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IntroductionTremor is a common clinical problem seen in a number of diseases. Robust classification and diagnosis of tremor remains controversial due to overlap in clinical features and lack of established biomarkers. This hampers effective research including therapeutic trials. We present our research protocol for a cross-sectional study which aims to find more robust methods of tremor classification and diagnosis.MethodsAdults with upper limb tremor of varying aetiologies, diagnosed using current clinical criteria (including essential tremor, Parkinsonian tremor, and dystonic tremor), and age-matched controls are eligible for recruitment. Participants undergo a clinical and neurophysiological assessment, including accelerometry, surface electromyography, long-latency stretch reflexes, temporal discrimination, and tonic vibration reflexes. Data will be analysed using a cluster analysis to identify robust tremor syndromes and biomarkers associated with them. We aim to recruit 100 participants prior to analysis.ResultsAt time of writing, 13 participants with upper limb tremor have been studied (6 with essential tremor, 5 with dystonic tremor, and 2 with indeterminate tremor; mean age 66 years, range 18–85). Participants tolerated the clinical and neurophysiological studies well with 100% completion rate after recruitment. With current rates of recruitment we anticipate completion of recruitment and commencement of data analysis in October 2019.ConclusionsOur protocol aims to identify robust tremor phenotypes and biomarkers for them. This will allow patients with tremor to be classified into more biologically homogeneous diagnostic categories, aiding future research into the mechanism of tremor and more rational clinical trial design.

Hemicrania continua (HC) is an indomethacin responsive primary headache that is characterised by a continuous strictly unilateral headache with periodic exacerbations. About 15% may have a remitting subtype of HC. Herein, we are reporting a 36-year-old man who had a 5-year history of episodic right-sided headaches. The headaches used to occur in a discrete series lasting 4–6 weeks, separated by pain-free remissions of 10–11 months. In each relapse, he had continuous background pain with superimposed exacerbations. The superimposed exacerbations were 1–2 attacks per day, lasting for 2–5 hours, and were associated with ipsilateral cranial autonomic symptoms. However, the patient did not respond to usual therapies of custer headache (CH). He had a complete response to indomethacin. We suggest that remitting subtype of HC may mimic CH. A therapeutic trial of indomethacin should be done in all strictly unilateral headaches who are not responding to other drugs.

Subpopulations and Intermediate Outcomes in COPD Study (SPIROMICS) is a multicentre observational study of chronic obstructive pulmonary disease (COPD) designed to guide future development of therapies for COPD by providing robust criteria for subclassifying COPD participants into groups most likely to benefit from a given therapy during a clinical trial, and identifying biomarkers/phenotypes that can be used as intermediate outcomes to reliably predict clinical benefit during therapeutic trials. The goal is to enrol 3200 participants in four strata. Participants undergo a baseline visit and three annual follow-up examinations, with quarterly telephone calls. Adjudication of exacerbations and mortality will be undertaken.

We report a unique case of optic nerve lymphoma after completion of chemotherapy for non-Hodgkin’s lymphoma. The uncommon nature of presentation, our therapeutic dilemma and the further course of treatment are reported. In cases with extremely poor prognosis, unnecessary treatment puts additional strain both financially and psychologically on the patients and their family. Therapeutic focus should be on hospice care and family counselling. The decision to not treat is a crucial component of cancer management; however, the ethics of this decision are yet to be suitably addressed by the literature.

We read the article by Molina-Infante et al 1 with great concern as it proposes a major change in the current practice guidelines for managing patients presenting for care by gastroenterologists worldwide. Proton pump inhibitor-responsive oesophageal eosinophilia (PPI-REE)1 is characterised by an eosinophilic infiltrate of the oesophageal epithelium that is responsive to PPI therapy alone. The authors suggest that endoscopies should be performed prior to a therapeutic trial of PPI, so as not to miss this subtype of eosinophilic oesophagitis (EoE). We maintain that these two entities not only have yet to be proven to be the same pathophysiological process, but also that performing an initial endoscopy with biopsy would not change the current practice of first using a PPI before or after the …

Eosinophilic esophagitis is a chronic allergen driven immune mediated disease that is increasingly recognized as a leading cause of dysphagia and foregut symptoms in children and adults. Much knowledge has been gained in recent years on the genetic and environmental risk factors for this disease, the associated inflammatory milieu, and the long term complications from esophageal remodeling. In this review we will highlight recent progress made in research into this disease, focusing on adults. We will discuss ongoing efforts to develop a minimally invasive technique that may obviate the need for repeated endoscopic assessment of disease activity. Moreover, we will review studies using novel tools such as mucosal impedance and functional lumen imaging as potential surrogate markers for mucosal integrity and esophageal remodeling. With regard to the treatment of eosinophilic inflammation, we will discuss the controversies surrounding responsiveness to proton pump inhibitors in some patients. Therapeutic trials continue to support the use of topical glucocorticoids and empiric food elimination diets as first line treatments. We will discuss ongoing efforts to optimize the elimination diet protocol to decrease the level and duration of food restrictions. Looking ahead, our growing knowledge on the pathogenesis of eosinophilic esophagitis has enabled further advancement of promising targeted biologic therapies.

In the current (see page 360) and forthcoming issues of Thorax we are publishing a series examining current practice and evidence of the epidemiology and pathogenesis, prevention and treatment of pulmonary exacerbations in patients with cystic fibrosis (CF) and bronchiectasis.1–4 This follows on from a recent series examining aspects of exacerbations of chronic obstructive pulmonary disease and asthma. These reviews involved authors from Australia, USA and the UK, and each has considered the topics from both a paediatric and adult perspective. Several themes emerge in these reviews, including: (1) the challenges of diagnostic precision of definitions of respiratory exacerbations; (2) the need to develop new and/or novel endpoints for therapeutic trials for the treatment of exacerbations; and (3) the urgent need for multicentre studies to investigate both preventive and therapeutic interventions for patients with CF and bronchiectasis.

Ataxia is common in various forms of human prion diseases but there is a dearth of validated assessment tools and data on the subject. Originally used for inherited cerebellar ataxias, the Scale for Assessment and Rating of cerebellar Ataxia (SARA) and Composite Cerebellar Functional Severity Score (CCFS) have been incorporated into the National Prion Monitoring Cohort (NPMC) as semi-quantitative measures of posture, gait, kinetic dysfunction and speech in patients with sporadic and inherited Creutzfeldt-Jakob disease (CJD). SARA and CCFS assessments were completed for patients with sporadic CJD (sCJD, n=119), and inherited prion disease (IPD, n=46). Patients were concurrently scored on the Medical Research Council Prion Disease Rating Scale (MRC PDRS), a functionally-oriented measure of disease progression validated in CJD patients. SARA scores in sCJD and IPD patients showed a strong, statistically significant correlation with the MRC PDRS. The SARA score may be useful in providing semi-quantitative evidence of deteriorating co-ordination in sCJD and IPD patients; serial attainment of scores could represent an objective measure of response to clinical therapeutic trials in CJD.

Cutaneous larva migrans (CLM) is common in children in tropical and subtropical areas but exceptionally rare in temperate zones.1 We report a case of CLM in a child from a temperate climate country. An 8-year-old boy was seen with a facial skin eruption. The boy lived in an industrialised city in Romania, but spent 2 months of his summer holidays in a rural village, 150 km away, playing with cats and dogs. Initial pruritus on the left cheek was followed by progressive serpiginous erythematous papules along the left aspect of …

Objectives To identify the main determinants of quality of life (QoL) alteration in patients with active primary Sjogren9s syndrome (pSS) participating in a large therapeutic trial. Methods At the inclusion visit in the TEARS trial, 120 patients with active pSS completed the Short Form survey 36 (SF36), a validated tool measuring the level of QoL. The association of demographic data, patient-reported outcomes (including the EULAR SS Patient Reported Index (ESSPRI) score), objective measurements of dryness and autoimmunity, and the physician evaluation of systemic activity (using the EULAR SS Disease Activity Index (ESSDAI) score) with SF36 physical and mental components were assessed by univariate then multivariate linear regression analyses. Results SF36 results showed a marked alteration of QoL in this population of patients with active pSS. The strongest predictors of a low QoL (for both physical and mental components, Table 1) were patient-reported symptoms, best assessed using the ESSPRI, with pain and ocular dryness intensity displaying independent association with QoL. Conversely, systemic activity level was not associated to QoL alteration, even in the subset of patients with moderate to high systemic activity as defined by the ESSDAI. Conclusions pSS cardinal symptoms (dryness, fatigue and pain) are the major predictors of QoL alteration and should be targeted in future therapeutic trials in addition to systemic involvement. Disclosure of Interest None declared

Variants of chronic myeloproliferative disorders (CMPD) were compared according to their clinical features and classified by bone marrow biopsy appearances. Subsequently, this classification was further evaluated using survival data and histological variables from iliac crest biopsy specimens of an additional 1391 patients, making a total of 2241 patients available for analysis of outcome. The patients were grouped again into three main classes: "typical"; "variant"; and "transformed". "Typical" comprised the "classic" groups. "Variant" included the less uniform myeloproliferative syndromes, distinguished also by more variable clinical features, a different prognosis, and a greater tendency to fibrotic and blastic transformation. "Transformed" defined the end stages of both "typical" and "variant" types. Ten subgroups were distinguished by different histology and prognosis. Particular prognostic importance was assigned to atypia and immaturity of haemopoiesis, predominance of individual haemopoietic cell line, number and anomalies of megakaryocytes and progressive fibrosis. It is suggested that the proposed subclassification would be helpful for studies of epidemiology and therapeutic trials by allowing more homogeneous groups to be recognised.

Commentary on: Wilt TJ, Brawer MK, Jones KM, et al. Prostate Cancer Intervention versus Observation Trial (PIVOT) Study Group. Radical prostatectomy versus observation for localized prostate cancer. N Engl J Med 2012; 367: 203– 13.[OpenUrl][1][CrossRef][2][PubMed][3][Web of Science][4] The beneficial role of prostate cancer screening and treatment has recently been called into question. The results of two recent trials have provided conflicting results with regard to the ability of prostate cancer screening to reduce prostate cancer-specific mortality.1 The Prostate Cancer Intervention versus Observation Trial (PIVOT) goes one step further by attempting to assess the efficacy of radical prostatectomy compared with observation, on overall and prostate cancer specific, survival in patients with localised prostate cancer. While there have been two trials conducted previously to address this issue, both took place prior to the prostate-specific antigen (PSA) era and they produced conflicting results.2 ,3 This … [1]: {openurl}?query=rft.jtitle%253DNew%2BEngland%2BJournal%2Bof%2BMedicine%26rft.stitle%253DNEJM%26rft.issn%253D0028-4793%26rft.aulast%253DWilt%26rft.auinit1%253DT.%2BJ.%26rft.volume%253D367%26rft.issue%253D3%26rft.spage%253D203%26rft.epage%253D213%26rft.atitle%253DRadical%2Bprostatectomy%2Bversus%2Bobservation%2Bfor%2Blocalized%2Bprostate%2Bcancer.%26rft_id%253Dinfo%253Adoi%252F10.1056%252FNEJMoa1113162%26rft_id%253Dinfo%253Apmid%252F22808955%26rft.genre%253Darticle%26rft_val_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Ajournal%26ctx_ver%253DZ39.88-2004%26url_ver%253DZ39.88-2004%26url_ctx_fmt%253Dinfo%253Aofi%252Ffmt%253Akev%253Amtx%253Actx [2]: /lookup/external-ref?access_num=10.1056/NEJMoa1113162&link_type=DOI [3]: /lookup/external-ref?access_num=22808955&link_type=MED&atom=%2Febmed%2F18%2F4%2F139.atom [4]: /lookup/external-ref?access_num=000306522900004&link_type=ISI

When I opened this book, the first thing I noticed was the very few similarities between this and the previous edition. The authors are the same (although their order has changed), the evidence “cube” is still on the front cover, and the title is still Clinical epidemiology . However, the subtitle gives the clue to the major change: from A basic science for clinical medicine to How to do clinical practice research . This book couldn’t be any more different from the previous edition; gone are the statistics (as it states, “this book isn’t about biostatistics,” and the authors “apologize” for the oversimplification in terms of the numbers) and gone is the use of clinical research in clinical practice (this “how to use” research is the domain of the several good evidence-based medicine [EBM] books around). So what is this book about? This new edition is now clearly focused in how to do clinical practice. It is aimed at investigators at any stage of their career, “from beginning students to seasoned investigators,” and is a culmination of the authors’ experiences in undertaking …

Davie’s suggestion of a therapeutic trial may be useful and has been used formerly as part of a diagnostic strategy.1 2 3 But we would caution against relying on the response to furosemide because this drug reduces oedema from any cause, whereas non-cardiac oedema will not respond to angiotensin converting enzyme inhibitors. However, the use of B-type natriuretic peptide and echocardiography provides—in addition to diagnosis—prognostic, aetiological, and therapeutic information. There are several possible investigations for coronary disease and an individualised approach is recommended. …

Background SLEDAI-2K Responder Index-50 (S2K RI-50) is a novel index that measures partial recovery (PR), ≥50% improvement in active descriptors. Objectives To determine: 1) PR and complete recovery (CR) in active systems on standard of care (SOC) treatment and 2) the benefit of measuring ≥50% improvement in active descriptors with S2K RI-50. Methods Patients seen from February 2009 to May 2012 with at least one active system were analysed. We excluded patients with CNS or with nephrotic range proteinuria lupus nephritis. CR was measured with SLEDAI-2K and PR with S2K RI-50. Results 548 patients (90% F) with at least one active SLEDAI-2K system were analyzed. Age at lupus diagnosis was 29.2 ± 12.3 years and disease duration at study inclusion was 15.2 ± 11.0 years. Among the 8 system studied at baseline, the most commonly represented systems were: immunology, renal, mucocutaneous and musculoskeletal. In 117 patients with mucocutaneous involvement, CR by SLEDAI-2K was achieved by 68 patients at 6 months, by 95 patients at 12 months and 106 patients at 2 years. PR and CR by S2K RI-50 were identified in 83 patients at 6 months, 105 patients at 12 months and 113 patients at 2 years. The number of patients who achieved PR and CR by S2K RI-50 was greater than the number of patients who achieved CR by SLEDAI-2K in all studied systems (Table 1). The total possible score for the mucocutaneous system by SLEDAI-2K is 6. At baseline visit the total score for the mucocutaneous system was 2.56±1.01. At 6 months the score decreased to 1.02±1.51, at 12 months to 0.47±1.07 and to 0.27±0.91 at 2 years by SLEDAI-2K. At 6 months the score decreased to 0.87±1.35, 12 months to 0.40±0.95 and at 2 years to 0.20±0.67. The decrease of S2K RI-50 scores was greater than the decrease of SLEDAI-2K scores in all active systems. Conclusions With SOC treatment, patients improve progressively over a 2 year period. The use of S2K RI-50 allows the capture of an additional number of patients with ≥50% improvement in active systems not discerned by SLEDAI-2K. S2K RI-50 will allow for an earlier signal of efficacy with new agents in therapeutic trials. Disclosure of Interest None Declared

Since 2008 TRACK-HD has chronicled the earliest stages of the neurodegenerative disease processes in premanifest and mild to moderately symptomatic individuals who carry the Huntington9s disease expansion mutation. TRACK-HD was designed to observe natural disease progression in premanifest and early stage HD with the aim to establish sensitive and specific clinical and biological markers of disease progression. Such markers potentially serve as a basis for eventually defining outcome measures for future disease-modifying therapeutic trials. We recently reported longitudinal effect sizes for disease-progression in early stage Huntington9s disease over 24 months. Some of these 24 month data will be presented in this talk in more detail, including insights into what we have learnt about predictors of Huntington9s disease progression in both premanifest and early stage subjects. Analysis of the 36 month data is ongoing; this new data will also be presented including a range of novel clinical measures that now show significant change in the premanifest group over this period. We have also identified baseline predictors of disease progression which may help enrichment for future disease-modifying clinical trials. We are also now in a position to model progression in a range of functional and imaging measures across the spectrum of disease. Finally I will briefly introduce our new study – Track-On HD – which aims to identify neural compensatory networks that may occur in the premanifest phase of neurodegeneration in HD. This study will test the hypothesis that functional reorganisation of networks may precede widespread structural loss in premanifest HD, and that symptom onset may reflect a decompensation of these neural compensatory networks.

Introduction The Leicester Cough Monitor (LCM) is a validated 24-h automated cough frequency monitor. Shorter recordings are more convenient for patients and take less time to analyse but their validity for assessing cough is not known. We assessed the relationship between short duration and 24-h recordings. Methods 100 patients (57 females) with chronic cough underwent 24-h ambulatory cough frequency monitoring with the LCM. Patients completed diaries to identify awake and sleep periods. Cough frequency was determined by automated analysis and presented as 24-h cough frequency (CF 24 ), awake cough frequency, sleep cough frequency, and short duration (1–6 h). Subjective cough severity was assessed by cough visual analogue scale and quality of life questionnaire (Leicester Cough Questionnaire, LCQ). The optimal short cough recording duration was determined by assessing its relationship with awake cough frequency and subjective cough severity. The responsiveness of short duration recordings was tested in 20 patients undergoing trials of therapy. Results The median (IQR) 24-h cough frequency was 11.5 (5.8 to 26.6) coughs/h, awake cough frequency 13.2 (7.6 to 37.5) coughs/h and sleep cough frequency 4.2 (1.0 to 9.2) coughs/h. 4-h cough counts correlated strongly with both awake and 24-h cough counts; r 2 =0.88 and r 2 =0.87 respectively (Abstract S117 Figure 1). There was a moderate relationship between 4-h cough frequency (CF 4 ) and LCQ and cough VAS (r=−0.48, p 4 after therapeutic trials was 0.55. Conclusions Shorter duration cough frequency recordings with the LCM accurately reflect daytime and 24-h cough frequency in patients with chronic cough. They can be used to assess daytime cough frequency and the response to trials of therapy.

MRC Prion-1 Trial enabled investigation of longitudinal MRI and cognitive assessments as potential biomarkers for future therapeutic trials in human prion diseases. The cross-sectional data provides opportunity to examine neuroanatomical differences in patients with inherited prion diseases (IPD) and controls. Voxel-based morphometry (VBM) and voxel-based analysis of magnetisation transfer ratio (VBA-MTR) was performed on 17 symptomatic (IS) IPD patients, 6 asymptomatic (AS) mutation carriers and 13 controls (Co). An ANCOVA consisting of diagnostic grouping (Co, IS, AS) with age and total intracranial volume as covariates and a threshold of p

Imagine an intervention whose effects vary within and between individuals and depend on subtle interactions between deliverers and recipients, and in which exposure is uncertain. Given this complexity, who would contemplate conducting a randomised controlled trial? In fact, all these issues must be dealt with in drug or therapeutic trials, as well as in …

Under the auspices of the EULAR Standing Committee for International clinical Studies Including therapeutic Trials (ESCISIT), the EULAR Scleroderma Trials And Research (EUSTAR) group was officially founded in June 2004 during the Berlin EULAR congress. This was the culmination of 18 months’ intense activity by many people across Europe, and a summary is available on the website (http://www.EUSTAR.org). The logo (fig 1) features a star from a painting by Paul Klee, who himself succumbed to this dreadful disease. Figure 1 EUSTAR logo. An integral part of the EUSTAR mission was the development of a Minimal Essential Data Set, called MEDS. This consists of a simple two page form …

Twenty years after editorial behaviour that has been described by one observer as “absolutely outrageous,” the journal at the heart of the affair has apologised to the doctors concerned. In 1983 Dr Jon Tyson and colleagues, from the department of paediatrics at the University of Texas, published an analysis of the quality of therapeutic trials in perinatal medicine in the Journal of Pediatrics. The authors concluded that the papers they looked at were …

Source Citation Camilleri M, Northcutt AR, Kong S, et al. Efficacy and safety of alosetron in women with irritable bowel syndrome: a randomised, placebo-controlled trial. Lancet. 2000 Mar 25;355:10...

Symptoms resulting from congenital nystagmus can be significantly reduced by wearing corneal contact lenses. A 90 minute therapeutic trial with contact lenses was performed on a 20-year-old affected patient and produced a beneficial effect. Upon removal of the lenses however the patient showed a transient rebound phenomenon with oscillopsia lasting about 20 minutes. This phenomenon, although it might be expected in theory, has apparently not previously been observed either because it is rare or because in most patients it is not clinically apparent. The purpose of this report is not to discourage treating patients with congenital nystagmus by means of contact lenses, but rather to draw attention to the occasional occurrence of such a rebound phenomenon and to discuss its theoretical significance.

Source Citation Hatlebakk JG, Hyggen A, Madsen PH, et al., on behalf of the Norwegian Heartburn Study Group. Heartburn treatment in primary care: randomised, double blind study for 8 weeks. BMJ. 19...

A new syndrome of neonatal convulsions is described. Ninety cases were documented from one maternity hospital between 1973 and 1977. The appearance of this syndrome increased the annual incidence of neonatal convulsions from fewer than 3 to more than 16 per 1000 live births. Fits began on about the fifth day in apparently healthy babies. Investigations and therapeutic trials have not shown the cause. There were no deaths and all babies were discharged from hospital apparently well. The term fifth day fits is suggested with criteria for this diagnosis.

Three of six patients with chronic hepatic encephalopathy treated with levodopa showed a significant improvement. One patient was probably improved whilst the remaining two patients failed to show any benefit. Serial electroencephalography did not demonstrate significant changes. Treatment with levodopa was associated with an improvement in `speed-based' tasks as assessed by computerized psychometry. A significant rise in cerebral oxygen consumption was found during levodopa therapy. Gastrointestinal side effects were dose limiting. It is concluded that a therapeutic trial of levodopa in patients with chronic hepatic encephalopathy is indicated when the response to conventional therapy has been poor.

Forty five patients with acute ulcerative colitis were randomly allocated to receive (a) sulphasalazine, (b) levamisole, or (c) a combination of sulphasalazine and levamisole. Each group contained 15 patients. The ulcerative colitis activity index (UCAI), the remission and relapse rates were compared at three monthly intervals for one year. The UCAI fell in each group. Detailed analysis of all clinical and biochemical parameters used for estimation of UCAI showed that the only difference was in patients receiving combined therapy who continued to have a raised ESR and platelet count. Fewer patients, however, went into remission on levamisole therapy (46.6%) compared with the other two groups (66.6%). The cumulative relapse rate was 20% for those receiving levamisole compared with 6.6% in the other groups. Side effects were observed in 20% of patients receiving levamisole, 26% receiving sulphasalazine, and 40% in those having combined therapy. The results indicate that levamisole is unlikely to have a major role in the management of patients with ulcerative colitis.

Sixty-four patients with proven ulcerative colitis who had been maintained on sulphasalazine as their sole form of treatment for a minimum period of one year were entered into a controlled trial of sulphasalazine versus dummy tablets for a period of six months. All the patients admitted were not only symptom-free but also showed no evidence of inflammation on sigmoidoscopy and rectal biopsy. A patient was judged to have relapsed when there was a recurrence of colitic symptoms accompanied by sigmoidoscopic and histological evidence of inflammation. The patients who received dummy tablets had more than four times the relapse rate of those receiving sulphasalazine. The results were similar in patients who had been on maintenance treatment with sulphasalazine for less than three years before entry into the trial and in those who had been on this treatment for more than three years. It is concluded that maintenance treatment of ulcerative colitis with sulphasalazine should be continued indefinitely unless contraindicated by side effects.

Statistical procedures may subserve either of two ends. In the conduct of government, commerce, and manufacture it may be legitimate to invoke them with no aim other than to prescribe a course of action which limits certain assignable risks. We speak appropriately of any such prescription as conditional. In biological research our primary concern is to establish propositions worthy to take their place in the corpus of scientific knowledge accepted as a basis for subsequent action unrestricted by immediate administrative preoccupations. We speak of any such assertion as unconditional. Much needless confusion concerning the credentials of statistical techniques arises through failure to recognize how far each is meaningful in one or other domain. Since our concern in this context is with the validification of results obtained in the conduct of scientific research, unconditional statisti cal inference alone is relevant to the end in view.

Faecal bile salt elimination, which was determined in patients with ulcerative colitis, was mostly within normal limits, suggesting that in this disease water and electrolyte diarrhoea was hardly contributed to by excessive amounts of bile salts in the large bowel. In a therapeutic trial cholestyramine had no beneficial effect on the general condition, diarrhoea, or faecal composition, findings which further strengthen the view that bile salts play no role in the diarrhoea of ulcerative colitis, provided that the disease is limited to the large bowel. Faecal elimination of cholesterol as bile salts and neutral steroids tended initially to be higher than normal, but increased less than in controls during treatment with cholestyramine, particularly in the heavier patients. Serum cholesterol was low in the patients with ulcerative colitis and decreased by cholestyramine less (27%) than in controls (39%).

The bone mineral mass was estimated by photon absorptiometry in 23 epileptic patients on long-term treatment with phenytoin and in 20 normal subjects before and during treatment with vitamin D or placebo. Initially, subnormal values of bone mineral mass were found in the epileptic patients. The group of epileptic patients treated with vitamin D showed a significant increase in bone mineral mass. The group of epileptic patients treated with placebo and the normal subjects treated with vitamin D or placebo showed no change in bone mineral mass.