Replenishing the spirit by meditative prayer and guided imagery

Transcutaneous electrical nerve stimulation (TENS) has been proven effective in pain relief of primary dysmenorrhea (PD). We evaluated the efficacy of a new TENS device (Freelady, Life Care, Tiberias, Israel), designed to correct disadvantages of older models used in previous studies, in 102 nulliparous women with PD, who were treated with various types of pain relief medications. Marked pain relief was reported by 58 patients (56.9%) and moderate relief by 31 (30.4%). These subjective findings were supported by the fact that the same number of patients (58 and 31) either stopped analgesic use altogether during the trial or reduced the quantity of analgesics, respectively. The device examined proved to be efficient and safe in controlling the pain and disability caused by PD.     

An optimal filtering technique to reduce the influence of low-frequency noise on click-evoked otoacoustic emissions

The aim of this paper was to study the physical performance, pain, pain behavior and disability in patients with subacute low back pain (LBP). The patients were blue-collar workers and had been sick-listed for 8 weeks due to subacute low back pain. A total of 103 patients were randomized, 51 of them to the intervention group and the other to a control group. Recordings of physical performance and complaints of LBP were done before and after treatment in the intervention group. The proportion of patients with no complaints of LBP was significantly greater in the intervention group than in the control group at the one-year follow-up. The patients who intra-individually improved their physical performance also intra-individually decreased their complaints of LBP. The intra-individual improvements were suggested to be important for the individual return to work.     

Zatebradine: pharmacokinetics of a novel heart-rate-lowering agent after intravenous infusion and oral administration to healthy subjects

Although high-frequency low-intensity transcutaneous electric nerve stimulation (TENS) has been extensively used to relieve low back pain, experimental studies of its effectiveness have yielded contradictory findings mainly due to methodological problems in pain evaluation and placebo control. In the present study, separate visual analog scales (VAS) were used to measure the sensory-discriminative and motivational-affective components of low back pain. Forty-two subjects were randomly assigned to 1 of 3 groups: TENS, placebo-TENS, and no treatment (control). In order to measure the short-term effect of TENS, VAS pain ratings were taken before and after each treatment session. Also, to measure long-term effects, patients rated their pain at home every 2 h throughout a 3-day period before and 1 week, 3 months and 6 months after the treatment sessions. In comparing the pain evaluations made immediately before and after each treatment session, TENS and placebo-TENS significantly reduced both the intensity and unpleasantness of chronic low back pain. TENS was significantly more efficient than placebo-TENS in reducing pain intensity but not pain unpleasantness. TENS also produced a significant additive effect over repetitive treatment sessions for pain intensity and relative pain unpleasantness. This additive effect was not found for placebo-TENS. When evaluated at home, pain intensity was significantly reduced more by TENS than placebo-TENS 1 week after the end of treatment, but not 3 months and 6 months later. At home evaluation of pain unpleasantness in the TENS group was never different from the placebo-TENS group.(ABSTRACT TRUNCATED AT 250 WORDS)     

Suprachiasmatic nucleus organization

OBJECTIVE: To assess the effect of a combined exercise and motivation program on the compliance and level of disability of patients with chronic and recurrent low back pain. DESIGN: A double-blind prospective randomized controlled trial. SETTING: Physical therapy outpatient department, tertiary care. PATIENTS: Ninety-three low back pain patients were randomly assigned to either a standard exercise program (n = 49) or a combined exercise and motivation program (n = 44). INTERVENTIONS: Patients were prescribed 10 physical therapy sessions and were advised to continue exercising after treatment termination. The motivation program consisted of five compliance-enhancing interventions. Follow-up assessments were performed at 3 1/2 weeks, 4 months, and 12 months. MAIN OUTCOME MEASURES: Disability (low back outcome score), pain intensity, physical impairment (modified Waddell score, fingertip-to-floor distance, abdominal muscle strength), working ability, motivation, and compliance. RESULTS: The patients in the motivation group were significantly more likely to attend their exercise therapy appointments (p = .0005). Four and 12 months after study entry there was a significant difference in favor of the motivation group with regard to the disability score (p = .004) and pain intensity (p < or = .026). At 4 months, there was a significant advantage for the motivation group in the fingertip-to-floor distance (p = .01) and in abdominal muscle strength (p = .018). No significant differences were found in motivation scores, self-reported compliance with long-term exercise, and modified Waddell score. In terms of working ability, there was a trend favoring the combined exercise and motivation program. CONCLUSION: The combined exercise and motivation program increased the rate of attendance at scheduled physical therapy sessions, ie, short-term compliance, and reduced disability and pain levels by the 12-month follow-up. However, there was no difference between the motivation and control groups with regard to long-term exercise compliance.     

Efficiency and costs of medical exercise therapy, conventional physiotherapy, and self-exercise in patients with chronic low back pain. A pragmatic, randomized, single-blinded, controlled trial with 1-year follow-up

STUDY DESIGN: A multicenter, randomized, single-blinded controlled trial with 1-year follow-up. OBJECTIVES: To evaluate the efficiency of progressively graded medical exercise therapy, conventional physiotherapy, and self-exercise by walking in patients with chronic low back pain. SUMMARY AND BACKGROUND DATA: Varieties of medical exercise therapy and conventional physiotherapy are considered to reduce symptoms, improve function, and decrease sickness absence, but this opinion is controversial. METHODS: Patients with chronic low back pain or radicular pain sick-listed for more than 8 weeks and less than 52 weeks (Sickness Certificate II) were included. The treatment lasted 3 months (36 treatments). Pain intensity, functional ability, patient satisfaction, return to work, number of days on sick leave, and costs were recorded. RESULTS: Of the 208 patients included in this study, 71 were randomly assigned to medical exercise therapy, 67 to conventional physiotherapy, and 70 to self-exercise. Thirty-three (15.8%) patients dropped out during the treatment period. No difference was observed between the medical exercise therapy and conventional physiotherapy groups, but both were significantly better than self-exercise group. Patient satisfaction was highest for medical exercise therapy. Return to work rates were equal for all 3 intervention groups at assessment 15 months after therapy was started, with 123 patients were back to work. In terms of costs for days on sick leave, the medical exercise therapy group saved 906,732 Norwegian Kroner (NOK) ($122,531.00), and the conventional physiotherapy group saved NOK 1,882,560 ($254,200.00), compared with the self-exercise group. CONCLUSIONS: The efficiency of medical exercise therapy and conventional physiotherapy is shown. Leaving patients with chronic low back pain untampered poses a risk of worsening the disability, resulting in longer periods of sick leave.     

Isolation in immunodeficient mice of Sarcocystis neurona from opossum (Didelphis virginiana) faeces, and its differentiation from Sarcocystis falcatula

BACKGROUND: There has been conflicting evidence of the effect of angiotensin-converting enzyme (ACE) inhibitors on exercise tolerance. Meta-analysis of published results has suggested that a beneficial effect of ACE inhibitors is demonstrated if a trial design is adequate. SETTING: Multicentre International Trial. METHODS: In a double-blind, randomized, multicentre trial, 292 patients with moderate (New York Heart Association Grades II and III) heart failure were treated with trandolapril or placebo in addition to diuretics, and followed for 16 weeks. Exercise tolerance on a treadmill was assessed at baseline and after 4, 8, 12 and 16 weeks of treatment. Both a modified Bruce and a modified Naughton protocol were used. RESULTS: Exercise tolerance improved in both treatment groups, with no significant benefit from trandolapril treatment. CONCLUSION: Trandolapril does not improve exercise tolerance as measured by treadmill testing.     

Acupuncture and amitriptyline for pain due to HIV-related peripheral neuropathy: a randomized controlled trial. Terry Beirn Community Programs for Clinical Research on AIDS

CONTEXT: Peripheral neuropathy is common in persons infected with the human immunodeficiency virus (HIV) but few data on symptomatic treatment are available. OBJECTIVE: To evaluate the efficacy of a standardized acupuncture regimen (SAR) and amitriptyline hydrochloride for the relief of pain due to HIV-related peripheral neuropathy in HIV-infected patients. DESIGN: Randomized, placebo-controlled, multicenter clinical trial. Each site enrolled patients into 1 of the following 3 options: (1) a modified double-blind 2 x 2 factorial design of SAR, amitriptyline, or the combination compared with placebo, (2) a modified double-blind design of an SAR vs control points, or (3) a double-blind design of amitriptyline vs placebo. SETTING: Terry Beirn Community Programs for Clinical Research on AIDS (HIV primary care providers) in 10 US cities. PATIENTS: Patients with HIV-associated, symptomatic, lower-extremity peripheral neuropathy. Of 250 patients enrolled, 239 were in the acupuncture comparison (125 in the factorial option and 114 in the SAR option vs control points option), and 136 patients were in the amitriptyline comparison (125 in the factorial option and 11 in amitriptyline option vs placebo option). INTERVENTIONS: Standardized acupuncture regimen vs control points, amitriptyline (75 mg/d) vs placebo, or both for 14 weeks. MAIN OUTCOME MEASURE: Changes in mean pain scores at 6 and 14 weeks, using a pain scale ranging from 0.0 (no pain) to 1.75 (extremely intense), recorded daily. RESULTS: Patients in all 4 groups showed reduction in mean pain scores at 6 and 14 weeks compared with baseline values. For both the acupuncture and amitriptyline comparisons, changes in pain score were not significantly different between the 2 groups. At 6 weeks, the estimated difference in pain reduction for patients in the SAR group compared with those in the control points group (a negative value indicates a greater reduction for the "active" treatment) was 0.01 (95% confidence interval [CI], -0.11 to 0.12; P=.88) and for patients in the amitriptyline group vs those in the placebo group was -0.07 (95% CI, -0.22 to 0.08; P=.38). At 14 weeks, the difference for those in the SAR group compared with those in the control points group was -0.08 (95% CI, -0.21 to 0.06; P=.26) and for amitriptyline compared with placebo was 0.00 (95% CI, -0.18 to 0.19; P=.99). CONCLUSIONS: In this study, neither acupuncture nor amitriptyline was more effective than placebo in relieving pain caused by HIV-related peripheral neuropathy.     

Antianginal response to once-daily diltiazem CD in patients receiving concomitant beta-blockers, long-acting nitrates, or both. Diltiazem CD Study Group

STUDY OBJECTIVE: To determine the safety and efficacy of diltiazem CD 180 mg administered once/day in patients with chronic stable angina inadequately controlled with P-blockers, long-acting nitrates, or both. DESIGN: Multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. SETTING: Medical clinics in the private and academic sectors. PATIENTS: Of 172 patients, 170 completed the 2-week double-blind treatment period. INTERVENTION:. Patients received either diltiazem CD 180 mg or placebo once/day in combination with existing antianginal therapy. MEASUREMENTS AND MAIN RESULTS: The time to termination of exercise tolerance testing, 24 hours after the dose increased significantly in the diltiazem CD group (37.2 sec) compared with the placebo group (21.3 sec, p=0.0438). Time to onset of angina during exercise testing also increased (57.6 vs 35.0 sec, respectively, p=0.0324), as did time to moderate angina (37.5 vs 20.6 sec, respectively, p=0.0354). The rates of total angina attacks and of angina attacks on exertion were significantly reduced in the diltiazem CD group versus placebo (p<0.05). Significant reductions in systolic and diastolic blood pressures and heart rate-blood pressure product measured at rest, submaximum exercise, and exercise termination were observed in diltiazem CD-treated patients compared with placebo (p<0.05). The frequency of treatment-related adverse events was identical in the two groups, 15.1%. CONCLUSION: Diltiazem CD 180 mg once/day is an effective, safe, and beneficial initial dosage when added to existing antianginal therapy.     

Anger management style and emotional reactivity to noxious stimuli among chronic pain patients and healthy controls: The role of endogenous opioids.

Objective: Previous work suggests that elevated trait anger-out exacerbates pain responses in part through endogenous opioid dysfunction. The authors examined whether this opioid dysfunction affects not only perceived pain intensity, but also emotional responses to being hurt. Design: 79 chronic low back pain (LBP) patients and 46 healthy controls received opioid blockade (8 mg naloxone i.v.) and placebo in randomized, counterbalanced order in separate sessions. During each session, participants sequentially experienced finger pressure pain and ischemic forearm pain tasks, with emotional state assessed at baseline and postpain. Main Outcome Measures: Blockade effects indexing opioid modulation of emotional reactivity were derived by subtracting placebo from blockade condition emotional reactivity. Results: Significant Participant Type × Anger-Out interactions on blockade effects indicated that in LBP participants but not in controls, greater anger-out was associated with deficient opioid modulation of anxiety, anger, and fear reactivity to noxious stimulation. Across participant types, greater anger-in was associated with impaired opioid modulation of anxiety and fear reactivity. Anger-in opioid effects were partially due to overlap with general negative affect. Conclusions: Opioid dysfunction associated with trait anger-out may affect not only perceived pain intensity, but also pain-related suffering in individuals with chronic pain conditions. Implications for understanding the health effects of anger management styles are discussed. (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Adjuvant therapy for osteosarcoma in dogs: results of randomized clinical trials using combined liposome-encapsulated muramyl tripeptide and cisplatin

Two randomized, double-blind clinical trials in dogs with spontaneous appendicular osteosarcoma treated with combination chemoimmunotherapy are reported. In both trials, dogs without overt metastasis underwent complete amputation of the affected limb. In trial 1, 40 dogs were treated with cisplatin chemotherapy [(CDDP), 70 mg/m2 i.v. every 28 days x 4]. Following CDDP, dogs without evidence of overt metastasis (n = 25) were randomized to receive liposome-encapsulated muramyl tripeptide phosphatidylethanolamine ](L-MTP-PE), 2 mg/m2 i.v.) or placebo liposomes (lipid equivalent) twice weekly for 8 weeks. Of 14 dogs in the placebo group, 13 (93%) died of metastasis; the median survival time was 9.8 months. Of 11 dogs in the L-MTP-PE group, 8 (73%) developed metastasis; the median survival time was 14.4 months, which was significantly longer than that of the placebo group (P < 0.01). In trial 2, 64 dogs received CDDP (70 mg/m2 i.v. every 21 days x 4) and were randomized to concurrently receive L-MTP-PE (2 mg/m2 i.v.) twice or once weekly, or placebo liposomes once weekly for 8 weeks. Median survival times were 10.3, 10.5, and 7.6 months, respectively. There were no significant differences among the three treatment groups in trial 2. Survival times for dogs receiving L-MTP-PE in trial 1 were significantly longer than those for dogs in trial 2 that received four doses of CDDP concurrently with twice weekly L-MTP-PE (P < 0. 04). The results of the first trial confirm our previous observation that L-MTP-PE has antimetastatic activity in dogs with osteosarcoma when given following amputation. The results of the second trial demonstrate that there is no survival advantage of administering L-MTP-PE concurrently with CDDP.     

The status of human filariasis in north-western zone of Bauchi State, Nigeria

PURPOSE: To review the efficacy of nonmedicinal, noninvasive therapies in hip and knee osteoarthritis. DATA SOURCES: Search of English-language literature from 1966 through 1993 using MEDLINE by cross-referencing "osteoarthritis" (therapy subheadings) with "controlled trial," "comparative study," or "trial(s)." STUDY SELECTION: Fifteen controlled trials of diathermy (deep heat), exercise, acupuncture, transcutaneous electrical nerve stimulation, topically applied capsaicin, low-energy laser, and pulsed electromagnetic fields were found. No experimental studies of superficial heat and cold, orthotic devices, vibration, or weight loss were identified. RESULTS: Exercise reduces pain and improves function in patients with osteoarthritis of the knee. No support exists in the literature for pre-exercise ultrasound treatment. Single, well-designed studies suggest that topically applied capsaicin and laser treatment reduce pain associated with knee osteoarthritis. Data on the other three therapies were sparse (transcutaneous electrical nerve stimulation, pulsed electromagnetic fields) or inconsistent (acupuncture). CONCLUSIONS: More data are needed to determine the optimal exercise regimen for treating knee osteoarthritis and to evaluate the role of topical capsaicin, laser therapy, acupuncture, transcutaneous electrical nerve stimulation, and pulsed electromagnetic fields. No data specifically address the role of any of these therapies in hip osteoarthritis.     

Transcutaneous electrical nerve stimulation in unstable angina pectoris

BACKGROUND: Silent ischemia is a strong predictor of unfavorable outcome in unstable angina pectoris. Dynamic continuous vector cardiography provides online detection of ischemic episodes. Transcutaneous electrical nerve stimulation (TENS) has been reported to have antianginal effects in patients with severe coronary artery disease and this is associated with a reduction in myocardial ischemia. The aim of the present study was to investigate the applicability of TENS in patients with unstable angina in the coronary care unit and the effects on vector cardiographic and biochemical markers of ischemia. METHODS: Thirty patients (14 in the TENS group and 16 in a placebo group) were included in a single-blind, placebo-controlled study after being admitted to the coronary care unit. Continuous vector cardiography, leakage of cardiac enzymes and consumption of analgesics were recorded for 24 h. RESULTS: TENS was well tolerated and did not interfere with standard treatment, although vectorcardiographic recording during actual stimulation was disturbed. There was a reduction in the number of silent ischemic ST change vector magnitude episodes (P = 0.02) and their duration (P = 0.01) in the TENS-treated group, and a nonsignificant reduction in the total number of ST change vector magnitude (painful plus silent) episodes (P = 0.09) and their duration (P = 0.05) and in leakage of cardiac enzymes (P = 0.12). There were no detectable differences in terms of episodes of pain leading to stimulation or consumption of analgesics. CONCLUSIONS: TENS seems to be a safe additional treatment in unstable angina pectoris and may reduce the number of ischemic events, by mechanisms apparently unrelated to the reduction of pain.     

A population-based, randomized clinical trial on back pain management

STUDY DESIGN: Population-based randomized clinical trial. OBJECTIVES: To develop and test a model of management of subacute back pain, to prevent prolonged disability. SUMMARY OF BACKGROUND DATA: The present management of back pain seems inadequate, and development of innovative models has been urged. METHODS: A model for the treatment of subacute work-related back pain has been developed and evaluated in a population-based randomized clinical trial. Workers (n = 130) from eligible workplaces in the Sherbrooke area (N = 31), who had been absent from work for more than 4 weeks for back pain, were randomized, based on their workplace, in one of four treatment groups: usual care, clinical intervention, occupational intervention, and full intervention (a combination of the last two). The duration of absence from regular work and from any work was evaluated using survival analysis. Functional status and pain were compared at study entry and after 1 year of follow-up. RESULTS: The full intervention group returned to regular work 2.41 times faster than the usual care intervention group (95% confidence interval 1.19-4.89; P < 0.01). The specific effect of the occupational intervention accounted for the most important part of this result, with a rate ratio of return to regular work of 1.91 (95% confidence interval = 1.18-3.10; P < 0.01). Pain and disability scales demonstrated either a statistically significant reduction or a trend toward reduction in the three intervention groups, compared with the trend in the usual care intervention group. CONCLUSIONS: Close association of occupational intervention with clinical care is of primary importance in impeding progression toward chronicity of low back pain.     

The effect of regular exercise on women receiving danazol for treatment of endometriosis

OBJECTIVE: To determine the effects of regular exercise on women receiving danazol for the treatment of endometriosis. METHODS: Thirty-nine patients were randomized to a danazol-only or a danazol/exercise regimen in a prospective clinical trial carried out at tertiary care institutions. Patients in the danazol/exercise group were instructed to exercise four times per week, for 40 min per session, at an intensity of 20 metabolic units. Side effect profiles, pelvic symptoms, aerobic fitness, strength and hormone levels were compared for all subjects. The number of side effects of danazol was analyzed by the method of generalized estimating equations. RESULTS: The number of side effects reported during a 4-week period was 1.09-2.17 times greater for the danazol-only than for the danazol/exercise group. All patients had improvement of symptoms during treatment. The danazol/exercise group had significantly lower testosterone levels during treatment. The time to recurrence of endometriosis was not different between groups. CONCLUSIONS: Exercise during danazol therapy reduces the number of androgenic side effects. Relief of pain and time to recurrence are unaffected.     

Effect of nilvadipine on high-voltage activated Ca2+ channels in rat CNS neurons

Acute rejection following orthotopic liver transplantation is a common problem despite current immunosuppressive regimens. Ursodeoxycholic acid (UDCA) has been shown in small, open-labeled studies to prevent rejection episodes, although its effects on complications such as infections, length of hospital stay, and survival have not been evaluated. We conducted a randomized, placebo-controlled, double-blind trial to determine if UDCA (10-15 mg/kg/d) added to a cyclosporine-based immunosuppressive regimen was associated with a decrease in the incidence of at least one episode of acute cellular rejection. Secondary end-points included determining differences in the total number of rejection episodes, the use of muromonab-CD3, the incidence of infections, length of hospital stay, and survival at 90 days and 1 year. Fifty-two patients were randomized, 28 to the treatment group and 24 to the placebo group. During the 3 months of the trial, there was no difference between the placebo and UDCA groups in the number of patients who were rejection-free; however, there were significantly fewer patients in the treatment group who had multiple episodes of acute rejection (0 vs. 6; P = .007). Patients in the treatment group experienced a significantly lower incidence of bacterial infections (4% vs. 29%; P = .02), shorter hospital stay (25 days vs. 34 days; P = .03), and better 90-day survival (100% vs. 83%; P = .04) and 1-year survival (93% vs. 79%). The addition of UDCA to a cyclosporine-based immunosuppressive regimen results in significantly fewer patients experiencing multiple episodes of rejection and improved survival at 90 days and at 1 year. The use of UDCA as adjuvant therapy for patients undergoing liver transplantation who are treated with a cyclosporine-based immunosuppressive regimen should be considered.     

Effect of gallopamil on myocardial microperfusion in patients with stable effort angina: a randomized, cross-over, double-blind, placebo-controlled trial

We evaluated the efficacy and safety of daily administration of gallopamil 150 mg/day and its effects on myocardial perfusion in a medium-term, randomized, double-blind, cross-over, placebo-controlled trial. We studied 19 patients (17 males and 2 females; mean age 57 +/- 6.8 years) with stable effort angina, angiographically documented coronary artery disease and reversible perfusion defects during exercise thallium-201 myocardial scintigraphy of at least one segment of the left ventricle. After 2 weeks of a single-blind placebo run-in period, during which each patient underwent at least 2 exercise tests and a 48-hour Holter ECG recording, all patients were treated with either placebo or gallopamil 50 mg t.i.d. for 28 days. At the end of this period, patients crossed over to the alternate regimen. This phase was double blind. After treatment with placebo or gallopamil, patients underwent exercise tests, 24-hour Holter ECG recording and thallium-201 myocardial scintigraphy. Weekly angina frequency and trinitroglycerin (TNT) consumption and safety were also evaluated. No patients dropped out of the study because of major side effects. The number of total ischemic and symptomatic events recorded at 24-hour ECG monitoring, weekly angina frequency and TNT consumption were significantly reduced during gallopamil treatment. After gallopamil administration, exercise duration significantly increased (run-in: 419 +/- 116 s, placebo: 420 +/- 118 s, gallopamil: 511 +/- 144 s; p < 0.05), and ST segment depression was significantly reduced (run-in: -1.3 +/- 0.3 mm, placebo: -1.3 +/- 0.3 mm, gallopamil: -0.94 +/- 0.68 mm; p < 0.01), while heart rate, systolic blood pressure and rate-pressure product were unchanged at rest, at submaximal and at peak exercise. Qualitative and quantitative evaluation of myocardial perfusion and the myocardial uptake percentage of thallium-201 in ischemic zones were significantly improved by gallopamil treatment. These findings demonstrate that gallopamil can improve myocardial perfusion and reduce myocardial oxygen consumption.     

Repetitive conundrums of centromere structure and function

BACKGROUND: Adult participants in randomized controlled trials often have better outcomes than patients who are eligible but not enrolled. OBJECTIVE: To examine whether newborn infants who were allocated to placebo in an investigational drug trial had better outcomes than infants who were eligible but not randomized (eligible NR). Study design: During a randomized controlled trial of antithrombin therapy in premature infants with respiratory distress syndrome, data were collected prospectively on all 76 infants in the eligible NR group. Study outcomes were compared with those of all 61 infants who were randomized to placebo. The same exogenous surfactant was used in all patients. RESULTS: In the placebo group the mean (SD) birth weight was 1201 (314) g, mean (SD) gestational age was 28.8 (2.3) weeks, and 51% were male. In infants in the eligible NR group, mean (SD) birth weight was 1141 (262) g, mean (SD) gestational age was 28.3 (2. 3) weeks, and 58% were male; 57% of infants in both groups had been exposed to steroids before birth. The median duration of mechanical ventilation was reduced from 6.2 days in the eligible NR group to 4. 8 days in the placebo group (P =.008). There was also a trend toward less frequent and less severe intraventricular hemorrhage in trial participants. CONCLUSIONS: These data are consistent with the hypothesis that sick newborn infants may benefit from participation in a randomized controlled trial.     

Spinal cord stimulation in chronic intractable angina pectoris: a randomized, controlled efficacy study

BACKGROUND: Spinal cord stimulation is known to be a successful treatment for chronic intractable angina pectoris. Its effect may be anti-ischemic. It is uncertain if the clinical effect is partly caused by a placebo effect of surgery for implantation of a stimulator. In this study, clinical efficacy is investigated, together with a possible placebo effect. METHODS AND RESULTS: Efficacy of spinal cord stimulation as a treatment for chronic intractable angina pectoris was studied for 6 weeks in 13 treated patients and 12 control patients with chronic angina. Assessments were exercise capacity and ischemia, daily frequency of anginal attacks and nitrate tablet consumption, and quality of life (perceived quality of life and pain). Compared with control, exercise duration (P =.03) and time to angina (P =.01) increased; anginal attacks and sublingual nitrate consumption (P =.01) and ischemic episodes on 48-hour electrocardiogram (P =.04) decreased. ST-segment depression on the exercise electrocardiogram decreased at comparable workload (P =.01). Anginal attacks and consumption of sublingual nitrates decreased (P =.01), perceived quality of life increased (P =.03), and pain decreased (P =.01). CONCLUSIONS: Spinal cord stimulation is effective in chronic intractable angina pectoris, and its effect is exerted through anti-ischemic action. Efficacy is unlikely to be explained as a placebo effect from surgery.     

The use of 5,6 benzo-[alpha]-pyrone (coumarin) and heating by microwaves in the treatment of chronic lymphedema of the legs

Sixty patients with leg lymphedema from a variety of etiologies were divided into randomized two groups, matched by Grade, duration, age, sex, and cause of lymphedema. Using a double-blind format, one group received 5,6 benzo-[alpha]-pyrone (coumarin 1,2 benzopyrone, 400 mg/day) for six months; the other received a placebo. For the next six months, both groups received a standardized regimen of heat (using microwaves) coupled with compression garments. Benzopyrone produced approximately 20% reduction in the volume (p = 10(-4)) and improvement in circumferences and tonometry (p = 10(-5) and 10(-7)). Symptoms (feelings of swelling, pain, heaviness and loss of mobility) were also significantly improved (p = 0.03 to 10(-7)). During the second six months, when microwave heat therapy was added to drug therapy, the patients who had previously received the placebo showed significant improvement (p = 0.03 to 10(-9)) in signs and symptoms of lymphedema. Some, but not all, of the group that was receiving benzopyrones were also significantly improved by heat therapy (p = 0.8 to 0.002). Taking benzopyrones for 12 months plus heat treatment for six months was significantly better, for some criteria, than the placebo plus heat therapy (p = 0.7 to 0.04). On the other hand, heat plus either placebo or benzopyrone was often significantly better than either the active or inactive drug without heat (p = 0.8 to 10(-9)).     

The effect of anaesthetics on the dynamic heterogeneity of lipid membranes

A randomized multicenter study was performed in order to investigate the acceptance of a low-dose OC (30 micrograms of ethinyloestradiol and 150 micrograms of desogestrel), using a 9 weeks on and 1 week off schedule (prolonged regimen, n = 198), compared to a traditional 3 weeks on, 1 week off schedule (standard regimen, n = 96). Haemoglobin and blood pressure remained the same in both groups during the study. No significant differences were found in body weight changes between the two groups. There was significantly more breakthrough bleeding and spotting in the group with prolonged regimen than in the group with standard regimen, but both breakthrough bleeding and spotting decreased during the trial. Irregular bleeding was significantly less in women who were already using OC, compared to "new starters." No serious side effects occurred. Significantly more women stopped the trial because of bleeding problems in the group with prolonged regimen, while there were significantly more women who stopped the trial because of headache in the group with standard regimen. After completing 12 months, or after premature withdrawal from the study, each women completed a questionnaire. Sixty-three per cent of the women preferred the studied alternative and twenty-six per cent preferred the traditional OC.