Improvement In Sleep Scores Research Articles

Effectiveness of promethazine on preoperative and intraoperative sequelae in cleft palate surgeries.

Anxiety and nosocomial infection are the most common reported problems in children undergoing cleft surgeries. Research shows that there is an enigma in the use of antihistamine therapy in children for the management of upper respiratory tract infection. 'Promethazine' is a first-generation H1 receptor antagonist, and antihistamine also has strong sedative effects. Our study aims at evaluating the Effectiveness of Promethazine (Phenergan) in preoperative and intra operative sequelae in cleft surgeries. This is a single-centre, parallel, randomized, double-blinded randomized control clinical trial, which was conducted among 128 children between 2 and 4 years of age undergoing cleft palate surgery under general anaesthesia. After randomization, the case group was subjected to promethazine syrup 1 mg/kg body weight twice a day, orally for 3 days. The primary outcomes were preoperative anxiety levels which were recorded by children fear scale. The secondary outcomes include preoperative sleep quality and cough rate of children which are recorded by using sleep and cough objective scale respectively. The intraoperative heart rate is monitored with an ECG connected to a monitor. Promethazine causes a reduction in the anxiety level by 70%, 64% reduction in cold and cough, improvement in sleep score by 70% and the heart rate was found to be stable throughout the surgery when compared to the control group. As the benefits of promethazine in cleft palate surgery rule over its adverse effects, promethazine is considered safe to be used as premedication for children undergoing cleft palate surgeries.

Effect of promethazine in cleft surgeries among Indian children.

The use of antihistamine therapy in children for the management of upper respiratory tract infections remains a topic of debate. In this study, we focused on evaluating the effectiveness of promethazine (Phenergan), a first-generation H1 receptor antagonist and sedative, in addressing preoperative and intra-operative sequelae in cleft surgeries. A single-centered, parallel, randomized, double-blinded controlled clinical trial was conducted on 128 children aged 2 to 4 years undergoing cleft palate surgery under general anesthesia. The case group received Phenergan syrup orally twice a day for three days, while the control group received a placebo. Primary outcomes measured preoperative anxiety levels using a children's fear scale, while secondary outcomes assessed preoperative sleep quality and cough rate through objective scales. Intraoperative heart rate was monitored using an ECG connected to a monitor. The results demonstrated that the administration of promethazine resulted in a 34% reduction in anxiety levels, a 46% reduction in cold and cough, a 38% improvement in sleep score, and stable heart rates throughout the surgery compared to the control group. Based on these findings, promethazine is considered a safe premedication option for children undergoing cleft palate surgeries; given its benefits outweigh its adverse effects.

0343 In-person Expert Pillow Fitting Process Improves Sleep Quality and Duration

Abstract Introduction The myriad of anecdotal claims about the benefits of different pillow types may complicate consumers’ ability to find a pillow that can support better sleep. Services that provide consumers with personalized recommendations may address this problem. This study examined the sleep of research participants using pillows selected during an in-store pillow fitting process compared to using their original pillows. Methods Healthy adults (71% female, ages 21-59) who reported interest in a new pillow participated in a 9-week field study using a pre-post intervention design. The intervention consisted of being guided through the Mattress Firm in-store pillow fitting process to be paired with a pillow that provided the best fit and support based on body type and sleeping position preferences. During the 4-week baseline period, participants used their regular pillow. Once they were fit for their new pillow, participants slept with that pillow for 5 weeks, including a 1-week adjustment period. Sleep was measured objectively using SleepScore Max every night and by daily and pre-post self-report. Multilevel regression and paired t-tests and were used to test for statistical significance. Results There were 722 nights of tracked sleep across participants (n=17). Objective sleep measurements showed nightly improvement in SleepScore, a measure of objective sleep quality (p=.003), longer time in bed (+13 minutes, p=.034),longer sleep duration (+16 minutes, p=.010), a lower proportion of the night awake after falling asleep (p=.009), and better sleep maintenance (p=.009). In addition, participants got more deep sleep (+5.6 minutes, p=.017) and showed improved BodyScore, a measure of deep sleep (p=.031). Self-reported measures showed improvements in pillow comfort and overall comfort in bed; perceived ability to sleep through the night; perceived reduction in number of awakenings and amount of time awake at night; better overall sleep quality; and feeling more well-rested in the morning when using the fitted pillows compared to baseline (all ps <.05). Conclusion Objective and self-reported sleep improved among healthy adults using a pillow selected by an expert, in-person pillow fitting process. The results suggest that a pillow fitting process can improve sleep by helping individuals find a pillow that provides a personalized fit and optimal comfort. Support (If Any) Mattress Firm INC

The Effect of a Gluten-Free Diet on Sleep Disturbances in Children with Celiac Disease.

PurposeSleep disturbances are common in patients with celiac disease (CD), but their response to a gluten-free diet (GFD) treatment remains scarce. This study investigated the alteration in sleep disturbances within 6 months of starting a GFD in children with CD.Patients and MethodsA total of 103 children initially diagnosed with CD, with no psychiatric diagnosis and not receiving psychotropic medication, were included in this study. Sociodemographic data were collected, and the Children’s Sleep Habits Questionnaire (CSHQ) was completed both before and after six months of initiating a GFD.ResultsOverall, the total average CSHQ score was 46; after starting the GFD, this decreased to 40, which was under the clinically significant cutoff level for sleep disturbance (p < 0.001). A total of 74 patients (71.8%) had a CSHQ score above the clinically significant cutoff before treatment, which decreased to 40 patients (38.8%) six months after GFD (p < 0.001). A significant improvement was detected in all CSHQ subscale scores and in the total CSHQ score after starting the GFD (p < 0.001). Parasomnia and the total CSHQ score were higher in children who were diagnosed incidentally compared to symptomatic children but did not differ after GFD (p < 0.005). In 39 patients (37.8%), the total CSHQ score remained high 6 months after starting the GFD. Maternal and paternal ages were significantly higher in children whose scores remained high (p < 0.05).ConclusionA significant improvement in sleep scores was detected after starting a GFD, regardless of initial age, sex, and symptom status. With a GFD, children may fall asleep more easily and sleep for longer with less interruptions. GFD may help to reduce sleep disturbances in CD, but future studies should investigate the certain conditions in patients who do not respond to a GFD.

Evaluation of the effects of ketogenic diet therapy on sleep quality in children with drug-resistant epilepsy and their mothers

BackgroundSleep disorders are common in drug-resistant children with epilepsy and their mothers. Ketogenic diet therapy (KDT) may have positive effects on sleep quality. The aim of this study was to evaluate the sleep quality of children with epilepsy and their mothers after starting KDT. MethodsUsing a prospective cross-sectional model, pre- and post-KDT questionnaires were given to the study subjects. A children’s sleep habits questionnaire was administered to children with epilepsy, and the Pittsburgh sleep questionnaire was administered to their mothers. Sociodemographic and some clinical categorical variables of the patient group were evaluated using descriptive statistics. Evaluation of the data was conducted using the Wilcoxon and paired t-tests as parametric and non-parametric tests. ResultsOf 24 patients scheduled to begin KDT between January 2019 and January 2020, 14 were included in the study. Regarding sleep quality, improvement was reported in 7 (50%) of 14 patients, deterioration in 5 (35.7%) patients, and no change was seen in 2 (14.3%) patients. Sleep quality was reported to improve in all working mothers. Seven (50%) patients reported no seizures and 6 (42.9%) patients reported more than 50% seizure reduction. Although there were improvements in sleep scores in both groups, these improvements were not statistically significant. A significant decrease in sleep anxiety was reported in children after the third month of the KDT (p = 0.09). ConclusionsThe results of this study determined that three months of KDT offered significant improvement on the sleep anxiety of children with epilepsy. It was thought that paying attention to patient selection may lead to better sleep quality by increasing compliance to KDT. However, a larger scale study and longer term follow-up should be done.

P126 The effectiveness of pharmacological interventions and cognitive behavioural therapy in improving sleep in fibromyalgia: a systematic review

Abstract Background/Aims Fibromyalgia (FM) is a common yet complex musculoskeletal condition. Sleep disturbance frequently coexists with FM yet optimal management of this important association is unclear. Current standard treatment for FM in general often includes a combination of pharmacological and psychological treatments - most commonly cognitive behavioural therapy (CBT). This systematic review aims to critically appraise the evidence regarding the effectiveness of these treatments at improving sleep in FM. Methods Pre-defined search terms were entered into PubMed, Cochrane CENTRAL, Embase, Medline and CINAHL. Randomised controlled trials (RCTs) studying the effectiveness of any pharmacological intervention or CBT (including electronic CBT) in managing FM-associated sleep disturbances in adults were included. Results Of 682 RCTs identified, 56 (n = 17,005; aged 18-84) met the inclusion criteria: 45 pharmacological studies assessing 24 medications and 11 CBT-based studies. Sleep assessment methods varied between studies, the most common being the visual analogue scale. The most common pharmacological interventions were pregabalin (n = 8) and milnacipran (n = 8), followed by sodium oxybate (n = 4), amitriptyline (n = 4) and fluoxetine (n = 3). Although outcome measures differed across the pregabalin studies, they all showed varying degrees of sleep improvement. Conversely, only 2/8 studies of milnacipran showed improved sleep scores. All 4 studies investigating sodium oxybate showed significant improvements in the Jenkins Sleep Scale. Only 1/4 study analysing amitriptyline and 1/3 assessing fluoxetine showed statistically significant improvement in sleep scores compared to placebo. The remaining 18 pharmacological studies included multiple antidepressants and analgesic agents, with a wide range of efficacy at improving sleep scores. The 11 CBT-based studies typically compared CBT to sleep hygiene or standard pharmacological therapies. Traditional, online and combined CBT methodologies (all n = 4), CBT for insomnia (CBT-I) (n = 7) and/or pain (CBT-P) (n = 4) were all evaluated. Studies conducting CBT-I and CBT-P showed significant improvements in the Pittsburgh Sleep Quality Index and self-reported sleep diaries. Long-term traditional CBT improved sleep in both included studies. One study using multicomponent CBT also showed significant sleep improvements. Only one study assessed online CBT, showing no significant results, though there was a trend towards improved sleep. Conclusion The optimal management of sleep disorders in FM is complex and needs to be tailored to the individual patient. We have shown that there are varying degrees of efficacy throughout a range of commonly used drugs in FM. Unfortunately, lack of consistency in outcome measures between studies makes it difficult to draw definitive conclusions pertaining to superiority between these agents. Conversely, CBT interventions appear to show consistent sleep improvement in FM. It is not clear whether this translates to online variations of CBT. We believe that a longitudinal appraisal of sleep as a primary variable, with robust consistent outcome measures, using pharmacological interventions with CBT would benefit future research. Disclosure A. Pathak: None. I. Brennan: None. R. Amarnani: None. A. Soni: Grants/research support; UCB Prize Fellowship.

Music tuned to 432 Hz versus music tuned to 440 Hz for improving sleep in patients with spinal cord injuries: a double-blind cross-over pilot study.

Background and aim of the work.Among people with spinal cord injuries, sleep disorders are considered one of the top well-being priorities. Some studies suggest that listening to music promotes sleep and improves its quality. These studies usually used music standardised at the frequency of 440 Hz. The aim of the present study is to compare the effects of listening to music tuned to 440 Hz and music tuned to 432 Hz on sleep in patients with spinal cord injuries.Methods.Double-blind cross-over pilot study in a single Italian Spinal Unit. 12 patients with spinal injuries were provided with mp3 players loaded with their favourite music tuned to 440 Hz or 432 Hz. They were invited to listen to music for 30 minutes each day, in the two periods of the study. “Sleep Scale for Medical Study” modified for this study, and the “Perceived Stress Scale” were chosen.Results.The participants were eight males (mean age =58.12, SD ±13.62), and four females (mean age =56.25, SD ±14.17). Five were quadriplegics and seven were paraplegics. Listening times and wash-out periods were variable. The stress decreased, but not significantly, with listening to music at both frequencies. After listening to music at 432 Hz there was a significant improvement in sleep scores (+3.6, p=0.02), while there was no improvement in sleep scores listening to music at 440 Hz (-1.50, p=0.34).Conclusions.The results suggest that further studies on music interventions at 432 Hz should be performed. It is advisable to increase sample sizes and use a range of different research methods. (www.actabiomedica.it)

Effect of caffeine on sleep and behaviour in nursing home residents with dementia

Background and goalSleep problems and challenging behavioural symptoms are frequently reported among nursing home residents with dementia. Coffee with caffeine is consumed frequently by these residents and can have a negative effect on sleep and behaviour in older persons with dementia. In this interventional study, the effect of caffeine reduction on sleep and challenging behavioural symptoms in nursing home residents with dementia was investigated.MethodsIn 21 nursing home residents with dementia living in 1 dementia special care unit, caffeine was gradually eliminated in the afternoon and evening. During pre-intervention and post-intervention period the care workers daily scored sleep by a specially developed sleep questionnaire. Behavioural symptoms were scored in the afternoon and evening using four items of the NPI-NH: agitation/aggression, apathy, irritability and aberrant motor behaviour.ResultsA significant improvement in sleep scores (Wilcoxon signed-rank test, p = 0.015) and apathy (Wilcoxon signed-rank test, p = 0.020) was found after eliminating caffeine intake in the afternoon and evening. No significant changes occurred in agitation/aggression, irritability and aberrant motor behaviour.DiscussionThis pre-post pilot study found a significant positive effect of caffeine reduction on sleep and apathy and warrants further investigation in a larger controlled study.

Comparative Effectiveness of Ultrasound-Guided Intratendinous Prolotherapy Injection with Conventional Treatment to Treat Focal Supraspinatus Tendinosis.

Objective To evaluate the efficacy of dextrose prolotherapy injection for focal supraspinatus rotator cuff tendinosis via outcomes such as functional score, range of movement, and real-time ultrasound parameters. Materials and Methods 12 adult patients with focal supraspinatus tendinosis recruited after they had less than 30% improvement in functional (DASH) scores after one month of physiotherapy following initial presentation. Seven patients had 0.5–1.0 ml of prolotherapy injection (12.5% dextrose, 0.5% lignocaine) injected into the area of focal tendinosis under ultrasound guidance. Meanwhile, five patients continued standard physiotherapy with no intervention performed. Regional area of echogenicity in decibels, DASH, range of movements of the shoulder, pain, and sleep scores were measured at baseline and at 12 weeks. Results The prolotherapy group showed significant improvement in shoulder abduction (p=0.030) and an improvement in sleep score (p=0.027). The echogenicity of area of tendinosis significantly increases at the end of treatment (p=0.009). However, there was a nonsignificant reduction in pain score in the injection group (43.5%) and in the control group (25%) at 12 weeks (p > 0.005). Conclusion Ultrasound-guided intratendinous prolotherapy injection significantly improves patient's range of abduction and improves sleep within 12 weeks of treatment compared to conventional physiotherapy management. Trial Registration This study was registered under Current Controlled Trials (UK) and given International Standard Randomised Controlled Trial Number (ISRCTN) of 43520960.

The Effect of Over-the-Counter Medication on Symptom Severity Following Sport-Related Concussion

PURPOSE: Although over-the-counter (OTC) medications are commonly administered following sport-related concussion, their effect on reducing symptoms remains unknown. We sought to examine the effect of nonsteroidal anti-inflammatory drugs (NSAIDs) and melatonin on post-concussion symptom severity. METHODS: We conducted a prospective cohort study of patients who presented to a sport concussion clinic within 21 days of injury. We examined the effect of NSAID use on the sum of “Headache” and “Pressure in the Head” scores (HA score) on the post-concussion symptom scale (PCSS) endorsed by the international consensus on concussion in sport. In addition, we examined the effect of melatonin on “Trouble Falling Asleep” scores (Sleep score). Patients who reported taking NSAIDs (n=30) and melatonin (n=16) were matched by age, gender, HA or Sleep score respectively, and overall PCSS scores with controls (n=70 and 35 respectively) who did not report the use of these medications. Mean differences in PCSS scores from the initial clinic visit and first follow-up visit were compared by repeated measures ANOVA. RESULTS: There was significant improvement in mean HA score for both NSAID users (6.4 vs. 3.7; p<0.001) and non-users (6.6 vs.2.8; p<0.001). The mean difference in HA score between initial visit and follow-up visit of NSAID users was not significantly different than that of non-users (2.7 vs. 3.8; p=0.102). Similarly, there was significant improvement in Sleep score between visits in both melatonin users (3.8 vs. 2.0; p<0.001) and non-users (3.7 vs. 1.6; p<0.001) showed. The mean difference in Sleep score between initial visit and follow-up visit, however, did not differ between those who used melatonin and those who didn’t (1.8 vs. 2.1; p=0.691). CONCLUSION: Headache symptom severity and difficulty falling asleep are commonly treated following concussion using OTC medications such as NSAIDs and melatonin. Our results suggest that symptom severity improves over time, but this effect may not be enhanced by the use of OTC medications.

Mastication movements and sleep quality of patients with myofascial pain: Occlusal device therapy improvements

Patients with myofascial pain experience impaired mastication, which might also interfere with their sleep quality. The purpose of this study was to evaluate the jaw motion and sleep quality of patients with myofascial pain and the impact of a stabilization device therapy on both parameters. Fifty women diagnosed with myofascial pain by the Research Diagnostic Criteria were enrolled. Pain levels (visual analog scale), jaw movements (kinesiography), and sleep quality (Epworth Sleepiness Scale; Pittsburgh Sleep Quality Index) were evaluated before (control) and after stabilization device use. Range of motion (maximum opening, right and left excursions, and protrusion) and masticatory movements during Optosil mastication (opening, closing, and total cycle time; opening and closing angles; and maximum velocity) also were evaluated. Repeated-measures analysis of variance in a generalized linear mixed models procedure was used for statistical analysis (α=.05). At baseline, participants with myofascial pain showed a reduced range of jaw motion and poorer sleep quality. Treatment with a stabilization device reduced pain (P<.001) and increased both mouth opening (P<.001) and anteroposterior movement (P=.01). Also, after treatment, the maximum opening (P<.001) and closing (P=.04) velocities during mastication increased, and improvements in sleep scores for the Pittsburgh Sleep Quality Index (P<.001) and Epworth Sleepiness Scale (P=.04) were found. Myofascial pain impairs jaw motion and quality of sleep; the reduction of pain after the use of a stabilization device improves the range of motion and sleep parameters.

Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome

Improving sleep for patients with restless legs syndrome. Part II: meta-analysis of vibration therapy and drugs approved by the FDA for treatment of restless legs syndrome Fred Burbank,1 Mark J Buchfuhrer,2 Branko Kopjar3 1Salt Creek International Women&#39;s Health Foundation, San Clemente, CA, 2Stanford University Center for Sleep Sciences, Downey, CA, 3Department of Health Services, University of Washington, Seattle, WA, USA Background: Vibratory stimulation pads have been shown to improve sleep in patients with restless legs syndrome (RLS) to a greater extent than sham therapy. The current gold standard of treatment is drugs approved by the US Food and Drug Administration (FDA) for use in RLS. The aim of this meta-analysis was to compare the efficacy and safety of vibratory stimulation pads, sham pads, and drugs approved by the FDA for use in RLS. Methods: We searched the PubMed, Embase, and clinical trial websites to identify the relevant randomized, double-blind, and placebo-controlled or sham-controlled studies. Fifteen studies including a combined total of 3455 patients with at least moderately severe primary RLS met our search criteria. Efficacy was defined as the standardized mean difference in sleep improvement between treatment and controls. Safety was assessed by comparing the odds ratios of any adverse events and adverse events leading to study withdrawal between treatment and control subjects. Results: Improvement in Medical Outcomes Study (MOS) sleep inventory scores from baseline was significantly greater in patients treated with vibratory stimulation pads than in those receiving sham pads (Hedges&#39;s g, standardized mean difference &minus;0.39, P &le; 0.02). There was no difference in improvement in sleep scores between patients treated with vibratory stimulation pads (&minus;0.39) and those receiving an approved RLS drug (&minus;0.44, P &gt; 0.70). The risk of any adverse event or withdrawal because of an adverse event was not significantly different between patients treated with vibratory stimulation pads and those assigned to sham pads (Mantel-Haenszel odds ratio 2.16 [P &gt; 0.14] and 1.39 [P &gt; 0.80], respectively). The odds ratios for patients reporting any adverse events and adverse events leading to withdrawal were not significantly different between patients treated with vibratory stimulation pads (2.16 and 1.39, respectively) and those who received approved RLS drugs (2.11 [P &gt; 0.89] and 2.07 [P &gt; 0.82], respectively, mixed-effects model). Conclusion: For patients with moderately severe RLS, vibratory stimulation pads were more effective than sham pads for improving sleep, as effective as FDA-approved RLS drugs, and as safe as both sham pads and FDA-approved RLS drugs. Keywords: meta-analysis, restless legs syndrome, sleep, vibration, counterstimulation, drug therapy

Effects of dorsal root ganglion destruction by adriamycin in patients with postherpetic neuralgia

To investigate the effects of dorsal root ganglion destruction in patients with postherpetic neuralgia (PHN). Seventy-two patients with PHN selected were randomly divided into two groups (n=36). Group A was the control group (treated by injection) and group B was the group of dorsal root ganglion destruction by adriamycin. Visual analog scale scores (VAS), SAS, SF-MPQ scores. Clinical effects and therapy safety were evaluated before therapy, one week, three and six months after therapy. Forty-four patients were available for intention-to-treat analysis. The average pain scores on the Likert scale were significantly reduced at each point in group B. Patients in group B reported clinical effectiveness at six months as excellent response, good response, improved but unsatisfactory or unchanged 16, 12 and 8.VAS scores at each time point after the operation were lower than that before operation and in group A, there was significant difference. Patients showed significant improvement in sleep scores in group B. There was significant difference at T2 in group A than T1. There was no significant difference in group A at T3, T4 after the operation than that before operation. Between group comparison: there was significant difference between group A and group B at each time point after the operation. Dorsal root ganglion destruction by adriamycin under guidance of C-arm perspective, the puncture operation was accurate without any adverse reaction or serious complications, which could effectively relieve pain of patients with postherpetic neuralgia, but the long-term effects needed further study.

Self-Reported Rates of Sleep Disturbance in Patients with Symptomatic Bone Metastases Attending an Outpatient Radiotherapy Clinic

To examine the reported rates and predictive factors for sleep disturbance in patients with bone metastases. Patients with symptomatic bone metastases treated with palliative radiotherapy (RT) were eligible. At initial consultation, demographic information, baseline Brief Pain Inventory (BPI) questionnaire, and analgesic consumption were recorded. The BPI functional interference sleep item was categorized into none (0), mild (1-3), moderate (4-6), and severe (7-10). Follow-up BPI was collected in person or via telephone post-RT at week 4, 8, and 12. Subgroup analysis for BPI between responders and nonresponders was performed. Ordinal logistic regression analysis was used to search for the relationship between sleep disturbance and other covariates. Four hundred patients were enrolled between May 2003 and June 2007. Two hundred thirty-five males (59%) were accrued. The median age was 68 years old (range, 30-91). Within the study population, primary cancer sites included breast (25%), lung (25%), prostate (24%), bladder (4%), pancreas/gastric (3%), and other primaries (18%). In the BPI functional interference items, the mean baseline score for sleep disturbance was 4.8. When categorized in terms of severity, 99 (25%) patients had moderate sleep disturbance and 144 (36%) patients had severe sleep disturbance, respectively. There was an improvement in sleep scores for both responders and nonresponders at week 4 and 8, but scores worsened for nonresponders at week 12. Age, Karnofsky Performance Scale (KPS), pain score, and lung primary were the significant variables associated with sleep disturbance. The scores for sleep disturbance improved significantly post-RT in responders at week 4 and 12.

Pregabalin Ameliorated Abdominal Pain from Adhesions

Purpose: Abdominal pain is a common post-surgical complication that lacks effective therapy. Pregabalin is FDA approved for treatment of neuropathic pain. The purpose of this study was to determine if pregabalin ameliorates abdominal pain from adhesions. Methods: We designed a double-blind placebo-controlled 12-week crossover study using pregabalin to treat patients with abdominal pain from adhesions defined as a negative evaluation for abdominal pain and documented adhesions within 5 years. The first 8 weeks was a randomized placebo controlled trial of pregabalin followed by a 4 week open label study for all patients. Our primary objectives were to demonstrate a significant reduction in pain scores on the 11 point Likert scale and a 2 point pain score drop from baseline. A secondary objective analyzed was improvement in sleep score based on an 11 point Likert scale. Results: Eighteen women enrolled in the study, mean age, 46.05. Eleven patients received drug and 9 placebo. The study was discontinued early because of low enrollment. Seven patients withdrew from the study early (4 placebo, 3 drug). One patient on study drug was withdrawn after hospital admission for suicidal ideation. Using intention to treat analysis, the pain score drop was significantly greater in the pregabalin group than in the placebo group (p=0.024) during the randomized treatment. In addition the pregabalin group but not the control group (-3.62 vs -1.88) had a mean decrease in pain score of greater than 2. The sleep score improvement was greater in pregabalin patients but this difference was not significant (p=0.375). The sleep score improvements dropped more than 2 points in the pregabalin but not placebo patients (-2.34 vs -1.48). As expected, when treated with pregabalin, the placebo patients had a significantly greater improvement in pain and sleep scores than the pregabalin-treated group during the open label portion of the study (p=0.043 and 0.024 respectively). Conclusion: Pregabalin effectively ameliorated abdominal pain and improved sleep parameters in women with documented adhesions. Our data suggests that a larger trial is warranted to further assess the role of pregabalin for treatment of adhesion-mediated abdominal pain. This research was supported by an industry grant from Pfizer.

The Relationship Among Symptoms, Sleep Disturbances and Quality of Life in Patients With Interstitial Cystitis

We conducted a retrospective analysis to determine associations among symptoms, sleep disturbances and quality of life in responder and nonresponder groups of patients with interstitial cystitis. Patients in a multidose pentosan polysulfate sodium clinical trial with a diagnosis of interstitial cystitis who were randomized to 300 mg pentosan polysulfate sodium per day (128) completed the Interstitial Cystitis Symptom Index, an adapted Medical Outcomes Study Sleep scale and the Medical Outcomes Study Short Form-12 Health Survey at baseline, and at weeks 8, 16, 24 and 32. Responders were defined as those achieving a 30% or greater reduction in Interstitial Cystitis Symptom Index score from baseline to study end point (week 32 or last observation carried forward). A positive correlation at baseline was observed between sleep scores and Short Form-12 physical and mental components (r = 0.43 and 0.37, respectively, p <0.0001). Patients showed statistically significant improvement in Interstitial Cystitis Symptom Index and sleep scores by week 32. Responders (48, 43%) had a mean change in sleep score of 11.8 +/- 22.4 while nonresponders (64, 57%) had a mean change of 1.6 +/- 15.7 (p = 0.0055 between groups). The reduction in Interstitial Cystitis Symptom Index score correlated with improvement in sleep score from baseline to study end point (r = -0.33, p = 0.0003). At the study end point responders demonstrated a significant improvement in the Short Form-12 physical component compared with baseline (p <0.0001). Reduction in interstitial cystitis symptoms may be associated with patient reported improvement in sleep and quality of life.

Gabapentin versus nortriptyline in post-herpetic neuralgia patients: a randomized, double-blind clinical trial – The GONIP Trial

Gabapentin and nortriptyline have not been compared in a randomized trial in post-herpetic neuralgia (PHN). The present study was, therefore, undertaken to determine their comparative efficacy and tolerability in the treatment of post-herpetic neuralgia. The study was a randomized, double-blind, parallel-group trial of 9 weeks duration. Adult PHN patients with history of > 8 weeks of PHN pain after healing of rash, a pain intensity of at least 40 mm on a 100 mm visual analog scale at screening and at randomization, and average pain score of at least 4 on the Likert scale during the baseline week were included in the study. Gabapentin and nortriptyline were given in incremental doses at 2-weekly intervals till a maximum tolerated dose was obtained. The primary efficacy parameter was change in pain score (11-point Likert scale) from baseline to the end of the study period. 70 patients were available for intention-to-treat analysis. The average pain scores on the Likert scale were significantly reduced at the end of study in both the treatment groups with 47.6% and 42.8% reduction in pain scores in nortriptyline and gabapentin groups, respectively. Patients showed significant improvement in sleep scores in both the treatment groups nortriptyline (46.0%) and gabapentin (52.0%). The VAS and the SF-MPQ scores for pain were significantly reduced in both the groups. Gabapentin was, however, better tolerated as compared to nortriptyline. Gabapentin was shown to be equally efficacious but was better tolerated compared to nortriptyline and can be considered a suitable alternative for the treatment of PHN.

Randomized trial comparing polymer-coated extended-release morphine sulfate to controlled-release oxycodone HCl in moderate to severe nonmalignant pain

ABSTRACTObjective: To assess the long-term efficacy, tolerability and safety of polymer-coated extended- release morphine sulfate (P-ERMS) (KADIAN) compared with controlled-release oxycodone HCl (CRO) (OxyContin) in treating chronic, nonmalignant, moderate to severe pain in a community- based outpatient population.* KADIAN is a licensed trademark of Alpharma Branded Products Division Inc., Piscataway, NJ, USA† OxyContin is a registered trademark of Purdue Pharma L.P., Stamford, CT, NJ, USADesign: Phase IV, prospective, randomized, open-label.Participants: Adults (N = 112) with chronic, nonmalignant, moderate to severe pain with visual numeric scale (VNS) scores ≥ 4 (0 = no pain; 10 = worst pain).Interventions: Patients were randomized to receive either P-ERMS once-daily (QD) dosing or CRO twice-daily (BID) dosing for a 24‐week treatment period. Upward titration of dose and switching P-ERMS to BID or CRO to thrice-daily (TID) dosing was allowed Weeks 2–24.Main outcome measures: Quality of life (Physical [PCS] and Mental [MCS] Component Summary scores of the SF-36v2 Health Survey), pain and sleep scores (0–10), and patient and clinician assessments of current therapy (–4 to +4).Results: Patients in both treatment groups experienced significant improvements in PCS scores (P-ERMS, +2.6; CRO, +3.1; p < 0.05 vs. baseline); patients taking CRO also demonstrated improvements in MCS scores (+4.7, p < 0.05 vs. baseline). Both groups attained significant reductions from baseline to 24 weeks in pain (P-ERMS, –2.0; CRO, –1.4; p ≤ 0.001 vs. baseline); the reduction with P-ERMS was clinically meaningful (as defined by at least a 2‐point reduction in VNS score). Patients attained significant improvement in sleep scores (P-ERMS, –2.6; CRO, –1.6; p < 0.001 vs. baseline; p < 0.05, P-ERMS vs. CRO). At Week 24, both groups indicated significantly increased patient (P-ERMS, +2.6; CRO, +1.7; p < 0.001 vs. baseline) and clinician (P-ERMS, +4.0; CRO, +3.1; p < 0.001 vs. baseline) global assessments of therapy. After 24 weeks, all patients on P-ERMS were dosing within the FDA-approved frequencies (65% QD, 35% BID); 56% of patients on CRO dosed BID, but 38% dosed TID and 6% dosed four times daily (QID). Most common adverse events were constipation, nausea, and somnolence, with no significant difference between treatment groups.Conclusions: P-ERMS and CRO both relieved chronic nonmalignant pain in this community-based population; however, patients taking P-ERMS dosed in accordance with FDA-approved frequencies (QD/BID); 44% of those taking CRO dosed more frequently (TID/QID).