RESUMO
OBJECTIVE: To investigate whether simethicone expediates the remission of abdominal distension after laparoscopic cholecystectomy (LC). METHODS: This retrospective study involved LC patients who either received perioperative simethicone treatment or not. Propensity score matching (PSM) was employed to minimize bias. The primary endpoint was the remission rate of abdominal distension within 24 h after LC. Univariable and multivariable logistic regression analyses were conducted to identify independent risk factors affecting the early remission of abdominal distension after LC. Subsequently, a prediction model was established and validated. RESULTS: A total of 1,286 patients were divided into simethicone (n = 811) and non-simethicone groups (n = 475) as 2:1 PSM. The patients receiving simethicone had better remission rates of abdominal distension at both 24 h and 48 h after LC (49.2% vs. 34.7%, 83.9% vs. 74.8%, respectively), along with shorter time to the first flatus (14.6 ± 11.1 h vs. 17.2 ± 9.1 h, P < 0.001) compared to those without. Multiple logistic regression identified gallstone (OR = 0.33, P = 0.001), cholecystic polyp (OR = 0.53, P = 0.050), preoperative abdominal distention (OR = 0.63, P = 0.002) and simethicone use (OR = 1.89, P < 0.001) as independent factors contributing to the early remission of abdominal distension following LC. The prognosis model developed for predicting remission rates of abdominal distension within 24 h after LC yielded an area under the curve of 0.643 and internal validation a value of 0.644. CONCLUSIONS: Simethicone administration significantly enhanced the early remission of post-LC abdominal distension, particularly for patients who had gallstones, cholecystic polyp, prolonged anesthesia or preoperative abdominal distention. TRIAL REGISTRATION: ChiCTR2200064964 (24/10/2022).
Assuntos
Colecistectomia Laparoscópica , Complicações Pós-Operatórias , Pontuação de Propensão , Simeticone , Humanos , Estudos Retrospectivos , Feminino , Masculino , Pessoa de Meia-Idade , Simeticone/uso terapêutico , Simeticone/administração & dosagem , Complicações Pós-Operatórias/prevenção & controle , Adulto , Resultado do Tratamento , Idoso , Abdome/cirurgiaRESUMO
INTRODUCTION: The purpose of this study was to assess whether simethicone reduces the rectal volume (RV) and gas volume (GV), to increase treatment accuracy and to decrease toxicity of prostate radiation therapy. METHODS: 30 patients were randomised to simethicone or no intervention. Cone-beam computed tomography (CBCT) scans were performed on Days 1-3 and weekly until completion of radiation. RV and GV were measured using volume delineation. Toxicity data were collected. RESULTS: 264 CBCTs were analysed. RV and GV were not significantly different in the simethicone group compared with the control group at each time point (P >0.05) after adjusting for Week 0 values as a covariate. The simethicone group showed an average reduction in RV and GV of 10% and 21%, respectively, compared with the control group (P >0.05). Standard deviations were calculated over 10 time points, which were grouped to represent the first 2-3 weeks of radiation therapy versus subsequent weeks. These were not significantly different between the simethicone and control group. However, there was a statistically significant decrease in the variability of RV at time points 6-10 compared with time points 1-5 within the simethicone group (P = 0.012), but no significant difference was found between these grouped time points in the control group (P = 0.581). The toxicity questionnaires showed no significant difference between the groups. CONCLUSIONS: Simethicone did not decrease the RV or GV overall. However, simethicone appeared to significantly decrease the RV variability from Week three onwards. This suggests that taking simethicone two to three weeks before starting radiation therapy may reduce RV variability, although a larger study is needed to confirm this.
Assuntos
Neoplasias da Próstata , Radioterapia Guiada por Imagem , Tomografia Computadorizada de Feixe Cônico , Humanos , Masculino , Neoplasias da Próstata/diagnóstico por imagem , Neoplasias da Próstata/radioterapia , Radioterapia Guiada por Imagem/métodos , Reto/diagnóstico por imagem , Simeticone/uso terapêuticoRESUMO
BACKGROUND: Exercise-induced gastrointestinal (GI) symptoms are frequently reported by athletes during training and competitions. A standardized combination of artichoke leaves and ginger root extracts has shown beneficial effects in managing GI discomfort in otherwise healthy subjects. METHODS: In this pilot study, we assessed the effectiveness of artichoke leaves and ginger root extracts combination associated with simethicone in reducing exercise-related GI symptoms in endurance athletes. The effects of the combination on upper/lower GI and systemic symptoms were assessed at baseline and after 4 weeks through a questionnaire. RESULTS: Fifty endurance athletes took the extracts' combination 320 mg + simethicone 40 mg chewable pills. The extracts combination and simethicone were effective in reducing the mean intensity of upper GI (86.6%) lower GI (85.9%) and systemic symptoms (81.9%), with superior results compared to placebo. The most remarkable effects were reported in the lower GI tract, with a significant decrease in flatulence, intestinal cramps, loose stools and diarrhea. Athletes also benefited from a reduction in belching and bloating and in dizziness, headache and muscle cramps, although the decrease in systemic symptoms was not significant. CONCLUSIONS: The supplementation of standardized artichoke and ginger extracts, combined with simethicone, may be effective in decreasing digestive discomfort and alteration of gastric motility not only in healthy subjects but also in endurance athletes.
Assuntos
Cynara scolymus , Zingiber officinale , Atletas , Humanos , Projetos Piloto , Extratos Vegetais/uso terapêutico , Simeticone/uso terapêuticoRESUMO
BACKGROUND AND AIMS: water is an imperfect agent for lens cleansing during endoscopy due to its incompetence to clean hydrophobic dirt, whereas amphiphilic surfactants have the potential to overcome the limitation of water. The trial was aimed to evaluate the cleansing effectiveness of 2 typical surfactants (simethicone solution and oolong tea) for colonoscopic lens. METHODS: Oolong tea (O-), low concentration simethicone solution (S1-), high concentration simethicone solution (S2-) and distilled water (D-) were used as washing solutions for colonoscopic lens. Study I: The tip of the colonoscope was immersed in lard oil in order to simulate the blur, and photographs were taken toward a standard colonoscopy image in-vitro pre- and post- each cleansing procedure. The blurred areas of each image were quantified and compared. Study II: 395 consecutive patients who were due to colonoscopy examination were enrolled and randomized into O-, S2-, D-group. The volume of washing solution used and cleansing level during the examination procedure, adenoma and polyp detected per colonoscopy, insertion time and withdraw time were analyzed. RESULTS: Study I: There were no differences in 4 groups for the blurred areas on images before lens cleansing. The blurred areas after lens cleansing were significantly smaller in 3 groups (O- 8.47â±â20.91 vs S1- 13.06â±â10.71 vs S2- 6.76â±â8.49 vs D- 38.24â±â29.69, Pâ<â.05) than water. The decline range of blurred areas after lens cleansing in oolong tea, low concentration simethicone solution, high concentration simethicone solution groups were significantly higher than that in distilled water group (O- 87.35â±â20.81 vs S1- 78.12â±â19.24 vs S2- 89.57â±â8.50 vs D- 53.39â±â28.45, Pâ<â.05). Study II: The volume of washing solution used in S2-group was significantly smaller than that in O-group and D-group. The cleansing level of the colonoscopic lens of O-group was significantly superior than that of S2-group and D-group. CONCLUSIONS: The in-vitro test showed oolong tea and simethicone solution can effectively cleans the colonoscopic lens. The clinical trial demonstrated that oolong tea instead of water is effective to provide better visualization during colonoscopy.Registration: Chictr.org.cn No: ChiCTR1900025606.
Assuntos
Colonoscopia/instrumentação , Manutenção/normas , Simeticone/uso terapêutico , Chá , Colonoscopia/métodos , Método Duplo-Cego , Reutilização de Equipamento/normas , Humanos , Manutenção/métodos , Manutenção/estatística & dados numéricos , Simeticone/farmacologia , Água/administração & dosagemRESUMO
OBJECTIVE: To conduct a systematic review of systematic reviews and national guidelines to assess the effectiveness of four treatment approaches (manual therapy, probiotics, proton pump inhibitors and simethicone) on colic symptoms including infant crying time, sleep distress and adverse events. METHODS: We searched PubMed, Embase, Cochrane and Mantis for studies published between 2009 and 2019. Inclusion criteria were systematic reviews and guidelines that used evidence and expert panel opinion. Three reviewers independently selected articles by title, abstract and full paper review. Data were extracted by one reviewer and checked by a second. Selected studies were assessed for quality using modified standardised checklists by two authors. Meta-analysed data for our outcomes of interest were extracted and narrative conclusions were assessed. RESULTS: Thirty-two studies were selected. High-level evidence showed that probiotics were most effective for reducing crying time in breastfed infants (range -25 min to -65 min over 24 hours). Manual therapies had moderate to low-quality evidence showing reduced crying time (range -33 min to -76 min per 24 hours). Simethicone had moderate to low evidence showing no benefit or negative effect. One meta-analysis did not support the use of proton pump inhibitors for reducing crying time and fussing. Three national guidelines unanimously recommended the use of education, parental reassurance, advice and guidance and clinical evaluation of mother and baby. Consensus on other advice and treatments did not exist. CONCLUSIONS: The strongest evidence for the treatment of colic was probiotics for breastfed infants, followed by weaker but favourable evidence for manual therapy indicated by crying time. Both forms of treatment carried a low risk of serious adverse events. The guidance reviewed did not reflect these findings. PROSPERO REGISTRATION NUMBER: CRD42019139074.
Assuntos
Cólica/terapia , Antiespumantes/uso terapêutico , Humanos , Lactente , Manipulações Musculoesqueléticas , Guias de Prática Clínica como Assunto , Probióticos/uso terapêutico , Inibidores da Bomba de Prótons/uso terapêutico , Literatura de Revisão como Assunto , Simeticone/uso terapêutico , Resultado do TratamentoRESUMO
BACKGROUND: Simethicone is an adjunct frequently used during bowel preparation before colonoscopy and currently there is no consensus on whether it should be recommended in standard bowel preparation. We performed a systematic review and meta-analysis to determine the effect simethicone has on bowel cleanliness, adenoma detection rate (ADR), and tolerability. METHODS: We searched the literature for studies that compared colon cleansing of patients that received standard bowel preparation alone and in combination with simethicone prior to colonoscopy. The primary outcomes were colon cleanliness, ADR, and tolerability. RESULTS: Sixteen randomized controlled trials with 5630 patients were included in meta-analysis. Overall, polyethylene glycol (PEG) with simethicone improves colon cleansing compared with PEG alone (odds ratio [OR] 1.48, CI 1.11 to 1.97, P = 0.008). This improvement was seen for single dosing (OR 1.83, CI 1.20 to 2.79, P = 0.005) but not for split dosing (OR 1.32, CI 0.72 to 2.43, P = 0.38). Overall, simethicone had no effect on ADR (OR 1.22, CI 0.81 to 1.83, P = 0.33), but in patients receiving single dosing, simethicone significantly increased ADR (OR 1.96, CI 1.22 to 3.16, P = 0.005). The rates of nausea (OR 0.96, CI 0.75 to 1.24, P = 0.75), vomiting (OR 1.00, CI 0.69 to 1.44, P = 0.99), and abdominal pain (OR 0.69, CI 0.40 to 1.18, P = 0.17) were not significantly different between PEG and PEG + simethicone cohorts. For abdominal bloating, the PEG cohort had greater odds of experiencing bloating than the PEG + simethicone cohort (OR 2.33, CI 1.70 to 3.20, P < 0.00001). CONCLUSIONS: Simethicone improves colon cleanliness and ADR; however, this improvement is not seen in patients receiving split-dose PEG. Furthermore, simethicone decreases abdominal bloating but has no effect on nausea, vomiting, and abdominal pain. Simethicone may be a useful bowel preparation adjunct in patients unable to receive split-dose PEG.
Assuntos
Catárticos/uso terapêutico , Colonoscopia , Simeticone/uso terapêutico , Adenoma/diagnóstico por imagem , Neoplasias do Colo/diagnóstico por imagem , Humanos , Polietilenoglicóis/uso terapêuticoRESUMO
OBJECTIVES: Infantile colic is a common benign disease occurring in early infancy that may have a great impact on family life. In the present study, the effectiveness and safety of the complex homeopathic medicine Enterokind was compared with Simethicone for treating infantile colic. DESIGN AND SETTING: Current data were drawn from a prospective, multicenter, randomized, open-label, controlled clinical trial that was conducted in 2009 in 3 Russian outpatient clinics. Children received either Enterokind (Chamomilla D6, Cina D6, Colocynthis D6, Lac defloratum D6 and Magnesium chloratum D6) or Simethicone. Data from infants ≤ 6 months with infantile colic are presented here. MAIN OUTCOME MEASURES: The main outcomes assessments were the change of total complaints score (maximum 17 points) and total objective symptoms score (maximum 22 points) after 10 days of treatment. RESULTS: Data from 125 infants ≤ 6 months with infantile colic were analyzed. The differences in total complaints and objective symptoms scores between baseline and day 10, estimated from the ANCOVA model, were found to be highly significant (pâ¯<â¯0.0001; ITT) in favor of Enterokind, both for complaints (Δ=-2.38; 95% confidence interval (CI): [-2.87; -1.89]) and for objective symptoms (Δ=-2.07; 95% CI: [-2.65; -1.49]). 1 adverse event (AE), vomiting, occurred under Enterokind and was rated to be unlikely related to it; 4 AEs occurred under Simethicone. All AEs were non-serious. CONCLUSIONS: The current study indicates that Enterokind is an effective and safe homeopathic treatment for functional intestinal colic in infants ≤ 6 months.
Assuntos
Cólica/tratamento farmacológico , Criança , Pré-Escolar , Ensaios Clínicos como Assunto , Homeopatia/métodos , Humanos , Lactente , Recém-Nascido , Estudos Prospectivos , Simeticone/uso terapêuticoRESUMO
BACKGROUND AND AIMS: Combining simethicone (SIM) with a colon preparation agent has been shown to improve mucosal visibility during screening colonoscopy, but its effect on the adenoma detection rate (ADR) remains unclear. SIM is commonly used through the endoscope to eliminate bubbles during endoscopy. However, this practice recently has been associated with endoscope-transmitted infections. Our aims were to determine the role of SIM added to a polyethylene glycol preparation on the ADR, procedure times, colon preparation, and intraprocedural use of SIM. METHODS: This was a randomized, controlled, observer-blinded, clinical trial of patients undergoing screening colonoscopy. Patients with a high risk of colorectal cancer were excluded. Patients were randomly assigned to 2 different preparations: polyethylene glycol plus SIM or polyethylene glycol. Two endoscopists blinded to patient preparation regimens scored its quality by using the Boston Bowel Preparation scale (BBPS) and the bubble scale. Interobserver agreement was calculated. The polyp detection rate, ADR, intraprocedural use of SIM, cecal intubation time, and withdrawal time were recorded. For study purposes, cecal intubation time and withdrawal time were combined to determine the effective procedure time. RESULTS: No significant difference between the polyethylene glycol plus SIM and polyethylene glycol arms was seen regarding the ADR (33.3% vs 38.8%; P = .881) and effective procedure time (759.3 ± 253.1 seconds vs 800.2 ± 459.6 seconds; P = .373), respectively. Intraprocedural use of SIM as well as the bubble scale score were significantly lower in the polyethylene glycol plus SIM arm (1.6% vs 48.9%; P ≤ .05) and (0.1 vs 2.1; P ≤ .05), respectively. Conversely, no difference was found in the BBPS scores. The interobserver agreement for both scores was strong (bubble scale score kappa = .537; P < .05; BBPS score kappa = .184; P <.05). CONCLUSION: Adding SIM to a polyethylene glycol preparation did not improve the ADR or effective procedure time. Nevertheless, it resulted in lower bubble scale scores, and more importantly, in less intraprocedural use of SIM. This simple and inexpensive intervention may have the potential to reduce the risk of endoscope-transmitted infections. (Clinical trial registration number: NCT03119168.).
Assuntos
Adenoma/diagnóstico , Antiespumantes/uso terapêutico , Colonoscopia , Neoplasias Colorretais/diagnóstico , Simeticone/uso terapêutico , Administração Oral , Detecção Precoce de Câncer , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Polietilenoglicóis/uso terapêutico , Indicadores de Qualidade em Assistência à Saúde , Método Simples-CegoRESUMO
PURPOSE: Endoscopic retrograde cholangiopancreaticography (ERCP) is performed for diagnostic and therapeutic purposes in patients with pancreaticobiliary diseases. We investigated the role of simethicone and concomitant otilonium bromide during ERCP. PATIENTS AND METHODS: This prospective randomized study included 120 patients who underwent ERCP (study and control group=60 patients each). The study group received otilonium bromide and simethicone. The control group received no medication. RESULTS: The quantity of duodenal foam and bubbles in the study group was significantly lesser than that in the control group. The duodenal motility score was 2.1±0.7 and 4.3±0.9 in the study and the control groups, respectively. Endoscopist satisfaction was good in 82%, moderate in 15%, and poor in 3% of ERCPs in the study group and good in 15%, moderate in 65%, and poor in 25% of ERCPs in the control group. The study group showed a shorter ERCP duration than the control group. CONCLUSIONS: Simethicone and otilonium bromide administered concomitantly reduce duodenal motility and foam/bubble formation, which facilitates papilla of Vater catheterization to reduce procedure time.
Assuntos
Antiespumantes/uso terapêutico , Colangiopancreatografia Retrógrada Endoscópica/métodos , Motilidade Gastrointestinal/efeitos dos fármacos , Duração da Cirurgia , Compostos de Amônio Quaternário/uso terapêutico , Simeticone/uso terapêutico , Adulto , Idoso , Doenças Biliares/diagnóstico por imagem , Doenças Biliares/cirurgia , Duodeno/efeitos dos fármacos , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Pancreatopatias/diagnóstico por imagem , Pancreatopatias/cirurgia , Cuidados Pré-Operatórios/métodos , Estudos Prospectivos , Melhoria de Qualidade , Resultado do TratamentoRESUMO
BACKGROUND: Postoperative ileus is a poorly understood multifactorial outcome following colorectal surgery that presents significant clinical challenges and contributes to increased morbidity, length of stay, and healthcare cost. To date, there are few pharmacological interventions that shorten the duration of postoperative ileus. OBJECTIVE: This study is the first to evaluate the efficacy of simethicone in treating postoperative ileus symptoms in patients undergoing colorectal surgery. DESIGN: A multicenter, double-blinded, placebo controlled randomized controlled trial. SETTINGS: This trial was conducted at two academic tertiary care centres in Ontario, Canada. PARTICIPANTS: 118 patients undergoing colorectal surgery. INTERVENTIONS: Patients were randomized to receive either a five-day course of oral simethicone (nâ¯=â¯58) or a placebo (nâ¯=â¯60). MAIN OUTCOME MEASURES: The primary outcome was time to first passage of flatus. Secondary outcomes included time to first bowel movement, postoperative length of stay, and postoperative pain. Statistical analyses were performed on an intention-to-treat basis. Statistical significance set at pâ¯=â¯0.05. RESULTS: The median time to first passage of flatus in simethicone arm was 25.2â¯h and 26.7â¯h in controls (Pâ¯=â¯0.98). There were no significant differences in the median time to first bowel movement (simethiconeâ¯=â¯41.1â¯h vs. controlâ¯=â¯42.9â¯h, Pâ¯=â¯0.91) or median length of hospital stay (simethiconeâ¯=â¯4.5 days vs. controlâ¯=â¯4.0 days, Pâ¯=â¯0.63). CONCLUSIONS: This study failed to show a difference in return of gastrointestinal motility in patients receiving simethicone following colorectal surgery. Postoperative ileus remains a significant clinical and economic burden to the healthcare system and further research is needed to identify a reliable and effective method of treatment.
Assuntos
Antiespumantes/uso terapêutico , Procedimentos Cirúrgicos do Sistema Digestório/efeitos adversos , Íleus/tratamento farmacológico , Complicações Pós-Operatórias/tratamento farmacológico , Simeticone/uso terapêutico , Idoso , Canadá , Colo/cirurgia , Defecação/efeitos dos fármacos , Método Duplo-Cego , Feminino , Motilidade Gastrointestinal/efeitos dos fármacos , Humanos , Íleus/etiologia , Tempo de Internação , Masculino , Pessoa de Meia-Idade , Dor Pós-Operatória/etiologia , Complicações Pós-Operatórias/etiologia , Período Pós-Operatório , Reto/cirurgia , Resultado do TratamentoRESUMO
BACKGROUND: Premedication in upper gastrointestinal endoscopy for higher lesions detection rate has not been well studied so far. This study aimed to confirm whether premedication could improve the detection rate of early cancer or precancerous lesions and mucosal visibility. METHOD: From July 2015 to December 2015, 7200 participants from 6 centers were screened by endoscopy with one of the 4 following premedications randomly: (1) water (group D); (2) pronase (group A); (3) simethicone (group B); (4) pronase and simethicone (group C). Early cancer and precancerous lesions detection rates were taken as the primary endpoints, and mucosal visibility was taken as the secondary endpoint. They were compared among four groups to determine different premedication effects in terms of different anatomical sites. Trial was registered at Chinese Clinical Trial Registry; the registration number is ChiCTR-IOR-17010985. RESULTS: The upper gastrointestinal overall precancerous lesion detection rates among four groups were 8.7, 8.4, 10.0, and 10.3%, the overall early cancer detection rates were 1.3, 1.4%, 1.5, and 1.6%, both without significant difference (p = 0.138 and 0.878). However, the visibility score distributions between control group (D) and premedication groups (A, B, and C) were all statistically significant, with all anatomical sites p values < 0.001. Subgroup analyses, from 2 centers without screening before, also showed significant difference in esophageal (3.9, 3.3, 4.5, and 8.4% with p = 0.004) and overall (7.0, 5.5, 7.3, and 12.0% with p = 0.004) precancerous lesion detection rate. CONCLUSIONS: Premedication with pronase and simethicone may not increase lesion detection rates but could significantly increase the upper gastrointestinal mucosal visibility.
Assuntos
Antiespumantes/uso terapêutico , Detecção Precoce de Câncer/métodos , Endoscopia Gastrointestinal , Expectorantes/uso terapêutico , Neoplasias Gastrointestinais/diagnóstico por imagem , Lesões Pré-Cancerosas/diagnóstico por imagem , Pré-Medicação/métodos , Adulto , Idoso , Método Duplo-Cego , Esquema de Medicação , Quimioterapia Combinada , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Mucosa/diagnóstico por imagem , Pronase/uso terapêutico , Simeticone/uso terapêuticoRESUMO
AIM: An increase in intestinal gas production due to small intestinal bowel overgrowth (SIBO) is a contributing factor for flatus incontinence. The aims of our study were to assess the efficacy of metronidazole in a select population of patients with flatus incontinence associated with SIBO and to compare its efficacy with that of a combination of simethicone and activated charcoal (SC; Carbosylane) in randomized experimental arms. METHODS: Adult patients suffering from flatus incontinence associated with SIBO diagnosed by a glucose breath test were enrolled in the study. They were given metronidazole or Carbosylane (SC) for 10 days. The reduction in the mean daily number of gas leakages reported in a 3-day diary before and at the end of the treatment was used as the primary endpoint. RESULTS: Of 52 consecutive subjects with flatus incontinence, 23 (44%) had SIBO, 16 (33%) of whom were included in and completed the study. The relative reduction in flatus incontinence episodes was significantly higher in the metronidazole than in the SC group (66.8±34.8% vs. 25±50%, P = 0.03), decreasing by more than 50% in 7 (87.5%) of the subjects in the metronidazole group compared with only 1 (12.5%) in the SC group (odds ratio 1.9, 95% confidence interval 0.9-56.9, P = 0.06). CONCLUSION: Our results show a promising trend indicating that metronidazole might significantly improve flatus incontinence associated with SIBO and might be more successful in treating flatus incontinence than gas absorbents.
Assuntos
Antibacterianos/uso terapêutico , Infecções Bacterianas/tratamento farmacológico , Incontinência Fecal/tratamento farmacológico , Flatulência/tratamento farmacológico , Metronidazol/uso terapêutico , Adulto , Idoso , Testes Respiratórios , Carvão Vegetal/química , Esquema de Medicação , Incontinência Fecal/microbiologia , Feminino , Flatulência/microbiologia , Gases , Microbioma Gastrointestinal , Glucose/análise , Humanos , Intestino Delgado/microbiologia , Intestino Delgado/fisiopatologia , Masculino , Pessoa de Meia-Idade , Razão de Chances , Projetos Piloto , Estudos Prospectivos , Qualidade de Vida , Simeticone/uso terapêutico , Resultado do TratamentoRESUMO
Infant colic (IC) is a common condition in young babies seen by primary care health professionals, especially health visitors. Nevertheless, the diagnostic criteria for IC are vague, which has resulted in a lack of clarity in published guidance on its causes and treatment. Credence has been given to alternative therapies, while health professionals are sceptical about the efficacy of over-the-counter treatments. Some 4004 parents of babies considered to have IC participated in this retrospective real world evidence study on the efficacy of a simeticone suspension in the treatment of IC. They were recruited via social media sources and were eligible for inclusion if their baby had received at least one dose of the simeticone suspension. Data were collected via an online questionnaire. The results showed that crying and discomfort-associated behaviour reduced and the babies' sleeping patterns improved following use of the suspension. More than two-thirds (69.7%) of respondents, who either used the suspension on its own or alongside another treatment, reported improvements in the signs of IC within one day. Almost all (93.2%) considered that its use was associated with either complete resolution of IC or had some effect on symptoms.
Assuntos
Antiespumantes/uso terapêutico , Cólica/tratamento farmacológico , Choro , Pais , Simeticone/uso terapêutico , Feminino , Humanos , Lactente , Recém-Nascido , Masculino , Enfermeiros de Saúde Comunitária , Estudos Retrospectivos , Sono , Inquéritos e Questionários , Resultado do TratamentoRESUMO
Infantile colic is a self-limiting disorder of excessive infant crying or fussiness that peaks at 6 weeks of age and typically improves by 3 months of age. The etiology of infantile colic has yet to be definitively elucidated, but there is increasing research to support its relationship to migraine. The aims of this review are to present recent research investigating the connection between infantile colic and migraine. The importance of identifying this connection is useful in reducing invasive and potentially harmful investigations and to identify age appropriate pharmacologic interventions that would be safe in this population.
Assuntos
Cólica/tratamento farmacológico , Diciclomina/uso terapêutico , Dietoterapia , Transtornos de Enxaqueca/tratamento farmacológico , Inibidores da Bomba de Prótons/uso terapêutico , Simeticone/uso terapêutico , Cólica/complicações , Cólica/diagnóstico , Humanos , Transtornos de Enxaqueca/complicações , Transtornos de Enxaqueca/diagnósticoRESUMO
BACKGROUND: Acute diarrhoea is a frequent health problem in both travellers and residents that has a social and economic impact. This study compared the efficacy and tolerability of two loperamide-simeticone formulations and a Saccharomyces boulardii capsule as symptomatic treatment. METHODS: This was a prospective, randomised, single (investigator)-blind, three-arm, parallel group, non-inferiority clinical trial in adult subjects with acute diarrhoea at clinics in Mexico and India, with allocation to a loperamide-simeticone 2/125 mg caplet or chewable tablet (maximum eight in 48 h) or S. boulardii (250 mg twice daily for 5 days). OUTCOME MEASURES: The primary outcome measure was the number of unformed stools between 0 and 24 h following the initial dose of study medication (NUS 0-24). The secondary outcome measures were time to last unformed stool (TLUS), time to complete relief of diarrhoea (TCRD), time to complete relief of abdominal discomfort (TCRAD) and the subject's evaluation of treatment effectiveness. Follow-up endpoints at 7 days were feeling of complete wellness; stool passed since final study visit; and continued or recurrent diarrhoea. SUBJECTS: In this study, 415 subjects were randomised to either a loperamide-simeticone caplet (n = 139), loperamide-simeticone chewable tablet (n = 139) or S. boulardii capsule (n = 137) and were included in the intention-to-treat analysis. RESULTS: With regards to mean NUS 0-24, the loperamide-simeticone caplet was non-inferior to loperamide-simeticone tablets (3.4 vs. 3.3; one-sided 97.5 % confidence interval ≤0.5), with both significantly lower than S. boulardii (4.3; p < 0.001). The loperamide-simeticone groups had a shorter median TLUS [14.9 and 14.0 vs. 28.5 h (loperamide-simeticone caplet and chewable tablet groups, respectively, vs. S. boulardii); p < 0.001], TCRD (26.0 and 26.0 vs. 45.8 h; p < 0.001) and TCRAD (12.2 and 12.0 vs. 23.9 h; p < 0.005) than S. boulardii. Treatment effectiveness for overall illness, diarrhoea and abdominal discomfort relief was greater (p < 0.001) in the loperamide-simeticone groups than with S. boulardii. At 7-day follow-up most subjects reported passing stool at least once since the final study visit (loperamide-simeticone caplet 94.1 %, loperamide-simeticone chewable tablet 94.8 %, S. boulardii 97.0 %), did not experience continued or recurrent diarrhoea [loperamide-simeticone caplet 3.7 % (p < 0.03 vs. S. boulardii), loperamide-simeticone chewable tablet 3.7 %, S. boulardii 5.7 %] and felt completely well [loperamide-simeticone caplet 96.3 % (p < 0.02 vs. S. boulardii), loperamide-simeticone chewable tablet 96.3 % (p < 0.02 vs. S. boulardii), S. boulardii 88.6 %]. All treatments were well-tolerated with few adverse events. CONCLUSIONS: The loperamide-simeticone caplet was non-inferior to the original loperamide-simeticone chewable tablet formulation; both formulations can be expected to demonstrate similar clinical efficacy in the relief of symptoms of acute diarrhoea. Both loperamide-simeticone formulations were superior to the S. boulardii capsule in the primary and secondary endpoints. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00807326.
Assuntos
Diarreia/tratamento farmacológico , Combinação de Medicamentos , Loperamida/uso terapêutico , Probióticos/uso terapêutico , Saccharomyces , Simeticone/uso terapêutico , Doença Aguda , Adulto , Idoso , Feminino , Humanos , Loperamida/efeitos adversos , Masculino , Pessoa de Meia-Idade , Probióticos/efeitos adversos , Projetos de Pesquisa , Simeticone/efeitos adversos , Método Simples-Cego , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVES: Gastroesophageal reflux (GER) is a frequently occurring condition in infants capable of causing distressing symptoms. The aim of our study is to evaluate the efficacy of Mg alginate plus simethicone (Gastrotuss Baby, DMG Italia SRL, Pomezia, Italy), compared with rice-starch-thickened formula or with reassurance alone, in the treatment of GER in infants. METHODS: The present randomized controlled trial was conducted in full-term infants affected by symptoms suggestive of GER, evaluated through a validated questionnaire (Infant Gastroesophageal Reflux Questionnaire Revised). The patients were randomized into 3 groups according to treatment (group A: Mg alginate plus simethicone; group B: thickened formula; group C: reassurance with lifestyle changes). Evaluation of symptom scores was performed after 1 month (T1) and 2 months (T2). RESULTS: A total of 64 (85.3%) of 75 enrolled infants (median age 5 months; range 1-10) concluded the study. After 1 month of treatment (T1), infants treated with Mg alginate plus simethicone showed a statistically significant improvement in symptoms compared with the thickened formula and reassurance (Pâ<â0.03, <0.0001, respectively). At the end of the study, all 3 groups of patients showed a significant reduction in symptom scores (Pâ<â0.002, <0.038, <0.03, respectively). Median symptom score values were more significantly reduced in group A than in group B and in group C (group A vs group B Pâ<â0.002; group A vs group C Pâ<â0.0001; group B vs group C Pâ<â0.001). CONCLUSIONS: Mg alginate plus simethicone seems to be more efficacious on GER symptom scores than thickened formula and reassurance with lifestyle changes alone.
Assuntos
Alginatos/uso terapêutico , Antiespumantes/uso terapêutico , Refluxo Gastroesofágico/tratamento farmacológico , Simeticone/uso terapêutico , Quimioterapia Combinada , Feminino , Refluxo Gastroesofágico/terapia , Ácido Glucurônico/uso terapêutico , Ácidos Hexurônicos/uso terapêutico , Humanos , Lactente , Fórmulas Infantis/administração & dosagem , Estilo de Vida , Masculino , Estudos Prospectivos , Índice de Gravidade de Doença , Inquéritos e QuestionáriosRESUMO
BACKGROUND: A two-arm non-inferiority trial without a placebo is usually adopted to demonstrate that an experimental treatment is not worse than a reference treatment by a small pre-specified non-inferiority margin due to ethical concerns. Selection of the non-inferiority margin and establishment of assay sensitivity are two major issues in the design, analysis and interpretation for two-arm non-inferiority trials. Alternatively, a three-arm non-inferiority clinical trial including a placebo is usually conducted to assess the assay sensitivity and internal validity of a trial. Recently, some large-sample approaches have been developed to assess the non-inferiority of a new treatment based on the three-arm trial design. However, these methods behave badly with small sample sizes in the three arms. This manuscript aims to develop some reliable small-sample methods to test three-arm non-inferiority. METHODS: Saddlepoint approximation, exact and approximate unconditional, and bootstrap-resampling methods are developed to calculate p-values of the Wald-type, score and likelihood ratio tests. Simulation studies are conducted to evaluate their performance in terms of type I error rate and power. RESULTS: Our empirical results show that the saddlepoint approximation method generally behaves better than the asymptotic method based on the Wald-type test statistic. For small sample sizes, approximate unconditional and bootstrap-resampling methods based on the score test statistic perform better in the sense that their corresponding type I error rates are generally closer to the prespecified nominal level than those of other test procedures. CONCLUSIONS: Both approximate unconditional and bootstrap-resampling test procedures based on the score test statistic are generally recommended for three-arm non-inferiority trials with binary outcomes.
Assuntos
Ensaios Clínicos como Assunto/métodos , Interpretação Estatística de Dados , Projetos de Pesquisa , Cisaprida/uso terapêutico , Simulação por Computador , Humanos , Transtornos de Enxaqueca/tratamento farmacológico , Simeticone/uso terapêutico , Resultado do TratamentoRESUMO
INTRODUCTION: Irritable bowel syndrome (IBS) is a chronic gastrointestinal (GI) disorder that affects 15-20% of the Western population. BACKGROUND: There are currently few therapeutic options available for the treatment of IBS. The aim of this study is to evaluate the efficacy and the safety of a medical device containing a combination of Simethicone and Bacillus coagulans in the treatment of IBS. PATIENTS AND METHODS: This is a monocentric double-blind, placebo-controlled parallel group clinical trial. Adult subjects suffering from IBS as defined by Rome III criteria were enrolled. Bloating, discomfort, abdominal pain were assessed as primary end point. Subjects received the active treatment or placebo 3 time a day after each meal for 4 weeks of study period. Subjects were submitted to visit at Day 0 (T1), at Days 14 (T2) and 29 (T3). RESULTS: Fifty-two patients were included into the study. Intragroup analysis showed a significant reduction of the bloating, discomfort and pain in Colinox® group (CG) compared to placebo group (PG). Between group analysis confirmed, at T1-T3, significant differences between CG and PG in bloating and discomfort. DISCUSSION: Simethicone is an inert antifoaming able to reduce bloating, abdominal discomfort. Literature offers increasing evidence linking alterations in the gastrointestinal microbiota and IBS and it is well known that probiotics are important to restore the native gut microbiota. The Colinox medical device is specifically targeted against most intrusive symptom of IBS (bloating) and it is also able to counteract the most accredited ethiopathogenetic factor in IBS (alterations of intestinal microbiota). CONCLUSIONS: This is the first randomized double-blind placebo-controlled clinical trial demonstrating the efficacy and safety of a combination of simethicone and Bacillus coagulans in treatment of IBS.
Assuntos
Antiespumantes/uso terapêutico , Bacillus/crescimento & desenvolvimento , Intestinos/efeitos dos fármacos , Intestinos/microbiologia , Síndrome do Intestino Irritável/terapia , Probióticos/uso terapêutico , Simeticone/uso terapêutico , Dor Abdominal/etiologia , Dor Abdominal/prevenção & controle , Adulto , Idoso , Antiespumantes/efeitos adversos , Bacillus/classificação , Terapia Combinada , Método Duplo-Cego , Feminino , Humanos , Síndrome do Intestino Irritável/complicações , Síndrome do Intestino Irritável/diagnóstico , Síndrome do Intestino Irritável/microbiologia , Masculino , Pessoa de Meia-Idade , Probióticos/efeitos adversos , Cidade de Roma , Simeticone/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: In routine practice, irritable bowel syndrome (IBS) symptoms are often difficult to be relieved and impair significantly patients' quality of life (QoL). A randomised, double-blind, placebo-controlled study has shown the efficacy of alverine citrate/simeticone (ACS) combination for IBS symptom relief. AIM: As IBS symptoms are often intermittent, this pragmatic study was designed to compare the efficacy of an on-demand ACS treatment vs. that of usual treatments. METHODS: Rome III IBS patients were enrolled by 87 general practitioners who were randomly allocated to one of two therapeutic strategies: on-demand ACS or usual treatment chosen by the physician. The primary outcome measure was the improvement of the IBSQoL score between inclusion and month 6. RESULTS: A total of 436 patients (mean age: 54.4 years; women: 73.4%) were included, 222 in the ACS arm and 214 patients in the usual treatment arm, which was mainly antispasmodics. At 6 months, improvement of IBSQoL was greater with ACS than with the usual treatment group (13.8 vs. 8.4; p < 0.0008). The IBS-severity symptom score (IBS-SSS) was lower with ACS than in the usual treatment arm with a mean (SE) decrease of 170.0 (6.6) vs. 110.7 (6.7), respectively (p = 0.0001). An IBS-SSS < 75 was more frequent in the ACS group (37.7% vs. 16.0%; p < 0.0001). Improvement of both abdominal pain and bloating severity was also greater with the on-demand ACS treatment, which was associated with both lower direct and indirect costs. CONCLUSIONS: After 6 months, on-demand ACS treatment led to a greater improvement of QoL, reduced the burden of the disease and was more effective for IBS symptom relief than usual treatments.
Assuntos
Antiespumantes/uso terapêutico , Síndrome do Intestino Irritável/tratamento farmacológico , Propilaminas/uso terapêutico , Agonistas do Receptor de Serotonina/uso terapêutico , Simeticone/uso terapêutico , Dor Abdominal/prevenção & controle , Método Duplo-Cego , Combinação de Medicamentos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Qualidade de Vida , Resultado do TratamentoRESUMO
BACKGROUND: Small bowel cleansing by capsule endoscopy has never been addressed in children. METHODS: Randomized controlled trial to evaluate the effect of five bowel preparation regimens on the mucosal visibility surface (as percentage of visualized surface area). Group A: a clear liquid diet for 12 h on the day before; Group B: high volume polyethylene glycol (50 mL/kg, up to 2Lt/die); Group C: low volume polyethylene glycol (25 mL/kg up to 1Lt/die); Group D: 20 mL (376 mg) of oral simethicone; Group E: 25 mL/kg (up to 1Lt/die) of polyethylene glycol solution plus 20 mL (376 mg) of oral simethicone. RESULTS: Overall, 198 patients (53% male, median age 13 years) were enrolled. Preparation regimen visualization scores were 14.1 ± 4.2, 18.9 ± 5.1, 17.8 ± 5.5, 14.9 ± 4.8 and 20.9 ± 4.6 in groups A, B, C, D and E, respectively (P < 0.01). Positive findings were found in 172 cases (87%), but no significant differences were observed in the diagnostic yield and tolerability. Interobserver agreement, k = 0.89 (95% CI 0.83 ± 0.71). CONCLUSION: This is the first report in children that supports the use of 25 mL/kg (up to 1Lt/die) of polyethylene glycol solution plus 20 mL (376 mg) of oral simethicone as the preparation of choice for capsule endoscopy.