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1.
Neuro Endocrinol Lett ; 39(1): 1-8, 2018 Mar.
Article in English | MEDLINE | ID: mdl-29604618

ABSTRACT

OBJECTIVE: A herbal combination (saffron extract, passion flower herb extract, cocoa seed extract, radish extract and black cumin extract) called "Relief" was designed as a supportive therapy of alcohol withdrawal syndrome (AWS). This combination was based on the scientific evidence of each constituent effect on AWS-like symptoms. In addition, our preclinical studies have shown the effectiveness of Relief on AWS detoxification. The rationale of the study was to document whether the oral intake of the designed content of Relief could have a positive effect on the course of alcohol detoxification by reducing some of the AWS in hospitalized patients. METHODS: This pilot study was performed as non-interventional, open, single-armed, prospective on 32 hospitalized patients entered for detoxification of alcohol withdrawal syndrome. Each patient received daily three capsules of Relief for 15 days, and AWS parameters were monitored, in addition to serum liver enzymes and quality of life which was evaluated using the Befindlichkeits-Skala (Bf-SR) scaling system. RESULTS: Relief administration significantly reduced the percentage of patients with hyperhidrosis (r=0.815, p<0.001), reduced serum liver enzymes by ~50-80% (p<0.05), and increased normalization of appetite (r=0.777, p<0.001). Besides, before the treatment began the Bf-SR scale was 28.3±4.3, which was typical for neurological syndromes such as depression or insomnia, and during Relief administration the Bf-SR scale significantly dropped to 15.6±2.4 (p<0.001). As for the safety, four, but not serious, adverse events were observed; two of them may be product related. Finally, 84.4% of patients' assessed Relief treatment as good to excellent and 87.5% of the patients declared an interest in reusing Relief for the next detoxification period. CONCLUSIONS: Despite the limitations of the present study, the findings showed the potential of Relief for the improvement of the clinical situation of patients with symptoms of alcohol withdrawal and therefore, justify a full-scale well-controlled study design to be implemented.


Subject(s)
Alcohol Withdrawal Delirium/drug therapy , Plant Preparations/therapeutic use , Adult , Alcohol Withdrawal Delirium/psychology , Alcoholism/rehabilitation , Appetite Stimulants/therapeutic use , Dietetics , Drug Combinations , Female , Humans , Hyperhidrosis/etiology , Hyperhidrosis/prevention & control , Inpatients , Liver/enzymology , Liver Function Tests , Male , Middle Aged , Pilot Projects , Plant Preparations/adverse effects , Prospective Studies , Quality of Life , Socioeconomic Factors
2.
Internist (Berl) ; 57(11): 1126-1131, 2016 Nov.
Article in German | MEDLINE | ID: mdl-27456044

ABSTRACT

A 45-year-old woman presented with chronic cough, pleuritic chest pain, and night sweat. High-resolution computed tomography revealed multiple bilateral nodular lesions in a centrilobular distribution, primarily located in the upper and mid lung zones with relative sparing of the lung bases. No lymphadenopathy or pleural effusions were detected. Histological analysis confirmed the suspected diagnosis of pulmonary Langerhans cell histiocytosis. After smoking cessation the patient recovered completely.


Subject(s)
Cough/prevention & control , Histiocytosis, Langerhans-Cell/diagnosis , Histiocytosis, Langerhans-Cell/prevention & control , Hyperhidrosis/etiology , Hyperhidrosis/prevention & control , Pleurisy/prevention & control , Smoking/adverse effects , Chest Pain/diagnosis , Chest Pain/etiology , Chest Pain/prevention & control , Chronic Disease , Cough/diagnosis , Cough/etiology , Female , Histiocytosis, Langerhans-Cell/complications , Humans , Hyperhidrosis/diagnosis , Middle Aged , Pleurisy/diagnosis , Pleurisy/etiology , Smoking Cessation , Treatment Outcome
3.
Wien Klin Wochenschr ; 127(17-18): 703-6, 2015 Sep.
Article in English | MEDLINE | ID: mdl-25576334

ABSTRACT

OBJECTIVE: In this case report, we describe a case in which the clinical pharmacy team was asked to provide recommendations on possible continued use of combination antidepressants in a 62-year-old Slovenian female patient with major depressive disorder following agomelatine and duloxetine hydrochloride-induced excessive sweating. When agomelatine was administered as an additional treatment, drug-induced excessive sweating was observed after a daily intake of 90 mg of duloxetine hydrochloride and 25 mg of agomelatine. After thorough discussion, it was decided not to rechallenge with agomelatine because of the serious adverse effect. After agomelatine discontinuation and switching to trazodone, symptoms immediately improved. DISCUSSION: Duloxetine hydrochloride-induced sweating has been reported frequently, but excessive sweating induced by agomelatine and duloxetine hydrochloride has not been reported in the literature. The adverse effect was determined by a clinical pharmacist using the Naranjo probability scale and was probably associated with agomelatine use (6 points) and possibly associated with duloxetine hydrochloride use (4 points). The exact mechanism for this adverse effect in this patient is not known, but we believe that a pharmacodynamic drug-drug interaction between agomelatine and duloxetine hydrochloride had occurred. CONCLUSION: Such a case has not yet been described in literature; however, an adverse effect associated with drug-drug interaction can occur, as this report clearly demonstrates. The benefits of this antidepressant combination need to be carefully balanced with the risks associated with its use. This case report also highlights the increased potential for adverse reactions when prescribing antidepressant combinations and importance of clinical pharmacists' involvement in the psychiatric patients' pharmacotherapy.


Subject(s)
Acetamides/adverse effects , Duloxetine Hydrochloride/adverse effects , Hyperhidrosis/chemically induced , Hyperhidrosis/prevention & control , Antidepressive Agents/adverse effects , Drug Combinations , Drug Interactions , Female , Humans , Hyperhidrosis/diagnosis , Middle Aged
4.
Internist (Berl) ; 55(3): 322-4, 326-8, 2014 Mar.
Article in German | MEDLINE | ID: mdl-24522559

ABSTRACT

A 28-year-old man presented with loss of appetite, night sweats, eczema, and axillary and inguinal lymph node swelling. The tentative diagnosis of malignant lymphoma was made. To confirm the diagnosis, extirpation of a lymph node and a skin biopsy were performed. Systemic treatment with methylprednisolone resulted in an improvement of eczema and lymph node swelling. Because of the histological findings and clinical course, we diagnosed dermatopathic lymphadenopathy, also known as Pautrier-Woringer syndrome.


Subject(s)
Eczema/etiology , Eczema/prevention & control , Feeding and Eating Disorders/etiology , Hyperhidrosis/etiology , Lymphatic Diseases/complications , Lymphatic Diseases/drug therapy , Methylprednisolone/therapeutic use , Adult , Axilla , Eczema/diagnosis , Feeding and Eating Disorders/diagnosis , Feeding and Eating Disorders/prevention & control , Humans , Hyperhidrosis/diagnosis , Hyperhidrosis/prevention & control , Inguinal Canal , Lymphatic Diseases/diagnosis , Male , Treatment Outcome
5.
Thorac Cardiovasc Surg ; 62(5): 434-8, 2014 Aug.
Article in English | MEDLINE | ID: mdl-23344772

ABSTRACT

OBJECTIVE: Compensatory hyperhidrosis is one of the most common and serious adverse effects following sympathectomy. We performed a local anesthetic procedure that predicts the occurrence and severity of compensatory hyperhidrosis, and evaluated the feasibility, safety, and efficacy of the procedure. METHODS AND METHODS: From July 2009 to July 2010, 20 patients with severe primary palmar hyperhidrosis underwent predictive procedures. A sympathetic nerve block was obtained via thoracoscopic approach under local anesthesia. The patients were evaluated for compensatory hyperhidrosis 1 week after the procedure before deciding whether to proceed with sympathectomy. RESULTS: Of the 20 patients, 17 patients proceeded with sympathectomy and 3 refused the final procedure. Following sympathectomy, the occurrence and severity of compensatory hyperhidrosis in the remaining 17 patients were statistically analyzed with two tailed paired t test, and there is no significant difference between the predictive and final procedures (t = 1.69, df = 16, p > 0.1). CONCLUSION: Predictive procedure using local anesthesia to detect compensatory hyperhidrosis before sympathectomy may be useful for helping patients to decide whether to undergo the operation.


Subject(s)
Anesthetics, Local/pharmacology , Autonomic Nerve Block , Hyperhidrosis/surgery , Sympathectomy/adverse effects , Adolescent , Adult , Feasibility Studies , Female , Humans , Hyperhidrosis/etiology , Hyperhidrosis/prevention & control , Male , Preoperative Care , Sympathetic Nervous System/drug effects , Treatment Outcome , Young Adult
7.
HNO ; 60(11): 1007-10, 2012 Nov.
Article in German | MEDLINE | ID: mdl-22733280

ABSTRACT

The production of sweat in the temporal skin region may be a serious problem for patients with hearing aids, active middle ear implants or cochlear implants. We report on two patients suffering from a loss of function of their hearing aid and a reduction of the "wear comfort" of an active middle ear implant. The patients underwent intracutaneous botulinum toxin (BTX) treatment of the temporal skin region. In both patients a distinct improvement of their complaints occurred, enabling them to use their hearing aids and active middle ear implants continuously. BTX injections are suited to improve sweat-caused complaints in patients with hearing aids, active middle ear implants and cochlear implants.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Cochlear Implants/adverse effects , Hearing Aids/adverse effects , Hyperhidrosis/etiology , Hyperhidrosis/prevention & control , Ossicular Prosthesis/adverse effects , Aged , Female , Humans , Hyperhidrosis/drug therapy , Male , Middle Aged , Treatment Outcome
8.
Hautarzt ; 63(6): 469-76, 2012 Jun.
Article in German | MEDLINE | ID: mdl-22638981

ABSTRACT

Eight years after its approval, intralesional injections of botulinum toxin type A have become established as an easily performed, highly effective and almost complication-free therapeutic option in primary axillary hyperhidrosis. Sweat production is decreased to about a sixth of previous amounts, and the effect persists for 7 months on average. Restoration of the often significantly impaired quality of life has been convincingly documented in large studies. The effect of botulinum toxin is based on the inhibition of the release of acetylcholine into the synaptic cleft. In addition to this approved use, botulinum toxin is also successfully employed in other forms of focal hyperhidrosis, particularly in gustatory sweating. However, its use in palmoplantar hyperhidrosis, the second most common form of primary hyperhidrosis, is limited because of the pain from numerous injections, need for increased doses of the expensive toxin and the relatively short effective period of about 4 months. Botulinum toxin type B appears to be comparably effective as type A products but is more often associated with systemic adverse events.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Hand Dermatoses/drug therapy , Hand Dermatoses/prevention & control , Hyperhidrosis/drug therapy , Hyperhidrosis/prevention & control , Humans , Treatment Outcome
9.
Menopause ; 19(7): 749-59, 2012 Jul.
Article in English | MEDLINE | ID: mdl-22336748

ABSTRACT

OBJECTIVE: The aim of this study was to examine the effectiveness of group cognitive behavioral therapy (CBT) and guided self-help CBT in reducing hot flush and night sweat (HF/NS) problem rating at 6 and 26 weeks after randomization. METHODS: This was a randomized control trial of 140 women having 10 or more problematic HF/NS a week for at least a month. The primary outcome was HF/NS problem rating (1-10) at 6 weeks after randomization. Secondary outcomes were physiologically measured HF/NS at 6 weeks; HF/NS problem rating at 6 weeks; and frequency, mood (Women's Health Questionnaire), and health-related quality of life (General Health Survey Short Form-36) at 6 and 26 weeks. Intention-to-treat analysis was used, and between-group differences were estimated using linear mixed models. RESULTS: Baseline mean (SD) HF/NS weekly frequency was 63.15 (49.24), and problem rating was 5.87 (2.28). Group and self-help CBT both significantly reduced HF/NS problem rating at 6 weeks-group CBT versus no treatment control (NTC; adjusted mean difference, 2.12; 95% CI, 1.36-2.88; P < 0.001) and self-help CBT versus NTC (adjusted mean difference, 2.08; 95% CI, 1.29-2.86; P < 0.001)-and at 26 weeks-group CBT versus NTC (adjusted mean difference, 1.33; 95% CI, 0.54-2.13; P = 0.001) and self-help CBT versus NTC (adjusted mean difference, 1.19; 95% CI, 0.36-2.02; P = 0.005). Group and self-help CBT significantly reduced night sweat frequency at 6 and 26 weeks. There were improvements in mood and quality of life at 6 weeks and improved emotional and physical functioning for group CBT at 26 weeks. CONCLUSIONS: These results suggest that CBT delivered in group or self-help format is an effective treatment option for women during the menopause transition and postmenopause with problematic HF/NS.


Subject(s)
Cognitive Behavioral Therapy/methods , Hot Flashes/prevention & control , Hyperhidrosis/prevention & control , Menopause , Affect , Female , Humans , Middle Aged , Psychotherapy, Group , Quality of Life , Self Care , Surveys and Questionnaires , Treatment Outcome
10.
Am J Phys Med Rehabil ; 90(4): 321-9, 2011 Apr.
Article in English | MEDLINE | ID: mdl-21765248

ABSTRACT

OBJECTIVE: Botulinum toxin type A is established in the treatment of hyperhidrosis. This pilot study was designed to prove the alleviating effect of botulinum toxin type B (BTX-B) in sweating of the residual limb, as BTX-B, even in low doses, is supposed to possess a more specific action in sympathetic nerves than botulinum toxin type A does at a wider radius of diffusion. DESIGN: Nine lower limb amputees received 1750 U BTX-B injected at the site of maximum sweating. Before injections and 4 wks and 3 mos after, patients rated their impairments regarding sweating of the residual limb, steadiness of gait, use of the prosthetic device, quality-of-life, work performance, quality of sleep, and skin problems using a numeric rating scale (NRS; 0-10). RESULTS: Sweating of the residual limb before BTX-B application was rated a median of 7 (interquartile range, 6-10) on the NRS, with significant improvements after 4 wks (NRS, 3 [2-4]; P = 0.027) and 3 mos (NRS, 3 [1-4]; P = 0.020). Impaired quality of artificial limb use likewise improved from a baseline NRS of 9 (5-9) to 2 (1-4) after 4 wks and 3 (1-4) (P = 0.027) after 3 mos, consistent with limited duration of use (P = 0.023). Steadiness of gait, quality-of-life, and work performance increased accordingly, and skin problems decreased clearly but not significantly. Unexpectedly, stump pain was also reduced (baseline: NRS, 5 [4-8]; 4 wks: NRS, 4 [3-5], P = 0.109; 3 mos: NRS, 3 [2-4], P = 0.008). CONCLUSIONS: Low-dose BTX-B significantly reduced sweating of the residual limb, thereby improving the use of the artificial limb, steadiness of gait, and quality-of-life. Because this has a tremendous impact on amputees, we are in dire need for systematic, larger studies.


Subject(s)
Amputation Stumps , Botulinum Toxins/therapeutic use , Hyperhidrosis/prevention & control , Lower Extremity , Artificial Limbs , Botulinum Toxins, Type A , Cohort Studies , Female , Gait , Humans , Hyperhidrosis/etiology , Injections, Subcutaneous , Male , Middle Aged , Pilot Projects , Quality of Life , Treatment Outcome
13.
J Bras Pneumol ; 34(11): 967-77, 2008 Nov.
Article in English, Portuguese | MEDLINE | ID: mdl-19099105

ABSTRACT

With the objective of establishing guidelines for the prevention, diagnosis and treatment of compensatory hyperhidrosis, consensus meetings were held. Attendees included a general surgeon and thoracic surgeons affiliated with the Brazilian Society of Thoracic Surgery. The topics addressed were those that would ostensibly broaden multidisciplinary knowledge. Based on recent guidelines for the prevention, diagnosis and (clinical and surgical) treatment of compensatory hyperhidrosis, as well as on a review of the medical literature, the participants prepared a preliminary text, whose recommendations were revised and subsequently approved by all of the participants. The consensus text was posted on the Internet, becoming the object of further corrections and revisions prior to taking on its present form.


Subject(s)
Hyperhidrosis , Humans , Hyperhidrosis/physiopathology , Hyperhidrosis/prevention & control , Hyperhidrosis/therapy , Lumbosacral Plexus/surgery , Patient Care Team , Practice Patterns, Physicians' , Severity of Illness Index , Sympathectomy
14.
J. bras. pneumol ; 34(11): 967-977, nov. 2008. ilus
Article in Portuguese | LILACS | ID: lil-623386

ABSTRACT

Com o objetivo de se estabelecer diretrizes para a prevenção, o diagnóstico e o tratamento da hiperidrose compensatória, foram realizadas reuniões consensuais com a participação de cirurgiões torácicos filiados à Sociedade Brasileira de Cirurgia Torácica e um cirurgião geral em que foram abordados tópicos de modo a abranger conhecimentos multidisciplinares. A partir de textos recentes com diretrizes para a prevenção, o diagnóstico e tratamento (clínico e cirúrgico) da hiperidrose compensatória, e baseados em revisão bibliográfica, os participantes elaboraram um texto preliminar, cujas recomendações foram submetidas à aprovação dos participantes, possibilitando uma revisão geral do texto final. Deste modo, obteve-se um texto básico que, veiculado pela internet, tornou-se objeto de novas correções e revisões até alcançar a forma final atual.


With the objective of establishing guidelines for the prevention, diagnosis and treatment of compensatory hyperhidrosis, consensus meetings were held. Attendees included a general surgeon and thoracic surgeons affiliated with the Brazilian Society of Thoracic Surgery. The topics addressed were those that would ostensibly broaden multidisciplinary knowledge. Based on recent guidelines for the prevention, diagnosis and (clinical and surgical) treatment of compensatory hyperhidrosis, as well as on a review of the medical literature, the participants prepared a preliminary text, whose recommendations were revised and subsequently approved by all of the participants. The consensus text was posted on the Internet, becoming the object of further corrections and revisions prior to taking on its present form.


Subject(s)
Humans , Hyperhidrosis , Hyperhidrosis/physiopathology , Hyperhidrosis/prevention & control , Hyperhidrosis/therapy , Lumbosacral Plexus/surgery , Patient Care Team , Practice Patterns, Physicians' , Severity of Illness Index , Sympathectomy
15.
J Thorac Cardiovasc Surg ; 135(3): 635-41, 2008 Mar.
Article in English | MEDLINE | ID: mdl-18329485

ABSTRACT

OBJECTIVE: Thoracoscopic sympathectomy has become an accepted therapeutic option for palmar hyperhidrosis. Objective assessment of sweat output after sympathectomy, however, has not been reported to date. We report for the first time sweat output measurements after sympathectomy during a 3-year postoperative period. METHODS: Thoracoscopic sympathectomy was performed by division of T2 and T3 sympathetic ganglia in 17 healthy adult patients with no comorbidities. Preoperative and postoperative sweat measurements were done at 29 degrees C (below sweat threshold, at baseline, after conversation, and after a mental arithmetic challenge) and at 40 degrees C (baseline and after exercise) with the ventilated capsule technique in left palm, sole, and chest wall. Serial postoperative measurements were conducted at 1 and 6 months and 1, 2, and 3 years. RESULTS: Sweat output fell significantly after sympathectomy relative to preoperative levels under all experimental conditions (P < .001, analysis of variance) in the left palm. Differences in sweat outputs in the left palm were statistically significant between groups at baseline and postoperatively after mental arithmetic challenge and exercise at 40 degrees C (P < .05, analysis of variance). Compensatory increases in the sweat outputs from the left sole and chest were observed after sympathectomy. No patients had recurrence of preoperative sweat output values at follow-up. CONCLUSION: According to objective sweat output measurements, thoracoscopic sympathectomy results in long-term control of palmar hyperhidrosis. This evaluation method is valuable in investigating recurrence of symptoms or compensatory hyperhidrosis after sympathectomy, providing a robust and objective criterion for planning intervention.


Subject(s)
Hyperhidrosis/surgery , Sympathectomy/methods , Adolescent , Adult , Case-Control Studies , Female , Follow-Up Studies , Hand , Humans , Hyperhidrosis/diagnosis , Hyperhidrosis/prevention & control , Male , Middle Aged , Monitoring, Physiologic/methods , Patient Satisfaction , Postoperative Period , Reference Values , Secondary Prevention , Severity of Illness Index , Sweating , Thoracic Surgery, Video-Assisted/methods , Thoracic Vertebrae , Treatment Outcome
16.
Drug Saf ; 31(2): 109-26, 2008.
Article in English | MEDLINE | ID: mdl-18217788

ABSTRACT

The human sweating response is subject to the influence of diverse classes of drugs. Some act centrally at the hypothalamus or at spinal thermoregulatory centres, while others act at sympathetic ganglia or at the eccrine-neuroeffector junction. Pharmacological disturbances of sweating have broad clinical implications. Drugs that induce hyperhidrosis, or sweating in excess of that needed to maintain thermoregulation, can cause patient discomfort and embarrassment, and include cholinesterase inhibitors, selective serotonin reuptake inhibitors, opioids and tricyclic antidepressants. Drugs that induce hypohidrosis, or deficient sweating, can increase the risk of heat exhaustion or heat stroke and include antimuscarinic anticholinergic agents, carbonic anhydrase inhibitors and tricyclic antidepressants. As acetylcholine is the principal neuroeccrine mediator, anhidrosis is one of the clinical hallmarks by which acute anticholinergic toxicity may be recognized. The symptom of dry mouth often accompanies the less apparent symptom of hypohidrosis because the muscarinic M(3) acetylcholine receptor type predominates at both sweat and salivary glands. Management options include dose reduction, drug substitution or discontinuation. When compelling medical indications require continuation of a drug causing hyperhidrosis, the addition of a pharmacological agent to suppress sweating can help to reduce symptoms. When hypohidrotic drugs must be continued, deficient sweating can be managed by avoiding situations of heat stress and cooling the skin with externally applied water. The availability of clinical tests for the assessment of sudomotor dysfunction in neurological disease has enhanced recognition of the complex effects of drugs on sweating. Advances in the understanding of drug-induced anhidrosis have also enlarged the therapeutic repertoire of effective treatments for hyperhidrosis.


Subject(s)
Hyperhidrosis/chemically induced , Hyperhidrosis/prevention & control , Hypohidrosis/chemically induced , Hypohidrosis/prevention & control , Algorithms , Antidepressive Agents/adverse effects , Cholinesterase Inhibitors/adverse effects , Humans , Hyperhidrosis/epidemiology , Hypohidrosis/epidemiology , Incidence , Models, Biological , Selective Serotonin Reuptake Inhibitors/adverse effects , United States
17.
Dermatol Nurs ; 20(6): 467-70, 2008 Dec.
Article in English | MEDLINE | ID: mdl-19241743

ABSTRACT

Primary focal hyperhidrosis is a common and serious medical condition that causes considerable psychosocial morbidity. Diagnostic and effective management strategies can improve patients' quality of living dramatically.


Subject(s)
Hyperhidrosis/diagnosis , Hyperhidrosis/prevention & control , Antiperspirants/therapeutic use , Botulinum Toxins, Type A/therapeutic use , Cholinergic Antagonists/therapeutic use , Diagnosis, Differential , Humans , Hyperhidrosis/epidemiology , Hyperhidrosis/etiology , Hyperhidrosis/psychology , Iontophoresis , Neuromuscular Agents/therapeutic use , Prevalence , Quality of Life/psychology , Severity of Illness Index , United States/epidemiology
19.
Dermatol Surg ; 33(1): 57-61, 2007 Jan.
Article in English | MEDLINE | ID: mdl-17214679

ABSTRACT

BACKGROUND: Palmar hyperhidrosis is characterized by excessive sweating on the palm, and among the various treatment modalities, tap water iontophoresis has been widely used. OBJECTIVE: The objective of this study was to assess the effect of a new "dry-type" iontophoretic device that was locally manufactured and did not use tap water to control sweating. METHODS: Ten subjects with palmar hyperhidrosis were enrolled in this study. To be treated the patients were instructed that they only have to grasp the device. Only one palm was treated for 2 weeks, and then the treatment was discontinued the following next 2 weeks. The other palm was not treated as a control. At the end of second week, biopsy specimens were obtained from untreated and treated palm, respectively, and examined histologically. RESULTS: Nine of 10 patients were satisfied with this therapy reducing their sweat outputs from 33% to 51% of baseline at the end of 2 weeks' treatment, and after 2 weeks of discontinuation of treatment sweat productions returned to near baseline. The pathologic examinations showed some occlusions and destruction of intraepithelial eccrine ducts only in the treated palm. CONCLUSION: We suggest that dry-type iontophoresis could reduce palmar sweating more conveniently than other conventional methods.


Subject(s)
Hand Dermatoses/prevention & control , Hyperhidrosis/prevention & control , Iontophoresis/instrumentation , Adolescent , Adult , Equipment Design , Female , Follow-Up Studies , Hand Dermatoses/pathology , Humans , Hyperhidrosis/pathology , Male , Patient Satisfaction , Treatment Outcome
20.
BJOG ; 112(2): 228-33, 2005 Feb.
Article in English | MEDLINE | ID: mdl-15663589

ABSTRACT

OBJECTIVE: To assess the effects of tibolone on climacteric symptoms, endometrium and serum lipid/lipoproteins in postmenopausal women receiving tamoxifen after surgery for breast cancer. DESIGN: Double-blind, randomised, placebo-controlled, multicentre pilot study. SETTING: Hospital outpatient clinic. SAMPLE: Seventy postmenopausal women receiving tamoxifen following surgery for early breast cancer. METHODS: Women received 20 mg/day oral tamoxifen plus either 2.5 mg/day oral tibolone or placebo for 12 months. MAIN OUTCOME MEASURES: Frequency and severity of hot flushes (diary cards); intensity of hot flushes and sweats (Landgren scale); interference of hot flushes and sweats with normal life; frequency and intensity of other climacteric symptoms; endometrial thickness and histology; vaginal bleeding; breast cancer recurrence and serum lipid/lipoproteins. RESULTS: Daily card data showed no change in the daily number of hot flushes with either tibolone or placebo (P= 0.219) after three months. There was a significant reduction in the severity of flushes with tibolone compared with placebo (-0.4 vs 0.2, P= 0.031). The Landgren scale showed a mean change in the number of hot flushes of -0.6 with tibolone and +1.1 with placebo after 12 months (P= 0.022). Endometrial biopsies were normal and vaginal bleeding was similar in both groups. A significant decrease in triglycerides (-23% vs 1.4%) and HDL (-12% vs 19%) was seen with tibolone compared with placebo after 12 months. CONCLUSIONS: Tibolone prevented an increase in hot flushes in postmenopausal women given tamoxifen following surgery for breast cancer without untoward effects on the endometrium. Beneficial effects on serum lipid profile were noted.


Subject(s)
Antineoplastic Combined Chemotherapy Protocols/therapeutic use , Breast Neoplasms/surgery , Administration, Oral , Aged , Biopsy , Breast Neoplasms/blood , Breast Neoplasms/drug therapy , Chemotherapy, Adjuvant , Double-Blind Method , Endometrium/pathology , Estrogen Antagonists/administration & dosage , Estrogen Receptor Modulators/administration & dosage , Female , Hot Flashes/etiology , Hot Flashes/prevention & control , Humans , Hyperhidrosis/etiology , Hyperhidrosis/prevention & control , Lipids/blood , Mammography , Middle Aged , Neoplasm Recurrence, Local/diagnostic imaging , Neoplasm Recurrence, Local/etiology , Norpregnenes/administration & dosage , Pilot Projects , Postmenopause/drug effects , Tamoxifen/administration & dosage
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