quality of life
The aim of this RCT was to examine symptom responses resulting from a home-based reflexology intervention delivered by a friend/family caregiver to women with advanced breast cancer undergoing chemotherapy, targeted, and/or hormonal therapy.
Patient-caregiver dyads (N = 256) were randomized to 4 weekly reflexology sessions or attention control. Caregivers in the intervention group were trained by a reflexology practitioner in a 30-min protocol. During the 4 weeks, both groups completed telephone symptom assessments using the M. D. Anderson Symptom Inventory. Those who completed at least one weekly call were included in this secondary analysis (N = 209). Each symptom was categorized as mild, moderate, or severe using established interference-based cut-points. Symptom response meant an improvement by at least one category or remaining mild. Symptom responses were treated as multiple events within patients and analysed using generalized estimating equations technique.
Reflexology was more successful than attention control in producing responses for pain with no significant differences for other symptoms. In the reflexology group, greater probability of response across all symptoms was associated with lower number of comorbid condition and lower depressive symptomatology at baseline. Compared to odds of responses on pain (chosen as a referent symptom), greater odds of symptom response were found for disturbed sleep and difficulty remembering with older aged participants.
Adjusted odds ratios (ORs) of symptom responses for reflexology arm versus control (adjusted for age, number of comorbid conditions, depressive symptoms at baseline, and treatment type: chemotherapy with or without hormonal therapy versus hormonal therapy alone)
Symptom OR (95% CI) p value
Fatigue 1.76 (0.99, 3.12) 0.06
Pain 1.84 (1.05, 3.23) 0.03
Disturbed sleep 1.45 (0.76, 2.77) 0.26
Shortness of breath 0.58 (0.26, 1.30) 0.19
Remembering 0.96 (0.51, 1.78) 0.89
Lack of appetite 1.05 (0.45, 2.49) 0.91
Dry mouth 1.84 (0.86, 3.94) 0.12
Numbness and tingling 1.40 (0.75, 2.64) 0.29
Depression 1.38 (0.78, 2.43) 0.27
The authors concluded that home-based caregiver-delivered reflexology was helpful in decreasing patient-reported pain. Age, comorbid conditions, and depression are potentially important tailoring factors for future research and can be used to identify patients who may benefit from reflexology.
This is certainly one of the more rigorous studies of reflexology. It is well designed and reported. How valid are its findings? To a large degree, this seems to depend on the somewhat unusual statistical approach the investigators employed:
Baseline characteristics were summarized by study group for outcome values and potential covariates. The unit of analysis was patient symptom; multiple symptoms were treated as nested within the patient being analyzed, using methodology described by Given et al. [24] and Sikorskii et al. [17]. Patient symptom responses were treated as multiple events, and associations among responses to multiple symptoms within patients were accounted for by specifying the exchangeable correlation structure in the generalized estimating equations (GEE) model. The GEE model was fitted using the GENMOD procedure in SAS 9.4 [25]. A dummy symptom variable with 9 levels was included in the interaction with the trial arm to differentiate potentially different effects of reflexology on different symptoms. Patient-level covariates included age, number of comorbid conditions, type of treatment (chemotherapy or targeted therapy with or without
hormonal therapy versus hormonal therapy only), and the CES-D score at baseline. Odds ratios (ORs) and their 95% confidence intervals (CIs) were obtained for the essential parameter of study group for each symptom.
Another concern is the fact that the study crucially depended on the reliability of the 256 carers. It is conceivable, even likely, I think, that many carers from both groups were less than strict in adhering to the prescribed protocol. This might have distorted the results in either direction.
Finally, the study was unable to control for the possibly substantial placebo response that a reflexology massage unquestionably provokes. Therefore, we are not able to tell whether the observed effect is due to the agreeable, non-specific effects of touch and foot massages, or to the postulated specific effects of reflexology.
This ‘Manifesto of the European Committee for Homeopathy (ECH) and the European Federation of Homeopathic Patients Associations (EFHPA)‘ has just been published. It is worth considering in more detail, I think. So, I will first reproduce the document in its entirety and subsequently provide some critical assessment of it.
Homeopathy: a solution for major healthcare problems in the EU
- Helps to reduce the need of antibiotics in human and veterinary health care, thus reducing the problem of antimicrobial resistance [i],[ii]
- Increases quality of life and reduces severity of complaints in patients with chronic disease, when integrated in health care [iii],[iv],[v],[vi],[vii],[viii]
- Can reduce the use of long-term conventional prescription drugs, when integrated in health care [ix]
Homeopathy: safe and cost-effective with a high patient satisfaction
- Can lead to lower health care costs, when integrated in health care, [x],[xi],[xii],
- Is safe, with high patient satisfaction [xiii],[xiv],[xv],[xvi]
- Patients using homeopathy have better outcomes than users of conventional treatment, with similar costs [xvii]
- Quality, safety and correct labelling of homeopathic products is guaranteed by Directive 2001/83 EC
EU consumers expect and demand homeopathy as part of their health care
- Reported as the most used medical complementary medicine in Europe [xviii]
- Three out of four European citizens know about homeopathy and out of them 29% use it for their day-to day health care [xix]
Scientific evidence of the highest calibre confirms the clinical efficacy of homeopathic medicine
- Clinical effects of homeopathic medicines have been confirmed by systematic reviews and meta- analyses [xx],[xxi],[xxii],[xxiii],[xxiv],[xxv],[xxvi]
There is convincing evidence for biological efficacy of homeopathic medicine
- Irrefutable scientific evidence has been published on the positive effects of homeopathic products in laboratory settings [xxvii],[xxviii]
References
[i] Grimaldi-Bensouda L, Bégaud B, Rossignol M, et al. Management of upper respiratory tract infections by different medical practices, including homeopathy, and consumption of antibiotics in primary care: the EPI3 cohort study in France 2007-2008. PLoS One. 2014 Mar 19;9(3):e89990
[ii] Camerlink I, Ellinger L, Bakker EJ, Lantinga EA. Homeopathy as replacement to antibiotics in the case of Escherichia coli diarrhoea in neonatal piglets. Homeopathy. 2010 Jan;99(1):57-62
[iii] Witt CM, Lüdtke R, Baur R, Willich SN. Homeopathic medical practice: long-term results of a cohort study with 3981 patients. BMC Public Health 2005; 5:115
[iv] Spence DS, Thompson EA, Barron SJ. Homeopathic treatment for chronic disease: a 6-year, university-hospital outpatient observational study. J Altern Complement Med 2005; 11:793–798
[v] Mathie RT, Robinson TW. Outcomes from homeopathic prescribing in medical practice: a prospective, research-targeted, pilot study. Homeopathy 2006; 95:199–205
[vi] Thompson EA, Mathie RT, Baitson ES, et al. Towards standard setting for patient-reported outcomes in the NHS homeopathic hospitals. Homeopathy 2008; 97:114–121
[vii] Witt CM, Lüdtke R, Mengler N, Willich SN. How healthy are chronically ill patients after eight years of homeopathic treatment?–Results from a long term observational study BMC Public Health 2008;8:413
[viii] Rossi E, Endrizzi C, Panozzo MA, Bianchi A, Da Frè M. Homeopathy in the public health system: a seven-year observational study at Lucca Hospital (Italy). Homeopathy 2009; 98:142–148
[ix] Grimaldi-Bensouda L, Abenhaim L, Massol J, et al. EPI3-LA-SER group. Homeopathic medical practice for anxiety and depression in primary care: the EPI3 cohort study. BMC Complement Altern Med. 2016 May 4; 16:125
[x] Kooreman P, Baars EW. Patients whose GP knows complementary medicine tend to have lower costs and live longer. Eur J Health Econ. 2012 Dec;13(6):769-76
[xi] Baars EW, Kooreman P. A 6-year comparative economic evaluation of healthcare costs and mortality rates of Dutch patients from conventional and CAM GPs. BMJ Open. 2014 Aug 27;4(8):e005332
[xii] Colas A, Danno K, Tabar C, Ehreth J, Duru G. Economic impact of homeopathic practice in general medicine in France. Health Econ Rev. 2015;5(1):55
[xiii] Van Wassenhoven M, Galen Y. An observational study of patients receiving homeopathic treatment. Homeopathy 2004 Jan;93(1):3-11
[xiv] Marian F, Joost K, Saini KD, von Ammon K, Thurneysen A, Busato A. Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine. BMC Complement Altern Med. 2008 Sep 18; 8:52
[xv] Witt C, Keil T, Selim D, et al. Outcome and costs of homoeopathic and conventional treatment strategies: a comparative cohort study in patients with chronic disorders. Complement Ther Med. 2005;13(2):79-86
[xvi] Marian F, Joost K, Saini KD, von Ammon K, Thurneysen A, Busato A. Patient satisfaction and side effects in primary care: An observational study comparing homeopathy and conventional medicine. BMC Complement Altern Med. 2008 Sep 18; 8:52
[xvii] Bornhöft G, Wolf U, von Ammon K, Righetti M, Maxion-Bergemann S, Baumgartner S, Thurneysen AE, Matthiessen PF. Effectiveness, safety and cost-effectiveness of homeopathy in general practice – summarized health technology assessment.Forsch Komplementmed. 2006;13 Suppl 2:19-29. Epub 2006 Jun 26. Review
[xviii] Eardley S, Bishop FL, Prescott P, Cardini F, Brinkhaus B, Santos K Ͳ Rey, Vas J, von Ammon K, Hegyi G, Dragan S, Uehleke B, Fønnebø V, Lewith G. CAM use in Europe. The patients’ perspective.Part I: A systematic literature review of CAM prevalence in the EU. 2012. Online retrieved 19-11-2019. https://cam-europe.eu/wp-content/uploads/2018/09/CAMbrella-WP4-part_1final.pdf
[xix] Report of the European Commission, 1997. Online retrieved 15-12-2019 via https://www.hri-research.org/resources/essentialevidence/use-of-homeopathy-across-the-world/
[xx] Linde K, Clausius N, Ramirez G, Melchart D, Eitel F, Hedges LV, Jonas WB. Are the clinical effects of homeopathy placebo effects? A meta-analysis of placebo-controlled trials. Lancet. 1997 Sep 20;350(9081):834-4.
[xxi] Cucherat M, Haugh MC, Gooch M, Boissel JP.Evidence of clinical efficacy of homeopathy. A meta-analysis of clinical trials. HMRAG. Homeopathic Medicines Research Advisory Group. Eur J Clin Pharmacol. 2000 Apr;56(1):27-33
[xxii] Hahn RG. Homeopathy: meta-analyses of pooled clinical data. Forsch Komplementmed. 2013;20(5):376-81
[xxiii] Mathie RT, Van Wassenhoven M, Jacobs J et al. Model validity and risk of bias in randomised placebo-controlled trials of individualised homeopathic treatment. Complement Ther Med. 2016 Apr; 25:120-5
[xxiv] Mathie RT, Lloyd, SM, Legg, LA, Clausen J, Moss S, Davidson JR, Ford: Randomised placebo-controlled trials of individualised homeopathic treatment: systematic review and meta-analysis. Syst Rev 2014 Dec 6; 3:142
[xxv] Mathie RT, Clausen J. Veterinary homeopathy: systematic review of medical conditions studied by randomised placebo-controlled trials. Vet Rec. 2014 Oct 18;175(15):373-81.
[xxvi] Mathie RT, Clausen J. Veterinary homeopathy: meta-analysis of randomised placebo-controlled trials. Homeopathy. 2015 Jan;104(1):3-8.
[xxvii] Tournier A, Klein SD, Würtenberger S, Wolf U, Baumgartner S. Physicochemical Investigations of Homeopathic Preparations: A Systematic Review and Bibliometric Analysis-Part 2. J Altern Complement Med. 2019 Jul 10
[xxviii] Witt CM, Bluth M, Albrecht H, Weisshuhn TE, Baumgartner S, Willich SN. The in vitro evidence for an effect of high homeopathic potencies–a systematic review of the literature. Complement. Ther Med. 2007 Jun;15(2):128-38
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Did I state above that the manifesto is worth considering in more detail? I need to retract or modify this statement.
Here are the considerations that are relevant, in my view:
- The statements in the manifesto are based on wishful thinking and do not reflect the reality based on the best evidence available today.
- The manifesto is the result of a mixture of cherry-picking and/or misinterpreting the evidence.
- Most of the cited studies have been discussed on this blog in previous posts which disclose their flaws and/or erroneous conclusions.
So, instead of discussing all the tedious details yet again, I will present here a corrected version of the manifesto:
Homeopathy: no solution for major healthcare problems in the EU
- Does not help to reduce the need of antibiotics in human and veterinary health care, thus reducing the problem of antimicrobial resistance
- does not increases quality of life and reduces severity of complaints in patients with chronic disease, when integrated in health care
- Cannot reduce the use of long-term conventional prescription drugs, when integrated in health care
Homeopathy: neither safe nor cost-effective with a high patient satisfaction
- Cannot lead to lower health care costs, when integrated in health care
- Is unsafe
- Patients using homeopathy have no better outcomes than users of conventional treatment, but cause higher costs
- Quality and correct labelling of homeopathic products is guaranteed by Directive 2001/83 EC
Some EU consumers expect and demand homeopathy as part of their health care
- Reported as a much-used complementary medicine in Europe
- Three out of four European citizens know about homeopathy and out of them many use it for their day-to day health care
Scientific evidence of the highest calibre fails to confirm the clinical efficacy of homeopathic medicine
- Clinical effects of homeopathic medicines have been confirmed by systematic reviews and meta- analyses to be no better than placebo
There is no convincing evidence for biological efficacy of homeopathic medicine
- No irrefutable scientific evidence has been published on the positive effects of homeopathic products in laboratory settings
In the Republic of Ireland, chiropractors are not regulated and there is no legislation governing the profession. That means anyone who feels like it can call him/herself a chiropractor and start treating or advising patients regardless of what condition they may be suffering from. The ‘CHIROPRACTIC ASSOCIATION OF IRELAND‘ (CAI) is the professional organisation that represents chiropractors in the country. The purpose of the CAI is to maintain professional standards, liaise with various government and health bodies, and to be a professional voice for Chiropractic.
Recently, the CAI has warned that a proposed law banning practitioners of so-called alternative medicine (SCAM) from claiming they can treat cancer without any medical evidence could have “unintended and unforeseen” consequences for its members. The CAI wrote to health minister Simon Harris claiming that a lack of “clarity” in the bill could have serious implications for chiropractic patients and chiropractors.
I am inclined to agree: the bill would reduce the cash-flow of many charlatans trying to make a fast buck on the desperation of cancer patients. But most probably, Tony Accardi, the president of the CAI, did not have this in mind when he said that, if patients with cancer inform a medical practitioner they are seeing a chiropractor, it may be construed that the chiropractor is “attempting to treat the cancer even though [it] may be for neck/back pain or overall wellbeing”.
As the evidence is hardly convincing that chiropractic is effective for neck/back pain or wellbeing (see numerous previous posts on this blog), we might well ask what else chiropractors have to offer for cancer patients. This website, for instance, is one of many that makes concrete claims:
Chiropractic treatment can benefit cancer patients in many ways. It can reduce stress, increase mobility, and optimize function, and generally improve quality of life.
By easing headaches and nausea, and relieving muscle tightness and neuropathy pain, chiropractic can help patients follow through with their treatment plans, which may even help extend their lives.
Chiropractors treating cancer patients approach patient care in much the same way as other primary care providers by:
- Gathering a comprehensive health history
- Conducting a thorough physical exam
- Ordering necessary diagnostic tests
- Deciding on an appropriate treatment plan
The chiropractic course of treatment often includes spinal manipulation and adjustments that provide patients with pain relief as well as overall improvement in function.
Chiropractic care can also be a viable alternative to pain medication for cancer patients. Although the use of medication is common in the management of a patient’s pain, it’s estimated that at least half of all cancer patients do not receive tolerable relief from their pain. Chiropractic care can address this issue, potentially even decreasing a cancer patient’s dependence on pain medication.
Cancer treatment has historically been focused on treating the disease itself. While doctors of chiropractic don’t treat cancer directly, they function very effectively as part of an integrated care plan to help the patient obtain the best treatment results possible.
The CHIROPRACTIC CANCER FOUNDATION FOR CHILDREN go even further:
Dr. Garvey has a strong belief in the human body’s innate ability to combat cancer cells and other diseases. He has first-hand experience with cancer since Dr. Garvey, himself, was diagnosed with Leukemia at the age of eleven. Stress and poor circulation can undermine the body’s natural healing powers and interfere with the central nervous systems’s ability to communicate effectively. At the foundation, we believe that chiropractic adjustments and other natural healing techniques can mitigate or reverse stresses that lead to poor health and even life threatening diseases such as cancer.
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The claims can thus be summarised as follows:
- reduce the stress suffered by cancer patients,
- increase their mobility,
- optimize their function,
- improve their quality of life,
- alleviate cancer pain,
- serve as an alternative to pain medication,
- decrease cancer patients’ dependence on pain medication,
- the ‘innate’ (vital force which, according to DD Palmer is stimulated by chiropractic adjustments of spinal subluxations) can combat cancer.
Considering the above-mentioned dispute, it is only fair to ask: where is the evidence that chiropractic achieves the above (or indeed anything else)? I have to admit, I don’t find any sound evidence for any of these claims. But, of course, I might be biased or blind.
So, if anybody knows of compelling evidence to support the above claims, it would be helpful to let me have it. Meanwhile, it might be an excellent idea for the Irish government to go ahead with their plan of banning practitioners of so-called alternative medicine (SCAM) from claiming they can treat cancer without any medical evidence, don’t you think?
Neurolinguistic programming (NLP) was developed in the mid-seventies. It is a so-called alternative therapy (SCAM) that is not easy to define. Those who started it and those involved in it use such vague language that NLP means different things to different people. One metaphor keeps recurring: NLP claims to help people change by teaching them to program their brains. We were given brains, we are told, without an instruction manual, and NLP offers a user-manual for the brain. Consciously or unconsciously, NLP is based on the assumptions that:
- the unconscious mind constantly influences our conscious thoughts and actions;
- Freud’s theories are correct;
- hypnotherapy is effective.
Wikipedia is more outspoken about it: Neuro-linguistic programming (NLP) is a pseudoscientific approach to communication, personal development, and psychotherapy…
Despite the fact that NLP is unproven (to say the least), the COLLEGE OF MEDICINE AND INTEGRATED HEALTH (COMAIH) is sufficiently impressed by NLP to offer a course for GPs and SCAM practitioners. Here is their announcement:
Neurolinguistic Healthcare in association with the College of Medicine brings you a 2-day Introduction to Hypnosis, Neurolinguistic Programming (NLP) and Neurolinguistic Healthcare (NLH). Dr Wong and Dr Akhtar who lead the course are Trainers in NLP and Hypnosis and GPs who apply their skills in daily practice within the 10-minute consultation. The course is suitable for both medical professionals and complementary therapists. This is a limited training event offered by them to share their years of knowledge and skills with you.
You will learn:
-
- A basic overview of NLP and the most useful aspects to use it to begin making effective changes in how you and the people you treat think and behave
- An understanding of the NLH model of the mind so that you understand the concepts of therapy using this mixed hypnosis/ NLP approach in relation to health.
- The ability to Hypnotise effectively in a very short period of time with practical experience – the ability to go through all the stages of hypnosis – the induction, deepening, therapy, and emergence, including rapid hypnosis techniques. (Hypnosis courses which are less practical often charge in excess of £2000 for this)
- Learn at least 3 therapeutic techniques, including the NLP therapeutic techniques which work much better in trance, so using and applying the skills you will learn in hypnosis
- Access to an online mentorship programme with Dr Akhtar or Dr Wong for 6 months and who will provide 3x30mins group webinar meetings after the course to ensure any remaining questions get answered and that you are actually going forth to apply these skills. (worth another £600 in value)
- Access to an online learning membership site with educational videos and other content like pain relief techniques, papers with therapeutic scripts, etc
This is an opportunity to learn a different way of helping people from doctors who target the 10-minute consultation with fast, effective formal hypnosis techniques and sleight-of-mouth. It is possible to make change happen in 10-minutes.
Note that attending this course will not make you a certified hypnotherapist, but confer you the skills you will learn to use personally and in the context of guided meditations and relaxations that are commonplace now.
And what evidence do I have for stating that NLP is unproven?
Is there an up-to-date and sound systematic review of NLP?
The answer is yes.
This systematic review of NLP included 10 experimental studies. Five studies were RCTs and five were uncontrolled pre-post studies. Targeted health conditions were anxiety disorders, weight maintenance, morning sickness, substance misuse, and claustrophobia during MRI scanning. NLP interventions were mainly delivered across 4-20 sessions although three were single session. Eighteen outcomes were reported and the RCT sample sizes ranged from 22 to 106. Four RCTs reported no significant between group differences with the fifth finding in favour of NLP. Three RCTs and five pre-post studies reported within group improvements. Risk of bias across all studies was high or uncertain.
The authors concluded that there is little evidence that NLP interventions improve health-related outcomes. This conclusion reflects the limited quantity and quality of NLP research, rather than robust evidence of no effect. There is currently insufficient evidence to support the allocation of NHS resources to NLP activities outside of research purposes.
Surprised?
I am not!
I did not expect the COMAIH to allow critical thinking to get in the way of quackery-promotion.
The aim of this update of a Cochrane review was to assess the effectiveness and safety of homeopathic treatment for irritable bowel syndrome (IBS). Hold on, the bit about safety is odd here and does not bode well: one cannot possibly assess the safety of an intervention on the basis of just a few trials.
Randomised controlled trials (RCTs), cohort and case-control studies that compared homeopathic treatment with placebo, other control treatments, or usual care, in adults with IBS were considered for inclusion. Two authors independently assessed the risk of bias and extracted data. The primary outcome was global improvement in IBS as measured by an IBS symptom severity score. Secondary outcomes included quality of life, abdominal pain, stool frequency, stool consistency, and adverse events. The overall certainty of the evidence supporting the primary and secondary outcomes was assessed using the GRADE criteria. The Cochrane risk of bias tool was used to assess risk of bias.
Four RCTs (307 participants) were included. Two studies compared clinical homeopathy (homeopathic remedy, asafoetida or asafoetida plus nux vomica) to placebo for IBS with constipation (IBS-C). One study compared individualised homeopathic treatment (consultation plus remedy) to usual care for the treatment of IBS in female patients. One study was a three armed RCT comparing individualised homeopathic treatment to supportive listening or usual care.
The risk of bias in three studies (the two studies assessing clinical homeopathy and the study comparing individualised homeopathic treatment to usual care) was unclear on most criteria and high for selective reporting in one of the clinical homeopathy studies. The three armed study comparing individualised homeopathic treatment to usual care and supportive listening was at low risk of bias in four of the domains and high risk of bias in two (performance bias and detection bias).
A meta-analysis of the studies assessing clinical homeopathy, (171 participants with IBS-C) was conducted. At short-term follow-up of two weeks, global improvement in symptoms was experienced by 73% (46/63) of asafoetida participants compared to 45% (30/66) of placebo participants (RR 1.61, 95% CI 1.18 to 2.18; 2 studies, very low certainty evidence).
In the other clinical homeopathy study at two weeks, 68% (13/19) of those in the asafoetida plus nux vomica arm and 52% (12/23) of those in the placebo arm experienced a global improvement in symptoms (RR 1.31, 95% CI 0.80 to 2.15; very low certainty evidence).
In the study comparing individualised homeopathic treatment to usual care (N = 20), the mean global improvement score (feeling unwell) at 12 weeks was 1.44 + 4.55 (n = 9) in the individualised homeopathic treatment arm compared to 1.41 + 1.97 (n=11) in the usual care arm (MD 0.03; 95% CI -3.16 to 3.22; very low certainty evidence).In the study comparing individualised homeopathic treatment to usual care, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 237.3 + 110.22 (n = 60) in the usual care arm (MD -26.86, 95% CI -88.59 to 34.87; low certainty evidence).
The mean quality of life score (EQ-5D) at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.41 (SD 23.31) in usual care participants (MD 5.66, 95% CI -4.69 to 16.01; low certainty evidence). In the study comparing individualised homeopathic treatment to supportive listening, the mean IBS symptom severity score at 6 months was 210.44 + 112.4 (n = 16) in the individualised homeopathic treatment arm compared to 262 + 120.72 (n = 18) in the supportive listening arm (MD -51.56, 95% CI -129.94 to 26.82; very low certainty evidence). The mean quality of life score at 6 months in homeopathy participants was 69.07 (SD 17.35) compared to 63.09 (SD 24.38) in supportive listening participants (MD 5.98, 95% CI -8.13 to 20.09; very low certainty evidence). None of the included studies reported on abdominal pain, stool frequency, stool consistency, or adverse events.
The authors concluded that the results for the outcomes assessed in this review are uncertain. Thus no firm conclusions regarding the effectiveness and safety of homeopathy for the treatment of IBS can be drawn. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy for IBS compared to placebo or usual care.
[The previous version of this review was published in 2013 and concluded: A pooled analysis of two small studies suggests a possible benefit for clinical homeopathy, using the remedy asafoetida, over placebo for people with constipation-predominant IBS. These results should be interpreted with caution due to the low quality of reporting in these trials, high or unknown risk of bias, short-term follow-up, and sparse data. One small study found no statistically difference between individualised homeopathy and usual care (defined as high doses of dicyclomine hydrochloride, faecal bulking agents and diet sheets advising a high fibre diet). No conclusions can be drawn from this study due to the low number of participants and the high risk of bias in this trial. In addition, it is likely that usual care has changed since this trial was conducted. Further high quality, adequately powered RCTs are required to assess the efficacy and safety of clinical and individualised homeopathy compared to placebo or usual care.]
This is a thorough review that is technically well-done (no wonder, as it had to comply with Cochrane standards!). However, as with some other Cochrane reviews of homeopathy, acupuncture and other SCAMs, one might object to the phraseology used in the conclusions (the part that most people would focus on). Don’t get me wrong, the conclusions are technically correct; however, they are not as clear as they should be and hide the essence of the evidence, in my view.
Systematic reviews have one main purpose: they need to inform the reader whether there is or is not good evidence that the treatment in question works for the condition in question. This question is not well addressed by stating THE RESULTS ARE UNCERTAIN. The truth is that a firm conclusion can very well be drawn: THERE IS NO GOOD EVIDENCE THAT ANY FORM OF HOMEOPATHY IS EFFECTIVE FOR IBS!
Surely that’s correct and firm enough!!!
Why do the authors not dare to put this clearly?
Probably because some of them are well-known, long-term proponents of homeopathy.
Why does the Cochrane Collaboration allow them to get away with their petty attempt of obfuscation?
Search me!
I just came across the most amazing cancer cure: it’s called VIDATOX 30C, and it is a true wonder.
Well, on second thought, I might take that this back.
Is it really true?
Or is it perhaps a most despicable health fraud?
The Vidatox website makes the following claims for VIDATOX:
- it is based on 5 proteins from scorpion venom;
- it is a 30C potency, which means that it is diluted by a factor of 1:1000000000000000000000000000000000000000000000000000000000000
- it selectively acts on diseased cells without harming healthy ones;
- it is angiogenic;
- it stimulates the immune system;
- it attacks growing tumours;
- it is anti-metastatic;
- it blocks tumour angiogenesis;
- it has anti-inflammatory effects;
- it has prolonged analgesic effects;
- it enhances the effects of chemo- and radiation therapies;
- it reduces the side-effects of chemo- and radiation therapies;
- it is not addictive;
- it is a therapeutic alternative for human cancers;
- it is in general use in oncology;
- it has a powerful detoxification effect;
- it has no side-effects;
- it improves the well-being of patients;
- its efficiency in tumour treatment is proven;
- the medication ‘passed all the clinical trials’;
- it increases survival;
- it is a ‘certified product’;
- it should be kept away from electromagnetic fields.
With all these claims and all ths splendid science mentioned on the website, one would expect to find plenty of papers on Vidatox. A Medline search resulted in 1 (one!) paper on the subject. Here is the abstract:
Complementary and alternative medicine (CAM) is the term used to describe many kinds of products, practices, and systems that are not part of conventional medicine. Cancer patients usually do everything they can to combat the disease, manage its symptoms, and cope with the side effects of treatment. Unfortunately, patients who use CAM underestimate the risk of interaction with cancer therapy or worse they omit conventional therapy thus reducing the possibility of cancer remission. Herein we analyzed the effects of Vidatox 30 CH (venom extracted from the Junceus Rhopalurus scorpion) on hepatocellular carcinoma (HCC), the second leading cause of cancer-related deaths. We found out that Vidatox increases HCC proliferation and invasion whereas it does not seem to interact with sorafenib, the orally active multikinase inhibitor approved for the treatment of advanced hepatocellular carcinoma. Our results suggest that the concentration of Vidatox used in the present study has not anti-neoplastic effects and care must be taken in hiring Vidatox in patients with HCC.
The authors of this paper also make the following comment:
According to Gonzalez, Vidatox was tested on more than 10,000 cancer patients with “positive results” ranging from an “improved quality of life” to a “slowing of tumor growth” (http://vidatoxromania.ro/en/what-is-vidatox/) (http://www.bt.com.bn/science-technology/2010/10/29/cuba-release-new-cancer-drug). There are no data from controlled clinical studies neither for Escozul nor for Vidatox 30-CH in refereed journals. The available information derived from interviews with patients involved or provided within the sites of alternative therapies. Essentially, scientific evidences about the biological activity of Vidatox in cancer cells are missing.
So, is Vidatox homeopathy’s answer to cancer or is it simply a disgusting fraud?
What do you think?
So-called alternative medicine (SCAM) is a seriously dangerous option for cancer patients who aim at curing their cancer with it. One cannot warn patients often and strongly enough, I believe. But when it comes to supportive cancer treatment (care that does not aim at changing the natural history of the disease), SCAM might have a place. I said ‘might’ because its exact role is far from clear.
The aim of this study was to investigate the effects of a complex, nurse-led, supportive care intervention using SCAM on patients’ quality of life (QoL) and associated patient-reported outcomes. In this prospective, pragmatic, bicentric, randomized controlled trial, women with breast or gynaecologic cancers undergoing a new regimen of chemotherapy (CHT) were randomly assigned to routine supportive care plus intervention (intervention group, IG) or routine care alone (control group, CG). The intervention consisted of SCAM applications and counseling for symptom management, as well as SCAM information material. The primary endpoint was global QoL measured with the EORTC-QLQ-C30 before and after SCAM.
In total, 126 patients were randomly assigned into the IG and 125 patients into the CG. The patients’ medical and socio-demographic characteristics were homogenous at baseline and at follow-up. No group effects on QoL were found upon completion of CHT, but there was a significant group difference in favour of the IG, 6 months later. IG patients did also experience significant better emotional functioning and less fatigue.
The authors concluded that the tested supportive intervention did not improve patients’ QoL outcomes directly after CHT (T3), but was associated with significant QoL improvements when considering the change from baseline to the time point T4, which could be assessed 6 months after patients’ completion of CHT. This delayed effect may have resulted due to a strengthening of patients’ self-management competencies.
A prospective, pragmatic, bicentric, randomized controlled trial! Doesn’t this sound rigorous? In fact, this term merely hides a trial that was destined to generate a positive result. As it followed the infamous A+B versus B design, it hardly had a chance to not come out positive.
The only thing I find amazing is that the short-term results failed to be statistically significant. Far too many SCAM researchers, it seems to me, view science as a tool for promoting their dubious ideas.
The use of SCAM with the aim of improving QoL might be helpful. But this assumption cannot be accepted on the basis of opinion; we need good science to find out which forms of SCAM are worth employing. Sadly, studies like the above are not in this category.
If you ask me, it is high time that this misleading nonsensical and unethical pseudo-research stops!
Many cancer patients use so-called alternative medicine (SCAM) such as Traditional Chinese Medicine (TCM). On this blog, we have repeatedly discussed whether this does more good than harm. This study sheds new light on the question. Specifically, it aims to explore the benefits of TCM therapy in the long-term survival of patients with hepatocellular carcinoma in China.
In total, 3483 patients with HCC admitted to the Beijing Ditan Hospital of Capital Medical University were enrolled. The researchers used 1:1 frequency matching by sex, age, diagnosis time, Barcelona Clinic Liver Cancer staging, and type of treatments to compare the TCM users (n = 526) and non-TCM users (n = 526). A Cox multivariate regression model was employed to evaluate the effects of TCM therapy on the HR value and Kaplan-Meier survival curve for mortality risk in HCC patients. A log-rank test was performed to analyse the effect of TCM therapy on the survival time of HCC patients.
The Cox multivariate analysis indicated that TCM therapy was an independent protective factor for 5-year survival in patients with HCC. The Kaplan-Meier curve also showed that after PS matching, TCM users had a higher overall survival rate and a higher progression-free survival rate than non-TCM users. TCM users, regardless of the classification of etiology, tumor stage, liver function level, or type of treatment, all benefited significantly from TCM therapy. The most commonly used Chinese patent medications used were Fufang Banmao Capsule, Huaier Granule, and Jinlong Capsule.
The authors concluded that using traditional Chinese medications as adjuvant therapy can probably prolong median survival time and improve the overall survival among patients with HCC. Further scientific studies and clinical trials are needed to examine the efficiency and safety.
I was unable to access the full article and therefore am unable to provide a detailed critique of it. From reading the abstract, I should point out, however, that this was not an RCT. To minimise bias, the researchers used a matching technique to generate two comparable groups. Such methods can be successful in matching for the named parameters, but they cannot match for the plethora of variables that might be relevant but were not measured. Therefore, the survival difference between the two groups might be due not to the therapies they received, but to the fact that the groups were not comparable in terms of factors that impact on survival.
Another important point about this paper is the obvious fact that it originates from China. We know from several independent investigations that such studies almost never report negative findings. We also know that TCM is a hugely important export item for China. Adding two and two together should therefore make us sceptical. I for one take the present findings with more than a pinch of salt.
The Clinic for Complementary Medicine and Diet in Oncology was opened, in collaboration with the oncology department, at the Hospital of Lucca (Italy) in 2013. It uses a range of alternative therapies aimed at reducing the adverse effects of conventional oncology treatments.
Their latest paper presents the results of complementary medicine (CM) treatment targeted toward reducing the adverse effects of anticancer therapy and cancer symptoms, and improving patient quality of life. Dietary advice was aimed at the reduction of foods that promote inflammation in favour of those with antioxidant and anti-inflammatory properties.
This is a retrospective observational study on 357 patients consecutively visited from September 2013 to December 2017. The intensity of symptoms was evaluated according to a grading system from G0 (absent) to G1 (slight), G2 (moderate), and G3 (strong). The severity of radiodermatitis was evaluated with the Radiation Therapy Oncology Group (RTOG) scale. Almost all the patients (91.6%) were receiving or had just finished some form of conventional anticancer therapy.
The main types of cancer were breast (57.1%), colon (7.3%), lung (5.0%), ovary (3.9%), stomach (2.5%), prostate (2.2%), and uterus (2.5%). Comparison of clinical conditions before and after treatment showed a significant amelioration of all symptoms evaluated: nausea, insomnia, depression, anxiety, fatigue, mucositis, hot flashes, joint pain, dysgeusia, neuropathy.
The authors concluded that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ demand for a reduction of the adverse effects of anticancer treatments and the symptoms of cancer itself, thus improving patient’s quality of life and combining safety and equity of access within public healthcare systems. It is, therefore, necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs.
Why do I call this ‘wishful thinking’?
I have several reasons:
- A retrospective observational study cannot establish cause and effect. It is likely that the findings were due to a range of factors unrelated to the interventions used, including time, extra attention, placebo, social desirability, etc.
- Some of the treatments in the therapeutic package were not CM, reasonable and evidence-based. Therefore, it is likely that these interventions had positive effects, while CM might have been totally useless.
- To claim that the integration of evidence-based complementary treatments seems to provide an effective response to cancer patients’ is pure fantasy. Firstly, some of the CMs were certainly not evidence-based (the clinic’s prime focus is on homeopathy). Secondly, as already pointed out, the study does not establish cause and effect.
- The notion that it is necessary for physicians (primarily oncologists) and other healthcare professionals in this field to be appropriately informed about the potential benefits of CMs is not what follows from the data. The paper shows, however, that the authors of this study are in need to be appropriately informed about EBM as well as CM.
I stumbled across this paper because a homeopath cited it on Twitter claiming that it proves the effectiveness of homeopathy for cancer patients. This fact highlights why such publications are not just annoyingly useless but acutely dangerous. They mislead many cancer patients to opt for bogus treatments. In turn, this demonstrates why it is important to counterbalance such misinformation, critically evaluate it and minimise the risk of patients getting harmed.
Many charities in the UK (and most other countries) openly promote bogus treatments. After having been reminded of this fact regularly, the UK Charity Commission have decided to look into this issue. Arguably, such charities – I have previously discussed ‘YES TO LIFE’ as an example (in total there are several hundred ‘SCAM charities’ operating in the UK today)- do not provide a valuable public service and should therefore not benefit from such status and tax privileges. While the commission is contemplating, an article in the NEW SCIENTIST provided more information on this important issue. Here are a few excerpts:
A commission briefing document says the most important issue is the level of evidence it will require to judge whether a provider of complementary therapy dispenses services of benefit to public health, thereby qualifying legally for charitable status. The document says that at present, suitable evidence includes peer-reviewed research in recognised medical journals such as The Lancet or the BMJ, or recognition by the Department of Health or other government regulatory bodies. Personal testimonies and anecdotal evidence are not sufficient to demonstrate efficacy, says the commission, and nor are non-scientific articles and features promoting methods, treatments or therapies.
However, organisations such as the Good Thinking Society have presented evidence that these standards are not being applied rigorously, meaning some organisations may have been granted charitable status without the necessary evidence that their therapies are of benefit to public health. The commission is reassessing how its existing guidelines are enforced. It is also seeking guidance on how to deal with conflicting or inconsistent evidence, or evidence that certain therapies might cause harm – by displacing conventional therapies, for example.
Complementary providers argue that it’s unfair to be judged purely on evidence in mainstream medical journals, as demanded by the Good Thinking Society. “We know there’s a well-being factor with some complementary medicines which could be palliative, or a placebo effect,” says Jayney Goddard, director of The Complementary Medical Association. “These include massage or meditation, for example, which have tremendously supportive effects, but if the evidence isn’t forthcoming, it means those charities currently offering them might not be able to in future.” If the consultation does ultimately result in revocation of charitable status for some providers, Goddard argues that this would make it harder for them to raise donations and benefit from tax breaks that make their services more affordable.
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The argument of Jayney Goddard borders on the ridiculous, of course. If treatment X improves well-being beyond placebo and generates more good than harm, it is clearly effective and the above debate does not even apply. But it obviously does not suffice to claim that treatment X improves well-being, it is mandatory to demonstrate it with sound evidence. If, on the other hand, treatment X has not been shown to be effective beyond placebo, it must be categorised as unproven or bogus. And promoting bogus treatments/ideas/concepts (including diverting patients from evidence-based treatments and undermining rational thought in our society at large) is unquestionably harmful both to individual patients and to society as a whole.
SCAM charities are thus dangerous, unethical and an obstacle to progress. They not only should lose their charitable privileges as a matter of urgency, but they should also be fined for endangering public health.