Critique of Selected Clinical Trials

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The following clinical studies attempted to show that aromatherapy was more efficient than massage alone but they showed mainly negative results; however, in some cases, the authors clearly emphasized some very small positive results and this was then accepted and the report was welcomed in aromatherapy journals as a positive trial that supported aromatherapy.

Massage, aromatherapy massage, or a period of rest in 122 patients in an intensive care unit (ICU) (Dunn et al., 1995) showed no difference between massage with or without lavender oil and no treatment in the physiological parameters and all psychological parameters showed no effects throughout, bar a significantly greater improvement in mood and in anxiety levels between the rest group and essential oil massage group after the first session. The trial had a large number of changeable parameters: it involved patients in the ICU for about 5 days (age range 2-92 years), who received 1-3 therapy sessions in 24 h given by six different nurses. Massage was performed on the back or outside of limbs or scalp for 15-30 min with lavender (Lavandula vera at 1% in grapeseed oil, which was the only constant parameter). The patients wore oxygen masks, for some of the time. It seems unlikely that confused patients in ICU could remember the massage or its effects and a child of 2 years could not be expected to answer any pertinent questions.

Massage with and without Roman chamomile in 51 palliative care patients (Wilkinson, 1995) showed that both groups experienced the same decrease in symptoms and severity after three full body massages in 3 weeks. There was, however, a statistically significant difference between the two groups after the first aromatherapy massage and also an improvement in the "quality of life" from pre- to postmassage. German chamomile was likely to have been used, not Roman chamomile as stated, according to the chemical composition and potential bioactivity given.

Aromatherapy with and without massage, and massage alone on disturbed behavior in four patients with severe dementia (Brooker et al., 1997), was an unusual single-case study evaluating the use of "true" aromatherapy (using inhaled lavender oil) for 10 treatments of each, randomly given to each patient over a 3-month period and assessed against 10 no-treatment periods. Two patients became more agitated following their treatment sessions and only one patient seemed to have benefited. According to the staff providing the treatment, however, the use of all the treatments seemed to have been beneficial to the patients, suggesting pronounced bias.

An investigation of the psychophysiological effects of aromatherapy massage following cardiac surgery (Stevenson, 1994) showed experimenter bias due to the statement that "neroli is also especially valuable in the relief of anxiety, it calms palpitations, has an antispasmodic effect and an anti-inflammatory effect ... it is useful in the treatment of hysteria, as an antidepressant and a gentle sedative." None of this has been scientifically proven, but as this was not a double-blind study and presumably the author did the massaging, communicating, and collating information alone, bias is probable. Statistical significances were not shown, nor the age ranges of the 100 patients, and no differences between the aromatherapy-only and massage-only groups were shown, except for an immediate increase in respiratory rate when the two control groups (20 min chat or rest) were compared with the aromatherapy massage and massage-only groups.

Atopic eczema in 32 children treated by massage with and without essential oils (Anderson et al., 2000) in a single-case experimental design across subjects showed that this complementary therapy provided no statistically significant differences between the two groups after 8 weeks of treatment. This indicated that massage and thereby regular parental contact and attention showed positive results, which was expected in these children. However, a continuation of the study, following a 3-month period of rest, using only the essential oil massage group showed a possible sensitization effect, as the symptoms worsened.

Massage using two different types of lavender oil on postcardiotomy patients (Buckle, 1993) was proclaimed to be a "double-blind" study but had no controls and the results by the author did not appear to be assessed correctly (Vickers, 1996). The author attempted to show that the "real" lavender showed significant benefits in the state of the patients compared with the other oil. However, outcome measures were not described and the chemical composition and botanical names of the "real" and "not real" lavender remains a mystery, as three lavenders were stated in the text. Although the results were insignificant, this paper is quoted widely as proof that only "real" essential oils work through aromatherapy massage.

Aromatherapy trails in childbirth have been of dubious design and low scientific merit and, not surprisingly, have yielded confusing results (Burns and Blaney, 1994), mainly due to the numerous parameters incorporated. In the study by Burns and Blaney (1994), many different essential oils were used in various uncontrolled ways during childbirth and assessed using possibly biased criteria as to their possible benefits to the mother and midwife. The first pilot study used 585 women in a delivery suite over a 6-month period using lavender, clary sage, peppermint, eucalyptus, chamomile, frankincense, jasmine, lemon, and mandarin. These oils were either used singly or as part of a mixture where they could be used as the first, second, third, or fourth essential oil. The essential oils were applied in many different ways and at different times during parturition, for example, sprayed in a "solution" in water onto a face flannel, pillow, or bean bag; in a bath; foot bath; an absorbent card for inhalation; or in almond oil for massage. Peppermint oil was applied as an undiluted drop on the forehead and frankincense onto the palm.

Midwives and mothers filled in a form as to the effects of the essential oils including their relaxant value, effect on nausea and vomiting, analgesic action, mood enhancer action, accelerator, or not of labor. The results were inconclusive and there was a bias toward the use of a few oils, for example, lavender was stated to be "oestrogenic and used to calm down uterine tightenings if a woman was exhausted and needed sleep" and clary sage was given to "encourage the establishment of labor." This shows complete bias and a belief in unproven clinical attributes by the authors and presumably those carrying out the study. Which of the lavender, peppermint, eucalyptus, chamomile, or frankincense species were used remains a mystery.

The continuation of this study (Burns et al., 2000) on 8058 mothers during childbirth was intended to show that aromatherapy would "relieve anxiety, pain, nausea and/or vomiting, or strengthen contractions." Data from the unit audit were compared with those of 15,799 mothers not given aromatherapy treatment. The results showed that 50% of the aromatherapy group mothers found the intervention "helpful" and only 14% "unhelpful." The use of pethidine over the year declined from 6% to 0.2% by women in the aromatherapy group. The study also (apparently) showed that aromatherapy may have the potential to augment labor contractions for women in dysfunctional labor, in contrast to scientific data showing that the uterine contractions decrease due to administration of any common essential oils (Lis-Balchin and Hart, 1997).

It is doubtful whether a woman would in her first labor, or in subsequent ones, be able to judge whether the contractions were strengthened or the labor shortened due to aromatherapy. It seems likely that there was some placebo effect (itself a very powerful effector) due to the bias of the experimenters and the "suggestions" made to the aromatherapy group regarding efficacy of essential oils, which were obviously absent in the case of the control group.

Lavender oil (volatilized from a burner during the night in their hospital room) has been successful in replacing medication to induce sleep in three out of four geriatrics (Hardy et al., 1995). There was a general deterioration in the sleep patterns when the medication was withdrawn, but lavender oil seemed to be as good as the original medication. However, the deterioration in the sleep patterns (due to "rebound insomnia"?) may simply have been due to recovery of normal sleep patterns when lavender was given (Vickers, 1996).

The efficacy of peppermint oil was studied on postoperative nausea in 18 women after gynecological operations (Tate, 1997) using peppermint oil or a control, peppermint essence (obviously of similar odor). A statistically significant difference was found between the controls and the test group. The test group required less antiemetics and received less opioid analgesia. However, the use of a peppermint essence as a control seems rather like having two test groups as inhalation was used.

A group of 313 patients undergoing radiotherapy were randomly assigned to receive either carrier oil with fractionated oils, carrier oil only, or pure essential oils of lavender, bergamot, and cedarwood administered by inhalation concurrently with radiation treatment. There were no significant differences in Hospital Anxiety and Depression Score (HADS) and other scores between the randomly assigned groups. Aromatherapy, as administered in this study, was not found to be beneficial (Graham et al., 2003).

Heliotropin, a sweet, vanilla-like scent, reduced anxiety during magnetic resonance imaging (Redd and Manne, 1991), which causes distress to many patients as they are enclosed in a "coffin"-like apparatus. Patients experienced approximately 63% less overall anxiety than a control group of patients.

A double-blind randomized trial was conducted on 66 women undergoing abortions (Wiebe, 2000). Ten minutes were spent sniffing a numbered container with either a mixture of the essential oils (vetivert, bergamot, and geranium) or a hair conditioner (placebo). Aromatherapy involving essential oils was no more effective than having patients sniff other pleasant odors in reducing pre-operative anxiety.

An audit into the effects of aromatherapy in palliative care (Evans, 1995) showed that the most frequently used oils were lavender, marjoram, and chamomile. These were applied over a period of 6 months by a therapist available for 4 h on a weekly basis in the ward. Relaxing music was played throughout, each session to allay fears of the hands-on massage. The results revealed that 81% of the patients stated that they either felt "better" or "very relaxed" after the treatment; most appreciated the music greatly. The researchers themselves confessed that it is uncertain whether the benefits were the result of the patient being given individual attention, talking with the therapist, the effects of touch and massage, the effects of the aromatherapy essential oils, or the effects of the relaxation music.

Aromatherapy massage studied in eight cancer patients did not show any psychological benefit. However, there was a statistically significant reduction in all of the four physical parameters, which suggests that aromatherapy massage affects the autonomic nervous system, inducing relaxation. This finding was supported by the patients themselves, all of whom stated during interview that they felt "relaxed" after aromatherapy massage (Hadfield, 2001).

Forty-two cancer patients were randomly allocated to receive weekly massages with lavender essential oil in carrier oil (aromatherapy group), carrier oil only (massage group), or no intervention for 4 weeks (Soden et al., 2004). Outcome measures included a visual analogue scale (VAS) of pain intensity, the Verran and Snyder-Halpern Sleep Scale (VSH), the Hospital Anxiety and Depression Scale (HADS), and the Rotterdam Symptom Checklist (RSCL). No significant long-term benefits of aromatherapy or massage in terms of improving pain control, anxiety, or quality of life were shown. However, sleep scores improved significantly in both the massage and the combined massage (aromatherapy and massage) groups. There were also statistically significant reductions in depression scores in the massage group. In this study of patients with advanced cancer, the addition of lavender essential oil did not appear to increase the beneficial effects of massage.

A randomized controlled pilot study was carried out to examine the effects of adjunctive aromatherapy massage on mood, quality of life, and physical symptoms in patients with cancer attending a specialist unit (Wilcock et al., 2004). Patients were randomized to conventional day care alone, or day care plus weekly aromatherapy massage using a standardized blend of oils for 4 weeks. At baseline and at weekly intervals, patients rated their mood, quality of life, and the intensity and bother of two symptoms most important to them. However, although 46 patients were recruited to the study, only 11 of 23 (48%) patients in the aromatherapy group and 18 of 23 (78%) in the control group completed all 4 weeks. Mood, physical symptoms, and quality of life improved in both groups but there was no statistically significant difference between groups, but all patients were satisfied with the aromatherapy and wished to continue it.

Aromatherapy sessions in deaf and deaf-blind people became an accepted, enjoyable, and therapeutic part of the residents' lifestyle in an uncontrolled series of case studies. It appeared that this gentle, noninvasive therapy could benefit deaf and deaf-blind people, especially as their intact senses can be heightened (Armstrong and Heidingsfeld, 2000).

A scientifically unacceptable study of the effect of aromatherapy on endometriosis, reported only at an aromatherapy conference (Worwood, 1996), involved 22 aromatherapists who treated a total of 17 women in two groups over 24 weeks. One group was initially given massage with essential oils and then not "touched" for the second period, while the second group had the two treatments reversed. Among the many parameters measured were constipation, vaginal discharge, fluid retention, abdominal and pelvic pain, degree of feeling well, renewed vigor, depression, and tiredness. The data were presented as means (or averages, possibly, as this was not stated) but without standard errors of mean (SEM) and lacked any statistical analyses. Unfortunately, the study has been accepted by many aromatherapists as being a conclusive proof of the value in treating endometriosis using aromatherapy.

In all the trials above, there was a more positive outcome for aromatherapy if there were no stringent scientific double-blind and randomized control measures, suggesting that in the latter case, bias is removed.

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