Systematic review of disease-modifying therapies to assess unmet needs in multiple sclerosis: tolerability and adherence

2012 ◽  
Vol 18 (7) ◽  
pp. 932-946 ◽  
Author(s):  
G Giovannoni ◽  
E Southam ◽  
E Waubant
Keyword(s):  
Multiple Sclerosis ◽  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Disease Modifying Therapies ◽  
Disease Modifying

Reviews of therapeutic drugs usually focus on the highly selected and closely monitored patient populations from randomized controlled trials. The objective of this study was to review systematically the tolerability and adherence of multiple sclerosis disease-modifying therapies, using data from both randomized controlled trials and observational settings. Relevant literature was identified using predefined search terms, and adverse event and study discontinuation data were extracted and categorized according to study type (randomized controlled trial or observational) and study duration. A total of 151 papers were selected for analysis; 33% were classified as randomized controlled trials and 62% as observational studies. Most of the papers concerned interferon preparations and glatiramer acetate; the limited available information on mitoxantrone and natalizumab precluded extensive examination of these. The most common adverse events were flu-like symptoms (interferon therapies only) and injection-site reactions. Mean discontinuation rates ranged from 16% to 27%. There were no marked differences in tolerability or adherence data from randomized controlled trials and observational studies, but the incidence of adverse events remained high in lengthy studies and discontinuations accumulated with time. The present systematic review of randomized clinical trial and observational data highlights the tolerability and adherence issues associated with commonly used first-line multiple sclerosis treatments.

scholarly journals Impact of Ramadan Diurnal Intermittent Fasting on Hypoglycemic Events in Patients With Type 2 Diabetes: A Systematic Review of Randomized Controlled Trials and Observational Studies

2021 ◽  
Vol 12 ◽  
Author(s):  
Dana Abdelrahim ◽  
MoezAlIslam E. Faris ◽  
Mohamed Hassanein ◽  
Ayman Z. Shakir ◽  
Ayesha M. Yusuf ◽  
...  
Keyword(s):  
Systematic Review ◽  
Type 2 Diabetes ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Dietary Behaviors ◽  
Controlled Trials ◽  
Ramadan Fasting ◽  
Randomized Controlled ◽  
The Impact

Ramadan is the 9th month of the lunar calendar during which Muslims abstain from food and drink between dawn and sunset for 30 consecutive days. Ramadan fasting is observed by all healthy Muslim adults, as well many Muslims with type 2 diabetes (T2DM). Hypoglycemic events (HE) are a serious complication associated with diabetes management and are associated with increased cardiovascular disease risk. Conflicting results have been reported concerning the incidence of HE among people with T2DM observing Ramadan fasting. This review summarizes available scientific evidence on the occurrence of HE and the effects of different moderators on the incidence of HE among patients with T2DM during Ramadan. We conducted a systematic review of available observational studies and randomized controlled trials (RCTs) for patients with T2DM who fasted during Ramadan, with HE as the primary outcome. Ten databases were searched for relevant studies from inception until October 31, 2020. In total, 68 studies (35 RCTs and 33 observational studies) met the inclusion criteria. Non-sulfonylureas hypoglycemic medications showed superior effects in lowering the incidence of HE over sulfonylureas hypoglycemic medications. Variable moderators were associated with experiencing HE during Ramadan in both observational studies and RCTs, including sex, geographical location, body anthropometric indicators, season, dietary behaviors, fasting duration, time since diagnosis, and pre-fasting education. This comprehensive systematic review covered the largest number of observational and clinical studies investigating the impact of Ramadan on HE among patients with T2DM. The study highlights the significance of different moderators that influence the effect of Ramadan fasting on HE, including dietary behaviors, fasting time duration, sex, season, country, pre-fasting education, age, and time since diagnosis. The study also highlighted the impact of different hypoglycemic medications on HE and noted the superiority of non-sulfonylureas over sulfonylureas hypoglycemic medications in lowering the risk for hypoglycemia in people with T2DM during Ramadan fasting.

scholarly journals The Effectiveness and Safety of Probiotic Supplements for Psoriasis: A Systematic Review and Meta-Analysis of Randomized Controlled Trials and Preclinical Trials

2021 ◽  
Vol 2021 ◽  
pp. 1-14
Author(s):  
Liuting Zeng ◽  
Ganpeng Yu ◽  
Yang Wu ◽  
Wensa Hao ◽  
Hua Chen
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Intestinal Flora ◽  
Controlled Trials ◽  
Skin Thickness ◽  
Randomized Controlled ◽  
Probiotic Treatment ◽  
Preclinical Trials

Background. Patients with psoriasis need long-term medication to control their condition. Recent studies suggest that changing the intestinal flora may be a potential treatment. Methods. The databases were utilized to search the randomized controlled trials (RCTs) and preclinical trials about probiotic supplement in the treatment of psoriasis. The retrieval time is from the establishment of these databases to December 2020. RevMan5.3 was used for the risk assessment of bias and meta-analysis. This systematic review was registered in PROSPERO (CRD42021232756). Results. A total of 3 RCTs involving 164 participants were included. Two RCTs showed that probiotics can improve PASI and thereby improve the condition. For inflammation-related indicators, only one RCT showed that probiotics can improve the levels of CRP and TNF-α but have no obvious improvement effect on IL6. One RCT demonstrated the total effective rate of probiotics in the treatment of psoriasis. For adverse events, one RCT showed that the incidence of adverse events of probiotic treatment was low. Preclinical studies showed that continuous intervention with oral probiotics can significantly improve the progression of psoriasis and reduce the expression of inflammatory factors. The meta-analysis showed that the PASI between two groups was of no statistical significance (SMD 1.83 [-0.41, 4.07], P = 0.11 ). Meanwhile, probiotics may improve skin thickness (SMD -5.87 [-11.34, -0.41], P = 0.04 ) in animal model. Conclusion. Prebiotics may have a positive effect on alleviating the clinical symptoms of psoriasis, but a large sample of RCTs is still needed to support its therapeutic effect in psoriasis.

scholarly journals The Timing of Initiating Complementary Feeding in Preterm Infants and Its Effect on Overweight: A Systematic Review

2018 ◽  
Vol 72 (4) ◽  
pp. 307-315 ◽  
Author(s):  
Karin M. Vissers ◽  
Edith J.M. Feskens ◽  
Johannes B. van Goudoever ◽  
Arieke J. Janse
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Preterm Infants ◽  
Complementary Feeding ◽  
Controlled Trial ◽  
Controlled Trials ◽  
Z Score ◽  
Term Infants ◽  
Randomized Controlled ◽  
Significant Difference

Background: What is the appropriate time to start complementary feeding for preterm infants? The answer to this question is yet under debate. The timing of initiating complementary feeding may be associated with overweight in term infants. This systematic review aimed to study the effect of the timing of initiating complementary feeding on overweight in preterm infants. Predefined search items included preterm infants, complementary feeding, overweight, and their synonyms. Summary: The search identified 15,749 articles, of which 5 articles were included. Three studies presented data of randomized controlled trials and 2 studies were cohort studies. Two randomized controlled trials found no significant difference in body mass index (BMI) Z-score between the intervention groups at 12 months of age. One randomized controlled trial presented a significant greater mean rate of growth in length per week until 12 months in the preterm weaning strategy-group compared with the current best practices. One observational study concluded that each month the infants received complementary food later, the Z-score for length and weight was reduced by 0.1. Key Messages: No clear conclusion could be drawn from the included studies. This review illustrates the need for further research to access the effect of the timing of initiating complementary feeding on overweight in preterm infants.

Evaluating the reporting of adverse events in controlled clinical trials conducted in 2010–2015 on migraine drug treatments

Cephalalgia ◽  
2018 ◽  
Vol 38 (12) ◽  
pp. 1885-1895
Author(s):  
Peer Tfelt-Hansen ◽  
Janus Kaufmann Lindqvist ◽  
Thien Phu Do
Keyword(s):  
Adverse Events ◽  
Randomized Controlled Trials ◽  
International Headache Society ◽  
Controlled Trial ◽  
Migraine Treatment ◽  
Controlled Trials ◽  
Acute Administration ◽  
Drug Trials ◽  
Randomized Controlled ◽  
Number Of Patients

Background In 2008, the International Headache Society published guidelines on the “evaluation and registration of adverse events in clinical drug trials on migraine”. They listed seven recommendations for reporting adverse events in randomized controlled trials on migraine. The present study aimed to evaluate adherence to these recommendations, and based on the results, to recommend improvements. Methods We searched the PubMed/MEDLINE database to identify controlled trials on migraine drugs published from 2010 to 2015. For each trial, we noted whether five of the recommended parameters were presented. In addition, we noted whether adverse events were reported in abstracts. Results We identified 73 trials; 51 studied acutely administered drugs and 22 studied prophylactic drugs for migraine. The number of patients with any adverse events were reported in 74% of acute-administration and 86% of prophylactic drug trials. Only 30 (41%) of the 73 studies reported adverse events with data in the abstracts, and 27 (37%) abstracts did not mention adverse events. Conclusion Adverse events, both frequency and symptoms, should be reported to allow a fair judgement of benefit/tolerability ratio when randomized controlled trials in migraine treatment are published. Clinically significant adverse events should be included in the abstract of every randomized controlled trial in migraine treatment.

scholarly journals Liver-related safety assessment of green tea extracts in humans: a systematic review of randomized controlled trials

2016 ◽  
Vol 70 (11) ◽  
pp. 1221-1229 ◽  
Author(s):  
T Isomura ◽  
S Suzuki ◽  
H Origasa ◽  
A Hosono ◽  
M Suzuki ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Randomized Controlled Trials ◽  
Green Tea ◽  
Case Reports ◽  
Intervention Group ◽  
Control Group ◽  
Controlled Trials ◽  
Cochrane Central Register ◽  
Randomized Controlled

Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5–9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.

scholarly journals SURGICAL TECHNIQUES FOR THE TREATMENT OF RECTAL ENDOMETRIOSIS: A SYSTEMATIC REVIEW OF RANDOMIZED CONTROLLED TRIALS AND OBSERVATIONAL STUDIES

2021 ◽  
Vol 58 (4) ◽  
pp. 548-559
Author(s):  
Pedro POPOUTCHI ◽  
Oswaldo Wiliam MARQUES JUNIOR ◽  
Pedro AVERBACH ◽  
Celso Augusto Milani CARDOSO FILHO ◽  
Marcelo AVERBACH
Keyword(s):  
Systematic Review ◽  
Surgical Treatment ◽  
Randomized Controlled Trials ◽  
Observational Studies ◽  
Surgical Techniques ◽  
Segmental Resection ◽  
Common Disease ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Rectal Endometriosis

ABSTRACT BACKGROUND Endometriosis is a common disease in reproductive-age women and it is estimated to occur in up to 50% of those with infertility. Intestinal involvement is reported in up to a third of the cases. This condition is related to chronic pain and loss of quality of life, resulting in emotional, social and economic costs. Treatment consists of hormonal block and surgical resection, with variable side effects and efficacy. The best choice for surgical treatment for rectal endometriosis is a matter of discussion regarding the indication and the best technique to be employed. OBJECTIVE To summarize data on indications, results and complications of surgical techniques for the treatment of rectal endometriosis. METHODS: This comprehensive systematic review is a compilation of the available literature and discussion, carried out by a team with experience in the surgical treatment of intestinal endometriosis. Data regarding indications, results and complications of conservative and radical techniques for the surgical treatment of rectal endometriosis was carefully reviewed. Searches of PubMed, EMBASE, and CENTRAL up to May 2021 were performed to identify randomized controlled trials (RCTs) and observational studies that compared at least two of the three surgical techniques of interest (i.e., shaving, discoid resection, segmental resection). RESULTS: One RCT and nine case series studies with a total of 3,327 patients met the eligibility criteria. Participants ages ranged from a mean of 30.0 to 37.9 years old. Mean follow-up ranged from 1.2 to 42.76 months. With regards the methodological quality, overall the included studies presented a low risk of bias in the majority of the domains. Surgical treatment of rectal endometriosis is indicated for patients with obstructive symptoms and those with pain scores above 7/10. Patients with disease involving beyond muscularis propria of the rectum, documented in magnetic resonance imaging or transvaginal pelvic ultrasound with intestinal preparation, are candidates for discoid or segmental resection. The presence of multifocal disease, extension greater than 3 cm and infiltration greater than 50% of the loop circumference favor the radical technique. The distance from the lesion to the anal verge, age, symptoms and reproductive desire are other factors that influence the choice of the technique to be employed. The risk of complications and unfavorable functional results seems to be directly related to the complexity of the procedure. CONCLUSION: The choice of surgical technique performed for the treatment of rectal endometriosis is a matter of discussion and depends not only on the preoperative staging, but also on the patient’s expectations, risks and potential complications, recurrence rates and the expertise of the multidisciplinary team.

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