A randomized controlled trial of early physiotherapy for high-risk infants

The potential therapeutic applications of encapsulated cells are enormous. In the US alone, it has been estimated that nearly half-a-trillion dollars are spent each year to care for patients who suffer tissue loss or dysfunction. Over 6 million patients suffer from neurodegenerative disorders such as Alzheimer's disease and Parkinson's disease, over 14 million patients suffer from diabetes, and millions more from liver failure, hemophilia, and other diseases caused by the loss of specific vital cellular functions. It appears likely that by the end of the decade clinical trials of encapsulated cells to treat many of these diseases will become a reality. The Food and Drug Administration has already authorized studies to evaluate the safety and biological activity of several types of systems. A number of issues will have to be addressed, including the sourcing of raw materials, the design and building of manufacturing facilities, the scale-up and optimization process, storage and distribution of the product, and quality control.     

A randomized controlled trial of brief interventions for body dissatisfaction.

The authors examined the relative effectiveness of 3 different approaches to the experience of body dissatisfaction compared to a control and ruminative attention control condition, with respect to increasing weight and appearance satisfaction. One hundred female undergraduates (mean age = 24.38, SD = 9.39) underwent a body dissatisfaction induction procedure, which significantly decreased levels of weight and appearance satisfaction. Participants were then randomized, 20 to each of 5 groups: control, ruminative attention control, acceptance, distraction, and cognitive dissonance. With the exception of the control group, participants were briefly trained in their assigned technique and were asked to practice this over the next 5 min while repeated measures of weight and appearance satisfaction were recorded. Acceptance, cognitive dissonance, and distraction were superior to both control conditions in increasing weight satisfaction and were superior to a control condition in improving appearance satisfaction. Only acceptance was superior in improving appearance satisfaction compared to a ruminative attention control. The evidence suggests that acceptance is a promising approach to investigate further with respect to its efficacy for reducing body dissatisfaction. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized controlled trial of hypnosis for burn wound care.

Purpose/Objective: There have been few randomized controlled studies on the effectiveness of clinical hypnotic analgesia. The authors' goal was to improve on previous methodologies and gain a better understanding of the effects of hypnosis on different components of pain in a clinical setting. Research Method/Design: This study used a randomized controlled design in which the nurses and data collectors were unaware of treatment condition to compare hypnotic analgesia with an attention-only placebo for burn pain during wound debridements. Data were analyzed on a total of 46 adult participants. Results: The authors found that the group receiving hypnosis had a significant drop in pain compared with the control group when measured by the McGill Pain Questionnaire but not when measured by other pain rating scales. Conclusion: The McGill Pain Questionnaire total score reflects multiple pain components, such as its affective component and various qualitative components, and is not merely a measure of pain intensity. Thus, the findings suggest that hypnosis affects multiple pain domains and that measures that assess these multiple domains may be more sensitive to the effects of hypnotic analgesia treatments. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Parents and procedures: a randomized controlled trial

INTRODUCTION: Previous work has shown that parents prefer to be present when their children undergo common invasive procedures, although physicians are ambivalent about parental presence. PURPOSE: To determine the effect of a parent-focused intervention on the pain and performance of the procedure, anxiety of parents and clinicians, and parental satisfaction with care. POPULATION: Children younger than 3 years old undergoing venipuncture, intravenous cannulation, or uretheral catheterization. SETTING: Pediatric emergency department of Boston City Hospital. DESIGN: Randomized controlled trial with three groups; parents present and given instructions on how to help their children; parents present, but no instructions given; and parents not present. INTERVENTION: The parents were instructed to touch, talk to, and maintain eye contact during the procedure. RESULTS: A total of 431 parents was randomized to the intervention (N = 153), present (N = 147), and not present (N = 131) groups. The groups were equivalent with respect to measured sociodemographic variables and parents' previous experience in the pediatric emergency department. No differences emerged with respect to pain (3-point scale measured by parent and clinician, and analysis of cry); performance of the procedure (number of attempts, completion of procedure by first clinician, time); clinician anxiety; or parental satisfaction with care. Parents who were present were more likely to rate the pain of the children as extreme/severe (52%) in comparison to clinicians (15%, kappa .07, poor agreement) and were significantly less anxious than parents who were not present. CONCLUSION: Overall, the intervention was not effective in reducing the pain of routine procedures. Parental presence did not negatively affect performance of the procedure or increase clinician anxiety. Parents who were present were less anxious than those who were not present. CLINICAL IMPLICATION: In general, parents have indicated that they want to be present when their children undergo procedures. The results of this study challenge the traditional belief that parental presence negatively affects our ability to successfully complete procedures. We should encourage parents who want to be present to stay during procedures.     

Moxibustion for correction of breech presentation: a randomized controlled trial

CONTEXT: Traditional Chinese medicine uses moxibustion (burning herbs to stimulate acupuncture points) of acupoint BL 67 (Zhiyin, located beside the outer corner of the fifth toenail), to promote version of fetuses in breech presentation. Its effect may be through increasing fetal activity. However, no randomized controlled trial has evaluated the efficacy of this therapy. OBJECTIVE: To evaluate the efficacy and safety of moxibustion on acupoint BL 67 to increase fetal activity and correct breech presentation. DESIGN: Randomized, controlled, open clinical trial. SETTING: Outpatient departments of the Women's Hospital of Jiangxi Province, Nanchang, and Jiujiang Women's and Children's Hospital in the People's Republic of China. PATIENTS: Primigravidas in the 33rd week of gestation with normal pregnancy and an ultrasound diagnosis of breech presentation. INTERVENTIONS: The 130 subjects randomized to the intervention group received stimulation of acupoint BL 67 by moxa (Japanese term for Artemisia vulgaris) rolls for 7 days, with treatment for an additional 7 days if the fetus persisted in the breech presentation. The 130 subjects randomized to the control group received routine care but no interventions for breech presentation. Subjects with persistent breech presentation after 2 weeks of treatment could undergo external cephalic version anytime between 35 weeks' gestation and delivery. MAIN OUTCOME MEASURES: Fetal movements counted by the mother during 1 hour each day for 1 week; number of cephalic presentations during the 35th week and at delivery. RESULTS: The intervention group experienced a mean of 48.45 fetal movements vs 35.35 in the control group (P<.001; 95% confidence interval [CI] for difference, 10.56-15.60). During the 35th week of gestation, 98 (75.4%) of 130 fetuses in the intervention group were cephalic vs 62 (47.7%) of 130 fetuses in the control group (P<.001; relative risk [RR], 1.58; 95% CI, 1.29-1.94). Despite the fact that 24 subjects in the control group and 1 subject in the intervention group underwent external cephalic version, 98 (75.4%) of the 130 fetuses in the intervention group were cephalic at birth vs 81 (62.3%) of the 130 fetuses in the control group (P = .02; RR, 1.21; 95% CI, 1.02-1.43). CONCLUSION: Among primigravidas with breech presentation during the 33rd week of gestation, moxibustion for 1 to 2 weeks increased fetal activity during the treatment period and cephalic presentation after the treatment period and at delivery.     

Re: A randomized controlled trial of Intravenous clodronate

Pancoast's syndrome arises from neoplasms in 95% of cases but infection is a rare cause. We describe a patient with Pancoast's tumor secondary to tuberculosis. Pain caused by plexopathy and lack of diagnosis by noninvasive means led to the need for open biopsy.     

Decision making during a phase III randomized controlled trial

Experiments such as clinical trials should be carried out with specific objectives. For example, in a trial designed to prevent disease, specific considerations should be made concerning the impact of the trial on the health of the target population, including the participants in the trial. These objectives should be assessed continually in light of data accumulating from the trial. Accumulating evidence should be judged in the context of changing circumstances external to the trial, and the trial's design possibly modified. An important type of modification is stopping the trial. This is a sequential decision problem that can be addressed using a Bayesian approach and the methods of dynamic programming. As an example we consider a vaccine trial for the prevention of haemophilus influenzae type b. The objective we consider is minimizing the number of cases of this disease in a Native American population over a specified horizon. We assess the prior probability distribution of vaccine efficacy. We also assess the probability of regulatory approval for widespread use of the vaccine, depending on the data presented to the regulatory officials. In deciding whether to continue the trial we weigh the impact of the possible future results by their (predictive) probabilities. We address the sensitivity of the optimal stopping policy to the prior probability distribution, to the assessed probability of regulatory approval, and to the horizon.     

Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial

CONTEXT: Postherpetic neuralgia (PHN) is a syndrome of often intractable neuropathic pain following herpes zoster (shingles) that eludes effective treatment in many patients. OBJECTIVE: To determine the efficacy and safety of the anticonvulsant drug gabapentin in reducing PHN pain. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel design, 8-week trial conducted from August 1996 through July 1997. SETTING: Sixteen US outpatient clinical centers. PARTICIPANTS: A total of 229 subjects were randomized. INTERVENTION: A 4-week titration period to a maximum dosage of 3600 mg/d of gabapentin or matching placebo. Treatment was maintained for another 4 weeks at the maximum tolerated dose. Concomitant tricyclic antidepressants and/or narcotics were continued if therapy was stabilized prior to study entry and remained constant throughout the study. MAIN OUTCOME MEASURES: The primary efficacy measure was change in the average daily pain score based on an 11-point Likert scale (0, no pain; 10, worst possible pain) from baseline week to the final week of therapy. Secondary measures included average daily sleep scores, Short-Form McGill Pain Questionnaire (SF-MPQ), Subject Global Impression of Change and investigator-rated Clinical Global Impression of Change, Short Form-36 (SF-36) Quality of Life Questionnaire, and Profile of Mood States (POMS). Safety measures included the frequency and severity of adverse events. RESULTS: One hundred thirteen patients received gabapentin, and 89 (78.8%) completed the study; 116 received placebo, and 95 (81.9%) completed the study. By intent-to-treat analysis, subjects receiving gabapentin had a statistically significant reduction in average daily pain score from 6.3 to 4.2 points compared with a change from 6.5 to 6.0 points in subjects randomized to receive placebo (P<.001). Secondary measures of pain as well as changes in pain and sleep interference showed improvement with gabapentin (P<.001). Many measures within the SF-36 and POMS also significantly favored gabapentin (P< or =.01). Somnolence, dizziness, ataxia, peripheral edema, and infection were all more frequent in the gabapentin group, but withdrawals were comparable in the 2 groups (15 [13.3%] in the gabapentin group vs 11 [9.5%] in the placebo group). CONCLUSIONS: Gabapentin is effective in the treatment of pain and sleep interference associated with PHN. Mood and quality of life also improve with gabapentin therapy.     

Computerized behavior therapy for opioid-dependent outpatients: A randomized controlled trial.

The authors evaluated the efficacy of an interactive, computer-based behavioral therapy intervention, grounded in the community reinforcement approach (CRA) plus voucher-based contingency management model of behavior therapy. Our randomized, controlled trial was conducted at a university-based research clinic. Participants comprised 135 volunteer adult outpatients who met DSM-IV criteria for opioid dependence. All participants received maintenance treatment with buprenorphine and were randomly assigned to one of three treatments: (a) therapist-delivered CRA treatment with vouchers, (b) computer-assisted CRA treatment with vouchers, or (c) standard treatment. The therapist-delivered and computer-assisted CRA plus vouchers interventions produced comparable weeks of continuous opioid and cocaine abstinence (M = 7.98 and 7.78, respectively) and significantly greater weeks of abstinence than the standard intervention (M = 4.69; p     

A randomized controlled trial of guided imagery in bulimia nervosa

BACKGROUND: The objective of this study was to test a guided imagery therapy designed to enhance self-comforting in bulimia nervosa. METHODS: A randomized controlled trial compared 6 weeks of individual guided imagery therapy with a control group. Fifty participants who met DSM-III-R criteria for bulimia nervosa completed the study. Measures of eating disorder symptoms, psychological functioning and the experience of guided imagery therapy were administered. RESULTS: The guided imagery treatment had substantial effects on the reduction of bingeing and purging episodes; the imagery group had a mean reduction of binges of 74% and of vomiting of 73%. The imagery treatment also demonstrated improvement on measures of attitudes concerning eating, dieting and body weight in comparison to the control group. In addition, the guided imagery demonstrated improvement on psychological measures of aloneness and the ability for self-comforting. CONCLUSIONS: Evidence from this study suggests that guided imagery was an effective treatment for bulimia nervosa, at least in the short-term.     

Brief cognitive therapy for panic disorder: A randomized controlled trial.

Cognitive therapy (CT) is a specific and highly effective treatment for panic disorder (PD). Treatment normally involves 12–15 1-hr sessions. In an attempt to produce a more cost-effective version, a briefer treatment that made extensive use of between-sessions patient self-study modules was created. Forty-three PD patients were randomly allocated to full CT (FCT), brief CT (BCT), or a 3-month wait list. FCT and BCT were superior to wait list on all measures, and the gains obtained in treatment were maintained at 12-month follow-up. There were no significant differences between FCT and BCT. Both treatments had large (approximately 3.0) and essentially identical effect sizes. BCT required 6.5 hr of therapist time, including booster sessions. Patients' initial expectation of therapy success was negatively correlated with posttreatment panic-anxiety. Cognitive measures at the end of treatment predicted panic-anxiety at 12-month follow-up. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Outcome of subacute stroke rehabilitation: a randomized controlled trial

We compared the biological activity of a new group of keto-C-glycosides to that of a narrow spectrum of unsaturated ketonucleosides in a panel of non-small-cell lung cancer (NSCLC) cells with various levels of intrinsic resistance to standard chemotherapy drugs. Unlike cisplatin, etoposide, adriamycin, or taxol, for which a significant difference in the cytotoxic effect was observed between sensitive cell lines (H460, H125, and MGH4) and drug-resistant cell lines (H661, MGH7, and FADU), nucleoside analogs were equally cytotoxic in NSCLC cell lines, with compound 92 being 10-fold more active than compound 43, 44, 81, or 161, while compound 3 was the least active. Apoptotic measurements with flow cytometric analysis of terminal uridine deoxynucleotide nick end-labeled cells revealed that the cytotoxic activity of these nucleosides correlated with their potency to induce apoptosis. Compound 92 triggered death in cells with wild-type p53, mutated p53, or p53 gene deletion. Our findings suggest that keto-C-glycosides may be promising alternative anticancer agents which merit further studies in in vivo cancer models refractory to standard chemotherapy drugs.     

A randomized controlled trial of online versus clinic-based CBT for adolescent anxiety.

Objective: The study examined the relative efficacy of online (NET) versus clinic (CLIN) delivery of cognitive behavior therapy (CBT) in the treatment of anxiety disorders in adolescents. Method: Participants included 115 clinically anxious adolescents aged 12 to 18 years and their parent(s). Adolescents were randomly assigned to NET, CLIN, or wait list control (WLC) conditions. The treatment groups received equivalent CBT content. Clinical diagnostic interviews and questionnaire assessments were completed 12 weeks after baseline and at 6- and 12-month follow-ups. Results: Assessment at 12 weeks post-baseline showed significantly greater reductions in anxiety diagnoses and anxiety symptoms for both NET and CLIN conditions compared with the WLC. These improvements were maintained or further enhanced for both conditions, with minimal differences between them, at 6- and 12-month follow-ups. Seventy-eight percent of adolescents in the NET group (completer sample) no longer met criteria for the principal anxiety diagnosis at 12-month follow-up compared with 80.6% in the CLIN group. Ratings of treatment credibility from both parents and adolescents were high for NET and equivalent to CLIN. Satisfaction ratings by adolescents were equivalent for NET and CLIN conditions, whereas parents indicated slightly higher satisfaction ratings for the CLIN format. Conclusions: Online delivery of CBT, with minimal therapist support, is equally efficacious as clinic-based, face-to-face therapy in the treatment of anxiety disorders among adolescents. This approach offers a credible alternative to clinic-based therapy, with benefits of reduced therapist time and greater accessibility for families who have difficulty accessing clinic-based CBT. (PsycINFO Database Record (c) 2011 APA, all rights reserved)     

Preventing sleep problems in infants: a randomized controlled trial

In the pre-school years sleep problems are one of the most common subjects on which parents seek advice from health professionals. In the majority of cases a sleepless child causes significant stress within the family, and if parents do not obtain sufficient sleep this can have a detrimental effect on their physical and emotional well-being. In a small number of cases a child who wakes frequently and will not settle back to sleep may be at risk of physical abuse. In recent years it has been suggested that it may be possible to prevent sleep problems developing by providing parents with advice in the post-natal period. Parents have stated that they find this type of intervention helpful, however, there has been no attempt to establish whether a preventive approach is effective. The aim of this research was to evaluate the efficacy of health education in reducing the incidence of sleep problems. Adopting an experimental approach, participants were randomly allocated to a control group or an intervention group. Parental knowledge of sleep and settling behaviour was manipulated when the children in the intervention group were 3 months old. The sleeping behaviour of the infants in both groups was compared 6 months later, when the children were 9 months old. Data was collected from 86 families in the intervention group and 83 families in the control group. A comprehensive analysis of the sleeping behaviour demonstrated that a significantly smaller percentage of babies in the intervention group had settling and night-waking difficulties than in the control group.     

Brief motivational interventions for heavy college drinkers: A randomized controlled trial.

In this randomized controlled trial, the authors evaluated brief motivational interventions (BMIs) for at-risk college drinkers. Heavy drinking students (N = 509; 65% women, 35% men) were randomized into 1 of 6 intervention conditions formed by crossing the baseline Timeline Followback (TLFB) interview (present versus absent) and intervention type (basic BMI, BMI enhanced with a decisional balance module, or none). Assessments completed at baseline, 1, 6, and 12 months measured typical and risky drinking as well as drinking-related problems. Relative to controls, the TLFB interview reduced consumption but not problems at 1 month. The basic BMI improved all drinking outcomes beyond the effects of the TLFB interview at 1 month, whereas the enhanced BMI did not. Risk reduction achieved by brief interventions maintained throughout the follow-up year. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

A randomized controlled trial of two methods for collection of sterile urine in neonates

The cause of laryngeal and pharyngeal carcinomas is likely multifactorial. Smoking is an important factor, but mucosal damage from gastroesophageal reflux may also contribute. The purpose of this study was to determine whether gastroesophageal reflux is more common in patients with laryngeal or pharyngeal carcinomas than in those without these malignancies. Over an 8-year period, we correlated the results of clinical and radiographic examinations of the pharynx and esophagus to pH monitoring results in 798 patients with a variety of upper aerodigestive tract symptoms and who underwent both pH monitoring and barium esophagography. In this group, 63 patients (52 men, 11 women) had laryngeal or pharyngeal carcinomas, and 735 patients (319 men, 416 women) had neither malignancy. Abnormal pH findings were defined as a total percentage of esophageal acid exposure time of 6% or more as determined with the esophageal probe, or any reflux event detected with the pharyngeal probe. Thirty-four of 63 patients with carcinomas (54%) had abnormal pH-monitoring results: Esophageal acid exposure was abnormal in 10 patients, pharyngeal acid exposure was abnormal in 7 patients, and acid exposure was abnormal in both areas in 17 patients. Of the 735 patients without malignancies, 365 (50%) had abnormal pH-monitoring results (p > 0.05). In this population of patients, abnormal results of pH monitoring were common, occurring in 399 (50%) of 798 patients, but no significant difference was found between results in those with and without laryngeal or pharyngeal carcinomas. Therefore, our study found that gastroesophageal reflux as shown by pH monitoring was not more common in patients with these malignancies.     

A randomized controlled trial of home care: clinical outcome for five surgical procedures

The clinical function of patients receiving home care after five surgical procedures was assessed. Hospital patients who normally would have received minimal nursing care at the end of their hospital stay were randomly assigned to an experimental home-care group or a control group who were discharged from hospital after the normal length of stay. Comprisons of "untoward events" (discomfort, infection, delayed healing, or complications) are reported for the two groups in five surgical categories (varicose vein stripping, herniorrhaphy, cholecystectomy, anal and rectal operations and abdominal hysterectomy) where the home-care program operated efficientyl. No apparent differences in the rates of untoward events were noted between hospital and home-care groups. It is concluded that home care should be considered for reasons other than clinical function, such as socio-economic functioning, the wishes of the patient, or more efficient use of hospital space.