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耐糖能障害または空腹時血糖障害の人に対する中薬(中医学の薬草療法)

Abstract

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Background

Around 308 million people worldwide are estimated to have impaired glucose tolerance (IGT); 25% to 75% of these will develop diabetes within a decade of initial diagnosis. At diagnosis, half will have tissue‐related damage and all have an increased risk for coronary heart disease.

Objectives

The objective of this review was to assess the effects and safety of Chinese herbal medicines for the treatment of people with impaired glucose tolerance or impaired fasting glucose (IFG).

Search methods

We searched the following databases: The Cochrane Library, PubMed, EMBASE, AMED, a range of Chinese language databases, SIGLE and databases of ongoing trials.

Selection criteria

Randomised clinical trials comparing Chinese herbal medicines with placebo, no treatment, pharmacological or non‐pharmacological interventions in people with IGT or IFG were considered.

Data collection and analysis

Two authors independently extracted data. Trials were assessed for risk of bias against key criteria: random sequence generation, allocation concealment, blinding of participants, outcome assessors and intervention providers, incomplete outcome data, selective outcome reporting and other sources of bias.

Main results

This review examined 16 trials lasting four weeks to two years involving 1391 participants receiving 15 different Chinese herbal medicines in eight different comparisons. No trial reported on mortality, morbidity or costs. No serious adverse events like severe hypoglycaemia were observed. Meta‐analysis of eight trials showed that those receiving Chinese herbal medicines combined with lifestyle modification were more than twice as likely to have their fasting plasma glucose levels return to normal levels (i.e. fasting plasma glucose <7.8 mmol/L and 2hr blood glucose <11.1 mmol/L) compared to lifestyle modification alone (RR 2.07; 95% confidence intervall (CI) 1.52 to 2.82). Those receiving Chinese herbs were less likely to progress to diabetes over the duration of the trial (RR 0.33; 95% CI 0.19 to 0.58). However, all trials had a considerable risk of bias and none of the specific herbal medicines comparison data was available from more than one study. Moreover, results could have been confounded by rates of natural reversion to normal glucose levels.

Authors' conclusions

The positive evidence in favour of Chinese herbal medicines for the treatment of IGT or IFG is constrained by the following factors: lack of trials that tested the same herbal medicine, lack of details on co‐interventions, unclear methods of randomisation, poor reporting and other risks of bias.

PICO

Population
Intervention
Comparison
Outcome

El uso y la enseñanza del modelo PICO están muy extendidos en el ámbito de la atención sanitaria basada en la evidencia para formular preguntas y estrategias de búsqueda y para caracterizar estudios o metanálisis clínicos. PICO son las siglas en inglés de cuatro posibles componentes de una pregunta de investigación: paciente, población o problema; intervención; comparación; desenlace (outcome).

Para saber más sobre el uso del modelo PICO, puede consultar el Manual Cochrane.

Plain language summary

耐糖能障害または空腹時血糖障害の人に対する中薬(中医学の薬草療法)

世界の約3億800万人が「耐糖能障害」であると報告されている。それらの人々は通常の血糖(グルコース)値よりも高値を呈すが、糖尿病1型または2型の診断基準を満たさない。中薬(中医学の薬草療法)の治療により、糖尿病の発病、または心血管疾患の合併症を予防または遅延する方法が提供される可能性がある。「耐糖能障害」と最初に診断されてから10年以内に、25~75%の人が糖尿病に移行すると推定される。

本レビューは15種類の中薬を用いた16件のランダム化比較試験を調査した。試験は4週間から2年(平均9カ月)継続し、計1391例の参加者を対象とした。全死因死亡、糖尿病合併症および経済的アウトカムは検討されていなかった。重篤な有害事象は報告されなかった。

存在するエビデンスは、中薬が高血糖を下げ正常化することができると示唆している。試験において、かなりのゆがみ(バイアス)があるため、耐糖能障害および糖尿病発症の遅延に対する中薬の効果に関して確信を持って結論に導くには、質が高く正確に評価された研究が必要である。