alternative medicine
Researchers from the Department of Physiotherapy, Guru Jambheshwar University of Science and Technology, Hisar, Haryana, India, and the Mother Teresa Saket College of Physiotherapy, Saket, Panchkula, Haryana, India, have just published a systematic review which is remarkable in several ways. Let me therefore present to you the abstract unaltered:
Background: Spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden. Various manual therapeutic techniques such as spinal manipulations and mobilizations can be used to treat and manage pain and movement dysfunctions such as spinal mal-alignments and associated complications. These manual therapeutic techniques can affect the cardiovascular parameters.
Objective: The objective of this systematic review and meta-analysis is to assess the effect of spinal manipulation and mobilization on cardiovascular parameters.
Methods: We conducted a systematic review and meta-analysis to assess the effects of spinal mobilization and manipulation on cardiovascular responses. Mean changes in Systolic Blood Pressure (SBP), Diastolic Blood Pressure (DBP) and Heart Rate (HR) were primary outcome measures. RevMan 5.3 software was used for the meta-analyses. Quality of the included studies was assessed by PEDro Rating scale. Risk of bias was assessed by Cochrane collaboration tool of risk of bias.
Results: Results of meta-analysis showed that there was statistically significant decrease in SBP ( MD=-4.56 , 95% CI=-9.20 , 0.08; p≤0.05 ) with moderate heterogeneity ( I2=75% , p<0.0002 ) in experimental group as compared to control group. There was statistically non-significant decrease in DBP ( MD=-1.96 , 95% CI=-4.60 , 0.69; p=0.15 ) with high heterogeneity ( I2=91% , p<0.00001 ), Change HR was statistically non-significant ( MD=-0.24 , 95% CI=-3.59 , 3.11; p=0.89 ) with moderate heterogeneity ( I2=60% , p=0.01 ). Exclusion of short duration studies in sensitivity analysis revealed a statistically significant change in DBP ( MD=-0.94 , 95% CCI=-1.85 , -0.03 ; p=0.04 ). However, the result was statistically non-significant for HR after sensitivity analysis.
Conclusion: Spinal manipulations and mobilizations may result in significant decrease of systolic as well as diastolic Blood Pressure.
After reading the full paper, I was uncertain whether to laugh or to cry. Then I decided for the former option.
Any paper that starts with the statement ‘spinal pain or misalignment is a very common disorder affecting a significant number of populations resulting in substantial disability and economic burden‘ can only be a hoax! In case you are uncertain about the reason of my amusement: spinal pain is not the same as spinal misalignment, and spinal misalignment (in the sense it is used here) is the figment of the imagination of a 18 carat charlatan called DD Palmer.
The rest of the article offers more superb hilarity: the authors write, for instance, that spinal malalignments (such as scoliosis) are mainly caused by body’s abnormal posture, asymmetries in bone growth and abnormalities of neuromuscular system. Scoliosis is an abnormal lateral curvature of the spine, not a spinal malalignment and certainly not one that can be treated with spinal manipulation.
Then the authors state that spinal pain and malalignment mainly occur due to structure deterioration, altered biomechanics and abnormal posture. Workplace physical and psychosocial factors, emotional problems, smoking, poor job satisfaction, awkward posture and poor work environment can be the possible risk factors for spinal pain and malalignment. This leads to various musculoskeletal, psychosomatic, cardiovascular and respiratory dysfunctions which affect the functional capacity of the patient as well as quality of life. Oh really?
So, the findings of the authors’ meta-analysis do suggest a tiny effect on blood pressure.
Compared to what?
In the paper, the review authors repeatedly try to make us believe it is compared to placebo. However, this is not true; mostly it was compared to no treatment.
Was the hypotensive effect verified in hypertensive patients?
No, it was measured mostly in healthy volunteers.
Is the effect clinically relevant?
No, I don’t think so!
Is it comparable to or better than the one achievable with established treatments for hypertension?
No! In fact it is much smaller.
Does that bother the authors?
No, on the contrary, they state that in this meta-analysis, spinal manipulation and mobilization resulted in statistically significant reduction in SBP. Therefore, it can be used as an adjuvant therapy for the management of hypertension.
Were the studies using spinal manipulation as an adjuvant therapy?
No, mostly not.
Is the effect lasting long enough to be relevant for the management of hypertension?
No.
I better stop here because already my whole body hurts from laughing so much. Please, do read the full text, if you are in need of some comic relief.
And, I almost forgot: many thanks to the Indian researchers for this hilarious hoax!
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Or did you perhaps mean all that seriously?
This recent Cochrane review assessed the effects of so-called alternative medicine (SCAM) for post-caesarean pain. Randomised clinical trials (RCTs), including quasi-RCTs and cluster-RCTs, comparing SCAM, alone or associated with other forms of pain relief, versus other treatments or placebo or no treatment, for the treatment of post-CS pain were included.
A total of 37 studies (3076 women) investigating 8 different SCAM therapies for post-CS pain relief were found. There was substantial heterogeneity among the trials. The primary outcome measures were pain and adverse effects. Secondary outcome measures included vital signs, rescue analgesic requirement at 6 weeks after discharge; all of which were poorly reported or not reported at all.
Acupuncture/acupressure
The quality of the RCTs was low. Whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus placebo plus analgesia) have any effect on pain. Acupuncture or acupressure plus analgesia (versus analgesia) may reduce pain at 12 hours (standardised mean difference (SMD) -0.28, 95% confidence interval (CI) -0.64 to 0.07; 130 women; 2 studies; low-certainty evidence) and 24 hours (SMD -0.63, 95% CI -0.99 to -0.26; 2 studies; 130 women; low-certainty evidence). It is uncertain whether acupuncture or acupressure (versus no treatment) or acupuncture or acupressure plus analgesia (versus analgesia) have any effect on the risk of adverse effects.
Aromatherapy
Aromatherapy plus analgesia may reduce pain when compared with placebo plus analgesia at 12 hours (mean difference (MD) -2.63 visual analogue scale (VAS), 95% CI -3.48 to -1.77; 3 studies; 360 women; low-certainty evidence) and 24 hours (MD -3.38 VAS, 95% CI -3.85 to -2.91; 1 study; 200 women; low-certainty evidence). The authors were uncertain whether aromatherapy plus analgesia has any effect on adverse effects (anxiety) compared with placebo plus analgesia.
Electromagnetic therapy
Electromagnetic therapy may reduce pain compared with placebo plus analgesia at 12 hours (MD -8.00, 95% CI -11.65 to -4.35; 1 study; 72 women; low-certainty evidence) and 24 hours (MD -13.00 VAS, 95% CI -17.13 to -8.87; 1 study; 72 women; low-certainty evidence).
Massage
There were 6 RCTs (651 women), 5 of which were quasi-RCTs, comparing massage (foot and hand) plus analgesia versus analgesia. All the evidence relating to pain, adverse effects (anxiety), vital signs and rescue analgesic requirement was very low-certainty.
Music therapy
Music therapy plus analgesia may reduce pain when compared with placebo plus analgesia at one hour (SMD -0.84, 95% CI -1.23 to -0.46; participants = 115; studies = 2; I2 = 0%; low-certainty evidence), 24 hours (MD -1.79, 95% CI -2.67 to -0.91; 1 study; 38 women; low-certainty evidence), and also when compared with analgesia at one hour (MD -2.11, 95% CI -3.11 to -1.10; 1 study; 38 women; low-certainty evidence) and at 24 hours (MD -2.69, 95% CI -3.67 to -1.70; 1 study; 38 women; low-certainty evidence). It is uncertain whether music therapy plus analgesia has any effect on adverse effects (anxiety), when compared with placebo plus analgesia because the quality of evidence is very low.
Reiki
The investigators were uncertain whether Reiki plus analgesia compared with analgesia alone has any effect on pain, adverse effects, vital signs or rescue analgesic requirement because the quality of evidence is very low (one study, 90 women). Relaxation Relaxation may reduce pain compared with standard care at 24 hours (MD -0.53 VAS, 95% CI -1.05 to -0.01; 1 study; 60 women; low-certainty evidence).
Transcutaneous electrical nerve stimulation (TENS)
TENS (versus no treatment) may reduce pain at one hour (MD -2.26, 95% CI -3.35 to -1.17; 1 study; 40 women; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce pain compared with placebo plus analgesia at one hour (SMD -1.10 VAS, 95% CI -1.37 to -0.82; 3 studies; 238 women; low-certainty evidence) and at 24 hours (MD -0.70 VAS, 95% CI -0.87 to -0.53; 108 women; 1 study; low-certainty evidence). TENS plus analgesia (versus placebo plus analgesia) may reduce heart rate (MD -7.00 bpm, 95% CI -7.63 to -6.37; 108 women; 1 study; low-certainty evidence) and respiratory rate (MD -1.10 brpm, 95% CI -1.26 to -0.94; 108 women; 1 study; low-certainty evidence). The authors were uncertain whether TENS plus analgesia (versus analgesia) has any effect on pain at six hours or 24 hours, or vital signs because the quality of evidence is very low (two studies, 92 women).
The authors concluded that some SCAM therapies may help reduce post-CS pain for up to 24 hours. The evidence on adverse events is too uncertain to make any judgements on safety and we have no evidence about the longer-term effects on pain. Since pain control is the most relevant outcome for post-CS women and their clinicians, it is important that future studies of SCAM for post-CS pain measure pain as a primary outcome, preferably as the proportion of participants with at least moderate (30%) or substantial (50%) pain relief. Measuring pain as a dichotomous variable would improve the certainty of evidence and it is easy to understand for non-specialists. Future trials also need to be large enough to detect effects on clinical outcomes; measure other important outcomes as listed in this review, and use validated scales.
I feel that the Cochrane Collaboration does itself no favours by publishing such poor reviews. This one is both poorly conceived and badly reported. In fact, I see little reason to deal with pain after CS differently than with post-operative pain in general. Some of the modalities discussed are not truly SCAM. Most of the secondary endpoints are irrelevant. The inclusion of adverse effects as a primary endpoint seems nonsensical considering that SCAM studies are notoriously bad at reporting them. Many of the allegedly positive findings rely on trial designs that cannot control for placebo effects (e.g A+B versus B); therefore they tell us nothing about the effectiveness of the therapy.
Most importantly, the conclusions are not helpful. I would have simply stated that none of the SCAM modalities are supported by convincing evidence as treatments for pain control after CS.
Patients with advanced non-small cell lung cancer (NSCLC) have limited treatment options. Alongside conventional anticancer treatment, additive homeopathy might help to alleviate side effects of conventional therapy. The aim of this study was to investigate whether additive homeopathy might influence quality of life (QoL) and survival in NSCLC patients.
In this prospective, randomized, placebo-controlled, double-blind, three-arm, multi-centre, phase III study, the researchers evaluated the possible effects of additive homeopathic treatment compared to placebo in patients with stage IV NSCLC, with respect to QoL in the two randomized groups and survival time in all three groups. Treated patients visited the university teaching hospital every 9 weeks: 150 patients with stage IV NSCLC were included in the study.
- 51 patients received individualized homeopathic remedies plus conventional treatments,
- 47 received placebo plus conventional treatments,
- 52 control patients without any homeopathic treatment were treated with conventional therapies and observed for survival only.
For groups 1 and 2, the study was double-blind. The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. The remedies were manufactured by stepwise dilution and succussion, thereby preparing stable GMP grade formulations.
QoL as well as functional and symptom scales showed significant improvement in the homeopathy group when compared with placebo after 9 and 18 weeks of homeopathic treatment (p < .001). Median survival time was significantly longer in the homeopathy group (435 days) versus placebo (257 days; p = .010) as well as versus control (228 days; p < .001). Survival rate in the homeopathy group differed significantly from placebo (p = .020) and from control (p < .001).
The authors concluded that QoL improved significantly in the homeopathy group compared with placebo. In addition, survival was significantly longer in the homeopathy group versus placebo and control. A higher QoL might have contributed to the prolonged survival. The study suggests that homeopathy positively influences not only QoL but also survival. Further studies including other tumour entities are warranted.
First of all, let me thank my friend Dana Ullman for alerting me to this new and interesting study. I have read what seems to be the full paper several times and have to admit that it puzzles me (and perhaps this version is just some type of pre-publication paper). Firstly, there seems to be no methods section (the abstract is followed by several tables and a discussion), and I am left guessing much of the details. Secondly, the paper raises several questions in my mind:
- What is the purpose of group 3? The authors call it a control group and state it allows assessing the real homeopathic effect on the homeopathic cohort as the real effect will be the natural historical effect minus the placebo effect and the homeopathic effect. Does that make sense?
- Was the study under-powered? From my reading of the text, the answer seems to be yes.
- What is the full list of conventional treatments the patients received, and did they differ between the 3 groups?
- If I understand it correctly, the study patients did not receive immuno-oncological therapy. Does that fact not render the study unethical?
- What homeopathic potencies were prescribed in group 1? The paper says: The constituents of the different homeopathic remedies were mainly of plant, mineral, or animal origin. This is unlikely, as most homeopathic remedies contain nothing.
- The authors seem to have used individualised homeopathy according to Hahnemann’s instructions. Did Hahnemann not strictly forbid combining his approach with other types of treatment?
- How well respected is THE ONCLOLOGIST, the journal that published the paper?
- Was the article peer-reviewed? If so, by whom?
- Was the placebo indistinguishable from the verum?
- Was the success of patient-blinding checked?
- Have similar findings regarding survival been reported previously? The authors call this finding ‘unexpected’; I find it more than that; it is baffling.
- Should we accept such surprising findings, or would it be more prudent to wait until independent replications are available?
- The first author of this trial is Prof Frass who has featured on this blog several times before (see for instance here, here, here, here and here). Frass has published several studies of homeopathy and invariably manages to produce positive results. Am I the only one to find this odd?
I would be most grateful, if the readers of this blog could assist me in finding answers to some of the above questions.
This study assessed the patterns of dietary supplement usage among cancer survivors in the United States in a population-based setting. National Health and Nutrition Examination Survey (NHANES) datasets (1999-2016) were accessed, and adult respondents (≥ 20 years old) with a known status of cancer diagnosis and a known status of dietary supplements intake were included. Multivariable logistic regression analysis was then used to assess factors associated with dietary supplements intake. Moreover, and to evaluate the impact of dietary supplements on overall survival among respondents with cancer, multivariable Cox regression analysis was conducted.
A total of 49,387 respondents were included in the current analysis, including a total of 4,575 respondents with cancer. Among respondents with cancer, 3,024 (66.1%) respondents reported the use of dietary supplements; while 1,551 (33.9%) did not report the use of dietary supplements. Using multivariable logistic regression analysis, factors associated with the use of dietary supplements included:
- older age (OR: 1.028; 95% CI: 1.027-1.030);
- white race (OR for black race vs. white race: 0.67; 95% CI: 0.63-0.72);
- female gender (OR for males vs. females: 0.56; 95% CI: 0.53-0.59),
- higher income (OR: 1.13; 95% CI: 1.11-1.14),
- higher educational level (0.59; 95% CI: 0.56-0.63),
- better self-reported health (OR: 1.36; 95% CI: 1.17-1.58),
- health insurance (OR: 1.35; 95% CI: 1.27-1.44),
- history of cancer (OR: 1.20; 95% CI: 1.10-1.31).
Using multivariable Cox regression analysis and within the subgroup of respondents with a history of cancer, the use of dietary supplements was not found to be associated with a difference in overall survival (HR: 1.13; 95% CI: 0.98-1.30).
The authors concluded that dietary supplement use has increased in the past two decades among individuals with cancer in the United States, and this increase seems to be driven mainly by an increase in the use of vitamins. The use of dietary supplements was not associated with any improvement in overall survival for respondents with cancer in the current study cohort.
Many cancer patients, when they first get diagnosed, are tested for vitamin D levels and found to be low or borderline. Consequently, they get a prescription for supplements. Other than this, there is rarely an indication to take any vitamins or other dietary supplements. Yet, cancer patients take them because they think these ‘natural’ preparations can do no harm (and because the industry can be persuasive [there is big money at stake] and the odd breed of ‘integrated’ oncologists might even recommend them). Sadly, this assumption is not correct. The biggest danger, in my view, is the possibility of supplements to interact with one of the many drugs that cancer patients need to take. So, in a way, it is reassuring that, on average, there is no detrimental effect on overall survival.
The paper will probably also reignite the perennial discussion about the effects of vitamin C on the natural history of cancer. My understanding is that there is none (and this verdict seems to be supported by the findings reported here). But I am, of course, aware that this is a ‘hot potato’ and that some readers will think differently. To them I say: please show me the evidence.
A 2020 article that I just came across concluded with this rather remarkable statement:
High-dose enzyme therapy is a natural cancer protocol that has been highly successful in treating this much-feared disease.
Since we can find a plethora of similar claims on social media and elsewhere, it is high time, I think, to dedicate a post to this alleged cancer cure.
Enzyme therapy involves the administration of proteolytic enzymes by mouth. Proteolytic enzymes are large molecules that are nevertheless said to be absorbed in the gut before they are dispersed into different compartments of the body where they can be detected in various concentrations. Proteolytic enzymes (serine endopeptidases such as trypsin or chymotrypsin and cysteine endo-proteinases such as bromelain and papain or combinations of those enzymes) have long been available for diverse medical indications, including cancer. They are claimed to exert anticancer activities by restoring the reduced cytotoxic activity of patients’ sera.
Enzyme therapy has been subjected to experimental investigations and to a few studies in cancer patients. A systematic review claimed that, for plasmacytoma patients, systemic enzyme therapy was shown to increase the response rates, the duration of remissions, and the overall survival times.[1]
This statement is based on just one study. Here is its abstract[2]:
Purpose: To evaluate the impact of an additive therapy with an oral enzyme (OE) preparation given for more than 6 months additionally to standard combination chemotherapy (vincristine/melphalan/cyclophosphamide/prednisone (VMCP)- or methylprednisolone/ vincristine/CCNU/cyclophosphamide/melphalan (MOCCA)-regimen) in the primary treatment of patients with multiple myeloma stages I-III.
Methods: A cohort of 265 patients with multiple myeloma stages I-III was consecutively treated at our institution in two parallel groups (control group (n = 99): chemotherapy +/-OE for less than 6 months; OE-group (n = 166): chemotherapy + OE for more than 6 months). The median follow-up time in the stages I, II, and III for the OE-group was 61, 37, and 46.5 months, respectively; for the control group the respective values were 33, 51.5, and 31.5 months. The primary endpoint of the study was disease-specific survival. Secondary endpoints were response to therapy, duration of first response and side effects. The chosen method for evaluation was the technique of a retrolective cohort analysis with a concurrent control group. Survival analysis was performed by the Kaplan-Meier method and multivariate analysis was done with the Cox proportional hazards model.
Results: Significantly higher overall response rates and longer duration of remissions were observed in the OE-group. Primary responders showed a longer mean survival time than non-responders. Additive therapy with OE given for more than 6 months decreased the hazard of death for patients at all stages of disease by approximately 60%. Observation time was not long enough to estimate the median survival for patients at stages I and II; for stage III patients it was 47 months in the control group versus 83 months for the patients treated with OE (P = 0.0014) which means a 3-year gain of survival time. Significant prognostic factors for survival, in the Cox regression analysis, were stage of disease and therapy with OE. The OE-therapy was generally well tolerated (3.6% of patients with mild to moderate gastrointestinal symptoms).
Conclusion: OEs represent a promising new additive therapy in multiple myeloma which will be further evaluated in a randomized phase III trial in the USA.
My searches located no prospective clinical trials supporting the notion that enzyme therapy is an effective cancer cure for any type of human cancer. So, what about the bold statement quoted above? In my view, it is a dangerous and highly irresponsible claim that endangers the lives of many vulnerable cancer patients desperately looking for alternative cancer cures.
REFERENCES
[1] Beuth J. Proteolytic enzyme therapy in evidence-based complementary oncology: fact or fiction? Integr Cancer Ther. 2008 Dec;7(4):311-6. doi: 10.1177/1534735408327251. PMID: 19116226.
[2] Sakalová A, Bock PR, Dedík L, Hanisch J, Schiess W, Gazová S, Chabronová I, Holomanova D, Mistrík M, Hrubisko M. Retrolective cohort study of an additive therapy with an oral enzyme preparation in patients with multiple myeloma. Cancer Chemother Pharmacol. 2001 Jul;47 Suppl:S38-44. doi: 10.1007/s002800170008. PMID: 11561871.
Recently, I had a notable comment on one of my posts:
“these treatments are not the best we can offer to LBP-patients.”
Have to agree with you. As a stand alone treatment the research is underwhelming. When used as part of a suite of therapies they have some utility. All therapeutic approaches when studied in isolation are underwhelming (including exercise and rehab). Research needs to reflect how chiro’s/physio’s/osteo’s practice.
The post was about a new RCT suggesting that neither spinal manipulation nor spinal mobilization is effective treatments for chronic low back pain. And the comment came, of course, from an ardent defender of chiropractic. As I have heard this type of argument so often – from virtually all types of providers of so-called alternative medicine (SCAM) – it is perhaps worth considering it in more detail.
What does it mean?
It means that those SCAM-providers who believe in the argument think that, in order for their SCAM to work, it needs to be accompanied by some other therapy. To me, this assumption has always raised doubts.
- My fake 5£ note is worth nothing, unless you add a real fiver to it.
- This mine sweeper will work fine, as long as you use another one in parallel.
- This drink is very strong, but you need a double vodka in order to feel it.
Yes, of course, I am exaggerating. So, let’s use a few more sensible examples from the realm of healthcare:
- This new medication is effective only if you combine it with the standard drug for this disease.
- Ultrasound therapy reduces shoulder pain, as long as you also take a pain-killer.
- This slimming aid works wonders, if you stop eating while you take it.
- Chiropractic manipulations work wonders, but you need to combine them with exercise therapy.
- Crystal healing is very effective, as long as you don’t discontinue your conventional treatments.
A + B is only more than B, if A amounts to more than zero.
If A is zero, A + B = B.
If A is negative, A + B is less than B.
Of course, the argument could also mean that treatment A needs the addition of treatment B, because there is a synergism between the two. Synergism is the interaction of treatments such that the total effect is greater than the sum of the individual effects. It is a phenomenon that occurs with certain medications; it can be studied and must be proven before we can accept it as relevant. Has synergism been studied for any of the SCAMs? No, not as far as I am aware. This means, in SCAM, it is unproven. Until it is proven, we thus should not claim it.
So, what does it mean when SCAM-providers say AS A STAND-ALONE THERAPY MY SCAM IS NO GOOD; IT NEEDS ANOTHER TREATMENT TO WORK?
Call me a cynic, but I think it is an admission that the SCAM in question is ineffective (or perhaps even detrimental).
In my last post, I reported that there are no rigorous studies of homeopathy for diabetes. This was only partly true: there are no such trials to test homeopathy’s effects on the disease itself, but I did find a study of homeopathy for diabetic complications.
It comes from India and seems to be based on proper preliminary ground-work:
A prospective multi-centric clinical observational study was published in 2013 in the journal ‘HOMEOPATHY’. It was carried out from October 2005 to September 2009 by Central Council for Research in Homeopathy (CCRH) at its five institutes/units. Its authors were Patients suffering from diabetes mellitus (DM) and presenting with symptoms of diabetic polyneuropathy (DPN) were screened, investigated and were enrolled in the study after fulfilling the inclusion and exclusion criteria. Patients were evaluated by the diabetic distal symmetric polyneuropathy symptom score (DDSPSS) developed by the Council. A total of 15 homeopathic medicines were identified after repertorizing the nosological symptoms and signs of the disease. The appropriate constitutional medicine was selected and prescribed in 30, 200 and 1 M potency on an individualized basis. Patients were followed up regularly for 12 months.
Of 336 patients (167 males and 169 females) enrolled in the study, 247 patients (123 males and 124 females) were analysed. All patients who attended at least three follow-up appointments and baseline curve conduction studies were included in the analysis.). A statistically significant improvement in DDSPSS total score (p = 0.0001) was found at 12 months from baseline. Most objective measures did not show significant improvement. Lycopodium clavatum (n = 132), Phosphorus (n = 27) and Sulphur (n = 26) were the medicines most frequently prescribed. Adverse event of hypoglycaemia was observed in one patient only.
The authors concluded that this study suggests homeopathic medicines may be effective in managing the symptoms of DPN patients. Further studies should be controlled and include the quality of life (QOL) assessment.
As good as their word, they then conducted a more rigorous trial which was published this year:
This study (authored in 2020 by and published in ‘EXPLORE’, an even worse journal than ‘HOMEOPATHY’, in my view) assessed the efficacy of individualized homoeopathic medicines in management of diabetic distal symmetric polyneuropathy (DDSP). It was designed as a multi-centric double-blind, placebo controlled, randomised clinical trial and conducted by the Central Council for Research in Homoeopathy at 6 centres with a sample size of 84. Based on earlier observational studies and repertorial anamnesis of DDSP symptoms 15 homoeopathic medicines were shortlisted and validated scales were used for evaluating the outcomes post-intervention.
The primary outcome measure was change in Neuropathy Total Symptom Score-6 (NTSS-6) from baseline to 12 months. Secondary outcomes included changes in peripheral nerve conduction study (NCS), World Health Organization Quality of Life BREF (WHOQOL-BREF) and Diabetic Neuropathy Examination (DNE) Score at 12 months.
The data of 68 enrolled cases was considered for data analysis. Statistically significant difference (p<0.014) was found in NTSS-6 post intervention in the Verum group. Positive trend was noted for Verum group as per the graph plotted for DNE score and assessment done for NCS. No significant difference was found between the groups for WHOQOL-Bref. Out of 15 pre-identified homoeopathic medicines 11 medicines were prescribed in potencies in ascending order from 6C to 1M.
The authors concluded that further studies must be taken up with larger sample size and defined parameters for NCS to assess the effectiveness of homoeopathy.
This looks to me as though the trial failed to produce a positive result on inter-group comparisons. The abstract is unfortunately not very clear, and I have no access to the full text (in case someone has, please send it to me). Judging from the abstract, the study has several important flaws. For instance, it was small and we don’t know why only 68 of 84 patients were considered for analysis. Normally, an intention to treat analysis would be needed for analysis of all 84 patients.
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So, does homeopathy have anything to offer to patients with diabetes?
As far as I can see, the answer is NO!
I’d be happy to change my mind, provided someone shows me convincing evidence.
Indian homeopaths published a remarkable article in the journal ‘HOMEOPATHY’ proposing Mercurius solubilis as genus epidemicus for the current pandemic. Here it is:
From mid-June to mid-July 2020, our team of homeopathic doctors treated 104 patients in two COVID treatment centers—Pandit Bhimsen Joshi Hospital and Sheth P.V. Doshi Hospital—on the outskirts of Mumbai, India, with adjuvant homeopathy. It was observed by the patients, hospital staff, and the management that those patients on adjuvant homeopathy were discharged 3 to 7 days earlier than other comparable patients in the same wards, allowing us gradually to accommodate more severely ill patients who required oxygen, continuous positive airway pressure, or a ventilator.
Twenty-five different homeopathic medicines in total were prescribed to the patients, each receiving individualized treatment according to his or her symptoms. After collecting 143 clinical and individualizing (homeopathic) symptoms of 104 patients and converting those symptoms into rubrics, we repertorized the combined data with the help of the software Hompath, with an aim to arrive at a genus epidemicus. We observed that the medicine Merc Sol was at the top of the combined repertorization chart. After reviewing repertory sheets of all 104 patients, we discovered that Merc Sol was at the fourth or fifth place of all individual repertorization charts as well.
To substantiate our deduction, we studied the Materia Medica of Merc Sol from the original provings of Hahnemann[1] and other sourcebooks.[2] [3] [4] We also searched research articles and case studies about toxicological effects of mercury.[5] [6] [7] [8] These showed that acute exposure to mercury produces an acute respiratory distress syndrome-like presentation, a picture similar to the COVID symptomatology. Moreover, anosmia, aphthae, gastrointestinal and ocular manifestations that are seen in patients with COVID-19 were produced also by mercury the toxin and mercury the homeopathy-proved medicine. This finding is in accordance with the homeopathic Law of Similars: a substance producing a symptom in a healthy person is able to cure a similar symptom in a sick person.
To confirm our hypothesis, we identified 13 common symptoms of Merc Sol, such as indented tongue, salivation, perspiration, and night aggravation, which were present in various intensities in the previously treated 104 patients. We created a 13-point questionnaire and, after obtaining suitable Ethics Committee approval and individual informed consent from the patients, we evaluated 68 further patients in the above-mentioned COVID hospitals. People with at least eight confirmed symptoms from the questionnaire were prescribed Merc Sol 200c thrice a day for a week. In our 2-week study at both the locations, we observed a speedy recovery and a hospital stay reduction by 5 to 7 days in all the 68 patients when Merc Sol was used along with the standard Indian Council of Medical Research clinical protocol. Many of them were not newly admitted patients but were those who exceeded the mandatory minimum hospital stay. We are now using Merc Sol as a preventive medicine for over 1,000 people in a COVID hot-spot area in Powai, Mumbai, with the expressed permission of local authorities.
Following the Hahnemannian method of arriving at a genus epidemicus [9] (§ 99–103), and deducing it from the combined data of symptoms of more than 100 patients, we arrived at the conclusion that Merc Sol, “the deceitful malefic mercury” known for various symptomatic presentations and tissue destruction, is genus epidemicus of this pandemic. Our efforts are in accordance with the logic of homeopathy proffered by Dr. Stuart Close[10]: exact observation, correct interpretation, rational explanation, and scientific construction.
We now appeal to the global homeopathy community to test our findings in their respective areas, designing specific research projects to explore the utility of Mercurius solubilis in the COVID-19 pandemic as genus epidemicus.
If it were not such a serious matter, I might joke that everyone with a dental amalgam filling must be protected from COVID-19. But it is rather too serious to make fun, I am afraid. Therefore, I will just point out to all those homeopaths across the globe who follow their Indian colleagues’ appeal something rather basic: it is bad science to confirm their hypothesis. Science works by falsifying hypotheses. And a proper hypothesis needs, of course, more that the implausible hunches of some evangelic believers in the homeopathic cult.
Manual therapy is a commonly recommended treatment of low back pain (LBP), yet few studies have directly compared the effectiveness of thrust (spinal manipulation) vs non-thrust (spinal mobilization) techniques. This study evaluated the comparative effectiveness of spinal manipulation and spinal mobilization at reducing pain and disability compared with a placebo control group (sham cold laser) in a cohort of young adults with chronic LBP.
This single-blinded (investigator-blinded), placebo-controlled randomized clinical trial with 3 treatment groups was conducted at the Ohio Musculoskeletal and Neurological Institute at Ohio University from June 1, 2013, to August 31, 2017. Of 4903 adult patients assessed for eligibility, 4741 did not meet inclusion criteria, and 162 patients with chronic LBP qualified for randomization to 1 of 3 treatment groups. Participants received 6 treatment sessions of (1) spinal manipulation, (2) spinal mobilization, or (3) sham cold laser therapy (placebo) during a 3-week period. Licensed clinicians (either a doctor of osteopathic medicine or physical therapist), with at least 3 years of clinical experience using manipulative therapies provided all treatments.
Primary outcome measures were the change from baseline in Numerical Pain Rating Scale (NPRS) score over the last 7 days and the change in disability assessed with the Roland-Morris Disability Questionnaire (scores range from 0 to 24, with higher scores indicating greater disability) 48 to 72 hours after completion of the 6 treatments.
A total of 162 participants (mean [SD] age, 25.0 [6.2] years; 92 women [57%]) with chronic LBP (mean [SD] NPRS score, 4.3 [2.6] on a 1-10 scale, with higher scores indicating greater pain) were randomized.
- 54 participants were randomized to the spinal manipulation group,
- 54 to the spinal mobilization group,
- 54 to the placebo group.
There were no significant group differences for sex, age, body mass index, duration of LBP symptoms, depression, fear avoidance, current pain, average pain over the last 7 days, and self-reported disability. At the primary end point, there was no significant difference in change in pain scores between spinal manipulation and spinal mobilization (0.24 [95% CI, -0.38 to 0.86]; P = .45), spinal manipulation and placebo (-0.03 [95% CI, -0.65 to 0.59]; P = .92), or spinal mobilization and placebo (-0.26 [95% CI, -0.38 to 0.85]; P = .39). There was no significant difference in change in self-reported disability scores between spinal manipulation and spinal mobilization (-1.00 [95% CI, -2.27 to 0.36]; P = .14), spinal manipulation and placebo (-0.07 [95% CI, -1.43 to 1.29]; P = .92) or spinal mobilization and placebo (0.93 [95% CI, -0.41 to 2.29]; P = .17). A comparison of treatment credibility and expectancy ratings across groups was not statistically significant (F2,151 = 1.70, P = .19), indicating that, on average, participants in each group had similar expectations regarding the likely benefit of their assigned treatment.
The authors concluded that in this randomized clinical trial, neither spinal manipulation nor spinal mobilization appeared to be effective treatments for mild to moderate chronic LBP.
This is an exceptionally well-reported study. Yet, one might raise a few points of criticism:
- The comparison of two active treatments makes this an equivalence study, and much larger sample sizes are required or such trials (this does not mean that the comparisons are not valid, however).
- The patients had rather mild symptoms; one could argue that patients with severe pain might respond differently.
- Chiropractors could argue that the therapists were not as expert at spinal manipulation as they are; had they employed chiropractic therapists, the results might have been different.
- A placebo control group makes more sense, if it allows patients to be blinded; this was not possible in this instance, and a better placebo might have produced different findings.
Despite these limitations, this study certainly is a valuable addition to the evidence. It casts more doubt on spinal manipulation and mobilisation as an effective therapy for LBP and confirms my often-voiced view that these treatments are not the best we can offer to LBP-patients.
I have to thank one of our regular commentators for inspiring me to write this post. He recently contributed this insight about homeopathic provings:
If you didn’t experience anything from a proving you didn’t perform it properly.
It is an argument that, in different forms and shapes, I have heard very often. Essentially it holds that, if an investigation or a test fails to produce the desired result, the methodology must have been faulty. Donald Trump is, I fear, about to use it in the upcoming US election: if he is voted out, he will claim that there was too much fraud going on. Therefore, he cannot accept the result as valid. Thus it is his democratic duty to remain in post, he is likely to claim.
In medicine, the argument has been popular since millennia. In our book TRICK OR TREATMENT?, we recount the story of blood letting. Based on the doctrine of the 4 humours, it was believed for centuries to be a panacea. If someone died after losing litres of blood to the believers in the doctrine, the assumption was not that he had been bled to death, but that he had sadly not received enough of the ‘cure all’. Eventually, some bright chap had the novel idea of running a rigorous test of blood-letting, and it turned out that the patients who had received the treatment had a worse chance of survival than those who had escaped it. Aaaahhh !!!, shouted the blood-letters, this shows that the concept of the scientific test is flawed.
Checking the methodological rigour of clinical studies (or homeopathic provings) can be a tricky and tedious business. It requires proper learning and experience – qualities that SCAM fanatics rarely possess. Amongst other things, one needs to know about:
- trial design,
- statistics,
- sources of bias,
- confounding,
- and the many tricks people use to hide flaws in published studies.
This is not easy and it takes time – lots of time – to acquire the necessary skills. Having discussed such issues with enthusiasts of so-called alternative medicine (SCAM) for decades, I realise that it would be unrealistic to expect of them to spend all this time learning all these complicated things (they have to make a living, you know!). I therefore propose an entirely new and much simpler method of differentiating between valid and invalid research of SCAM. It rests on merely 2 golden rules:
- Any research methodology is valid, if it produces the desired result.
- Any research methodology is invalid, if it fails to produce the desired result.
In analogy to these two rules, one can easily extrapolate further. For instance, one can state that:
- any person who generates or promotes the desired result is honest;
- any person who contradicts the desired result is corrupt (bought by ‘Big Pharma’).
I am sure my readers all see the beauty of this revolutionary, new system: it’s easy to learn, practical to apply, it avoids controversy and it takes full account of the previously much-neglected needs of the SCAM fraternity.
