitegrast in patients with DED. We systematically searched Embase, Medline, PubMed, and Web of Science for randomized controlled trials (RCTs) and nonrandomized studies evaluating lifitegrast effects on symptomatic DED. Then, inferior corneal staining score, total corneal staining score (TCSS), nasal lissamine staining score (NLSS), total lissamine staining score, ocular discomfort score (ODS), eye discomfort score (visual analog scale (VAS) score), eye dryness score (EDS), ocular surface disease index score (OSDI-S), and tear break-up time (TBUT) were assessed. Clinical global impression and safety profiles were also evaluated. The studies were pooled in a random-effects model. We included five RCTs, one case-control study, and four longitudinal or retrospective studies, comprising 3197 participants. In the meta-analysis, lifitegrast was superior to the placebo because it improved TCSS, NLSS, TBUT, ODS, eye discomfort score, EDS, and OSDI-Sin DED. However, lifitegrast showed higher risks for ocular and non-ocular treatment-emergent adverse events (TEAEs) overall or at a mild or moderate level. Nonetheless, its incidence of adverse events slightly differed from that in the placebo, especially instillation site discomforts and dysgeusia, thereby considered safe and tolerable. Claims of withdrawal during follow-up caused by TEAEs were extremely rare. Lifitegrast improves DED, although dysgeusia, installation site pain, and irritation may be a concern for some. Overall, most of the adverse events are tolerable. Lifitegrast can alleviate refractory DED and improves patients' quality of life.
PubMed: 36078948
DOI: 10.3390/jcm11175014 -
Supportive Care in Cancer : Official... May 2017In the literature, there is limited research about the changed meaning of food, the eating and the eating experience during treatment in patients with head and neck... (Meta-Analysis)
Meta-Analysis Review
PURPOSE
In the literature, there is limited research about the changed meaning of food, the eating and the eating experience during treatment in patients with head and neck cancer. This systematic review includes findings from a qualitative research synthesis to gain a deeper understanding of the influence and experiences of dysphagia, dysgeusia, oral mucositis and xerostomia in head and neck cancer patients (HNC) and suggests recommendations for care practice.
METHOD
A systematic review and meta-synthesis techniques were adopted to identify, appraise and synthesize the relevant literature regarding the experience of nutritional symptoms of HNC patients conducted according to the PRISMA guidelines. Several electronic databases such as PubMed, CINAHL, Scopus, PsycINFO and the Cochrane Library databases were searched.
RESULTS
A systematic search yielded 121 papers, of which 12 met the inclusion criteria. A thematic account of shared nutritional symptom experiences reported across studies is highlighted and presented. Eight major themes covering three key supportive care domains were identified: impact of symptoms (symptoms during treatment, symptoms working together, affecting daily living activities and physical changes, symptoms and food changes), changing social networks and support (social life restrictions, support of peers), nutritional concerns and strategies (coping strategies, professional support).
CONCLUSIONS
Dysphagia, dysgeusia, oral mucositis and xerostomia negatively affected the patients' quality of life throughout the period of treatment. The patients' nutritional symptom experiences do not occur in isolation. Therefore, acknowledging the patients' eating difficulties and challenges can guarantee appropriate management and support to best manage symptoms in a timely manner.
Topics: Eating; Head and Neck Neoplasms; Humans; Life Change Events; Nutritional Status; Quality of Life
PubMed: 28204992
DOI: 10.1007/s00520-017-3618-7 -
Cancer Treatment Reviews Apr 2016Combined-modality treatment of head and neck cancer is becoming more common, driven by the idea that organ(s) preservation should maintain patient appearance and the... (Review)
Review
The effects of swallowing disorders, dysgeusia, oral mucositis and xerostomia on nutritional status, oral intake and weight loss in head and neck cancer patients: A systematic review.
BACKGROUND
Combined-modality treatment of head and neck cancer is becoming more common, driven by the idea that organ(s) preservation should maintain patient appearance and the function of organ(s) involved. Even if treatments have improved, they can still be associated with acute and late adverse effects. The aim of this systematic review was to retrieve current data on how swallowing disorders, dysgeusia, oral mucositis, and xerostomia affect nutritional status, oral intake and weight loss in head and neck cancer (HNC) patients.
METHODS
A systematic literature search covered four relevant electronic databases from January 2005 to May 2015. Retrieved papers were categorised and evaluated considering their methodological quality. Two independent reviewers reviewed manuscripts and abstracted data using a standardised form. Quality assessment of the included studies was performed using the Edwards Method Score.
RESULTS
Of the 1459 abstracts reviewed, a total of 25 studies were included. The most studied symptom was dysphagia, even if symptoms were interconnected and affected one other. In most of the selected studies the level of evidence was between 2 and 3, and their quality level was from medium to low.
CONCLUSIONS
There are limited data about dysgeusia, oral mucositis and xerostomia outcomes available for HNC patients. There is a lack of well-designed clinical trials and multicenter-prospective cohort studies, therefore further research is needed to ascertain which aspects of these symptoms should be measured.
Topics: Combined Modality Therapy; Deglutition Disorders; Dysgeusia; Head and Neck Neoplasms; Humans; Nutritional Status; Outcome Assessment, Health Care; Quality of Life; Stomatitis; Weight Loss; Xerostomia
PubMed: 27010487
DOI: 10.1016/j.ctrv.2016.03.006 -
JAMA Network Open Oct 2023Hyponatremia and the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) are associated with significant mortality and morbidity. The effectiveness and...
IMPORTANCE
Hyponatremia and the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) are associated with significant mortality and morbidity. The effectiveness and safety of oral urea for SIADH are still debated.
OBJECTIVE
To evaluate the efficacy and safety of urea for the treatment of SIADH.
EVIDENCE REVIEW
A systematic search of Medline and Embase was conducted for controlled and uncontrolled studies of urea for SIADH in adult patients. The primary outcome was serum sodium concentration after treatment. Secondary outcomes included the proportion of patients with osmotic demyelination syndrome (ODS), intracranial pressure, and resource use such as length of stay.
FINDINGS
Twenty-three studies involving 537 patients with SIADH were included, of which 462 were treated with urea. The pooled mean baseline serum sodium was 125.0 mmol/L (95% CI, 122.6-127.5 mmol/L). The median treatment duration with oral urea was 5 days. Urea increased serum sodium concentration by a mean of 9.6 mmol/L (95% CI, 7.5-11.7 mmol/L). The mean increase in serum sodium after 24 hours was 4.9 mmol/L (95% CI, 0.5-9.3 mmol/L). Adverse events were few, mainly consisting of distaste or dysgeusia, and no case of ODS was reported. Resource use was too infrequently reported to be synthesized.
CONCLUSIONS AND RELEVANCE
In this systematic review of the use of urea in SIADH and despite the lack of randomized clinical trials, lower-quality evidence was identified that suggests that urea may be an effective, safe, and inexpensive treatment modality that warrants further exploration.
Topics: Adult; Humans; Urea; Inappropriate ADH Syndrome; Vasopressins; Demyelinating Diseases; Sodium
PubMed: 37902751
DOI: 10.1001/jamanetworkopen.2023.40313 -
Prostaglandins, Leukotrienes, and... Feb 2018Omega-3 fatty acids [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] are widely recommended for health promotion. Over the last decade, prescription omega-3... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Omega-3 fatty acids [eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)] are widely recommended for health promotion. Over the last decade, prescription omega-3 fatty acid products (RxOME3FAs) have been approved for medical indications. Nonetheless, there is no comprehensive analysis of safety and tolerability of RxOME3FAs so far.
METHODS
A systematic review of randomized controlled trials (RCTs) was carried out based on searches in six electronic databases. The studies involving marketed RxOME3FA products were included, and adverse-effect data were extracted for meta-analysis. Subgroup analysis and meta-regression were conducted to explore the sources of potential heterogeneity.
RESULTS
Among the 21 included RCTs (total 24,460 participants; 12,750 from RxOME3FA treatment cohort and 11,710 from control cohort), there was no definite evidence of any RxOME3FA-emerging serious adverse event. Compared with the control group, RxOME3FAs were associated with more treatment-related dysgeusia (fishy taste; p = 0.011) and skin abnormalities (eruption, itching, exanthema, or eczema; p < 0.001). Besides, RxOME3FAs had mild adverse effects upon some non-lipid laboratory measurements [elevated fasting blood sugar (p = 0.005); elevated alanine transaminase (p = 0.022); elevated blood urea nitrogen (p = 0.047); decreased hemoglobin (p = 0.002); decreased hematocrit (p = 0.009)]. Subgroup analysis revealed that EPA/DHA combination products were associated with more treatment-related gastrointestinal adverse events [eructation (belching; p = 0.010); nausea (p = 0.044)] and low-density lipoprotein cholesterol elevation (p = 0.009; difference in means = 4.106mg/dL).
CONCLUSION
RxOME3FAs are generally safe and well tolerated but not free of adverse effects. Post-marketing surveillance and observational studies are still necessary to identify long-term adverse effects and to confirm the safety and tolerability profiles of RxOME3FAs.
Topics: Blood Glucose; Cholesterol, LDL; Dietary Supplements; Docosahexaenoic Acids; Dysgeusia; Eczema; Eicosapentaenoic Acid; Exanthema; Humans; Patient Safety; Randomized Controlled Trials as Topic
PubMed: 29482765
DOI: 10.1016/j.plefa.2018.01.001 -
Obesity (Silver Spring, Md.) Jun 2021The study objective was to examine the association between phentermine/topiramate therapy and weight loss and adverse events in adults with overweight or obesity by... (Meta-Analysis)
Meta-Analysis
OBJECTIVE
The study objective was to examine the association between phentermine/topiramate therapy and weight loss and adverse events in adults with overweight or obesity by meta-analysis and systematic review.
METHODS
Medical Subject Headings and free-text terms were selected to search for eligible trials in PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), and Embase up to April 18, 2020. The quality of randomized controlled trials was evaluated by the Cochrane risk-of-bias tool. Meta-analysis was performed using random-effect models.
RESULTS
Phentermine/topiramate therapy resulted in an average weight loss of 7.73 kg (95% CI: 6.60-8.85) in general compared with placebo. The weight loss was related to the dose of phentermine/topiramate. Compared with placebo, the average weight loss was 3.55 kg (95% CI: 2.22-4.88) for 3.75/23 mg, 7.27 kg (95% CI: 6.40-8.13) for 7.5/46 mg, and 8.25 kg (95% CI: 6.92-9.79) for 15/92 mg. For phentermine/topiramate participants in different weight-loss subgroups, the weight loss of participants with ≥5%, ≥10%, and ≥15% baseline weight loss was 3.18 (95% CI: 2.75-3.67), 5.32 (95% CI: 4.53-6.25), and 5.65 (95% CI: 3.55-9.01), respectively. Compared with placebo, the adverse events associated with the treatment mainly included dysgeusia (odds ratio [OR] = 8.86, 95% CI: 5.65-13.89), paresthesia (OR = 8.51, 95% CI: 6.20-11.67), dry mouth (OR = 6.71, 95% CI: 5.03-8.94), disturbance in attention (OR = 4.48, 95% CI: 2.39-8.41), irritability (OR = 4.10, 95% CI: 2.29-7.33), hypoesthesia (OR = 3.81, 95% CI: 1.32-11.00), constipation (OR = 2.43, 95% CI: 2.02-2.93), and dizziness (OR = 2.26, 95% CI: 1.72-2.98). Phentermine/topiramate also reduced waist circumference, blood pressure, blood sugar levels, and lipid levels.
CONCLUSIONS
Phentermine/topiramate has considerable benefit in reducing body weight, and the efficacy was closely related to the dosage. However, it increased the risk of nervous system-related adverse events.
Topics: Adult; Blood Pressure; Body Weight; Drug Therapy, Combination; Female; Fructose; Humans; Male; Middle Aged; Obesity; Overweight; Phentermine; Randomized Controlled Trials as Topic; Topiramate; Treatment Outcome; Weight Loss
PubMed: 33864346
DOI: 10.1002/oby.23152