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Journal of Ethnopharmacology Sep 2023Functional dyspepsia (FD), a chronic upper gastrointestinal syndrome, seriously affects the quality of life of patients and poses a significant economic burden. Since... (Meta-Analysis)
Meta-Analysis Review
ETHNOPHARMACOLOGICAL RELEVANCE
Functional dyspepsia (FD), a chronic upper gastrointestinal syndrome, seriously affects the quality of life of patients and poses a significant economic burden. Since the pathological mechanisms of FD have not been fully elucidated, conventional therapies such as prokinetics, proton pump inhibitors, and antidepressants have some limitations. Siho-sogan-san (SHS) is commonly used as a therapeutic alternative in traditional medicine; however, scientific and clinical evidence supporting its application in FD remains insufficient.
AIM OF THE STUDY
This review aimed to assess the safety and effectiveness of SHS and in combined with Western medicine (WM) for the treatment of FD.
METHODS
Eleven databases, including EMBASE, Medline, and Cochrane Library, were searched for randomized controlled trials (RCTs) on FD published before December 31, 2022. After two independent reveiwers sceened and selected studies according to the inclusion and exclusion criteria, clinical data was pooled and synthesized via Review Manager software. The outcome parameters included total clinical effectiveness rate (TCE), time for symptom improvement, levels of motilin and corticotropin-releasing hormone (CRH), and adverse events. Cochrane's risk of bias tool was used for quality assessment.
RESULTS
A total of 12 studies that included 867 participants comparing WM with SHS or combination therapy (SHS plus WM) were identified. Through a meta-analysis of five studies including 363 patients, SHS compared with WM showed a positive result in safely increasing TCE [risk ratio = 1.36, 95% confidence interval (CI) 1.22 to 1.51, P < 0.00001]. The time for symptom improvement, including abdominal pain, belching, nausea, vomiting, and abdominal distension, was significantly more shortened in the combination therapy than WM group. Furthermore, combination therapy resulted in greater secretion of motilin than WM alone [mean difference = 67.95, 95% CI 39.52 to 96.39, P < 0.00001]. No remarkable difference was observed in CRH levels between the combination therapy and WM groups. For a subgroup analysis, the administration of SHS based on the type of pattern identification (PI) showed larger effect size than in the group that do not consider PI.
CONCLUSIONS
These results suggest that SHS and combination therapy can be considered effective and safe options for the treatment of FD. However, owing to the low quality of the included studies, more well-designed investigational studies and RCTs with longer treatment and follow-up period are needed.
Topics: Humans; Dyspepsia; Motilin; Drugs, Chinese Herbal; Phytotherapy; Plants, Medicinal; Medicine, Traditional
PubMed: 37127143
DOI: 10.1016/j.jep.2023.116518 -
Diseases (Basel, Switzerland) Dec 2022There is growing evidence of the association of Microscopic Colitis (MC) with the use of specific medications such as proton pump inhibitors (PPIs), Selective serotonin...
There is growing evidence of the association of Microscopic Colitis (MC) with the use of specific medications such as proton pump inhibitors (PPIs), Selective serotonin reuptake inhibitors (SSRIs), Non-Steroidal anti-inflammatory drugs (NSAIDs), Statins and H2-receptor antagonists (H2RA). In our study, we calculated the pooled odds of MC in patients using these drugs. We performed a detailed search of major databases, including PubMed/Medline, Scopus, web of science, and Embase, to include the studies in which odds of MC were reported after using above mentioned drugs. A random-effects model was used to pool the estimates. Thirteen studies were included in our analysis consisting of 304,482 patients (34,194 cases and 270,018 controls). In eight studies, the control group consisted of a random population selected based on age, gender and same birth year, whereas 3 studies recruited patients who presented with diarrhea and underwent colonoscopy and biopsy to rule out MC. Two studies reported odds of MC for both diarrhea and random control groups. Patients taking PPIs were more likely to develop MC, AOR 2.65 (95% CI 1.81-3.50, 98.13%). Similarly, higher odds of association were found in patients taking SSRIs (OR 2.12, 95% CI 1.27-2.96, 96.46%), NSAIDs (OR 2.02, 95% CI 1.33-2.70, 92.70%) and Statins (OR 1.74, 95% CI 1.19-2.30, 96.36%). No difference in odds of developing MC was seen in patients using H2RA compared to the control group (OR 2.70, 95% CI 0.32-5.08, 98.67%). We performed a subgroup analysis based on the control group and found higher odds of MC in patients on PPIs compared to the random control group (OR 4.55, 95% CI 2.90-6.19, 98.13%). Similarly, higher odds of MC were noted for SSRI (OR 3.23, 95% CI 1.54-4.92, 98.31%), NSAIDs (OR 3.27, 95% CI 2.06-4.48, 95.38%), and Statins (OR 2.23, 95% CI 1.41-3.06, 98.11%) compared to the random control group. Contrary lower odds of MC were seen in the PPI and H2RA group compared to the diarrhea control group (OR 0.68, 95% CI 0.48-0.88, 7.26%), (OR 0.46, 95% CI 0.14-0.78, 0%) respectively. We found no difference in odds of MC in patients on SSRIs (OR 0.96, 95% CI 0.49-1.42, 37.89%), NSAIDs (OR 1.13, 95% CI 0.49-1.76, 59.37%) Statins (OR 0.91, 95% 0.66-1.17, 0%) and H2RA (OR 3.48, 95% CI -0.41-7.36, 98.89%) compared to the diarrhea control group. We also analyzed the association use of PPIs and NSAIDs with the development of collagenous colitis (CC) and lymphocytic colitis. Only the use of NSAIDs was associated with increased odds of developing collagenous colitis (OR 1.61, 95% CI 1.50-1.72, 0%). No increased odds of CC and LC were seen in PPI users. PPIs, NSAIDs, SSRIs, and Statins are associated with an increased risk of MC compared to the random control group. On the contrary, the use of PPIs, NSAIDs, SSRIs, and Statins is not associated with an increased risk of MC when compared to the diarrhea control group.
PubMed: 36648871
DOI: 10.3390/diseases11010006 -
International Journal of Radiation... Nov 2023Adjuvant proton beam therapy (PBT) is increasingly available to patients with breast cancer. It achieves better planned dose distributions than standard photon radiation... (Meta-Analysis)
Meta-Analysis
PURPOSE
Adjuvant proton beam therapy (PBT) is increasingly available to patients with breast cancer. It achieves better planned dose distributions than standard photon radiation therapy and therefore may reduce the risks. However, clinical evidence is lacking.
METHODS AND MATERIALS
A systematic review of clinical outcomes from studies of adjuvant PBT for early breast cancer published in 2000 to 2022 was undertaken. Early breast cancer was defined as when all detected invasive cancer cells are in the breast or nearby lymph nodes and can be removed surgically. Adverse outcomes were summarized quantitatively, and the prevalence of the most common ones were estimated using meta-analysis.
RESULTS
Thirty-two studies (1452 patients) reported clinical outcomes after adjuvant PBT for early breast cancer. Median follow-up ranged from 2 to 59 months. There were no published randomized trials comparing PBT with photon radiation therapy. Scattering PBT was delivered in 7 studies (258 patients) starting 2003 to 2015 and scanning PBT in 22 studies (1041 patients) starting 2000 to 2019. Two studies (123 patients) starting 2011 used both PBT types. For 1 study (30 patients), PBT type was unspecified. Adverse events were less severe after scanning than after scattering PBT. They also varied by clinical target. For partial breast PBT, 498 adverse events were reported (8 studies, 358 patients). None were categorized as severe after scanning PBT. For whole breast or chest wall ± regional lymph nodes PBT, 1344 adverse events were reported (19 studies, 933 patients). After scanning PBT, 4% (44/1026) of events were severe. The most prevalent severe outcome after scanning PBT was dermatitis, which occurred in 5.7% (95% confidence interval, 4.2-7.6) of patients. Other severe adverse outcomes included infection, pain, and pneumonitis (each ≤1%). Of the 141 reconstruction events reported (13 studies, 459 patients), the most prevalent after scanning PBT was prosthetic implant removal (34/181, 19%).
CONCLUSIONS
This is a quantitative summary of all published clinical outcomes after adjuvant PBT for early breast cancer. Ongoing randomized trials will provide information on its longer-term safety compared with standard photon radiation therapy.
Topics: Humans; Female; Breast Neoplasms; Proton Therapy
PubMed: 36868521
DOI: 10.1016/j.ijrobp.2023.02.023 -
Asian Pacific Journal of Cancer... Nov 2023Radiation therapy is used to treat head and neck cancer (HNC) patients. Proton beam therapy (PBT) is one of the newer treatment options. This systematic review will...
BACKGROUND
Radiation therapy is used to treat head and neck cancer (HNC) patients. Proton beam therapy (PBT) is one of the newer treatment options. This systematic review will describe the cost and cost-effectiveness of PBT compared with other first-line treatment options based on available literature and provide a better understanding of its usage in HNC in the future.
METHODS
This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Systematic searches were conducted in PUBMED, EMBASE and SCOPUS till February 2022. Original pharmacoeconomic articles written in English that considered PBT for HNC were included; the title, abstract and full text of the search items were screened. The included studies were critically appraised using the Drummond Checklist followed by data extraction.
RESULTS
Eight of the ten included studies were of good quality; most were cost-effectiveness or cost comparison studies and used the Markov model and lifetime horizon. The dominant comparator was intensity-modulated radiotherapy. The willingness to pay threshold ranged from $30,828 to $150,000 per QALY. The incremental cost-effectiveness ratio (ICER) was between $4,436.1 and $695,000 per QALY. In HNC patients with human papillomavirus infection, the ICER was lower ($288,000/QALY) from the payer's perspective, but much higher ($390,000/QALY) from the societal perspective.
CONCLUSION
Our systematic review showed that appropriate patient selection can make PBT cost-effective. HPV-associated tumors can be cost-effectively treated with PBT. From the payer's perspective, PBT is a cost-effective treatment option. In younger patients, PBT can result in lesser incidence of adverse effects, and hence, can reduce the subsequent need for long-term supportive care. Lower fractionation schedules can also make PBT a cost-effective treatment.
Topics: Humans; Proton Therapy; Financial Stress; Head and Neck Neoplasms; Chemical Fractionation; Dose Fractionation, Radiation; Papillomavirus Infections
PubMed: 38019221
DOI: 10.31557/APJCP.2023.24.11.3643 -
Therapeutic Advances in Gastroenterology 2023Vonoprazan, a novel acid-suppressive drug, is non-inferior to proton pump inhibitors (PPIs) for the management of gastric acid-related diseases. However, the safety of...
BACKGROUND
Vonoprazan, a novel acid-suppressive drug, is non-inferior to proton pump inhibitors (PPIs) for the management of gastric acid-related diseases. However, the safety of vonoprazan has not been systematically evaluated yet.
OBJECTIVES
To elucidate the incidence and type of adverse events (AEs) in patients taking vonoprazan.
DESIGN
Systematic review and meta-analysis.
DATA SOURCES AND METHODS
PubMed, EMBASE, and Cochrane Library databases were searched for all studies reporting the safety of vonoprazan. The incidences of any AEs, drug-related AEs, serious AEs, AEs leading to drug discontinuation, and common AEs were pooled. Odds ratios (ORs) were calculated to compare the incidence of AEs between patients taking vonoprazan and PPIs.
RESULTS
Seventy-seven studies were included. The pooled incidences of any AEs, drug-related AEs, serious AEs, and AEs leading to drug discontinuation were 20, 7, 1, and 1%, respectively. The incidences of any AEs (OR = 0.96, = 0.66), drug-related AEs (OR = 1.10, = 0.44), serious AEs (OR = 1.14, = 0.36), and AEs leading to drug discontinuation (OR = 1.09, = 0.55) were not significantly different between patients taking vonoprazan and PPIs. In subgroup analyses, patients with peptic ulcer disease (PUD) had higher incidences of any AEs, serious AEs, and AEs leading to drug discontinuation than those with gastroesophageal reflux disease (GERD), () infection, and artificial ulcer after gastric endoscopic submucosal dissection (ESD), but patients with infection had a higher incidence of drug-related AEs than those with PUD, GERD, and artificial ulcer after gastric ESD. The incidence of AEs was higher in patients taking long-term use of vonoprazan than those taking short-term use of vonoprazan.
CONCLUSION
Vonoprazan is well tolerated and shows similar safety compared to PPIs. The safety of vonoprazan may be primarily influenced by its indications and duration.
REGISTRATION
PROSPERO CRD42022314982.
PubMed: 37113190
DOI: 10.1177/17562848231167858 -
Gut Nov 2023There is currently no recommendation regarding preferred drugs for active eosinophilic oesophagitis (EoE) because their relative efficacy is unclear. We conducted an...
BACKGROUND
There is currently no recommendation regarding preferred drugs for active eosinophilic oesophagitis (EoE) because their relative efficacy is unclear. We conducted an up-to-date network meta-analysis to compare proton pump inhibitors, off-label and EoE-specific topical steroids, and biologics in EoE.
METHODS
We searched MEDLINE, Embase, Embase Classic and the Cochrane Central Register of Controlled Trials from inception to June 2023. We included randomised controlled trials (RCTs) comparing efficacy of all drugs versus each other, or placebo, in adults and adolescents with active EoE. Results were reported as pooled relative risks with 95% CIs to summarise effect of each comparison tested, with drugs ranked according to P score RESULTS: Seventeen RCTs were eligible for systematic review. Of these, 15 studies containing 1813 subjects with EoE reported extractable data for the network meta-analysis. For histological remission defined as ≤6 eosinophils/high-power field (HPF), lirentelimab 1 mg/kg monthly ranked first. For histological remission defined as ≤15 eosinophils/HPF, budesonide orally disintegrating tablet (BOT) 1 mg two times per day ranked first. For failure to achieve symptom improvement, BOT 1 mg two times per day and budesonide oral suspension (BOS) 2 mg two times per day were significantly more efficacious than placebo. For failure to achieve endoscopic improvement based on the EoE Endoscopic Reference Score, BOT 1 mg two times per day and BOS 1 mg two times per day or 2 mg two times per day were significantly more efficacious than placebo.
CONCLUSIONS
Although this network meta-analysis supports the efficacy of most available drugs over placebo for EoE treatment, significant heterogeneity in eligibility criteria and outcome measures among available trials hampers the establishment of a solid therapeutic hierarchy.
PubMed: 37491157
DOI: 10.1136/gutjnl-2023-329873 -
Clinical and Translational Radiation... Nov 2022A systematic review and meta-analysis were performed to better understand the benefits of particle beam therapy for nasopharyngeal cancer (NPC) treatment. The survival... (Review)
Review
BACKGROUND/PURPOSE
A systematic review and meta-analysis were performed to better understand the benefits of particle beam therapy for nasopharyngeal cancer (NPC) treatment. The survival outcomes and toxicity of primary and recurrent NPC patients treated with proton or carbon ion beam therapy were investigated.
METHOD
PubMed, Scopus, and Embase were searched between 1 January 2007 to 3 November 2021. The inclusion and exclusion criteria included studies with either primary or recurrent NPC patients, sample size of ≥10 patients, and proton or carbon ion beam therapy as interventions. Twenty-six eligible studies with a total of 1502 patients were included. We used a random-effect meta-analysis to examine the impact of particle beam therapy on primary NPC patients and qualitatively described the results among recurrent patients. The primary outcome was overall survival (OS), while secondary outcomes included progression-free survival (PFS), local control (LC) and toxicity.
RESULTS
The pooled OS at 1-year, 2-year and 3-year and 5-year for primary NPC patients who received particle beam therapy were 96 % (95 % confidence interval (CI) = 92 %-98 %), 93 % (95 % CI = 83 %-97 %), 90 % (95 % CI = 73 %-97 %) and 73 % (95 % CI = 52 %-87 %) respectively. The pooled 1-year and 2-year PFS, and LC for these patients were above 90 %. For locally recurrent NPC patients, the 1-year OS rate ranged from 65 % to 92 %, while the 1-year LC rate ranged from 80 % to 88 %. Both proton and carbon ion beam therapy were generally safe among primary and recurrent patients, with ≥G3 late toxicity rates of 20 % or less. Approximately a 5 % mortality rate was reported among recurrent patients.
CONCLUSIONS
This systematic review and meta-analysis demonstrated particle beam therapy has great potential in treating NPC, yielding excellent survival outcomes with low toxicity. However, further investigations are needed to assess the long-term outcomes and cost-effectiveness of this newer form of radiotherapy.
PubMed: 36065359
DOI: 10.1016/j.ctro.2022.08.011 -
Cureus Sep 2023Achalasia, a neurodegenerative disease caused by the progressive destruction of ganglion cells in the myenteric plexus, is accompanied by incomplete relaxation of the... (Review)
Review
Comparison of the Clinical Efficacy, Safety, and Postoperative Outcomes Between Peroral Esophageal Myotomy and Laparoscopic Heller's Myotomy With Fundoplication: A Systematic Review.
Achalasia, a neurodegenerative disease caused by the progressive destruction of ganglion cells in the myenteric plexus, is accompanied by incomplete relaxation of the lower esophageal sphincter. Laparoscopic Heller's myotomy (LHM) coupled with fundoplication has been the gold standard procedure for achalasia. Peroral esophageal myotomy (POEM) has recently gained popularity as it is minimally invasive, has fewer adverse events, and has excellent short-term outcomes. So, we aimed to compare the clinical efficacy, safety, and postoperative outcomes between LHM and POEM. We did a systematic review by following the Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) guidelines for 2020 and exploring research databases such as PUBMED and PMC Central, Google Scholar, and Research Gate. After appropriate screenings, articles relevant to the review were scrutinized based on the eligibility criteria. Quality assessment tools such as the Newcastle-Ottawa Scale (NOS) and the assessment of multiple systematic reviews (AMSTAR) were used to finalize the articles. A total of 11 articles (seven observational studies, two RCTs, and two systematic reviews) were included in the review after a quality check. The study included 2127 patients, classified into 981 for POEM and 1146 for LHM, who had undergone treatment for achalasia. Most of the studies had a follow-up of ≤ two years. Comparing efficacy, POEM had similar results to LHM in terms of Eckardt scores. However, abnormal DeMeester scores were found in POEM. Adverse events were significantly higher in LHM when compared to POEM in terms of safety. Peroral esophageal myotomy also stood out as having a shorter procedure time, a shorter hospital stay, and lesser odds of being a clinical failure. As for postoperative outcomes, despite treatment with proton pump inhibitors, LHM was more effective in preventing the development of esophagitis compared to POEM due to partial fundoplication.Postoperative reflux and the development of esophagitis remain certain with POEM and need to be followed up with more studies with longer follow-ups. However, POEM still stands as a better choice compared to LHM in terms of efficacy and safety.
PubMed: 37818506
DOI: 10.7759/cureus.44877 -
Cureus Aug 2023Peptic ulcer disease (PUD) refers to the occurrence of an open erosion in the inner lining of the stomach, duodenum, or sometimes lower esophagus. Treatments like proton... (Review)
Review
Comparing the Safety and Efficacy of Proton Pump Inhibitors and Histamine-2 Receptor Antagonists in the Management of Patients With Peptic Ulcer Disease: A Systematic Review.
Peptic ulcer disease (PUD) refers to the occurrence of an open erosion in the inner lining of the stomach, duodenum, or sometimes lower esophagus. Treatments like proton pump inhibitors (PPIs) or histamine 2 receptor antagonists (H2RAs) are available on the market to efficiently treat the break in the mucosal lining. However, there is little evidence about the effects of the medication on the type and location of the ulcer and the epigastric pain caused by disintegration and increased acidity in the stomach. Given the above, we conducted a systematic review comparing the safety and efficacy of PPIs and H2RAs in various ulcer locations (gastric, duodenal, and pre-pyloric) and the effect of prolonging the treatment with the same medication or changing into a drug from another class in treatment-resistant ulcers. We employed major research literature databases and search engines such as PubMed, Medical Literature Analysis and Retrieval System Online (MEDLINE), Science Direct, and Google Scholar to find relevant articles. After a thorough screening, a quality check using various tools, and applying filters that suited our eligibility criteria, we identified eight articles, of which five were random clinical trials (RCTs), two review articles, and one meta-analysis. This study compares the different side effects of PPIs and H2RAs. Most studies concluded that omeprazole is superior in healing ulcers and bringing pain relief and that patients resistant to H2RAs can be treated better when switched to a PPI. This study also discusses the adverse effects of chronic use, such as diarrhea, constipation, headaches, and gastrointestinal infections. Patients on long-term PPI therapy are required to take calcium supplements to prevent the risk of fractures in older adults. Regarding long-term outcomes, PPIs remain the mainstay of treatment for peptic ulcer disease, based on the papers we reviewed.
PubMed: 37779765
DOI: 10.7759/cureus.44341 -
Surgical Innovation Dec 2023Laparoscopic Nissen fundoplication (LNF) is the most common standard technique worldwidely for Gastroesophageal reflux disease (GERD). Another type of fundoplication,... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Laparoscopic Nissen fundoplication (LNF) is the most common standard technique worldwidely for Gastroesophageal reflux disease (GERD). Another type of fundoplication, laparoscopic Toupet fundoplication (LTF), intends to reduce incidence of postoperative complications. A systematic review and meta-analysis are required on short- and long-term outcomes based on randomized controlled trials (RCTs) between LNF and LTF.
METHODS
We searched databases including PubMed, Cochrane, Embase, and Web of Knowledge for RCTs comparing LNF and LTF. Outcomes included postoperative reflux recurrence, postoperative heartburn, dysphagia and postoperative chest pain, inability to belch, gas bloating, satisfaction with intervention, postoperative esophagitis, postoperative DeMeester scores, operating time (min), in-hospital complications, postoperative use of proton pump inhibitors, reoperation rate, postoperative lower oesophageal sphincter (LOS) pressure (mmHg). We assessed data using risk ratios and weighted mean differences in meta-analyses.
RESULTS
Eight eligible RCTs comparing LNF (n = 605) and LTF (n = 607) were identified. There were no significant differences between the LNF and LTF in terms of postoperative reflux recurrence, postoperative heartburn, postoperative chest pain, satisfaction with intervention, reoperation rate in short and long term, in-hospital complications, esophagitis in short term, and gas bloating, postoperative DeMeester scores, postoperative use of proton pump inhibitors, reoperation rate in long term. LTF had lower LOS pressure (mmHg), fewer postoperative dysphagia and inability to belch in short and long term and gas bloating in short term compared to LNF.
CONCLUSION
LTF were equally effective at controlling reflux symptoms and improving the quality of life, but with lower rate of complications compared to LNF. We concluded that LTF surgical treatment was superior for over 16 years old patients with typical symptoms of GERD and without upper abdominal surgical history upon high-level evidence of evidence-based medicine.
Topics: Humans; Adolescent; Fundoplication; Deglutition Disorders; Heartburn; Proton Pump Inhibitors; Treatment Outcome; Gastroesophageal Reflux; Laparoscopy; Esophagitis; Pain, Postoperative; Chest Pain
PubMed: 36998190
DOI: 10.1177/15533506231165829