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

aromatherapy

The Sunday Times reported yesterday reported that five NHS trusts currently offer moxibustion to women in childbirth for breech babies, i.e. babies presenting upside down. Moxibustion is a form of Traditional Chinese Medicine (TCM) where mugwort is burned close to acupuncture points. The idea is that this procedure would stimulate the acupuncture point similar to the more common way using needle insertion. The fifth toe is viewed as the best traditional acupuncture point for breech presentation, and the treatment is said to turn the baby in the uterus so that it can be delivered more easily.

At least four NHS trusts are offering acupuncture and reflexology with aromatherapy to help women with delayed pregnancies, while 15 NHS trusts offer hypnobirthing classes. Some women are asked to pay fees of up to £140 for it. These treatments are supposed to relax the mother in the hope that this will speed up the process of childbirth.

The Nice guidelines on maternity care say the NHS should not offer acupuncture, acupressure, or hypnosis unless specifically requested by women. The reason for the Nice warning is simple: there is no convincing evidence that these therapies are effective.

Campaigner Catherine Roy who compiled the list of treatments said: “To one degree or another, the Royal College of Midwives, the Care Quality Commission and parts of the NHS support these pseudoscientific treatments.

“They are seen as innocuous but they carry risks, can delay medical help and participate in an anti-medicalisation stance specific to ‘normal birth’ ideology and maternity care. Nice guidelines are clear that they should not be offered by clinicians for treatment. NHS England must ensure that pseudoscience and non-evidence based treatments are removed from NHS maternity care.”

Birte Harlev-Lam, executive director of the Royal College of Midwives (RCM), said: “We want every woman to have as positive an experience during pregnancy, labour, birth and the postnatal period as possible — and, most importantly, we want that experience to be safe. That is why we recommend all maternity services to follow Nice guidance and for midwives to practise in line with the code set out by the Nursing and Midwifery Council.”

A spokeswoman for Nice said it was reviewing its maternity guidelines. NHS national clinical director for maternity and women’s health, Dr Matthew Jolly, said: “All NHS services are expected to offer safe and personalised clinical care and local NHS areas should commission core maternity services using the latest NICE and clinical guidance. NHS trusts are under no obligation to provide complementary or alternative therapies on top of evidence-based clinical care, but where they do in response to the wishes of mothers it is vital that the highest standards of safety are maintained.”

On this blog, we have repeatedly discussed the strange love affair of midwives with so-called alternative medicine (SCAM), for instance, here. In 2012, we published a summary of 19 surveys on the subject. It showed that the prevalence of SCAM use varied but was often close to 100%. Much of it did not seem to be supported by strong evidence for efficacy. We concluded that most midwives seem to use SCAM. As not all SCAMs are without risks, the issue should be debated openly. Today, there is plenty more evidence to show that the advice of midwives regarding SCAM is not just not evidence-based but also often dangerous. This, of course, begs the question: when will the professional organizations of midwifery do something about it?

The tales of Kate Moss’s excesses are legendary. Sex and drugs and rock ‘n’ roll have always been an integral part of the supermodel’s life. Stories of wild behavior, random sexual encounters, and copious drug use seemed endless. Now, it seems she is adding a new element to her tumultuous career:

Quackery.

The supermodel is the latest in the long line of VIPs jumping on the quackery bandwagon by marketing her very own brand of over-priced nonsense. She was reported to have worked with Victoria Young, a homeopath and “spiritual guide”, on the products. There’s a Dawn Tea at £20 for 25 tea bags, “inspired by Kate’s English garden” – “With ingredients like hibiscus, rosemary, and nettle leaf, this first step of the Dawn Ritual gently energizes and strengthens the body”. There’s also a Dusk Tea.

There is also a 100ml bottle called Sacred Mist for £120. It is described as “a unique eau de parfum blended with essential oils for the body and surroundings.” There’s a 30ml bottle for £105 called Golden Nectar, which is pro-collagen. CBD oil drops to “holistically support body, mind, and soul”. A 50ml face cream for £95. A 100ml face cleanser for £52.

The website of Moss’ new enterprise claims that “COSMOSS draws on the extraordinary life experience of Kate Moss — someone whose career and image has touched on and influenced so many others and yet has taken her own, rich journey of transformation gradually and privately. COSMOSS is a celebration of every day exactly as it is, with all its imperfections. Each product has been meticulously crafted with wellbeing in mind, using potent, natural substances. Each ritual opens a door to balance, restoration, and love; each fragrance and infusion recentres and completes. COSMOSS is self-care created for life’s modern journeys to make them beautiful, mesmerising and magical.”

In a far cry from her past, Moss explained: “I’ve been meditating, doing yoga, just being much healthier. All the stuff that can make you feel more grounded and balanced.”

Personally, I am glad to hear that Kate is off cocaine and now into other, less harmful ‘natural substances’. Her customers wellbeing might not improve, but I suspect her bank account might.

An article in THE TIMES seems worth mentioning. Here are some excerpts:

… Maternity care at Nottingham University Hospitals NHS Trust (NUH) is the subject of an inquiry, prompted by dozens of baby deaths. More than 450 families have now come forward to take part in the review, led by the expert midwife Donna Ockenden. The trust now faces further scrutiny over its use of aromatherapy, after experts branded guidelines at the trust “shocking” and not backed by evidence. Several bereaved families have said they recall aromatherapy being heavily promoted at the trust’s maternity units.

It is being prosecuted over the death of baby Wynter Andrews just 23 minutes after she was born in September 2019. Her mother Sarah Andrews wrote on Twitter that she remembered aromatherapy being seen as “the answer to everything”. Internal guidelines, first highlighted by the maternity commentator Catherine Roy, suggest using essential oils if the placenta does not follow the baby out of the womb quickly enough…  the NUH guidelines say aromatherapy can help expel the placenta, and suggest midwives ask women to inhale oils such as clary sage, jasmine, lavender or basil, while applying others as an abdominal compress. They also describe the oils as “extremely effective for the prevention of and, in some cases, the treatment of infection”. The guidelines also suggest essential oils to help women suffering from cystitis, or as a compress on a caesarean section wound. Nice guidelines for those situations do not recommend aromatherapy…

The NUH adds frankincense “may calm hysteria” and is “recommended in situations of maternal panic”. Roy said: “It is shocking that dangerous advice seemed to have been approved by a team of healthcare professionals at NUH. There is a high tolerance for pseudoscience in NHS maternity care … and it needs to stop. Women deserve high quality care, not dangerous quackery.” …

________________________________

The journalist who wrote the article also asked me for a comment, and I emailed her this quote: “Aromatherapy is little more than a bit of pampering; no doubt it is enjoyable but it is not an effective therapy for anything. To use it in medical emergencies seems irresponsible to say the least.” The Times evidently decided not to include my thoughts.

Having now read the article, I checked again and failed to find good evidence for aromatherapy for any of the mentioned conditions. However, I did find an article and an announcement both of which are quite worrying, in my view:

Aromatherapy is often misunderstood and consequently somewhat marginalized. Because of a basic misinterpretation, the integration of aromatherapy into UK hospitals is not moving forward as quickly as it might. Aromatherapy in UK is primarily aimed at enhancing patient care or improving patient satisfaction, and it is frequently mixed with massage. Little focus is given to the real clinical potential, except for a few pockets such as the Micap/South Manchester University initiative which led to a Phase 1 clinical trial into the effects of aromatherapy on infection carried out in the Burns Unit of Wythenshawe Hospital. This article discusses the expansion of aromatherapy within the US and follows 10 years of developing protocols and policies that led to pilot studies on radiation burns, chemo-induced nausea, slow-healing wounds, Alzheimers and end-of-life agitation. The article poses two questions: should nursing take aromatherapy more seriously and do nurses really need 60 hours of massage to use aromatherapy as part of nursing practice?

My own views on aromatherapy are expressed in our now not entirely up-to-date review:

Aromatherapy is the therapeutic use of essential oil from herbs, flowers, and other plants. The aim of this overview was to provide an overview of systematic reviews evaluating the effectiveness of aromatherapy. We searched 12 electronic databases and our departmental files without restrictions of time or language. The methodological quality of all systematic reviews was evaluated independently by two authors. Of 201 potentially relevant publications, 10 met our inclusion criteria. Most of the systematic reviews were of poor methodological quality. The clinical subject areas were hypertension, depression, anxiety, pain relief, and dementia. For none of the conditions was the evidence convincing. Several SRs of aromatherapy have recently been published. Due to a number of caveats, the evidence is not sufficiently convincing that aromatherapy is an effective therapy for any condition.

In this context, it might also be worth mentioning that we warned about the frequent usage of quackery in midwifery years ago. Here is our systematic review of 2012 published in a leading midwifery journal:

Background: in recent years, several surveys have suggested that many midwives use some form of complementary/alternative therapy (CAT), often without the knowledge of obstetricians.

Objective: to systematically review all surveys of CAT use by midwives.

Search strategy: six electronic databases were searched using text terms and MeSH for CAT and midwifery.

Selection criteria: surveys were included if they reported quantitative data on the prevalence of CAT use by midwives.

Data collection and analysis: full-text articles of all relevant surveys were obtained. Data were extracted according to pre-defined criteria.

Main results: 19 surveys met the inclusion criteria. Most were recent and from the USA. Prevalence data varied but were usually high, often close to 100%. Much use of CATs does not seem to be supported by strong evidence for efficacy.

Conclusion: most midwives seem to use CATs. As not all CATs are without risks, the issue should be debated openly.

I am tired of saying ‘I TOLD YOU SO!’ but nevertheless find it a pity that our warning remained (yet again) unheeded!

Two million people in UK are estimated to be currently suffering from long COVID, says the Office for National Statistics. Fatigue continues to be the most common symptom – experienced by 55% of those with self-reported long COVID – followed by 32% with shortness of breath, 23% with a cough, and 23% with muscle ache. The problem is only going to increase in the near future. Thus, many people are frantically looking for an effective therapy. Practitioners of so-called alternative medicine (SCAM) are no exception.

This study aimed to evaluate the potential for inhalation of essential oils to improve energy levels among otherwise healthy female survivors of acute COVID-19 who experience a lack of energy more than five months after recovery.

This was a randomized double-blind, placebo-controlled trial to evaluate the potential for inhalation of Longevity™, a proprietary essential oil blend manufactured by Young Living Essential Oils (Lehi, Utah, USA), on energy levels among female survivors of COVID-19 who continue to experience fatigue more than 5 months recovery from the acute infection. Forty women were randomized to two groups: intervention and placebo. The placebo product contained an inert, odorless fractionated coconut oil. Both groups inhaled the assigned product twice daily for fourteen consecutive days. Fatigue scores were measured using the Multidimensional Fatigue Symptom Inventory (MFSI). Secondary outcomes included scores on each of the MFSI’s ten subscales.

Individuals who inhaled the essential oil blend for 2 weeks had significantly lower fatigue scores after controlling for baseline scores, employment status, BMI, olfactory function, and time since diagnosis, with a large effect size (F (1,39) = 6.15, p = .020, partial eta squared = 0.198). Subscale analysis identified subscales of vigor, as well as global, behavioral, general, and mental fatigue as benefiting from the intervention. This study provides evidence that a proprietary aromatherapy blend can significantly improve energy levels among women who are experiencing fatigue after recovering from COVID-19.

The authors concluded that the use of aromatherapy with Longevity™ essential oil blend to boost energy levels in women who have recovered from COVID-19 provides a novel, non-invasive approach to improving quality of life in this population. This intervention is particularly beneficial for global and mental fatigue, as well as vigor. Other subdomains may experience improvements to energy levels with a smaller effect size; future studies should be conducted to explore this potential.

This trial was funded by Young Living Essential Oils. Perhaps, this explains why there is no mention of the elephant in the room: the trial was not blind! Participants in the verum group knew that they received aromatherapy. Likewise, participants in the placebo group knew that they received the placebo.

Could this fact have influenced the outcome? Certainly!

Could the trial have been designed better? Certainly!

All the investigators needed to do is to use a nice-smelling oil that, according to aromatherapists, does not boost energy, as the placebo.

As it stands, we have no idea whether the authors’ assumption that the verum oil caused the effect is true.

Pity!

Or maybe not?

Perhaps Young Living Essential Oils, the sponsor of the study and producer of the oil never wanted to know the truth. Maybe they are happy to abuse science as a marketing tool?

Aromatherapy, the use of essential oils for medicinal purposes, exists in several guises. One of them is inhalation aromatherapy which is a complementary therapy used in different clinical settings. But is there any sound evidence about its effectiveness?

The aim of this review was to assess the effectiveness of inhalational aromatherapy in the care of hospitalized pediatric patients.

A systematic review of clinical trials and quasi-experimental studies was conducted, based on PRISMA recommendations, searching Medline, Web of ScienceScopus, SciELO, LILACS, CINAHLScience Direct, EBSCO, and updated databases. The Down and Black 2020, RoB 2020 CLARITY, and ROBINS-I 2020 scales were used through the Distiller SR software to verify the studies’ internal validity and risk of bias.

From 446 articles identified, 9 fulfilled the inclusion criteria. Seven were randomized controlled trials (RCTs), one pilot RCT, and one non-randomized quasi-experimental trial.

Different outcomes were analyzed, with pain being the most frequently measured variable. None of the 6 studies that evaluated pain showed significant effects with inhalation aromatherapy. Additionally, non-significant effects were found regarding nausea, vomiting, and behavioral/emotional variables.

The authors concluded that the findings are still inconclusive, and more evidence is required from future studies with high methodological quality, blinding, and adequate sample sizes.

Inconclusive?

Really?

Call me a skeptic, but I think the findings show quite clearly that there is no sound evidence to suggest that inhalation aromatherapy might be effective for kids.

Psychosocial distress, depression, or anxiety are frequent problems of women after a breast cancer diagnosis and treatment. Many try so-called alternative medicine (SCAM) in an attempt to deal with them. But is this effective?

The purpose of this study was to assess the potential benefit of lavender oil as a perioperative adjunct to improve anxiety, depression, pain, and sleep in women undergoing microvascular breast reconstruction.

This was a prospective, single-blinded, randomized, controlled trial of 49 patients undergoing microvascular breast reconstruction. Patients were randomized to receive lavender oil or a placebo (coconut oil) throughout their period of hospitalization. The effect of lavender oil on perioperative stress, anxiety, depression, sleep, and pain was measured using the hospital anxiety and depression scale, Richards-Campbell Sleep Questionnaire, and the visual analogue scale.

Twenty-seven patients were assigned to the lavender group and 22 patients were assigned to the control group. No significant differences were seen in the perioperative setting between the groups with regard to anxiety (p = 0.82), depression, sleep, or pain scores. No adverse events were noted, and no significant differences in surgery-related complications were observed. When evaluating the entire cohort, postoperative anxiety scores were significantly lower than preoperative scores, while depression scores were significantly higher postoperatively as compared with preoperatively.

The authors concluded that, in the setting of microvascular breast reconstruction, lavender oil and aromatherapy had no significant adverse events or complications; however, there were no measurable advantages pertaining to metrics of depression, anxiety, sleep, or pain as compared with the control group.

One could argue that the sample size of the trial was too low to pick up small differences in the outcome measures. Yet, even then, the findings do not suggest that the treatment did make a large enough difference to justify the effort and expense of the treatment.

One could also argue that – who cares? – if a patient wants aromatherapy (or another SCAM that is harmless), why not? The answer to this is the fact that researchers have the ethical duty to identify the most effective treatment, and clinicians have the ethical duty to employ not just any odd therapy but the one that works demonstrably best. Seen from this perspective, the place of SCAM in cancer care seems far less certain than many enthusiasts try to make us believe.

Who does not like a nice fragrance?

Who would object to aromatherapy?

Nobody, I suppose.

But, if its called THERAPY, we surely must ask whether it is therapeutic. And is aromatherapy therapeutic? Let’s see:

This randomized, placebo-controlled clinical trial tested whether patients with post-dural puncture headache (PDPH) caused by spinal anesthesia would benefit from aromatherapy. A total od 50 patients received 15-minute inhalations of either lavender oil or liquid paraffin as placebo. The severity of headache was scored before (baseline) and after the intervention – immediately, 30, 60, 90, and 120 minutes after – using a visual analog scale. In addition, the dosage and frequency of the pain killers as well as adverse effects of the intervention were recorded.

Both groups showed a reduction in headache scores post intervention. However, the headache scores between the groups was significantly different immediately after the intervention in favor of lavender oil (difference: 1.60 ± 0.63, P = .015). Furthermore, it was observed that the mean changes of the headache scores compared to the baseline were significant at each time interval in favor of the placebo group (P < .05), except immediately after the intervention. No significant difference was observed in Diclofenac intake between groups (P = .440), and no adverse effects were noted.

The authors concluded that aromatherapy with lavender oil was observed to reduce the severity of PDPH only immediately after the intervention, while only minimal effects were observed at successive time intervals. However, it is noted that the study was likely underpowered and further studies are recommended to better understand the effects of lavender oil on PDPH and compare its effects to other herbal products or pharmacological agents commonly used for managing headaches.

I find it laudable that some researchers conduct clinical trials even of so-called alternative medicines (SCAMs) which many of us might view as trivial. I find it more laudable that they try to do this rigorously by adding a placebo control group to the study. And I would find it even more laudable, if they did this adequately.

Considering parafin oil to be a placebo in a study of lavender oil inhalation can hardly be called adequate. Placebos are used in clinical trials mostly to account for the expectation of patients. This means that, whenever possible, patients need to be blinded to the group aloocation and the placebo must be indistinguishable from the verum. In the present trial, the patients could obviously tell the difference between the smell of lavender and the absence of any smell in the control group. Thus, their expectation could easily suffice to bring about the findings observed in the study. This means that the trial does not neccessarily demonstrate the effects of armoatherapy, but might (and most probably does) merely show the power of expectation.

How can one design such a trial more rigorously? you will ask.

There are several options. For instance, for the control group, one could use an artificial fragrance not made from natural lavender. Alternatively, one could include only patients who are unfamiliar with the smell of lavender and use a similaryly pleasant fragrance from a different plant as the control intervention.

As it stands, the study – even though aimed at testing the hypothesis that aromatherpy with lavender has specific effects on pain – tells us next to nothing.

… except, of course that it is always worth thinking very carefully about the adequate way to conduct a clinical trial.

In these pre-Xmas days, many homes will smell of cinnamon. It’s certainly a wonderful spice for creating an atmosphere. But ther are also other uses for ciannamon.

Current treatments for overactive bladder (OAB) have limited efficacy, low persistence and a high rate of adverse events commonly leading to treatment cessation in clinical practice. Clinicians in Asia commonly use traditional Chinese medicine as an alternative for OAB treatment despite it having uncertain efficacy and safety. To evaluate the efficacy and safety of cinnamon patch (CP) treatment for alleviating symptoms of OAB, this double-blind randomized, placebo-controlled trial was conducted.

The 6-week study was conducted in an outpatient setting; 66 subjects diagnosed as having OAB were enrolled and treated with a placebo (n=33) or CP (n=33). The OAB symptom score (OABSS) was selected as the primary end point, and a patient perception of bladder condition (PPBC), an urgency severity scale (USS), and post-voiding residual urine (PVR) volume were selected as secondary end points.

In total, 66 participants (40 women and 26 men), 60 years of age, were included in the intention-to-treat analyses. Baseline characteristics were comparable between the CP and placebo groups. Treatment with a CP showed statistically significant differences in reductions in OABSS scores, PPBC scores, and USS scores.

The authors concluded that compared to a placebo, treatment with CP might be considered an effective and safe complementary therapy for OAB. Further studies employing a positive control, different dosage forms, larger sample sizes, and longer treatment periods are warranted.

Cinnamon (Cinnamomum zeylanicum and Cinnamon cassia)belongs to the Lauraceae family. It contains manganese, iron, dietary fiber, and calcium as well as cinnamaldehyde, cinnamic acid, cinnamate, and  numerous other components such as polyphenols and antioxidant, anti-inflammatory, antidiabetic, antimicrobial, anticancer effects. Several reports have dealt with the numerous properties of cinnamon in the forms of bark, essential oils, bark powder, and phenolic compounds, and each of these properties can play a key role in human health.

The new study is interesting and prompts me to ponder:

So, for the time being, I think, I prefere cinnamon, the spice, to cinnamon, the medicine.

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.

This Cochrane review assessed the efficacy and safety of aromatherapy for people with dementia. The researchers  included randomised controlled trials which compared fragrance from plants in an intervention defined as aromatherapy for people with dementia with placebo aromatherapy or with treatment as usual. All doses, frequencies and fragrances of aromatherapy were considered. Participants in the included studies had a diagnosis of dementia of any subtype and severity.

The investigators included 13 studies with 708 participants. All participants had dementia and in the 12 trials which described the setting, all were resident in institutional care facilities. Nine trials recruited participants because they had significant agitation or other behavioural and psychological symptoms in dementia (BPSD) at baseline. The fragrances used were:

  • lavender (eight studies);
  • lemon balm (four studies);
  • lavender and lemon balm,
  • lavender and orange,
  • cedar extracts (one study each).

For six trials, assessment of risk of bias and extraction of results was hampered by poor reporting. Four of the other seven trials were at low risk of bias in all domains, but all were small (range 18 to 186 participants; median 66). The primary outcomes were:

  • agitation,
  • overall behavioural,
  • psychological symptoms,
  • adverse effects.

Ten trials assessed agitation using various scales. Among the 5 trials for which the confidence in the results was moderate or low, 4 trials reported no significant effect on agitation and one trial reported a significant benefit of aromatherapy. The other 5 trials either reported no useable data or the confidence in the results was very low. Eight trials assessed overall BPSD using the Neuropsychiatric Inventory and there was moderate or low confidence in the results of 5 of them. Of these, 4 reported significant benefit from aromatherapy and one reported no significant effect.

Adverse events were poorly reported or not reported at all in most trials. No more than two trials assessed each of our secondary outcomes of quality of life, mood, sleep, activities of daily living, caregiver burden. There was no evidence of benefit on these outcomes. Three trials assessed cognition: one did not report any data and the other two trials reported no significant effect of aromatherapy on cognition. The confidence in the results of these studies was low.

The authors reached the following conclusions: We have not found any convincing evidence that aromatherapy (or exposure to fragrant plant oils) is beneficial for people with dementia although there are many limitations to the data. Conduct or reporting problems in half of the included studies meant that they could not contribute to the conclusions. Results from the other studies were inconsistent. Harms were very poorly reported in the included studies. In order for clear conclusions to be drawn, better design and reporting and consistency of outcome measurement in future trials would be needed.

This is a thorough review. It makes many of the points that I so often make regarding SCAM research:

  • too many of the primary studies are badly designed;
  • too many of the primary studies are too small;
  • too many of the primary studies are poorly reported;
  • too many of the primary studies fail to mention adverse effects thus violating research ethics;
  • too many of the primary studies are done by pseudo-scientists who use research for promotion rather than testing hypotheses.

It is time that SCAM researchers, ethic review boards, funders, editors and journal reviewers take these points into serious consideration – if only to avoid clinical research getting a bad reputation and losing the support of patients without which it cannot exist.

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