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Fluvoxamine versus fluoxetine in major depressive episode: a double- blind randomised comparison buy biaxin 250 mg overnight delivery gastritis y embarazo. A comparison of fluvoxamine and fluoxetine in the treatment of major depression biaxin 500 mg on line gastritis symptoms burning. Paroxetine and fluoxetine effects on mood and cognitive functions in depressed nondemented elderly patients 500mg biaxin with visa gastritis diet . A Canadian multicenter generic biaxin 500mg amex diet gastritis kronik, double-blind study of paroxetine and fluoxetine in major depressive disorder. De Wilde J, Spiers R, Mertens C, Bartholome F, Schotte G, Leyman S. A double-blind, comparative, multicentre study comparing paroxetine with fluoxetine in depressed patients. A double-blind study of paroxetine compared with fluoxetine in geriatric patients with major depression. Fava M, Amsterdam JD, Deltito JA, Salzman C, Schwaller M, Dunner DL. A double- blind study of paroxetine, fluoxetine, and placebo in outpatients with major depression. Fava M, Hoog SL, Judge RA, Kopp JB, Nilsson ME, Gonzales JS. Acute efficacy of fluoxetine versus sertraline and paroxetine in major depressive disorder including effects of baseline insomnia. A double blind comparison of paroxetine and fluoxetine in patients with major depression. A double-blind multicenter trial comparing sertraline and fluoxetine in outpatients with major depression. Management of depression in real-life settings: knowledge gained from large-scale clinical trials. Newhouse PA, Krishnan KR, Doraiswamy PM, Richter EM, Batzar ED, Clary CM. A double-blind comparison of sertraline and fluoxetine in depressed elderly outpatients. Clinical and economic comparison of sertraline and fluoxetine in the treatment of depression. A 6-month double-blind study Second-generation antidepressants 121 of 190 Final Update 5 Report Drug Effectiveness Review Project in a primary-care setting in France. A double-blind comparison of fluvoxamine and paroxetine in the treatment of depressed outpatients. Evaluation of double-blind comparison of fluvoxamine and paroxetine in the treatment of depressed outpatients in menopause transition. Aberg-Wistedt A, Agren H, Ekselius L, Bengtsson F, Akerblad AC. Sertraline versus paroxetine in major depression: clinical outcome after six months of continuous therapy. Double-blind multicenter comparison of fluvoxamine versus sertraline in the treatment of depressed outpatients. Franchini L, Gasperini M, Perez J, Smeraldi E, Zanardi R. A double-blind study of long- term treatment with sertraline or fluvoxamine for prevention of highly recurrent unipolar depression. Four-year follow-up study of sertraline and fluvoxamine in long-term treatment of unipolar subjects with high recurrence rate. Duloxetine in the treatment of major depressive disorder: a double-blind clinical trial. Detke MJ, Wiltse CG, Mallinckrodt CH, McNamara RK, Demitrack MA, Bitter I. Duloxetine in the acute and long-term treatment of major depressive disorder: a placebo- and paroxetine-controlled trial. Hong CJ, Hu WH, Chen CC, Hsiao CC, Tsai SJ, Ruwe FJ. Double-blind, randomized comparison of mirtazapine and paroxetine in elderly depressed patients. Mirtazapine compared with paroxetine in major depression. Mirtazapine orally disintegrating tablet versus sertraline: a prospective onset of action study. Allard P, Gram L, Timdahl K, Behnke K, Hanson M, Sogaard J. Efficacy and tolerability of venlafaxine in geriatric outpatients with major depression: a double-blind, randomised 6-month comparative trial with citalopram. Second-generation antidepressants 122 of 190 Final Update 5 Report Drug Effectiveness Review Project 93. Comparative efficacy and tolerability of escitalopram oxalate versus venlafaxine XR. A double-blind comparison of escitalopram and venlafaxine extended release in the treatment of major depressive disorder. Randomized, double-blind comparison of venlafaxine and fluoxetine in outpatients with major depression. Venlafaxine compared with fluoxetine in outpatients with depression and concomitant anxiety. A double-blind, randomized, placebo-controlled trial of once- daily venlafaxine extended release (XR) and fluoxetine for the treatment of depression. Once-daily venlafaxine extended release (XR) compared with fluoxetine in outpatients with depression and anxiety. Efficacy of venlafaxine extended release in patients with major depressive disorder and comorbid generalized anxiety disorder. Efficacy and tolerability of venlafaxine and fluoxetine in outpatients with major depression. A double-blind comparison of venlafaxine and fluoxetine for treatment of major depression in outpatients. A double-blind, randomized, 12-week comparison study of the safety and efficacy of venlafaxine and fluoxetine in moderate to severe depression in general practice. Smith D, Dempster C, Glanville J, Freemantle N, Anderson I. Efficacy and tolerability of venlafaxine compared with selective serotonin reuptake inhibitors and other antidepressants: a meta-analysis. The efficacy and tolerability of venlafaxine and paroxetine in outpatients with depressive disorder or dysthymia. A comparison of once-daily venlafaxine XR and paroxetine in depressed outpatients treated in general practice. Randomized Trial of Sertraline Versus Venlafaxine XR in Major Depression: Efficacy and Discontinuation Symptoms. Randomized, double-blind comparison of venlafaxine and sertraline in outpatients with major depressive disorder. Bupropion versus selective serotonin-reuptake inhibitors for treatment of depression. Double-blind comparison of bupropion and fluoxetine in depressed outpatients. Second-generation antidepressants 123 of 190 Final Update 5 Report Drug Effectiveness Review Project 110. A placebo-controlled comparison of the effects on sexual functioning of bupropion sustained release and fluoxetine.

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Co-receptor defects explain only a few of the cases purchase 250mg biaxin with amex gastritis symptoms treatment, and efficient antiviral immunity capable of con- trolling HIV reaction was observed occasionally (Smith 2015) (see Pathogenesis) generic biaxin 500 mg free shipping gastritis special diet. However order biaxin 250 mg line gastritis diet food recipes, despite maintaining very low levels of plasma viremia generic biaxin 500mg online gastritis diet 0 carbs, elite controllers have elevated immune activation and accelerated atherosclerosis. In a prospective trial, controllers had a statistically significant decrease in ultrasensitive plasma and rectal HIV RNA levels with ART (Hatano 2013). Moreover, markers of T cell activa- tion/dysfunction in blood and gut mucosa also decreased substantially with ART. Similar reductions were observed in the subset of “elite” controllers with pre-ART plasma HIV RNA levels below conventional assays (<40 copies/mL). These observa- tions raise the question whether a functional cure is comparable to well-tolerated ART and whether the degree of HIV suppression in elite controllers is equivalent to that achieved by ART when it comes to clinical outcomes. Goals and principles of therapy 159 Can (very) early ART lead to a cure? In 2013, the case of the perinatal infected “Mississippi Baby” gained worldwide attrac- tion. This infant had been antiretrovirally treated only 31 hours after birth (Persaud 2013). The baseline viral load of 19,812 copies/ml felt down to 265 copies/ml at day 19 and was then undetectable for 18 months. The baby was then lost to the health care system for the next six months. Unexpectedly, the viral suppression remained undetectable when tested for HIV upon return. More than two years this girl had no signs of the virus in her blood despite cessation of treatment. An ultrasensitive assay revealed 4 copies HIV-DNA/million PBMCs but no HIV-specific immune responses. Protective HLA types as seen in elite controllers were not observed. The finding encouraged scientists hoping to find a way to save children from a lifetime of ART. However, the virus resurfaced in the patient 27 months after ART stopped (Ledford 2014). It became obvious that the “post-treatment control” had only been transient. Moreover, similar pediatric cases were published in which virologic rebound occurred within days of discontinuation of ART, despite immediate treatment after delivery (Butler 2015). Also in 2013, PTC cases had been published from France (Sáez-Cirión 2013). In the so-called VISCONTI cohort (Viro-Immunological Sustained CONtrol after Treatment Interruption), 14 HIV+ patients were reported in which prolonged ART had been initiated within the first 35–70 days post infection. Viremia remained controlled (less than 500 copies/ml) for a median of 7. Most of these PTCs lacked the protective HLA B alleles that are overrepresented in elite con- trollers. Thus, it seems that early and prolonged ART may allow some individuals with a rather unfavorable background to achieve long-term infection control. Further studies from France and Thailand also demonstrated that the viral reservoir remains limited with early ART (Hocqueloux 2013, Ananworanich 2013). But how often does treatment of primary HIV infection lead to post-treatment control? Unfortunately, it remained unclear how many patients in total were included in the VISCONTI cohort. More recent data suggest a low likelihood of PTC even when ART is started within 12 weeks of HIV-1 infection (Maenza 2015). Moreover, the hitherto largest randomized trial in this field yielded only moderate success of early ART (SPARTAC 2013). A total of 366 patients with primary HIV infec- tion (less than 6 months after seroconversion) were randomized for 12–48 weeks ART or to remain untreated. A 48-week course of ART delayed disease progression which was defined as CD4 T cells of less than 350 cells/µl or long-term ART initia- tion. However, there were no significant differences in the incidence of AIDS, death, or serious adverse events and the delay in disease progression was lost soon after ART interruption. Although the risk/benefit of initiating ART in primary HIV infec- tion remains a matter of discussion (Lodi 2012, Jain 2013), once a decision for ART has been made, therapy should be continued (see also chapter on acute infection). The main question is what can be achieved in patients with chronic infection. Several barriers to a cure in these patients have to be overcome (Katlama 2013), such as the intrinsic stability of the viral genome in latently infected cells such as long-lived memory T cells, and the sustained low- level viral replication in different compartments. Not to mention severe metholog- ical problems measuring the latent reservoir. It remains unclear what should be measured in which cells with which tools (Siliciano 2013). Proviral DNA measured by PCR from PBMC detects much more (300-fold) provirus 160 ART than the viral outgrowth assays (VOA) which measures replication competent virus. The lack of a precise correlation between VOA and PCR-based proviral DNA assays raise the possibility that the successful clearance of latently infected cells may be masked by a large pool of cells with defective proviruses (Eriksson 2013). These defec- tive proviruses are detected by PCR but may not require eradication to accomplish an effective cure. Less than 1% of proviruses are induced to release infectious virus after maximum in vitro activation. However, analysis of a large number of proviral clones from treated patients showed 12% with intact genomes and normal long terminal repeat (LTR) function, indicating that they may become activated in vivo (Ho 2013). A better understanding of the discrepancy between infected cell frequencies measured by viral outgrowth versus PCR assays is an urgent priority in HIV cure research (Eriksson 2013). The latent reservoirs At this point in time, eradication of HIV, the removal of all HIV from the body, is a theoretical goal. The main reason is that latently HIV-infected cells comprise a life- long reservoir (Saksena 2003). Even after years of suppression, viral transcription can be detected (Finzi 1999, Furtado 1999, Sigal 2011). This is particularly true in blood cells, but also in the lymph nodes and in sperm (Lafeuillade 2001, Nunnari 2002), where HIV may persist hiding from immune recognition (Fukazawa 2015). Replication also takes place in cells of the gastrointestinal tract, even if no virus is detected in the blood. Even after myoablative chemotherapy and autologous stem cell transplantation, latent reservoirs persist (Cillo 2013). After stopping ART in such patients, a rebound is seen rapidly (Henrich 2013+2014), and possibly occurs at multiple sites (Rothenberger 2015). In addition, latently infected reservoirs consist of very heterogenic cell populations, among the T memory and stem cells (Buzon 2014). The stability of these cells is probably independent of residual virus replication. Theoretically, how long does it take until the last latently infected cells are removed? The calculated time to eradication of these reservoirs was 73. Even in patients with no measurable blips during at least three years of stable ART and with a tendency for a more rapid decrease of viral load, the time to eradication was 51. Virus in resting CD4 memory cells with minimal evolution persists, even after close to 9 years on ART (Nottet 2009). Moreover, recent research suggest that the latent reservoir is larger than previously thought (Dolgin 2013).

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Diazepam cheap 500mg biaxin high fiber diet gastritis, a benzodiazepine buy biaxin 500mg overnight delivery gastritis diet 411, was the first medication thought to be effective for spasticity purchase biaxin 500 mg on-line gastritis diet coffee. It acts by 18 generic biaxin 500 mg on line gastritis colitis diet, 19 central blockade of GABAA receptors. Other medications used to treat spasticity but not formally approved for this indication include other benzodiazepines, clonidine, gabapentin, and 17 botulinum toxin. The skeletal muscle relaxants carisoprodol, chlorzoxazone, cyclobenzaprine, metaxalone, methocarbamol, and orphenadrine have been approved for treatment of Skeletal Muscle Relaxants Page 4 of 237 Final Report Update 2 Drug Effectiveness Review Project musculoskeletal disorders, but not for spasticity. They constitute a heterogeneous group of 20 medications. Cyclobenzaprine is closely related to the tricyclic antidepressants, carisoprodol 21 20 is metabolized to meprobamate, methocarbamol is structurally related to mephenesin, 22 chlorzoxazone is a benzoxazolone derivative, and orphenadrine is derived from 23 diphenhydramine. The mechanism of action for most of these agents is unclear, but may be related in part to sedative effects. These drugs are often used for treatment of musculoskeletal 12 conditions whether muscle spasm is present or not. Although there is some overlap between clinical usage (tizanidine in particular has been studied for use in patients with musculoskeletal 24 complaints), in clinical practice each skeletal muscle relaxant is used primarily for either spasticity or for musculoskeletal conditions. The purpose of this report is to determine whether there is evidence that one or more skeletal muscle relaxant is superior to others in terms of efficacy or safety. This report was originally submitted in February 2003 and updated annually. Update #1 was completed in January 2004 from searches performed in October 2003. Update #2 is based on searches performed in November 2004. New data for Update #2 are highlighted in the text and tables of this report. Since the last update, the Food and Drug Administration (FDA) has not approved any new skeletal muscle relaxants. Scope and Key Questions The scope of the review and key questions were originally developed and refined by the Oregon Evidence-based Practice Center with input from a statewide panel of experts (pharmacists, primary care clinicians, pain care specialists, and representatives of the public). Subsequently, the key questions were reviewed and revised by representatives of organizations participating in the Drug Effectiveness Review Project (DERP). The participating organizations of DERP are responsible for ensuring that the scope of the review reflects the populations, drugs, and outcome measures of interest to both clinicians and patients. The participating organizations approved the following key questions to guide this review: 1. What is the comparative efficacy of different muscle relaxants in reducing symptoms and improving functional outcomes in patients with a chronic neurologic condition associated with spasticity, or a chronic or acute musculoskeletal condition with or without muscle spasms? What are the comparative incidence and nature of adverse effects (including addiction and abuse) of different muscle relaxants in patients with a chronic neurologic condition associated with spasticity, or a chronic or acute musculoskeletal condition with or without muscle spasms? Are there subpopulations of patients for which one muscle relaxant is more effective or associated with fewer adverse effects? Skeletal Muscle Relaxants Page 5 of 237 Final Report Update 2 Drug Effectiveness Review Project Several aspects of the key questions deserve comment: Population. The population included in this review is adult or pediatric patients with spasticity or a musculoskeletal condition. We defined spasticity as muscle spasms associated with an upper motor neuron syndrome. Musculoskeletal conditions were defined as peripheral conditions resulting in muscle or soft tissue pain or spasms. We also excluded patients with restless legs syndrome or nocturnal myoclonus. We included the following oral drugs classified as skeletal muscle relaxants: baclofen, carisoprodol, chlorzoxazone, cyclobenzaprine, dantrolene, metaxalone, methocarbamol, orphenadrine, and tizanidine. Benzodiazepenes were not considered primary drugs in this report. However, diazepam, clonazepam, and clorazepate were reviewed when they were compared in head-to-head studies with any of the skeletal muscle relaxants listed above. Other medications used for spasticity but considered to be in another drug class, such as gabapentin (a neuroleptic) and clonidine (an antihypertensive), were also only reviewed when they were directly compared to an included skeletal muscle relaxant. Quinine was only included if it was compared to a skeletal muscle relaxant. The dose of skeletal muscle relaxants used in trials may affect either the efficacy or 25 adverse event profile. One clinical trial of cyclobenzaprine, for example, found equivalent efficacy at 10 and 20 mg tid, but increased adverse events with the higher dose. A study on dantrolene also found a ‘ceiling’ effect at doses of 200 mg daily, with no increased efficacy but 26 more side effects above that dose. Most trials titrated skeletal muscle relaxants to the maximum tolerated dose or a pre-specified ceiling dose, but there are no standardized methods of titration and determining target doses. The main efficacy measures were relief of muscle spasms or pain, functional status, quality of life, withdrawal rates, and adverse effects (including sedation, addiction, and abuse). We excluded non-clinical outcomes such as electromyogram measurements or spring tension measurements. There is no single accepted standard on how to measure the included outcomes. Clinical trials of skeletal muscle relaxants have often used different scales to measure important clinical outcomes such as spasticity, pain, or muscle 27 strength. Many trials have used unvalidated or poorly described methods of outcome assessment. Studies that use the same scale often report results differently (for example, mean raw scores after treatment, mean improvement from baseline, or number of patients “improved”). All of these factors make comparisons across trials difficult. Spasticity is an especially difficult outcome to measure objectively. The most widely used standardized scales to measure spasticity in patients with upper motor neuron syndromes 28 29 are the Ashworth and modified Ashworth scales. In these scales, the assessor tests the resistance to passive movement around a joint and grades it on a scale of 0 (no increase in tone) to 4 (limb rigid in flexion or extension). The modified Ashworth scale adds a “1+” rating between the 1 and 2 ratings of the Ashworth scale. For both of these scales, the scores are usually added for four lower and four upper limb joints, for a total possible score of 0-32, though scoring methods can vary. Some experts have pointed out that resistance to passive movement may measure tone better than it does spasticity and that the Ashworth scale and other ‘objective’ measures of spasticity may not correlate well with patient symptoms or 30 functional ability. Other areas of uncertainty regard the significance of the 1+ rating in the modified Ashworth scale and how a non-continuous ordinal variable should be statistically Skeletal Muscle Relaxants Page 6 of 237 Final Report Update 2 Drug Effectiveness Review Project 31 analyzed. An important advantage of the Ashworth scale is that it is a consistent way to measure spasticity or tone across studies, and has been found to have moderate 31 reproducibility. Other measures of spasticity include the pendulum test, muscle spasm counts, and patient assessment of spasticity severity on a variety of numerical (e. The best technique may be to perform both objective and subjective assessments of spasticity, but validated subjective assessment techniques of spasticity are lacking. Muscle strength is usually assessed with the time-honored British Medical Research Council Scale, which is based on the observation of resistance provided by voluntary muscle 16 activity and used in everyday clinical practice.

Thompson WG biaxin 500 mg with mastercard gastritis back pain, Creed F 250 mg biaxin for sale chronic gastritis flatulence, Drossman DA buy cheap biaxin 250mg online gastritis dogs, Heaton KW cheap biaxin 500 mg overnight delivery gastritis diet using frozen, Mazzacca G. Functional bowel disease and functional abdominal pain. Tomas-Ridocci M, Anon R, Minguez M, Zaragoza A, Ballester J, Benages A. What is the most effective way for relieving constipation in children aged >1 year? Tytgat GN, Heading RC, Muller-Lissner S, Kamm MA, Scholmerich J, Berstad A, et al. Contemporary understanding and management of reflux and constipation in the general population and pregnancy: a consensus meeting. A comparative study: the efficacy of liquid paraffin and lactulose in management of chronic functional constipation. Biofeedback training in treatment of childhood constipation: a randomised controlled study. Constipation Drugs Page 90 of 141 Final Report Drug Effectiveness Review Project 109. Constipation and solitary encopresis; diagnostic work-up and therapy]. Management of constipation in residents with dementia: sorbitol effectiveness and cost. Management of constipation in residents with dementia: sorbitol effectiveness and cost. Macrogol 4000 in treatment of chronic functional constipation of aged patients. Chinese Journal of New Drugs and Clinical Remedies (China) 2004;23:101-03. Constipation Drugs Page 91 of 141 Final Report Drug Effectiveness Review Project EVIDENCE TABLES Constipation Drugs Page 92 of 141 Final Report Drug Effectiveness Review Project C h ronicC onstipationandIB S-C 32 ST U DY : A uth ors,article#: A ndorskyand G oldner Y ear: 1990 C ountry:U SA F U N DIN G : N R R ESEA R C H O B JEC T IV E: Com pareclinicalefficacyandsafetyof PE G 3350vs. Y ear: 1995 C ountry:U S F U N DIN G : Proctor& G am bleCo. N /A Duration: 8weeks 8weeks Samplesize: 11 11 IN C L U SIO N C R IT ER IA : Subjectivechronic constipation:definedaspassageof <= 3stools/weekforatleast6m onths;subjects entered4-wkbaselinephase,andonlythosewhowereconfirm edonbasisof stooldiariestodem onstrate constipationwererandom ized;fullym obile& healthyonbasisof m edicalhistory& physicalex am ;19- 85yrs. Y ear:1995 PO PU L A T IO N G roupssimilar atbaseline:N o,theydifferinsex anddurationof constipation C H A R A C T ER IST IC S: psyllium placebo M eanage(years): 52. Y ear:1995 R ESU L T S: H ealth O utcomeM easures: • Stoolfrequencyincreasedsignificantlyafter8wkspsyllium treatm ent(3. A dh erence/C ompliance: N R Constipation Drugs Page 98 of 141 Final Report Drug Effectiveness Review Project A N A L Y SIS: IT T :Y es Postrandomizationexclusions:N o A DEQ U A T ER A N DO M IZ A T IO N : N R A DEQ U A T EA L L O C A T IO N N R C O N C EA L M EN T : B L IN DIN G O F O U T C O M E yes A SSESSO R S: A T T R IT IO N (overall): O verallattrition: 0 Differentialattritionh igh : N o A T T R IT IO N (treatmentspecific): psyllium placebo T otalattrition: 0 0 W ith drawalsdueto adverseevents: 0 0 Q U A L IT Y R A T IN G : F air Constipation Drugs Page 99 of 141 Final Report Drug Effectiveness Review Project C h ronicC onstipationandIB S-C 43 ST U DY : A uth ors,article#:A ttar etal. F U N DIN G : N R R ESEA R C H O B JEC T IV E: Tocom paretheefficacyof PE G andlactuloseinchronic constipation DESIG N : Studydesign:singleblindR CT— asthetreatm entsdifferedinappearanceandtaste,patientsm ayknow whichtheyreceived Setting:M ulti-center, m ulticenter,10centersinF ranceandScotland,patientsrecruitedfrom outpatient gastroenterologyandgeriatric institutions Samplesize:115 IN T ER V EN T IO N : PEG 3350 (with electrolytes) lactulose Dose: 13. Y ear:2004 PO PU L A T IO N G roupssimilar atbaseline: Y es C H A R A C T ER IST IC S: PEG 3350 lactulose M eanage(years): 55 55 Patientsaged 65 yearsor older (% ): 41. Y ear:1999 A DV ER SEEV EN T S: PEG 3350 lactulose O veralladverseeffectsreported: N R N R M ediandailyepisodesof: • diarrhea 0. A dh erence/C ompliance: N R A N A L Y SIS: IT T :no Postrandomizationexclusions:N R A DEQ U A T ER A N DO M IZ A T IO N : yes A DEQ U A T EA L L O C A T IO N N R C O N C EA L M EN T : B L IN DIN G O F O U T C O M E D efacto“no”becausepatientsm ayhaveknownthedrug duetotaste/appearance,theoutcom eassessors A SSESSO R S: andprovidersm ayhavelearnedthataswell A T T R IT IO N (overall): O verallattrition: 13% Differentialattritionh igh :no A T T R IT IO N (treatmentspecific): PEG 3350 lactulose T otalattrition: 10 6 W ith drawalsdueto adverseevents: 2 1 Q U A L IT Y R A T IN G : Poor Constipation Drugs Page 102 of 141 Final Report Drug Effectiveness Review Project C h ronicC onstipationandIB S-C 33 ST U DY : A uth ors,article#: C leveland etal. Y ear: 2001 C ountry:U SA F U N DIN G : Braintreelaboratories R ESEA R C H O B JEC T IV E: Com pareclinicalefficacyandsafetyof PE G 3350withplacebo DESIG N : Studydesign:crossoverdoubleblindR CT Setting:a“busyN ew H am pshirepractice” Samplesize:23 IN T ER V EN T IO N : PEG 3350 (w/o electrolytes) placebo Dose: 17g perday N /A Duration: 2weeks 2weeks Samplesize: N R N R IN C L U SIO N C R IT ER IA : M enandwom enage18andover;historyof constipation;M usthavehad3orfewerBM sduring a7day placebocontrolperiodtoenter[nom entionof “chronic”constipation— toenterm usthavehadahistory of constipationand3orfewerBM sduring 7dayentryperiod] EX C L U SIO N C R IT ER IA : O rganic causeof constipationverifiedwithcolonoscopyorbarium enem a;pregnancy;weight<100 pounds;previousgastric surgery;m orethan3bowelm ovem entsduring therun-inperiod O T H ER M EDIC A T IO N S/ Patientsinstructednottotakeanyotherlax atives IN T ER V EN T IO N S A L L O W ED: Constipation Drugs Page 103 of 141 Final Report Drug Effectiveness Review Project A uth ors:C leveland etal. Y ear:2001 PO PU L A T IO N G roupssimilar atbaseline:N R C H A R A C T ER IST IC S: O verall M eanage(years): 47. Y ear:2001 A DV ER SEEV EN T S: PEG 3350 placebo O veralladverseeffectsreported: N R N R • D iarrhea(“loosestoolsorm ild diarrhea”) N = 3(13. A dh erence/C ompliance: A totalof 56% of thestudypopulationrequestedterm ination;11patients(44%)requestedearly term inationduring placebovs. Y ear: 1998 C ountry:U K F U N DIN G : InpartbyR ickettsandColem anProducts,L td R ESEA R C H O B JEC T IV E: Com pareclinicalefficacyandsafetyof psyllium versuslactuloseorotherlax atives DESIG N : Studydesign:openR CT Setting:m ulticenter,outpatientbutthispointissom ewhatunclear Samplesize:394 IN T ER V EN T IO N : psyllium lactulose bisacodyl,docusatesodium, senna,magnesium sulfate Dose: 3. EX C L U SIO N C R IT ER IA : Pregnancy;requiredhospitalization;passing bloodinrectum ;gastrointestinalcarcinom a;thosealready taking bulking agents;patientswhoahistoryof lax ativeabuse;thosetaking drugsthatcanalterbowel habits;thosewithunstablediabetes;thosewithothergastrointestinaldiseases O T H ER M EDIC A T IO N S/ L ax ativesordrugsaltering bowelhabitsnotallowed IN T ER V EN T IO N S A L L O W ED: Constipation Drugs Page 106 of 141 Final Report Drug Effectiveness Review Project A uth ors:Dettmar etal. Y ear:1998 PO PU L A T IO N G roupssimilar atbaseline: C H A R A C T ER IST IC S: psyllium lactulose oth er M eanage(years): N R N R N R Patientsaged 65 yearsor older (% ): N R N R N R Sex(% female): 63%(4unknown) 63% 65%(1unknown) Eth nicity(% C aucasian): N R N R N R M eanbodymassindex: N R N R N R O th er germanech aracteristics: • D urationof constipation N R N R N R (m ean) N R N R N R • Bowelfrequency(BM /week) N R N R N R • Straining (%) N R N R N R • A bdom inalpain N R N R N R • H ardstools(%) N R N R N R • N orm alstools(%) N R N R N R • U seof lax atives(%) N R N R N R • U seof constipationdiet(%) N R N R N R • U seof bulk-form ing agents(%) N R N R N R O U T C O M EA SSESSM EN T : PrimaryO utcomeM easures:drug effectiveness;palatability;acceptability;bowelfunctioncom pared withpretreatm ent(diarycardsusedtorecordeachday) T imingofassessments:after2and4weeks,adverseeventsassessedbetweenweeks1-2and3-4 R ESU L T S: H ealth O utcomeM easures:psyllium vs. Y ear:1998 A DV ER SEEV EN T S: psyllium lactulose oth er O veralladverseeffectsreported: • diarrhea 1. Y ear: 2000 C ountry:U S F U N DIN G : Braintreelaboratories R ESEA R C H O B JEC T IV E: Todeterm inetheefficacyandsafetyof anew lax ative,PE G 3350 DESIG N : Studydesign:placebo-controlled,double-blind,m ulticenter,R CT Setting: m ulti-center Samplesize:151 IN T ER V EN T IO N : PEG 3350 (w/o electrolytes) placebo Dose: 17g perday 17g perday Duration: 2weeks 2weeks Samplesize: 80 71 IN C L U SIO N C R IT ER IA : H istoryof constipation;lessthantwobowelm ovem entsperweekduring 7dayqualification EX C L U SIO N C R IT ER IA : A llergytoPE G 3350;priorG I surgery;knownorsuspectedG I obstruction;ileus;heartfailure;ascites; otherknownchronic bowel,liver,renalorcardiopulm onarydisorders;pregnancy;lactation;weight<100 lb O T H ER M EDIC A T IO N S/ N R IN T ER V EN T IO N S A L L O W ED: Constipation Drugs Page 109 of 141 Final Report Drug Effectiveness Review Project A uth ors:DiPalmaetal. Y ear:2000 PO PU L A T IO N G roupssimilar atbaseline:N R C H A R A C T ER IST IC S: PEG 3350 placebo M eanage(years): 46. Y ear:2000 A DV ER SEEV EN T S: PEG 3350 placebo O veralladverseeffectsreported: • diarrhea N R N R • headache N R N R • nausea N R N R • abdom inalpain N R N R • flatulence N R N R • severecram p 12 22. Y ear: 1986 C ountry:U K F U N DIN G : SearlePharm aceuticals R ESEA R C H O B JEC T IV E: Toevaluatetheefficacyandsafetyof psyllium infunctionalconstipation DESIG N : Studydesign:R CT,blinding statusisN R Setting:U K ,m ulti-sitestudyconductedby17generalpractitioners Samplesize:201 IN T ER V EN T IO N : psyllium placebo Dose: 3. Y ear:1986 PO PU L A T IO N G roupssimilar atbaseline: C H A R A C T ER IST IC S: psyllium placebo M eanage(years): 50 48 Patientsaged 65 yearsor older (% ): N R N R Sex(% female): 74% 76% Eth nicity(% C aucasian): N R N R M eanbodymassindex: N R N R O th er germanech aracteristics: • D urationof constipation M edian2years M edian3years (m ean) • Bowelfrequency(BM /week) 2. Y ear:1986 A DV ER SEEV EN T S: psyllium placebo O veralladverseeffectsreported: • diarrhea N R N R • headache N R N R • nausea N R N R • abdom inalpain 51. R eductioninm oderateorseverestraining ondefecationwasgreaterintheispaghulagroup (p= 0. R easons includedabdom inalpain,wind,bubblystom ach,nauseavom iting,nausea,vom iting,diarrhea,pyrex ia, andfeeling unwell,m alaise. A dh erence/C ompliance: 91% adherence A N A L Y SIS: IT T :no Postrandomizationexclusions:yes(5) A DEQ U A T ER A N DO M IZ A T IO N : ProcedureN R A DEQ U A T EA L L O C A T IO N N R C O N C EA L M EN T : B L IN DIN G O F O U T C O M E N o A SSESSO R S: A T T R IT IO N (overall): O verallattrition:9% attrition Differentialattritionh igh :no A T T R IT IO N (treatmentspecific): psyllium placebo T otalattrition: 6. Y ear: 2004 C ountry:U SA F U N DIN G : N R R ESEA R C H O B JEC T IV E: Toevaluatethesafetyof PE G 3350inchildrenunder2forthetreatm entof constipation. DESIG N : Studydesign:R etrospectivechartreview Setting:outpatient Samplesize:75 IN T ER V EN T IO N : PEG 3350 Dose: Startedat1m g/kg/dayadjustedbyparentstoproduce2softstoolsperdayasneeded Duration: 6m onths Samplesize: 75 IN C L U SIO N C R IT ER IA : A llchildren<2yearsof ageattim etheystartedPE G ;idiopathic constipationdefinedbyN A SPG H A N criteria;seenbetween2000and2003 EX C L U SIO N C R IT ER IA : H irschsprung’sdisease;chronic intestinalpseudo-obstructionorprevioussurgeryonthecolonoranus; diseasestatesplacing lim itsontheactof defecationlikehypotonia,cerebralpalsy,severem ental retardation O T H ER M EDIC A T IO N S/ N R IN T ER V EN T IO N S A L L O W ED: Constipation Drugs Page 115 of 141 Final Report Drug Effectiveness Review Project A uth ors:L oening-B auckeetal. Y ear:2004 PO PU L A T IO N G roupssimilar atbaseline:N /A C H A R A C T ER IST IC S: PEG 3350 M eanage(years): 17m onths Patientsaged 65 yearsor older (% ): 0 Sex(% female): 52. Y ear:2004 A DV ER SEEV EN T S: PEG 3350 (treatment4 month sor less) PEG 3350 (treatment6 month sor more) O veralladverseeffectsreported: N R N R • diarrhea 7 2 • headache • nausea • abdom inalpain • flatulence • treatm entrelatedupsets • distension Significantdifferencesinadverse A E swerenotdefined,som ewerepre-specified. L ab tests— CBC,electrolytes,L F Tsperform edoccasionallyandallcheckedwerenorm al. A dh erence/C ompliance: N oncom pliance1% short-term and2% long term A N A L Y SIS: IT T :N /A Postrandomizationexclusions:N /A A DEQ U A T ER A N DO M IZ A T IO N : N /A A DEQ U A T EA L L O C A T IO N N /A C O N C EA L M EN T : B L IN DIN G O F O U T C O M E N /A A SSESSO R S: A T T R IT IO N (overall): O verallattrition:N /A Differentialattritionh igh :N /A A T T R IT IO N (treatmentspecific): PEG 3350 T otalattrition: W ith drawalsdueto adverseevents: N onereported Q U A L IT Y R A T IN G : Poor Constipation Drugs Page 117 of 141 Final Report Drug Effectiveness Review Project C h ronicC onstipationandIB S-C 42 ST U DY : A uth ors,article#: M cR orieetal. Y ear: 1998 C ountry:U SA F U N DIN G : ProctorandG am bleCom panyandtheO klahom aF oundationforD igestiveR esearch R ESEA R C H O B JEC T IV E: Com pareclinicalefficacyandsafetyof psyllium anddocusatesodium DESIG N : Studydesign:doubleblindR CT Setting:N R ,m ulti-center Samplesize:187 IN T ER V EN T IO N : psyllium docusatesodium Dose: 5. Y ear:1998 PO PU L A T IO N G roupssimilar atbaseline:N R C H A R A C T ER IST IC S: psyllium docusate O verall M eanage(years): Patientsaged 65 yearsor older (% ): 37. Y ear:1998 A DV ER SEEV EN T S: psyllium docusatesodium O veralladverseeffectsreported: • diarrhea N R N R • headache N R N R • nausea N R N R • abdom inalpain N R N R • flatulence N R N R • X • Y Significantdifferencesinadverse events: A dh erence/C ompliance: N R A N A L Y SIS: IT T :no Postrandomizationexclusions:yes(9%) A DEQ U A T ER A N DO M IZ A T IO N : N R A DEQ U A T EA L L O C A T IO N N R C O N C EA L M EN T : B L IN DIN G O F O U T C O M E Y es A SSESSO R S: A T T R IT IO N (overall): O verallattrition: N R Differentialattritionh igh :N R A T T R IT IO N (treatmentspecific): psyllium docusatesodium T otalattrition: N R N R W ith drawalsdueto adverseevents: N R N R Q U A L IT Y R A T IN G : Poor Constipation Drugs Page 120 of 141 Final Report Drug Effectiveness Review Project C h ronicC onstipationandIB S-C 77 ST U DY : A uth ors,article#: M ich ailetal. Y ear: 2004 C ountry:U SA F U N DIN G : N R R ESEA R C H O B JEC T IV E: E valuatethesafetyof PE G 3350inchildrenagedlessthan18m onthsorlesswithchronic constipation DESIG N : Studydesign:retrospectivecohort Setting:N R Samplesize:28 IN T ER V EN T IO N : PEG 3350 Dose: 17g/240m L water(titratedafter24hourstoproduceonenonform edbowelm ovem entperday) Duration: 3weeksto21m onths Samplesize: 28 IN C L U SIO N C R IT ER IA : M aleandfem alechildrenlessthan18m onths;constipationdefinedbyR asquin-W eberetal. Y ear:2004 PO PU L A T IO N G roupssimilar atbaseline: C H A R A C T ER IST IC S: PEG 3350 M eanage(years): N R Patientsaged 65 yearsor older (% ): N R Sex(% female): N R Eth nicity(% C aucasian): N R M eanbodymassindex: N R O th er germanech aracteristics: • D urationof constipation N R (m ean) N R • Bowelfrequency(BM /week) 2. Y ear:2004 A DV ER SEEV EN T S: PEG 3350 O veralladverseeffectsreported: • diarrhea 14. Y ear: 2003 C ountry:U SA F U N DIN G : BraintreeL abs R ESEA R C H O B JEC T IV E: Toassessthelong-term safetyprofileandacceptanceof PE G 3350inchildrenwithchronic constipation. DESIG N : Studydesign:Prospectivecohortstudy Setting:Pediatric clinicsatareferralcenter Samplesize:83 IN T ER V EN T IO N : PEG 3350 w/o electrolytes N o C omparison Dose: 0. EX C L U SIO N C R IT ER IA : Childrenincludedin2otherstudiesconductedbytheauthors;historyof H irschsprung’sdisease; anorectalm alform ation;system ic diseaseleading toconstipation O T H ER M EDIC A T IO N S/ N R IN T ER V EN T IO N S A L L O W ED: Constipation Drugs Page 124 of 141 Final Report Drug Effectiveness Review Project A uth ors:Pash ankar etal. Y ear:2006 PO PU L A T IO N G roupssimilar atbaseline:N /A C H A R A C T ER IST IC S: PEG 3350 w/o electrolytes M eanage(years): 7.

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