-
Maedica Jun 2015Galactorrhoea has varied causes including physiological as in pregnancy, lactation, stress, or it can be pathological or drug induced. Its evaluation comprises of a...
Galactorrhoea has varied causes including physiological as in pregnancy, lactation, stress, or it can be pathological or drug induced. Its evaluation comprises of a thorough history, physical examination, laboratory tests and imaging studies. We report herewith two interesting cases of galactorrhoea. The first case was a rare adverse effect of a commonly used drug (domperidone and rabeprazole) and the second case was of mild hypothyroidism leading to galactorrhoea. Prolactin levels were normal in both the cases, emphasizing that not every case of galactorrhoea is associated with high serum levels of prolactin. Secondly, galactorrhoea may be present in patients who are clinically euthyroid, in such cases dynamic tests of thyroid function can identify the cause of galactorrhoea.
PubMed: 28275406
DOI: No ID Found -
Journal of Personalized Medicine Aug 2021One nutritional challenge in critically ill patients is enteral feeding intolerance (EFI), but current prokinetic agents have uncertain efficacy and safety profiles. We...
One nutritional challenge in critically ill patients is enteral feeding intolerance (EFI), but current prokinetic agents have uncertain efficacy and safety profiles. We conducted a longitudinal, single-center, retrospective study to evaluate the efficacy and safety of domperidone administered via the feeding tube versus intravenous (IV) metoclopramide among adult patients with EFI. The primary outcome was feeding success, defined as the proportion of patients with average percentage of daily protein prescription >80% of the target dose. The secondary outcomes were safety endpoints. Among 28,814 intensive care unit (ICU) admissions, 552 patients with EFI were included, 38 receiving IV metoclopramide and 514 receiving tube feeding domperidone. The proportion of feeding success in patients receiving tube feeding domperidone and IV metoclopramide was 42.02% and 21.05%, respectively. After 1:2 matching (IV metoclopramide to tube feeding domperidone), the proportion of feeding success was 40.79% in patients receiving tube feeding domperidone. Basically, after matching, there were no differences in any safety endpoints (mortality and length of stay during ICU and hospitalization, organ-support-treatment free days) or adverse events (recurrence of EFI, electrolyte disturbance, abdominal and other symptoms) between the two groups ( > 0.05). A logistic regression analysis in the matched cohort indicated that domperidone administered via the feeding tube was independently associated with feeding success. We found that tube feeding domperidone was efficient in increasing enteral nutrition delivery performance among critically ill adult patients with EFI.
PubMed: 34575623
DOI: 10.3390/jpm11090846 -
PloS One 2021Galactagogues are substances thought to increase breast milk production, however evidence to support their efficacy and safety remain limited. We undertook a survey...
BACKGROUND
Galactagogues are substances thought to increase breast milk production, however evidence to support their efficacy and safety remain limited. We undertook a survey among Australian women to examine patterns of use of galactagogues and perceptions regarding their safety and effectiveness.
METHODS
An online, cross-sectional survey was distributed between September and December 2019 via national breastfeeding and preterm birth support organisations, and networks of several research institutions in Australia. Women were eligible to participate if they lived in Australia and were currently/previously breastfeeding. The survey included questions about galactagogue use (including duration and timing), side effects and perceived effectiveness (on a scale of 1 [Not at all effective] to 5 [Extremely effective]).
RESULTS
Among 1876 respondents, 1120 (60%) reported using one or more galactagogues. Women were 31.5 ± 4.8 years (mean ± standard deviation) at their most recent birth. Sixty-five percent of women were currently breastfeeding at the time of the survey. The most commonly reported galactagogues included lactation cookies (47%), brewer's yeast (32%), fenugreek (22%) and domperidone (19%). The mean duration of use for each galactagogue ranged from 2 to 20 weeks. Approximately 1 in 6 women reported commencing galactagogues within the first week postpartum. Most women reported receiving recommendations to use herbal/dietary galactagogues from the internet (38%) or friends (25%), whereas pharmaceutical galactagogues were most commonly prescribed by General Practitioners (72%). The perceived effectiveness varied greatly across galactagogues. Perceived effectiveness was highest for domperidone (mean rating of 3.3 compared with 2.0 to 3.0 among other galactagogues). Over 23% of domperidone users reported experiencing multiple side effects, compared to an average of 3% of women taking herbal galactagogues.
CONCLUSIONS
This survey demonstrates that galactagogues use is common in Australia. Further research is needed to generate robust evidence about galactagogues' efficacy and safety to support evidence-based strategies and improve breastfeeding outcomes.
Topics: Adult; Australia; Breast Feeding; Female; Galactogogues; Humans; Infant, Newborn; Lactation; Milk, Human; Mothers; Pregnancy; Premature Birth; Young Adult
PubMed: 34197558
DOI: 10.1371/journal.pone.0254049 -
European Journal of Pharmacology Jun 2021It is unclear whether metoclopramide and domperidone act on human cardiac serotonin 5-HT-receptors. Therefore, we studied transgenic mice that only express the human...
It is unclear whether metoclopramide and domperidone act on human cardiac serotonin 5-HT-receptors. Therefore, we studied transgenic mice that only express the human 5-HT receptor in cardiomyocytes in the atrium and in the ventricle (5-HT-TG), their wild type-littermates (WT) and isolated human atrial preparations. We found that only metoclopramide but not domperidone enhanced the force of contraction in left atrial preparations (pEC = 6.0 ± 0.1; n = 7) from 5-HT-TG, isolated spontaneously beating right atrial preparations (pEC = 6.1 ± 0.1; n = 7) from 5-HT-TG, Langendorff perfused hearts from 5-HT-TG, living 5-HT-TG and human right atrial muscle preparations obtained during bypass surgery of patients suffering from coronary heart disease. The maximum inotropic effect of metoclopramide was smaller (81 ± 2%) than that of 5-HT on the left atria from 5-HT-TG. The maximum increase in the beating rate due to metoclopramide was 93 ± 2% of effect of 5-HT on right atrial preparations from 5-HT-TG. Metoclopramide and domperidone were inactive in WT. We found that metoclopramide but not domperidone increased the phosphorylation state of phospholamban in the isolated perfused hearts or muscle strips of 5-HT-TG, but not in WT. Metoclopramide, but not domperidone, shifted the positive inotropic or chronotropic effects of 5-HT in isolated left atrial and right atrial preparations from 5-HT-TG dextrally, resp., to higher concentrations: the pEC of 5-HT for increase in force was in the absence of metoclopramide 8.6 ± 0.1 (n = 5) versus 8.0 ± 0.3 in the presence of 1 μM metoclopramide (n = 5; P < 0.05); and the beating rate was 7.8 ± 0.2 (n = 7) in the absence of metoclopramide versus 7.2 ± 0.1 in the presence of 1 μM metoclopramide (n = 6; P < 0.05). These results suggested that metoclopramide had an antagonistic effect on human cardiac 5-HT receptors. In summary, we showed that metoclopramide, but not domperidone, was a partial agonist at human cardiac 5-HT-receptors.
Topics: Aged; Animals; Calcium-Binding Proteins; Cardiovascular Agents; Domperidone; Dopamine Antagonists; Heart; Humans; In Vitro Techniques; Male; Metoclopramide; Mice, Transgenic; Middle Aged; Myocardial Contraction; Myocytes, Cardiac; Phosphorylation; Receptors, Serotonin, 5-HT4; Serotonin 5-HT4 Receptor Agonists; Serotonin 5-HT4 Receptor Antagonists
PubMed: 33811834
DOI: 10.1016/j.ejphar.2021.174074 -
Evidence-based Complementary and... 2020Acupuncture has been found to be an effective treatment for functional dyspepsia (FD). Currently, several types of acupuncture have been developed but it is not clear... (Review)
Review
BACKGROUND
Acupuncture has been found to be an effective treatment for functional dyspepsia (FD). Currently, several types of acupuncture have been developed but it is not clear which type is suitable for FD. Currently, doctors often rely on experience to decide which form of acupuncture to apply. Herein, we employed network meta-analysis (NMA) to compare the effectiveness of various methods of acupuncture in the treatment of functional dyspepsia.
METHODS
We searched for randomized controlled trials (RCTs) of acupuncture treatments for functional dyspepsia in seven databases; PubMed, the Cochrane Library, Embase, Wanfang database, China National Knowledge Infrastructure (CNKI) database, Chinese Science and Technique Journals (CQVIP), and Chinese Biomedical Database (CBM) from the date of database inception to October 10, 2019. Cochrane risk of bias tool was used to analyze the risk of bias of the included RCTs. Pairwise meta-analyses were performed with RevMan 5.3 and the network meta-analysis of the included RCTs was performed using the frequentist framework.
RESULTS
A total of 35 studies involving 3301 patients and 10 interventions were eligible for this study. NMA results showed that five types of acupuncture (manual acupuncture, acupoint application, moxibustion, acupoint catgut embedding, and warm acupuncture alone) all were superior to prokinetics (itopride, mosapride, and domperidone) and sham acupuncture in terms of improving the symptoms of functional dyspepsia. Specifically, manual acupuncture and electroacupuncture were more effective in improving the MOS 36 Item Short-Form Health Survey (SF-36) compared to itopride and sham acupuncture, and electroacupuncture was the best among the three acupuncture therapies (acupuncture, electroacupuncture, and acupoint catgut embedding). Moxibustion and manual acupuncture were more effective in improving Nepean Dyspepsia Life Quality Index (NDLQI) compared to itopride, domperidone, and sham acupuncture; moxibustion ranks first among the three acupuncture therapies (acupuncture, electroacupuncture, moxibustion).
CONCLUSIONS
These results showed that manual acupuncture alone was the most effective therapy for FD. It should, therefore, be considered as an alternative treatment for FD patients who are unresponsive to prokinetics or intolerant to the adverse effects of prokinetics. We recommend further multiple centers and high-quality RCT studies to confirm the present findings.
PubMed: 32256643
DOI: 10.1155/2020/3872919 -
The Canadian Journal of Hospital... Nov 2014Domperidone, an effective prokinetic agent, is commonly used to manage symptoms of gastroparesis. Health regulatory agencies have issued warnings about an increased risk... (Review)
Review
BACKGROUND
Domperidone, an effective prokinetic agent, is commonly used to manage symptoms of gastroparesis. Health regulatory agencies have issued warnings about an increased risk of sudden cardiac death associated with use of this drug.
OBJECTIVE
To evaluate the evidence for domperidone-associated sudden cardiac death and to determine whether this drug can be safely used for gastroparesis in patients undergoing dialysis.
DATA SOURCES
Two databases (MEDLINE [1965 to September 2014] and Embase [1980 to September 2014]) were searched using the Medical Subject Headings "domperidone", "sudden cardiac death", and "cardiac arrhythmia". The search was limited to studies conducted in humans and published in English. Advisories from health regulatory agencies (Health Canada, the European Medicines Agency, and the US Food and Drug Administration) were identified and reviewed.
STUDY SELECTION
Studies eligible for inclusion in this narrative review were randomized controlled trials and cohort, case-control, cross-sectional, and other epidemiological studies comparing use and non-use of domperidone for the outcome of sudden cardiac death in adults. Abstracts of eligible case reports and case series were also included.
DATA SYNTHESIS
Despite inconsistencies in their decisions, the various drug regulatory authorities have acknowledged the potential safety concern of increased risk of sudden cardiac death associated with domperidone. To date, no randomized controlled studies have shown an increased risk of this outcome secondary to domperidone use. Current regulatory recommendations and approval decisions are based on 2 large observational epidemiological studies that generated a signal of increased risk. The strengths and limitations of these studies were evaluated in detail. No direct evidence applicable to patients with end-stage renal disease was found. In vitro evidence suggests that the risk of sudden cardiac death is dose-related.
CONCLUSIONS
Given gaps in the literature, use of domperidone for patients undergoing dialysis should be assessed on a case-by-case basis. Extreme caution should be used for patients taking more than 30 mg/day of this drug.
PubMed: 25548402
DOI: 10.4212/cjhp.v67i6.1407 -
Parasites & Vectors Oct 2021Immunotherapeutic drugs, such as domperidone, have been shown to be promising treatments against canine leishmaniosis (CanL), but limited data are available. The aim of...
BACKGROUND
Immunotherapeutic drugs, such as domperidone, have been shown to be promising treatments against canine leishmaniosis (CanL), but limited data are available. The aim of this pilot study (therapeutic, prospective and non-controlled) was to evaluate the effect of domperidone on serum antibody titers of Leishmania infantum, globulins, gamma globulins, acute-phase proteins (e.g. C-reactive protein [CRP]), big endothelin-1 (big ET-1), serum creatinine (SC) and proteinuria in dogs with leishmaniosis affected by chronic kidney disease (CKD).
METHODS
Dogs were recruited if "exposed" to or "infected" with L. infantum and affected by CKD (IRIS stage 1 [proteinuric] or IRIS stage 2-3a [SC < 3.5 mg/dl; proteinuric or non-proteinuric]). After inclusion, an oral suspension of domperidone was administered, and the dogs were followed up for 180 days, with checks at 30, 60, 90 and 180 days after initial treatment.
RESULTS
Of the 14 recruited dogs, nine showed a statistically significant reduction in SC (χ = 9.1, df = 3, P = 0.028), but not in the urine protein/creatinine ratio (χ = 6.43, df = 3, P = 0.092). All dogs showed a significant reduction in antibody titers for L. infantum (χ = 9.56, df = 2, P = 0.008), globulins (χ = 11.08, df = 3, P = 0.011) and gamma globulins (χ = 12.38, df = 3, P = 0.006) during the study period. There was also a statistically significant reduction in CRP (χ = 16.7, df = 3, P = 0.001), but not in big ET-1 (χ = 2.04, df = 3, P = 0.563).
CONCLUSIONS
This study provides preliminary results on the ability of domperidone to improve SC and reduce anti-L. infantum antibody titers, globulins, gamma globulins and CRP in dogs with leishmaniosis and CKD.
Topics: Acute-Phase Proteins; Animals; Antibodies, Protozoan; Biomarkers; Creatinine; Dog Diseases; Dogs; Domperidone; Female; Inflammation; Leishmania infantum; Leishmaniasis; Male; Pilot Projects; Prospective Studies; Renal Insufficiency, Chronic
PubMed: 34629081
DOI: 10.1186/s13071-021-05030-8 -
Journal of Controlled Release :... Jul 2023The nose-to-brain (N2B) pathway has garnered attention because it transports drugs directly into the brain. Although recent studies have suggested the necessity of...
The nose-to-brain (N2B) pathway has garnered attention because it transports drugs directly into the brain. Although recent studies have suggested the necessity of selective drug administration to the olfactory region for effective N2B drug delivery, the importance of delivering the formulation to the olfactory region and the detailed pathway involved in drug uptake in primates brain remain unclear. Here, we developed a combination system for N2B drug delivery comprising a proprietary mucoadhesive powder formulation and a dedicated nasal device (N2B-system) and evaluated it for nasal drug delivery to the brain in cynomolgus monkeys. This N2B-system demonstrated a much greater formulation distribution ratio in the olfactory region in an in vitro experiment using a 3D-printed nasal cast and in vivo experiment using cynomolgus monkeys, as compared to that in other nasal drug delivery systems that comprise of a proprietary nasal powder device developed for nasal absorption and vaccination and a commercially available liquid spray. Additionally, Texas Red-labeled dextran (TR-DEX, 3 kDa) was administered using the N2B-system to estimate the drug transition pathway from the nasal cavity to the brain. TR-DEX preferentially localized to the olfactory epithelium and reached the olfactory bulb through the cribriform foramina. Moreover, domperidone, a model drug with poor blood-brain barrier permeability, was administered to assess the brain uptake of medicine after olfactory region-selective administration by using the N2B-system. Domperidone accumulation in the brain was evaluated using positron emission tomography with intravenously administered [F]fallypride based on competitive inhibition of the dopamine D2 receptor (D2R). Compared to other systems, the N2B-system significantly increased D2R occupancy and domperidone uptake in the D2R-expressing brain regions. The current study reveals that the olfactory region of the nasal cavity is a suitable target for efficient nasal drug delivery to the brain in cynomolgus monkeys. Thus, the N2B-system, which targets the olfactory region, provides an efficient approach for developing effective technology for nasal drug delivery to the brain in humans.
Topics: Humans; Animals; Administration, Intranasal; Powders; Domperidone; Macaca fascicularis; Brain; Drug Delivery Systems; Pharmaceutical Preparations
PubMed: 37315691
DOI: 10.1016/j.jconrel.2023.06.005 -
PloS One 2022Insufficient milk production is a common problem affecting breastfeeding women, in particular following Cesarean delivery. Wang Nam Yen herbal tea is a promising... (Randomized Controlled Trial)
Randomized Controlled Trial
BACKGROUND
Insufficient milk production is a common problem affecting breastfeeding women, in particular following Cesarean delivery. Wang Nam Yen herbal tea is a promising traditional Thai medicine used by postpartum women to stimulate milk production, as an alternative to pharmaceutical galactagogues. We aimed to compare the efficacy of Wang Nam Yen herbal tea, domperidone, and placebo, in increasing milk production in mothers who underwent Cesarean delivery.
METHODS
Women who underwent uncomplicated cesarean delivery at Sunpasitthiprasong Hospital were randomized into three groups. The participants received the treatments daily for three consecutive days. The primary outcome was breast milk volume at 72 hours after delivery. Secondary outcomes were pregnancy and neonatal outcomes, adverse events, and participant satisfaction.
RESULTS
Of the 1,450 pregnant women that underwent cesarean delivery, 120 women were enrolled. Their mean age and gestational ages were 28.7 years and 38.4 weeks, respectively. Breast milk volume at 72 hours postpartum was significantly different among the three groups (p = 0.030). The post hoc Bonferroni correction indicated a significant difference in breast milk volume between Wang Nam Yen herbal tea group and placebo control group (p = 0.007) while there was no difference between Wang Nam Yen herbal tea group and domperidone group (p = 0.806) and between domperidone group and placebo control group (p = 0.018). There was no difference in pregnancy and neonatal outcomes, adverse events, and participant satisfaction among the three groups.
CONCLUSION
Wang Nam Yen herbal tea was effective in augmenting breast milk production at 72 hours postpartum in mothers following cesarean delivery, and there was no evidence that herbal tea and domperidone differed in terms of augmenting breast milk production.
TRIAL REGISTRATION
The study was approved by the institutional review board of Sunpasitthiprasong Hospital (No.061/2559) and was registered TCTR20170811003 with the Thai Clinical Trial Registry.
Topics: Adolescent; Adult; Cesarean Section; Domperidone; Female; Galactogogues; Humans; Lactation; Milk, Human; Placebo Effect; Postpartum Period; Pregnancy; Teas, Herbal; Treatment Outcome; Young Adult
PubMed: 35100251
DOI: 10.1371/journal.pone.0247637 -
Clinical Drug Investigation Nov 2019Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia... (Observational Study)
Observational Study
BACKGROUND AND OBJECTIVE
Risk-minimization measures (RMM), including label revisions were implemented in Europe for domperidone because of evidence of increased incidence of cardiac arrhythmia and sudden cardiac death. In accordance with the guideline on good pharmacovigilance practices, the European Medicines Agency Pharmacovigilance Risk Assessment Committee requested to conduct two studies to evaluate the effectiveness of these risk minimization measures.
METHODS
In Belgium, France, Germany, Spain, and the UK, surveys were conducted to assess physicians' knowledge on the updated domperidone labeling information, and a drug-utilization study (DUS) was conducted using healthcare databases to assess domperidone prescribing patterns before and after the RMM. Four DUS sensitivity analyses (scenarios) evaluated uncertainty regarding domperidone treatment duration and indication.
RESULTS
Among 1805 physicians participating in the survey, most were aware of the approved indication (nausea and vomiting, 80%), treatment duration (≤ 7 days, 70%), and maximum adult daily dose (10 mg three times daily, 84%). Only 33% selected the on-label indication from a list of indications for which they would prescribe domperidone. Awareness was low for medications contraindicated for concomitant use (26%) and contraindicated conditions (4%). In the DUS, under the optimistic scenario, a large improvement in labeling compliance from pre- to post-implementation period was observed in France (27% vs. 69%), while Belgium, Germany, Spain, and the UK showed small improvements (< 10%). In the other scenarios, there was little to no improvement in compliance with the revised labeling from the pre- to post-implementation periods in most countries.
CONCLUSIONS
The survey findings documented that most physicians in all five countries were aware of the main aspects of the revised labeling. Results of the DUS were inconclusive regarding the effect of the RMM and compliance with the revised labeling for all countries except France.
Topics: Adult; Antiemetics; Arrhythmias, Cardiac; Cardiac Conduction System Disease; Cross-Sectional Studies; Death, Sudden, Cardiac; Domperidone; Drug Labeling; Drug Utilization; Europe; Female; Humans; Male; Middle Aged; Nausea; Physicians; Retrospective Studies; Risk Assessment; Surveys and Questionnaires; Vomiting
PubMed: 31325111
DOI: 10.1007/s40261-019-00831-3