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Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice
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Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice Jerome Sarris a,b,*, Stephanie Gadsden c, Isaac Schweitzer a a
The University of Melbourne, Faculty of Medicine, Department of Psychiatry, Australia Swinburne University of Technology, Centre for Human Psychopharmacology, Australia c Merge Health, Melbourne, Australia b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 6 February 2013 Received in revised form 3 June 2013 Accepted 14 June 2013
Overview: We conducted the first observational study of a case series of naturopathic consultations of adults who presented with self-reported depression or anxiety. Aims: To evaluate the efficacy and safety of Australian naturopathy on the outcome of depressed mood and anxiety, assess which interventions are being prescribed, and to explore the patient’s experiences of being treated by a naturopath. Methods: Outcomes from consultations (from one or two follow-up visits over approximately four to six weeks), were assessed via a mixed methods approach. This involved an analysis of quantitative data from DASS-21, POMS-65, and GHQ-28 scales, and qualitative data via subjective feedback of patient’s treatment experience from purpose-designed semi-structured questionnaires. Clinician’s prescriptions were also categorised and quantified. Results: Eleven naturopaths provided data for analysis, consisting of 31 consultations from 15 patients. From the eight participants that had follow-up data, across Time from baseline to their final follow-up consultation, a significant reduction occurred for DASS depression, anxiety, and stress; and GHQ somatic symptoms, anxiety/insomnia and social dysfunction. Results were mirrored on the POMS. Nutrient supplementation was prescribed by 67% of practitioners, with 84% prescribing an herbal medicine. Dietary or exercise advice was recommended in 52%, and 32% of consultations, respectively. Meditation/ relaxation techniques were taught in 35% of consultations. Sleep hygiene advice was provided in 32% of cases, and counselling was offered 38% of the time. Summary: Preliminary evidence in this uncontrolled study revealed that naturopathic medicine may be beneficial in improving mood and reducing anxiety. However, insufficient study participation by naturopaths (leading to a small study sample) and the uncontrolled unblinded design, restrict the strength of this conclusion. A future study involving a larger sample, using rigorous methodology is now required to validate this pilot data. ß 2013 Published by Elsevier Ltd.
Keywords: Whole system research Naturopathic medicine Naturopathy Complementary medicine Herbal medicine Depression Anxiety
1. Introduction Naturopathic medicine (naturopathy) is a healing system that adopts a biopsychosocial model to treat people via an individualised person-centred ‘‘whole system’’ approach to address the underlying cause/s of disease [1,2]. This system of medicine also emphasises disease prevention and the enhancement of wellbeing. Naturopathy regards all biological systems as interrelated and fluidic, and views disease causation as being profoundly influenced
* Corresponding author at: The University of Melbourne, Department of Psychiatry & The Melbourne Clinic, 2 Salisbury Street, Richmond, Victoria 3121, Australia. Tel.: +61 03 9429 4688; fax: +61 03 9427 7558. E-mail address: [email protected] (J. Sarris).
by a complex of array of internal and external factors. Naturopaths commonly prescribe a range of complementary and alternative medicines (such as herbal medicines and nutritional supplements) and therapies (CAM), in addition to proffering ‘‘lifestyle medicine’’ (e.g. modification of diet, exercise, vices, and relaxation/meditation, work/life balance, sleep hygiene), and in certain jurisdictions minor surgery [2,3]. Some clinicians may also provide counselling, massage, homoeopathy, or acupuncture (depending on training). While clinical studies using isolated herbal or nutritional supplements are being increasingly conducted, assessment of the actual practice of naturopathy has only been recently explored in a few clinical trials. Studies exploring the naturalistic clinical practice of any system of medicine using randomised controlled trial (RCT) designs is challenging. Many caveats exist when applying a reductive model to determine efficacy of any CAM
2212-9626/$ – see front matter ß 2013 Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.aimed.2013.06.001
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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modality [4]. Naturopaths often use individualised prescriptions to treat the individual ‘‘whole’’ person (not just a disease or symptom), and this holistic practice cannot be adequately assessed via RCTs that reduce a complex intervention into single reductive components [5]. Application of ‘‘whole systems research’’, can explore the patient’s therapeutic relationship with the practitioner via the use of a qualitative component in studies, and this may clarify patient’s perceptions and expectations of the treatment [6]. Mental illnesses, and in particular depression and anxiety, are a major area of treatment for CAM clinicians [7]. Herbal medicine is widely used by individuals for mental health conditions, with US data from the National Comorbidity Survey Replication (2002) [8] finding that adults with mental health issues were significantly more likely to have used herbal medicines than their healthier counterparts. A variety of CAMs are also used prevalently by people with depression or anxiety. US data from a nationally representative sample of 2055 people interviewed during 1997–1998 revealed that 57% of those with anxiety attacks, and 54% of those with severe depression reported using some CAM during the previous 12 months [9]. Twenty percent of the sample with anxiety, and 19% of those with severe depression visited a CAM practitioner for treatment during the year. As reflected in CAM practice, a variety of eclectic individualised interventions are commonly used in an integrative manner to treat mental health disorders [10]. In treating depression and anxiety, naturopaths view the causation as being complex, with many interrelated influences considered to be involved [11]. The study of integrative healing systems such as naturopathy, may provide advantages in the treatment of non-severe forms of depression and anxiety over conventional pharmaceutical drugs, which may cause side-effects and appear to have at best moderate efficacy in mildmoderate depression [12]. As the causation/s of depression and anxiety can be viewed as multifactorial [13], individualised naturopathic care which treats people with biological, psychosocial, and lifestyle considerations, may provide benefits beyond standard care. Depression and anxiety are prevalent disorders, which are personally and socioeconomically destructive [14], and as discussed above, a significant percentage of sufferers seek CAM healthcare to treat these conditions [15,16]. However, to date no evidence exists exploring the prescriptive practices in this specific area, and the potential efficacy of naturopathic medicine in treating depression or anxiety (which often occur comorbidly) [17]. Due to this, research is vital to fill this gap in the field for the potential benefit of the profession and for sufferers of mental illness. The Naturopathic Medicine for Improving Mood and Reducing Anxiety Study was created to address this [18]. The primary aims of the observational pilot study were to evaluate the efficacy and safety of Australian naturopathy on the outcome of depressed mood and anxiety, assess which interventions are being prescribed, and to explore the patient’s experiences of being treated by a naturopath. 2. Methods 2.1. Design and assessments The study was a naturalistic observational exploration of naturopathic consultations for the primary complaint of depression or anxiety, conducted over one to three consultations occurring over a four to six week period. Patient inclusion criteria consisted of any adults (aged 18–70) presenting with either self-reported depressed mood or/and anxiety (ongoing for more than two weeks) as their primary complaint and reason for treatment (although they could have other comorbid health issues). Due to the naturalistic observational design, the only exclusion criterion was that
participants must have had competent English skills to be able to understand and fill out the assessment forms. Data collection occurred during week 0 (first visit baseline) and at two subsequent follow-up consultations, as following the naturalistic naturopath/ patient treatment process. Treatment effects were assessed on the Depression Anxiety Stress Scale (DASS) [19] [primary outcome] consisting of depression, anxiety, and stress subscales; the Profile of Mood States (POMS-65) [20], consisting of tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusionbewilderment and vigour-activity subscales, in addition to a total mood disturbance score (obtained by adding the five factors and subtracting the vigour-activity); and the General Health Questionnaire (GHQ-28)[21] consisting of a somatic, anxiety/insomnia, social dysfunction, depression symptom subscales. While these scales are not commonly used by naturopaths, they are validated assessment tools used in psychiatry research to quantify treatment effects on mood, anxiety, and general health. Participant experiences and side-effects were explored via a semi-structured qualitative assessment form which asked participants to write about their perceived benefits or negative experiences, or unusual effects from naturopathic treatment (qualitative forms were filled out at follow-up consultations). Naturopaths also filled out a purpose-designed form to chart their prescription, with tick-boxes listing common naturopathic treatments under the headings: General Interventions (e.g. dietary advice), Supplements (e.g. Omega-3), and Herbal Medicines (e.g. St John’s wort). Treatment by naturopathic clinicians was not influenced by participation in the study, i.e. each naturopath practiced and prescribed as they would normally. Participants paid for their consultations and supplements as per a standard consultation (thereby not biasing the results due to potential confounding of financial inducement). Compliance, withdrawal, and dosage data were not sought, due to the need to keep the time requirements of study involvement limited. 2.2. Procedure The two main aspects of participation in the study involved: 1) Patients filling out demographics, mood and anxiety, and qualitative assessment forms. 2) Naturopaths filling out a purpose-designed form detailing their prescription. Interested naturopaths were recruited from private practice and training colleges (3rd or 4th year students under supervision) via email and print advertising, and were shown the study process via a webinar (video instruction provided via a web link). They were provided an information sheet and consent form stating they wished to participate in the study and that they will ask patients with mood or anxiety symptoms (as their principle complaint) to participate in the study to record their experiences. Clinicians did not perform any formal diagnoses of psychiatric disorders (e.g. via DSM). In the first session, consenting patients filled out a basic demographics form (de-identified), and completed the DASS-21, POMS-65, and GHQ-28. After the naturopathic prescription was decided, the naturopath filled out the prescription form documenting the interventions used. During subsequent follow-up sessions (occurring usually after one to three weeks), the consultation followed normal procedure as per the clinician’s treatment protocol. Patients continued to fill out at the end of the sessions the DASS-21, POMS-65, and GHQ-28, in addition to the qualitative form. Clinicians were asked to ensure that the patients could fill the forms out in private, and have them placed in an envelope to be self-sealed (to encourage an honest disclosure of their experiences).
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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3. Results 3.1. Clinician characteristics Eleven clinicians participated in the study, providing data from consultations. This participatory sample was from 43 clinicians who originally signed up to the study (of whom 32 did not provide any assessment data). The average age of the naturopaths was 36 12 (range 21–60), with 10 out of 11 being female. Their time in practice averaged 7.8 8.1 (range 1–25) years. Two participants had bachelor degrees, five had advanced diplomas or diplomas, while four were final year students. Seven clinicians worked in private practice with the other four being in a student clinic. 3.2. Patient characteristics A total of 15 patients participated in the study (one patient participated twice, returning to the clinician after a four month break for retreatment – this was recorded as a new consultation). The average age of the patients was 34.7 8.6 (range 25–50) years, with 10 out of 15 being female. Five had high school level education, nine university or trade college level education, with one having a postgraduate degree. Seven were married, with eight being single or separated. Eleven patients were either full or part-time employed, two were studying fulltime, with two having home duties. Ten out of 15 had a previous depression diagnosis with six having a current selfreported depressive episode. Nine had a previous anxiety diagnosis, with 12 having a current self-reported anxiety episode. Eight were receiving current treatment for either depression or anxiety, one was taking general pharmaceutical medication for depression, five were taking pharmaceutical medication and receiving psychological care, and five were using solely psychological care. None had a medical reason, or were taking a medication, that could be responsible for causing their depressed mood or anxiety. Baseline results of the 15 patients were: DASS-depression 19.50 11.9, DASS-anxiety 14.63 8.60, DASS-stress 26.00 7.40; POMS-total mood disturbance 82.94 40.57, POMS-tension-anxiety 17.63 5.10, POMS-depression-dejection 26.80 16.29, POMS-angerhostility 17.50 12.68, POMS-vigour-activity 8.81 4.34, POMS-fatigue-inertia 15.88 7.12, POMS-confusion-bewilderment 14.00 5.75; GHQ-28-somatic 9.94 4.20; GHQ-28-anxiety 11.31 4.50, GHQ-28-social 14.13 7.51, and GHQ-28 depression 7.31 7.51. These baseline results indicate that the sample studied had moderate levels of depression and anxiety, and a high level of perceived stress.
A total of 31 consultations were available for analysis. Nutrient supplementation was prescribed by 67% of practitioners, with 84%
Zinc
Flower essences
0
%
Suppplement
Fig. 1. Nutritional supplements prescribed during naturopathic consultations.
prescribing an herbal medicine (21% liquid, 19% tablets, 33% liquid and tablets, and 11% dried herbs). Dietary or exercise advice was recommended in 52%, and 32% of consultations, respectively. Meditation/relaxation techniques were taught in 35% of consultations. Sleep hygiene advice was provided in 32% of cases. Counselling was offered 38% of the time. Caffeine and alcohol reduction was advocated in 23% and 29% of consultations, respectively. In five (16%) consultations, massage was provided to the patient. Common supplements prescribed included B vitamins (45%) or multi-vitamins (19%), and magnesium (39%) (Fig. 1). Flower essences were prescribed in 19% of consultations. Sadenosyl methionine, L-tryptophan or 5-HTP, amino acids, and homoeopathy were not prescribed in any consultations. For herbal medicines, St John’s wort was the most commonly prescribed (58%), followed by Withania (36%), Passionflower (32%), Chamomile (26%), Siberian ginseng (23%); with Kava, Lavender, Rhodiola, and Lemon balm being used 19% of the time (Fig. 2). 3.4. Depression, anxiety, and general health outcomes A total of eight patients returned for at least one follow-up consultation, and had data available for analysis. From baseline to the conclusion of the second follow-up (with data being carried forward from the 1st follow-up if the patient dropped out), a significant effect occurred for Time, with patients having a reduction of patient-rated depression, anxiety, and stress on the DASS-21 (see Table 1 and Fig. 3). Specifically, depression was reduced by 9.50 (F = 18.13, p = 0.002); anxiety by 9.25 points (F = 13.78, p = 0.005), and stress by 12.00 points (F = 18.80, p = 0.002). On the POMS-65, total mood disturbance was significantly reduced across Time by 33.13 points (F = 11.66, p = 0.001),
70 60 50 40 30 20 10
3.3. Prescriptions used
Aromatherapy
10
Vitamin D
20
Vitamin C
30
Celloids
40
Folic acid
50
Magnesium
Vitamin Bs
60
Omega-3
Data was analysed using SPSS 20.0. A repeated measures ANOVA was used to assess any changes within participants across time from baseline to follow-up 1 and follow-up 2. Data from the last observation was carried forward in cases of drop-outs, with ‘‘intention-to-treat’’ being utilised. This consisted of including data from patients with at least one follow-up session being collected postbaseline. No power calculation for a specific sample size was sought a priori as the purpose was to collect as much data as possible within a one year period. The study was provided approval by The Melbourne Clinic Human Ethics Committee (no.182), and registered on ANZCTR (ACTRN12611000756921). The study was conducted across Australia, and was based out of the University of Melbourne (Department of Psychiatry at The Melbourne Clinic). For further information about the study and its purpose and aims cf. Sarris et al. [18].
70
Mul-vitamin
2.3. Data analysis
3
0
%
Herbal Medicine
Bacopa Damiana Chamomile Lavender Lemonbalm Licorice Kava Ginkgo Passionflower Oats Rehmannia St John's wort Rhodiola Siberian Ginseng Scullcap Withania Valerian Vervain Zizyphus
Fig. 2. Herbal medicines prescribed during naturopathic consultations.
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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Table 1 Depression, anxiety, stress, and psychosocial outcomes (n = 8). Assessment DASS-21 Depression Anxiety Stress POMS-65 Total mood disturbance Tension-anxiety Depression-dejection Anger-hostility Vigour-activity Fatigue-inertia Confusion-bewilderment GHQ-28 Somatic Anxiety/insomnia Social Depression
Baseline
Follow-up 1
Follow-up 2
P value*
18.00 (12.87) 16.75 (10.30) 25.50 (7.31)
9.25 (10.20) 6.50 (7.31) 14.50 (8.05)
8.50 (8.86) 7.50 (8.80) 13.50 (8.33)
0.002 0.005 0.002
76.38 18.38 23.75 15.00 9.25 16.25 12.25
(41.65) (6.14) (19.13) (10.61) (4.65) (7.25) (6.58)
43.25 13.25 13.50 9.88 11.75 8.38 10.00
43.00 13.13 13.63 11.63 14.63 9.75 9.50
0.001 0.029 0.003 0.030 0.032 0.016 0.046
9.63 12.75 14.88 7.25
(3.62) (3.54) (8.60) (8.83)
6.00 5.88 6.30 2.38
(39.00) (5.85) (15.70) (10.38) (4.30) (4.81) (5.29) (7.23) (4.67) (3.28) (2.88)
3.88 6.50 5.38 2.30
(49.20) (6.96) (16.30) (15.67) (2.70) (4.83) (5.53) (2.47) (4.00) (2.67) (2.76)
0.018 <0.001 <0.001 0.079
* Repeated-measures ANOVA, significance over time. DASS-21 = Depression Anxiety Stress Scale; POMS-65 = Profile of Mood States; GHQ-28 = General Health Questionnaire.
tension-anxiety by 5.25 points (F = 4.63, p = 0.029), depressiondejection by 10.12 (F = 9.37, p = 0.003), anger-hostility nonsignificantly by 3.37 (F = 2.47, p = 0.120), vigour-activity was significantly increased by 5.38 points (F = 4.47, p = 0.032) and fatigue-inertia was significantly reduced by 6.5 points (F = 5.62, p = 0.016), confusion-bewilderment was also reduced by 2.75 points (F = 3.86, p = 0.046). On the GHQ-28, a significant reduction occurred for patient-rated somatic symptoms 5.75 (F = 5.46, p = 0.018), anxiety and insomnia symptoms 6.25 (F = 14.71, p < 0.001), and social dysfunction 9.50 (F = 14.02, p < 0.001; Fig. 4). While depression symptoms on the GHQ-28 were reduced by 5.00 points, the result was just outside of statistical significance (F = 4.20, p = 0.079). 3.5. Safety issues and participant experience No significant adverse effects were noted by either patients or the clinicians. In one instance a patient commented that they felt more tired the first few days of taking the prescription. Common patient feedback revealed a decrease in anxiety or improvement of mood ‘‘My mood has lifted a little’’ [patient 15], ‘‘My anxiety has reduced substantially. . .I have been more happy. . . My energy
DASS-Depression
25
DASS-Anxiety
levels have been high’’ [patient 11]. Other patients also reported increased energy levels, for example patient 13 reported their ‘‘energy levels increasing every week’’. One person who was withdrawing from sertraline (Zoloft) noted that after commencing the herbal liquid formula that she ‘‘felt more connected in what I was doing and overall feel more at ease with everyday situations’’, also saying ‘‘I feel more of an overall calmness’’ [patient 9]. In the final consultation when their sertraline was titrated down to 25 mg of (reduced in the previous weeks from 150 mg) she reported that her calmness was maintained by taking the herbal prescription ‘‘I am more calm than I ever was before’’ [patient 9]. Aside from initial minor withdrawal issues in the first week (insomnia) by the patient withdrawing from sertraline, no significant adverse effects from any of the prescriptions were reported. Conversely, patient 11 reported that they ‘‘were down a little for a day or two’’ having run out of tablets. They also reported having ‘‘more vivid dreams’’ than they usually have. One person felt more positive about implementing the lifestyle changes recommended ‘‘Feeling better as a result of more exercise. . . and implementing a sleep plan’’ [patient 14]. Other salient feedback included a comment that the herbal liquid ‘‘tastes terrible’’ [patient 15]. Another minor side-effect was mentioned by one person having ‘‘nausea after taking the fish oil’’ [patient 13]. They also reported that they had trouble remembering to take all of the supplements. 15 GHQ-Somac
DASS-Stress
20
GHQ-Anx/Insom
12.5
GHQ-Social 10
15
GHQ-Depress
* 7.5
10
**
** ***
***
5
*
5 2.5
0
****
0
Baseline
Follow-up 1
Follow-up 2
Fig. 3. Results over Time on the DASS-21 (n = 8).
Baseline
Follow-up 1
Follow-up 2
Fig. 4. Results over Time on the GHQ-28 (n = 8).
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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4. Discussion This pilot study tentatively reveals that naturopathic medicine is potentially effective in improving patients’ mood and reducing their anxiety and perceived stress. While this result is encouraging, the significance is tempered by the small sample and uncontrolled design. The results revealed on validated psychological scales (DASS-21 and POMS-65), and a validated general health scale (GHQ-28), indicate that this integrative therapeutic CAM approach may be beneficial in reducing depressed mood, anxiety, stress, and somatic symptoms. The strength of these results is reflected by a strong clinical response, with marked reduction of symptoms occurring on the psychiatric scales used. Additionally, a reduction of fatigue and an improvement in energy was found on the POMS. Of interest, the study uncovered what type of prescriptive advice and interventions are used by some naturopaths to treat depression and anxiety. Most of the nutrient supplements [22] and herbal medicines [23], and lifestyle medicine [24,25] used by the naturopaths have evidentiary support as monotherapies. Regardless, flower essences were used by 19% of clinicians, and to our knowledge there is no supportive evidence of this approach for psychological disorders (or pain) [26–28]. However, it is curious to note that one patient reported that while they did not know whether it was specifically the flower essences that were responsible for the psychological benefit of naturopathic treatment, they commented that the physical sensation of spraying it on the tongue was distracting, and they liked the experience. While most of the individual monotherapies and lifestyle modifications used by the naturopaths had evidentiary support, what was previously not known was whether if prescribed in an integrative format if this approach would be therapeutically beneficial in treating depression and anxiety. The result from this pilot study tentatively supports the effectiveness of this integrative approach. The combination of treatments prescribed in addition to common psychosocial education offered by clinicians, and the effect of the clinician’s therapeutic relationship, may have an additive effect beyond that of self-prescribed supplements. Still, it should be noted that after the first follow-up the beneficial results reached a plateau. While this reflects a marked initial therapeutic effect, longer-term studies are needed to see if this is either a ‘‘placebo’’ response, or a true sustained clinical effect. Aside from our study, currently only clinical trial study has attempted to explore the effectiveness of naturopathy for the specific treatment of either depression or anxiety. A 12 week RCT (n = 75) conducted by Cooley et al. [29], employed adults with moderate to severe anxiety of longer than 6 weeks duration who were randomised to receive Naturopathic Care (NC) (n = 41) or standardised psychotherapy intervention (PT) (n = 40) over a 12 week period. Participants in the NC group received a range of interventions including dietary counselling, deep breathing relaxation techniques, a standard multi-vitamin, and Withania somnifera (600 mg per day of standardised root). The PT intervention group received psychotherapy, and matched deep breathing relaxation techniques, and placebo tablets. Results revealed significant differences between groups on the outcomes anxiety, fatigue, general mental health, concentration, social functioning, perceived vitality, and overall quality of life, with the NC group exhibiting greater clinical benefit. No serious adverse reactions were observed from naturopathic treatment. While this study reveals encouraging results of naturopathy for reducing anxiety and improving wellbeing, it should be noted that the study was not ‘‘naturalistic’’ (i.e. it did not assess individualised treatment), and thus does not reflect true individualised prescription and practice. Due to this, there is still a need to investigate naturalistic naturopathic practice (especially involving individualised herbal medicine prescription), and to further explore this in the critical
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area of mental health. Further, as naturopathic medicine is a diverse practice, the quantification of clinician’s use of several other diagnostic techniques and therapeutic applications is also of merit. Although our study is novel, in that it observes true naturopathic practice, limitations to this whole system research design are acknowledged. Firstly, this study was not ‘‘controlled’’ (i.e. not compared to a placebo intervention or positive control such as standard care), and it is possible that over time the client’s depression and anxiety symptoms may have naturally improved. Secondly, the sample size of clinicians (target 100) and patients (target 200) participating in the study did not meet expectations. Another limitation is that the study collected data from three consultations, with only two follow-ups, and thus longer-term assessment of efficacy and safety is not available. In some cases, the effects of the prescription and lifestyle adjustments may take many months to take full effect. An additional limitation acknowledged is that there were marked variations of practitioner education levels and the treatments they provided. Another limitation was that clinicians did not formally diagnose ‘‘major depression’’, or any specific anxiety disorder; thus we can only report the effect of treatment on patient’s perceived psychological symptoms. The use of unblinded self-report scales by patients given to their clinicians, may have biased them to report their outcomes more positively (although naturopaths were instructed to have their patients to fill their forms in private and place in a sealed envelope). A further source of potential bias that may present from this naturalistic study design, concerns the ‘‘expectancy of efficacy’’ of patients pursuing naturopathic treatment. As mentioned above, the sample size recruited was small due to underwhelming involvement by naturopaths, with only 11 providing patient data from 43 who signed up. This lack of involvement by clinicians is further reflected in that the study was advertised to a potential pool of over 2000 clinicians. This was surprising, as evidence supporting naturopathic practice is largely absent, and is critically needed to advance the field. In other fields such as psychology, clinician involvement to collect data and participate in research is emphasised in study and training, as it is recognised as important to ensure the evolution of its evidencebased practice. Advertising was sufficient, thus this appears to not have hindered participation. Thankfully, some naturopaths were motivated to participate in the study, and while many more showed initial interest, they did not provide any data from their consultations. Some barriers identified involve the inexperience of naturopaths with conducting research, the time commitment (also potentially from them having no direct benefit or interest in the study), and the time taken for patients to fill out the forms (10 min per consultation). Solutions for conducting future observational studies may involve the use of incentives for clinicians e.g. book vouchers, self-addressed envelopes for data mailing, and increased training and support from researchers. The results from this pilot study are encouraging and may support further study of naturopathy for mental health applications. The data, although modest, can now potentially be used to apply for a grant to fund a much larger controlled study of naturopathy in the treatment of depression and anxiety. A future study with a more robust methodological design would seek to study a clinical sample of people with DSM-IV diagnosed major depression or an anxiety disorder/s, comparing a more standardised form of practice via the use of a formulated decision tree using specific evidence-based intervention combinations for individual presentations. Further, more detail being sought on patient’s current/past medication and compliance with the naturopathic prescription, safety issues, in addition to the use of formal diagnostic criteria, would also be valuable. While not the focus of our study, future work in this area that would be of benefit
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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to the field, includes exploration of the profile of global naturopathic practice, assessment of methodological elements such as inclusion/exclusion criteria and recruitment rates, in addition to exploration of why patients withdraw from naturopathic clinical trials. In conclusion, in this small observational pilot study, a potentially beneficial effect was found for naturopathic medicine for reducing depressed mood, anxiety, and stress; this encourages further research in this area.
[10] [11]
[12]
[13] [14]
Acknowledgements Dr Jerome Sarris is funded by an Australian National Health & Medical Research Council fellowship (NHMRC funding ID 628875), in a strategic partnership with The University of Melbourne and the Centre for Human Psychopharmacology at Swinburne University of Technology. Thanks to Endeavour College of Health, Integria Healthcare, Soho-Flordis, The NHAA and ANPA for advertising the study. We are sincerely grateful for the following practitioners for participating and collecting data: Sue Quin, Alison Walsh, Catherine Walker, Belinda Hills, Kate McCandless, Yvonne Mundy, Jenie Stroh, Fiona O’Neil, Saskia Reus-Smit, Despina Kamper, Jessica Daff, and Victoria Webb (apologies if any contributing clinician’s names are mistakenly omitted). Thanks are also extended to Karen Savage for assistance with the data. References
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[1] Di Stefano V. Holism and complementary medicine: origins and principles. Crows Nest, NSW: Allen & Unwin; 2006. [2] Sarris J, Wardle J, editors. Clinical naturopathy: an evidence-based guide to practice. Sydney: Elsevier; 2010. [3] Fleming SA, Gutknecht NC. Naturopathy and the primary care practice. Primary Care 2010;37(1):119–36 [Epub 02.03.10]. [4] Wardle J, Oberg EB. The intersecting paradigms of naturopathic medicine and public health: opportunities for naturopathic medicine. Journal of Alternative and Complementary Medicine 2011;17(11):1079–84 [Epub 11.11.11]. [5] Verhoef M, Vanderheyden L. Combining qualitative methods and RCTs in CAM intervention research. In: Adams J, editor. Researching complementary and alternative medicine. Milton Park, Oxon: Routledge; 2007. [6] Verhoef MJ, Lewith G, Ritenbaugh C, Boon H, Fleishman S, Leis A. Complementary and alternative medicine whole systems research: beyond identification of inadequacies of the RCT. Complementary Therapies in Medicine 2005;13(3):206–12 [Epub 10.09.05]. [7] Adams J, Sibbritt D, Lui CW. The urban-rural divide in complementary and alternative medicine use: a longitudinal study of 10,638 women. BMC Complementary and Alternative Medicine 2011;11:2 [Epub 07.01.11]. [8] Ravven SE, Zimmerman MB, Schultz SK, Wallace RB. 12-month herbal medicine use for mental health from the national Comorbidity Survey Replication (NCS-R). Annals of Clinical Psychiatry 2011;23(2):83–94 [Epub 07.05.11]. [9] Kessler RC, Soukup J, Davis RB, Foster DF, Wilkey SA, Van Rompay MM, et al. The use of complementary and alternative therapies to treat anxiety and
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Advances in Integrative Medicine journal homepage: www.elsevier.com/locate/aimed
Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice Jerome Sarris a,b,*, Stephanie Gadsden c, Isaac Schweitzer a a
The University of Melbourne, Faculty of Medicine, Department of Psychiatry, Australia Swinburne University of Technology, Centre for Human Psychopharmacology, Australia c Merge Health, Melbourne, Australia b
A R T I C L E I N F O
A B S T R A C T
Article history: Received 6 February 2013 Received in revised form 3 June 2013 Accepted 14 June 2013
Overview: We conducted the first observational study of a case series of naturopathic consultations of adults who presented with self-reported depression or anxiety. Aims: To evaluate the efficacy and safety of Australian naturopathy on the outcome of depressed mood and anxiety, assess which interventions are being prescribed, and to explore the patient’s experiences of being treated by a naturopath. Methods: Outcomes from consultations (from one or two follow-up visits over approximately four to six weeks), were assessed via a mixed methods approach. This involved an analysis of quantitative data from DASS-21, POMS-65, and GHQ-28 scales, and qualitative data via subjective feedback of patient’s treatment experience from purpose-designed semi-structured questionnaires. Clinician’s prescriptions were also categorised and quantified. Results: Eleven naturopaths provided data for analysis, consisting of 31 consultations from 15 patients. From the eight participants that had follow-up data, across Time from baseline to their final follow-up consultation, a significant reduction occurred for DASS depression, anxiety, and stress; and GHQ somatic symptoms, anxiety/insomnia and social dysfunction. Results were mirrored on the POMS. Nutrient supplementation was prescribed by 67% of practitioners, with 84% prescribing an herbal medicine. Dietary or exercise advice was recommended in 52%, and 32% of consultations, respectively. Meditation/ relaxation techniques were taught in 35% of consultations. Sleep hygiene advice was provided in 32% of cases, and counselling was offered 38% of the time. Summary: Preliminary evidence in this uncontrolled study revealed that naturopathic medicine may be beneficial in improving mood and reducing anxiety. However, insufficient study participation by naturopaths (leading to a small study sample) and the uncontrolled unblinded design, restrict the strength of this conclusion. A future study involving a larger sample, using rigorous methodology is now required to validate this pilot data. ß 2013 Published by Elsevier Ltd.
Keywords: Whole system research Naturopathic medicine Naturopathy Complementary medicine Herbal medicine Depression Anxiety
1. Introduction Naturopathic medicine (naturopathy) is a healing system that adopts a biopsychosocial model to treat people via an individualised person-centred ‘‘whole system’’ approach to address the underlying cause/s of disease [1,2]. This system of medicine also emphasises disease prevention and the enhancement of wellbeing. Naturopathy regards all biological systems as interrelated and fluidic, and views disease causation as being profoundly influenced
* Corresponding author at: The University of Melbourne, Department of Psychiatry & The Melbourne Clinic, 2 Salisbury Street, Richmond, Victoria 3121, Australia. Tel.: +61 03 9429 4688; fax: +61 03 9427 7558. E-mail address: [email protected] (J. Sarris).
by a complex of array of internal and external factors. Naturopaths commonly prescribe a range of complementary and alternative medicines (such as herbal medicines and nutritional supplements) and therapies (CAM), in addition to proffering ‘‘lifestyle medicine’’ (e.g. modification of diet, exercise, vices, and relaxation/meditation, work/life balance, sleep hygiene), and in certain jurisdictions minor surgery [2,3]. Some clinicians may also provide counselling, massage, homoeopathy, or acupuncture (depending on training). While clinical studies using isolated herbal or nutritional supplements are being increasingly conducted, assessment of the actual practice of naturopathy has only been recently explored in a few clinical trials. Studies exploring the naturalistic clinical practice of any system of medicine using randomised controlled trial (RCT) designs is challenging. Many caveats exist when applying a reductive model to determine efficacy of any CAM
2212-9626/$ – see front matter ß 2013 Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.aimed.2013.06.001
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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modality [4]. Naturopaths often use individualised prescriptions to treat the individual ‘‘whole’’ person (not just a disease or symptom), and this holistic practice cannot be adequately assessed via RCTs that reduce a complex intervention into single reductive components [5]. Application of ‘‘whole systems research’’, can explore the patient’s therapeutic relationship with the practitioner via the use of a qualitative component in studies, and this may clarify patient’s perceptions and expectations of the treatment [6]. Mental illnesses, and in particular depression and anxiety, are a major area of treatment for CAM clinicians [7]. Herbal medicine is widely used by individuals for mental health conditions, with US data from the National Comorbidity Survey Replication (2002) [8] finding that adults with mental health issues were significantly more likely to have used herbal medicines than their healthier counterparts. A variety of CAMs are also used prevalently by people with depression or anxiety. US data from a nationally representative sample of 2055 people interviewed during 1997–1998 revealed that 57% of those with anxiety attacks, and 54% of those with severe depression reported using some CAM during the previous 12 months [9]. Twenty percent of the sample with anxiety, and 19% of those with severe depression visited a CAM practitioner for treatment during the year. As reflected in CAM practice, a variety of eclectic individualised interventions are commonly used in an integrative manner to treat mental health disorders [10]. In treating depression and anxiety, naturopaths view the causation as being complex, with many interrelated influences considered to be involved [11]. The study of integrative healing systems such as naturopathy, may provide advantages in the treatment of non-severe forms of depression and anxiety over conventional pharmaceutical drugs, which may cause side-effects and appear to have at best moderate efficacy in mildmoderate depression [12]. As the causation/s of depression and anxiety can be viewed as multifactorial [13], individualised naturopathic care which treats people with biological, psychosocial, and lifestyle considerations, may provide benefits beyond standard care. Depression and anxiety are prevalent disorders, which are personally and socioeconomically destructive [14], and as discussed above, a significant percentage of sufferers seek CAM healthcare to treat these conditions [15,16]. However, to date no evidence exists exploring the prescriptive practices in this specific area, and the potential efficacy of naturopathic medicine in treating depression or anxiety (which often occur comorbidly) [17]. Due to this, research is vital to fill this gap in the field for the potential benefit of the profession and for sufferers of mental illness. The Naturopathic Medicine for Improving Mood and Reducing Anxiety Study was created to address this [18]. The primary aims of the observational pilot study were to evaluate the efficacy and safety of Australian naturopathy on the outcome of depressed mood and anxiety, assess which interventions are being prescribed, and to explore the patient’s experiences of being treated by a naturopath. 2. Methods 2.1. Design and assessments The study was a naturalistic observational exploration of naturopathic consultations for the primary complaint of depression or anxiety, conducted over one to three consultations occurring over a four to six week period. Patient inclusion criteria consisted of any adults (aged 18–70) presenting with either self-reported depressed mood or/and anxiety (ongoing for more than two weeks) as their primary complaint and reason for treatment (although they could have other comorbid health issues). Due to the naturalistic observational design, the only exclusion criterion was that
participants must have had competent English skills to be able to understand and fill out the assessment forms. Data collection occurred during week 0 (first visit baseline) and at two subsequent follow-up consultations, as following the naturalistic naturopath/ patient treatment process. Treatment effects were assessed on the Depression Anxiety Stress Scale (DASS) [19] [primary outcome] consisting of depression, anxiety, and stress subscales; the Profile of Mood States (POMS-65) [20], consisting of tension-anxiety, depression-dejection, anger-hostility, fatigue-inertia, confusionbewilderment and vigour-activity subscales, in addition to a total mood disturbance score (obtained by adding the five factors and subtracting the vigour-activity); and the General Health Questionnaire (GHQ-28)[21] consisting of a somatic, anxiety/insomnia, social dysfunction, depression symptom subscales. While these scales are not commonly used by naturopaths, they are validated assessment tools used in psychiatry research to quantify treatment effects on mood, anxiety, and general health. Participant experiences and side-effects were explored via a semi-structured qualitative assessment form which asked participants to write about their perceived benefits or negative experiences, or unusual effects from naturopathic treatment (qualitative forms were filled out at follow-up consultations). Naturopaths also filled out a purpose-designed form to chart their prescription, with tick-boxes listing common naturopathic treatments under the headings: General Interventions (e.g. dietary advice), Supplements (e.g. Omega-3), and Herbal Medicines (e.g. St John’s wort). Treatment by naturopathic clinicians was not influenced by participation in the study, i.e. each naturopath practiced and prescribed as they would normally. Participants paid for their consultations and supplements as per a standard consultation (thereby not biasing the results due to potential confounding of financial inducement). Compliance, withdrawal, and dosage data were not sought, due to the need to keep the time requirements of study involvement limited. 2.2. Procedure The two main aspects of participation in the study involved: 1) Patients filling out demographics, mood and anxiety, and qualitative assessment forms. 2) Naturopaths filling out a purpose-designed form detailing their prescription. Interested naturopaths were recruited from private practice and training colleges (3rd or 4th year students under supervision) via email and print advertising, and were shown the study process via a webinar (video instruction provided via a web link). They were provided an information sheet and consent form stating they wished to participate in the study and that they will ask patients with mood or anxiety symptoms (as their principle complaint) to participate in the study to record their experiences. Clinicians did not perform any formal diagnoses of psychiatric disorders (e.g. via DSM). In the first session, consenting patients filled out a basic demographics form (de-identified), and completed the DASS-21, POMS-65, and GHQ-28. After the naturopathic prescription was decided, the naturopath filled out the prescription form documenting the interventions used. During subsequent follow-up sessions (occurring usually after one to three weeks), the consultation followed normal procedure as per the clinician’s treatment protocol. Patients continued to fill out at the end of the sessions the DASS-21, POMS-65, and GHQ-28, in addition to the qualitative form. Clinicians were asked to ensure that the patients could fill the forms out in private, and have them placed in an envelope to be self-sealed (to encourage an honest disclosure of their experiences).
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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3. Results 3.1. Clinician characteristics Eleven clinicians participated in the study, providing data from consultations. This participatory sample was from 43 clinicians who originally signed up to the study (of whom 32 did not provide any assessment data). The average age of the naturopaths was 36 12 (range 21–60), with 10 out of 11 being female. Their time in practice averaged 7.8 8.1 (range 1–25) years. Two participants had bachelor degrees, five had advanced diplomas or diplomas, while four were final year students. Seven clinicians worked in private practice with the other four being in a student clinic. 3.2. Patient characteristics A total of 15 patients participated in the study (one patient participated twice, returning to the clinician after a four month break for retreatment – this was recorded as a new consultation). The average age of the patients was 34.7 8.6 (range 25–50) years, with 10 out of 15 being female. Five had high school level education, nine university or trade college level education, with one having a postgraduate degree. Seven were married, with eight being single or separated. Eleven patients were either full or part-time employed, two were studying fulltime, with two having home duties. Ten out of 15 had a previous depression diagnosis with six having a current selfreported depressive episode. Nine had a previous anxiety diagnosis, with 12 having a current self-reported anxiety episode. Eight were receiving current treatment for either depression or anxiety, one was taking general pharmaceutical medication for depression, five were taking pharmaceutical medication and receiving psychological care, and five were using solely psychological care. None had a medical reason, or were taking a medication, that could be responsible for causing their depressed mood or anxiety. Baseline results of the 15 patients were: DASS-depression 19.50 11.9, DASS-anxiety 14.63 8.60, DASS-stress 26.00 7.40; POMS-total mood disturbance 82.94 40.57, POMS-tension-anxiety 17.63 5.10, POMS-depression-dejection 26.80 16.29, POMS-angerhostility 17.50 12.68, POMS-vigour-activity 8.81 4.34, POMS-fatigue-inertia 15.88 7.12, POMS-confusion-bewilderment 14.00 5.75; GHQ-28-somatic 9.94 4.20; GHQ-28-anxiety 11.31 4.50, GHQ-28-social 14.13 7.51, and GHQ-28 depression 7.31 7.51. These baseline results indicate that the sample studied had moderate levels of depression and anxiety, and a high level of perceived stress.
A total of 31 consultations were available for analysis. Nutrient supplementation was prescribed by 67% of practitioners, with 84%
Zinc
Flower essences
0
%
Suppplement
Fig. 1. Nutritional supplements prescribed during naturopathic consultations.
prescribing an herbal medicine (21% liquid, 19% tablets, 33% liquid and tablets, and 11% dried herbs). Dietary or exercise advice was recommended in 52%, and 32% of consultations, respectively. Meditation/relaxation techniques were taught in 35% of consultations. Sleep hygiene advice was provided in 32% of cases. Counselling was offered 38% of the time. Caffeine and alcohol reduction was advocated in 23% and 29% of consultations, respectively. In five (16%) consultations, massage was provided to the patient. Common supplements prescribed included B vitamins (45%) or multi-vitamins (19%), and magnesium (39%) (Fig. 1). Flower essences were prescribed in 19% of consultations. Sadenosyl methionine, L-tryptophan or 5-HTP, amino acids, and homoeopathy were not prescribed in any consultations. For herbal medicines, St John’s wort was the most commonly prescribed (58%), followed by Withania (36%), Passionflower (32%), Chamomile (26%), Siberian ginseng (23%); with Kava, Lavender, Rhodiola, and Lemon balm being used 19% of the time (Fig. 2). 3.4. Depression, anxiety, and general health outcomes A total of eight patients returned for at least one follow-up consultation, and had data available for analysis. From baseline to the conclusion of the second follow-up (with data being carried forward from the 1st follow-up if the patient dropped out), a significant effect occurred for Time, with patients having a reduction of patient-rated depression, anxiety, and stress on the DASS-21 (see Table 1 and Fig. 3). Specifically, depression was reduced by 9.50 (F = 18.13, p = 0.002); anxiety by 9.25 points (F = 13.78, p = 0.005), and stress by 12.00 points (F = 18.80, p = 0.002). On the POMS-65, total mood disturbance was significantly reduced across Time by 33.13 points (F = 11.66, p = 0.001),
70 60 50 40 30 20 10
3.3. Prescriptions used
Aromatherapy
10
Vitamin D
20
Vitamin C
30
Celloids
40
Folic acid
50
Magnesium
Vitamin Bs
60
Omega-3
Data was analysed using SPSS 20.0. A repeated measures ANOVA was used to assess any changes within participants across time from baseline to follow-up 1 and follow-up 2. Data from the last observation was carried forward in cases of drop-outs, with ‘‘intention-to-treat’’ being utilised. This consisted of including data from patients with at least one follow-up session being collected postbaseline. No power calculation for a specific sample size was sought a priori as the purpose was to collect as much data as possible within a one year period. The study was provided approval by The Melbourne Clinic Human Ethics Committee (no.182), and registered on ANZCTR (ACTRN12611000756921). The study was conducted across Australia, and was based out of the University of Melbourne (Department of Psychiatry at The Melbourne Clinic). For further information about the study and its purpose and aims cf. Sarris et al. [18].
70
Mul-vitamin
2.3. Data analysis
3
0
%
Herbal Medicine
Bacopa Damiana Chamomile Lavender Lemonbalm Licorice Kava Ginkgo Passionflower Oats Rehmannia St John's wort Rhodiola Siberian Ginseng Scullcap Withania Valerian Vervain Zizyphus
Fig. 2. Herbal medicines prescribed during naturopathic consultations.
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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4
Table 1 Depression, anxiety, stress, and psychosocial outcomes (n = 8). Assessment DASS-21 Depression Anxiety Stress POMS-65 Total mood disturbance Tension-anxiety Depression-dejection Anger-hostility Vigour-activity Fatigue-inertia Confusion-bewilderment GHQ-28 Somatic Anxiety/insomnia Social Depression
Baseline
Follow-up 1
Follow-up 2
P value*
18.00 (12.87) 16.75 (10.30) 25.50 (7.31)
9.25 (10.20) 6.50 (7.31) 14.50 (8.05)
8.50 (8.86) 7.50 (8.80) 13.50 (8.33)
0.002 0.005 0.002
76.38 18.38 23.75 15.00 9.25 16.25 12.25
(41.65) (6.14) (19.13) (10.61) (4.65) (7.25) (6.58)
43.25 13.25 13.50 9.88 11.75 8.38 10.00
43.00 13.13 13.63 11.63 14.63 9.75 9.50
0.001 0.029 0.003 0.030 0.032 0.016 0.046
9.63 12.75 14.88 7.25
(3.62) (3.54) (8.60) (8.83)
6.00 5.88 6.30 2.38
(39.00) (5.85) (15.70) (10.38) (4.30) (4.81) (5.29) (7.23) (4.67) (3.28) (2.88)
3.88 6.50 5.38 2.30
(49.20) (6.96) (16.30) (15.67) (2.70) (4.83) (5.53) (2.47) (4.00) (2.67) (2.76)
0.018 <0.001 <0.001 0.079
* Repeated-measures ANOVA, significance over time. DASS-21 = Depression Anxiety Stress Scale; POMS-65 = Profile of Mood States; GHQ-28 = General Health Questionnaire.
tension-anxiety by 5.25 points (F = 4.63, p = 0.029), depressiondejection by 10.12 (F = 9.37, p = 0.003), anger-hostility nonsignificantly by 3.37 (F = 2.47, p = 0.120), vigour-activity was significantly increased by 5.38 points (F = 4.47, p = 0.032) and fatigue-inertia was significantly reduced by 6.5 points (F = 5.62, p = 0.016), confusion-bewilderment was also reduced by 2.75 points (F = 3.86, p = 0.046). On the GHQ-28, a significant reduction occurred for patient-rated somatic symptoms 5.75 (F = 5.46, p = 0.018), anxiety and insomnia symptoms 6.25 (F = 14.71, p < 0.001), and social dysfunction 9.50 (F = 14.02, p < 0.001; Fig. 4). While depression symptoms on the GHQ-28 were reduced by 5.00 points, the result was just outside of statistical significance (F = 4.20, p = 0.079). 3.5. Safety issues and participant experience No significant adverse effects were noted by either patients or the clinicians. In one instance a patient commented that they felt more tired the first few days of taking the prescription. Common patient feedback revealed a decrease in anxiety or improvement of mood ‘‘My mood has lifted a little’’ [patient 15], ‘‘My anxiety has reduced substantially. . .I have been more happy. . . My energy
DASS-Depression
25
DASS-Anxiety
levels have been high’’ [patient 11]. Other patients also reported increased energy levels, for example patient 13 reported their ‘‘energy levels increasing every week’’. One person who was withdrawing from sertraline (Zoloft) noted that after commencing the herbal liquid formula that she ‘‘felt more connected in what I was doing and overall feel more at ease with everyday situations’’, also saying ‘‘I feel more of an overall calmness’’ [patient 9]. In the final consultation when their sertraline was titrated down to 25 mg of (reduced in the previous weeks from 150 mg) she reported that her calmness was maintained by taking the herbal prescription ‘‘I am more calm than I ever was before’’ [patient 9]. Aside from initial minor withdrawal issues in the first week (insomnia) by the patient withdrawing from sertraline, no significant adverse effects from any of the prescriptions were reported. Conversely, patient 11 reported that they ‘‘were down a little for a day or two’’ having run out of tablets. They also reported having ‘‘more vivid dreams’’ than they usually have. One person felt more positive about implementing the lifestyle changes recommended ‘‘Feeling better as a result of more exercise. . . and implementing a sleep plan’’ [patient 14]. Other salient feedback included a comment that the herbal liquid ‘‘tastes terrible’’ [patient 15]. Another minor side-effect was mentioned by one person having ‘‘nausea after taking the fish oil’’ [patient 13]. They also reported that they had trouble remembering to take all of the supplements. 15 GHQ-Somac
DASS-Stress
20
GHQ-Anx/Insom
12.5
GHQ-Social 10
15
GHQ-Depress
* 7.5
10
**
** ***
***
5
*
5 2.5
0
****
0
Baseline
Follow-up 1
Follow-up 2
Fig. 3. Results over Time on the DASS-21 (n = 8).
Baseline
Follow-up 1
Follow-up 2
Fig. 4. Results over Time on the GHQ-28 (n = 8).
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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4. Discussion This pilot study tentatively reveals that naturopathic medicine is potentially effective in improving patients’ mood and reducing their anxiety and perceived stress. While this result is encouraging, the significance is tempered by the small sample and uncontrolled design. The results revealed on validated psychological scales (DASS-21 and POMS-65), and a validated general health scale (GHQ-28), indicate that this integrative therapeutic CAM approach may be beneficial in reducing depressed mood, anxiety, stress, and somatic symptoms. The strength of these results is reflected by a strong clinical response, with marked reduction of symptoms occurring on the psychiatric scales used. Additionally, a reduction of fatigue and an improvement in energy was found on the POMS. Of interest, the study uncovered what type of prescriptive advice and interventions are used by some naturopaths to treat depression and anxiety. Most of the nutrient supplements [22] and herbal medicines [23], and lifestyle medicine [24,25] used by the naturopaths have evidentiary support as monotherapies. Regardless, flower essences were used by 19% of clinicians, and to our knowledge there is no supportive evidence of this approach for psychological disorders (or pain) [26–28]. However, it is curious to note that one patient reported that while they did not know whether it was specifically the flower essences that were responsible for the psychological benefit of naturopathic treatment, they commented that the physical sensation of spraying it on the tongue was distracting, and they liked the experience. While most of the individual monotherapies and lifestyle modifications used by the naturopaths had evidentiary support, what was previously not known was whether if prescribed in an integrative format if this approach would be therapeutically beneficial in treating depression and anxiety. The result from this pilot study tentatively supports the effectiveness of this integrative approach. The combination of treatments prescribed in addition to common psychosocial education offered by clinicians, and the effect of the clinician’s therapeutic relationship, may have an additive effect beyond that of self-prescribed supplements. Still, it should be noted that after the first follow-up the beneficial results reached a plateau. While this reflects a marked initial therapeutic effect, longer-term studies are needed to see if this is either a ‘‘placebo’’ response, or a true sustained clinical effect. Aside from our study, currently only clinical trial study has attempted to explore the effectiveness of naturopathy for the specific treatment of either depression or anxiety. A 12 week RCT (n = 75) conducted by Cooley et al. [29], employed adults with moderate to severe anxiety of longer than 6 weeks duration who were randomised to receive Naturopathic Care (NC) (n = 41) or standardised psychotherapy intervention (PT) (n = 40) over a 12 week period. Participants in the NC group received a range of interventions including dietary counselling, deep breathing relaxation techniques, a standard multi-vitamin, and Withania somnifera (600 mg per day of standardised root). The PT intervention group received psychotherapy, and matched deep breathing relaxation techniques, and placebo tablets. Results revealed significant differences between groups on the outcomes anxiety, fatigue, general mental health, concentration, social functioning, perceived vitality, and overall quality of life, with the NC group exhibiting greater clinical benefit. No serious adverse reactions were observed from naturopathic treatment. While this study reveals encouraging results of naturopathy for reducing anxiety and improving wellbeing, it should be noted that the study was not ‘‘naturalistic’’ (i.e. it did not assess individualised treatment), and thus does not reflect true individualised prescription and practice. Due to this, there is still a need to investigate naturalistic naturopathic practice (especially involving individualised herbal medicine prescription), and to further explore this in the critical
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area of mental health. Further, as naturopathic medicine is a diverse practice, the quantification of clinician’s use of several other diagnostic techniques and therapeutic applications is also of merit. Although our study is novel, in that it observes true naturopathic practice, limitations to this whole system research design are acknowledged. Firstly, this study was not ‘‘controlled’’ (i.e. not compared to a placebo intervention or positive control such as standard care), and it is possible that over time the client’s depression and anxiety symptoms may have naturally improved. Secondly, the sample size of clinicians (target 100) and patients (target 200) participating in the study did not meet expectations. Another limitation is that the study collected data from three consultations, with only two follow-ups, and thus longer-term assessment of efficacy and safety is not available. In some cases, the effects of the prescription and lifestyle adjustments may take many months to take full effect. An additional limitation acknowledged is that there were marked variations of practitioner education levels and the treatments they provided. Another limitation was that clinicians did not formally diagnose ‘‘major depression’’, or any specific anxiety disorder; thus we can only report the effect of treatment on patient’s perceived psychological symptoms. The use of unblinded self-report scales by patients given to their clinicians, may have biased them to report their outcomes more positively (although naturopaths were instructed to have their patients to fill their forms in private and place in a sealed envelope). A further source of potential bias that may present from this naturalistic study design, concerns the ‘‘expectancy of efficacy’’ of patients pursuing naturopathic treatment. As mentioned above, the sample size recruited was small due to underwhelming involvement by naturopaths, with only 11 providing patient data from 43 who signed up. This lack of involvement by clinicians is further reflected in that the study was advertised to a potential pool of over 2000 clinicians. This was surprising, as evidence supporting naturopathic practice is largely absent, and is critically needed to advance the field. In other fields such as psychology, clinician involvement to collect data and participate in research is emphasised in study and training, as it is recognised as important to ensure the evolution of its evidencebased practice. Advertising was sufficient, thus this appears to not have hindered participation. Thankfully, some naturopaths were motivated to participate in the study, and while many more showed initial interest, they did not provide any data from their consultations. Some barriers identified involve the inexperience of naturopaths with conducting research, the time commitment (also potentially from them having no direct benefit or interest in the study), and the time taken for patients to fill out the forms (10 min per consultation). Solutions for conducting future observational studies may involve the use of incentives for clinicians e.g. book vouchers, self-addressed envelopes for data mailing, and increased training and support from researchers. The results from this pilot study are encouraging and may support further study of naturopathy for mental health applications. The data, although modest, can now potentially be used to apply for a grant to fund a much larger controlled study of naturopathy in the treatment of depression and anxiety. A future study with a more robust methodological design would seek to study a clinical sample of people with DSM-IV diagnosed major depression or an anxiety disorder/s, comparing a more standardised form of practice via the use of a formulated decision tree using specific evidence-based intervention combinations for individual presentations. Further, more detail being sought on patient’s current/past medication and compliance with the naturopathic prescription, safety issues, in addition to the use of formal diagnostic criteria, would also be valuable. While not the focus of our study, future work in this area that would be of benefit
Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001
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to the field, includes exploration of the profile of global naturopathic practice, assessment of methodological elements such as inclusion/exclusion criteria and recruitment rates, in addition to exploration of why patients withdraw from naturopathic clinical trials. In conclusion, in this small observational pilot study, a potentially beneficial effect was found for naturopathic medicine for reducing depressed mood, anxiety, and stress; this encourages further research in this area.
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Acknowledgements Dr Jerome Sarris is funded by an Australian National Health & Medical Research Council fellowship (NHMRC funding ID 628875), in a strategic partnership with The University of Melbourne and the Centre for Human Psychopharmacology at Swinburne University of Technology. Thanks to Endeavour College of Health, Integria Healthcare, Soho-Flordis, The NHAA and ANPA for advertising the study. We are sincerely grateful for the following practitioners for participating and collecting data: Sue Quin, Alison Walsh, Catherine Walker, Belinda Hills, Kate McCandless, Yvonne Mundy, Jenie Stroh, Fiona O’Neil, Saskia Reus-Smit, Despina Kamper, Jessica Daff, and Victoria Webb (apologies if any contributing clinician’s names are mistakenly omitted). Thanks are also extended to Karen Savage for assistance with the data. References
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Please cite this article in press as: Sarris J, et al. Naturopathic medicine for treating self-reported depression and anxiety: An observational pilot study of naturalistic practice. Adv Integr Med (2013), http://dx.doi.org/10.1016/j.aimed.2013.06.001