Foods for Special Medical Purposes: A Novel Clinical Adjuvant Therapy Approach

1. Introduction

Food for Special Medical Purposes (FSMP) refers to specially processed and formulated food products designed to meet the nutritional or dietary requirements of individuals with eating restrictions, digestive/absorption disorders, metabolic disturbances, or specific disease conditions. Since "specific disease state populations" typically present clinical manifestations such as eating restrictions, digestive/absorption disorders and metabolic disturbances, FSMP must be used under the guidance of physicians or clinical dietitians. FSMP plays significant roles in improving patients' nutritional status, promoting recovery, shortening hospital stays, and reducing medical costs.

In recent years, the "Healthy China" initiative has gained widespread recognition, with medical institutions at all levels increasingly emphasizing nutritional departments. Clinical nutrition management and continuous improvement have become integral components of hospital accreditation standards. Recently, the National Health Commission issued the Implementation Rules for the Tertiary Hospital Accreditation Standards (2020 Edition), which include the following nutrition therapy implementation details:

1. Conduct nutritional screening, assessment, diagnosis and treatment for inpatients. Gradually implement nutritional screening for hospitalized patients to understand their nutritional status. Establish standardized clinical nutrition therapy pathways based on nutrition screening-assessment-diagnosis-treatment, provide nutrition therapy for malnourished inpatients according to nutritional step therapy principles, and regularly evaluate the outcomes.

2. Provide nutritional dietary guidance, therapeutic meals and diet plans to meet patients' treatment needs.

3. Nutrition departments should actively participate in multidisciplinary diagnosis and treatment, establish nutrition support teams; provide nutritional consultations for special, difficult, critical, major surgery and multidisciplinary cases; develop nutrition support plans as needed and document them in medical records accordingly.

Nutrition therapy has become an essential component of diagnosis and treatment, playing crucial roles in improving treatment outcomes, promoting patient recovery, and ensuring patient safety. Hospitals should conduct nutritional assessments for inpatients and provide appropriate nutrition therapy.

2. Incidence of Malnutrition in Various Diseases

The population with the highest incidence of malnutrition in China is hospitalized patients. Statistical data show [1] that approximately 65% of hospitalized patients in China require clinical nutrition support, yet at least 70% of them fail to receive effective nutritional intervention. It should be noted that the purpose of nutritional support is to improve patients' malnutrition, enhance bodily functions to tolerate disease treatments, and ultimately improve quality of life. Medical procedures such as surgery, radiotherapy/chemotherapy or molecular targeted therapies remain the fundamental approaches to disease treatment.

For example, during anti-tumor treatments (the leading cause of death), while killing cancer cells, these therapies also damage normal cells, especially rapidly proliferating ones. Moreover, radiotherapy/chemotherapy can suppress bone marrow proliferation, often causing metabolic damage to gastrointestinal mucosal epithelial cells and ulcers, while also impairing liver function and the immune system, leading to symptoms like anorexia, dyspepsia and gastrointestinal bleeding [2][3]. When patients become malnourished during treatment, their tolerance to surgery and radiotherapy/chemotherapy decreases, compromising treatment efficacy. Multiple studies report that some patients have to discontinue chemotherapy due to significant body weight loss [4][5][6]. Therefore, providing appropriate clinical nutrition support for patients undergoing anti-tumor treatment is absolutely necessary.

Published monographs, guidelines and expert consensuses on nutritional therapy for cancer patients include: Chinese Guidelines for Cancer Nutrition Therapy (The 2015 edition was the world's first systematic monograph on cancer nutrition therapy using evidence-based medicine methods. The book contains 17 chapters covering the entire clinical process from guideline development principles and methods, general rules of cancer nutrition therapy, nutritional screening/assessment, access establishment, formula selection, intervention implementation, outcome evaluation, complication prevention, nursing care to home nutrition guidance.) [7], Expert Consensus on Nutritional Therapy for Malignant Tumor Patients [8], Expert Consensus on Nutritional Therapy for Radiotherapy Patients [9], Interpretation of Chinese Expert Consensus on Nutrition Access for Malignant Tumors: Non-surgical Jejunostomy [10], Expert Consensus on Enteral Nutrition for Radiotherapy Patients with Malignant Tumors [11], Chinese Expert Consensus on Perioperative Nutritional Therapy for Gastric Cancer (2019 Edition) [12], Consensus on Nutritional Therapy for Biliary Tract Tumor Patients [13], Expert Consensus on Nutritional Therapy for Nasopharyngeal Carcinoma [14], Expert Consensus on Nutritional Therapy for Ovarian Cancer Patients [15], Chinese Expert Consensus on Perioperative Nutritional Therapy for Colorectal Cancer (2019 Edition) [16], Expert Consensus on Enteral Nutrition for Esophageal Cancer Patients Undergoing Radiotherapy [17], Expert Consensus on Nutrition and Supportive Therapy for Head and Neck Cancer Patients Undergoing Radiotherapy [18], Expert Consensus on Nutritional Management for Malignant Tumor Patients During Rehabilitation [19], Consensus on Nutritional Intervention for Terminal Cancer Patients [20], etc.

Similarly, malnutrition caused by other diseases also requires attention. The prevalence and malnutrition rates of various diseases are shown in Table 1.

Table 1. Incidence of Malnutrition in Various Diseases

The necessity of nutritional support will be illustrated using diabetes and sarcopenia as examples. According to the latest data from the International Diabetes Federation, there were 382 million people with diabetes worldwide in 2013, projected to reach 592 million by 2035. Due to China's large population base, there are 116.4 million diabetic patients, ranking first globally. Diabetes treatment requires comprehensive approaches including blood glucose monitoring, appropriate exercise, and scientific nutrition therapy. Nutritional therapy for diabetic patients can both improve their condition and treatment outcomes while reducing costs. In 2017, Guo Xiaohua [21] analyzed data from 102 large samples in China, showing that compared with conventional treatment, type 2 diabetic patients receiving medical nutrition therapy achieved better outcomes at lower costs. Thus, medical nutrition therapy deserves recommendation and clinical application.

Published monographs, guidelines and expert consensuses on nutritional therapy for diabetic patients include: Clinical Practice Guidelines for Parenteral and Enteral Nutrition (2008 Edition) [22], Clinical Nutrition [23], Clinical Application Guidance for Foods for Special Medical Purposes [24], Modern Nutrition Therapy [25], Expert Consensus on Medical Nutrition Therapy for Diabetes (2013) [26], Interpretation of UK Evidence-Based Guidelines for Diabetes Prevention and Management Nutrition (2018) [27], Chinese Expert Consensus on Remission of Type 2 Diabetes [28], Optimization of Management Concepts and Strategies for Elderly Diabetes - Interpretation of Chinese Expert Consensus on Diagnosis and Treatment of Elderly Type 2 Diabetes (2018 Edition) [29], etc.

The main clinical manifestations of sarcopenia are decreased skeletal muscle mass and function in limbs. Research shows that muscle mass decline may begin as early as young adulthood, starting with atrophy and loss of type II muscle fibers, continuing throughout life. Muscle function (strength and power output) decline may begin around age 35, decreasing at 1-2% annually, accelerating after 50, progressing faster after 60, and peaking after 75. Comparatively, functional decline is more significant than mass loss. Beyond direct impacts on skeletal muscle structure and function, sarcopenia increases risks of falls and fractures, reduces physical performance, raises hospitalization rates and frequency, increases care burden, and even elevates mortality risk.

Sarcopenia incidence is influenced by multiple factors. Surveys show incidence rates in Taiwan and Hong Kong regions are 6.7-8.4% for males and 0.4-2.6% for females; cross-ethnic comparisons reveal Shanghai residents over 70 have 4.8% (female) and 13.2% (male) rates, lower than Caucasians but similar to Japanese and Koreans; screening of Chinese urban and rural elderly populations found overall incidence of 9.8% for those over 60 (male 6.7%, female 12.0%), with rural areas at 13.1% versus urban 7.0%, indicating higher prevalence among rural elderly in western China.

As China gradually becomes an aging society, relevant data predict the population over 60 will exceed 300 million by 2025, making China a super-aged nation. Meanwhile, the proportion of elderly with sarcopenia continues rising, increasing societal healthcare and family support burdens while significantly impacting seniors' lives. FSMP for sarcopenia can improve patients' nutritional status, enhance quality of life, reduce life-threatening risks, and has broad application prospects.

Published monographs, guidelines and expert consensuses on nutritional therapy for sarcopenia patients include: Clinical Practice Guidelines for Parenteral and Enteral Nutrition (2008 Edition) [22], Clinical Nutrition [23], Clinical Application Guidance for Foods for Special Medical Purposes [24], Modern Nutrition Therapy [25], Guidelines for Nutrition Therapy of Sarcopenia [30], Chinese Expert Consensus on Sarcopenia [31], Chinese Expert Consensus on Nutrition and Exercise Intervention for Sarcopenia (Excerpt) [32], etc.

3. Conclusion

Patient malnutrition directly reduces immunity, increases infection rates during treatment, delays surgical wound healing, and impacts quality of life while increasing hospitalization frequency, duration and costs. FSMP provides a simple, convenient and economical approach to clinical nutrition therapy, offering crucial support for disease treatment, recovery and bodily function maintenance, gaining increasing popularity among patients and the general public. In China, FSMP must be used under physician or clinical dietitian guidance, with specific complete nutrition formulas only sold in hospitals and pharmacies, while standard complete and incomplete nutrition formulas can also be sold in food stores and online.