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BMJ Clinical Evidence Jun 2009More than half of pregnant women suffer from nausea and vomiting, which typically begins by the 4th week and disappears by the 16th week of pregnancy. The cause of... (Review)
Review
INTRODUCTION
More than half of pregnant women suffer from nausea and vomiting, which typically begins by the 4th week and disappears by the 16th week of pregnancy. The cause of nausea and vomiting in pregnancy is unknown, but may be due to the rise in human chorionic gonadotrophin concentration. In 1 in 200 women, the condition progresses to hyperemesis gravidarum, which is characterised by prolonged and severe nausea and vomiting, dehydration, and weight loss.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of treatment for nausea and vomiting in early pregnancy? What are the effects of treatments for hyperemesis gravidarum? We searched: Medline, Embase, The Cochrane Library, and other important databases up to May 2008 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 30 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: acupressure; acupuncture; antihistamines; corticosteroids; corticotrophins; diazepam; dietary interventions other than ginger; domperidone; ginger; metoclopramide; ondansetron; phenothiazines; and pyridoxine (vitamin B6).
Topics: Acupressure; Administration, Oral; Domperidone; Female; Humans; Metoclopramide; Nausea; Phytotherapy; Pregnancy; Single-Blind Method; United States Food and Drug Administration; Vomiting
PubMed: 21726485
DOI: No ID Found -
The Cochrane Database of Systematic... Oct 2014Functional dyspepsia (FD) has been a worldwide complaint. More effective therapies are needed with fewer adverse effects than are seen with conventional medications.... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Functional dyspepsia (FD) has been a worldwide complaint. More effective therapies are needed with fewer adverse effects than are seen with conventional medications. Acupuncture, as a traditional therapeutic method, has been widely used for functional gastrointestinal disorders in the East. Manual acupuncture and electroacupuncture have been recognized treatments for FD, but to date, no robust evidence has been found for the effectiveness and safety of these interventions in the treatment of this condition.
OBJECTIVES
This review was conducted to assess the efficacy and safety of manual acupuncture and electroacupuncture in the treatment of FD.
SEARCH METHODS
Trials meeting the inclusion criteria were identified through electronic searches of the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Allied and Complementary Medicine Database (AMED), Chinese Biology Medicine Disc (CBMdisc), China National Knowledge Infrastructure (CNKI), the Wanfang Database, the VIP Database, and six trial registries. Handsearching was done to screen the reference sections of potential trials and reviews.
SELECTION CRITERIA
Randomized controlled trials (RCTs) were included if investigators reported efficacy and safety of manual acupuncture or electroacupuncture for patients with FD diagnosed by Rome II or Rome III criteria, compared with medications, blank control, or sham acupuncture.
DATA COLLECTION AND ANALYSIS
Data were extracted by independent review authors. Study limitations were assessed by using the tool of The Cochrane Collabration for assessing risk of bias. For dichotomous data, risk ratios (RRs) and 95% confidence intervals (95% CIs) would be applied, and for continuous data, mean differences (MDs) and 95% CIs. A fixed-effect model was applied in the meta-analysis, or a descriptive analysis was performed. The quality of evidence for the outcome measure was assessed by the Grading of Recommendations Assessment, Development and Evaluation (GRADE) methods.
MAIN RESULTS
Seven studies were included in the review, involving 542 participants with FD (212 males and 330 females). These studies generally had an unclear risk of bias based on inadequate descriptions of allocation concealment and a high risk of bias based on lack of blinding. None of the studies reported on outcomes of the Functional Digestive Disorder Quality of Life questionnaire (FDDQL), the Satisfaction With Dyspepsia Related Health scale (SODA), the Digestive Health Status Instrument (DHSI), or effective/inefficient rate and symptom recurrence six months from completion of acupuncture treatment.Four RCTs of acupuncture versus medications (cisapride, domperidone, and itopride) were included in the review. No statistically significant difference was noted in the reduction in FD symptom scores and the frequency of FD attack by manual acupuncture, manual-electroacupuncture, or electroacupuncture compared with medications. In three trials of acupuncture versus sham acupuncture, all descriptive or quantitative analysis results implied that acupuncture could improve FD symptom scores and scores on the Neck Disability Index (NDI), the 36-Item Short Form Health Survey (SF-36), the Self-Rating Anxiety Scale (SAS), and the Self-Rating Depression Scale (SDS) more or as significantly as sham acupuncture. With regard to adverse effects, acupuncture was superior to cisapride treatment (one study; all minor events), but no statistically significant difference was reported between acupuncture and sham acupuncture. No adverse effects data were reported in studies examining manual acupuncture versus domperidone, manual-electroacupuncture versus domperidone, or electroacupuncture versus itopride.Nevertheless, all evidence was of low or very low quality. The body of evidence identified cannot yet permit a robust conclusion regarding the efficacy and safety of acupuncture for FD.
AUTHORS' CONCLUSIONS
It remains unknown whether manual acupuncture or electroacupuncture is more effective or safer than other treatments for patients with FD.
Topics: Acupuncture Therapy; Benzamides; Benzyl Compounds; Cisapride; Domperidone; Dyspepsia; Electroacupuncture; Female; Gastrointestinal Agents; Humans; Male; Randomized Controlled Trials as Topic
PubMed: 25306866
DOI: 10.1002/14651858.CD008487.pub2 -
Gastroenterology May 2019Studies have reported a lack of association between improvements in gastric emptying (GE) and upper gastrointestinal (UGI) symptoms with promotility drugs. However, GE... (Meta-Analysis)
Meta-Analysis
BACKGROUND & AIMS
Studies have reported a lack of association between improvements in gastric emptying (GE) and upper gastrointestinal (UGI) symptoms with promotility drugs. However, GE test methods were suboptimal in some studies. We assessed improvements in GE and UGI symptoms in patients given promotility agents in studies with optimal or moderate test methods (scintigraphy or breath test, solid meal, >2 hours duration) compared to studies with suboptimal GE test methods.
METHODS
With an expert librarian, we completed an extensive search of publications in the Ovid MEDLINE (1946 to present), EMBASE (1988 to January 2018), and EBM Reviews Cochrane Central Register of Controlled Trials, without restrictions on language or year. Two independent reviewers evaluated the following inclusion criteria: randomized, blinded, parallel, or crossover trials of 5HT agonists, D receptor antagonist, or ghrelin agonists; trials that measured change in GE (T) or composite UGI symptoms; trials of patients with functional dyspepsia and gastroparesis; and trials of GE test methods. Standardized mean differences (units expressed as SD) were used to standardize symptom assessments that were not uniform across studies. Random effects model was used to analyze data and meta-regression was used to evaluate the association between change in GE and UGI symptoms.
RESULTS
Of 899 studies considered, 22 studies assessed change in GE; 23 evaluated UGI symptoms; and 14 evaluated GE and UGI symptoms. Promotility agents significantly accelerated GE (T) in all studies (mean reduction in T, 16.3 minutes; 95% confidence interval, -22.1 to -10.6 minutes) and in studies that used optimal GE test methods (mean reduction in T, 23.6 minutes; 95% confidence interval, -32.3 to -14.9 minutes). Promotility agents also significantly reduced UGI symptoms (mean reduction, 0.25 SD; 95% confidence interval, -0.37 to -0.13 SD). Meta-regression found no significant association between change in GE and UGI symptoms. However, when only studies with optimal GE test methods were evaluated, there was a significant positive association between improvement in GE and UGI symptoms (P = .02).
CONCLUSIONS
In a meta-analysis of published trials, we found promotility agents to significantly accelerate GE (when optimal test methods were used) and to produce significant improvements in UGI symptoms.
Topics: Breath Tests; Cisapride; Domperidone; Dopamine D2 Receptor Antagonists; Dyspepsia; Gastric Emptying; Gastroparesis; Ghrelin; Humans; Macrocyclic Compounds; Oligopeptides; Radionuclide Imaging; Randomized Controlled Trials as Topic; Serotonin 5-HT4 Receptor Agonists; Symptom Assessment
PubMed: 30711628
DOI: 10.1053/j.gastro.2019.01.249 -
Archives of Pediatrics & Adolescent... Sep 2008To perform a systematic review and meta-analysis to determine whether taking antiemetic drugs reduces vomiting and decreases the need for further intervention in... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To perform a systematic review and meta-analysis to determine whether taking antiemetic drugs reduces vomiting and decreases the need for further intervention in children with gastroenteritis without causing significant adverse effects.
DATA SOURCES
Computerized databases, reference lists, and expert recommendations.
STUDY SELECTION
Prospective controlled trials evaluating medication use in children with vomiting from gastroenteritis.
INTERVENTION
Antiemetic drug therapy.
MAIN OUTCOME MEASURES
Emesis cessation, use of intravenous fluid for rehydration, hospital admission, return to care, and medication adverse effects.
RESULTS
The 11 articles that met the inclusion criteria evaluated various antiemetic agents: ondansetron (n = 6), domperidone (n = 2), trimethobenzamide (n = 2), pyrilamine-pentobarbital (n = 2), metoclopramide (n = 2), dexamethasone (n = 1), and promethazine (n = 1). Meta-analysis of 6 randomized, double-masked, placebo-controlled trials of ondansetron demonstrated decreased risk of further vomiting (5 studies; relative risk [RR], 0.45; 95% confidence interval [CI], 0.33-0.62; number needed to treat [NNT] = 5), reduced need for intravenous fluid (4 studies; RR, 0.41; 95% CI, 0.28-0.62; NNT = 5), and decreased risk of immediate hospital admission (5 studies; RR, 0.52; 95% CI, 0.27-0.95; NNT = 14). Diarrheal episodes increased in ondansetron-treated patients in 3 studies. Ondansetron use did not significantly affect return to care (5 studies; RR, 1.34; 95% CI, 0.77-2.35).
CONCLUSIONS
Ondansetron therapy decreases the risk of persistent vomiting, the use of intravenous fluid, and hospital admissions in children with vomiting due to gastroenteritis. Future treatment guidelines should incorporate ondansetron therapy for select children with gastroenteritis.
Topics: Acute Disease; Antiemetics; Child; Gastroenteritis; Humans; Vomiting
PubMed: 18762604
DOI: 10.1001/archpedi.162.9.858 -
Revista Medica de Chile Jan 2015Domperidone is widely prescribed in patients with gastrointestinal disorders but some cardiac adverse effects have been recently reported. (Review)
Review
BACKGROUND
Domperidone is widely prescribed in patients with gastrointestinal disorders but some cardiac adverse effects have been recently reported.
AIM
To evaluate the risk of QT prolongation, ventricular arrhythmias and sudden cardiac death associated with the use of oral domperidone in adults without cancer.
MATERIAL AND METHODS
Systematic searches in MEDLINE, LILACS, SciELO, the Cochrane Library and regulatory agencies websites were performed, followed by a manual search of cited references. The search strategy consisted of combining free and indexed text words without any date or language restriction.
RESULTS
Three case-control studies met the inclusion criteria; none of them evaluated QT interval prolongation. With low risk of bias, each study quantified the risk of ventricular arrhythmia or sudden cardiac death (VA/SCD). The odds ratios for these events in these studies were 4.7 (95% confidence interval (CI): 1.4-16), 1.59 (95% CI: 1.28-1.98) and 11.02 (95% CI: 2.02-62.3) respectively. A significantly increased risk was observed in patients older than 60 years of age or receiving doses > 30 mg/day.
CONCLUSIONS
Heterogeneity between selected studies did not allow the computation of a summary measure. However, evidence was found that an increased risk of VA/SCD is associated with the use of oral domperidone in adults.
Topics: Adult; Antiemetics; Arrhythmias, Cardiac; Death, Sudden, Cardiac; Domperidone; Female; Gastroesophageal Reflux; Humans; Male; Middle Aged; Nausea; Odds Ratio; Risk Factors; Vomiting
PubMed: 25860264
DOI: 10.4067/S0034-98872015000100002 -
Obstetrics and Gynecology International 2012Background. There is a controversy within the medical community regarding the role of domperidone as a galactagogue and the drug has been removed from the US market...
Background. There is a controversy within the medical community regarding the role of domperidone as a galactagogue and the drug has been removed from the US market owing to safety concerns. Objective. To perform a systematic review and meta-analysis of the available data assessing the effect of domperidone on breast milk production in women experiencing insufficient lactation. Study Selection. Randomized controlled trials (RCTs) examining the effect of domperidone on breast milk production of puerperal women were eligible for inclusion. Data Analysis. Absolute and relative changes from baseline were calculated for individual studies and pooled using a random effects model. Results. Three RCTs including 78 participants met the inclusion criteria. All showed a statistically significant increase in breast milk production following treatment with domperidone. The analysis of pooled data demonstrated a statistically significant relative increase of 74.72% (95% CI = 54.57; 94.86, P < 0.00001) in daily milk production with domperidone treatment compared to placebo. No maternal or neonatal adverse events were observed in any of the trials. Conclusions. Evidence from a few small RCTs of moderate to high quality suggests that domperidone produces a greater increase in breast milk supply than placebo.
PubMed: 22461793
DOI: 10.1155/2012/642893 -
The Cochrane Database of Systematic... Oct 2018Dyspepsia is a common condition associated with gastrointestinal (GI) disease. Prokinetics are the treatment of choice for functional dyspepsia (FD). However, the role... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Dyspepsia is a common condition associated with gastrointestinal (GI) disease. Prokinetics are the treatment of choice for functional dyspepsia (FD). However, the role of prokinetics in FD treatment is still controversial.
OBJECTIVES
We conducted a systematic review and meta-analysis of randomised control trials (RCTs) examining the efficacy of prokinetics in the treatment of FD. The primary outcome was overall absence of or improvement of symptoms and symptom scores at the end of treatment. We also evaluated quality of life (QoL) and adverse events as secondary outcomes.
SEARCH METHODS
We performed a systematic search of MEDLINE, Embase, the Cochrane Library, and CINAHL, from 1946 until September 2017. RevMan 5.3 was used to calculate pooled risk ratios (RR) of symptoms persisting or without improved QoL or adverse events, mean difference (MD) or standardised mean difference (SMD) of post-treatment symptoms scores, changes of symptom scores, and QoL, when appropriate with 95% confidence intervals (CI), using a random-effects model. Quality of evidence was evaluated using GRADE methodology.
SELECTION CRITERIA
We included studies that were parallel group RCTs comparing one prokinetic with either placebo or another prokinetic of the same or different class for the treatment of FD. Studies involved adults who presented with dyspepsia symptoms and who had negative or insignificant findings on endoscopy as well as no other organic and metabolic disorders. Studies only including participants with primarily reflux or heartburn symptoms were excluded.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed study eligibility, study quality and performed data extraction.
MAIN RESULTS
From an initial 1388 citations, we identified 43 studies in 40 papers. Of those, 29 studies with 10,044 participants compared six prokinetics with placebo for the outcome of absence of symptoms or symptom improvement. There was a statistically significant effect of prokinetic treatment in reducing global symptoms of FD (RR of remaining dyspeptic = 0.81, 95% CI 0.74 to 0.89; number needed to treat for an additional beneficial outcome (NNTB) =7, very low-quality evidence) with considerable heterogeneity; I = 91% (P < 0.00001). After removing cisapride from the analysis, the effect of prokinetics in global symptom improvement still persisted, compared to placebo (RR 0.87, 95% CI 0.80 to 0.94), but was still based on very low-quality evidence. The result showed persistence of significant improvement in subgroups of studies at unclear or at low risk of bias (RR 0.86, 95% CI 0.80-0.92), and in subgroups by molecules of cisapride (RR 0.71, 95% CI 0.54 to 0.93; NNTB = 4), acotiamide (RR 0.94, 95% CI 0.91 to 0.98; NNTB = 20) and tegaserod(RR 0.89, 95% CI 0.82 to 0.96; NNTB = 14).Ten studies compared different types of prokinetics with each other and the most commonly used comparator was domperidone, 10 mg three times a day (eight of the 10 studies). There was a significantly better post-treatment symptom score in other prokinetics, compared to domperidone (SMD -0.19, 95% CI -0.35 to -0.03, very low-quality evidence), but no difference in reducing global symptom (RR 0.94, 95% CI 0.83 to 1.07), and mean difference symptom scores (SMD -0.13, 95% CI -0.31 to 0.05). We found five studies that assessed quality of life, but there was no benefit in improving quality of life with prokinetic treatment (SMD 0.11, 95% CI -0.10 to 0.33; participants = 1774). The adverse events in individual prokinetics was not different from placebo (RR 1.09, 95% CI 0.95 to 1.25; participants = 3811; studies = 17). However, when we looked at the adverse effects by each prokinetic, there were overall greater adverse effects in the active treatment group with cisapride (RR 1.31, 95% CI 1.03 to 1.65; P = 0.03). The most common side effects were diarrhoea, abdominal discomfort and nausea. The funnel plot was asymmetric (Egger's test, P = 0.02) implying reporting bias or other small-study effects may be, in part, driving the benefit of prokinetics compared to placebo in this meta-analysis. The GRADE assessment of the quality of the evidence in each outcome are mostly low or very low due to concerns around risk of bias in study design, unexplained heterogeneity and possible publication bias.
AUTHORS' CONCLUSIONS
Due to low, or very low, quality of evidence, we are unable to say whether prokinetics are effective for the treatment of functional dyspepsia . We are uncertain which of the individual prokinetic drugs is the most effective as well as whether prokinetics can improve quality of life. Apart from cisapride, prokinetics are well-tolerated. Good quality RCTs are needed to verify the efficacy of prokinetics.
Topics: Benzamides; Benzyl Compounds; Cisapride; Domperidone; Dyspepsia; Erythromycin; Gastrointestinal Agents; Humans; Indoles; Morpholines; Numbers Needed To Treat; Quality of Life; Randomized Controlled Trials as Topic; Thiazoles
PubMed: 30335201
DOI: 10.1002/14651858.CD009431.pub3 -
British Journal of Clinical Pharmacology Jun 2005To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux... (Review)
Review
Should domperidone be used for the treatment of gastro-oesophageal reflux in children? Systematic review of randomized controlled trials in children aged 1 month to 11 years old.
AIM
To determine whether there is robust evidence of efficacy for domperidone in reducing the symptoms of gastro-oesophageal reflux (GOR) and gastro-oesophageal reflux disease (GORD) in children.
METHODS
Systematic review of randomized controlled trials (RCTs). A search was made of the Cochrane Library Issue 2004 (Central Register of Controlled Trials and Database of Systematic Reviews), Medline (Pub-med) 1966 to present and Embase from 1974 to 2004, and reference citations of the RCTs that had been found electronically.
RESULTS
Four RCTs were identified. Only the two older trials showed any benefits of domperidone on clinical symptoms of GORD in older children, which were the primary outcome measures. In the trial undertaken by Clara, a good or excellent result was obtained in 93% of the domperidone group compared with 33% of the controls (P < 0.05). In the trial undertaken by de Loore, after 2 weeks of treatment 75% of patients treated with domperidone were found not to be vomiting, compared with 43% in the metoclopramide group and 7% in the placebo group. The trial by Corraccio gave no detailed results regarding the primary outcomes of effect of domperidone on symptoms but simply reported 'cured', 'improved' or 'unchanged'. The secondary pH-metric outcome of the number of reflux episodes, was reduced with domperidone.
CONCLUSION
From the limited evidence available, there was no robust evidence of efficacy for the treatment of GOR with domperidone in young children. Given the usually benign nature of the condition, the widespread use of unlicensed medicines for GOR is not warranted.
Topics: Antiemetics; Child; Child, Preschool; Domperidone; Dopamine Antagonists; Evidence-Based Medicine; Gastroesophageal Reflux; Humans; Infant; Randomized Controlled Trials as Topic; Research Design; Treatment Outcome
PubMed: 15948939
DOI: 10.1111/j.1365-2125.2005.02422.x -
Journal of Human Lactation : Official... Aug 2019Insufficient milk production is among the most cited reasons by mothers for discontinuing breastfeeding. Medications that can increase milk production, such as... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Insufficient milk production is among the most cited reasons by mothers for discontinuing breastfeeding. Medications that can increase milk production, such as domperidone, an off-label galactagogue, are often prescribed. Domperidone is controversial as it is not approved for any purpose in the United States and is approved only for gastrokinetic purposes in Canada and other countries.
RESEARCH AIM
The aim was to update the existing literature on the efficacy of domperidone as a galactagogue compared to placebo when given to mothers with insufficient human milk production. The primary outcome is the change in expressed human milk volume per day from baseline.
METHODS
The authors independently searched the literature from inception to May 2018. The search included any randomized controlled trials examining the efficacy of domperidone increasing mothers' expressed human milk, measured via a human milk pump. Both authors independently assessed quality and risk of bias and extracted relevant data. Meta-analysis on expressed human milk volume per day was performed.
RESULTS
Seven studies met the inclusion criteria for review; two were excluded from the meta-analysis due to quality grading and insufficient reporting of the outcome of interest. Five studies ( = 239) were combined in the meta-analysis. The effect size showed an increase in the mean difference of expressed human milk volume in mothers given domperidone, 93.97 mL per day (95% CI [71.12, 116.83 mL]; random effect, 0.00, 0%).
CONCLUSION
This meta-analysis reports a significant improvement in expressed human milk volume per day with the use of domperidone in mothers experiencing insufficient human milk production.
Topics: Breast Feeding; Domperidone; Dopamine Antagonists; Female; Humans; Milk, Human; Postnatal Care; Randomized Controlled Trials as Topic
PubMed: 30481478
DOI: 10.1177/0890334418812069 -
Preventive Veterinary Medicine Nov 2014The objective of this study was to systematically review the efficacy of topically applied insecticide treatments of dogs (impregnated collars, spot-ons), and... (Review)
Review
A systematic review of the efficacy of prophylactic control measures for naturally occurring canine leishmaniosis. Part II: topically applied insecticide treatments and prophylactic medications.
The objective of this study was to systematically review the efficacy of topically applied insecticide treatments of dogs (impregnated collars, spot-ons), and prophylactic medications to prevent natural Leishmania infantum (L. infantum) infection in dogs. Randomised controlled trials (RCT), non-randomised clinical trials, cohort studies and case-control studies that investigated preventive efficacy for natural L. infantum infection in dogs were eligible for inclusion. Two review authors independently assessed each study against the inclusion criteria, independently extracted relevant data from all included studies and assessed the risk of methodological shortcomings in each individual study. The odds ratio (OR) and absolute risk reduction (ARR) for dichotomous outcomes and mean difference for continuous outcomes were calculated. Meta-analysis was not performed due to heterogeneity of the studies identified. The search yielded 937 articles, from which 84 full text articles were selected for second stage screening. Eleven eligible studies were included; four on collars (two RCTs), three on spot-ons (two RCTs - one looking at two different dosing regimens), three on prophylactic medications (all RCTs) and one on both collars and spot-ons summarised in this paper. All of the studies were considered to be at a high risk of methodological shortcomings, with the exception of one spot-on study which was considered to be at an unclear risk of methodological shortcomings. Deltamethrin collars, 65% permethrin, 10% imidacloprid with 50% permethrin spot-ons and domperidone prophylactic medication tended to significantly reduce the proportion of dogs infected with L. infantum based on either parasitological or serological evidence.
Topics: Animals; Antiprotozoal Agents; Dog Diseases; Dogs; Insecticides; Leishmaniasis
PubMed: 25062787
DOI: 10.1016/j.prevetmed.2014.06.016