A short course of cardiac rehabilitation program is highly cost effective in improving long-term quality of life in patients with recent myocardial infarction or percutaneous coronary intervention. A randomized controlled outcome and follow-up study of Mann's time-limited psychotherapy. A randomized trial on the effect of a multimodal intervention on physical capacity, functional performance and quality of life in adult patients undergoing allogeneic SCT. A randomised controlled trial comparing rehabilitation against standard therapy in multiple sclerosis patients receiving intravenous steroid treatment. Randomized trial of chemotherapy versus chemotherapy plus radiotherapy for stage I-II Hodgkin's disease. Implementation of outpatient schema therapy for borderline personality disorder with versus without crisis support by the therapist outside office hours: A randomized trial. Intense immunosuppression in chronic progressive multiple sclerosis: the Kaiser study. Extended-field radiotherapy is superior to MOPP chemotherapy for the treatment of pathologic stage I-IIA Hodgkin's disease: eight-year update of an Italian prospective randomized study. Atorvastatin combined to interferon to verify the efficacy (ACTIVE) in relapsing-remitting active multiple sclerosis patients: a longitudinal controlled trial of combination therapy. A randomized controlled trial of group cognitive-behavioral therapy vs. enhanced supportive therapy for auditory hallucinations. A placebo-controlled, randomized, double-masked, variable dosage, clinical trial of azathioprine with and without methylprednisolone in multiple sclerosis. Up-front tandem high-dose chemotherapy compared with standard chemotherapy with doxorubicin and paclitaxel in metastatic breast cancer: results of a randomized trial. Randomized, controlled, double-blind multicenter comparison of the efficacy and tolerability of ziprasidone and olanzapine in acutely ill inpatients with schizophrenia or schizoaffective disorder. Functional vs. strength training in disabled elderly outpatients. Intensive immunosuppression in progressive multiple sclerosis. A randomized, three-arm study of high-dose intravenous cyclophosphamide, plasma exchange, and ACTH. Effect of patient education on adherence to drug treatment for rheumatoid arthritis: a randomised controlled trial. A randomized controlled trial to evaluate the efficacy of community based physical therapy in the treatment of people with rheumatoid arthritis. Health-related quality of life for patients with progressive multiple sclerosis: influence of rehabilitation. Intermittent cyclophosphamide with prednisone versus placebo for polyneuropathy with IgM monoclonal gammopathy.
To evaluate the long-term effect of a cardiac rehabilitation and prevention program (CRPP) on quality of life (QOL) and its cost effectiveness.
                Prospective, randomized controlled trial.
                University-affiliated outpatient cardiac rehabilitation and prevention center.
                A total of 269 patients (76% men; mean age, 64+/-11 y) with recent acute myocardial infarction (AMI; n=193) or after elective percutaneous coronary intervention (PCI; n=76) were randomized in a ratio of 2 to 1.
                Patients received either CRPP (an 8-wk exercise and education class in phase 2) or conventional therapy without exercise program (control group). They were followed until they had completed all 4 phases of the program (ie, 2 y).
                QOL assessments, by using the Medical Outcomes Study 36-Item Short-Form Health Survey (SF-36) and Symptoms Questionnaire, were performed at the end of each phase. Direct health care cost was calculated, whereas cost utility was estimated as money spent (in US dollars) per quality-adjusted life-year (QALY) gained.
                In the CRPP group, 6 of the 8 SF-36 dimensions improved significantly by phase 2 and were maintained throughout the study period. Patients were less anxious and depressed, and felt more relaxed and contented. In the control group, none of the SF-36 dimensions were improved by phase 2, and bodily pain was increased. In phase 4, only 4 dimensions were improved. Symptoms were unchanged except for increased hostility score. There was a significant gain in net time trade-off in the CRPP group after phase 2. The direct health care expenses in the CRPP and control groups were 15,292 dollars and 15,707 dollars per patient, respectively. Therefore, the cost utility calculated was 640 dollars saved per QALY gained. Savings attributable to CRPP were primarily explained by the lower rate (13% vs 26% of patients, chi2 test=3.9, P <.05) and cost of subsequent PCI (P =.01).
                In an era of managing patients with coronary heart disease, a short-course CRPP was highly cost effective in providing better QOL to patients with recent AMI or after elective PCI. In addition, the improvement of QOL was quick and sustained for at least 2 years after CRPP. Thirty-three patients were assessed for suitability for time-limited psychotherapy (TLP). A battery of outcome measures was composed of patient self-report measurements and objective judgments by external ("masked") raters. Patients were randomly assigned to either the experimental group, which received TLP immediately, or the control group, whose TLP was delayed for 3 months. Patients were evaluated on outcome measures at TLP termination and again at 6 and 12 months after termination. Significant improvement was observed in the experimental group after TLP, but the control patients did not show any systemic changes after waiting. However, after TLP, the control patients improved significantly. The average effect size measured by the differences between gain scores of the experimental patients (before vs. after treatment) and those of the control patients (before vs. after waiting) was 0.986 SD. The gains achieved after therapy were stable in both groups after 6- and 12-month follow-ups. The aim of this randomized controlled trial was to investigate the effect of a 4- to 6-week multimodal program of exercise, relaxation and psychoeducation on physical capacity, functional performance and quality of life (QOL) in allogeneic hematopoietic cell transplantation (allo-HSCT) adult recipients. In all, 42 patients were randomized to a supervised multimodal intervention or to a control group receiving usual care. The primary end point was on aerobic capacity measured in VO(2) max. Secondary end points were muscle strength, functional performance, physical activity level, QOL, fatigue, psychological well-being and clinical outcomes. The multimodal intervention had a significant effect on physical capacity: VO(2) max (P<0.0001) and muscle strength: chest press (P<0.0001), leg extension (P=0.0003), right elbow flexor (P=0.0009), right knee extensor (P<0.0001) and functional performance (stair test) (0.0008). Moreover, the intervention group showed significantly better results for the severity of diarrhea (P=0.014) and fewer days of total parenteral nutrition (P=0.019). Longitudinal changes in QOL, fatigue and psychological well-being favored the intervention group, but did not reach statistical significance. Assignment of a multimodal intervention during allo-HSCT did not cause untoward events, sustained aerobic capacity and muscle strength and reduced loss of functional performance during hospitalization. There is evidence to support both the use of intravenous methylprednisolone (IVMP) in multiple sclerosis (MS) relapse and physiotherapy in the management of MS, but no studies have investigated the combination of steroids and rehabilitation together.
                To evaluate the benefits of IVMP with planned, comprehensive multidisciplinary team (MDT) care compared to IVMP with standard care.
                In this randomised controlled trial, patients confirmed to have had a definite MS relapse severe enough to warrant IVMP (1 g daily for three days) were randomised to two groups. The control group was managed according to the standard ward routine; the treatment group received planned coordinated multidisciplinary team assessment and treatment. Baseline assessments, including demographics and Expanded Disability Status Scale (EDSS) were carried out on both groups. The primary outcome measures were Guy's Neurological Disability Scale (GNDS), and Amended Motor Club Assessment (AMCA). The secondary measures were the Barthel Index (BI), Human Activity Profile (HAP), and Short Form Item 36 Health Survey (SF-36). All measures have published data on reliability and validity. Measures were administered at one and three months.
                Forty subjects, including 27 females, completed data collection. There were no significant differences between the two groups at baseline. Results showed statistically significant differences in GNDS (p = 0.03), AMCA (p = 0.03), HAPM (p < 0.01), HAPA (p = 0.02), and BI (p = 0.02) at three months in favour of planned MDT care.
                This study indicates that combining steroids with planned MDT care is superior to administering them in a standard neurology or day ward setting. Further research is necessary in order to confirm this finding. A total of 277 patients with untreated Hodgkin's disease, clinical stages I-II, were randomized to cyclophosphamide, vinblastine, procarbazine, and prednisone (CVPP) alone for 6 monthly cycles or to CVPP plus radiation therapy (RT), 3,000 rad, to involved areas (CVPP plus RT). One or more of the following factors were considered as unfavorable prognosis: age greater than 45 years, more than two lymph node areas involved, or bulky disease. In the favorable group, disease-free survival (77% vs. 70%) or overall survival (92% vs. 91%) at 84 months for CVPP versus RT plus CVPP was similar. Patients with unfavorable prognosis treated with RT plus CVPP had longer disease-free survival (75% vs. 34%) (P = .001) and overall survival (84% vs. 66%) than patients treated with CVPP alone. This study aimed to evaluate the success of implementing outpatient schema focused therapy (ST) for borderline patients in regular mental healthcare and to determine the added value of therapist telephone availability outside office hours in case of crisis (TTA).
                To enhance the implementation, the following adaptations regarding the original ST protocol were applied: a reduction in the frequency and duration of the therapy; training therapists of eight regular healthcare centers in ST with a structured and piloted program supported by a set of films (DVDs) with examples of ST techniques; training and supervision given by Dutch experts. Telephone availability outside office hours was randomly allocated to 50% of the therapists of each treatment center. Patient's outcome measures were assessed with a semi-structured interview and self-report measures on BPD, quality of life, general psychopathology and an ST questionnaire, before, during and after treatment.
                Data on 62 DSM-IV defined BPD patients were available. Intention-to-treat analyses showed that after 1.5 years of ST 42% of the patients had recovered from BPD. No added value of therapist telephone availability (TTA) was found on the BPDSI score nor on any other measure after 1.5 years of ST.
                ST for BPD can be successfully implemented in regular mental healthcare. Treatment results and dropout were comparable to a previous clinical trail. No additional effect of extra crisis support with TTA outside office hours ST was found. The value of a short course of intensive immunosuppression with cyclophosphamide in stabilising chronic progressive multiple sclerosis (MS) was examined in a randomised single-blinded, placebo-controlled clinical trial. Forty two patients, from the Kaiser Permanente Medical Care Program, Northern California, were studied. Twenty two patients received a short course of cyclophosphamide in an outpatient neurology clinic until their leucocyte counts fell below 4000/mm3, and 20 patients received folic acid. Level of disability, impairment of functional systems, and performance of social roles were assessed before randomisation and reassessed 12, 18, and 24 months after therapy. In both the cyclophosphamide and folic acid groups, the mean level of disability increased from the baseline examination to the 12 month follow up examination (the primary endpoint) by 0.5 on Kurtzke's Expanded Disability Status Scale, indicating similar disease progression in the two groups. Although immunosuppression therapy can be safely administered to MS patients in an outpatient clinic, evidence of substantial benefits was not found. To compare the effectiveness of chemotherapy (CHT) with extended-field radiotherapy (RT) in the treatment of early-stage Hodgkin's disease (ESHD), we report an 8-year updated analysis of a study in which treatment with six cycles of mechlorethamine, vincristine, procarbazine, and prednisone (MOPP) CHT was randomly compared with extended-field RT.
                From August 1979 to December 1982, 89 adult patients with pathologic stage I-IIA Hodgkin's disease (HD) were randomly allocated to receive either RT with mantle field followed by periaortic irradiation (n = 45) or six monthly courses of MOPP CHT (n = 44).
                All patients in the RT arm and 40 of 44 in the CHT arm achieved complete remission. Twelve relapses occurred in each group. Eight patients treated with MOPP and two of the RT arm died of HD. Three other patients of the CHT group died because of a second cancer. With a median follow-up greater than 8 years, the overall survival rate is significantly higher in the RT than in the CHT group (93% v 56%; P less than .001), whereas the rates of freedom from progression and relapse-free survival (RFS) were similar in the two groups (76% v 64% and 70% v 71%, respectively). Of the 12 patients relapsing after RT, 11 (92%) achieved a second CR, compared with only six of the 12 (50%) in the MOPP group. Analysis of the response rate to salvage treatments showed that the type of relapse in the MOPP group was a prognostic indicator for the achievement of a second CR, whereas in the RT group, a second CR was obtained regardless of the characteristics of the relapses. At 80 months, the probability of survival of relapsing patients calculated from time of relapse was 85% and 15% in the RT and CHT groups, respectively (P = .02).
                We conclude that RT alone is the treatment of choice for adult patients with ESHD with favorable prognostic factors. A large body of evidence suggests that, besides their cholesterol-lowering effect, statins exert anti-inflammatory action. Consequently, statins may have therapeutic potential in immune-mediated disorders such as multiple sclerosis. Our objectives were to determine safety, tolerability and efficacy of low-dose atorvastatin plus high-dose interferon beta-1a in multiple sclerosis patients responding poorly to interferon beta-1a alone. Relapsing-remitting multiple sclerosis patients, aged 18-50 years, with contrast-enhanced lesions or relapses while on therapy with interferon beta-1a 44 microg (three times weekly) for 12 months, were randomized to combination therapy (interferon + atorvastatin 20 mg per day; group A) or interferon alone (group B) for 24 months. Patients underwent blood analysis and clinical assessment with the Expanded Disability Status Scale every 3 months, and brain gadolinium-enhanced magnetic resonance imaging at screening, and 12 and 24 months thereafter. Primary outcome measure was contrast-enhanced lesion number. Secondary outcome measures were number of relapses, EDSS variation and safety laboratory data. Forty-five patients were randomized to group A (n = 21) or B (n = 24). At 24 months, group A had significantly fewer contrast-enhanced lesions versus baseline (p = 0.007) and significantly fewer relapses versus the two pre-randomization years (p < 0.001). At survival analysis, the risk for a 1-point EDSS increase was slightly higher in group B than in group A (p = 0.053). Low-dose atorvastatin may be beneficial, as add-on therapy, in poor responders to high-dose interferon beta-1a alone. There has been little research examining group cognitive-behavioral therapy (CBT) for schizophrenia, especially compared to an active control treatment. The purpose of this study was to investigate the effectiveness of group CBT for auditory hallucinations compared to an enhanced supportive therapy (ST). Sixty five participants with schizophrenia spectrum disorders and persistent hallucinations were randomly assigned to group CBT or enhanced group ST. Primary outcomes focused on beliefs about voices and global auditory hallucinations severity. Secondary outcomes included psychotic symptoms, self-esteem, social functioning, insight, depression, and hospitalization. Controlling for baseline levels, these outcomes were evaluated across post-treatment, 3 month and 12 month follow-ups. Participants who received enhanced ST were less likely to both resist voices and to rate them as less malevolent through 12-month follow-up relative to participants who received CBT. Group CBT was associated with lower general and total symptom scores on the PANSS through 12-month-followup relative to participants who received enhanced ST. Outcomes improved through 12-month follow-up in both therapy groups, with enhanced ST having more specific impact on auditory hallucinations, and CBT impacting general psychotic symptoms. Ninety-eight patients with multiple sclerosis (MS) in the chronic progression phase entered a 3-year clinical trial to determine if azathioprine (AZ) alone or with adrenal cortical steroids stabilizes the course of MS. In group AM, the patients took AZ throughout and methylprednisolone (MP) for the first 36 weeks. Group AP received AZ and placebo instead of MP. Group PP took placebos for both drugs. We adjusted the AZ to maintain the total white blood cell count within 3,000 to 4,000/mm3; we gave the MP in a fixed dose "pulse" and alternate-day regimen. The "intent-to-treat" groups had no statistically significant differences in the rates of progression among the 3 treatments. Subgroup analysis suggests that patients in the AM group who completed treatment exactly according to protocol did statistically significantly better than the placebo recipients using the sum of Standard Neurological Examination scores, slightly better using the quantitative neuro-performance tests, but no better using Mickey's Illness Severity Scores or Kurtzke's Disability Status Scale. Also, the AZ-treated groups had half the relapse rate of the placebo-treated group. Adverse reactions to AZ accounted for most withdrawals. Hematologic and hepatic abnormalities were significantly associated with AZ, but serious non-MS abnormalities were uncommon and were equally distributed among the 3 groups. Addition of MP to the AZ slightly improved the efficacy of the treatment, but also increased the adverse effects. The benefits of AZ with or without steroids did not outweigh the risks, and therefore we do not recommend this treatment for patients with chronic progressive MS. The role of high-dose chemotherapy (HDCT) in metastatic breast cancer remains controversial. Trials with late intensification HDCT have failed to show an advantage in overall survival. This study was initiated to compare up-front tandem HDCT and standard combination therapy in patients with metastatic breast cancer.
                Patients without prior chemotherapy for metastatic disease were randomly assigned to standard combination therapy with doxorubicin and paclitaxel (AT) or double HDCT with cyclophosphamide, mitoxantrone, and etoposide followed by peripheral-blood stem-cell transplantation. HDCT was repeated after 6 weeks. Patients were stratified by menopausal and hormone-receptor status. The primary objective was to compare complete response (CR) rates.
                A total of 93 patients were enrolled onto the trial. Intent-to-treat CR rates for patients randomized to HDCT and AT were 12.5% and 11.1%, respectively (P = .84). Objective response rates were 66.7% for patients in the high-dose group and 64.4% for patients in the AT arm (P = .82). In an intent-to-treat analysis, there were no significant differences between the two treatments in median time to progression (HDCT, 11.1 months; AT, 10.6 months; P = .67), duration of response (HDCT, 13.9 months; AT, 14.3 months; P = .98), and overall survival (HDCT, 26.9 months; AT, 23.4 months; P = .60). HDCT was associated with significantly more myelosuppression, infection, diarrhea, stomatitis, and nausea and vomiting, whereas patients treated with AT developed more neurotoxicity.
                This trial failed to show a benefit for up-front tandem HDCT compared with standard combination therapy. HDCT was associated with more acute adverse effects. Limited randomized, controlled trial data exist on possible differences between atypical antipsychotics in efficacy, overall tolerability, and important indices of health status. The authors compared the efficacy and tolerability of ziprasidone and olanzapine in the treatment of acutely ill inpatients with schizophrenia or schizoaffective disorder.
                In this 6-week, multicenter, double-blind, parallel-design, flexible-dose trial, patients were randomly assigned to receive ziprasidone (N=136) or olanzapine (N=133). Primary efficacy measures were improvement in Brief Psychiatric Rating Scale and Clinical Global Impression (CGI) severity scale scores; secondary measures were scores on the CGI improvement scale, Positive and Negative Syndrome Scale, and Calgary Depression Scale for Schizophrenia. Tolerability assessments included fasting lipid profiles, fasting glucose and insulin measurements, electrocardiography, and monitoring of vital signs and body weight.
                The overall mean daily doses were 129.9 mg (SD=27.3) for ziprasidone and 11.3 mg (SD=2.8) for olanzapine. Both antipsychotics were efficacious in improving symptoms and global illness severity. The two treatment groups did not differ significantly in primary or secondary efficacy measures at endpoint or in by-visit analysis. Both agents were well tolerated. Body weight, total cholesterol, triglycerides, and low-density lipoprotein cholesterol significantly increased with olanzapine but not with ziprasidone; all between-group comparisons of these variables were significant and favored ziprasidone. Olanzapine, but not ziprasidone, was associated with significant increases in fasting insulin level. No patient in either group exhibited a corrected QT interval >/=500 msec.
                During 6 weeks' treatment, ziprasidone and olanzapine demonstrated comparable antipsychotic efficacy. Differences favoring ziprasidone were observed in metabolic parameters. To determine whether high-intensity functional training (FT) or strength training (ST) better enables impairment, disability, and functional gains among disabled community-dwelling elders.
                Randomized, blinded, prospective clinical trial in a large, tertiary care outpatient rehabilitation department. Fifteen elders (62-85 yrs old) referred for physical therapy with one or more impairments, including lower-limb arthritis, participated in 6 wks of FT (weekly outpatient and three to five times per week of home practice in rapid and correct execution of locomotor activities of daily living, including gait, stepping, and sit to stand) or progressive resistive ST using elastic bands with intensity, therapist contact, and home practice similar to those of FT.
                Both groups significantly improved their combined lower-extremity strength (hip abduction, ankle dorsiflexion, knee flexion, ankle plantarflexion, and knee extension) (P = 0.003), but no statistical difference between the ST and FT group gains (P = 0.203) was found. Subjects in both interventions improved their gait speed, but the FT group improved more than the ST group (P = 0.001). During chair rise, the FT group improved their maximum knee torque more than the ST group (P = 0.033), indicating that they employed a more controlled and efficient movement strategy.
                These data suggest that an intensive FT intervention results in strength improvements of comparable magnitude as those attained from ST and that FT also confers greater improvements in dynamic balance control and coordination while performing daily life tasks. Fifty-eight patients with severe, progressive multiple sclerosis were prospectively randomized to one of three treatments: 20 received intravenous ACTH, 20 received high-dose intravenous cyclophosphamide plus ACTH, and 18 were placed on a regimen consisting of plasma exchange, low-dose oral cyclophosphamide, and ACTH. The three groups were similar in age, sex, duration and type of disease, and degree of disability. Before treatment and six months and one year after treatment, a disability-status score, ambulation index, and functional-status score were determined, and a quantitative neurologic examination was performed. In the ACTH group, the number of patients stabilized or improved was 8 of 20 at six months and 4 of 20 at one year; in the cyclophosphamide-ACTH group, 18 of 20 at six months and 16 of 20 at one year; and in the plasma exchange group, 11 of 18 at six months and 9 of 18 at one year. High-dose cyclophosphamide plus ACTH was most effective in halting progression of the disease at both 6 and 12 months (at 12 months, cyclophosphamide-ACTH vs. ACTH, P = 0.0004; cyclophosphamide-ACTH vs. plasma exchange, P = 0.087). Thus, progressive multiple sclerosis may be stabilized by short-term, intensive immunosuppression with cyclophosphamide plus ACTH. To determine whether a patient education programme (PE) would improve rates of adherence to a slow acting antirheumatic drug and to assess any subsequent effect on patient outcome.
                A randomly controlled study comprising 100 patients with rheumatoid arthritis (49 control CG; 51 experimental EG) requiring D-penicillamine (DPA). The same practitioner saw patients on seven occasions, for the same length of time. The EG received 7 x 30 minute one to one sessions of PE, while the CG received standard management. The primary measure of adherence was a pharmacological marker (phenobarbitone) encapsulated with the DPA assayed at monthly intervals for six months. Plasma viscosity (PV), C reactive protein, articular index, morning stiffness, and pain score were used to assess outcome.
                454 blood samples were collected and assayed and the pharmacological marker showed the EG to be significantly more adherent on more occasions than the CG (p<0.05). Patterns of adherence over time showed that at 12 weeks 86% (38/44) of those in the EG compared with 64% (29/45) of the CG remained adherent (p=0.01). These trends continued and by the end of the study 85% (29/34) of the EG compared with 55% (23/42) of the CG were taking their DPA as prescribed. Fifteen patients (12 from the EG) experienced side effects requiring study withdrawal and 14 patients requested study withdrawal (two from the EG). On study entry patients in the CG had significantly higher levels of PV than the EG and this remained so throughout the research. However, on completion, the health status of patients in both groups had improved significantly (p<0.01).
                PE significantly increased adherence to DPA and its effects persisted over a period of six months. No additional clinical benefit was detected in the EG in comparison with the CG. To evaluate the short term efficacy of a community based physical therapy (PT) program for people with rheumatoid arthritis (RA) through a single blind randomized controlled trial.
                Adults with active RA were referred by their physician for community based PT. Participants were randomized to either an immediate intervention group [experimental group (EG)] or a wait list control group (CG). The intervention was a standardized program of education and exercise consisting of at least 4 visits or 3 h of PT over 6 weeks. Baseline, 6, and 12 week assessments were by a blinded independent assessor. The primary outcome instrument was the Stanford Arthritis Self-Efficacy Scale (SES) and secondary outcome measures included the ACREU Rheumatoid Arthritis Knowledge Questionnaire (KQ) and visual analog scale for pain (VAS). Duration of morning stiffness, grip strength, and tender joint count were also collected at each assessment. Outcome analysis was conducted using analysis of variance.
                Of 150 eligible and randomized participants, 127 completed the study according to protocol. Baseline analysis showed no differences between the EG and CG for demographics, disease status, or other characteristics. At the 6 week assessment, primary outcome analysis for those who completed the protocol identified a mean change (improvement) of 13.5% in the EG and 5.8% in the CG, representing a 7.7% difference in change scores between the 2 groups [F(1,121) = 6.03; p = 0.015]. A statistically significant difference in change scores was also identified for the KQ [F(1,120) = 6.67; p = 0.011], but not for the VAS. Disease status measures did not change, except for duration of morning stiffness, which improved by 68.8 min in the EG and 8.3 min in the CG (F(1,121) = 4.50; p = 0.036].
                Four hours of a community based PT intervention delivered over 6 weeks significantly improved self-efficacy, disease management knowledge and morning stiffness in people with RA. The health-related quality of life of patients with multiple sclerosis (MS) is an important aspect of care outcome. The purpose of this study was to compare health-related quality of life between patients who received weekly comprehensive outpatient rehabilitation for 1 year and a group that did not receive rehabilitation.
                Twelve patients receiving outpatient care for chronic progressive MS (mean age = 44.5 years, SD = 11.6) were compared with 19 similar patients (mean age = 49.2 years, SD = 9.2) on a waiting list who were not receiving outpatient care.
                A pretest-posttest longitudinal design was used to descriptively compare outcome measures. Multivariate regression analyses were used to determine which variables, controlled for baseline health status and other relevant patient characteristics, were related to the best outcomes at the time of the 1-year follow-up.
                The treatment group showed improvements in six health status measures on the Rand 36-Item Health Survey 1.0 (SF-36) that were not improved in the wait-listed group. Outpatient treatment was the sole predictor of positive outcome for energy/fatigue (partial R2 = .43) and change in general health (partial R2 = .19). In addition, the treatment group was associated with a positive outcome (together with other independent variables) in the domains of social function and social support.
                Patients with chronic progressive forms of MS appear to derive benefits from an ongoing comprehensive outpatient rehabilitation program. [Di Fabio RP, Choi T, Soderberg J, Hansen CR. Health-related quality of life for patients with progressive multiple sclerosis: influence of rehabilitation. The best treatment for polyneuropathy associated with IgM monoclonal gammopathy (MGUS) is unknown. Oral cyclophosphamide combined with prednisone showed limited efficacy in a previous open label pilot study. We therefore performed a double-blind, randomized, placebo-controlled study of combined oral cyclophosphamide and prednisone in IgM MGUS polyneuropathy.
                Thirty-five patients with progressive IgM MGUS polyneuropathy were included. After stratification for anti-MAG antibodies patients were randomized to oral cyclophosphamide 500 mg once daily for 4 days combined with oral prednisone 60 mg once daily for 5 days (treatment) (n = 16), or placebo (n = 19), repeated every 28 days for six times. Primary outcome was improvement of the Rivermead Mobility Index (RMI). Secondary outcomes were improvement of the modified Rankin scale, Medical Research Council and sensory sum scores, levels of M protein, EMG, and Short Form-36 scale after treatment. Patients were examined at 0, 6, 12, 18, and 24 months.
                After 6 months of treatment and at later follow-up, no difference in change of the RMI between the two groups was observed. Change of the Rankin scale was similar in both groups. Other outcome parameters showed more improvement in the treatment group: the MRC sum score improved more from 6 to 24 months after treatment; the sensory sum score improved more at 6 months; the SF 36 mean health change score and physical role score improved more; and the median nerve distal conduction (abductor pollicis brevis muscle) improved more in the treatment group. The most common adverse event was nausea.
                Compared with placebo treatment, this first double-blind randomized trial with cyclophosphamide and prednisone in IgM MGUS polyneuropathy showed no beneficial effect on the functional scales, but a beneficial effect on muscle strength and sensation was observed.
STPP shows promise, with modest to moderate, often sustained gains for a variety of patients. However, given the limited data and heterogeneity between studies, these findings should be interpreted with caution. Furthermore, variability in treatment delivery and treatment quality may limit the reliability of estimates of effect for STPP. Larger studies of higher quality and with specific diagnoses are warranted.