P.1.h.006 Study quality and placebo response in randomised controlled trials in schizophrenia conducted 1966–2009

2011 ◽  
Vol 21 ◽  
pp. S351-S352
Author(s):  
O. Agid ◽  
C. Siu ◽  
S. Potkin ◽  
K. McDonald ◽  
I. Benattia ◽  
...  
2021 ◽  
Vol 36 (Supplement_1) ◽  
Author(s):  
J Stein ◽  
D Coggin-Carr ◽  
J Harper

Abstract Study question How should acupuncture be rated on the Human Fertilisation and Embryology Authority traffic light scheme for IVF add-ons? Summary answer Randomised controlled trials examining the possible effects of acupuncture on IVF success rates are conflicting, and acupuncture should be rated amber. What is known already The use of complementary therapies in assisted reproduction and IVF has become increasingly more commonplace in recent years. Patients seeking to maximise their chances of conception are often interested in purchasing additional treatments (termed ‘add-ons’) to augment their treatment cycle, often at a high price even in the absence of robust underlying evidence. The use of acupuncture is popular due to putative holistic benefits including stress reduction, and the perceived lack of side-effects and minimal invasiveness. The HFEA traffic light system has not yet rated any complementary therapies, even though these are promoted by fertility clinics. Study design, size, duration A systematic review of randomised controlled trials (RCTs) of acupuncture during IVF treatment was conducted. A literature search for acupuncture studies was conducted on the PubMed database and the University College London (UCL) library database. Search terms used were “acupuncture” paired with “IVF”, “in vitro fertilisation”, “assisted reproduction” and “RCT”. Study quality and variance in treatment protocols were assessed, to understand both any evidence and its quality. Statistical analysis was performed using STATA. Participants/materials, setting, methods The UCL library database yielded 403 individual search results and PubMed database yielded 47. Papers were screened and sorted according to the inclusion and exclusion criteria. Inclusion: publication in English, in an English-language journal; RCT; intervention administered during IVF; either pregnancy rate (PR), ongoing/clinical PR or live birth rate (LBR) reported. Exclusion: reviews; not in English; not RCT; above outcomes not reported. Main results and the role of chance After final screening, a total of 34 acupuncture RCTs were included in the review and meta-analysis. The sample sizes of the studies analysed ranged from 44 to 809 (median 162). Only a minority of studies (18%, 6/34) involved blinding of both assessor and participant, while foregoing incorporation of blinding into study design was most common (44%, 15/34 studies). There was little consistency regarding the timing of acupuncture treatment during the IVF protocol across RCTs. A total of 21/34 studies (62%) had a protocol involving acupuncture administration before and after the embryo transfer procedure on the day of transfer. The number of needle insertions during the treatment protocols ranged from 5–13 (mean 8.7). Manual acupuncture only was performed in 8/34 (24%) of studies and 26/34 (76%) utilised electrical stimulation of at least some of the acupuncture needles. Out of 34 RCTs, only 10/34 studies (29%) reported LBR. The meta-analysis included all identified RCTs. The most clinically relevant outcome measure reported in each study found a slight benefit of acupuncture for overall IVF success (OR 1.37, 95% CI 1.13–1.65) however the effect was diluted when only comparing studies reporting LBR (OR 1.14 ,95% CI 0.81–1.61). Limitations, reasons for caution Methodological heterogeneity of acupuncture RCTs in IVF (needling location, stimulation, retention time, repetition and timing) complicates data pooling. Underlying neurophysiological mechanisms of action are still being clarified and may help delineate optimal regimens, potentially tailored to individual causes of infertility. Treatment safety and potential for worse outcomes must be considered. Wider implications of the findings: Complementary therapies are a popular add-on for IVF treatment but assessing them from a robust biomedical perspective is challenging due to issues with study design (including controls), study quality and general attitudes. For acupuncture, future research should arguably focus on biomedical perspectives and shift away from Traditional Chinese Medicine philosophies. Trial registration number Not applicable


2021 ◽  
Vol 8 ◽  
Author(s):  
Wenhao Cai ◽  
Fei Liu ◽  
Yongjian Wen ◽  
Chenxia Han ◽  
Manya Prasad ◽  
...  

Background: Pain management is an important priority in the treatment of acute pancreatitis (AP). Current evidence and guideline recommendations are inconsistent on the most effective analgesic protocol. This systematic review and meta-analysis of randomised controlled trials (RCTs) aimed to compare the safety and efficacy of analgesics for pain relief in AP.Methods: A literature search was performed to identify all RCTs assessing analgesics in patients with AP. The primary outcome was the number of participants who needed rescue analgesia. Study quality was assessed using Jadad score. Pooled odds ratios (ORs) or weighted mean differences (WMDs) with 95% confidence intervals (CI) were analysed using a random-effects model.Results: Twelve studies comprising 699 patients with AP (83% mild AP) were analysed. The tested analgesics significantly decreased the need for rescue analgesia (3 studies, OR.36, 95% CI 0.21 to 0.60) vs. placebo or conventional treatment. The analgesics also improved the pain score [Visual Analogue Scale (Δ-VAS)] at 24 h (WMD 18.46, 0.84 to 36.07) and by the 3rd to 7th days (WMD 11.57, 0.87 to 22.28). Opioids vs. non-opioids were associated with a decrease in the need for rescue analgesia (6 studies, OR 0.25, 95% CI 0.07 to 0.86, p = 0.03) but without significance in pain score. In subgroup analyses, opioids were similar to non-steroidal anti-inflammatory drugs (NSAIDs) regarding the primary outcome (4 studies, OR 0.56, 95% CI 0.24 to 1.32, p = 0.18). There were no significant differences in other clinical outcomes and rate of adverse events. Other studies, comparing epidural anaesthesia vs. patient-controlled analgesia and opioid (buprenorphine) vs. opioid (pethidine) did not show significant difference in primary outcome. Study quality issues significantly contributed to overall study heterogeneity.Conclusions: NSAIDs and opioids are equally effective in decreasing the need for rescue analgesia in patients with mild AP. The relative paucity of trials and high-quality data in this setting is notable and the optimal analgesic strategy for patients with moderately severe and severe AP still requires to be determined.


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