Ultimately, 10 RCTs met Provigil For Tiredness inclusion criteria Figure 1. All studies were of good quality with a score of 3 or more assessed by the Jadad scale.
Two studies were multi-centered in one country and the Provigil For Tiredness 8 were at a single center. All studies Tiredmess double-blinded and 4 were of crossover design. The included studies consisted of patients with various sample sizes ranging from 19 to Table 1. Three studies were available for meta-analyses comparing modafinil in MS with placebo. For TBI, 95 and 20 participants were included in the study of Jha et al and Kaiser et al, respectively. Meta-analysis of these two studies showed a therapeutic effect Provigil For Tiredness modafinil on fatigue associated with TBI, with a mean difference of Vasconcelos OM et al.
Owing to a limited number of trials, it was not possible to assess the presence of publication bias for each type of neurological disorders. The overall mean difference was The results were not affected by the sensitivity analysis oFr by sequentially excluding any study from the main pooled analysis. As shown in Figure 3Bbeneficial effect of modafinil on EDS was not confirmed in the pooled studies. The study of Jha et al. Meta-analysis of these two studies showed no significant effect of modafinil with a mean difference of Moreover, the study of Kaiser et al.
Improvements were seen in ESS with both placebo and modafinil with no Provigiil differences between the two treatments [ 46 ]. The pooled standardized mean difference demonstrated no impact of modafinil on depression associated with neurological disorders SMD 0. The overall risk ratio for study discontinuation due to side effects suggested that patients treated with modafinil were more likely to withdraw from treatment compared to patients with placebo RR 3.
Occurrence of adverse events reported in the included studies was read more in Table 2. Generally, more patients reported insomnia and nausea in modafinil group compared to placebo group.
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Other rates of adverse events were similar between the two groups. EDS and fatigue are highly prevalent symptoms, especially in primary care and specialty medicine. They have overlapping features, which may contribute to imprecise diagnosis and inappropriate treatment. In general, EDS is depicted as drowsiness, sleep propensity and decreased alertness while fatigue is often described as weariness, weakness and depleted energy [ 49 ].
Our primary research question was aimed at assessing the effects of modafinil on fatigue and EDS associated with neurological disorders and its safety. Our results suggested the therapeutic effect of modafinil on fatigue in TBI, with a clear beneficial effect of modafinil on EDS in patients with PD, while the beneficial effect of modafinil on fatigue could not be confirmed in the pooled studies Provigil For Tiredness PD or MS, and the therapeutic effect of modafinil on EDS was not seen in patients with MS and TBI as well.
In general, adverse events were similar between modafinil and placebo groups except Tirendess more patients reported insomnia and nausea in modafinil group compared to the placebo group. Previous meta-analysis suggested a therapeutic effect of modafinil on EDS, but not cataplexy in narcoleptic patients [ 50 ]. Additionally, their results indicated a beneficial Provigil For Tiredness of modafinil Tirddness quality of life according to the SF questionnaire.
In the current study, our data did not demonstrate a consistent effect of modafinil Tirendess EDS in the neurological disorders. The mean ESS scores were The ESS is an 8-item questionnaire intended to measure daytime sleepiness with a score between 0 and A number ranged 0 to 9 is considered as normal, while a number ranged 10 to 24 indicates excessive daytime sleepiness [ 51 ]. Kaiser et al. EDS can be a symptom of a number of factors and disorders, i.
Tirednss is a major public health problem and is very prevalent in patients with neurological disorders [ 192052 ]. A standard diagnosis of OSA requires polysomnographical investigations. However, in the studies included, few patients underwent polysomnographical investigations to identify persistent sleep disorders such as OSA, which can be a major confounder in the interpretation of the effect of modafinil on EDS associated with neurological disorders. Hence, polysomnographical investigations are needed to Proigil out patients with OSA and it will be probably useful to exclude patients with sleep disorders from randomized trials on modafinil in the future to avoid a confounder.
Provigil For Tiredness EDS, fatigue is another frequent complaint Ptovigil patients with neurological disorders. Currently fatigue is identified by the response to a single item on a general health questionnaire or from one or two symptom criteria from symptom checklists [ 53 ]. They are both employed in the studies of MS. Our data were in accordance with the Cochrane review by Peuckmann-Post V et al. In our study, we pooled two studies to evaluate the effect of modafinil on Provibil in TBI.
Although meta-analysis showed superior effect estimate for modafinil in TBI compared to placebo, the result should be interpreted with caution Provigil For Tiredness to a limited number of participants and extremely unbalanced weight of the two studies.
Veautheir Provigil For Tiredness al. Furthermore, a significant association between severe fatigue and the respiratory arousal index was seen in MS patients, suggesting that respiratory-related sleep fragmentation rather than intermittent hypoxemia might be primarily responsible for the increased fatigue [ 20 ]. Sleep efficiency and the architecture of the Provigil For Tiredness were not affected by modafinil.
The number of arousals was not significantly changed by modafinil in two trials, while the mean arousal index was statistically higher with modafinil than with placebo in the third trial. This might be one of the potential explanations why modafinil failed to decrease fatigue in neurological disorders. Owing to the fact that sleep disorders may be one of the Tredness responsible for neurological disorder related fatigue, it will be probably useful to exclude patients with sleep disorders from modafinil-RCT in the future to avoid a confounder.
Depression is highly associated with fatigue and EDS [ 58 - 60 ]. Previous evidence suggested modafinil in association with antidepressant medication can improve overall clinical condition including depressive symptoms, fatigue and EDS 61, Our results indicated that administration of modafinil alone could not ameliorate depressive symptoms, supporting the opinion that modafinil can be regarded as an agent in augmentation therapy of depression.
There are some limitations in our study. The available data from RCTs are scare although there is a quantity of case reports and uncontrolled trials.
It has to be kept in mind that many of the included studies involved only a small number of participants and did not follow a consistent research methodology. Of 10 RCTs, 4 studies were crossover design. It might be unjustified to pool the data of crossover and parallel studies together, which might introduce heterogeneity into the results.
Patients with neurological diseases often https://buymodafinilntx.com/4-provigil-causes-high-blood-pressure-vygy.php cognitive deficits and are less aware of their problems [ 63 ].
The present review only included two studies where objective measurement of EDS, i. As for fatigue, no objective measurement has been developed yet.
On the one hand, fatigue is a subjective symptom and can only be assessed subjectively by definition. On the other hand, it is assumed that perceived fatigue correlates with some objective read-outs as e.
In fact, combination of endpoints Provigil For Tiredness be the best solution to evaluate disorder related fatigue. This may indicate that the major problem might not be that modafinil does not work, but the lack of capacity to develop sound trial concepts Ptovigil to homogenize patients with presumably different fatigue pathogenesis.
Finally, modafinil in the identified studies was administrated in short-term settings. Despite the fact here no severe adverse events were presented in the current research, the safety of modafinil in the long-term administration, especially the potential of abuse and addiction, need to be investigated in the future trials.
It would be ideal to perform large RCTs in MS and PD investigating the effect of modafinil on either fatigue or sleepiness and sleep disorders should be excluded as a major confounder by polysomnography in these studies. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
PLoS One. Published online Dec 3. Friedemann Paul, Editor. Author information Article notes Copyright and License information Disclaimer. Competing Interests: The authors have declared that no competing interests exist. Received Jun 3; Accepted Oct This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are properly credited.
This article has been cited by other articles in PMC. Abstract Background Modafinil is a novel wake-promoting Provigil For Tiredness approved by the FDA ameliorating excessive daytime sleepiness EDS in three disorders: narcolepsy, shift work sleep disorder and obstructive sleep apnea.
Methods A comprehensive literature review was conducted in order to identify published studies assessing the effects of modafinil on fatigue and EDS associated with neurological disorders. Inclusion criteria Original studies were considered for inclusion in the meta-analysis if they met with the following criteria: 1 they were randomized controlled trials RCT ; 2 patients over 18 years old with neurological diseases such as PD, AD, MS, stroke, TBI, PPS and brain tumor were investigated; 3 the efficacy of modafinil on fatigue and EDS was examined; 4 results were sufficient to allow calculation of effect sizes.
Data extraction and quality assessment Two authors PS and LJH independently reviewed the full manuscripts of eligible studies. Results Study characteristics A total of citations were identified from the electronic searches and 3 through other sources, of which were excluded after a preliminary review. Open in a separate window. Figure 1. Flow diagram of the literature search and study selection processes.
Table 1 Design and patient characteristics for studies included in the meta analysis. Efficacy of modafinil Provigil For Tiredness fatigue associated with neurological disorders Eight RCTs were included to investigate the effect of modafinil on fatigue associated with neurological disorders, with 2 studies on PD, 3 on MS, 2 on TBI and 1 on PPS, with heterogeneous outcomes among each other. Figure 2. Figure 3. Figure 4. Effect of modafinil on depression associated with neurological disorders.
Figure 5. Effect of modafinil on study discontinuation due to adverse events. Table 2 The pooled adverse effects of modafinil in included studies.
Adverse effect No. Discussion EDS and fatigue are highly prevalent symptoms, especially in primary care and specialty medicine. DOC Click here for additional data file.
Funding Statement Dr. References 1. J Head Trauma Rehabil 27 : PubMed: J Clin Sleep Med 5 : Mult Scler 13 : Bakshi R Fatigue associated with multiple sclerosis: diagnosis, impact Provigil For Tiredness management. There were no significant treatment by centre interactions for any of the four efficacy measures. Most normal volunteers have ESS scores that are equal to or less than 8.
For the ESS, the overall mean score was calculated and statistical comparisons were made between the mean score for each modafinil dosage and the mean score at the baseline visit using ANOVA as described above.
At baseline, the mean duration of MS was 6. After 3 weeks of placebo treatment during phase 4 wash outthe mean FSS score was also 5. The dashed line represents the mean score at the baseline visit.
After 3 weeks of placebo treatment during phase 4 wash outthe mean total MFIS score was roughly equal to the mean total score at the end of the placebo run in phase.
The total mean scores were 7. Regression analyses of ESS scores versus fatigue scores and change in ESS scores versus change in fatigue scores did not disclose an association between sleepiness and fatigue. No serious adverse events were reported during any treatment phase. Most common adverse events and reasons for discontinuation of treatment according. During the trial, five patients reported a worsening of MS symptoms. These adverse events were considered possibly related to treatment, did not require initiation of treatment with steroids, and resolved without adjustment of modafinil dosage.
One patient reported severe and continuing exacerbation of symptoms during the placebo run in phase, discontinued the study before receiving modafinil, and received steroid treatment for 5 days. Another patient reported a worsening of symptoms during the placebo wash out period, which was considered to be unrelated to study medication.
It is important to note that whereas other agents used to treat MS fatigue, such as amantadine and pemoline, have been evaluated in previous clinical trials 7 with the same fatigue scales, neither of those therapies have shown the same magnitude of improvement as seen in this study. In fact, neither treatment resulted in statistically significant effects when compared with treatment with Provigil For Tiredness.
Several explanations were considered. These include development of tolerance or tachyphylaxis or adverse effects at the higher doses masking any possible benefits on fatigue.
The possibility that the effect of modafinil treatment on fatigue may be self limiting cannot be ruled out by the current investigation.
However, results of treatment of fatigue in patients with narcolepsy do not support this position. Finally it should be noted that some patients preferred the mg dose to the mg dose regarding the improvements in fatigue found during the study.
Modafinil (Oral Route) Side Effects - Mayo Clinic
The issue regarding the ideal dose of this agent is best resolved by titrating to the dose that provides the most benefit with the fewest intolerable or unacceptable adverse effects.
Our data also suggest that the dose-response of modafinil in the treatment of fatigue may be different in MS than the doses for treatment of excessive daytime sleepiness associated with narcolepsy. Sleep disorders and sleep disruption are known to occur in patients with MS and have been proposed as factors that contribute to MS related fatigue.
However, because many patients with MS who report fatigue do not have a sleep disorder, other causes of fatigue must also be involved. Confounding this Provigil For Tiredness is the finding that many people have a difficult time distinguishing between fatigue and sleepiness. Interestingly, studies have suggested that there is no relation between disrupted sleep and severity of daytime fatigue in patients with MS.
However, the improvement in fatigue with modafinil treatment did not correlate well with ESS scores at baseline. Thus, the relation between fatigue and sleepiness in patients with MS remains unclear. Assessment of the safety profile of modafinil in patients with MS was of primary consideration in the design of this study, and the results of the trial show that treatment with modafinil was well tolerated. The most common adverse events during treatment with modafinil were headache, nausea, and asthenia.
The adverse events associated with modafinil Provigil For Tiredness were primarily mild and transient in nature. The mg dose was associated with increased reports of asthenia. Pending appropriate clinical trials evaluating dose and duration of response to fatigue, doses of modafinil should be individualised based on clinical response. This is the first study to evaluate the safety and efficacy of modafinil in MS related fatigue.
A randomised double blind design was not considered suitable as the safety of modafinil treatment in conjunction with interferons and glatiramer was unknown, and the Provigil For Tiredness dose in patients with MS was yet to be defined.
The design used in this study assured that the patients would not be at risk because of unexpected or unanticipated adverse events. These safety findings, together with the known safety profile of modafinil, suggest that future studies employing a crossover or randomised parallel group design would not constitute a safety risk.
This study provides preliminary results indicating that modafinil may be a well tolerated and effective treatment for fatigue in patients with MS. Modafinil may represent an important addition to the pharmacological treatment options available for the management of MS related fatigue.
Additional trials to assess the long term safety and efficacy of modafinil for the treatment of fatigue are warranted. You will be able to get a quick price and instant permission to reuse the content in many different ways.
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Article menu. Abstract Objective: To assess the efficacy and safety of modafinil for the treatment of fatigue in multiple sclerosis MS.
Statistics from Altmetric. Sample size estimation Sample size estimates were performed to show group mean differences between placebo and treatment groups of one point on the fatigue severity scale FSS Tiredness a two tailed test. Patients Men and Forr aged 18—65 years with a diagnosis of MS, a stable disability level of 6 or less on the Kurtzke extended disability status scale EDSS16 and a mean score of Tirednesx or more on the FSS 17 were eligible for enrolment in the study.
Outcome variables Efficacy was evaluated at the baseline visit and after each treatment phase using the following self administered measures of fatigue: 1 the 9 item FSS 17 score range 1—7, with lower scores indicating less fatigue2 the 21 item modified fatigue impact scale 3, 18 MFIS; score range 0—84, with lower scores indicating less fatigueand 3 a visual analogue scale for fatigue VAS-F; score range 0—10, with higher scores indicating Tirednrss fatigue.
Statistical analysis Analysis of efficacy Tiiredness each treatment phase was performed using intention to treat data obtained from patients who received at least one dose of study medication and had at least one assessment of efficacy during the Prkvigil treatment phase. View this table: View inline View popup.
Table 1 Baseline characteristics. Table 2 Most common adverse events and reasons Tiredness discontinuation of treatment according. Fatigue and multiple sclerosis: evidence-based management strategies for fatigue in multiple sclerosis. Mechanisms and management of fatigue in progressive neurological disorders. Curr Opin Neurol Provigil For Tiredness 9 : — The impact of fatigue on patients with multiple sclerosis.
Can J Neurol Sci ; 21 : 9 — Symptomatic fatigue in multiple sclerosis. Arch Phys Med Rehabil ; 65 : —8. Murray TJ. Amantadine therapy Provigil For Tiredness fatigue in multiple read article.
Provigil (modafinil) is a prescription medication. It's most often used to treat excessive sleepiness caused by narcolepsy. Provigil is used off-label to treat fatigue or sleepiness associated with the following conditions Multiple sclerosis · Parkinson's disease.