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Seasonal affective disorder: Do non-drug interventions such as light and vitamin therapy lead to better results? IQWiG Reports – Commission No. HT18-04 [Internet] Cologne (Germany): Institute for Quality and Efficiency in Health Care (IQWiG); 2021 Apr 14.
Seasonal affective disorder: Do non-drug interventions such as light and vitamin therapy lead to better results? IQWiG Reports – Commission No. HT18-04 [Internet]
Show details6.1. Results on ethical aspects
Thirty-three publications were included for the evaluation of ethical aspects. No studies were found explicitly discussing ethical aspects related to phototherapy and vitamin D therapy in SAD. Ethical challenges related to SAD, phototherapy, and vitamin D therapy as well as the assessment thereof were analysed on the basis of the revised Socratic method according to Hofmann et al. 2014 [40]. Since the interventions were not associated with any major ethical challenges, the challenges which were identified were mostly related to the disease and to target groups. No studies specifically investigating ethics and SAD were found. Since SAD is a type of depression, SAD-related challenges were deemed equivalent to those associated with depression in general. Accordingly, the greatest ethical challenges relate to patients (vulnerability and prevention of harm), the disorder (SAD as a disease, stigma, underdiagnosis, medicalization, loss of autonomy), interventions, and comparator therapies (benefit-harm ratios).
6.1.1. Ethical challenges related to target patients
Many patients with SAD exhibit greater vulnerability: About half of them have a family history of psychiatric disorders, and many of them are prone to serotonergic comorbidities such as premenstrual syndrome, alcohol abuse, or excess weight [97,98]. Untreated depression is not only associated with psychological stress but can also jeopardize physical health. For instance, depression is associated with stress-related cerebral impairment [99,100] or coronary heart disease such as heart attacks [101]. Offering support to depression patients is therefore particularly important to prevent future harm and sequelae.
6.1.2. Ethical challenges related to the disorder
Is SAD a clinical picture or rather a “normal” part of winter? No societal consensus has been reached about this question due to common experiences with “winter fatigue” and biases against “ill-humoured individuals”, for which people with depression are often mistaken [102,103]. Patients reported healthcare providers’ lack of awareness as well as stigmatization as barriers to the recognition of SAD as a disorder (and possibly to its correct diagnosis) [104]. However, even patients expressed doubts as to whether listlessness, social withdrawal, and depressive moods might simply be part of winter, whether they actually represent a clinical picture or are unnecessarily medicalized [104]. When symptoms of depression become pathological, the patient’s autonomy and authentic personality are harmed due to a decrease in “energy, enthusiasm, concentration, hope, optimism, self-esteem, and self-respect” [102,105].
6.1.3. Ethical challenges related to the interventions
Although phototherapy and vitamin D therapy are associated with only minimal normative challenges, some ethical issues exist. Given a lack of data on the benefit and harm of vitamin D therapy, the benefit-harm ratio cannot be assessed. For phototherapy, any AEs must be taken into account alongside the indications of benefit, which are supported by metaanalyses [14]. Lack of SHI coverage of the service also promotes social inequality; both treatments require patient copayments [104]. Regarding comparator therapies, no conclusion can be drawn on the effectiveness of antidepressants when compared with placebo [23]. However, the benefit assessment showed a hint of fluoxetine being associated with more AEs than phototherapy. Patients also reported a dislike for taking antidepressants [104]. In the comparison of phototherapy versus cognitive behavioural therapy, neither was found to be superior. Both therapies require some time, but particularly the longer time period associated with cognitive behavioural therapy might represent an obstacle to patients experiencing an improvement in symptoms on time [104,106].
6.1.4. Ethical challenges related to the assessment
Ethical challenges related to this HTA include (1) disregarded comparator therapies, such as dietary changes or physical exercise, and (2) problems associated with the health economic analyses, e.g. their U.S.-centric perspective and the non-use of discounting and reference values. Any overestimates or underestimates of costs and cost effectiveness or any inappropriate transfer to the German healthcare context may affect price calculations, coverage decisions, and general treatment decisions in practice [84,85].
6.2. Results on social aspects
The information processing on social aspects was based on the comprehensive conceptional framework proposed by Mozygemba et al. 2016 [42]. Social aspects were evaluated based on 17 publications (studies, stakeholder websites) as well as insights gained from 2 patient interviews.
6.2.1. Social construct / perception of SAD
Both patients and psychiatrists typically perceive SAD as a biological rather than a psychological disorder [104]. This view also explains the idea of treating SAD with phototherapy and vitamin D therapy. Both measures aim to counteract lack of sunlight and its consequences. Psychological disorders such as depression are still less accepted in society than physical disorders and are often perceived as a personal weakness [107]. The focus on its biological causes could explain the lower stigmatization of SAD in society. Although diagnostic criteria have been established for SAD as a subtype of depression, doubts are widespread in society as to whether SAD actually represents a clinical picture or rather a “normal” aspect of winter [103]. Patients view physicians as lacking awareness of SAD, a fact which can result in delayed or missed diagnosis and treatment of SAD [104].
6.2.2. Social image / perception of the intervention
Phototherapy
Patients expect phototherapy to alleviate or eliminate depressive symptoms, increase functioning in the private and professional environment, and improve their quality of life [104]. The phototherapy device is to replace lack of sunlight in the winter and eliminate any deficiencies.
Among physicians, knowledge about SAD and phototherapy as a potential treatment option seems to vary. While in the clinical setting, specialists often recommend phototherapy against SAD [28], patients paint a different picture for the general care setting. They themselves reportedly know little about treatment options such as phototherapy, expecting physicians to provide more information as well as support and consultation in the selection of phototherapy devices [104].
Patient acceptance of phototherapy is likely high, particularly since many people have a negative attitude toward drug therapies, while phototherapy represents a nondrug alternative. Patients expect fewer AEs from phototherapy than, for instance, from a regularly taken antidepressant. However, the application of phototherapy is time-intensive and, for some, difficult to incorporate into daily life. This might lead to low treatment adherence or even treatment discontinuation and reduce the acceptance of phototherapy [9,108].
Vitamin D therapy
Patients expect vitamin D therapy to reduce depressive symptoms. Vitamin D, which is not synthesized in the skin in winter, can be taken as a supplement to compensate for any deficiencies.
Specialists apparently do not consider vitamin D a treatment option for SAD. This is in line with the current recommendations of the National Disease Management Guideline for unipolar depression, which does not list vitamin D as a treatment option for SAD [13]. Only 3 of 100 surveyed hospitals in German-speaking countries reported recommending vitamin D to treat SAD [28]. According to patients, vitamin D was more often recommended due to an identified deficiency rather than due to SAD [104].
Vitamin D therapy is easily integrated into daily life, but the lack of evidence of its effectiveness against SAD represents a barrier to its being prescribed by physicians [104]. Even so, given the high sales figures of vitamin D preparations in Germany, the use of vitamin D as a nutritional supplement (regardless of the indication) is likely widespread in the population [109].
6.2.3. Sociocultural aspects of the use of the intervention
Phototherapy
Long-term use of phototherapy requires its integration into patients’ daily routines. Potential problems mentioned by patients were lack of time in the mornings due to family obligations and conflicts with their work schedules, for instance due to shift work [92]. The fact that not all SHIs cover the cost of phototherapy might lead to social inequality since only individuals who can afford to pay for this intervention will use it [110,111].
Joint decision making by patients and physicians requires comprehensive knowledge about the disorder and the various treatment options. No cooperation between different healthcare professions is necessary, however, since phototherapy is typically self-administered by patients at home or independently at hospitals or physician’s offices following a short briefing.
Vitamin D therapy
The use of vitamin D therapy can likely be implemented in the target group without any sociocultural influences. However, some individuals might conceivably dislike vitamin supplements. SHIs do not cover any costs for the use of vitamin D in SAD, which might lead to inequalities in utilization. Cooperation between healthcare professionals is necessary if blood work for vitamin D deficiency is performed in external laboratories. Vitamin D is taken by patients at home.
6.3. Results on legal aspects
Information processing on legal aspects was based on the guideline developed by Brönneke et al. 2016 [44] for the identification of legal aspects and drew upon 17 documents.
6.3.1. Informed consent to treatment and duty to provide information on phototherapy and vitamin D therapy as treatment alternatives
According to Section 630e clause 3 German Civil Code [112], the informed consent discussion must include alternatives to the suggested measure if multiple methods which are equally medically indicated and commonly used might lead to substantially different burdens, risks, or chances of healing. Therefore, every physician must inform patients about phototherapy and vitamin D therapy if they are equally medically indicated, are part of standard medical practice, and represent less “invasive” methods, e.g. by replacing antidepressants. This applies even more so if physicians offer phototherapy or work at a facility that offers phototherapy or vitamin D treatment as alternatives to antidepressants.
6.3.2. Medical confidentiality and data protection
Medical confidentiality is important in general and particularly in such a sensitive area. In addition, data protection regulations must be observed [113].
6.3.3. Market approval
According to applicable law, phototherapy devices are considered medical devices within the meaning of the Medical Devices Act and are subject to the corresponding rules [114].
The dosage of vitamin D preparations determines whether they are considered nutritional supplements or medicinal products: An expert committee established for this purpose concluded that up to a daily dose of 20 μg, vitamin D likely has a nutrition-specific and physiological effect. Therefore, preparations with a daily vitamin D dose of up to 20 μg can be classified as nutritional supplements – but only if they meet all food law requirements and if the recommended therapeutic indications do not justify their classification as medicinal products. Higher-dose preparations are considered medicinal products. Exceptions may apply to foods for special medical purposes in compliance with the associated directive [115,116]. If they serve to restore, correct, or modify physiological functions, provided such impact is substantial, vitamin D preparations are classified as medicinal products by presentation within the meaning of Section 2 (1) line 2a AMG (German Medicinal Products Act). If they are intended for the purposes of healing, alleviation, or prevention of said disorders, vitamin D preparations are classified as medicinal products by presentation within the meaning of Section 2 (1) line 1 AMG [115].
6.3.4. General legal bases for the reimbursement of costs within the public health system
Since phototherapy devices are not mentioned in HeilM-RL [76], they typically do not qualify for reimbursement. Medical devices are generally not eligible to be prescribed, but, where medically necessary in exceptional cases, they can be prescribed like drugs to be reimbursed by the SHI (positive list). The medical devices currently rated as such by the G-BA are listed in Annex V of its Pharmaceuticals Guideline. However, this list does not include any phototherapy devices for treating mild depression. After all, according to a frequently cited justification with reference to Section 12 SGB V, SHIs must not approve services unless they are adequate, appropriate, and efficient and do not exceed what is necessary [117]. Since sufficient outdoor exercise might lead to the same result, the costs of administering artificial light as in phototherapy are not covered.
As far as can be ascertained, even vitamin D preparations not deemed medicinal products are generally not reimbursable. According to the Pharmaceuticals Guideline, nonprescription drugs shall be prescribed if they are medically necessary, appropriate, and adequate for the treatment of a disorder. The cost of vitamin D treatment is covered only in specified exceptional cases (“Approved exceptions from the exclusion of nonprescription drugs from the SHI benefit package”) – which do not include SAD treatment with vitamin D.
6.4. Results on organizational aspects
The information processing on organizational aspects followed the grid template proposed by Perleth et al. 2014 [43] for the assessment of organizational consequences of treatment methods. The evaluation of organizational aspects was based on 7 publications (studies, guideline, stakeholder websites).
6.4.1. Influence on the prerequisites of service provision
Phototherapy
Phototherapy can be either self-administered by patients at their homes [16] or provided on an outpatient basis in medical offices or hospitals offering phototherapy. The application of phototherapy requires no formal qualifications, but physicians must be able to diagnose SAD, be aware of the option of using phototherapy devices, and purchase a phototherapy device. No additional staff is needed since phototherapy can be self-administered by patients. Where phototherapy is offered by physicians in hospitals and practices, a professional must provide brief initial instructions to the patient and make a room available.
Vitamin D therapy
Vitamin D is self-administered in the form of tablets, capsules, and droplets by patients at their homes [118]. Physicians do not require any additional qualifications for prescribing vitamin D, but laboratory tests are initially needed to establish vitamin D deficiency. However, it must be noted that SAD currently does not represent an indication for vitamin D therapy and this HTA report did not find any studies proving the efficiency and safety of vitamin D therapy in SAD.
6.4.2. Influence on processes
Phototherapy
Despite the fact that the National Disease Management Guideline lists both phototherapy and antidepressants as first-line therapies for SAD [13], SHIs cover the costs of antidepressants – but not of phototherapy. In Germany, antidepressant therapy is the most common treatment method for acute SAD [28]. An increased use of the nondrug alternative of phototherapy would not be expected to result in any service provider rearrangements since it involves the same healthcare professionals as antidepressant therapy. No additional forms of communication would be needed since its administration does not require coordination with other service providers.
Vitamin D therapy
Vitamin D is not listed as a treatment option in SAD [13]. More widespread supplementation with vitamin D might put pressure on resources since it requires more laboratory testing for vitamin D deficiency. For this purpose, physicians who do not have their own laboratory must collaborate with an external laboratory.
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