The headache may be considered among the neuropathic pain syndromes of multiple sclerosis (MS). Several studies have showed that it is more frequent in MS patients than in controls or general ...population. Headache may occur at the pre-symptomatic phase, at clinical onset and during the course of the disease. Tension-type headache and migraine without aura are the most common primary headaches reported in MS patients. The disease-modifying therapies, such as interferons, may cause or exacerbate headache, although the new available treatments do not seem to increase the risk of pain. Pharmacological and not pharmacological approach may be considered in selected patients to prevent the risk of headache, ameliorate quality of life and increase the adherence to treatment.
To assess the relationship between breastfeeding and risk of puerperal relapses in a large cohort of patients with multiple sclerosis (MS).
We prospectively followed-up pregnancies occurring between ...2002 and 2008 in women with MS, recruited from 21 Italian MS centers, and gathered data on breastfeeding through a standardized interview. The risk of relapses after delivery was assessed using the Cox regression analysis.
A total of 302 out of 423 pregnancies in 298 women resulted in full-term deliveries. Patients were followed up for at least 1 year after delivery. The time-dependent profile of the relapse rate before, during, and after pregnancy did not differ between patients who breastfed and patients who did not. In the multivariate analysis, adjusting for age at onset, age at pregnancy, disease duration, disability level, and relapses in the year prior to pregnancy and during pregnancy, treatment with disease-modifying drugs (DMDs), and exposure to toxics, the only significant predictors of postpartum relapses were relapses in the year before pregnancy (hazard ratio HR = 1.5; 95%confidence interval CI 1.3-1.9; p < 0.001) and during pregnancy (HR = 2.2; 95% CI 1.5-3.3; p < 0.001).
In our sample, postpartum relapses were predicted only by relapses before and during pregnancy. Therefore, the reported association between breastfeeding and a lower risk of postpartum relapses may simply reflect different patient behavior, biased by the disease activity. Our results can assist neurologists facing the breastfeeding issue in mother counseling and shared decision-making. Especially, among patients with high risk of postpartum relapses, breastfeeding may not be feasible and early postpartum treatment should be an option.
To assess pregnancy and fetal outcomes after in utero exposure to interferon-β (IFNβ) in all pregnancies occurring in women with multiple sclerosis (MS) during the study period, with a specific focus ...on the risk of spontaneous abortion.
In this cohort study, data were gathered through a standardized, semi-structured interview. Patients who discontinued IFNβ less than 4 weeks from conception (exposed) were compared with those who had discontinued the drug at least 4 weeks from conception or who were never treated (not exposed). Possible confounders were handled through multivariate analyses adjusted for propensity score (PS).
We collected data on 396 pregnancies in 388 women, 88 classified as exposed (mean exposure 4.6 ± 5.8 weeks). IFNβ exposure was not associated with an increased risk of spontaneous abortion (PS-adjusted odds ratio OR 1.08, 95% confidence interval CI 0.4 to 2.9, p = 0.88), although it was associated with both lower baby weight (PS-adjusted β -113.8, p < 0.0001) and length (PS-adjusted β -1.102, p < 0.0001). Proportion of spontaneous abortion in exposed patients fell within the range expected for the Italian population in the same period. IFNβ exposure (PS-adjusted OR 2.11, 95% CI 1.18 to 3.78, p = 0.012) and cesarean delivery were the only predictors of preterm delivery. In the exposed group, we did not observe any significant fetal complications, malformations, or developmental abnormalities over a median follow-up of 2.1 years.
Our findings point to the relative safety of IFNβ exposure times of up to 4 weeks and can assist neurologists facing therapeutic decisions in women with MS with a pregnancy plan.
In 2004, the International Headache Society (IHS) re-defined the diagnostic criteria of Tolosa–Hunt syndrome (THS) specifying that granuloma, demonstrated by magnetic resonance imaging (MRI) or ...biopsy, is required for diagnosis. We reviewed the literature on THS published from 1988 (year of publication of first IHS criteria) to 2002, analysing individual cases in relation to the new IHS criteria. One hundred and twenty-four cases were identified. As far as it was possible to discern, clinical presentation was similar in all, but 44 (35±) were reported to have inflammation on MRI or bioptic evidence of granuloma, 41/124 (33±) had normal neuroimaging findings and 39 (31±) had a specific lesion, so the THS was secondary. These data confirm that clinical criteria for THS are common to several conditions and their application alone does not guarantee a correct diagnosis. The requirement for inflammation on MRI will result in better classification of painful ophthalmoplegias; nevertheless, an MRI protocol that best defines inflammation should be specified. The status of cases which fulfil the clinical criteria but have normal MRI remains to be clarified.
Background
Nasal continuous positive airway pressure (CPAP) in moderate-to-severe cases of obstructive sleep apnea can cause nasal discomfort and other undesirable problems.
Objective
The aim of our ...study was to test the effects of sodium hyaluronate on nasal problems that patients experienced in their daily lives, sleepiness, nasal resistance to airflow, nasal mucociliary clearance, changes in inflammatory markers, and compliance to CPAP in three groups of patients with obstructive sleep apnea syndrome on CPAP therapy.
Methods
A total of 102 patients with a confirmed diagnosis of obstructive sleep apnea syndrome (apnea-hypopnea index AHI of ≥10/hour) were randomized into three treatment groups: (1) hyaluronate plus CPAP, (2) saline solution plus CPAP, and (3) CPAP-only groups. Outcome measures were the extent of improvement in the Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ) mean scores, sleepiness, nasal resistance to airflow, nasal mucociliary clearance, changes in inflammatory markers, and compliance to CPAP. Significant improvement in each outcome measure was determined by comparing scores at baseline and after 4 weeks for each treatment group.
Results
Significant improvement in the MiniRQLQ overall mean score was observed both in the hyaluronate plus CPAP (p <0.00001) and saline solution plus CPAP groups (p <0.01), although the hyaluronate plus CPAP group had better improvement compared with the saline solution plus CPAP group (0.24 versus 0.12, respectively). An increase in nasal inflammatory markers and saccharin transit test score was observed in all three groups, although it was statistically lower in the hyaluronate plus CPAP group (all p <0.001).
Conclusion
Intranasal hyaluronate showed significant benefits in patients who received CPAP therapy, but future studies over a longer period of time after treatment should be performed to corroborate our findings.
OBJECTIVES Health related quality of life (HRQOL) inventories are multi-dimensional measures of patient-centred health status developed for clinical research. The MS quality of life 54 (MSQOL-54) is ...an MS-specific HRQOL inventory originally devised for English speaking patients. It consists of a core measure, the 36-item short form health survey (SF-36) previously adapted into Italian, and 18 additional items exploring domains relevant to patients with MS (MS-18 module). The authors translated and culturally adapted into Italian the MS-18 module of the MSQOL-54 questionnaire, and clinically validated the whole questionnaire. METHODS The MS-18 module was translated following the methodology of the International Quality of Life Assessment (IQOLA) project. The MSQOL-54 was validated in 204 consecutive patients with MS seen between April and September 1997 at three participating centres. The questionnaire was explained by the physician who also administered the expanded disability status scale (EDSS) and mini mental status scale examination, and the patient filled in the MSQOL-54 and Beck depression inventory questionnaires (BDI), with assistance if required. The contribution of impairments and disabilities to MSQOL-54 scores were assessed, and mean scores were compared with normative data for the general Italian population, and with the original sample of United States MS patients. RESULTS The mean age of the 204 patients was 42 years; mean EDSS score was 4.5 (range 0-8.5). Patients’ participation in the assessment was satisfactory, and all scales satisfied the usual psychometric standards. The characteristics of the United States sample matched those of our patients in all but gender (72% United States patientsv 52% Italian patients were women), and education (90% United States patients and 44% Italian patients completed high school); MSQOL-54 profiles were also similar. The EDSS was significantly associated with the physical health composite but not with the mental health composite score. Multiple linear regression modelling showed that age and BDI independently predicted physical health composite (p < 0.001), and mental health composite (p < 0.001). Clinical worsening in the previous year had an independent effect on the physical health composite (p < 0.001). CONCLUSIONS The Italian version of MSQOL-54 is easy to administer and is well accepted by patients. Neurological impairment has a limited influence on perceived quality of life, while age and depressive symptoms has a major influence.
Cyclophosphamide for multiple sclerosis La Mantia, Loredana; Milanese, Clara; Mascoli, Nerina ...
Cochrane database of systematic reviews,
01/2007, Letnik:
2009, Številka:
1
Journal Article
Recenzirano
Odprti dostop
Background
Multiple sclerosis is a presumed cell‐mediated autoimmune disease of the central nervous system. Cyclophosphamide (CFX) is a cytotoxic and immunosuppressive agent, used in systemic ...autoimmune diseases. Controversial results have been reported on its efficacy in MS. We conducted a systematic review of all relevant trials, evaluating the efficacy of CFX in patients with progressive MS.
Objectives
The main objective was to determine whether CFX slows the progression of MS.
Search methods
We searched the Cochrane MS Group Trials Register (June 2006), Cochrane Central Register of Controlled Trials (The Cochrane Library Issue 3, 2006), MEDLINE (PubMed)(January 1966 to June 2006), EMBASE (January 1988 to June 2006) and reference lists of articles. We also contacted researchers in the field.
Selection criteria
Randomised controlled trials (RCTs) evaluating the clinical effect of CFX treatment in patients affected by clinically definite progressive MS.
CFX had to be administered alone or in combination with adrenocorticotropic hormone (ACTH) or steroids. The comparison group had to be placebo or no treatment or the same co‐intervention (ACTH or steroids)
Data collection and analysis
Two reviewers independently decided the eligibility of the study, assessed the trial quality and extracted data. We also contacted study authors for original data.
Main results
Of the 461 identified references, we initially selected 70: only four RCTs were included for the final analysis. Intensive immunosuppression with CFX (alone or associated with ACTH or prednisone) in patients with progressive MS compared to placebo or no treatment (152 participants) did not prevent the long‐term (12, 18, 24 months) clinical disability progression as defined as evolution to a next step of Expanded Disability Status Scale (EDSS) score. However, the mean change in disability (final disability subtracted from the baseline) significantly favoured the treated group at 12 (effect size ‐ 0.21, 95% confidence interval ‐ 0.25 to ‐0.17) and 18 months (‐ 0.19, 95% confidence interval ‐ 0.24 to ‐ 0.14) but favoured the control group at 24 months (0.14, CI 0.07 to 0.21). We were unable to verify the efficacy of other schedules. Five patients died; sepsis and amenorrhea frequently occurred in treated patients (descriptive analysis).
Authors' conclusions
We were unable to achieve all of the objectives specified for the review. This review shows that the overall effect of CFX (administered as intensive schedule) in the treatment of progressive MS does not support its use in clinical practice.
Recent data have suggested that interferon-b (IFN-β) may aggravate headaches in multiple sclerosis (MS) patients. The aim of this study was to investigate the life-time prevalence of primary ...headaches in MS patients treated with interferons in comparison with patients treated with other disease-modifying agents. Attention was focused on the onset of headache and the changes in pre-existing headaches in relation to the onset of therapy. The study was open-labelled and not randomized. We studied 150 consecutive MS patients treated with IFN-β (109 patients: 54 with 1b, 55 with 1a) and with other drugs (41 patients: 14 with glatiramer acetate, 27 with azathioprine). All patients underwent a semi-structured interview to diagnose headache type, according to the International Headache Society criteria. The frequency of primary headaches was higher in the interferon-group (72%) compared to patients in the other group (54%) (P = 0.03). Worsening of pre-existing headaches or development of de novo headache occurred only in the interferon-group (41 and 48%, respectively) and not in the other group (P<0.001). These results show that headache should be considered among the side-effects of interferon in MS patients.
To assess the responsiveness of the three most used patient reported multiple sclerosis (MS) specific questionnaires: the Functional Assessment of MS (FAMS), the MS Impact Scale (MSIS-29) and the 54 ...item MS Quality of Life (MSQOL-54).
Prospective multicentre longitudinal study on 104 MS patients treated with intravenous steroids for clinical exacerbation.
Patient reported data, Expanded Disability Status Scale (EDSS) score and clinical information were collected at admission and 8 weeks later. "Internal" (distribution based) responsiveness was assessed by standardised response means (SRM). "External" (anchor based) responsiveness was assessed by receiver operating characteristic (ROC) curves in relation to corresponding changes in a pre-specified reference measure (anchor). The pre-specified anchor was patients' self-reported recovery assessed on a 5 point Likert scale.
SRM was 0.39 for FAMS, 0.58 for MSIS-29 physical scale, 0.45 for MSIS-29 psychological scale, 0.71 for MSQOL-54 physical health composite and 0.57 for MSQOL-54 mental health composite. Seventy-three patients (70%) reported they had improved; physicians agreed substantially with patient assessments (kappa statistic 0.70, 95% CI 0.54 to 0.85). Areas under ROC curves differed significantly from 0.50 only for the MSIS-29 and MSQOL-54 scales where areas ranged from 0.65 (95% CI 0.53 to 0.76) for the MSIS-29 psychological scale to 0.70 (95% CI 0.58 to 0.81) for the MSQOL-54 mental health composite. Areas under ROC curves assessed using a physician based anchor were similar to the patient based areas.
The responsiveness of the MS specific instruments was less than ideal. The MSIS-29 and MSQOL-54 were significantly more responsive, using both distribution based and anchor based approaches, than FAMS, and should be preferred in longitudinal studies.
The aim was to investigate the lifetime prevalence of headache and primary headache (diagnoses according to International Headache Society criteria) in multiple sclerosis (MS). The relationships ...between headache and clinical features of MS and MS therapy were also investigated. We studied 137 patients with clinically definite MS; 88 reported headache, 21 of whom developed headache after the initiation of interferon. The prevalence of all headaches in the remaining 116 patients was 57.7%. Migraine was found in 25.0%, tension-type headache in 31.9%, and cluster headache in one patient. A significant correlation (P = 0.007, Fisher's exact test) between migraine and relapsing-remitting MS was found. Primary headaches are common in MS patients. Further studies are needed to clarify the mechanisms underlying this association, particularly the association between migraine and relapsing-remitting MS, and the role of interferon in the development of new headache.
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