This survey of consumers of Sen-Sei-Ro who reported a history of cancer found that nearly all began using it after their cancer was diagnosed, and those who started using it earlier in their cancer course tended to report greater benefit. Most patients report benefit from consuming this product and large proportions feel using it is a "great help." A survey of people currently using the product by choice produces a bias toward reported benefit, which our results reflect, and the relatively low 33% survey response rate probably increases the bias. However, despite the evident predisposition in favor of the product and the generally positive reports for more global benefits from its use, most of these study participants report little substantial effect in either direction when queried about specific consequences of cancer or its treatment.
Our findings shed some light on these patients and our measures. Our factor analysis of items focusing on 17 more or less specific effects indicated two major constructs that characterize study participants' perceptions of potential benefits of using Sen-Sei-Ro: relief of cancer and treatment-related symptoms and improvement in overall functional status and well-being, which fits with previous studies of cancer patients' motivations for pursuing CAM [4, 22, 23]. Like others, we found that improvements in functional well-being were greater than relief of symptoms, suggesting that cancer patients use CAM products for their effects, rather like a health promoting tonic, in strengthening their body's ability to recover from the debility of cancer treatment and support its ability to fight against cancer [22, 24, 25]. Our results provide some additional evidence of the validity of these measures. Younger patients, women, study participants with longer usage and thus more time to recover from initial cancer treatments, and those whose cancers had less poor prognoses and less aggressive treatment are all generally less symptomatic and in better overall health, and all tended to report more benefit by both measures. These results are consistent with both patients' limited understanding of pathophysiology and the sensitivity of these scales to their true condition: they felt better and thus able to ascribe benefit to Sen-Sei-Ro than others expected to be worse off. The still lower benefit reported by prostate cancer patients may reflect their better overall well-being and few symptoms from disease or treatment, providing little potential for benefit from Sen-Sei-Ro. The 2 scales postulated here appear sensitive to patient changes in two domains relevant to CAM use and may prove useful as outcome measures in future controlled trials of these substances in cancer patients.
Previous studies have helped to characterize who is likely to use dietary supplements, such as Sen-Sei-Ro and complementary and alternative medicine products more broadly. In studies of cancer patients and other populations in North America and Europe, the probability of choosing these approaches is greater with female gender, older age, higher education, lower body mass and indicators of healthy lifestyles, such as frequent exercise, avoidance of smoking, and diets low in fat and high in fruits and vegetables [26–32]. In a large national study in Japan, Ishihara et al. reported that 11% of men and 16% of women used dietary supplements, with use associated with older age, lower body mass, and frequent exercise, as well as longer work days (for men), and greater stress . The reasons cancer patients give for using dietary supplements appear to revolve around three main themes, characterized in one study as surviving cancer (i.e., augmenting conventional treatment in fighting cancer), relieving both cancer symptoms and treatment side-effects, and repairing or boosting up, which includes detoxifying the body, boosting immunity and energy, and enhancing quality of life .
Other surveys of cancer patients have highlighted the goal of health restoration and promotion. The most common reasons for using CAM cited by breast cancer patients in Ontario were to boost the immune system (63%), increase quality of life (53%), and prevent cancer recurrence (43.5%) . Large numbers of both women (73%) and men (56%) in the SEER cohort in western Washington used dietary supplements, primarily to improve general health and well being (95% of supplement users) . However, relatively few cite symptom treatment as reason for using CAM: 21% mentioned treating side effects of conventional cancer treatments in the Ontario survey, and only 4% of the VA patients gave this reason.  A survey of cancer patients in the VA found that of the 61% who took a dietary supplement, 41% cited "energy increase" as their reason . When asked about benefits, 40% said it improved overall health, 21% reported increased energy, and only 9% said dietary supplements improved symptoms. Yet, an MD Anderson survey found that having received chemotherapy doubled the likelihood of its use and was the most common characteristic of users . Hedderson et al. found that cancer patients' decisions to use dietary supplements are associated with more severe treatment side effects and also a stronger desire for personal control .
The distinction between symptom relief and more global benefits echoes the distinction between the medical model of combating specific diseases and a more broadly understood relationship between diet and health. The concepts occasionally overlap, as in the well-established diet-heart theory linking dietary components, especially fats, to cardiac risk. However, the parallel diet-cancer theory has far less epidemiological support, and the concept of epidemic obesity in the US has apparently been embraced slowly and fitfully despite the striking data supporting it. The associations between CAM use and the healthy lifestyle and favorable socioeconomic variables, including higher educational and income levels, suggest that the broader concept of diet as a tonic, not a medicine, prevails in populations removed from severe economic adversity. As a result, the effects patients expect and perceive from Sen-Sei-Ro may have little to do with medical specifics such as the particular cancer diagnosis, the intensity of treatment and how recently it was given.
This distinction is useful for evaluating a substance taken both to obtain a global benefit, as well as to counter an array of specific symptoms. For example, antiemetic treatment against chemotherapy-induced nausea and vomiting produces quality of life benefits by reducing a specific noxious symptom complex that are much greater than the more global impact of erythropoietin on patients receiving chemotherapy. The two constructs we found correspond to patient goals for CAM identified in other studies. In another breast cancer patient cohort, CAM use was a marker of psychosocial distress, which may in part have motivated its use , since CAM is used more often by more seriously ill patients.
These results imply that patient-based measures of the effects CAM products must be strongly informed by patients' explanatory models of cancer "pharmacology," which may differ from their physicians', and measure the outcomes they value, according to their perspectives. Measures should focus on tonic effects on body strength and overall function as well as on symptom alleviation. If dietary supplements are not taken primarily for symptom relief, patients may not experience and report it, even if that is the reason their doctors prescribed the supplement. The stronger body patients hoped for may resist symptoms better, but the patient may consider that a lucky byproduct, not the main objective.
If the benefits of Sen-Sei-Ro and related products are likely to be global, rather than symptom-specific, investigations should target broad measures of well-being and systemic symptoms of anxiety or sadness, depression, appetite, maintaining body weight, daily activities, and socializing with others, in additional specific symptoms such as hair loss, nausea and pain. Our use of a 3-item Likert response set may be improved by using a 5-item scale, which would produce less granular data with better better statistical properties for psychometric analyses. We look forward to further development of this instrument to assess the use of this and other CAM substances in cancer patients. We plan to use these results to inform a series of focus groups to refine and supplement these items, pilot test additional items, subject the revised instrument to further validation studies and to use the final validated instrument in randomized trials of the efficacy of Sen-Sei-Ro and other CAM substances with putative health properties in cancer patients, if adequate research funding is available.