ABSTRACT
Introduction: Erectile dysfunction (ED) is a prevalent condition in urology, primarily managed with PDE5 inhibitors (PDE5Is). However, approximately 20% of patients do not experience improvement in overall sexual satisfaction (OS) after taking PDE5Is. Among these, traditional Chinese medicine (TCM) has emerged as a complementary approach, with formulas like Hongjing I granules (HJIG) showing promise in preliminary studies. This study aims to rigorously evaluate the effectiveness and safety of HJIG in mild to moderate ED cases, assessing improvement in both sexual function and TCM pattern alignment. Methods: This study is a randomized, double-blind, placebo-controlled multicentre trial. Recruitment will be conducted from patients who have a strong willingness to try using only traditional Chinese medicine treatment (This is very common in traditional Chinese medicine hospitals.). A total of 100 patients diagnosed with mild to moderate ED caused by qi deficiency and blood stasis will be recruited and randomly assigned to receive one of two treatments: HJIG (N = 50) or placebo (N = 50). Patients will receive 8 weeks of treatment and a 16-week follow-up starting from the fourth week of treatment. Outcome measures, including the International Index of Erectile Function-Erectile Function domain (IIEF-EF) score, Sexual Encounter Profile (SEP), and Traditional Chinese Medicine symptom score, will be evaluated. Discussion: The expected outcome of this trial is that the use of the herbal formula HIJG alone can improve overall sexual satisfaction (OS) in patients with mild to moderate ED, while also improving their traditional Chinese medicine symptom scores. This will provide evidence-based support for the use of Chinese medicine in the treatment of ED in China. Trial Registration: Chinese Clinical Trial Registry, ChiCTR2000041127, Registered on 19 December 2020, https://www.chictr.org.cn/showproj.html?proj=46469. Trial Status: Recruitment began in March 2021, therefore 80 patients have been recruited. It is expected to finish recruiting in December 2023.
ABSTRACT
We conducted a systematic review and meta-analysis to compare the efficacy and safety between laparoscopic reduction (LR) and open reduction (OR) of intussusception in infants and children. Literature searches were conducted to identify studies having compared LR and OR for children with intussusception failed to enema reduction. Parameters such as operative time, time to oral intake, length of hospital stay, overall postoperative complications, and recurrence were pooled and compared by meta-analysis. Among the 502 pediatric participants included in the 11 studies, 275 had received LR and 227 received OR. There were shorter length of hospital stays and time to oral intake with the LR approach compared with OR. However, no significant difference was found between LR and OR in the secondary outcome, such as the overall postoperative complications and recurrence. LR is a feasible, safe, and effective surgical procedure alternative to OR for pediatric intussusception. Compared with OR, LR has the advantage of shorter hospital stay and faster time to oral intake. Besides, the overall postoperative complications may be slightly lower in LR. We conclude that LR should be considered an acceptable option for children.