MD, PhD, MAE, FMedSci, FRSB, FRCP, FRCPEd.

Cancer

1 2 3 22

This multi-center, open-label, randomized controlled trial assessed the effects of anthroposophic treatments on toxicity related to intensive-phase chemotherapy treatment in children aged 1-18 with the primary outcome of the toxicity sum score. Secondary outcomes were chemotherapy-related toxicity, overall and event-free survival after 5 years in study patients.

The main sponsorship for the study was provided by: Helixor Heilmittel GmbH & Co. KG, Rosenfeld. Additional finacial support was provided by: WALA Heilmittel GmbH, Bad Boll/Eckwälden; Weleda AG, Schwäbisch Gmünd: Mahle Stiftung, Stuttgart; Software AG Stiftung, Darmstadt; Stiftung Helixor, Rosenfeld; and Injex Pharma AG, Berlin.

The intervention and control groups were both given standard chemotherapy according to malignancy & tumor type. The intervention arm was provided with anthroposophic supportive treatment (AST); given as anthroposophic base medication (AMP), as a base medication for all patients, and additional on-demand treatment tailored to the patient in the intervention groups. The control was given no AMP. The toxicity sum score (TSS) was assessed using NCI-CTC scales.

The AST consisted of base AMP including Helixor®, and on-demand supplementary AMP  given as needed for symptoms. Administration of the AST intervention and chemotherapy protocol were tailored for each type of pediatric malignancy included in the trial. This included both the base and the on-demand AMP, which were administered based on acute symptoms during intensive chemotherapy. The intervention group started the AST between the day of randomization and day 10 of the first chemotherapy cycle.

Data of 288 patients could be analyzed. The analysis did not reveal any statistically significant differences between the AST and the control group for the primary endpoint or the toxicity measures (secondary endpoints). Furthermore, groups did not differ significantly in the five-year overall and event-free survival follow-up.

The authors concluded that their findings showed that AST was able to be safely administered in a clinical setting, although no beneficial effects of AST between group toxicity scores, overall or event-free survival were shown.

In their discussion section, the authors explain the findings more clearly: “In the long term follow up, the explorative analysis of the data available for the 5-year follow up found no indications that efficacy of chemotherapy was influenced by AST. For long-term toxicities there were also no indications of an influence of AST.”

Question: what do we call a treatment that has neither adverse nor beneficial effects?

Could it be

PLACEBO?

If you have been following my blog for a while, you probably know the answer to this question. A recent article published in JAMA re-emphasizes it in an exemplary fashion:

According to National Health and Nutrition Examination Survey data, 52% of surveyed US adults reported using at least 1 dietary supplement in the prior 30 days and 31% reported using a multivitamin-mineral supplement. The most commonly cited reason for using supplements is for overall health and wellness and to fill nutrient gaps in the diet. Cardiovascular disease and cancer are the 2 leading causes of death and combined account for approximately half of all deaths in the US annually. Inflammation and oxidative stress have been shown to have a role in both cardiovascular disease and cancer, and dietary supplements may have anti-inflammatory and antioxidative effects.

Objective  To update its 2014 recommendation, the US Preventive Services Task Force (USPSTF) commissioned a review of the evidence on the efficacy of supplementation with single nutrients, functionally related nutrient pairs, or multivitamins for reducing the risk of cardiovascular disease, cancer, and mortality in the general adult population, as well as the harms of supplementation.

Population  Community-dwelling, nonpregnant adults.

Evidence Assessment  The USPSTF concludes with moderate certainty that the harms of beta carotene supplementation outweigh the benefits for the prevention of cardiovascular disease or cancer. The USPSTF also concludes with moderate certainty that there is no net benefit of supplementation with vitamin E for the prevention of cardiovascular disease or cancer. The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of supplementation with multivitamins for the prevention of cardiovascular disease or cancer. Evidence is lacking and the balance of benefits and harms cannot be determined. The USPSTF concludes that the evidence is insufficient to determine the balance of benefits and harms of supplementation with single or paired nutrients (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. Evidence is lacking and the balance of benefits and harms cannot be determined.

Recommendation  The USPSTF recommends against the use of beta carotene or vitamin E supplements for the prevention of cardiovascular disease or cancer. (D recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of multivitamin supplements for the prevention of cardiovascular disease or cancer. (I statement) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of the use of single- or paired-nutrient supplements (other than beta carotene and vitamin E) for the prevention of cardiovascular disease or cancer. (I statement)

The report also elaborates on potential harms:

For many of the vitamins and nutrients reviewed, there was little evidence of serious harms. However, an important harm of increased lung cancer incidence was reported with the use of beta carotene by persons who smoke tobacco or have occupational exposure to asbestos.

Excessive doses of vitamin supplements can cause several known adverse effects; for example, moderate doses of vitamin A supplements may reduce bone mineral density, and high doses may be hepatotoxic or teratogenic. Vitamin D has potential harms, such as a risk of hypercalcemia and kidney stones, when given at high doses. The potential for harm from other supplements at high doses should be carefully considered.

There is nothing new here, of course. I (and others) have been trying to get these points across for many years. But it is nevertheless most gratifying to see the message repeated by a top journal such as JAMA. I hope JAMA is more successful than I was in changing the behavior of the often all too gullible public!

Almost 10 years ago, I posted this:

When I decided to become a doctor I, like most medical students, did so mainly to help suffering individuals. When I became a researcher, I felt more removed from this original ideal. Yet I told myself that, by conducting research, I might eventually contribute to a better health care of tomorrow. Helping suffering patients was still firmly on the agenda. But then I realised that my articles in peer-reviewed medical journals somehow missed an important target: in alternative medicine, one ought to speak not just to health care professionals but also to consumers and patients; after all, it is they who often make the therapeutic decisions in this area.

Once I had realised this, I started addressing the general public by writing for The Guardian and other newspapers, giving public lectures and publishing books for a lay audience, like TRICK OR TREATMENT…The more I did this sort of thing, the more I noticed how important this activity was. And when a friend offered to help me set up a blog, I did not hesitate for long.

So, the reason for my enthusiasm for this blog turns out to be the same as the one that enticed me to go into medicine in the first place. I do believe that it is helpful for consumers to know the truth about alternative medicine. Considering the thousands of sources of daily misinformation in this area, there is an urgent need for well-informed, critical information. By providing it, I am sure I can assist people to make better therapeutic decisions. In a way, I am back where I started all those years ago: hoping to help suffering patients in the most direct way my expertise allows.

Helping vulnerable patients often means warning them from dangerous charlatans, and this is precisely what I frequently try to do with this blog. But how successful are my endeavors?

More often than not, I have no idea and can only hope for the best. Sometimes I do get some feedback that is encouraging and motivates me to carry on. Rarely, however, do I witness immediate, tangible success. And this is why the recent story is so remarkable:

  • On 6 June, an Australian acquaintance from the FRIENDS OF SCIENCE IN MEDICINE sent me some material about a planned lecture in the UK by someone promoting dangerous quackery.
  • I looked into it and published a blog post about it a few hours later.
  • A reader then suggested in the comments section of this post alerting the UK press to it.
  • Another reader contacted THE TIMES, and I wrote to several other journalists.
  • THE TIMES turned out to be interested in the story.
  • They did some research and interviewed Michael Marshall from the GOOD THINKING SOCIETY (and myself).
  • Today, THE TIMES published an article about the planned event.
  • Finally, a kind person made the article available to those who don’t want to pay for it.

The whole thing amounts to superb teamwork, in my view. It shows how like-minded people who do not even all know each other can manage to achieve a respectable result with little more than goodwill and dedication.

A respectable result?

Of course, the optimal result would be to stop Barbara O’Neill’s UK lectures. Let’s hope this is what eventually will happen – and please let me know if you know more.

I was made aware of an advertisement announcing that the ‘international health lecturer’, Barbara O’Neill, is soon (19-26 June) coming to the UK.

Who is Barbara O’Neill? I hear you ask.

Here is more interesting information about her:

The NSW Health Care Complaints Commission conducted an investigation into the professional conduct of Mrs Barbara O’Neill, an unregistered practitioner who provides services as a naturopath, nutritionist and health educator.

Complaints received by the Commission alleged that Mrs O’Neill makes dubious and dangerous health claims that are not evidence based or supported by mainstream medicine, regarding: infant nutrition; causes and treatment of cancer; antibiotics; and vaccinations.  Some of the non-evidence based comments made in Mrs O’Neill’s publications include:

  • raw goat’s milk is an appropriate substitute for breast milk in infant nutrition;
  • cancer is a fungus that can be treated with bicarbonate soda and can be cured by following a program that includes the cancer conquering diet and sodium bicarbonate wraps for the body;
  • pregnant women diagnosed with Strep B do not have to take antibiotics;
  • there are no safe vaccines; vaccinations have caused an epidemic of ADHD, autism, epilepsy and cot death.

The investigation found that Mrs O’Neill has limited qualifications in the area of nutrition and dietetics, which she attained more than 10 years ago. Of particular concern to the Commission is that Mrs O’Neill is providing health advice beyond the limits of her training and experience. Mrs O’Neill considers herself qualified to provide health advice in highly complex and specialised areas such as cancer treatment, use of antibiotics for Strep B and immunisation, in circumstances where it is clear her knowledge is limited.

The investigation also found that Mrs O’Neill does not recognise that she is misleading vulnerable people (including mothers and cancer sufferers) by providing very selective information.  The misinformation has real potential to have a detrimental effect on the health of individuals because Mrs O’Neill also discourages mainstream treatment for cancer, antibiotics and vaccinations.

The investigation determined that Mrs O’Neill breached the Code of Conduct for Unregistered Health Practitioners under Schedule 3 of the Public Health Regulation 2012 in respect of:

  • Clause 3(1): a health practitioner must provide health services in a safe and ethical manner;
  • Clause 5(1): a health practitioner must not hold himself or herself out as qualified, able or willing to cure cancer or other terminal illnesses;
  • Clause 7(1): a health practitioner must not attempt to dissuade clients from seeking or continuing with treatment by a registered medical practitioner;
  • Clause 12(1): a health practitioner must not engage in any form of misrepresentation in relation to the products or services he or she provides or as to his or her qualifications, training or professional affiliations;
  • Clause 15: a health practitioner must maintain accurate, legible and contemporaneous clinical records for each client consultation.

The Commission is satisfied that Mrs O’Neill poses a risk to the health and safety of members of the public and therefore makes the following prohibition order:

  • Mrs O’Neill is permanently prohibited from providing any health services, as defined in s4 Of the Health Care Complaints Act 1993, whether in a paid or voluntary capacity.

The Commission has determined to make its Statement of Decision publicly available under section 41B(3)(c) of the Health Care Complaints Act 1993 but has removed material which it considers to be confidential information.

The full Public Statement of Decision can be read here

____________________________

Barbara has clear and concise messages:

  • Vaccinations have caused an epidemic of ADHD, autism, epilepsy and cot death.
  • Cancer is a fungus that can be treated with bicarbonate soda.

Just what we needed in the UK!?

Or maybe not.

Yes, we did get used to being lied to by our PM. We are also slowly getting used to our NHS being vandalized by our Tory government. But that does not mean that we now should opt to cure cancer with baking soda.

Perhaps it would be better to use existing legislation (e.g. the cancer act) and stop this ‘international health lecturer’ in her tracks?

 

PS

In case you wonder who might organize such an event, it is this one:

Manna House Health Education & Wellness is a community interest company that works with people to improve their health. Manna House has been using natural health principles to help the body heal itself. It was established for the purpose of educating people in the principles and laws of healthful living.

Necrotizing infection (NI) of the breast associated with underlying malignancy is a rare phenomenon characterized by necrosis of breast parenchyma. It can cause a delay in diagnosis and even lead to sepsis. Researchers from the Aga Khan University Hospital in Karachi, PAK, present a case of a 42-year-old woman with NI of the right breast, while on homeopathic treatment for a right breast lump for six months. Tissue culture showed a polymicrobial infection and histopathology established the diagnosis of breast carcinoma. After treating the NI, her breast cancer was managed as per standard guidelines.

 

The married, nulliparous, diabetic, hypertensive patient was a non-smoker and presented to the emergency room with complaints of fever, severe pain, and foul-smelling bloody discharge from her right breast for two weeks. She had a history of a right breast lump for six months, for which she had been taking oral homeopathic remedies, the names of which were not recorded. On examination, she had a blood pressure of 132/76 mmHg, a pulse of 84 bpm, a temperature of 99 °F, and a respiratory rate of 14 breaths per minute. The right breast was tender and hard, with a 4 x 3-cm necrotic skin patch on the upper half with bleeding and a palpable right axillary lymph node. The rest of the examination was unremarkable.

The patient was advised to undergo a metastatic workup in the emergency room, which included a contrast-enhanced CT (CECT) of the chest, abdomen, and pelvis and a bone scan. The CT confirmed the presence of an air-filled cavity in the right breast with thin septations and enlarged right axillary lymph nodes; however, there was no enhancing mass to suggest neoplasm in either breast. The CT and bone scans were negative for metastasis. The presence of severely tender breast on clinical examination and air within the breast on ultrasound suggested the possibility of NI, which warranted an early surgical intervention to prevent impending sepsis.

Microscopic examination of the debrided tissue revealed an invasive breast carcinoma of no special type [invasive ductal carcinoma (IDC), NST grade III] along with extensive necrosis and dense acute and chronic inflammation. The right axillary node biopsy was positive for nodal metastasis, and the patient was staged as cT4N1MO. A tissue culture showed a few colonies of Staphylococcus aureus and Enterococcus species suggestive of NI. After a discussion at a multidisciplinary tumor board meeting, the patient underwent a right modified radical mastectomy. Her postoperative course was unremarkable.

____________________

I have said it often but I am afraid I need to say it again: the homeopathic remedy might be harmless, but that does not mean that homeopathy is not dangerous.

During their cancer treatment path, cancer patients use numerous drugs,e.g.:

  • anticancer medications,
  • supportive drugs,
  • other prescribed medications,
  • herbal remedies,
  • other OTC products.

This puts them at risk of significant drug interactions (DIs).

This study describes potential DIs in cancer patients and their prevalence and predictors.

A cross-sectional study was carried out in two centers in the northern West Bank, Palestine. The Lexicomp® Drug Interactions tool (Lexi-Comp, Hudson OH, USA) was applied to check the potential DIs. In addition, the Statistical Package for the Social Sciences (SPSS) was used to show the results and find the associations.

The final analysis included 327 patients. Most of the participants were older than 50 years (61.2%), female (68.5%), and had a solid tumor (74.6%). The total number of potential DIs was 1753, including 1510 drug-drug interactions (DDIs), 24 drug-herb interactions, and 219 drug-food interactions. Importantly, the prevalence of DDIs was 88.1%. In multivariate analysis, the number of potential DDIs significantly decreased with the duration of treatment (p = 0.007), while it increased with the number of comorbidities (p < 0.001) and the number of drugs used (p < 0.001).

The authors concluded that they found a high prevalence of DIs among cancer patients. This required health care providers to develop a comprehensive protocol to monitor and evaluate DIs by improving doctor-pharmacist communication and supporting the role of clinical pharmacists.

What the investigators did not study was the possibility of herb-herb and herb-non-herbal supplement interactions. The reason for this is probably simple: we know too little about these areas to make reasonable judgments. But even in the absence of such considerations, the prevalence of DDIs among cancer patients was high (88.1%). This means that the vast majority of cancer patients had at least one potential DDI. Over half of them were classified as moderately severe or worse.

The lessons seem to be to:

  • use only truly necessary drugs and omit all remedies that are of doubtful value,
  • educate the public about the risks of interactions,
  • be skeptical about the messages of integrative medicine,
  • consult a healthcare professional who is competent to make such judgments,
  • conduct more rigorous research to increase our knowledge in this complex area.

The Lancet is a top medical journal, no doubt. But even such journals can make mistakes, even big ones, as the Wakefield story illustrates. But sometimes, the mistakes are seemingly minor and so well hidden that the casual reader is unlikely to find them. Such mistakes can nevertheless be equally pernicious, as they might propagate untruths or misunderstandings that have far-reaching consequences.

A recent Lancet paper might be an example of this phenomenon. It is entitled “Management of common clinical problems experienced by survivors of cancer“, unquestionably an important subject. Its abstract reads as follows:

_______________________

Improvements in early detection and treatment have led to a growing prevalence of survivors of cancer worldwide.
Models of care fail to address adequately the breadth of physical, psychosocial, and supportive care needs of those who survive cancer. In this Series paper, we summarise the evidence around the management of common clinical problems experienced by survivors of adult cancers and how to cover these issues in a consultation. Reviewing the patient’s history of cancer and treatments highlights potential long-term or late effects to consider, and recommended surveillance for recurrence. Physical consequences of specific treatments to identify include cardiac dysfunction, metabolic syndrome, lymphoedema, peripheral neuropathy, and osteoporosis. Immunotherapies can cause specific immune-related effects most commonly in the gastrointestinal tract, endocrine system, skin, and liver. Pain should be screened for and requires assessment of potential causes and non-pharmacological and pharmacological approaches to management. Common psychosocial issues, for which there are effective psychological therapies, include fear of recurrence, fatigue, altered sleep and cognition, and effects on sex and intimacy, finances, and employment. Review of lifestyle factors including smoking, obesity, and alcohol is necessary to reduce the risk of recurrence and second cancers. Exercise can improve quality of life and might improve cancer survival; it can also contribute to the management of fatigue, pain, metabolic syndrome, osteoporosis, and cognitive impairment. Using a supportive care screening tool, such as the Distress Thermometer, can identify specific areas of concern and help prioritise areas to cover in a consultation.

_____________________________

You can see nothing wrong? Me neither! We need to dig deeper into the paper to find what concerns me.

In the actual article, the authors state that “there is good evidence of benefit for … acupuncture …”[1]; the same message was conveyed in one of the tables. In support of these categorical statements, the authors quote the current Cochrane review entitled “Acupuncture for cancer pain in adults”. Its abstract reads as follows:

Background: Forty per cent of individuals with early or intermediate stage cancer and 90% with advanced cancer have moderate to severe pain and up to 70% of patients with cancer pain do not receive adequate pain relief. It has been claimed that acupuncture has a role in management of cancer pain and guidelines exist for treatment of cancer pain with acupuncture. This is an updated version of a Cochrane Review published in Issue 1, 2011, on acupuncture for cancer pain in adults.

Objectives: To evaluate efficacy of acupuncture for relief of cancer-related pain in adults.

Search methods: For this update CENTRAL, MEDLINE, EMBASE, PsycINFO, AMED, and SPORTDiscus were searched up to July 2015 including non-English language papers.

Selection criteria: Randomised controlled trials (RCTs) that evaluated any type of invasive acupuncture for pain directly related to cancer in adults aged 18 years or over.

Data collection and analysis: We planned to pool data to provide an overall measure of effect and to calculate the number needed to treat to benefit, but this was not possible due to heterogeneity. Two review authors (CP, OT) independently extracted data adding it to data extraction sheets. Data sheets were compared and discussed with a third review author (MJ) who acted as arbiter. Data analysis was conducted by CP, OT and MJ.

Main results: We included five RCTs (285 participants). Three studies were included in the original review and two more in the update. The authors of the included studies reported benefits of acupuncture in managing pancreatic cancer pain; no difference between real and sham electroacupuncture for pain associated with ovarian cancer; benefits of acupuncture over conventional medication for late stage unspecified cancer; benefits for auricular (ear) acupuncture over placebo for chronic neuropathic pain related to cancer; and no differences between conventional analgesia and acupuncture within the first 10 days of treatment for stomach carcinoma. All studies had a high risk of bias from inadequate sample size and a low risk of bias associated with random sequence generation. Only three studies had low risk of bias associated with incomplete outcome data, while two studies had low risk of bias associated with allocation concealment and one study had low risk of bias associated with inadequate blinding. The heterogeneity of methodologies, cancer populations and techniques used in the included studies precluded pooling of data and therefore meta-analysis was not carried out. A subgroup analysis on acupuncture for cancer-induced bone pain was not conducted because none of the studies made any reference to bone pain. Studies either reported that there were no adverse events as a result of treatment, or did not report adverse events at all.

Authors’ conclusions: There is insufficient evidence to judge whether acupuncture is effective in treating cancer pain in adults.

This conclusion is undoubtedly in stark contrast to the categorical statement of the Lancet authors: “there is good evidence of benefit for … acupuncture …

What should be done to prevent people from getting misled in this way?

  1. The Lancet should correct the error. It might be tempting to do this by simply exchanging the term ‘good’ with ‘some’. However, this would still be misleading, as there is some evidence for almost any type of bogus therapy.
  2. Authors, reviewers, and editors should do their job properly and check the original sources of their quotes.

 

PS

In case someone argued that the Cochrane review is just one of many, here is the conclusion of an overview of 15 systematic reviews on the subject: The … findings emphasized that acupuncture and related therapies alone did not have clinically significant effects at cancer-related pain reduction as compared with analgesic administration alone.

 

Barrie R. Cassileth died on Feb. 26 at an assisted-living home in Beverly Hills, California. I knew about Barrie because she was the 1st author of a most remarkable study published in 1991 in the prestigious NEJM. Here is the abstract:

Background: Cancer treatments without proved efficacy have achieved new levels of popularity, particularly among well-educated patients. The value of these therapies is vigorously debated.

Methods: We compared the length of survival and quality of life in patients who received treatment at a prominent unorthodox cancer clinic in addition to conventional treatment and in matched control patients from an academic cancer center who received only conventional treatment. All the patients had documented extensive malignant disease associated with a predicted median survival time of less than one year. The study sample consisted of 78 pairs of patients matched according to sex, race, age, diagnosis, and time from the diagnosis of metastatic or recurrent disease, who were enrolled over a period of 3 1/2 years. Periodic follow-up (approximately every two months) continued until death.

Results: There was no difference between the two patient groups in length of survival. Median survival for both groups was 15 months (P = 0.22; relative risk, 1.23; 95 percent confidence interval, 0.88 to 1.72). Quality-of-life scores were consistently better among conventionally treated patients from enrollment on.

Conclusions: For this sample of patients with extensive disease and for this particular unorthodox treatment regimen, conventional and unorthodox treatments produced similar results.

In 1995, I met her for the first time when we both served on an NIH panel, and we kept in contact. When I had flown to Boston for a conference she even drove from New York to see me and have a chat. In 1998, she asked me to come to New York because she needed to discuss something important with me and wanted my advice. It turned out that she had been offered to create the Integrative Medicine Service at Memorial Sloan Kettering Cancer Center in New York sponsored by Laurance Rockefeller. She was very much in two minds about accepting. Her fear was that she would have to become an advocate of alternative medicine. I tried to reassure her and pointed out that I did not exactly turn into an advocate after accepting the Exeter post.

In the end, she accepted and, in the years that followed, we met several times at conferences, became friends, and published a few papers together. I even persuaded her to come to one of our annual conferences at Exeter as a keynote speaker. By then, she had clearly become an advocate of complementary medicine.

What had happened?

Barrie was very keen to differentiate alternative from complementary therapies in cancer care. The former she sharply condemned, while advocating the latter for improving the quality of life of cancer patients. When we discussed these issues, I argued that the ‘alternative versus complementary’ was a somewhat artificial division and that the overlap was large. I also pointed out that some of the complementary treatments she was backing were not based on good evidence. In other words, our views had begun to differ. We remained friends but gradually drifted apart and eventually lost contact.

Barrie Joyce Rabinowitz was born on April 22, 1938, in Philadelphia. She attended Bennington College in Vermont and spent a summer teaching art in Pownal, Massachusetts. She graduated with a degree in social sciences in 1959, a year after marrying Peter Cassileth. Barrie received a master’s degree in psychology from Albert Einstein University and a Ph.D. in medical sociology in 1978 from the University of Pennsylvania, where Peter Cassileth was an oncologist. As part of her doctoral program, Barrie worked closely with adult leukemia patients. After being hired at Pennsylvania as an assistant professor, she helped establish one of the first palliative cancer care programs in the US. Before accepting the post at Slone-Kettering, she taught at Duke, Harvard, and the University of North Carolina. In 2003, she became the founding president of the Society for Integrative Oncology.

While at Slone-Kettering, Barrie published several excellent books and high-quality studies of complementary medicine. She kept on working well after the normal retirement age. Her last RCT was only published in 2018. Here is the abstract:

Purpose: Approximately 20% of breast cancer survivors develop breast cancer-related lymphedema (BCRL), and current therapies are limited. We compared acupuncture (AC) to usual care wait-list control (WL) for treatment of persistent BCRL.

Methods: Women with moderate BCRL lasting greater than six months were randomized to AC or WL. AC included twice weekly manual acupuncture over six weeks. We evaluated the difference in circumference and bioimpedance between affected and unaffected arms. Responders were defined as having a decrease in arm circumference difference greater than 30% from baseline. We used analysis of covariance for circumference and bioimpedance measurements and Fisher’s exact to determine the proportion of responders.

Results: Among 82 patients, 73 (89%) were evaluable for the primary endpoint (36 in AC, 37 in WL). 79 (96%) patients received lymphedema treatment before enrolling in our study; 67 (82%) underwent ongoing treatment during the trial. We found no significant difference between groups for arm circumference difference (0.38 cm greater reduction in AC vs. WL, 95% CI – 0.12 to 0.89, p = 0.14) or bioimpedance difference (1.06 greater reduction in AC vs. WL, 95% CI – 5.72 to 7.85, p = 0.8). There was also no difference in the proportion of responders: 17% AC versus 11% WL (6% difference, 95% CI – 10 to 22%, p = 0.5). No severe adverse events were reported.

Conclusions: Our acupuncture protocol appeared to be safe and well tolerated. However, it did not significantly reduce BCRL in pretreated patients receiving concurrent lymphedema treatment. This regimen does not improve upon conventional lymphedema treatment for breast cancer survivors with persistent BCRL.

Her contribution to our knowledge about complementary therapies is outstanding, and I am sure that her papers will be cited for decades to come. She will be missed and remembered as an innovator in the field of palliative cancer care.

Barrie had been married three times. Her third husband, Richard Cooper, who was the Director of the Center for the Future of the Healthcare Workforce and a Senior Fellow in the Leonard Davis Institute of Health Economics at the University of Pennsylvania, died in 2016. Barrie is survived by her siblings, Stephen and Ruth Rabinowitz; her daughters, Jodi Cassileth Greenspan and Wendy Cassileth; her son, Gregory Cassileth; and 6 grandchildren.

Yes, Today is ‘WORLD SLEEP DAY‘ and you are probably in bed hoping this post will put you back to sleep.

I’ll do my best!

This study aimed to synthesise the best available evidence on the safety and efficacy of using moxibustion and/or acupuncture to manage cancer-related insomnia (CRI).

The PRISMA framework guided the review. Nine databases were searched from its inception to July 2020, published in English or Chinese. Randomised clinical trials (RCTs) of moxibustion and or acupuncture for the treatment of CRI were selected for inclusion. The methodological quality was assessed using the method suggested by the Cochrane collaboration. The Cochrane Review Manager was used to conduct a meta-analysis.

Fourteen RCTs met the eligibility criteria; 7 came from China. Twelve RCTs used the Pittsburgh Sleep Quality Index (PSQI) score as continuous data and a meta-analysis showed positive effects of moxibustion and or acupuncture (n = 997, mean difference (MD) = -1.84, 95% confidence interval (CI) = -2.75 to -0.94, p < 0.01). Five RCTs using continuous data and a meta-analysis in these studies also showed significant difference between two groups (n = 358, risk ratio (RR) = 0.45, 95% CI = 0.26-0.80, I 2 = 39%).

The authors concluded that the meta-analyses demonstrated that moxibustion and or acupuncture showed a positive effect in managing CRI. Such modalities could be considered an add-on option in the current CRI management regimen.

Even at the risk of endangering your sleep, I disagree with this conclusion. Here are some of my reasons:

  • Chinese acupuncture trials invariably are positive which means they are as reliable as a 4£ note.
  • Most trials were of poor methodological quality.
  • Only one made an attempt to control for placebo effects.
  • Many followed the A+B versus B design which invariably produces (false-) positive results.
  • Only 4 out of 14 studies mentioned adverse events which means that 10 violated research ethics.

Sorry to have disturbed your sleep!

Dr Akbar Khan, MD, represents a novel and exciting avenue through which, in this case, a conventionally- trained family physician has come to embrace a broad array of integrative techniques; he witnessed first hand the immense magnitude of safety and efficacy of the practice … Dr Khan describes with frustration the lack of interest displayed by conventional practitioners for safe and effective solutions simply because they come from the realm of natural medicine. “My greatest concern is helping patients.”

From left to right: Douglas Andrews, Akbar Khan, Silvana Marra and Humaira Khan

From left to right: Douglas Andrews, Akbar Khan, Silvana Marra and Humaira Khan

From left to right: Douglas Andrews, Akbar Khan, Silvana Marra and Humaira Khan[/caption]

An article in the ‘Toronto Sun’, however, tells a very different story. The doctor was found ‘incompetent’ in the treatment of cancer patients. Akbar Khan told one patient she had leukemia when she did not. He told others they were improving under his alternative remedies while their cancer was actually advancing. One of them was a little boy dying of a brain tumor.

Now the Toronto family doctor has been found guilty by the Ontario Physicians and Surgeons Discipline Tribunal of

  • incompetence,
  • failure to maintain the standard of practice,
  • and conduct that’s disgraceful, dishonorable or unprofessional

in his care of a total of 12 patients between 2012 and 2017. “Whether it was ‘snake oil,’ ‘witches’ brew’ or otherwise, whatever it was that Dr. Khan was offering his patients, it was not what he claimed,” concluded the tribunal in its decision.  “In doing so, Dr. Khan set aside his obligations as a physician to uphold the College’s CAM and consent policies, and in doing so, he failed his patients.”

Khan is the founder of the Medicor Cancer Centres, which offer “unique non-toxic approaches to cancer treatment.” He treated terminally-ill patients with the unproven treatments that he called “SAFE Chemotherapy” billed as “lifesaving” and more effective than conventional chemo.

There was insufficient science and evidence to support the conclusion that “SAFE chemotherapy” works, or that it can help people in the way that Dr. Khan claims it can, and he should not have used it,” the tribunal found. Yet, Khan never told his patients it wasn’t working. According to the college’s summary: “Therapy stopped only when his patients either could not afford it any longer, their condition had deteriorated to such a degree that they could not tolerate it, they were so ill that they were admitted to hospital, or they died.”

According to the tribunal, Khan’s patients paid (US)$4,200  for one cycle of “SAFE chemotherapy”, and they received between five to 24 cycles of it. One of the most heartbreaking cases involved Khan’s treatment of a six-year-old boy with brain cancer. In 2017, his parents rejected treating him with lifesaving chemo and radiation and transferred his care to Khan, who prescribed Dichloroacetate (DCA)  — which is a medication usually used for metabolic disorders, and not a proven cancer treatment. When a follow-up MRI showed their son’s tumor had grown and progressed to his spine, Khan told them it must be wrong and “his current therapy is actually working very well!” The boy died in 2018.

In another disturbing case, Khan used an “unapproved” test to diagnose a 59-year-old woman with acute leukemia — and informed her by email. He treated the devastated woman with honokol, a biological extract from magnolia bark, and Low Dose Naltrexone (LDN) — both of which are “not informed by evidence and science,” and “not the appropriate treatment for this patient’s presumed cancer.” Khan referred her to an oncologist who performed a bone marrow biopsy and then gave her the good news: “You do not have cancer. You’ve never had cancer. Go home and enjoy your life.” Yet, Khan insisted the oncologist was wrong. “We were frankly shocked that instead of reassuring Ms. B that her ordeal of worrying that she had leukemia could come to a close, Dr. Khan insisted to Ms. B that indeed, she did still have leukemia and urged her to keep taking LDN ‘to keep this under control,’” the tribunal wrote. “In short, Dr. Khan gave Ms. B a diagnosis that she did not have, for which he sold her a remedy that she did not need, which — as per evidence and science — turned out to be no remedy at all.”Khan’s response to the newspaper: “Since the legal process is still ongoing with the CPSO, I know my lawyer Marie Henein would not like me to comment at this time. Perhaps in the near future, I will be able to share with you another side to the story. If so, I will contact you.”

A penalty hearing has yet to be scheduled.

In case you are interested, here is a short CV of Dr. Khan:

2019 FAAO – Fellow of the American Academy of Ozone Therapy
2018 Certified medical ozone therapy doctor (general ozone therapy, basic ProlozoneTM therapy and advanced ProlozoneTM therapy), certified by the American Academy of Ozone Therapy
2018 IMD, Integrative Medical Doctor (Board of Integrative Medicine)
DHS, Doctor of Humanitarian Service (Board of Integrative Medicine)
1994 CCFP, Certificant of the College of Family Physicians of Canada (University of Toronto).
1992 MD, Doctor of Medicine (University of Toronto).
1 2 3 22
Recent Comments

Note that comments can be edited for up to five minutes after they are first submitted but you must tick the box: “Save my name, email, and website in this browser for the next time I comment.”

The most recent comments from all posts can be seen here.

Archives
Categories