苦瓜製劑/萃取物能否降低第二型糖尿病成人之血糖?Can bitter melon extracts lower blood sugar in adults with type 2 diabetes Mellitus?

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2020-07-20 已刊登
新刊登 綜 整 預防/治療/介入類型

作  者

陳映竹 林小玲* 黃秀英 沈瑞晶

實證知識類別

A 類:實證健康照護綜整

PICO

治療/預防性問題

治療/介入措施

內分泌與糖尿病 Endocrinology and Diabetes

科別

  • 臨床指引/實證照護成效 Clinical Guidelines/Evidence Based Outcomes

中文關鍵詞

苦瓜製劑 苦瓜 第二型糖尿病人 血糖

英文關鍵詞

Bitter melon extracts Momordica charantia Type 2 Diabetes Mellitus Blood sugar

機構名稱

臺北榮民總醫院

申請單位

護理部

中文摘要

形成臨床提問:
糖尿病病人控制血糖,多同時採用飲食、運動與藥物控制,而藥物控制是主要治療方式。臨床上糖尿病藥物長期使用可能產生耐受性,對心、肺、肝、腎功能不良病人,其用藥安全更需審慎。市面上出現許多苦瓜萃取物以降血糖之產品,許多病人會徵詢傳統食療協助糖尿病控制之效果,因病人詢問,故引發作者動機探討苦瓜製劑對第二型糖尿病人血糖之影響。
文獻搜尋的方法與分析:
依實證步驟確立PICO:苦瓜能否降低第二型糖尿病成人之血糖,關鍵字設定P:Type 2 Diabetes Mellitus、type 2 DM、noninsulin-dependent diabetes mellitus,I:Bitter gourd、Momordica charantia、bitter melon、bitter squash、balsam pear,O:Blood sugar、Blood glucose、Glycaemia、Glycemia、Fasting plasma glucose、HbA1C,搜尋電子資料庫含Cochrane、Pubmed、Medline、ProQuest Health、Google Scholar與華藝線上圖書館,再用布林邏輯以OR聯集、AND交集,限制Humans、Randomized Controlled Trial、Systematic Review、English、2014年至今,納入條件為符合關鍵字者,排除條件為非第2型糖尿病、非18歲以上成人、苦瓜併用其他食療。於PubMed、ProQuest Health、Cochrane資料庫中共納入系統性文獻回顧文獻2篇,與隨機對照試驗文獻1篇。
文獻的品質評讀:
以系統性文獻回顧與整合分析之文獻評析表與考科藍偏差風險工具分別評讀Systematic Review與Randomized Controlled Trial文獻,證據等級則依據牛津實證醫學中心證據等級表。第一篇系統性文獻回顧之統合分析結果顯示苦瓜製劑相較安慰劑可降低空腹血糖(MD= -0.72; I2=14%)、降低飯後血糖(MD= -1.43; I2=0%)與降低糖化血色素(MD= -0.31; I2=0%),成效達顯著;第二篇系統性文獻回顧之統合分析結果顯示苦瓜製劑相較安慰劑可降低空腹血糖(MD= -25.03; I2=98%)、也顯著降低糖化血色素(WMD= -0.2%);在隨機對照試驗結果顯示每天附加服用1.5克苦瓜錠劑對控制第2型糖尿病人血糖、降低總膽固醇、改善HDLc等有顯著差異(p< .05)。
結論與建議:
苦瓜製劑能降低空腹血糖值、飯後血糖及糖化血色素,然苦瓜製劑效果不比口服降血糖藥物。且每篇文獻對苦瓜種類、部位、劑型及劑量均不相同,影響同質性與精確性低,證據品質會降級。雖然苦瓜一直被用作第二型糖尿病的營養食品和藥用植物,然部分文獻結果相互矛盾,因此苦瓜製劑用於治療第二型糖尿病人的安全性及有效性仍受質疑。

英文摘要

Ask an answerable question (PICO):
Patients in diabetes control is mostly based on the three persistent approach among diet control, regular exercise and medication control. Of which medication control is the main method currently. However, long-term use of diabetes medication, not only the side effects from medication on physiological functions, but also be prone to tolerability. It is also being doubt to result in the safety of patients with heart or lung dysfunction or impaired liver and kidney functions. In order to achieve the control of blood sugar regulation and delay the occurrence of complications, many patients try to inquire traditional diet therapy to assist diabetes control. The author is asked by patients many often that bitter melon extracts could lower blood sugar. Therefore, the authors were motivated to discuss the effect of bitter melon extracts on blood sugar in type 2 diabetes.
The Method and Analysis of Literature Review:
The search of literatures was using EBM PICO method. "Can bitter gourd lower blood sugar in adults with type 2 diabetes Mellitus?" was asked as an answerable question. The key words were included Patients as “Type 2 Diabetes Mellitus, Type 2 DM, Noninsulin-dependent diabetes mellitus”, Interventions as “Bitter gourd, Momordica charantia, Bitter melon, Bitter squash, Balsam pear”, and Outcomes as “Blood sugar, Blood glucose, Glycaemia, Glycemia, Fasting plasma glucose, HbA1C”. The data banks of literatures were conducted from Cochrane Library, PubMed, Medline, ProQuest Health, Google Scholar, and Airiti Library. The search strategies by using the Boolean logic “AND, OR, and NOT” were implemented. “Humans” subjects, the research design of "Randomized Controlled Trial and Systematic Review", language as "English", searching years from 2014 to the present were limited. And the exclusion criteria were (1) non-type 2 diabetes, (2) non-18 years Adults, (3) non-bitter gourd or other dietary therapies. After exclusion of irrelevant or repeated papers, 2 systematic review with meta-analyses and 1 RCT were finally included.
Critical Appraisal:
The Systematic Review Appraisal Sheet (2019) and the Cochrane Risk of Bias Tool were accorded to appraise the quality of study in systematic review and randomized controlled trial respectively. The OCEBM Levels of Evidence table (2011) was used to rank the level of evidence body of study. The results of the first study of systematic review showed that bitter gourd compared to placebo had significant differences in reducing fasting blood glucose (MD= -0.72; I2=14%), reducing postprandial blood glucose (MD= -1.43; I2=0%), and reducing HbA1c (MD= -0.31; I2=0%). The results of the second study of systematic review showed that the bitter gourd compared to placebo also had significant differences in reducing fasting blood glucose (MD= -25.03; I2=98%) and reducing HbA1c (WMD= -0.2%). The results of the included randomized controlled trial showed that patients with type 2 diabetes who add on treatment with 1.5 gm/day of bitter gourd tablets daily had effective in controlling blood sugar, lowering total cholesterol and improving HDLc (p < .05).
Conclusions and Recommendations:
Bitter melon extracts could reduce fasting blood glucose, postprandial blood sugar and HbA1c, however, the oral hypoglycemic agents (OHAs) were more effective than bitter melon extracts in lowering elevated fasting plasma glucose level, postprandial glucose and HbA1C. Moreover, each study does not standardize the formulation, location, dosage form and amounts of bitter melon extracts. It results in high variability, imprecision and downgrade the quality of evidence. Although bitter melon extracts have been used as nutritious supplement or herbs for type 2 diabetes, some research results are still contradictory. Therefore, the safety and effectiveness of bitter melon extracts for the treatment of patients with type 2 diabetes are still controversy.