Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment.Many well-designed randomized controlled trials(RCTs)of depression have a high proportion ...Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment.Many well-designed randomized controlled trials(RCTs)of depression have a high proportion of placebo responders,with little understanding as to why.The present study assesses characteristics associated with the placebo response in a nutraceutical trial with a large proportion of placebo responders.Methods This is a secondary analysis of a nutraceutical depression RCT which identified no overall treatment benefit relative to placebo(n=69 in placebo group).We investigated participant characteristics such as socio-demographics,clinical features,and recruitment methods,and their association with the placebo response.Monoaminergic genetic polymorphisms were also assessed.Placebo response was measured based on change in Montgomery-Asberg Depression Rating Scale score.The association of these hypothesis-driven variables of interest and the placebo response was examined using linear mixed effects models.Results Greater levels of education,particularly pursuing post-high school education,better self-reported general health,marriage/de facto,greater improvement in the first trial week,and more failed antidepressant therapies in the current depressive episode were associated with greater placebo response.An increased placebo response was not found in those recruited via social media nor in those with concomitant antidepressant therapy.Single nucleotide polymorphisms from the tryptophan hydroxylase 1(TPH1)gene(A779C and A218C)were weakly associated with greater placebo response,although the evidence was attenuated after accounting for multiple comparisons.Conclusion This is,to our knowledge,the first study within nutraceutical research for depression to assess the association between participant characteristics and variation in the placebo response.Several variables appeared to predict the placebo response.Such findings may encourage future trial designs which could dampen placebo response,improve assay sensitivity,and allow for treatment effects to be potentially more detectable.展开更多
BACKGROUND A progressive reduction in the secretion of pancreatic enzymes in patients with chronic pancreatitis(CP)results in malabsorption and ultimate malnutrition.However,the pathogenesis of malnutrition is multifa...BACKGROUND A progressive reduction in the secretion of pancreatic enzymes in patients with chronic pancreatitis(CP)results in malabsorption and ultimate malnutrition.However,the pathogenesis of malnutrition is multifactorial and other factors such as chronic inflammation,alcohol excess and poor dietary intake all contribute.Patients may restrict their dietary intake due to poor appetite or to avoid gastrointestinal symptoms and abdominal pain.Whilst up to half of patients with chronic pancreatitis are reportedly malnourished,the dietary intake of patients with CP is relatively understudied and has not been systematically reviewed to date.AIM To perform a systematic review and meta-analysis of the dietary intakes of patients with CP compared to healthy controls,and to compare the dietary intake of patients with alcohol-related CP and non-alcohol-related CP.METHODS A systematic literature search was performed using EMBASE,MEDLINE,and Cochrane review on studies published between 1946 and August 30th,2019.Adult subjects with a diagnosis of CP who had undergone dietary assessment were included in the systematic review(qualitative analysis).Studies on patients with other pancreatic diseases or who had undergone pancreatic surgery were not included.Studies comparing the dietary intake of patients with CP to that of healthy controls were included in the meta-analysis(quantitative analysis).Metaanalysis was performed using Review Manager 5.3.Newcastle Ottawa Scale(NOS)was used to assess quality of studies.RESULTS Of 6715 studies retrieved in the search,23 were eligible for qualitative analysis while 12 were eligible for quantitative analysis.In the meta-analysis,the total energy(calorie)intake of patients with CP was similar to that of healthy controls[mean difference(MD):171.3;95%confidence interval(CI):-226.01,568.5;P=0.4],however patients with CP consumed significantly fewer non-alcohol calories than controls[MD:-694.1;95%CI:-1256.1,(-132.1);P=0.02].CP patients consumed more protein,but carbohydrate and fat intakes did not differ significantly.Those with alcohol-related CP consumed more mean(standard deviation)calories than CP patients with a non-alcohol aetiology[2642(1090)kcal and 1372(394)kcal,respectively,P=0.046],as well as more protein,fat,but not carbohydrate.CONCLUSION Although patients with CP had similar calorie intake to controls,studies that analysed the contribution of alcohol to energy intake showed that patients with CP consumed fewer non-alcohol calories than healthy controls.A high calorie intake,made up to a large degree by alcohol,may in part contribute to poor nutritional status in CP.展开更多
The rates of overweight and obesity are rising to epidemic proportions globally, especially among women. Obesity is increasingly common in the obstetric population as well. Sri Lanka is not an exception to this regard...The rates of overweight and obesity are rising to epidemic proportions globally, especially among women. Obesity is increasingly common in the obstetric population as well. Sri Lanka is not an exception to this regard. There is limited published data on maternal perceptions on obesity in pregnancy, gestational weight gain and its complications. The current study aimed to describe the maternal perception on obesity, their knowledge on complications of obesity in pregnancy and gestational weight gain in pregnant mothers. Hospital based descriptive cross sectional study was conducted among a systematic sample of 416 pregnant women registered for antenatal clinic care at De Soyza Maternity Hospital. Pre-tested interviewer administered questionnaire was used for data collection. Maternal BMI at booking visit was taken from the pregnancy record to assess the overweight/obesity prevalence among the study population. Nearly one third (32.2%) of the study population were overweight and 11.8% were obese. Fifty three percent (53%) of overweight women identified themselves as such, but 45% of them considered themselves to be normal weight. Most of the pregnant women in the study sample (59.6%) were unable to estimate the recommended weight gain in pregnancy. Women’s knowledge on the specific risks associated with maternal obesity was poor. Pregnant mother’s knowledge on obesity, gestational weight gain and its consequences were unsatisfactory. Bridging this knowledge gap is an important step towards improving perinatal outcomes for all pregnant mothers in the current obesity epidemic.展开更多
PURPOSE: The Drusen Laser Study evaluated macular laser to prevent choroidal neovascularization (CNV) and vision loss in high-risk age-related maculopathy (ARM). DESIGN: Prospective, interventional, randomized, contro...PURPOSE: The Drusen Laser Study evaluated macular laser to prevent choroidal neovascularization (CNV) and vision loss in high-risk age-related maculopathy (ARM). DESIGN: Prospective, interventional, randomized, controlled clinical trial in five hospital centers. METHODS: Patients in the unilateral group had neovascular ARM and drusen in the study eye. Study eyes were randomized to laser-treated or no-laser groups. For patients in the bilateral drusen group, eyes were randomized to right eye, laser or no laser; and left eye, alternative. Laser treatment comprised 12 argon spots. Outcome was best-corrected visual acuity and CNV signs, which were monitored for 3 years. RESULTS: In the unilateral group, vision loss occurred in 21 (28.8%) of 73 patients in laser vs 13 (19.7%) of 66 no-laser patients (P=.214). Incidence of CNV was 27 (29.7%) of 91 in laser vs 15 (17.65%) of 85 no-laser patients (P=.061). CNV onset was approximately 6 months earlier in laser-treated compared with no-laser patients (P=.05). In the bilateral group, vision loss occurred in six (8.3%)-of 72 laser-treated vs 10 (13.9%) of 72 fellow eyes (P=.3877). CNV incidence was 12 (11.6%) of 103 in laser-treated vs seven (6.8%) of 103 fellow eyes (P=.225). There was no difference in onset of CNV. CONCLUSIONS: Results do not support prophylactic laser of the fello weye of patients with neovascular ARM. Its role in patients with bilateral drusen remains unclear.展开更多
Background: Pain is a major problem for patients suffering from chronic pancreatitis. Unfortunately, medical therapy often fails to adequately control pain. Coeliac plexus block (CPB) is sometimes performed to treat i...Background: Pain is a major problem for patients suffering from chronic pancreatitis. Unfortunately, medical therapy often fails to adequately control pain. Coeliac plexus block (CPB) is sometimes performed to treat intractable pain in patients with chronic pancreatitis. Aims: Our primary objective was to determine the effect of CPB for pain management in a cohort of patients with chronic pancreatitis. We also sought to quantify opioid use in patients with chronic pancreatitis. Methods: We reviewed the database of pain referrals for chronic pancreatitis and recorded opioid use for each patient. We interviewed all patients who underwent CPB for chronic pancreatitis at TUH from January 2018-December 2020. Effect of the block, duration of pain relief, analgesia requirements, complications and patient satisfaction were recorded. Results: 62 inpatient referrals were made to the pain service over a 3-year period regarding pain management in chronic pancreatitis. 76% of patients referred for chronic pancreatitis pain management require regular long-term opioids. Mean daily oxycodone requirement in this group was 52 mg. 11 of these patients underwent CPB over a 3-year period. Mean age of patients who underwent CPB was 44 years. Effective reduction in pain scores (>50% improvement) was achieved in 7 of 11 patients. The mean NRS pain score decreased from 9.2 (±0.9) to 4.4 (±3.1). Mean duration of pain relief experienced was 69 days. Transient diarrhoea was reported by 1 patient. 4 patients reported a temporary decrease in oral analgesia requirement, while 3 patients reported a sustained decrease in analgesia requirement post CPB. For those who had further CPBs, the effect of repeated interventions was comparable to the initial procedure. Conclusion: High regular opioid consumption is common in patients with chronic pancreatitis. CPB can provide significant improvement in pain control and quality of life in appropriately selected patients. CPB can assist with opioid reduction and containment. It is not effective in all cases and there is high inter-patient variability. The procedure has a good safety profile.展开更多
Introduction:Pseudoainhum(dactylolysis spontanea)is characterized by the development of a fibrous band around the digit that gradually leads to autoamputation.Digital pain associated with Pseudoainhum may not be evide...Introduction:Pseudoainhum(dactylolysis spontanea)is characterized by the development of a fibrous band around the digit that gradually leads to autoamputation.Digital pain associated with Pseudoainhum may not be evident in patients with neuropathic conditions.Here,we present a rare case of pseudoainhum patient,which describes a very rare association of pseudoainhum with leprosy.Case presentation:A 48 year old male with lepromatous leprosy,with resorption of digits,charcot joints and tropical ulcers was seen in the clinic.The forth digit of the left hand had a narrowing due to a fibrous band at the 2nd inter phalangeal joint with shiny tethering distal phalanx.He could not recall the duration of the ainhum.He was not suffering from any pain.Discussion:The current report describes a very rare association of pseudoainhum with leprosy.The case involved a 48-year-old man in the dermatology ward with lepromatous leprosy presenting with a pseudoainhum.Conclusion:This case highlights the possibility of delayed presentation of patients with pseudoainhum to physicians when the patients have underlying neuropathic conditions that prevent feeling finger pain and cause abnormal appearance of the digits,especially in leprosy.展开更多
基金funded by an Australian National Health and Medical Research Council project grant (No. APP1048222) and was co-sponsored by FITBio Ceuticals (who provided the trial product and placebo)supported by an NHMRC Fellowship (No. APP1125000)supported by a NHMRC Senior Principal Research Fellowship (No. 1059660 and 1156072)
文摘Objective The placebo response in depression studies is the change in symptoms amongst those who receive an inactive treatment.Many well-designed randomized controlled trials(RCTs)of depression have a high proportion of placebo responders,with little understanding as to why.The present study assesses characteristics associated with the placebo response in a nutraceutical trial with a large proportion of placebo responders.Methods This is a secondary analysis of a nutraceutical depression RCT which identified no overall treatment benefit relative to placebo(n=69 in placebo group).We investigated participant characteristics such as socio-demographics,clinical features,and recruitment methods,and their association with the placebo response.Monoaminergic genetic polymorphisms were also assessed.Placebo response was measured based on change in Montgomery-Asberg Depression Rating Scale score.The association of these hypothesis-driven variables of interest and the placebo response was examined using linear mixed effects models.Results Greater levels of education,particularly pursuing post-high school education,better self-reported general health,marriage/de facto,greater improvement in the first trial week,and more failed antidepressant therapies in the current depressive episode were associated with greater placebo response.An increased placebo response was not found in those recruited via social media nor in those with concomitant antidepressant therapy.Single nucleotide polymorphisms from the tryptophan hydroxylase 1(TPH1)gene(A779C and A218C)were weakly associated with greater placebo response,although the evidence was attenuated after accounting for multiple comparisons.Conclusion This is,to our knowledge,the first study within nutraceutical research for depression to assess the association between participant characteristics and variation in the placebo response.Several variables appeared to predict the placebo response.Such findings may encourage future trial designs which could dampen placebo response,improve assay sensitivity,and allow for treatment effects to be potentially more detectable.
基金The Meath Foundation of Tallaght University Hospital,No.117/2020.
文摘BACKGROUND A progressive reduction in the secretion of pancreatic enzymes in patients with chronic pancreatitis(CP)results in malabsorption and ultimate malnutrition.However,the pathogenesis of malnutrition is multifactorial and other factors such as chronic inflammation,alcohol excess and poor dietary intake all contribute.Patients may restrict their dietary intake due to poor appetite or to avoid gastrointestinal symptoms and abdominal pain.Whilst up to half of patients with chronic pancreatitis are reportedly malnourished,the dietary intake of patients with CP is relatively understudied and has not been systematically reviewed to date.AIM To perform a systematic review and meta-analysis of the dietary intakes of patients with CP compared to healthy controls,and to compare the dietary intake of patients with alcohol-related CP and non-alcohol-related CP.METHODS A systematic literature search was performed using EMBASE,MEDLINE,and Cochrane review on studies published between 1946 and August 30th,2019.Adult subjects with a diagnosis of CP who had undergone dietary assessment were included in the systematic review(qualitative analysis).Studies on patients with other pancreatic diseases or who had undergone pancreatic surgery were not included.Studies comparing the dietary intake of patients with CP to that of healthy controls were included in the meta-analysis(quantitative analysis).Metaanalysis was performed using Review Manager 5.3.Newcastle Ottawa Scale(NOS)was used to assess quality of studies.RESULTS Of 6715 studies retrieved in the search,23 were eligible for qualitative analysis while 12 were eligible for quantitative analysis.In the meta-analysis,the total energy(calorie)intake of patients with CP was similar to that of healthy controls[mean difference(MD):171.3;95%confidence interval(CI):-226.01,568.5;P=0.4],however patients with CP consumed significantly fewer non-alcohol calories than controls[MD:-694.1;95%CI:-1256.1,(-132.1);P=0.02].CP patients consumed more protein,but carbohydrate and fat intakes did not differ significantly.Those with alcohol-related CP consumed more mean(standard deviation)calories than CP patients with a non-alcohol aetiology[2642(1090)kcal and 1372(394)kcal,respectively,P=0.046],as well as more protein,fat,but not carbohydrate.CONCLUSION Although patients with CP had similar calorie intake to controls,studies that analysed the contribution of alcohol to energy intake showed that patients with CP consumed fewer non-alcohol calories than healthy controls.A high calorie intake,made up to a large degree by alcohol,may in part contribute to poor nutritional status in CP.
文摘The rates of overweight and obesity are rising to epidemic proportions globally, especially among women. Obesity is increasingly common in the obstetric population as well. Sri Lanka is not an exception to this regard. There is limited published data on maternal perceptions on obesity in pregnancy, gestational weight gain and its complications. The current study aimed to describe the maternal perception on obesity, their knowledge on complications of obesity in pregnancy and gestational weight gain in pregnant mothers. Hospital based descriptive cross sectional study was conducted among a systematic sample of 416 pregnant women registered for antenatal clinic care at De Soyza Maternity Hospital. Pre-tested interviewer administered questionnaire was used for data collection. Maternal BMI at booking visit was taken from the pregnancy record to assess the overweight/obesity prevalence among the study population. Nearly one third (32.2%) of the study population were overweight and 11.8% were obese. Fifty three percent (53%) of overweight women identified themselves as such, but 45% of them considered themselves to be normal weight. Most of the pregnant women in the study sample (59.6%) were unable to estimate the recommended weight gain in pregnancy. Women’s knowledge on the specific risks associated with maternal obesity was poor. Pregnant mother’s knowledge on obesity, gestational weight gain and its consequences were unsatisfactory. Bridging this knowledge gap is an important step towards improving perinatal outcomes for all pregnant mothers in the current obesity epidemic.
文摘PURPOSE: The Drusen Laser Study evaluated macular laser to prevent choroidal neovascularization (CNV) and vision loss in high-risk age-related maculopathy (ARM). DESIGN: Prospective, interventional, randomized, controlled clinical trial in five hospital centers. METHODS: Patients in the unilateral group had neovascular ARM and drusen in the study eye. Study eyes were randomized to laser-treated or no-laser groups. For patients in the bilateral drusen group, eyes were randomized to right eye, laser or no laser; and left eye, alternative. Laser treatment comprised 12 argon spots. Outcome was best-corrected visual acuity and CNV signs, which were monitored for 3 years. RESULTS: In the unilateral group, vision loss occurred in 21 (28.8%) of 73 patients in laser vs 13 (19.7%) of 66 no-laser patients (P=.214). Incidence of CNV was 27 (29.7%) of 91 in laser vs 15 (17.65%) of 85 no-laser patients (P=.061). CNV onset was approximately 6 months earlier in laser-treated compared with no-laser patients (P=.05). In the bilateral group, vision loss occurred in six (8.3%)-of 72 laser-treated vs 10 (13.9%) of 72 fellow eyes (P=.3877). CNV incidence was 12 (11.6%) of 103 in laser-treated vs seven (6.8%) of 103 fellow eyes (P=.225). There was no difference in onset of CNV. CONCLUSIONS: Results do not support prophylactic laser of the fello weye of patients with neovascular ARM. Its role in patients with bilateral drusen remains unclear.
文摘Background: Pain is a major problem for patients suffering from chronic pancreatitis. Unfortunately, medical therapy often fails to adequately control pain. Coeliac plexus block (CPB) is sometimes performed to treat intractable pain in patients with chronic pancreatitis. Aims: Our primary objective was to determine the effect of CPB for pain management in a cohort of patients with chronic pancreatitis. We also sought to quantify opioid use in patients with chronic pancreatitis. Methods: We reviewed the database of pain referrals for chronic pancreatitis and recorded opioid use for each patient. We interviewed all patients who underwent CPB for chronic pancreatitis at TUH from January 2018-December 2020. Effect of the block, duration of pain relief, analgesia requirements, complications and patient satisfaction were recorded. Results: 62 inpatient referrals were made to the pain service over a 3-year period regarding pain management in chronic pancreatitis. 76% of patients referred for chronic pancreatitis pain management require regular long-term opioids. Mean daily oxycodone requirement in this group was 52 mg. 11 of these patients underwent CPB over a 3-year period. Mean age of patients who underwent CPB was 44 years. Effective reduction in pain scores (>50% improvement) was achieved in 7 of 11 patients. The mean NRS pain score decreased from 9.2 (±0.9) to 4.4 (±3.1). Mean duration of pain relief experienced was 69 days. Transient diarrhoea was reported by 1 patient. 4 patients reported a temporary decrease in oral analgesia requirement, while 3 patients reported a sustained decrease in analgesia requirement post CPB. For those who had further CPBs, the effect of repeated interventions was comparable to the initial procedure. Conclusion: High regular opioid consumption is common in patients with chronic pancreatitis. CPB can provide significant improvement in pain control and quality of life in appropriately selected patients. CPB can assist with opioid reduction and containment. It is not effective in all cases and there is high inter-patient variability. The procedure has a good safety profile.
文摘Introduction:Pseudoainhum(dactylolysis spontanea)is characterized by the development of a fibrous band around the digit that gradually leads to autoamputation.Digital pain associated with Pseudoainhum may not be evident in patients with neuropathic conditions.Here,we present a rare case of pseudoainhum patient,which describes a very rare association of pseudoainhum with leprosy.Case presentation:A 48 year old male with lepromatous leprosy,with resorption of digits,charcot joints and tropical ulcers was seen in the clinic.The forth digit of the left hand had a narrowing due to a fibrous band at the 2nd inter phalangeal joint with shiny tethering distal phalanx.He could not recall the duration of the ainhum.He was not suffering from any pain.Discussion:The current report describes a very rare association of pseudoainhum with leprosy.The case involved a 48-year-old man in the dermatology ward with lepromatous leprosy presenting with a pseudoainhum.Conclusion:This case highlights the possibility of delayed presentation of patients with pseudoainhum to physicians when the patients have underlying neuropathic conditions that prevent feeling finger pain and cause abnormal appearance of the digits,especially in leprosy.
