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PubMed2003

Intravenous immunoglobulin as adjunctive therapy for juvenile spasms.

Intravenous immunoglobulin has been reported to be an effective treatment for infantile spasms. Juvenile spasms are electrically and clinically similar to infantile spasms but occur in a later age group. We retrospectively reviewed the charts of five children (aged 4.5-11.5 years) at our institution. Their primary seizure type was juvenile spasms and they were treated with a single inpatient course of intravenous immunoglobulin (400 mg/kg/day intravenously for 5 consecutive days) on an adjunctive basis. Seizure frequency was determined from parental reports. By 3 months after treatment, improvement (a 50-92% reduction in seizure frequency) was noted in four patients; sustained benefit was seen in three patients for up to 12 months. One patient showed no response at 3 and 6 months and had an increase in seizure frequency at 1 year. We conclude that single-course intravenous immunoglobulin can be effective as adjunctive therapy for juvenile spasms and that benefit can persist for many months. However, larger controlled, prospective clinical trials are needed to validate this unconventional treatment modality for specific seizure types such as juvenile spasms.

Anticonvulsants↗

PubMed1995

Granulocyte-macrophage colony-stimulating factor as adjunct therapy in relapsed lymphoid malignancy: implications for economic analyses of phase III clinical trials.

With the increasing concern over the high cost of health care, policy makers have incorporated economic analyses into phase III clinical trials as the randomized clinical trials can provide important information on the efficacy and potential cost-effectiveness of new pharmaceutical agents. Economic analyses of single-hospital experience during phase III trials of granulocyte-macrophage colony-stimulating factor (GM-CSF) as adjunct therapy for high dose chemotherapy with autologous stem cell support found significant shortening of neutropenia with GM-CSF at each hospital, but shortened hospitalization (and lower costs) at only two of three hospitals. In this study, we added data from three additional hospitals and found that the 103 patients who received GM-CSF had, on average, 5.7 days shorter durations of severe neutropenia than the 95 patients who received placebo (p < 0.0001) and 3.4 days shorter in hospitalization (p = 0.06). However, the duration of hospitalization, the primary determinant of health care costs, was shorter for GM-CSF patients in only four of the six centers and the duration of hospitalization of placebo patients was shorter at the other two centers. Careful analyses must be carried out when phase III clinical trial results are used to derive estimates of cost-effectiveness of new pharmaceutical agents. The interpretation of economic analyses of phase III clinical trials raises issues related to the perspective of the investigators, study design, collection of data on resource utilization, learning curve effects and generalizability of the results to other settings.

Antineoplastic Agents↗

PubMed2002

Melatonin as adjunctive therapy in the prophylaxis of cluster headache: a pilot study.

BACKGROUND: The periodicity of cluster headache suggests involvement of the suprachiasmatic nucleus of the hypothalamus, the biological clock. The secretion of melatonin, a hormone produced by the pineal gland and regulated by the suprachiasmatic nucleus, is altered in patients with cluster headache. Melatonin shifts circadian rhythms. A previous study of melatonin for primary prophylaxis of cluster headache demonstrated a 50% response rate. OBJECTIVE: To evaluate the use of melatonin as adjunctive therapy in patients with cluster headache who have incomplete relief of their headaches on conventional therapy. METHODS: Nine patients participated in the study, six with chronic cluster headache and three with episodic cluster headache. Patients with chronic cluster headache completed a baseline diary for 1 month, followed by 1 month of melatonin treatment, then 1 month of placebo. Patients with episodic cluster headache received placebo for 1 month, then melatonin for 1 month. Patients continued their usual prophylactic and abortive treatments during the study. Headache frequency, intensity, and use of analgesics were recorded. The primary endpoint of the study was the mean number of headaches per day, with mean daily analgesic consumption and percentage of mild, moderate, and severe headaches as secondary endpoints. RESULTS: There were no significant differences between means on analysis of variance and t testing for the melatonin, placebo, and baseline months for all primary and secondary endpoints. There were no side effects reported. CONCLUSIONS: Patients with chronic cluster headache or patients with episodic cluster headache whose headaches are uncontrolled on conventional therapy do not appear to gain therapeutically from the addition of melatonin to their usual treatment regimens. It is perhaps the phase-shifting properties of melatonin that mediate its effect in patients with episodic cluster headache, and it may be necessary to treat from the beginning of the cluster bout to reset the circadian pacemaker, thus producing a more positive outcome.

Adjuvants, Immunologic↗

PubMed2003

Appropriate dosing of pergolide in monotherapy and adjunctive therapy in Parkinson's disease.

Pergolide is one of the most well-tested and widely used dopamine agonists for the treatment of Parkinson's disease; however, there is worrying evidence that sub-therapeutic dosing of pergolide is widespread in clinical practice. Clinical studies in Caucasians suggest that a pergolide dose of 3 mg/day provides the optimal efficacy to tolerability ratio and that, in Japanese patients, a dose in excess of 2.25 mg/day may be ideal. Whether pergolide is used early in patients with de-novo Parkinson's disease or as adjunctive therapy later in the disease, in order to optimize its clinical efficacy, it is recommended that practitioners aim to achieve at least these doses, or higher ones, if the drug is well tolerated.

Antiparkinson Agents↗

PubMed1989

Double-blind placebo-controlled evaluation of flunarizine as adjunct therapy in epilepsy with complex partial seizures.

Flunarizine was compared to placebo in a double-blind cross-over trial of 2 16-week treatment periods separated by a 4-week wash-out period. The patients had epilepsy with complex partial seizures with or without secondary generalised seizures. Twenty-nine patients entered the trial, but 7 dropped out. Of the 22 patients completing the trial, 13 were women; the median was 39 years (range 15-58) and the median duration of epilepsy 23 years (range 4-55). There was no statistically significant difference between flunarizine 15 mg daily and placebo as adjunct therapy in total seizure frequency, neuropsychological tests, and patient's preferences. No interactions with concomitant antiepileptic drugs and no laboratory abnormalities were registered.

Adolescent↗

PubMed2004

COX-2 inhibitors as adjunctive therapy in schizophrenia.

Cyclooxygenase-2 (COX-2) is constitutively expressed in the central nervous system, and is thought to have an important functional role therein. COX-2 interacts with neurotransmitters such as acetylcholine, 5-hydroxytryptamine and glutamate but is also involved in the regulation of the central nervous system immune system and in inflammation via the effects of prostaglandins, in particular prostaglandin E2. A general therapeutic effect of the COX-2 inhibitor celecoxib on symptoms of schizophrenia was observed during a prospective, randomised, double-blind study of celecoxib add-on treatment to the atypical antipsychotic risperidone. The results from this trial of adjunctive therapy with a COX-2 inhibitor in schizophrenia are encouraging, and the findings support the view that an immunological/inflammatory process is involved in the pathogenesis of the disease. The add-on to an antipsychotic design of the study was chosen due to ethical reasons; in less acute schizophrenic states a monotherapy with COX-2 inhibitors would be interesting. From a theoretical point of view, other psychiatric indications for selective COX-2 inhibitors are discussed. COX-2 inhibitors have failed to show therapeutic effects in Alzheimer's disease but studies from basic research and a clinical perspective suggest it has an effect on disturbed cognition. In depression, however, signs of inflammation have been described for many years. Although results of clinical studies with COX-2 inhibitors in depression are still lacking, clinical improvement of a depressive syndrome has been observed in patients who have been treated with the COX-2 inhibitor rofecoxib due to other indications. These preliminary clinical data are encouraging for clinical therapeutic effects of the selective COX-2 inhibitors in psychiatric disorders, although these effects have to be confirmed in larger clinical studies.

Animals↗

PubMed2005

Clinical experience with zonisamide monotherapy and adjunctive therapy in children with epilepsy at a tertiary care referral center.

We evaluated our clinical experience with zonisamide, a broad-spectrum antiepileptic drug, in a group of children with predominantly medically refractory epilepsy. A retrospective chart review was conducted on patients at our tertiary referral center following Institutional Review Board approval. Observers documented reports of seizure frequency, and seizure types were identified either clinically or by prior video-electroencephalography monitoring. We identified 68 patients (age range 1.9-18.1 years [median 6.9 years]; male to female ratio 1.3:1) treated with zonisamide for 0.7 to 28.9 months; at the last visit, 22% and 78% were on monotherapy and adjunctive therapy, respectively. The median duration of treatment and maintenance dose at the end of the follow-up were 11.2 months and 8.0 mg/kg/day, respectively. Seizure types included generalized (primary generalized tonic-clonic, myoclonic, tonic, atonic, absence) and partial (simple, complex, and secondarily generalized tonic-clonic seizures); 10 (15%) patients had both partial and generalized seizures. Sixteen (25.8%) patients were seizure free, although five of them were already in remission prior to starting zonisamide. Thirteen (21.0%) patients had a > 50% seizure reduction, 10 (16.1%) patients had a < 50% seizure reduction, 14 (22.6%) had no improvement in baseline seizures, and 9 (14.5%) reported having increased seizures. The latter were mostly associated with dosage alterations in concomitant antiepileptic drugs. Common side effects were central nervous system related, including behavioral or psychiatric (23.5%), cognitive dysfunction (12.0%), and sedation (10.3%). Eleven (16.2%) patients ultimately discontinued zonisamide, but only five were strictly due to side effects. Zonisamide is clinically effective against multiple seizure types in a significant proportion of children with epilepsy across a broad age range. Drug discontinuation as a result of side effects is uncommon.

Adolescent↗

PubMedDate not supplied

Olanzapine may be an effective adjunctive therapy in the management of acne excoriée: a case report.

BACKGROUND: The self-inflicted dermatoses such as acne excorieé and neurotic excoriations are often chronic, recurring, and resistant to standard dermatologic therapies. OBJECTIVE: We present a 28-year-old woman with longstanding acne excorieé, whose acne started at age 14 years and was followed by acne excorieé at age 16 years. The patient reported that her acne and self-excoriative behavior were exacerbated by psychological stress. The previously treatment-resistant acne excorieé responded favorably to treatment with the atypical antipsychotic agent olanzapine. METHODS: The patient was started on olanzapine 2.5 mg at bedtime. RESULTS: After 4 weeks of therapy with olanzapine she reported a significant decline in her self-excoriative behavior which was associated with an improvement in her acne excorieé. The patient used the olanzapine 2.5 mg for 6 months, during which time she also entered psychotherapy in order to deal with some psychosocial stressors that were exacerbating her self-excoriative behavior. The patient has not experienced a recurrence in her self-excoriative behavior or acne excorieé for 4 months after discontinuing the olanzapine. CONCLUSION: Olanzapine may prove to be a useful adjunctive therapy in some self-induced dermatoses including acne excorieé.

Acne Vulgaris↗

PubMed1995

The use of adjunctive therapy to alter the pathophysiology of bacterial meningitis.

The inflammation in the subarachnoid space (SAS) that develops in the course of bacterial meningitis may have a role in eradicating the infection, but also, ultimately, is the cause of the neurological sequelae associated with this infection. The presence of an inflammatory exudate in the SAS leads to alterations in the blood-brain barrier, altered cerebrospinal fluid dynamics, cerebral edema and increased intracranial pressure, and loss of cerebral auto-regulation. Our increasing understanding of the pathophysiology of meningeal inflammation has led to therapeutic interventions to limit the degree of meningeal inflammation and neurologic sequelae. The inflammatory cascade that leads to alterations in central nervous system physiology will be reviewed as well as the experimental evidence and clinical trials demonstrating the efficacy of adjunctive therapy in reducing meningeal inflammation and decreasing the incidence and severity of neurological sequelae in bacterial meningitis.

Animals↗

PubMed1995

Prednisone as adjunctive therapy in the management of pulmonary tuberculosis. Report of 12 cases and review of the literature.

A retrospective chart review was conducted over a 5-year period (1988 to 1993) in a tertiary inpatient care center on the effects of the addition of prednisone to the treatment regimens of 12 patients with pulmonary tuberculosis who continued to spike high temperatures and lose weight while showing bacteriologic response to effective antituberculosis therapy. After exclusion of other causes of fever, all patients were treated with 20 to 60 mg of prednisone daily until normalization of temperature and clinical improvement. Analyzed data included twice weekly sputum bacillary count, temperature record every 4 h, weekly patient weight, serum albumin level, liver function tests, and chest roentgenogram. The patients continued to spike temperatures of 38.3 degrees C to 40.5 degrees C (mean +/- SD = 39.6 degrees C +/- 0.6 degrees C) even after 18 to 53 days (mean +/- SD = 33.9 +/- 9.8 days) of antituberculosis therapy. Within 24 h after the addition of oral prednisone, temperature decreased in all 12 patients from a daily highest spike mean of 39.6 degrees C +/- 0.6 degrees C (SD) to 38.1 degrees C +/- 0.6 degrees C (SD) (p = 0.0022). The duration of required prednisone therapy was 20.1 +/- 9 days (mean +/- SD). During this period patients' appetites improved, and their weight increased from a mean (+/- SD) of 53.6 +/- 5.7 kg to 58.1 +/- 6.4 kg (p = 0.0022). The serum albumin level increased from a mean (+/- SD) of 2.51 +/- 0.4 g/dL to 3.21 +/- 0.4 g/dL (p = 0.0033). All the patients also showed clinical evidence of a decrease in toxic reactions associated with tuberculosis. There were no side effects from the addition of prednisone. This study shows the need for randomized controlled clinical trials to clarify the role of prednisone as adjunctive therapy in the management of pulmonary tuberculosis.

Adult↗

PubMed2002

Mitomycin C as adjunct therapy in correcting punctal stenosis.

PURPOSE: To assess the efficacy of intraoperative mitomycin C in improving the success rate of the posterior punctectomy procedure. METHODS: The charts of all patients who underwent posterior punctectomy between the years 1997 and 2000 were reviewed. The procedure was done without mitomycin C (n = 26 eyes, group A) until the end of 1998 and with mitomycin C (n = 25 eyes, group B) starting in 1999. The Kaplan-Meier curve was used for statistical evaluation. RESULTS: In group A, 5 of 26 (19.2%) eyes had complete anatomic obstruction and scarring of their puncta after surgery, compared with 0 of 25 (0.0%) eyes in group B. The difference was statistically significant (P<0.02). No significant complications were observed. CONCLUSIONS: Mitomycin C appears to be a safe and effective adjunct therapy in correcting punctal stenosis.

Adult↗

PubMed2003

Dietary n-3 fats as adjunctive therapy in a prototypic inflammatory disease: issues and obstacles for use in rheumatoid arthritis.

Eicosanoids derived from the n-6 fatty acid, arachidonic acid, and the cytokines interleukin-1beta and tumour necrosis factor-alpha are involved in the signs and symptoms of inflammatory joint disease, as well as the cartilage degradation seen in established rheumatoid arthritis (RA). Then n-3 fatty acids in fish and fish oil can inhibit production of both eicosanoid and cytokine inflammatory mediators and therefore, have the potential to modify RA pathology. Epidemiological studies suggest that fish intake may be preventive for RA and double-blind placebo-controlled studies demonstrate that dietary fish oil can alleviate the signs and symptoms of RA. The implementation of these findings will require among other things, a range of n-3 fat enriched foods, as well as physician awareness of the possibilities for dietary n-3 fat increases to be used as adjunctive therapy in RA.

Arthritis, Rheumatoid↗

PubMed2005

Effects of zinc supplementation as adjunct therapy on the systemic immune responses in shigellosis.

BACKGROUND: Zinc is lost during diarrheal diseases, and zinc deficiency induces intestinal morphology-altering inflammatory responses that zinc supplementation can correct. OBJECTIVE: We assessed the in vivo effect of zinc supplementation on systemic and mucosal responses in mildly to moderately malnourished (defined as <-1 but >-2 and <-2 but >-3 weight-for-height z scores, respectively, based on the National Center for Health Statistics growth reference) children with shigellosis. DESIGN: A double-blind placebo-controlled trial was conducted in Shigella flexneri-infected children aged 12-59 mo. Daily for 14 d, elemental zinc (20 mg) and multivitamins (vitamins A and D, thiamine, riboflavin, and nicotinamide) plus calcium were given at twice the US recommended dietary allowance to the zinc group (n=28), and multivitamins plus calcium were given to the control group (n=28). All subjects received standard antibiotic therapy. RESULTS: There was no significant interaction between zinc supplementation and time, but zinc supplementation showed a significant effect on serum zinc concentrations. With a >or=4-fold increase in serum shigellacidal antibody titers from baseline used as the cutoff, the proportion of children with shigellacidal antibody response was greater in the zinc group than in the control group (P<0.03). There was a significant (P=0.02) treatment x time interaction for the proportions of circulating CD20+ and CD20+CD38+ cells, which were higher on day 7 in the zinc group than in the control group (P<0.007). No effect was seen on histopathologic features or the expression of innate and inflammatory mediators in the rectum. CONCLUSION: Adjunct therapy with zinc during acute shigellosis significantly improved seroconversion to shigellacidal antibody response and increased the proportions of circulating B lymphocytes and plasma cells.

Analysis of Variance↗

PubMed2006

Ventilatory strategies and adjunctive therapy in ARDS.

Acute respiratory distress syndrome, a diagnosis based on physiologic and radiological criteria, occurs commonly in critical care setting. A major challenge in evaluating therapies that may improve survival in ARDS is that it is not a single disease entity but, rather, numerous different diseases that result in endothelial injury, where the most obvious manifestation is within the lung resulting in pulmonary oedema. It has been shown that poor ventilatory technique that is injurious to the lungs can propagate systemic inflammatory response and adversely affect the mortality. The current data suggest that high tidal volumes with high plateau pressures are deleterious and a strategy of ventilation with lower tidal volumes and lower plateau pressure is associated with lower mortality. There may be a role for recruitment manoeuvres as well. Other forms of respiratory support still require further research. The present understanding of optimal ventilatory management and other adjunctive therapies are reviewed.

Administration, Inhalation↗

PubMed1999

Physical training as an adjunct therapy in patients with congestive heart failure: patient selection, training protocols, results, and future directions.

Exercise intolerance in patients with chronic heart failure (CHF) shows no correlation to the degree of left ventricular dysfunction. This surprising finding has directed attention to peripheral changes in CHF: reduced endothelium-dependent vasodilation and altered skeletal muscle metabolism. Physical exercise training has evolved as an important therapeutic approach to influence these noncardiac causes of exercise intolerance. It has been shown to enhance the oxidative capacity of the working skeletal muscle, to attenuate ergoreflex activity, to correct endothelial dysfunction, and to improve ventilation. All exercise-induced adaptations converge to increase peak oxygen uptake by up to 2 mL/kg.min(-1). Uncertainty remains concerning optimal patient selection, training protocol, and long-term effects on cardiac function. For patients experiencing stable CHF while on optimal cardiac medication, a combination of in-hospital and home-based aerobic endurance training in combination with local muscle strength training seems most promising. Although exercise training offers no causal treatment of CHF, it has great potential as an adjunct therapy directed at improving exercise tolerance and expanding the physical limits of CHF patients.

Arrhythmias, Cardiac↗

PubMed1998

Adjunctive therapy for spinal cord protection during thoracoabdominal aortic aneurysm repair.

Paraplegia, resulting from spinal cord ischemia during thoracoabdominal aortic aneurysm (TAA) repair, continues to be a devastating complication. The incidence of neurological complications, including paraplegia and paraparesis following TAA repair, ranges from 4% to 32% and averages 13% for nondissecting TAA and higher for dissecting TAA. Our current understanding of spinal cord ischemia associated with TAA repair has evolved from animal research and clinical experience. The pathophysiology of spinal cord ischemia is intricately related to three physiological variables. These include the severity and duration of spinal cord ischemia, neuronal reperfusion after reestablishment of spinal cord blood flow, and the neuronal metabolic rate during the ischemic insult. We have developed a multimodality approach to the prevention of neurological deficits, during and after TAA repair, which includes minimizing the severity of spinal cord ischemia, reducing the anticipated reperfusion phenomenon, and lowering the spinal cord metabolic rate. Over the past 16 years, the senior author has undertaken surgical repair of 265 TAAs using a multimodality approach in the protection of spinal cord integrity. In our experience, a combination of adjunctive therapies is critical to minimize the ischemic interval, reduce the neuronal reperfusion injury, and decrease spinal cord metabolism. These techniques have evolved over time, resulting in an overall neurological deficit rate of 4.5% and a neurological deficit at the time of hospital discharge of 1.9%. This article will outline our multimodality approach for spinal cord protection during TAA repair.

Animals↗

PubMed1997

Comparison of carprofen and flunixin meglumine as adjunctive therapy in bovine respiratory disease.

In an open, controlled, multi-centre clinical field trial, seven 'naturally occurring' outbreaks of acute febrile (rectal temperature > or = 39.5 degrees C) respiratory disease in housed calves were treated with a single antimicrobial agent, and either the non-steroidal anti-inflammatory drug (NSAID) carprofen (n = 95) or flunixin meglumine (n = 92) on an alternate basis. Carprofen was administered as a single subcutaneous injection at a mean dosage of 1.4 mg kg-1 (range 1.2 to 1.9 mg kg-1) body weight on the first day and flunixin meglumine by intravenous injection at a mean dosage of 2.0 mg kg-1 (range 1.2 to 2.6 mg kg-1) body weight on the first 3 consecutive days. All calves were examined clinically immediately prior to initial treatment and on three occasions up to 1 week after the end of treatment. There were no statically significant differences between NSAID groups in reduction of clinical parameters between examinations, or in overall efficacy. This trial demonstrated that a single dose of carprofen was equally effective as three daily doses of flunixin meglumine as adjunctive therapy to antimicrobial treatment in acute respiratory disease in calves.

Animals↗

PubMed2005

Adjunctive therapy with pramlintide lowers HbA1c without concomitant weight gain and increased risk of severe hypoglycemia in patients with type 1 diabetes approaching glycemic targets.

AIMS: In long-term clinical trials in patients with type 1 diabetes spanning a wide range of HbA1c, addition of pramlintide to existing insulin regimens led to reductions in HbA1c that were accompanied by weight loss and no increase in overall severe hypoglycemia event rates. Given that weight gain and increased hypoglycemia risk contribute to the difficulty of attaining HbA1c targets (<7 %), the question arose whether pramlintide could benefit patients approaching, but not reaching glycemic targets with insulin alone. To address this question, we conducted a pooled analysis from 3 long-term clinical trials, including all patients with an entry HbA1c between 7.0 % and 8.5 %. METHODS: Within the subset of patients with an entry HbA1c between 7.0 % and 8.5 % (approximately 28 % of all patients enrolled in the 3 studies), 196 were treated with placebo + insulin (baseline HbA1c 7.9+/-0.4 %, body weight 76.0+/-14.3 kg [mean+/-SD]) and 281 with pramlintide+insulin (baseline HbA1c 7.9+/-0.4 %, body weight 75.4+/-13.1 kg). Endpoints included placebo-corrected changes from baseline to week 26 in HbA1c, body weight, and the event rate of severe hypoglycemia. RESULTS: Adjunctive therapy with pramlintide resulted in significant reductions in HbA1c and body weight from baseline to week 26 (0.3 % and 1.8 kg, placebo-corrected treatment differences, respectively, both p<or=0.0009). These changes occurred without an increase in the overall risk of severe hypoglycemia (1.40 pramlintide vs. 1.86 placebo, events/patient-year of exposure). CONCLUSIONS: Addition of pramlintide to insulin therapy may help patients with type 1 diabetes who are approaching, but not yet reaching, glycemic targets with insulin alone to achieve further reductions in HbA1c without concomitant weight gain and increased risk of severe hypoglycemia.

Adult↗