www.painphysicianjournal.com E379 Letter to the Editor In Response We would like to thank van der Kooij and his col- leagues for their interest in our paper and for taking the time to express their concerns regarding efficacy and safety concerns of opioids use in chronic low back pain (CLBP) patients. The letter to the editor by van der Kooij et al. raised potential concern about the Oxymorphone and its U.S. Food and Drug Administration (FDA)-withdrawal. Oxy- morphone (Opana ER) was first approved in 2006 for the management of moderate-to-severe pain. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting (1). The FDA declined company’s request to include labelling describing po- tentially abuse-deterrent properties for Opana ER due to insufficient data. In addition to this, injection abuse of reformulated Opana ER has been associated with a serious outbreak of human immunodeficiency virus (HIV) and hepatitis C, as well as cases of a serious blood disorder (thrombotic micro angiopathy). Randomized clinical trials published by Katz et al (2) and Hale et al (3) used the original oxymorphone form instead of the new formulation and observed that in both the trials oxymorphone shown significant pain reduction com- pared to placebo (30% pain reduction). Hence, in the present network meta-analyses, we included oxymor- phone to avoid the missing information on all opioids used in CLBP. The second concern by van der Kooij et al was about the efficacy outcomes and the ranking probabil- ity of oxymorphone based on the effectiveness in pain reduction. They also reported that oxymorphone does not show a clinically relevant benefit in systematic re- view of CLBP. In chronic pain clinical trials, different efficacy outcomes were used like mean change in pain inten- sity, 30% pain reduction and 50% pain reduction from baseline to follow-up (4). The supportive systematic review on efficacy of opioids mentioned by van der Kooij et al used mean change in pain intensity as ef- ficacy outcome and the opioids showed a small change in pain intensity compared with placebo (mean differ- ences [MD] −8.98; 95% CI −11.71 to −6.25; 13 trials, n = 3071) and this MD was less than minimal perceptible threshold (10 mm points on 100 MM VAS scale) (4). In such circumstances, the initiative on methods, measure- ment, and pain assessment in clinical trials (IMMPACT) recommended responder analyses (proportion of pa- tients showing clinical meaningful pain reduction from base line) as efficacy outcome in chronic pain clinical trials when trials show small treatment effect sizes (i.e., standardized MD) between the treatment groups (5). Responder analyses is useful to determine whether a subgroup of patients may experience meaningful or even substantial benefits even though the overall MD is small. In the present study, we considered both 30% and 50% of pain reduction from baseline to follow-up as efficacy outcomes. Separate network meta-analyses were done for both 30% and 50% of pain reduction efficacy outcomes. The opioids were ranked according to 30% and 50% efficacy outcomes and oxymorphone showed the highest probability. Further van der Kooij et al discouraged the pre- scribing of opioids as recommended by Olivera et al (6). The study by Olivera et al (6) is an overview of current clinical practice guidelines for patients with nonspecific low back pain. The study recommended that use of opioids should be discouraged due to the small ben- efit on pain intensity in CLBP as well as potential side effects (6). In contrast to this, the majority of the exist- ing guidelines (13 out of 15; 87%) recommended weak opioids for the management of CLBP for short term, if there is no improvement with nonsteroidal antiinflam- matory drugs or other treatments. Van der Kooij et al also raised concern about the safety outcome used in our study. In the present study, we considered total withdrawal due to any reason from the trial as safety outcome. It covers the patients who withdrew from the study due to lack of efficacy or adverse events or any other reason. The same was reported in methodology. Boya Chandrasekhr, MD Clinical Research Unit, Department of Pharmacy Practice, National Institute of Pharmaceutical Edu- cation and Research, SAS Nagar, India TO THE EDITOR:
Pain Physician: May/June 2021; 24:E377-E380 E380 www.painphysicianjournal.com 1. Food and drug administration. Oxymor- phone (marketed as Opana ER) Informa- tion. www.fda.gov/drugs/postmarket- drug-safety-information-patients-and- providers/oxymorphone-marketed-opa- na-er-information. 2017. Accessed on 04-20-2021. 2. Hale ME, Ahdieh H, Ma T, Rauck R, Oxy- morphone ER Study Group. Efficacy and safety of OPANA ER (oxymorphone ex- tended release) for relief of moderate to severe chronic low back pain in opioid- experienced patients: A 12-week, ran- domized, double-blind, placebo-con- trolled study. J Pain 2007; 8:175-184. 3. Katz N, Rauck R, Ahdieh H, et al. A 12- week, randomized, placebo-controlled trial assessing the safety and efficacy of oxymorphone extended release for opi- oid-naive patients with chronic low back pain. Curr Med Res Opin 2007; 23:117-128 4. Tucker HR, Scaff K, McCloud T, et al. Harms and benefits of opioids for man- agement of non-surgical acute and chronic low back pain: A systematic re- view. Br J Sports Med 2020; 54:664-2018- 099805. 5. Dworkin RH, Turk DC, Farrar JT, et al. Core outcome measures for chronic pain clinical trials: IMMPACT recommenda- tions. Pain 2005; 113:9-19. 6. Oliveira CB, Maher CG, Pinto RZ, et al. Clinical practice guidelines for the man- agement of non-specific low back pain in primary care: An updated overview. Eur Spine J 2018; 27:2791-2803. REFERENCES Dipika Bansal, MD Clinical Research Unit, Department of Pharmacy Practice, National Institute of Pharmaceutical Edu- cation and Research, SAS Nagar, India E-mail: dipikabansal079@gmail.com Babita Ghai, MD Department of Anaesthesia, Post Graduate Insti- tute of Medical Education and Research, Chandi- garh, India
Letter to the Editor
In Response
TO
THE
EDITOR:
We would like to thank van der Kooij and his colleagues for their interest in our paper and for taking
the time to express their concerns regarding efficacy
and safety concerns of opioids use in chronic low back
pain (CLBP) patients.
The letter to the editor by van der Kooij et al. raised
potential concern about the Oxymorphone and its U.S.
Food and Drug Administration (FDA)-withdrawal. Oxymorphone (Opana ER) was first approved in 2006 for
the management of moderate-to-severe pain. In 2012,
Endo replaced the original formulation of Opana ER
with a new formulation intended to make the drug
resistant to physical and chemical manipulation for
abuse by snorting or injecting (1). The FDA declined
company’s request to include labelling describing potentially abuse-deterrent properties for Opana ER due
to insufficient data. In addition to this, injection abuse
of reformulated Opana ER has been associated with
a serious outbreak of human immunodeficiency virus
(HIV) and hepatitis C, as well as cases of a serious blood
disorder (thrombotic micro angiopathy). Randomized
clinical trials published by Katz et al (2) and Hale et al
(3) used the original oxymorphone form instead of the
new formulation and observed that in both the trials
oxymorphone shown significant pain reduction compared to placebo (30% pain reduction). Hence, in the
present network meta-analyses, we included oxymorphone to avoid the missing information on all opioids
used in CLBP.
The second concern by van der Kooij et al was
about the efficacy outcomes and the ranking probability of oxymorphone based on the effectiveness in pain
reduction. They also reported that oxymorphone does
not show a clinically relevant benefit in systematic review of CLBP.
In chronic pain clinical trials, different efficacy
outcomes were used like mean change in pain intensity, 30% pain reduction and 50% pain reduction from
baseline to follow-up (4). The supportive systematic
review on efficacy of opioids mentioned by van der
Kooij et al used mean change in pain intensity as efficacy outcome and the opioids showed a small change
in pain intensity compared with placebo (mean differences [MD] −8.98; 95% CI −11.71 to −6.25; 13 trials, n
www.painphysicianjournal.com
= 3071) and this MD was less than minimal perceptible
threshold (10 mm points on 100 MM VAS scale) (4). In
such circumstances, the initiative on methods, measurement, and pain assessment in clinical trials (IMMPACT)
recommended responder analyses (proportion of patients showing clinical meaningful pain reduction from
base line) as efficacy outcome in chronic pain clinical
trials when trials show small treatment effect sizes (i.e.,
standardized MD) between the treatment groups (5).
Responder analyses is useful to determine whether a
subgroup of patients may experience meaningful or
even substantial benefits even though the overall MD
is small. In the present study, we considered both 30%
and 50% of pain reduction from baseline to follow-up
as efficacy outcomes. Separate network meta-analyses
were done for both 30% and 50% of pain reduction
efficacy outcomes. The opioids were ranked according
to 30% and 50% efficacy outcomes and oxymorphone
showed the highest probability.
Further van der Kooij et al discouraged the prescribing of opioids as recommended by Olivera et al (6).
The study by Olivera et al (6) is an overview of current
clinical practice guidelines for patients with nonspecific
low back pain. The study recommended that use of
opioids should be discouraged due to the small benefit on pain intensity in CLBP as well as potential side
effects (6). In contrast to this, the majority of the existing guidelines (13 out of 15; 87%) recommended weak
opioids for the management of CLBP for short term, if
there is no improvement with nonsteroidal antiinflammatory drugs or other treatments.
Van der Kooij et al also raised concern about the
safety outcome used in our study. In the present study,
we considered total withdrawal due to any reason
from the trial as safety outcome. It covers the patients
who withdrew from the study due to lack of efficacy
or adverse events or any other reason. The same was
reported in methodology.
Boya Chandrasekhr, MD
Clinical Research Unit, Department of Pharmacy
Practice, National Institute of Pharmaceutical Education and Research, SAS Nagar, India
E379
Pain Physician: May/June 2021; 24:E377-E380
Dipika Bansal, MD
Clinical Research Unit, Department of Pharmacy
Practice, National Institute of Pharmaceutical Education and Research, SAS Nagar, India
E-mail: dipikabansal079@gmail.com
Babita Ghai, MD
Department of Anaesthesia, Post Graduate Institute of Medical Education and Research, Chandigarh, India
REFERENCES
1.
2.
Food and drug administration. Oxymorphone (marketed as Opana ER) Information.
www.fda.gov/drugs/postmarketdrug-safety-information-patients-andproviders/oxymorphone-marketed-opana-er-information. 2017. Accessed on
04-20-2021.
Hale ME, Ahdieh H, Ma T, Rauck R, Oxymorphone ER Study Group. Efficacy and
safety of OPANA ER (oxymorphone extended release) for relief of moderate to
severe chronic low back pain in opioid-
E380
3.
4.
experienced patients: A 12-week, randomized, double-blind, placebo-controlled study. J Pain 2007; 8:175-184.
Katz N, Rauck R, Ahdieh H, et al. A 12week, randomized, placebo-controlled
trial assessing the safety and efficacy of
oxymorphone extended release for opioid-naive patients with chronic low back
pain. Curr Med Res Opin 2007; 23:117-128
Tucker HR, Scaff K, McCloud T, et al.
Harms and benefits of opioids for management of non-surgical acute and
5.
6.
chronic low back pain: A systematic review. Br J Sports Med 2020; 54:664-2018099805.
Dworkin RH, Turk DC, Farrar JT, et al.
Core outcome measures for chronic pain
clinical trials: IMMPACT recommendations. Pain 2005; 113:9-19.
Oliveira CB, Maher CG, Pinto RZ, et al.
Clinical practice guidelines for the management of non-specific low back pain in
primary care: An updated overview. Eur
Spine J 2018; 27:2791-2803.
www.painphysicianjournal.com
Fuel industry is a sector that has potential hazards and high risks. Risks in terms of operating processes should be known in order to measure the qualitative and quantitative impacts resulting from economic, worker safety and environmental impact. This is closely related to the operations of the fuel distribution process from the fuel tanker to distribution trucks. Fuel distribution has high risk impacts such as fire, leakage, explosion and fuel spills. LOPA (Layer of Protection Analysis) based on hazard identification was done to show the value of the SIL (Safety Integrity Level) in some scenarios. Risks calculation using LOPA technique is effective and realistic to be used for developing scenario in Hazard and Operability Study (HAZOPS). SIL calculations lead to economic impact analysis based on modern software that is easily understood and reliable. Adaptive Neuro Fuzzy Interface System (ANFIS) is appropriate to be used as an expert-based risk assessment methods that show layers of protection are qualitatively and quantitatively. ANFIS mechanism is combination of Fuzzy Interface System (FIS), which is described in the neural network architecture. Result of this evaluation can be used by management to influence decision making towards company's economic or public needs. The proof shows that is rating node SIL 1 to 3, NO SIL, SIL 0 and SIL 1. In addition, result of ANFIS Layer of Protection Analysis for economic impact is categorized in overall medium with total losses/year in US $ 10.000 – US $ 100.000.
Hegemony, for Antonio Gramsci, is the use of consent and coercion in order to establish control over a population or a state. It is this balance between the two that is fundamental to Gramsci’s theory. Furthermore, the distinctionbetween two types of intellectuals, traditional and organic, is central to the diffusion
of elite ideology and obtaining the consent of the masses. First, this study surveys the various Gramscian and neo-Gramscian literature, which develops the background for my central argument. The following section briefly examines the
construction of a “common sense” in America focusing on two fundamental aspects: American exceptionalism and Liberalism. Finally, my study takes a critical look at American policy during the Regan Administration, specifically focusing on Ronald Reagan’s ability to assume the role as an intellectual, used in the Gramscian
tradition. However, I argue, although Ronald Reagan recaptured the common sense of the American people, manipulation and coercion were instrumental in reestablishing American dominance. Thus, power during the Reagan administration
lacked a critical element of hegemony, consent, and can no longer be defined as hegemony in the Gramscian sense.
ABSTRAK to Know the level of health of a company is by having a measuremerent oe evaluation of company's achienement. That is why, to know the achievement of this industry cleary, it is needed to analiyze the achievement of financial industry to evalute the economic resource potential changes and its weknees that are controlled in the future. The aim of ths research is to analyze the achhievement of the financial of PT. Telekomunikasi indonesia Tbk. This research is including into descriptive qualitative research which is used descriptive approach. The technique to collect the data are used documentation, and it is used the secondary data as the financial account from 3003-2006 which is formed from balance income statement. The technique of ratio thad is liquidity ratio, solvability, activity, and profilibity. The researcher used time series analysis as the method. The result of the rearch show that the condition of financial company is fluctuated by the dibabilities of the current ratio, quich ratio, and cash ratio, to pay the debt and operational cost. Ratio activity is the total of aset turnovel and fixed asset tunovel which their rotation are moving slowly. Solvability ratio is the ratio debt and equidity ratio debt which their accound are very large and tend to incrrease every year. These show that the activity of the company are sponged by creditor. Profilibity ratio of the company is good whereas each ratio tends yo increase every year. Untuk mengetahui tingkat kesehatan suatu perusahaan dilakukan dengan penilaian terhadap kinerja perusahaan. Oleh karena itu untuk dapat mengetahui kinerja perusahaan tersebut, maka perlu melakukan analisis terhadap kinerja keuangan perusahaan guna untuk menilai perubahan potensi sumber daya dan kelemahan kinerja yang bisa di kendalikan dimasa
This article discusses the references to Jesus Christ and Christians in the works of the Nishapurian Ṣūfī Abū ʿAbd al-Raḥmān al-Sulamī (d. 412/1021). Without attempting to fully catalog the few references present in al-Sulamī's oeuvre, some representative examples are given, with a special focus on al-Sulamī's Qurʾān commentary. To the extent that one can detect a distinctive element in his portrait of Jesus vis-à-vis the larger Islamic tradition, al-Sulamī foregrounds the Nazarene's esoteric wisdom. Since Christians were a very small minority in Nishapur, it seems that this Ṣūfī master did not see an urgent reason to address the issue. Al-Sulamī's general lack of interest is consistent with the approaches of some other major Ṣūfī texts that emerged from Nishapur and its region in the period, thus challenging the notion that normative characteristics of the Ṣūfī path promote an openness to other religions or a curiosity about them. His literary corpus does not suggest any hostility on the part of al-Sulamī; it merely indicates a Ṣūfī master totally dedicated to cultivating Islamic adab according to the Sunna of Muḥammad.
We deploy kernel-based time-series prediction to suppress the phase noise induced by small deviations from ideal pump counter-phasing in a dual-pump optical phase conjugation system. We show experimentally 1.5-dB SNR improvement for 16-QAM signals at 4° pump-phase mismatch.
The influence of coupling agents on the melt rheological properties of natural fiber composites has been investigated in this work using capillary and rotational rheometers. Scanning electron microscopy was also employed to supplement the rheological data. It was found that molecular weight and molecular weight distribution of the polymer matrix and coupling agent characteristics influence the filler wetting and the melt flow properties of the filled composites. Generally, low molecular weight and narrow molecular weight distribution polyethylene matrix provides relatively larger increase of the viscosity of the composites. Coupling agents tend to increase the resistance to shearing, but wall slip effects may interfere with the measured values, especially at very high filler loadings. Entrance pressure loss in capillaries is also influenced by polymer matrix and coupling agent used.magnified image
Penelitian ini dilakukan di Kecamatan Batuan, Kabupaten Sumenep dengan jumlah sampel sebanyak 35 orang. Tujuan dari penelitian ini adalah 1). Untuk mengetahui gambaran kepemimpinan transformasional, motivasi, lingkungan kerja dan kinerja pegawai Kecamatan Batuan Kabupaten Sumenep, 2). Untuk menguji dan menganalisis apakah kepemimpinan transformasional, motivasi dan lingkungan kerja secara parsial berpengaruh signifikan terhadap kinerja pegawai di Kecamatan Batuan, Kabupaten Sumenep, 3). Untuk menguji dan menganalisis apakah kepemimpinan transformasional, motivasi dan lingkungan kerja secara simultan berpengaruh signifikan terhadap kinerja pegawai di Kecamatan Batuan Kabupaten Sumenep. Hasil penelitian menunjukkan bahwa 1). Secara parsial kepemimpinan transformasional, motivasi dan lingkungan kerja berpengaruh signifikan terhadap kinerja pegawai di Kecamatan Batuan Kabupaten Sumenep, hal ini dibuktikan dengan nilai t hitung masing-masing variabel bebas yaitu: kepemimpinan transformas...