DOCSLIB.ORG

Pharmacological Interventions for Pruritus in Adult Palliative Care Patients (Review)

Total Page：16

File Type：pdf, Size：1020Kb

Download full-text PDF Read full-text
Pharmacological Interventions for Pruritus in Adult Palliative Care Patients (Review) Cochrane Database of Systematic Reviews Pharmacological interventions for pruritus in adult palliative care patients (Review) Siemens W, Xander C, Meerpohl JJ, Buroh S, Antes G, Schwarzer G, Becker G Siemens W, Xander C, Meerpohl JJ, Buroh S, Antes G, Schwarzer G, Becker G. Pharmacological interventions for pruritus in adult palliative care patients. Cochrane Database of Systematic Reviews 2016, Issue 11. Art. No.: CD008320. DOI: 10.1002/14651858.CD008320.pub3. www.cochranelibrary.com Pharmacological interventions for pruritus in adult palliative care patients (Review) Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. TABLE OF CONTENTS HEADER....................................... 1 ABSTRACT ...................................... 1 PLAINLANGUAGESUMMARY . 2 SUMMARY OF FINDINGS FOR THE MAIN COMPARISON . ..... 4 BACKGROUND .................................... 6 OBJECTIVES ..................................... 9 METHODS ...................................... 9 RESULTS....................................... 15 Figure1. ..................................... 16 Figure2. ..................................... 22 Figure3. ..................................... 23 ADDITIONALSUMMARYOFFINDINGS . 34 DISCUSSION ..................................... 54 AUTHORS’CONCLUSIONS . 57 ACKNOWLEDGEMENTS . 58 REFERENCES ..................................... 59 CHARACTERISTICSOFSTUDIES . 69 DATAANDANALYSES. 164 Analysis 1.1. Comparison 1 Naltrexone versus placebo, Outcome 1 A) Pruritus on VAS scale (0-10 cm) in CP participants. .................................. 170 Analysis 1.2. Comparison 1 Naltrexone versus placebo, Outcome 2 A) Subgroup analysis by study design: pruritus on VAS scale (0-10 cm) in CP participants. 171 Analysis 1.3. Comparison 1 Naltrexone versus placebo, Outcome 3 A) Sensitivity analysis: random-effects model; pruritus on VAS scale (0-10 cm) in CP participants. 172 Analysis 1.4. Comparison 1 Naltrexone versus placebo, Outcome 4 B) % difference for pruritus on VAS scale (0-10 cm) in UPandCPparticipants. 172 Analysis 1.5. Comparison 1 Naltrexone versus placebo, Outcome 5 B) Subgroup analysis by nature of pruritus and study design; % difference for pruritus on VAS scale (0-10 cm). .......... 173 Analysis 1.6. Comparison 1 Naltrexone versus placebo, Outcome 6 B) Sensitivity analysis: random-effects model; % difference for pruritus on VAS scale (0-10) in UP and CP participants. .............. 174 Analysis 1.7. Comparison 1 Naltrexone versus placebo, Outcome 7 C) Risk for at least one adverse event per participant in UP and CP participants; cross-over design. ....... 175 Analysis 1.8. Comparison 1 Naltrexone versus placebo, Outcome 8 C) Subgroup analysis by nature of pruritus; risk for at least one adverse event per participant; cross-over design. ................. 176 Analysis 1.9. Comparison 1 Naltrexone versus placebo, Outcome 9 C) Sensitivity analysis: random-effects model; risk for at least one adverse event per participant; UP and CP patients; cross-over design. 177 Analysis 2.1. Comparison 2 Nalfurafine versus placebo, Outcome 1 A) Pruritus on VAS scale (0-10 cm) in UP participants; parallel-group design; Wikström b: Wikström a (week 2) + period 1 Wikström b. 178 Analysis 2.2. Comparison 2 Nalfurafine versus placebo, Outcome 2 A) Sensitivity analysis: random-effects model; pruritus on VAS scale (0-10 cm) in UP participants; parallel-group design; Wikström b: Wikström a (week 2) + period 1 Wikströmb. .................................. 179 Analysis 2.3. Comparison 2 Nalfurafine versus placebo, Outcome 3 B) Risk for at least one adverse drug reaction (ADR) per participant in UP participants; parallel-group and cross-overdesign.. 180 Analysis 2.4. Comparison 2 Nalfurafine versus placebo, Outcome 4 B) Sensitivity analysis: random-effects model; risk for at least one adverse event per participant; UP participants; parallel-group and cross-over design. 181 Analysis 3.1. Comparison 3 Ondansetron versus placebo or standard medication, Outcome 1 A) Pruritus on VAS scale (0- 10cm)inUPandCPparticipants. 182 Analysis 3.2. Comparison 3 Ondansetron versus placebo or standard medication, Outcome 2 A) Subgroup analysis by nature of pruritus and study design; pruritus on VAS scale (0-10 cm). .............. 183 Analysis 3.3. Comparison 3 Ondansetron versus placebo or standard medication, Outcome 3 A) Sensitivity analysis: random-effects model; pruritus on VAS scale (0-10 cm) in UP and CP participants. 184 Pharmacological interventions for pruritus in adult palliative care patients (Review) i Copyright © 2016 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Analysis 3.4. Comparison 3 Ondansetron versus placebo or standard medication, Outcome 4 B) Risk for at least one adverse event per participant in UP and CP participants. .............. 185 Analysis 3.5. Comparison 3 Ondansetron versus placebo or standard medication, Outcome 5 B) Subgroup analysis by nature of pruritus and study design; risk for at least one adverse event per participant. 186 Analysis 3.6. Comparison 3 Ondansetron versus placebo or standard medication, Outcome 6 B) Sensitivity analysis: random-effects model; risk for at least one adverse event per participant in UP and CP participants. 187 Analysis 4.1. Comparison 4 Gabapentin versus placebo, Outcome 1 A) Pruritus on VAS scale (0-10 cm) in UP participants. .................................. 188 Analysis 4.2. Comparison 4 Gabapentin versus placebo, Outcome 2 A) Subgroup analysis by study design; pruritus on VAS scale (0-10 cm) in UP participants. 189 Analysis 4.3. Comparison 4 Gabapentin versus placebo, Outcome 3 A) Sensitivity analysis: random-effects model; pruritus on VAS scale (0-10 cm); UP participants. 190 Analysis 5.1. Comparison 5 Rifampicin versus placebo or standard medication, Outcome 1 A) Pruritus on VAS scale (0- 100 mm) in CP participants; cross-over design. ........ 190 Analysis 5.2. Comparison 5 Rifampicin versus placebo or standard medication, Outcome 2 A) Sensitivity analysis: random- effects model; pruritus on VAS scale (0-100 mm) in CP participants; cross-over design. 191 Analysis 5.3. Comparison 5 Rifampicin versus placebo or standard medication, Outcome 3 B) Subgroup analysis by control; SMD: pruritus on different scales; CP participants; cross-over design. 192 Analysis 5.4. Comparison 5 Rifampicin versus placebo or standard medication, Outcome 4 B) Sensitivity analysis: random- effects model; subgroup analysis by control; SMD: pruritus on different scales; CP patients; cross-over design. 193 Analysis 6.1. Comparison 6 Flumecinol versus placebo, Outcome 1 A) Pruritus: significant improvement (yes/no); CP participants; parallel group design. ........ 194 Analysis 6.2. Comparison 6 Flumecinol versus placebo, Outcome 2 A) Subgroup analysis by dosage; pruritus: significant improvement (yes/no); CP participants; parallel-group design.................. 195 Analysis 6.3. Comparison 6 Flumecinol versus placebo, Outcome 3 A) Sensitivity analysis: random-effects model; pruritus: significant improvement (yes/no); CP participants; parallel-group design. 196 Analysis 7.1. Comparison 7 Cromolyn sodium (CS) versus placebo, Outcome 1 A) Pruritus on VAS scale (0-10 cm; values from Feily (2012) multiplied by factor 2); UP participants; parallel-group design. 196 Analysis 7.2. Comparison 7 Cromolyn sodium (CS) versus placebo, Outcome 2 A) Subgroup analysis by route of administration; values from Feily (2012) multiplied by factor 2); UP participants; parallel-group design. 197 Analysis 7.3. Comparison 7 Cromolyn sodium (CS) versus placebo, Outcome 3 A) Sensitivity analysis: random-effects model; values from Feily (2012) multiplied by factor 2; UP participants; parallel-group design. 198 Analysis 7.4. Comparison 7 Cromolyn sodium (CS) versus placebo, Outcome 4 B) Risk for at least one adverse event per participant; UP participants; parallel-group design. ............... 198 Analysis 7.5. Comparison 7 Cromolyn sodium (CS) versus placebo, Outcome 5 B) Subgroup analysis by route of administration; risk for at least one adverse event per participant; UP participants; parallel-group design. 199 Analysis 7.6. Comparison 7 Cromolyn sodium (CS) versus placebo, Outcome 6 B) Sensitivity analysis: random-effects model; risk for at least one adverse event per participant; UP participants; parallel-group design. 200 Analysis 8.1. Comparison 8 Topical capsaicin versus vehicle, Outcome 1 A) Pruritus on different scales; SMD in UP participants; cross-over design (Cho: 1. iPTH=<35pg/ml and 2. iPTH>35pg/ml). 201 Analysis 8.2. Comparison 8 Topical capsaicin versus vehicle, Outcome 2 A) Subgroup analysis by pruritus scales; SMD; UP participants; cross-over design (Cho: 1. iPTH=<35pg/ml and 2. iPTH>35pg/ml). 202 Analysis 8.3. Comparison 8 Topical capsaicin versus vehicle, Outcome 3 A) Sensitivity analysis: random-effects model; pruritus on different scales; UP participants; cross-over design (Cho: 1. iPTH=<35pg/ml and 2. iPTH>35pg/ml). 203 Analysis 8.4. Comparison 8 Topical capsaicin versus vehicle, Outcome 4 B) Risk for at least one adverse event per participant; UP participants, cross-over design. ........... 204 Analysis 8.5. Comparison 8 Topical capsaicin versus vehicle, Outcome 5 B) Sensitivity analysis: random-effects model; risk for at least one adverse event per participant; UP participants; cross-over design. 205 Analysis 9.1. Comparison 9 Zinc sulphate versus placebo, Outcome 1 A) Pruritus on different scales; SMD in UP participants; parallel-group design. ....... 206 Analysis 9.2. Comparison 9 Zinc
Load more

Recommended publications
  • Rare Diseases: GI/Metabolic
    Rare Diseases: GI / Metabolic Ciara Kennedy, PhD, MBA – Head of Cholestatic Liver Disease David Piccoli, MD – Chief of Gastroenterology, Hepatology & Nutrition, Children’s Hospital Of Philadelphia Our purpose We enable people with life-altering conditions to lead better lives. The “SAFE HARBOR” Statement Under the Private Securities Litigation Reform Act of 1995 Statements included in this announcement that are not historical facts are forward-looking statements. Forward-looking statements can be identified by words such as “aspiration”, “will”, “expect”, “forecast”, “aspiration”, “potential”, “estimates”, “may”, “anticipate”, “target”, “project” or similar expressions suitable for identifying information that refers to future events. Forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that: . Shire’s products may not be a commercial success; . revenues from ADDERALL XR are subject to generic erosion and revenues from INTUNIV will become subject to generic competition starting in December 2014; . the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues, financial condition and results of operations; . Shire conducts its own manufacturing operations for certain of its products and is reliant on third party contractors to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time.
    [Show full text]
  • Review Article Pruritus in Systemic Diseases: a Review of Etiological Factors and New Treatment Modalities
    Hindawi Publishing Corporation e Scientific World Journal Volume 2015, Article ID 803752, 8 pages http://dx.doi.org/10.1155/2015/803752 Review Article Pruritus in Systemic Diseases: A Review of Etiological Factors and New Treatment Modalities Nagihan Tarikci, Emek Kocatürk, Fule Güngör, IlteriG OLuz Topal, Pelin Ülkümen Can, and Ralfi Singer Department of Dermatology, Okmeydanı Training and Research Hospital, 34384 Istanbul, Turkey Correspondence should be addressed to Emek Kocaturk;¨ [email protected] Received 20 February 2015; Revised 11 June 2015; Accepted 16 June 2015 Academic Editor: Uwe Wollina Copyright © 2015 Nagihan Tarikci et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Pruritus is the most frequently described symptom in dermatology and can significantly impair the patient’s quality of life. In 10–50% of adults with persistent pruritus, it can be an important dermatologic clue for the presence of a significant underlying systemic disease such as renal insufficiency, cholestasis, hematologic disorder, or malignancy (Etter and Myers, 2002; Zirwas and Seraly, 2001). This review describes the presence of pruritus in different systemic diseases. It is quite important to discover the cause of pruritus for providing relief for the patients experiencing substantial morbidity caused by this condition. 1. Pruritus Endocrinal Disorders. Thyroid diseases, diabetes mellitus. Pruritus is a topic that has caused a great deal of controversy Paraneoplastic Diseases. Lymphomas and solid organ tumors. because it is difficult to characterize and define. Various indirect definitions proposed include a sensation which provokes the desire to scratch or an uneasy sensation of 2.
    [Show full text]
  • Report from the Inaugural Australian Pruritus Symposium, Sydney, Australia, August 10, 2013
    Acta Derm Venereol 2014; 94: 123 LETTER TO THE EDITOR Report from the Inaugural Australian Pruritus Symposium, Sydney, Australia, August 10, 2013 Frank Brennan1 and Dedee F. Murrell2* 1Palliative Medicine, Calvary Hospital, 91 Rocky Point Road, and 2Department of Dermatology, St George Hospital, University of New South Wales, Gray St, Kogarah, Sydney, NSW 2217 Australia. *E-mail: [email protected] Accepted Aug 28, 2013; Epub ahead of print Oct 24, 2013 Sir, on the mechanisms and management of opioid-induced The inaugural Australian symposium on pruritus was itch. Frank Brennan spoke on uraemic pruritus, Paul Gray, convened at St George Hospital, Sydney on August 10, a Pain Specialist with a particular interest in burns spoke 2013. The co-conveners were Professor Dedee Murrell, on the phenomenon of post-burns pruritus and Craig Le- Executive Vice President of the International Society of wis, Medical Oncologist surveyed the symptom of itch Dermatology (ISD) and Dr Frank Brennan, Palliative and its management in cancer medicine. Medicine Physician. The impetus behind the symposium A feature of the day was an interview with a patient was the recognition of two facts. Firstly, the significant in front of the symposium participants. The patient developments in the understanding of the pathophysio- presented with a challenging combination of pruritus logy of pruritus in recent years and, secondly, the paucity secondary to a life-long history of atopy and, in later of education and understanding by colleagues across years, uraemic pruritus. Connie Katelaris surveyed the multiple disciplines of those developments. Given that history and immunological results of the patient and the symptom of pruritus manifests in many diseases the made clinical recommendations.
    [Show full text]
  • European Guideline Chronic Pruritus Final Version
    EDF-Guidelines for Chronic Pruritus In cooperation with the European Academy of Dermatology and Venereology (EADV) and the Union Européenne des Médecins Spécialistes (UEMS) E Weisshaar1, JC Szepietowski2, U Darsow3, L Misery4, J Wallengren5, T Mettang6, U Gieler7, T Lotti8, J Lambert9, P Maisel10, M Streit11, M Greaves12, A Carmichael13, E Tschachler14, J Ring3, S Ständer15 University Hospital Heidelberg, Clinical Social Medicine, Environmental and Occupational Dermatology, Germany1, Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Poland2, Department of Dermatology and Allergy Biederstein, Technical University Munich, Germany3, Department of Dermatology, University Hospital Brest, France4, Department of Dermatology, Lund University, Sweden5, German Clinic for Diagnostics, Nephrology, Wiesbaden, Germany6, Department of Psychosomatic Dermatology, Clinic for Psychosomatic Medicine, University of Giessen, Germany7, Department of Dermatology, University of Florence, Italy8, Department of Dermatology, University of Antwerpen, Belgium9, Department of General Medicine, University Hospital Muenster, Germany10, Department of Dermatology, Kantonsspital Aarau, Switzerland11, Department of Dermatology, St. Thomas Hospital Lambeth, London, UK12, Department of Dermatology, James Cook University Hospital Middlesbrough, UK13, Department of Dermatology, Medical University Vienna, Austria14, Department of Dermatology, Competence Center for Pruritus, University Hospital Muenster, Germany15 Corresponding author: Elke Weisshaar
    [Show full text]
  • Update of the Guideline on Chronic Pruritus
    Update of the Guideline on Chronic Pruritus Developed by the Guideline Subcommittee “Chronic Pruritus” of the European Dermatology Forum Subcommittee Members: Prof. Dr. Elke Weisshaar, Heidelberg (Germany) Prof. Dr. Sonja Ständer, Münster (Germany) Prof. Dr. Erwin Tschachler, Wien (Austria) Prof. Dr. Torello Lotti, Florence (Italy) Prof. Dr. Johannes Ring, Munich (Germany) Prof. Dr. Laurent Misery, Brest (France) Dr. Markus Streit, Aarau (Switzerland) Prof. Dr. Thomas Mettang, Wiesbaden (Germany) Prof. Dr. Jacek Szepietowski, Wroclaw (Poland) Prof. Dr. Joanna Wallengren, Lund (Sweden) Dr. Peter Maisel, Münster (Germany) Prof. Dr. Uwe Gieler, Gießen (Germany) Prof. Dr. Malcolm Greaves (Singapore) Prof. Dr. Ulf Darsow, Munich (Germany) Prof. Dr. Julien Lambert, Antwerp (Belgium) Members of EDF Guideline Committee: Prof. Dr. Werner Aberer, Graz (Austria) Prof. Dr. Dieter Metze, Münster (Germany) Prof. Dr. Martine Bagot, Paris (France) Dr. Kai Munte, Rotterdam (Netherlands) Prof. Dr. Nicole Basset-Seguin, Paris (France) Prof. Dr. Gilian Murphy, Dublin (Ireland) Prof. Dr. Ulrike Blume-Peytavi, Berlin (Germany) Prof. Dr. Martino Neumann, Rotterdam (Netherlands) Prof. Dr. Lasse Braathen, Bern (Switzerland) Prof. Dr. Tony Ormerod, Aberdeen (UK) Prof. Dr. Sergio Chimenti, Rome (Italy) Prof. Dr. Mauro Picardo, Rome (Italy) Prof. Dr. Alexander Enk, Heidelberg (Germany) Prof. Dr. Johannes Ring, Munich (Germany) Prof. Dr. Claudio Feliciani, Rome (Italy) Prof. Dr. Annamari Ranki, Helsinki (Finland) Prof. Dr. Claus Garbe, Tübingen (Germany) Prof. Dr. Berthold Rzany, Berlin (Germany) Prof. Dr. Harald Gollnick, Magdeburg (Germany) Prof. Dr. Rudolf Stadler, Minden (Germany) Prof. Dr. Gerd Gross, Rostock (Germany) Prof. Dr. Sonja Ständer, Münster (Germany) Prof. Dr. Vladimir Hegyi, Bratislava (Slovakia) Prof. Dr. Eggert Stockfleth, Berlin (Germany) Prof. Dr.
    [Show full text]
  • Abstracts from the 9Th World Congress on Itch October 15–17, 2017
    ISSN 0001-5555 ActaDV Volume 97 2017 SEPTEMBER, No. 8 ADVANCES IN DERMATOLOGY AND VENEREOLOGY A Non-profit International Journal for Interdisciplinary Skin Research, Clinical and Experimental Dermatology and Sexually Transmitted Diseases Abstracts from the 9th World Congress on Itch October 15–17, 2017 Official Journal of - European Society for Dermatology and Wroclaw, Poland Psychiatry Affiliated with - The International Forum for the Study of Itch Immediate Open Access Acta Dermato-Venereologica www.medicaljournals.se/adv Abstracts from the 9th World Congress on Itch DV cta A enereologica V Organizing Committee Scientific Committee ermato- Congress President: Jacek C Szepietowski (Wroclaw, Poland) Jeffrey D. Bernhard (Massachusetts, USA) D Congress Secretary General: Adam Reich (Rzeszów, Poland) Earl Carstens (Davis, USA) Congress Secretary: Edyta Lelonek (Wroclaw, Poland) Toshiya Ebata (Tokyo, Japan) cta Alan Fleischer (Lexington, USA) A IFSI President: Earl Carstens (Davis, USA) IFSI Vice President: Elke Weisshaar (Heidelberg, Germany) Ichiro Katayama (Osaka, Japan) Ethan Lerner (Boston, USA) Staff members of the Department of Dermatology, Venereology and Allergology, Wroclaw Medical University, Wroclaw, Poland Thomas Mettang (Wiesbaden, Germany) Martin Schmelz (Mannheim, Germany) Sonja Ständer (Münster, Germany) DV Jacek C. Szepietowski (Wroclaw, Poland) cta Kenji Takamori (Tokyo, Japan) A Elke Weisshaar (Heidelberg, Germany) Gil Yosipovitch (Miami, USA) Contents of this Abstract book Program 1000 Abstracts: Lecture Abstracts 1008 Poster Abstracts 1035 Author Index 1059 dvances in dermatology and venereology A www.medicaljournals.se/acta doi: 10.2340/00015555-2773 Journal Compilation © 2017 Acta Dermato-Venereologica. Acta Derm Venereol 2017; 97: 999–1060 1000 9th World Congress of Itch Sunday, October 15, 2017 Abstract # 1:30-3:30 PM IFSI Board meeting DV 5:00-5:20 PM OPENING CEREMONY 5:00-5:10 PM Opening remarks cta Jacek C.
    [Show full text]
  • Pruritus Ani (Itchy Bottom)
    PRURITUS ANI (ITCHY BOTTOM) What is pruritus ani? Pruritus ani means a chronic (persistent) itchy feeling around the anus. The main symptom is an urge to scratch your anus which is difficult to resist. The urge to scratch may occur at any time. However, it tends to be more common after you have been to the toilet to pass faeces, and at night (particularly just before falling asleep). The itch may be made worse by heat, wool, moisture, leaking, soiling, stress, and anxiety. About 1 in 20 people develop pruritus ani at some stage. It is common in both adults and children. What causes pruritus ani? Pruritus ani is a symptom, not a final diagnosis. Various conditions may cause pruritus ani. However, in many cases the cause is not clear. This is called ‘idiopathic pruritus ani’, which means ‘itchy anus of unknown cause’. Known causes of pruritus ani There are various causes which include the following: Inflamed anal skin is a common cause (a localised dermatitis). The inflammation is usually due to the skin ‘reacting’ to small amounts of faeces (sometimes called stools or motions) left on the skin, and/or to sweat and moisture around the anus. Young children who may not wipe themselves properly, adults with sweaty jobs, and adults with a lot of hair round the anus may be especially prone to this. Thrush and fungal infections. These germs like it best in moist, warm, airless areas, such as around the anus. Thrush is more common in people with diabetes. Other infections such as scabies, herpes, anal warts and some other sexually transmitted diseases can cause itch around the anus.
    [Show full text]
  • Underlying Diseases and Co-Factors in Patients with Severe Chronic Pruritus: a 3-Year Retrospective Study
    Acta Derm Venereol 2007; 87: 510–516 CLINICAL REPORT Underlying Diseases and Co-factors in Patients with Severe Chronic Pruritus: a 3-year Retrospective Study Franz SOMMER, Peter HENSEN, Barbara BÖCKENHolt, Dieter METZE, Thomas A. LUGER and Sonja STÄNDER Clinical Neurodermatology, Department of Dermatology, University of Münster, Germany Chronic pruritus is a symptom of many diseases, with conditions (e.g. lichen simplex, pruritus ani, pruritus vul- studies pending investigating its prevalence or incidence. vae) had the second highest prevalence of 8.2%, with a The aim of this study was to describe the characteristics female:male ratio of 1.6:1 (2) (the highest prevalence was of the underlying diseases in a large number of patients. for “eczema”). A recent study of the prevalence of skin A total of 263 patients (110 men, 153 women; age range diseases in dermatological outpatients in Copenhagen 8–95 years; mean 55.9 years) were included in the study. found that 2.5% had pruritus and prurigo (3). The following data were collected from patients pre- Precise prevalence rates of pruritus in systemic diseases senting over a 3-year period: gender, age, history, skin are not known, except for conditions such as renal failure lesions, laboratory, histological and radiological investi- with haemodialysis (4–6). In other diseases, pruritus is a gations. An underlying dermatosis was identified in 41.8% rare, but sporadically occurring, symptom, for example in of patients, a systemic disease including unidentified hyperthyroidism and may not be attributed to the disease neoplasms in 13.3% and a neurological disorder in 0.4%.
    [Show full text]
  • Statistical Analysis Plan
    Cover Page for Statistical Analysis Plan Sponsor name: Novo Nordisk A/S NCT number NCT03061214 Sponsor trial ID: NN9535-4114 Official title of study: SUSTAINTM CHINA - Efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin in subjects with type 2 diabetes Document date: 22 August 2019 Semaglutide s.c (Ozempic®) Date: 22 August 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL Clinical Trial Report Status: Final Appendix 16.1.9 16.1.9 Documentation of statistical methods List of contents Statistical analysis plan...................................................................................................................... /LQN Statistical documentation................................................................................................................... /LQN Redacted VWDWLVWLFDODQDO\VLVSODQ Includes redaction of personal identifiable information only. Statistical Analysis Plan Date: 28 May 2019 Novo Nordisk Trial ID: NN9535-4114 Version: 1.0 CONFIDENTIAL UTN:U1111-1149-0432 Status: Final EudraCT No.:NA Page: 1 of 30 Statistical Analysis Plan Trial ID: NN9535-4114 Efficacy and safety of semaglutide once-weekly versus sitagliptin once-daily as add-on to metformin in subjects with type 2 diabetes Author Biostatistics Semaglutide s.c. This confidential document is the property of Novo Nordisk. No unpublished information contained herein may be disclosed without prior written approval from Novo Nordisk. Access to this document must be restricted to relevant parties.This
    [Show full text]
  • BAM8-22 and Its Receptor MRGPRX1 May Attribute to Cholestatic Pruritus
    www.nature.com/scientificreports OPEN BAM8-22 and its receptor MRGPRX1 may attribute to cholestatic pruritus Received: 10 April 2019 Babina Sanjel1,2, Han-Joo Maeng1,2 & Won-Sik Shim 1,2 Accepted: 11 July 2019 Pruritus is an unexpected symptom observed in cholestasis and its mechanism is still unclear. Here, we Published: xx xx xxxx show that bovine adrenal medulla (BAM) 8–22, an endogenous itch-inducing peptide, could be involved in cholestatic pruritus. It was found that bile duct ligation (BDL) mice, an obstructive cholestasis model, showed increased spontaneous scratching behaviour. Importantly, the mRNA level of proenkephalin, a precursor polypeptide of BAM8-22, was signifcantly increased in the skin of BDL mice. Furthermore, the mRNA level of Mrgprx1, which encodes a receptor for BAM8-22, was signifcantly increased in the dorsal root ganglia (DRG) of BDL mice. This was further confrmed by elevation of intracellular calcium levels upon BAM8-22 treatment in primarily-cultured DRG neurons. In addition, BDL mice showed augmented scratching behaviour by BAM8-22, indicating enhanced activity of MRGPRX1. Moreover, the skin homogenate of BDL mice induced elevation of intracellular calcium levels through MRGPRX1. Finally, among the various bile acids, chenodeoxycholic acid signifcantly increased proenkephalin transcription in a human keratinocyte cell line (HaCaT). In conclusion, cholestatic pruritus could be attributed in part to enhanced action of both BAM8-22 in the skin and its receptor MRGPRX1 in sensory neurons. Cholestasis, characterized by decreased bile fow, occurs due to impaired bile secretion from hepatocytes or obstruction of intra- or extrahepatic bile ducts. Generally, cholestasis is accompanied by typical symptoms such as increased accumulation of bile acids in circulation, jaundice, dark urine, and steatorrhea.
    [Show full text]
  • European Guideline on Chronic Pruritus in Cooperation with the European Dermatology Forum (EDF) and the European Academy of Dermatology and Venereology (EADV)
    European Guideline on Chronic Pruritus In cooperation with the European Dermatology Forum (EDF) and the European Academy of Dermatology and Venereology (EADV) Weisshaar, Elke; Szepietowski, Jacek C.; Darsow, Ulf; Misery, Laurent; Wallengren, Joanna; Mettang, Thomas; Gieler, Uwe; Lotti, Torello; Lambert, Julien; Maisel, Peter; Streit, Markus; Greaves, Malcolm W.; Carmichael, Andrew; Tschachler, Erwin; Ring, Johannes; Staenders, Sonja Published in: Acta Dermato-Venereologica DOI: 10.2340/00015555-1400 2012 Link to publication Citation for published version (APA): Weisshaar, E., Szepietowski, J. C., Darsow, U., Misery, L., Wallengren, J., Mettang, T., Gieler, U., Lotti, T., Lambert, J., Maisel, P., Streit, M., Greaves, M. W., Carmichael, A., Tschachler, E., Ring, J., & Staenders, S. (2012). European Guideline on Chronic Pruritus In cooperation with the European Dermatology Forum (EDF) and the European Academy of Dermatology and Venereology (EADV). Acta Dermato-Venereologica, 92(5), 563- 581. https://doi.org/10.2340/00015555-1400 Total number of authors: 16 General rights Unless other specific re-use rights are stated the following general rights apply: Copyright and moral rights for the publications made accessible in the public portal are retained by the authors and/or other copyright owners and it is a condition of accessing publications that users recognise and abide by the legal requirements associated with these rights. • Users may download and print one copy of any publication from the public portal for the purpose of private study or research. • You may not further distribute the material or use it for any profit-making activity or commercial gain • You may freely distribute the URL identifying the publication in the public portal Read more about Creative commons licenses: https://creativecommons.org/licenses/ LUND UNIVERSITY Take down policy If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
    [Show full text]
  • The Skin and Viral Liver Disease
    Chapter 10 The Skin and Viral Liver Disease Mastrolonardo M. Additional information is available at the end of the chapter http://dx.doi.org/10.5772/56140 1. Introduction It is undisputable that a multifaceted biological interplay exists between the skin and the liver. The integument can firstly be viewed as a ‘gate’ through which hepatotropic viruses may access the blood stream. In this respect, one may think of the huge number of B and C virus hepatites that must have been acquired in a more or less distant past due to either intravenous drug consumption, use of contaminated equipment in beauty and health care-related proce‐ dures, or even dermal tattooing. Moreover, one may consider that some cases of herpes simplex virus hepatitis have been reported in the literature which are not unlikely ascribable to systemic dissemination from primary muco-cutaneous lesional foci. Yet, the skin may also be viewed as a ‘mirror’ capable of projecting on the body surface more or less specific echoes of disease conditions involving the liver. A recent review of the issue by Hazin and coworkers [1] is introduced by the following simple but just as brilliant statement: “Dysfunction in the body’s second largest organ, the liver, often yields changes in the body’s largest organ, the skin”. The most trivial paradigm sustaining such an obvious assumption is jaundice when it is sustained by primary failure of hepatocytes to perform one of their main functions, that is to conjugate bilirubin into a secretable form. However, further and less obvious paradigms, such as cutaneous manifestations of mixed cryoglobulinemia in HCV infected patients, will also be discussed.
    [Show full text]