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

methodology

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Osteopathic visceral manipulation (VM) is a bizarre so-called alternative medicine (SCAM) that has been featured on this blog with some regularity, e.g.:

Rigorous trials fail to show that it works for anything. So, the obvious solution to this dilemma is to conduct dodgy trials!

This study tested the effects of VM on dysmenorrhea, irregular, delayed, and/or absent menses, and premenstrual symptoms in PCOS patients.

Thirty Egyptian women with polycystic ovary syndrome (PCOS), with menstruation-related complaints and free from systematic diseases and/or adrenal gland abnormalities, participated in a single-blinded, randomized controlled trial. They were recruited from the women’s health outpatient clinic in the faculty of physical therapy at Cairo University, with an age of 20-34 years, and a body mass index (BMI) ≥25, <30 kg/m2. Patients were randomly allocated into two equal groups (15 patients); the control group received a low-calorie diet for 3 months, and the study group that received the same hypocaloric diet added to VM to the pelvic organs and their related structures for eight sessions over 3 months. Evaluations for body weight, BMI, and menstrual problems were done by weight-height scale, and menstruation-domain of Polycystic Ovary Syndrome Health-Related Quality of Life Questionnaire (PCOSQ), respectively, at baseline and after 3 months from interventions. Data were described as mean, standard deviation, range, and percentage whenever applicable.

Of 60 Egyptian women with PCOS, 30 patients were included, with baseline mean age, weight, BMI, and a menstruation domain score of 27.5 ± 2.2 years, 77.7 ± 4.3 kg, 28.6 ± 0.7 kg/m2, and 3.4 ± 1.0, respectively, for the control group, and 26.2 ± 4.7 years, 74.6 ± 3.5 kg, 28.2 ± 1.1 kg/m2, and 2.9 ± 1.0, respectively, for the study group. Out of the 15 patients in the study group, uterine adhesions were found in 14 patients (93.3%), followed by restricted uterine mobility in 13 patients (86.7%), restricted ovarian/broad ligament mobility (9, 60%), and restricted motility (6, 40%). At baseline, there was no significant difference (p>0.05) in any of the demographics (age, height), or dependent variables (weight, BMI, menstruation domain score) among both groups. Post-study, there was a statistically significant reduction (p=0.000) in weight, and BMI mean values for the diet group (71.2 ± 4.2 kg, and 26.4 ± 0.8 kg/m2, respectively) and the diet + VM group (69.2 ± 3.7 kg; 26.1 ± 0.9 kg/m2, respectively). For the improvement in the menstrual complaints, a significant increase (p<0.05) in the menstruation domain mean score was shown in the diet group (3.9 ± 1.0), and the diet + VM group (4.6 ± 0.5). On comparing both groups post-study, there was a statistically significant improvement (p=0.024) in the severity of menstruation-related problems in favor of the diet + VM group.

The authors concluded that VM yielded greater improvement in menstrual pain, irregularities, and premenstrual symptoms in PCOS patients when added to caloric restriction than utilizing the low-calorie diet alone in treating that condition.

WHERE TO START?

  • Tiny sample size.
  • A trail design (A+B vs B) which will inevitably generate a positive result.
  • Questionable ethics.

VM is a relatively invasive and potentially embarrassing intervention for any woman; I imagine that this is all the more true in Egypt. In such circumstances, it is mandatory to ask whether a planned study is ethically justifiable. I would answer this question related to an implausible treatment like VM with a straight NO!

I realize that there may be people who disagree with me. But even those guys should accept that, at the very minimum, such a study must be designed such that it leads to a clear answer – is VM effective or not? The present trial merely suggests that the placebo effect associated with VM is powerful (which is hardly surprising for a therapy like VM).

Ayush-64 is an Ayurvedic formulation, developed by the Central Council for Research in Ayurvedic Sciences (CCRAS), the apex body for research in Ayurveda under the Ministry of Ayush. Originally developed in 1980 for the management of Malaria, this drug has now been repurposed for COVID-19 as its ingredients showed notable antiviral, immune-modulator, and antipyretic properties. Its ingredients are:

Alstonia scholaris R. Br. Aqueous extract of (Saptaparna) Bark-1 part
Picrorhiza Kurroa Royle Aqueous extract of (Kutki) Rhizome-1 part
Swertia chirata Buch-Ham. Aqueous extract of (Chirata) Whole plant-1 part
Caesalphinia crista, Linn. Fine powder of seed (Kuberaksha) Pulp-2 parts

The crucial question, of course, is does AYUSH-64 work?

An open-label randomized controlled parallel-group trial was conducted at a designated COVID care centre in India with 80 patients diagnosed with mild to moderate COVID-19 and randomized into two groups. Participants in the AYUSH-64 add-on group (AG) received AYUSH-64 two tablets (500 mg each) three times a day for 30 days along with standard conventional care. The control group (CG) received standard care alone.

The outcome measures were:

  • the proportion of participants who attained clinical recovery on days 7, 15, 23, and 30,
  • the proportion of participants with negative RT-PCR assay for COVID-19 at each weekly time point,
  • change in pro-inflammatory markers,
  • metabolic functions,
  • HRCT chest (CO-RADS category),
  • the incidence of Adverse Drug Reaction (ADR)/Adverse Event (AE).

Out of 80 participants, 74 (37 in each group) contributed to the final analysis. A significant difference was observed in clinical recovery in the AG (p < 0.001 ) compared to CG. The mean duration for clinical recovery in AG (5.8 ± 2.67 days) was significantly less compared to CG (10.0 ± 4.06 days). Significant improvement in HRCT chest was observed in AG (p = 0.031) unlike in CG (p = 0.210). No ADR/SAE was observed or reported in AG.

The authors concluded that AYUSH-64 as adjunct to standard care is safe and effective in hastening clinical recovery in mild to moderate COVID-19. The efficacy may be further validated by larger multi-center double-blind trials.

I do object to these conclusions for several reasons:

  1. The study cannot possibly determine the safety of AYUSH-64.
  2. Even for assessing its efficacy, it was too small.
  3. The trial design followed the often-discussed A+B vs B concept and is thus prone to generate false-positive results.

I believe that it is highly irresponsible, during a medical crisis like ours, to conduct studies that can only produce unreliable findings. If there is a real possibility that a therapy might work, we do need to test it, but we should take great care that the test is rigorous enough to generate reliable results. This, I think, is all the more true, if – like in the present case – the study was done with governmental support.

There is a lack of data describing the state of naturopathic or complementary veterinary medicine in Germany. This survey maps the currently used treatment modalities, indications, existing qualifications, and information pathways. It records the advantages and disadvantages of these medicines as experienced by veterinarians. Demographic influences are investigated to describe the distributional impacts of using veterinary naturopathy and complementary medicine.

A standardized questionnaire was used for the cross-sectional survey. It was distributed throughout Germany in a written and digital format from September 2016 to January 2018. Because of the open nature of data collection, the return rate of questionnaires could not be calculated. To establish a feasible timeframe, active data collection stopped when the previously calculated limit of 1061 questionnaires was reached.

With the included incoming questionnaires of that day, a total of 1087 questionnaires were collected. Completely blank questionnaires and those where participants did not meet the inclusion criteria were not included, leaving 870 out of 1087 questionnaires to be evaluated. A literature review and the first test run of the questionnaire identified the following treatment modalities:

  • homeopathy,
  • phytotherapy,
  • traditional Chinese medicine (TCM),
  • biophysical treatments,
  • manual treatments,
  • Bach Flower Remedies,
  • neural therapy,
  • homotoxicology,
  • organotherapy,
  • hirudotherapy.

These were included in the questionnaire. Categorical items were processed using descriptive statistics in absolute and relative numbers based on the population of completed answers provided for each item. Multiple choices were possible.

Overall 85.4% of all the questionnaire participants used naturopathy and complementary medicine. The treatments most commonly used were:

  • complex homoeopathy (70.4%, n = 478),
  • phytotherapy (60.2%, n = 409),
  • classic homoeopathy (44.3%, n = 301),
  • biophysical treatments (40.1%, n = 272).

The most common indications were:

  • orthopedic (n = 1798),
  • geriatric (n = 1428),
  • metabolic diseases (n = 1124).

Over the last five years, owner demand for naturopathy and complementary treatments was rated as growing by 57.9% of respondents (n = 457 of total 789). Veterinarians most commonly used scientific journals and publications as sources for information about naturopathic and complementary contents (60.8%, n = 479 of total 788). These were followed by advanced training acknowledged by the ATF (Academy for Veterinary Continuing Education, an organisation that certifies independent veterinary continuing education in Germany) (48.6%, n = 383). The current information about naturopathy and complementary medicine was rated as adequate or nearly adequate by many (39.5%, n = 308) of the respondents.

The most commonly named advantages in using veterinary naturopathy and complementary medicine were:

  • expansion of treatment modalities (73.5%, n = 566 of total 770),
  • customer satisfaction (70.8%, n = 545),
  • lower side effects (63.2%, n = 487).

The ambiguity and unclear evidence of the mode of action and effectiveness (62.1%, n = 483) and high expectations of owners (50.5%, n = 393) were the disadvantages mentioned most frequently. Classic homoeopathy, in particular, has been named in this context (78.4%, n = 333 of total 425). Age, gender, and type of employment showed a statistically significant impact on the use of naturopathy and complementary medicine by veterinarians (p < 0.001). The university of final graduation showed a weaker but still statistically significant impact (p = 0.027). Users of veterinary naturopathy and complementary medicine tended to be older, female, self-employed and a higher percentage of them completed their studies at the University of Berlin. The working environment (rural or urban space) showed no statistical impact on the veterinary naturopathy or complementary medicine profession.

The authors concluded that this is the first study to provide German data on the actual use of naturopathy and complementary medicine in small animal science. Despite a potential bias due to voluntary participation, it shows a large number of applications for various indications. Homoeopathy was mentioned most frequently as the treatment option with the most potential disadvantages. However, it is also the most frequently used treatment option in this study. The presented study, despite its restrictions, supports the need for a discussion about evidence, official regulations, and the need for acknowledged qualifications because of the widespread application of veterinary naturopathy and complementary medicine. More data regarding the effectiveness and the mode of action is needed to enable veterinarians to provide evidence-based advice to pet owners.

I can only hope that the findings are seriously biased and not a true reflection of the real situation. The methodology used for recruiting participants (it is fair to assume that those vets who had no interest in SCAM did not bother to respond) strongly indicates that this might be the case. If, however, the findings were true, one would have to conclude that, for German vets, evidence-based healthcare is still an alien concept. The evidence that the preferred SCAMs are effective for the listed conditions is very weak or even negative. If the findings were true, one would need to wonder how much of veterinary SCAM use amounts to animal abuse.

The objective of this study was to compare chronic low back pain patients’ perspectives on the use of spinal manipulative therapy (SMT) compared to prescription drug therapy (PDT) with regard to health-related quality of life (HRQoL), patient beliefs, and satisfaction with treatment.

Four cohorts of Medicare beneficiaries were assembled according to previous treatment received as evidenced in claims data:

  1. The SMT group began long-term management with SMT but no prescribed drugs.
  2. The PDT group began long-term management with prescription drug therapy but no spinal manipulation.
  3. This group employed SMT for chronic back pain, followed by initiation of long-term management with PDT in the same year.
  4. This group used PDT for chronic back pain followed by initiation of long-term management with SMT in the same year.

A total of 1986 surveys were sent out and 195 participants completed the survey. The respondents were predominantly female and white, with a mean age of approx. 77-78 years. Outcome measures used were a 0-to-10 numeric rating scale to measure satisfaction, the Low Back Pain Treatment Beliefs Questionnaire to measure patient beliefs, and the 12-item Short-Form Health Survey to measure HRQoL.

Recipients of SMT were more likely to be very satisfied with their care (84%) than recipients of PDT (50%; P = .002). The SMT cohort self-reported significantly higher HRQoL compared to the PDT cohort; mean differences in physical and mental health scores on the 12-item Short Form Health Survey were 12.85 and 9.92, respectively. The SMT cohort had a lower degree of concern regarding chiropractic care for their back pain compared to the PDT cohort’s reported concern about PDT (P = .03).

The authors concluded that among older Medicare beneficiaries with chronic low back pain, long-term recipients of SMT had higher self-reported rates of HRQoL and greater satisfaction with their modality of care than long-term recipients of PDT. Participants who had longer-term management of care were more likely to have positive attitudes and beliefs toward the mode of care they received.

The main issue here is that the ‘study’ was a mere survey which by definition cannot establish cause and effect. The groups were different in many respects which rendered them not comparable. For instance, participants who received SMT had higher self-reported physical and mental health on average than those who received PDT. Differences also existed between the SMT and the PDT groups for agreement with the notion that “spinal manipulation for LBP makes a lot of sense”; 96% of the SMT group and 35% of the PDT group agreed with it. Compare this with another statement, “taking /having prescription drug therapy for LBP makes a lot of sense” and we find that only 13% of the SMT cohort agreed with, 95% of the PDT cohort agreed. Thus, a powerful bias exists toward the type of therapy that each person had chosen. Another determinant of the outcome is the fact that SMT means hands-on treatments with time, compassion, and empathy given to the patient, whereas PDT does not necessarily include such features. Add to these limitations the dismal response rate, recall bias, and numerous potential confounders and you have a survey that is hardly worth the paper it is printed on. In fact, it is little more than a marketing exercise for chiropractic.

In summary, the findings of this survey are influenced by a whole range of known and unknown factors other than the SMT. The authors are clever to avoid causal inferences in their conclusions. I doubt, however, that many chiropractors reading the paper think critically enough to do the same.

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.

 

Today, several UK dailies report about a review of osteopathy just published in BMJ-online. The aim of this paper was to summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions. The authors conducted an overview of systematic reviews (SRs) and meta-analyses (MAs). SRs and MAs of randomised controlled trials evaluating the efficacy and safety of OMT for any condition were included.

The literature searches revealed nine SRs or MAs conducted between 2013 and 2020 with 55 primary trials involving 3740 participants. The SRs covered a wide range of conditions including

  • acute and chronic non-specific low back pain (NSLBP, four SRs),
  • chronic non-specific neck pain (CNSNP, one SR),
  • chronic non-cancer pain (CNCP, one SR),
  • paediatric (one SR),
  • neurological (primary headache, one SR),
  • irritable bowel syndrome (IBS, one SR).

Although with different effect sizes and quality of evidence, MAs reported that OMT is more effective than comparators in reducing pain and improving the functional status in acute/chronic NSLBP, CNSNP and CNCP. Due
to the small sample size, presence of conflicting results and high heterogeneity, questionable evidence existed on OMT efficacy for paediatric conditions, primary headaches and IBS. No adverse events were reported in most SRs. The methodological quality of the included SRs was rated low or critically low.

The authors concluded that based on the currently available SRs and MAs, promising evidence suggests the possible effectiveness of OMT for musculoskeletal disorders. Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS. Further well-conducted SRs and MAs are needed to confirm and extend the efficacy and safety of OMT.

This paper raises several questions. Here a just the two that bothered me most:

  1. If the authors had truly wanted to evaluate the SAFETY of OMT (as they state in the abstract), they would have needed to look beyond SRs, MAs or RCTs. We know – and the authors of the overview confirm this – that clinical trials of so-called alternative medicine (SCAM) often fail to mention adverse effects. This means that, in order to obtain a more realistic picture, we need to look at case reports, case series and other observational studies. It also means that the positive message about safety generated here is most likely misleading.
  2. The authors (the lead author is an osteopath) might have noticed that most – if not all – of the positive SRs were published by osteopaths. Their assessments might thus have been less than objective. The authors did not include one of our SRs (because it fell outside their inclusion period). Yet, I do believe that it is one of the few reviews of OMT for musculoskeletal problems that was not done by osteopaths. Therefore, it is worth showing you its abstract here:

The objective of this systematic review was to assess the effectiveness of osteopathy as a treatment option for musculoskeletal pain. Six databases were searched from their inception to August 2010. Only randomized clinical trials (RCTs) were considered if they tested osteopathic manipulation/mobilization against any control intervention or no therapy in human with any musculoskeletal pain in any anatomical location, and if they assessed pain as an outcome measure. The selection of studies, data extraction, and validation were performed independently by two reviewers. Studies of chiropractic manipulations were excluded. Sixteen RCTs met the inclusion criteria. Their methodological quality ranged between 1 and 4 on the Jadad scale (max = 5). Five RCTs suggested that osteopathy compared to various control interventions leads to a significantly stronger reduction of musculoskeletal pain. Eleven RCTs indicated that osteopathy compared to controls generates no change in musculoskeletal pain. Collectively, these data fail to produce compelling evidence for the effectiveness of osteopathy as a treatment of musculoskeletal pain.

It was published 11 years ago. But I have so far not seen compelling evidence that would make me change our conclusion. As I state in the newspapers:

OSTEOPATHY SHOULD BE TAKEN WITH A SIZABLE PINCH OF SALT.

 

 

This randomized, double-blind, two-armed, parallel, single-center, placebo-controlled study investigated the effectiveness and safety of the homeopathic medicine, Natrum muriaticum LM2, for mild cases of COVID-19.

Participants aged > 18 years, with influenza-like symptoms and a positive COVID test were recruited and randomized (1:1) into two groups that received different treatments during a period of at-home isolation. One group received the homeopathic medicine Natrum muriaticum, prepared with the second degree of the fifty-millesimal dynamization (LM2; Natrum muriaticum LM2), while the other group received a placebo.

The primary endpoint was time until recovery from COVID-19 influenza-like symptoms. Secondary measures included a survival analysis of the number and severity of COVID-19 symptoms (influenza-like symptoms plus anosmia and ageusia) from a symptom grading scale that was informed by the participant, hospital admissions, and adverse events. Kaplan-Meier curves were used to estimate time-to-event (survival) measures.

Data from 86 participants were analyzed (homeopathy, n = 42; placebo, n = 44). There was no difference in time to recovery between the two groups (homeopathy, n = 41; placebo, n = 41; P = 0.56), nor in a sub-group that had at least 5 moderate to severe influenza-like symptoms at the beginning of monitoring (homeopathy, n = 15; placebo, n = 17; P = 0.06). Secondary outcomes indicated that a 50% reduction in symptom score was achieved significantly earlier in the homeopathy group (homeopathy, n = 24; placebo, n = 25; P = 0.04), among the participants with a basal symptom score ≥ 5. Moreover, values of restricted mean survival time indicated that patients receiving homeopathy might have improved 0.9 days faster during the first five days of follow-up (P = 0.022). Hospitalization rates were 2.4% in the homeopathy group and 6.8% in the placebo group (P = 0.62). Participants reported 3 adverse events in the homeopathy group and 6 in the placebo group.

The authors concluded that the results showed that Natrum muriaticum LM2 was safe to use for COVID-19, but there was no statistically significant difference in the primary endpoints of Natrum muriaticum LM2 and placebo for mild COVID-19 cases. Although some secondary measures do not support the null hypothesis, the wide confidence intervals suggest that further studies with larger sample sizes and more symptomatic participants are needed to test the effectiveness of homeopathic Natrum muriaticum LM2 for COVID-19.

Homeopaths will probably claim that the trial was negative because homeopathic treatments must be individualized (true only for one school of homeopathy). More rational thinkers might point out that the study was woefully underpowered and therefore the positive trends seen in some of the subgroups are nothing other than background noise. Others again might notice that, due to the small sample size, the randomization was not successful in generating comparable groups: the placebo group was older, had more pre-existing conditions, and took more conventional medication than the homeopathy group. And they might point out that these differences could easily explain some of the findings.

Whichever way we turn it, the bottom line is simple:

Homeopathy is ineffective for COVID infections.

Ginseng plants belong to the genus Panax and include:

  • Panax ginseng (Korean ginseng),
  • Panax notoginseng (South China ginseng),
  • and Panax quinquefolius (American ginseng).

They are said to have a range of therapeutic activities, some of which could render ginseng a potential therapy for viral or post-viral infections. Ginseng has therefore been used to treat fatigue in various patient groups and conditions. But does it work for chronic fatigue syndrome (CFS), also often called myalgic encephalomyelitis (ME)? This condition is a complex, little-understood, and often disabling chronic illness for which no curative or definitive therapy has yet been identified.

This systematic review aimed to assess the current state of evidence regarding ginseng for CFS. Multiple databases were searched from inception to October 2020. All data was extracted independently and in duplicates. Outcomes of interest included the effectiveness and safety of ginseng in patients with CFS.

A total of two studies enrolling 68 patients were deemed eligible: one randomized clinical trial and one prospective observational study. The certainty of evidence in the effectiveness outcome was low and moderate in both studies, while the safety evidence was very low as reported from one study.

The authors concluded that the study findings highlight a potential benefit of ginseng therapy in the treatment of CFS. However, we are not able to draw firm conclusions due to limited clinical studies. The paucity of data warrants limited confidence. There is a need for future rigorous studies to provide further evidence.

To get a feeling of how good or bad the evidence truly is, we must of course look at the primary studies.

The prospective observational study turns out to be a mere survey of patients using all sorts of treatments. It included 155 subjects who provided information on fatigue and treatments at baseline and follow-up. Of these subjects, 87% were female and 79% were middle-aged. The median duration of fatigue was 6.7 years. The percentage of users who found a treatment helpful was greatest for coenzyme Q10 (69% of 13 subjects), dehydroepiandrosterone (DHEA) (65% of 17 subjects), and ginseng (56% of 18 subjects). Treatments at 6 months that predicted subsequent fatigue improvement were vitamins (p = .08), vigorous exercise (p = .09), and yoga (p = .002). Magnesium (p = .002) and support groups (p = .06) were strongly associated with fatigue worsening from 6 months to 2 years. Yoga appeared to be most effective for subjects who did not have unclear thinking associated with fatigue.

The second study investigated the effect of Korean Red Ginseng (KRG) on chronic fatigue (CF) by various measurements and objective indicators. Participants were randomized to KRG or placebo group (1:1 ratio) and visited the hospital every 2 weeks while taking 3 g KRG or placebo for 6 weeks and followed up 4 weeks after the treatment. The fatigue visual analog score (VAS) declined significantly in each group, but there were no significant differences between the groups. The 2 groups also had no significant differences in the secondary outcome measurements and there were no adverse events. Sub-group analysis indicated that patients with initial fatigue VAS below 80 mm and older than 50 years had significantly greater reductions in the fatigue VAS if they used KRG rather than placebo. The authors concluded that KRG did not show absolute anti-fatigue effect but provided the objective evidence of fatigue-related measurement and the therapeutic potential for middle-aged individuals with moderate fatigue.

I am at a loss in comprehending how the authors of the above-named review could speak of evidence for potential benefit. The evidence from the ‘observational study’ is largely irrelevant for deciding on the effectiveness of ginseng, and the second, more rigorous study fails to show that ginseng has an effect.

So, is ginseng a promising treatment for ME?

I doubt it.

Horticultural therapy (HT)?

What on earth is that?

Don’t worry, it was new to me too and I first thought of the treatment of plants.

HT is said to be a “time-proven practice. The therapeutic benefits of garden environments have been documented since ancient times. In the 19th century, Dr. Benjamin Rush, a signer of the Declaration of Independence and recognized as the “Father of American Psychiatry,” was first to document the positive effect working in the garden had on individuals with mental illness. In the 1940s and 1950s, rehabilitative care of hospitalized war veterans significantly expanded acceptance of the practice. No longer limited to treating mental illness, horticultural therapy practice gained in credibility and was embraced for a much wider range of diagnoses and therapeutic options. Today, horticultural therapy is accepted as a beneficial and effective therapeutic modality. It is widely used within a broad range of rehabilitative, vocational, and community settings. Horticultural therapy techniques are employed to assist participants to learn new skills or regain those that are lost. Horticultural therapy helps improve memory, cognitive abilities, task initiation, language skills, and socialization. In physical rehabilitation, horticultural therapy can help strengthen muscles and improve coordination, balance, and endurance. In vocational horticultural therapy settings, people learn to work independently, problem solve, and follow directions. Horticultural therapists are professionals with specific education, training, and credentials in the use of horticulture for therapy and rehabilitation. Read the formal definition of the role of horticultural therapists.”

As always, the question is DOES IT WORK?

This systematic review and meta-analysis aimed to evaluate HT for general health in older adults. Electronic databases as well as grey literature databases, and clinical trials registers were searched from inception to March 2021. Randomized controlled trials (RCTs), quasi-RCTs (QRCTs), and cohort studies about HT for adults aged over 60 were included in this review. Outcome measures were physical function, quality of life, BMI, mood tested by self-reported questionnaire and the expression of the immune cells.

Fifteen studies (thirteen RCTs and two cohort studies) involving 1046 older participants were included. Meta-analysis showed that HT resulted in better quality of life (MD 2.09, 95% CI [1.33, 2.85], P<0. 01) and physical function (SMD 0.82, 95% [0.36, 1.29], P<0.01) compared with no-gardener; the similar findings showed in BMI (SMD -0.30, 95% [-0.57, -0.04], P = 0.02) and mood tested by self-reported questionnaire (SMD 2.80, 95% CI [1.82, 3.79], P<0. 01). And HT might be beneficial for blood pressure and immunity, while all the evidence was moderate-quality judged by GRADE.

The authors concluded that HT may improve physical function and quality of life in older adults, reduce BMI and enhance positive mood. A suitable duration of HT may be between 60 to 120 minutes per week lasting 1.5 to 12 months. However, it remains unclear as to what constitutes an optimal recommendation.

I have considerable problems with this review and its conclusion:

  • It is simply untrue that there were 13 RCTs; several of these studies were clearly not randomized.
  • Most of the studies are of very poor quality. For instance, they often did not make the slightest attempt to control for non-specific effects, yet they concluded that the observed outcome was a specific effect of HT.

My biggest problem does, however, not relate to methodological issues. My main issue with this paper is one of definition. What is a ‘therapy’ and what not? If we call a bit of gardening a ‘therapy’ are we not descending to the level of those who call a bit of shopping ‘retail therapy’? To put it differently, is HT superior to retail therapy? And do we need RCTs to answer this question?

What is wrong with encouraging people who like gardening to just do it? I, for instance, like drumming; but I do not believe we need a few RCTs to prove that it is healthy. Not every past-time or hobby that makes you feel good is a therapy and needs to be scrutinized as such.

 

 

You haven’t heard of religious/spiritual singing and movement as a treatment for mental health?

Me neither!

But it does exist. This review explored the evidence of religious/spiritual (R/S) singing and R/S movement (dynamic meditation and praise dance), in relation to mental health outcomes.

After registering with PROSPERO (CRD42020189495), a systematic search of three major databases (CINAHL, MEDLINE, and PsycINFO) was undertaken using predetermined eligibility criteria. Reference lists of identified papers and additional sources such as Google Scholar were searched. The quality of studies was assessed using the Mixed Method Appraisal Tool (MMAT). Data were extracted, tabulated, and synthesized according to the Preferred Reporting Items for Systematic Reviews (PRISMA) guidelines.

Seven of the 259 identified articles met inclusion criteria. Three studies considered R/S singing, while four considered R/S movement. In R/S movements, three studies considered dynamic meditation while one investigated praise dance. Although moderate to poor in quality, included studies indicated a positive trend for the effectiveness of R/S singing and movement in dealing with mental health concerns.

The authors concluded that, while R/S singing and R/S movement (praise dance and dynamic meditation) may be of value as mental health strategies, findings of the review need to be considered with caution due to methodological constraints. The limited number and poor quality of included studies highlight the need for further quality research in these R/S practices in mental health.

I am glad the authors caution us not to take their findings seriously. To be honest, I was not in danger of making this mistake. Neither do I feel the need for further research in this area. Mental health is a serious issue, and personally, I think we should research it not by conducting ridiculous studies of implausible modalities.

PS

I do not doubt that the experience of singing or movement can help in certain situations. However, I have my doubts about religious/spiritual singing and movement therapy.

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