Pyridostigmine in postpolio syndrome: no decline in fatigue and limited functional improvement. Effects of lamotrigine on the symptoms and life qualities of patients with post polio syndrome: a randomized, controlled study. A double-blind, placebo-controlled trial of amantadine for the treatment of fatigue in patients with the post-polio syndrome. Modafinil for treatment of fatigue in post-polio syndrome: a randomized controlled trial. Intravenous immunoglobulin for post-polio syndrome: a randomised controlled trial. Treatment of patients with postpolio syndrome in a warm climate. A multicenter, randomized, double-blinded trial of pyridostigmine in postpolio syndrome. Randomized controlled trial of modafinil for the treatment of fatigue in postpolio patients. Randomized controlled trial of strength training in post-polio patients. Post-polio syndrome patients treated with intravenous immunoglobulin: a double-blinded randomized controlled pilot study. A double-blind, placebo-controlled trial of high-dose prednisone for the treatment of post-poliomyelitis syndrome. Response of pain to static magnetic fields in postpolio patients: a double-blind pilot study.
To investigate the effect of pyridostigmine on fatigue, physical performance, and muscle function in subjects with postpoliomyelitis syndrome.
                67 subjects with increased fatigue and new weakness in one quadriceps muscle showing neuromuscular transmission defects, were included in a randomised, double blind, placebo controlled trial of 60 mg pyridostigmine four times a day for 14 weeks. Primary outcome was fatigue (on the "energy" category of the Nottingham health profile). Secondary outcomes included two minute walking distance and quadriceps strength and jitter. Motor unit size of the quadriceps was studied as a potential effect modifier. The primary data analysis compared the changes from baseline in the outcomes in the last week of treatment between groups.
                31 subjects treated with pyridostigmine and 31 subjects treated with placebo completed the trial. No significant effect of pyridostigmine was found on fatigue. The walking distance improved more in the pyridostigmine group than in the placebo group (by 7.2 m (6.0%); p<0.01). Subgroup analysis showed that a significant improvement in walking performance was only found in subjects with normal sized motor units. Quadriceps strength improved more in the pyridostigmine group than in the placebo group (by 6.7 Nm (7.2%); p = 0.15). No effect of pyridostigmine was found on jitter.
                Pyridostigmine in the prescribed dose did not reduce fatigue in subjects with postpoliomyelitis syndrome. However, it may have a limited beneficial effect on physical performance, especially in subjects with neuromuscular transmission defects in normal sized motor units. The aim of this study is to find out if lamotrigine gives symptomatic relief and enhances quality of life in patients with post-polio syndrome. Thirty patients were randomly assigned to receive or not to receive lamotrigine treatment. Lamotrigine at a daily dose of 50-100 mg was given to the fifteen patients, and fifteen patients were used as the control group. Interventional advice and home exercises were given to all of the patients. Clinical assessments were made at baseline and repeated at the second and fourth weeks by the physician who was unaware of medication. The severity of pain, fatigue and muscle cramps were rated on a visual analogue scale. Health-related quality of life was measured using the Nottingham Health Profile. The patient's perceived level of fatigue was assessed using Fatigue Severity Scale. Comparing to the baseline values, statistically significant improvements were obtained in the mean scores of VAS, NHP and FSS at two weeks and four weeks in the patients on lamotrigine. No significant improvements were reported in the control group. These preliminary results indicate that lamotrigine relieves the symptoms and improves the life qualities of patients with post polio syndrome. Because amantadine has been shown to reduce fatigue in patients with multiple sclerosis, we performed a double-blind, placebo-controlled study to assess its efficacy in the disabling symptom of post-polio fatigue. Twenty-three patients completed six weeks of therapy. Fatigue was measured by the patients using visual analogue scales (twice per day) and numerical fatigue severity scales (once per week) and by overall impression (at end of therapy). Formal neuropsychological testing and serum drug levels were performed to assess compliance. On all measures, no significant difference was found between treatment and placebo groups. Fifty-four percent of patients given amantadine and 43% given placebo reported a decrease in fatigue; however, the visual analogue scales and fatigue severity scales failed to reflect any improvement. Several patients in the treatment group elected to continue amantadine therapy after the study was completed. Our findings suggest that amantadine is not significantly better than placebo in reducing the sensation of fatigue in post-polio syndrome, and that the measures we employed were insensitive to capture the subjective response experienced by a few patients. To determine if modafinil can improve fatigue in patients with post-polio syndrome.
                We used a randomized, placebo-controlled crossover trial. Intervention with modafinil (400 mg/day) and placebo occurred over 6-week periods. Primary endpoint (fatigue) was assessed using the Fatigue Severity Scale as the main outcome measure. Other measures included the Visual Analog Scale for Fatigue and the Fatigue Impact Scale. Secondary endpoint (health-related quality of life) was assessed using the 36-Item Short-Form. Analysis of variance for repeated measures was applied to assess treatment, period, and carryover effects.
                Thirty-six patients were randomized, 33 of whom (mean age: 61 years) completed required interventions. Treatment with modafinil was safe and well-tolerated. After adjusting for periods and order effects, no difference was observed between treatments.
                Based on the utilized measures of outcome modafinil was not superior to placebo in alleviating fatigue or improving quality of life in the studied post-polio syndrome population. Survivors of poliomyelitis often develop increased or new symptoms decades after the acute infection, known as post-polio syndrome. Production of proinflammatory cytokines within the CNS indicates an underlying inflammatory process, accessible for immunomodulatory treatment. We did a multicentre, randomised, double-blind, placebo-controlled study of intravenous immunoglobulin in post-polio syndrome.
                142 patients at four university clinics were randomly assigned infusion of either 90 g in total of intravenous immunoglobulin (n=73) or placebo (n=69) during 3 consecutive days, repeated after 3 months. Seven patients were withdrawn from the study. Thus, 135 patients were assessed per protocol. Primary endpoints were muscle strength in a selected study muscle and quality of life as measured with the SF-36 questionnaire (SF-36 PCS). Secondary endpoints were 6-minute walk test (6MWT), timed up and go (TUG), muscle strength in muscles not chosen as the study muscle, physical activity scale of the elderly (PASE), visual analogue scale (VAS) for pain, multidimensional fatigue inventory (MFI-20), balance, and sleep quality. Outcome tests were done immediately before the first infusion and 3 months after the second infusion. This study is registered with , number NCT00160082.
                Compared with baseline, median muscle strength differed by 8.3% between patients receiving intravenous immunoglobulin and placebo, in favour of the treatment group (p=0.029). SF-36 PCS did not differ significantly between the groups after treatment (p=0.321). Differences in the subscale vitality score (p=0.042) and PASE (p=0.018) favoured the active treatment group. MFI-20, TUG, muscle strength in the muscles not chosen as the study muscle, 6MWT, balance, and sleep quality did not differ between groups. For the whole study population there was no significant change in pain, as determined by VAS. Nevertheless, patients who reported pain at the study start improved in the intervention group but not in the placebo group (p=0.037). Intravenous immunoglobulin was well tolerated.
                Intravenous immunoglobulin could be a supportive treatment option for subgroups of patients with post-polio syndrome. Further studies on responding subgroups, long-term effects, and dosing schedules are needed. Treatment in warm climate of various patient groups including patients with postpolio syndrome is controversial.
                Eighty-eight patients with postpolio syndrome (61 women) were recruited, stratified according to sex, age (above/below 60 years old) and use/not use of electrical wheelchair, and randomized to three groups. Group 1 (n=30) underwent treatment in a rehabilitation centre in Tenerife for four weeks in November/December 1999. Group 2 (n=29) were treated in two similar centres in Norway for the same period of time, while Group 3 (n=29), the control group, followed their ordinary health care programme. All patients were tested at the start of study, and 3 and 6 months later, including physical tests and several questionnaire and qualitative interviews. Patients in Group 1 and 2 were also tested after the rehabilitation period.
                Group 1 and 2 improved significantly both in physical tests and subjective ratings. The positive effects in Group 1 tended to exceed the positive effects in Group 2, and the effects lasted longer. Six minutes walking distance in the two groups was 347 m and 316 m, respectively, before the treatment period, 429 m and 362 m immediately after, and 431 m and 356 m 3 months later. Subjective rating of pain (VAS-scale) was 42 and 43, respectively, before treatment, 17 and 31 immediately after, and 28 and 44 3-months later. In the control group, only minor changes were found.
                The study seems to document a positive effect of treatment of patients with postpolio syndrome in warm climate. Postpoliomyelitis syndrome (PPS) is likely due to degeneration and dysfunction of terminal axons of enlarged postpolio motor units. Age-related decline in growth hormone and insulin-like growth factor (IGF-I) may be a contributing factor. Neuromuscular junction abnormalities and decreased IGF-I levels may respond to the anticholinesterase pyridostigmine, with consequent improvement in strength, fatigue, and quality of life.
                To determine the effect of pyridostigmine in PPS on health-related quality of life, isometric muscle strength, fatigue, and serum IGF-I levels; and to assess the safety of pyridostigmine in PPS.
                The study was a multicenter, randomized, double-blinded, placebo-controlled trial of a 6-month course of pyridostigmine 60 mg three times per day in 126 PPS patients. The primary data analysis compared mean changes of outcomes between treatment and control groups at 6 months using an intention to treat approach. Secondary analyses included a comparison of outcomes at 6 and 10 weeks, and in compliant patients.
                The study showed no significant differences in pyridostigmine and placebo-treated patients with regard to changes in quality of life, isometric strength, fatigue, and IGF-I serum levels at 6 months in the primary analysis and in compliant patients. There were no differences in outcomes at 6 and 10 weeks between groups. However, very weak muscles (1 to 25% predicted normal at baseline) were somewhat stronger (p = 0.10, 95% CI of difference -9.5 to 73.3%), and in compliant patients IGF-I was somewhat increased (p = 0.15, 95% CI of difference -6.4 to 44.8 ng/mL) at 6 months with the medication. Pyridostigmine was generally well tolerated.
                This study showed no significant differences between pyridostigmine and placebo-treated PPS patients on measures of quality of life, isometric strength, fatigue, and serum IGF-I. The purpose of this study was to test whether modafinil is effective in alleviating the symptoms of fatigue in postpolio patients, because it has been helpful for such symptoms in other neurologic disorders. Using a double-blind, randomized, placebo-controlled cross-over design, 14 postpolio patients with moderate to severe fatigue were assigned to receive modafinil or placebo first. Piper Fatigue Scale, Epworth Sleepiness Scale, digit span, and reaction time tests were done at baseline and then at weekly intervals. The Piper Fatigue Scale scores improved by 27 +/- 40% (mean +/- SD) following modafinil and by 43 +/- 36% following placebo. Scores for most of the other tests did not change during the study. Therefore, we conclude that modafinil was not effective in alleviating the symptoms of fatigue in postpolio patients. Many post-polio patients develop new muscle weakness decades after the initial illness. However, its mechanism and treatment are controversial. The purpose of this study was to test the hypotheses that: (1) after strength training, post-polio patients show strength improvement comparable to that seen in the healthy elderly; (2) such training does not have a deleterious effect on motor unit (MU) survival; and (3) part of the strength improvement is due to an increase in voluntary motor drive. After baseline measures including maximum voluntary contraction force, voluntary activation index, motor unit number estimate, and the tetanic tension of the thumb muscles had been determined, 10 post-polio patients with hand involvement were randomized to either the training or control group. The progressive resistance training program consisted of three sets of eight isometric contractions, three times weekly for 12 weeks. Seven healthy elderly were also randomized and trained in a similar manner. Changes in the baseline parameters were monitored once every 4 weeks throughout the training period. The trained post-polio patients showed a significant improvement in their strength (P < 0.05). The magnitude of gain was greater than that seen in the healthy elderly (mean +/- SE, 41 +/- 16% vs. 29 +/- 8%). The training did not adversely affect MU survival and the improvement was largely attributable to an increase in voluntary motor drive. We therefore conclude that moderate intensity strength training is safe and effective in post-polio patients. Post-polio syndrome (PPS) is characterized by new muscle weakness, atrophy, fatigue and pain developing several years after the acute polio. Some studies suggest an ongoing inflammation in the spinal cord in these patients. From this perspective, intravenous immunoglobulin (IvIg) could be a therapeutic option. We performed a double-blinded randomized controlled pilot study with 20 patients to investigate the possible clinical effects of IvIg in PPS. Twenty patients were randomized to either IvIg 2 g/kg body weight or placebo. Primary endpoints were changes in pain, fatigue and muscle strength 3 months after treatment. Surrogate endpoints were changes in cerebrospinal fluid (CSF) cytokine levels. Secondary endpoints were pain, fatigue and isometric muscle strength after 6 months. Patients receiving IvIg reported a significant improvement in pain during the first 3 months, but no change was noted for subjective fatigue and muscle strength. CSF levels of tumour necrosis factor-alpha (TNF-alpha) were increased compared with patients with non-inflammatory neurological disorders. In conclusion, in this small pilot study no effect was seen with IvIg treatment on muscle strength and fatigue, however IvIg treated PPS patients reported significantly less pain 3 months after treatment. TNF-alpha was increased in the CSF from PPS patients. The results are promising, but not conclusive because of the low number of patients studied. nan To determine if the chronic pain frequently presented by postpolio patients can be relieved by application of magnetic fields applied directly over an identified pain trigger point.
                Double-blind randomized clinical trial.
                The postpolio clinic of a large rehabilitation hospital.
                Fifty patients with diagnosed postpolio syndrome who reported muscular or arthritic-like pain.
                Application of active or placebo 300 to 500 Gauss magnetic devices to the affected area for 45 minutes.
                Score on the McGill Pain Questionnaire.
                Patients who received the active device experienced an average pain score decrease of 4.4 +/- 3.1 (p < .0001) on a 10-point scale. Those with the placebo devices experienced a decrease of 1.1 +/- 1.6 points (p < .005). The proportion of patients in the active-device group who reported a pain score decrease greater than the average placebo effect was 76%, compared with 19% in the placebo-device group (p < .0001).
                The application of a device delivering static magnetic fields of 300 to 500 Gauss over a pain trigger point results in significant and prompt relief of pain in postpolio subjects.
Due to insufficient good quality data and lack of randomised studies it is impossible to draw definite conclusions on the effectiveness of interventions for PPS. Results indicate that IVIG, lamotrigine, muscle strengthening exercises and static magnetic fields may be beneficial but need further investigation.