OBJECTIVES: To evaluate the benefits and harms of any type of endoscopic sphincterotomy compared with a placebo drug, sham operation, or any pharmaceutical treatment, administered orally or endoscopically, alone or in combination, or a different type of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.
SEARCH METHODS: We used extensive Cochrane search methods. The latest search date was 16 May 2023.
SELECTION CRITERIA: We included randomised clinical trials assessing any type of endoscopic sphincterotomy versus placebo drug, sham operation, or any pharmaceutical treatment, alone or in combination, or a different type of endoscopic sphincterotomy in adults diagnosed with sphincter of Oddi dysfunction, irrespective of year, language of publication, format, or outcomes reported.
DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods and Review Manager to prepare the review. Our primary outcomes were: proportion of participants without successful treatment; proportion of participants with one or more serious adverse events; and health-related quality of life. Our secondary outcomes were: all-cause mortality; proportion of participants with one or more non-serious adverse events; length of hospital stay; and proportion of participants without improvement in liver function tests. We used the outcome data at the longest follow-up and the random-effects model for our primary analyses. We assessed the risk of bias of the included trials using RoB 2 and the certainty of evidence using GRADE. We planned to present the results of time-to-event outcomes as hazard ratios (HR). We presented dichotomous outcomes as risk ratios (RR) and continuous outcomes as mean difference (MD) with their 95% confidence intervals (CI).
MAIN RESULTS: We included four randomised clinical trials, including 433 participants. Trials were published between 1989 and 2015. The trial participants had sphincter of Oddi dysfunction. Two trials were conducted in the USA, one in Australia, and one in Japan. One was a multicentre trial conducted in seven US centres, and the remaining three were single-centre trials. One trial used a two-stage randomisation, resulting in two comparisons. The number of participants in the four trials ranged from 47 to 214 (median 86), with a median age of 45 years, and the mean proportion of males was 49%. The follow-up duration ranged from one year to four years after the end of treatment. All trials assessed one or more outcomes of interest to our review. The trials provided data for the comparisons and outcomes below, in conformity with our review protocol. The certainty of evidence for all the outcomes was very low. Endoscopic sphincterotomy versus sham Endoscopic sphincterotomy versus sham may have little to no effect on treatment success (RR 1.05, 95% CI 0.66 to 1.66; 3 trials, 340 participants; follow-up range 1 to 4 years); serious adverse events (RR 0.71, 95% CI 0.34 to 1.46; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Physical scale) (MD -1.00, 95% CI -3.84 to 1.84; 1 trial, 214 participants; follow-up 1 year), health-related quality of life (Mental scale) (MD -1.00, 95% CI -4.16 to 2.16; 1 trial, 214 participants; follow-up 1 year), and no improvement in liver function test (RR 0.89, 95% CI 0.35 to 2.26; 1 trial, 47 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus endoscopic papillary balloon dilation Endoscopic sphincterotomy versus endoscopic papillary balloon dilationmay have little to no effect on serious adverse events (RR 0.34, 95% CI 0.04 to 3.15; 1 trial, 91 participants; follow-up 1 year), but the evidence is very uncertain. Endoscopic sphincterotomy versus dual endoscopic sphincterotomy Endoscopic sphincterotomy versus dual endoscopic sphincterotomy may have little to no effect on treatment success (RR 0.65, 95% CI 0.32 to 1.31; 1 trial, 99 participants; follow-up 1 year), but the evidence is very uncertain. Funding One trial did not provide any information on sponsorship; one trial was funded by a foundation (the National Institutes of Diabetes and Digestive and Kidney Diseases, NIDDK), and two trials seemed to be funded by the local health institutes or universities where the investigators worked. We did not identify any ongoing randomised clinical trials.
AUTHORS' CONCLUSIONS: Based on very low-certainty evidence from the trials included in this review, we do not know if endoscopic sphincterotomy versus sham or versus dual endoscopic sphincterotomy increases, reduces, or makes no difference to the number of people with treatment success; if endoscopic sphincterotomy versus sham or versus endoscopic papillary balloon dilation increases, reduces, or makes no difference to serious adverse events; or if endoscopic sphincterotomy versus sham improves, worsens, or makes no difference to health-related quality of life and liver function tests in adults with biliary sphincter of Oddi dysfunction. Evidence on the effect of endoscopic sphincterotomy compared with sham, endoscopic papillary balloon dilation,or dual endoscopic sphincterotomyon all-cause mortality, non-serious adverse events, and length of hospital stay is lacking. We found no trials comparing endoscopic sphincterotomy versus a placebo drug or versus any other pharmaceutical treatment, alone or in combination. All four trials were underpowered and lacked trial data on clinically important outcomes. We lack randomised clinical trials assessing clinically and patient-relevant outcomes to demonstrate the effects of endoscopic sphincterotomy in adults with biliary sphincter of Oddi dysfunction.
METHODS: A literature review for articles published from 2013 to 2023 was carried out in scientific databases PubMed, Scopus, and Web of Science, identifying quantitative studies involving the assessment of KAP of the public concerning HPW disposal.
RESULTS: This review incorporated 12 studies conducted in Africa, South Asia, and Southeast Asia. Nine studies highlighted a consistent trend of limited to inadequate knowledge regarding safe medication disposal. Notwithstanding, respondents largely exhibited a positive attitude towards proper medication disposal. This encouraging disposition, unfortunately, stands in stark contrast to the reported practices, which appeared to be inadequate. This dissonance might be due to a deficit in accessible disposal facilities and information, compounded with insufficient guidance from healthcare professionals. Interestingly, the majority expressed support for take-back programs aimed at managing unused and expired medications.
CONCLUSION: This review identified a need for a comprehensive understanding of the interconnected dynamics among KAP components regarding safe medication disposal. The exploration of theoretical behavioural frameworks could help predict public intentions to adopt safe medication disposal practices. Ultimately, a multi-faceted approach that addresses knowledge gaps, reinforces positive attitudes, and promotes accessible safe medication disposal services can collectively safeguard the environment and public health.
METHODS: The study involved conducting intradermal injections on four cadavers and participants using a 2 mm length, 34-gauge needle (N-Finders, Inc., South Korea). During the cadaveric study, the polynucleotide prefilled syringe was dyed green, and an anatomist performed dissections, removing only the skin layer. Ultrasonographic observations were carried out to ensure accurate intradermal injection placement.
RESULTS: In all four cadavers, the facial injections at the anterior cheek region were precisely administered intradermally at a 30-degree injection angle. However, the 90-degree injection was found just below the dermal layer upon skin layer removal.
DISCUSSION: The findings suggest that using a 2 mm needle length allows for easy and convenient intradermal injections.
OBJECTIVE: The goal of this study was to identify and assess the efficacy of pharmaceutical care services in various pharmaceutical aspects throughout seventeen Middle Eastern nations.
METHOD: The Arkesy and O'Malley technique was used to conduct a scoping review. It was conducted using PubMed/Medline, Scopus, Cochrane Library, Springer Link, Clinical Trials, and Web of Science etc. The Van Tulder Scale was utilized in randomized trials research, whereas the dawn and black checklists were used in non-randomized trials research. A descriptive and numerical analysis of selected research was done. The scope of eligible PCs, pharmaceutical implementers, study outcomes, and quality were all identified by a thematic review of research.
RESULTS: There were about 431,753 citations found in this study, and 129 publications were found to be eligible for inclusion after analysing more than 271 full-text papers. The study design was varied, with 43 (33.3%) RCTs and 86 (66.7%) n-RCTs. Thirty-three (25.6%) of the studies were published in 2020. Jordan, Saudi Arabia, and Turkey were home to the majority of the studies (25.6%, 16.3%, and 11.6%) respectively. Thirty-seven studies (19.7%) were concerned with resolving drug related problems (DRPs), whereas 27 (14.4%) were concerned with increasing quality of life (QOL) and 23 (12.2%) with improving drug adherence. Additionally, the research revealed that the average ratings of the activities provided to patients improved every year.
CONCLUSION: Studies in the Middle East continue to provide evidence supporting the positive impact of pharmaceutical care services on both hard and soft outcomes measured in most studies. Yet there was rare focus on the value of the implemented services. Thus, rigorous evaluation of the economic impact of implemented pharmaceutical care services in the Middle East and assessment of their sustainability is must.