Day: June 12, 2024

Two-drug Therapy Reduced Relapse in Methamphetamine Use Disorder

Source: Wikimedia Commons

A clinical trial on a two-drug therapy for methamphetamine use disorder reduced use of the highly addictive drug for up to 12 weeks after initiation of treatment.

Participants in the ADAPT-2 clinical trial who received a combination of injectable naltrexone plus extended-release oral bupropion (NTX+BUPN) had a 27% increase in methamphetamine-negative urine tests, indicating reduced usage. By contrast, the placebo group had an 11% increase in negative tests.

The UCLA-led study is published in Addiction.

“These findings have important implications for pharmacological treatment for methamphetamine use disorder. There is no FDA-approved medication for it, yet methamphetamine-involved overdoses have greatly increased over the past decade,” said Michael Li, assistant professor-in-residence of family medicine at UCLA and the study’s lead author.

Methamphetamine use has continued growing over the years around the world, increasing from 33 million people in 2010 to 34 million in 2020. Overdose deaths from the drug have jumped fivefold in the US from 2012 to 2018, and are followed by Canada and Australia in increases. 

To curb the ongoing crisis, the National Institute on Drug Abuse (NIDA) Clinical Trials Network has supported various trials, including the ADAPT-2 trial, to test the effects of different pharmacological treatments for methamphetamine use disorder. ADAPT-2 was carried out from May 23, 2017 to July 25, 2019 across the eight trial sites that included UCLA. It included 403 participants, with 109 assigned to the drug combo group and the rest to the placebo group in the first stage. 

The latest findings are the second stage of the multi-site trial. The earlier stage had demonstrated that the two-drug combination worked at six weeks, but the unanswered question was whether the intervention remained efficacious over a longer period.

In the second stage, the researchers conducted urine tests on the participants at weeks seven and 12, and again post-treatment at weeks 13 and 16 comparing the group on NTX+BUPN with the placebo group.

There is a need for further research to determine whether the drug treatment effect lasts longer than 12 weeks and yields further methamphetamine use reductions, the researchers write.

“Prior stimulant use disorder treatment trials suggest that change in use is gradual (consistent with our findings), unlikely to result in sustained abstinence in a typical 12-week trial, and dependent on treatment duration,” they write. “This warrants future clinical trials to quantify changes in MA use beyond 12 weeks and to identify the optimal duration of treatment with this medication.”

Source: University of California – Los Angeles Health Sciences

Radiation Therapy Graduates Unplaced for Six Months by Health Department

Photo by National Cancer Institute on Unsplash

A number of radiation therapy graduates, who must by law complete the Department of Health’s Internship and Community Service Programme in order to practise medicine, say they have been waiting for nearly six months to be placed in hospitals.

They have finished their four-year studies and now need to complete a year-long internship, referred to as Comserve, in order to register and practice as medical professionals. Their primary role is to administer radiation treatment to patients with cancer.

The community service programme is administered by the National Department of Health.

“We are left in limbo, not sure when we will receive a post,” a graduate from the Western Cape, who wished to be anonymous, told GroundUp. He said that they’ve been told since the beginning of the year by Comserve officials that they are engaging with provinces to secure them placements.

He shared correspondence that said he was not yet allocated a position “due to the unavailability of funded posts”.

He said that it was “frustrating” that they are required by law to do Comserve yet the department cannot find them posts.

“We are all stressed out … We still have bills to pay from university. We are squatting with our parents. We were promised we were going to have a job after studying and now we can’t apply for other jobs. Our hands are cut off. We can’t do anything,” he said.

He said he knew of about nine other radiation therapists also waiting for placements.

Another graduate, from KwaZulu-Natal, said the lack of placement risked creating a backlog when next year’s graduates need to do Comserve.

“At the end of the day, our cancer patients are going to suffer … They need us and we have trained specifically to help them,” she said.

The failure to place graduates is happening despite staff shortages in radiation oncology departments in Gauteng.

On 30 April activists from SECTION27, Cancer Alliance and the Treatment Action Campaign (TAC) as well as cancer patients marched to the offices of the Gauteng department of health demanding that millions of rands set aside for radiation treatment be used.

In an open letter addressed to health MEC Nomantu Nkomo-Ralehoko, the organisations provided a backlog list of about 3000 patients awaiting radiation oncology treatment.

Salomé Meyer of the Cancer Alliance says there are radiation oncology staff shortages in Charlotte Maxeke Johannesburg Academic Hospital and Steve Biko Academic Hospital.

Both graduates GroundUp spoke to had applied to Charlotte Maxeke for their Comserve year.

In December 2023, the national department stated that nearly 10 400 Comserve applications were received. Of these just shy of 9400 applicants “were successfully placed, and this includes medical doctors, nurses, pharmacists and other health professionals at health facilities throughout the country”.

National Department of Health spokesperson Foster Mohale sent GroundUp an incoherent and incomplete WhatsApp response. “We only know those who were placed. We can’t tell those who were not placed because we are not sure of their career plans,” he wrote.

Asked about staff shortages, Mohale wrote that the department “prioritises all critical posts using limited budget”.

The Gauteng Department of Health did not respond to our questions about radiology therapist Comserve placements and staff shortages in its hospitals, despite committing to do so and repeated follow-ups.

Republished from GroundUp under a Creative Commons Attribution-NoDerivatives 4.0 International License.

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Protect against Pertussis Cases in Vulnerable Populations with Tdap Vaccination

Photo by Gustavo Fring on Pexels

Post-COVID-19, there has been a notable increase in vaccine fatigue and apathy, influenced significantly by social media.1 Higher trust in social media correlates with increased vaccine hesitancy, driven by the widespread dissemination of vaccine misinformation and conspiracy theories on these platforms.1 This has significantly impacted public perceptions and trust regarding vaccinations.1

Recently, statistics have indicated a notable increase in pertussis cases in South Africa. In December 2022, the National Institute for Communicable Diseases (NICD) reported a total of 408 cases countrywide.2 Most of these cases occurred in children younger than five years old as parents might not return to their healthcare professional to have their children vaccinated after six weeks of age.2

Pertussis is a vaccine-preventable disease

Recent research concluded that immunisation with the pertussis vaccine during pregnancy prevented 65% of pertussis infections through 6 months of age.3 These results indicate that maternal pertussis vaccination protects infants from infection during a period of greatest vulnerability to severe morbidity and mortality.3 The findings support the infant health benefits of recommendations to administer a dose of pertussis vaccine near 28 weeks of gestational age.3

Health authorities in South Africa have emphasised the importance of vaccination to control pertussis outbreaks.4 Immunity following vaccination lasts for approximately 5-6 years, necessitating booster doses.4  Episodic increases in pertussis cases occur in vaccinated populations every 3-5 years, making the completion of childhood primary series Tdap (tetanus, diphtheria, and acellular pertussis) vaccine and boosters important for prevention.4 The NICD also recommends vaccination of healthcare workers and pregnant women to reduce transmission to neonates and other vulnerable populations.4

“2024 marks the 50th anniversary of the Expanded Programme on Immunisation (EPI),” says Dr Lourens Terblanche, Vaccines Medical Head at global pharmaceutical company, Sanofi South Africa. “Every country has a national immunisation programme, and vaccines are universally recognised as best practice in terms of efficacy, tolerability, cost impact and successful public health interventions to prevent fatalities and enhance the quality of life. As we celebrate the lifesaving impact of EPI, we also need to strengthen routine immunisation initiatives, especially for pregnant women.”

Effective protection for children with Tdap vaccination

South Africa’s national immunisation schedule provides vaccinations against various diseases free of charge at state clinics, starting from birth, followed by additional doses at set times during a child’s early years.

“It is crucial to prioritise the health and well-being of patients, especially during critical stages such as pregnancy and childhood,” says Terblanche. “We urge all healthcare professionals to encourage pregnant women to receive their vaccinations timeously, and to ensure that their children’s vaccinations are up to date. Proactive efforts can significantly reduce the risk of vaccine-preventable diseases for mothers and children, safeguarding their health and the health of our communities.”

Terblanche reiterates that pertussis has the potential to cause serious and sometimes deadly complications in the paediatric population. “The majority of cases of pertussis occur in infants less than 2-3 months old, and the highest number of deaths are also seen in this age group. The situation is complicated by the fact that vaccinating infants themselves against pertussis can only start from 6 weeks of age, which is why strategies to protect them in this window of vulnerability is so important.”

Sanofi, in partnership with the National Department of Health, is urging healthcare providers throughout South Africa to encourage pregnant women to have the Tdap vaccination. Tdap vaccine Adacel is an integral component of preventive healthcare and is approved for use in individuals aged 10 through 64. This vaccine provides protection against pertussis, tetanus and diphtheria.5

Immunological response and efficacy

Adacel stimulates the immune system to produce antibodies that are specific to the toxins produced by tetanus and diphtheria bacteria, as well as the cells of the Bordetella pertussis bacteria. “This action provides a critical defensive shield against these diseases, with immunity that is significantly more robust and longer-lasting than natural immunity,” says Terblanche.

  • Adacel is indicated for immunisation during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age.5
  • The first dose of Adacel is administered at least 5 years after the last dose of DTaP or Td.5
  • Adacel is approved for a repeat vaccination as soon as 8 years after the initial Tdap dose.5
  • Adacel for tetanus-prone wound management may be administered as early as 5 years after a previous dose of a tetanus toxoid-containing vaccine.5

“Adacel can help a pregnant woman to create antibodies against the bacteria that cause pertussis, and these are passed to her baby before birth,” says Terblanche.

Impact of vaccination on global health

Today, vaccines have an excellent safety record and most “vaccine scares” have been shown to be false alarms.6 However, misguided safety concerns in some countries have led to a fall in vaccination coverage, causing the re-emergence of pertussis and measles.6

Vaccinations significantly reduce disease, disability, death, and health inequities globally:6

  • Public Health Impact: Vaccination has substantially lowered the incidence of diseases that were once prevalent and often fatal, contributing greatly to global health improvements comparable only to the provision of clean water.6
  • Economic Benefits: By reducing disease burden, vaccination cuts healthcare costs and promotes economic growth through lower morbidity and mortality rates.6
  • Global Disease Control: Successful vaccination programs have led to the eradication and control of numerous infectious diseases.6
  • Herd Immunity and Social Equity: Vaccination not only protects vaccinated individuals but also contributes to broader community health through herd immunity. This indirect protection is especially beneficial in low-income settings where direct vaccine coverage may not be comprehensive.6
  • Empowerment and Secondary Benefits: Beyond health, vaccination empowers women by enabling better family planning and increases educational and social opportunities through improved child survival rates.6
  • Reduction of Antibiotic Resistance: By preventing bacterial infections, vaccines reduce the need for antibiotics, thereby helping to slow the development of antibiotic-resistant strains.6

With Adacel, you can help make a difference in pertussis prevention. Let’s protect mothers, children and our communities and ensure everyone has the chance to lead a healthy life by getting vaccinated.

Tdap – tetanus, diphtheria, acellular pertussis

DTaP – diphtheria, tetanus, acellular pertussis

Td – tetanus, diphtheria

References

1. Carrieri V, Guthmuller S, Wübker A. Trust and COVID-19 vaccine hesitancy. Sci Rep. 2023 Jun 7;13(1):9245. doi: 10.1038/s41598-023-35974-z. PMID: 37286569; PMCID: PMC10245358.
2. Whooping Cough Cases Increase Rapidly, Officials Urge Vigilance. Health-e News. [Accessed 22 Apr 24]. Available from: https://health-e.org.za/2023/01/27/whooping-cough-cases-increase-rapidly-officials-urge-vigilance
3. Regan AK, Moore HC, Binks MJ, et al. Maternal Pertussis Vaccination, Infant Immunization, and Risk of Pertussis. Pediatrics. 2023;152(5):e2023062664.
4. Pertussis Preparedness: An update for Physicians, Accident & Emergency practitioners and Laboratorians. National Institute for Communicable Diseases. Centre for Respiratory Diseases And Meningitis. Revised December 2022. [Accessed 22 Apr 24]. Available from: https://www.nicd.ac.za/wp-content/uploads/2022/12/Pertussis-preparedness-and-alert-doc_12-Dec-2022_Final.pdf
5. Pertussis prevention starts here. Sanofi. [Accessed 22 Apr 24]. Available from: https://www.adacelvaccine.com/
6. Andre FE, Booy R, Bock HL, et al. Vaccination greatly reduces disease, disability, death and inequity worldwide. Bull World Health Organ. 2008 Feb; 86(2): 140–146. Published online 2007 Nov 27. doi: 10.2471/BLT.07.040089.

New Biomaterial Preserves Islets in Pancreas Removal Procedure

A 3D map of the islet density routes throughout the healthy human pancreas. Source: Wikimedia CC0

Northwestern University researchers have developed a new antioxidant biomaterial that someday could provide much-needed relief to people living with chronic pancreatitis. The study was published in the journal Science Advances.

Before surgeons remove the pancreas from patients with severe, painful chronic pancreatitis, they first harvest insulin-producing tissue clusters, called islets, and transplant them into the vasculature of the liver. The goal of the transplant is to preserve a patient’s ability to control their own blood-glucose levels without insulin injections.

Unfortunately, the process inadvertently destroys 50–80% of islets, and one-third of patients become diabetic after surgery. Three years post-surgery, 70% of patients require insulin injections, which are accompanied by a list of side effects, including weight gain, hypoglycaemia and fatigue.

In the new study, researchers transplanted islets from the pancreas to the omentum – the large, flat, fatty tissue that covers the intestines – instead of the liver. And, to create a healthier microenvironment for the islets, the researchers adhered the islets to the omentum with an inherently antioxidant and anti-inflammatory biomaterial, which rapidly transforms from a liquid to a gel when exposed to body temperature.

In studies with mouse and non-human primates, the gel successfully prevented oxidative stress and inflammatory reactions, significantly improving survival and preserving function of transplanted islets. It marks the first time a synthetic antioxidant gel has been used to preserve function of transplanted islets.

“Although islet transplantation has improved over the years, long-term outcomes remain poor,” said Northwestern’s Guillermo A. Ameer, who led the study. “There is clearly a need for alternative solutions. We have engineered a cutting-edge synthetic material that provides a supportive microenvironment for islet function. When tested in animals, we were successful. It kept islet function maximised and restored normal blood sugar levels. We also report a reduction in units of insulin that animals required.”

“With this new approach, we hope that patients will no longer have to choose between living with the physical pain of chronic pancreatitis or the complications of diabetes,” added Jacqueline Burke, a research assistant professor of biomedical engineering at Northwestern and the paper’s first author.

‘Compromised quality of life’

For patients living without a pancreas, side effects such as managing blood-sugar levels can be a lifelong struggle. By secreting insulin in response to glucose, islets help the body maintain glycaemic control. Without functioning islets, people must closely monitor their blood-sugar levels and frequently inject insulin.

“Living without functional islets places a great burden on patients,” Burke said. “They must learn to count carbs, dose insulin at the appropriate time and continuously monitor blood glucose. This consumes much of their time and mental energy. Even with great care, exogeneous insulin therapy is not as effective as islets for maintaining glucose control.”

“It’s a compromised quality of life,” Ameer said. “Instead of multiple insulin injections, we would love to collect and preserve as many islets as possible.”

But, unfortunately, the current standard of care for preserving islets often leads to poor outcomes. After the surgery to remove the pancreas, surgeons isolate islets from the pancreas and transplant them to the liver through portal vein infusion. This intraportal perfusion procedure has several common complications. Islets in direct contact with blood flow undergo an inflammatory response, more than half of the islets die, and transplanted islets can cause dangerous clots in the liver. For those reasons, physicians and researchers have been searching for an alternate transplantation site.

In previous clinical studies, researchers transplanted islets to the omentum instead of the liver in order to bypass issues with clotting. To secure the islets on the omentum, physicians used plasma from the patients’ own blood to form a biologic gel. While the omentum appeared to work better than the liver as a transplantation site, several issues, including clots and inflammation, remained.

“There’s been significant interest in the research and medical communities to find an alternate islet transplantation site,” Ameer said. “The results from the omentum study were encouraging, but outcomes were varied. We believe that’s because the use of the patients’ blood and the added components required to create the biologic gel can affect reproducibility among patients.”

A citrate solution

To protect the islets and improve outcomes, Ameer turned to the citrate-based biomaterials platform with inherent antioxidant properties developed in his laboratory. Used in products approved by U.S. Food and Drug Administration for musculoskeletal surgeries, citrate-based biomaterials have demonstrated the ability to control the body’s inflammatory responses. Ameer set out to investigate whether a version of these biomaterials with biodegradable and temperature-responsive phase-changing properties would provide a superior alternative to a biologic gel obtained from blood.

In cell cultures, both mouse and human islets stored within the citrate-based gel maintained viability much longer than islets in other solutions. When exposed to glucose, the islets secreted insulin, demonstrating normal functionality. Moving beyond cell cultures, Ameer’s team tested the gel in small and large animal models. Liquid at room temperature, the material turns into a gel at body temperature, so it’s simple to apply and easily stays in place.

In the animal studies, the gel effectively secured the islets onto the omentum of the animals. Compared to the current methods, more islets survived, and, over time, the animals restored normal blood glucose levels. According to Ameer, the success is partially due to the new material’s biocompatibility and antioxidant nature.

“Islets are very sensitive to oxygen,” Ameer said. “They are affected by both too little oxygen and too much oxygen. The material’s innate antioxidant properties protect the cells. Plasma from your own blood doesn’t offer the same level of protection.”

Integrating into tissues

After about three months, the body resorbed 80-90% of the biocompatible gel. But, at that point, it was no longer needed.

“What was fascinating is that the islets regenerated blood vessels,” Ameer said. “The body generated a network of new blood vessels to reconnect the islets with the body. That is a major breakthrough because the blood vessels keep the islets alive and healthy. Meanwhile, our gel is simply resorbed into the surrounding tissue, leaving little evidence behind.”

Next, Ameer aims to test his hydrogel in animal models over a longer period of time. He said the new hydrogel also could be used for various cell replacement therapies, including stem cell-derived beta cells for treating diabetes.

Source: Northwestern University

Össur South Africa Extends its Range of Non-invasive Prosthetics with Naked Prosthetics for Finger and Partial-hand Amputations

Össur South Africa has announced the availability of Naked Prosthetics to the local market. This range of custom-made prostheses, precisely tailored to the user’s amputation and individual hand structure, positively impacts those with finger and partial-hand amputations by providing functional finger prostheses of high quality.

“Partial hand limb loss is the most prevalent of upper limb loss, with over 90% of upper limb amputations involving the fingers. Finger and partial-hand amputations also accounts for a significant number of amputations each year,” says Ernst van Dyk, Managing Director, Össur South Africa.

Whilst more common amongst working age men, finger and partial-hand amputations occurs regardless of gender or age. “The lack of mobility resulting from a finger and partial-hand amputation is not limited to the area of amputation only. Many amputees experience loss of mobility beyond the area of amputation,” stresses van Dyk. No fewer than 5% experience a resultant impairment of the entire body and as many as 75% of heavy manual labourers are unable to return to work.

“With Naked Prosthetics we are dedicated to positively impacting the lives of finger and partial-hand amputees. We aim to provide them with functional, high-quality solutions that seamlessly integrate into their lives and empower them to not only resume employment but, as importantly, to engage in the activities they love, thereby assisting them to live a life without limitations,” says van Dyk.

Naked Prosthetics’ innovative solutions, the result of strong research and development (R&D) efforts and manufacturing capabilities, has been recognised by Business Insider as one of the medical technologies that are changing people’s lives[1]. It currently offers four custom-designed devices that are fabricated to within millimetres of a patient’s unique anatomy to mimic the complex motion of a finger.

  • The PIPDriver is a body-controlled prosthesis designed for a finger amputation or limb difference on the proximal or distal phalanx. Its design is anatomically adapted to the proximal and distal interphalangeal joints for intuitive and natural movements. Benefits include improved functionality for everyday activities. It is easy to clean and care for, easy to put on and take off and has a cage-like structure that protects the residual finger. Its slim and smooth design allows the prosthesis to be worn on two or more adjacent fingers. It also includes a conductive tip option for touchscreen operation.
  • The MCPDriver is a body-driven prosthesis designed for a finger amputation or limb difference on the MCP joint (also known as the knuckle) of the index, middle, ring, and/or the little finger. It restores the original finger length, thereby helping to imitate natural gripping patterns and excels at restoring pinch, key, cylindrical and power grasps as well as grip stability. Its durable stainless-steel linkages and robust components allow the user to return to a highly demanding lifestyle. Benefits include a silicone pad that cushions the backplate for improved comfort, interchangeable silicone adjustment inserts that can be used to vary the volume and adjusting discs to obtain the best possible fit. Its natural abduction and adduction allow for intuitive use. As a result, the acclimatisation time after the initial fitting can be considerably reduced. It also includes the conductive tip option for touchscreen operation.
  • The ThumbDriver is a body-controlled prosthesis designed for an amputation or limb difference on the MCP joint of the thumb. It can restore two and three-point grips, enable secure gripping patterns with medium to large diameters and improve fine motor functions and skills. It features an adjustable preflex option that allows you to adapt the prosthesis according to the requirements of the task at hand. As a result, functional gripping patterns can be more easily attained.
  • The GripLock Finger is a passive and positionable prosthetic finger designed for a finger amputation or limb difference on the MCP joint of the index, middle, ring, and/or little finger. It is intended for use in conjunction with a custom-made socket adapted by a certified prosthetist. You can flex the finger to various degrees with your other hand or on a hard surface. Subsequently, you can release and fully extend the GripLock Finger by pressing the latch (lever arm) on the back or flexing the finger beyond the last locking position. It restores the original length, supports the use of both hands, prevents a misalignment of the metacarpal bone and provides a valuable tool to master everyday activities.  GripLock Fingers can be combined with our MCPDriver, PIPDriver, and/or ThumbDriver.

Says Kai, a trained plant and machine operator who suffered the loss of his forefinger, middle and ring finger after a work-related accident. “Thanks to the precise adaptation to my individual anatomical conditions, the prosthesis is an irreplaceable everyday companion for me. When I come home at night, I take off the prosthesis in seconds – just like you kick off your shoes after a long day at work. I think it’s important to convey to other people in similar situations that a work accident like mine doesn’t have to mean the end of the world. You can come to terms with many situations and end up living a normal life.”

Similarly, Cara (an active member of the Finger and Partial Hand Amputee Peer & Support Group), lost two and a half fingers on her left hand due to an unforeseen accident. Prior to her accident, Cara was an avid yogi and enjoyed practicing inversions (yoga poses where the heart is higher from the ground than the head) and handstands. “I spent a year doing physical therapy to regain strength in my left hand, but I still felt as though I was struggling to hold and grip my mat as I practiced yoga,” she recalls. Every time she tried to balance her weight, she would fall backwards due to the lack of grip and support. Within one week of receiving her Naked Prosthetics PIPDrivers, Cara was able to hold a side plank during yoga. “You may feel hopeless in the moment, but it does get better. And you will be surprised at what you could learn. I am a different person now and I grew from the experience.”

“We are committed to helping digit amputees discover innovative and life-changing solutions. It’s all about function and getting people back to living full lives, without limitations,” continues van Dyk. “We believe our range of technologically advanced and custom-made prostheses helps to achieve exactly this and we are excited to be able to offer it to local amputees.”

To find out more, please visit: https://www.ossur.com/en-za/prosthetics/np-devices

[1] Naked Prosthetics’ Technology Recognized – The O&P EDGE Magazine (opedge.com)