Article type
Year
Abstract
Background: AIDS-related diarrhoea is a common cause of morbidity and mortality in HIV-positive individuals. A previous Cochrane Review revealed the application of Chinese herbal medicine (CHM) as an alternative therapy for the treatment of HIV and related complications.
Objectives: to assess the beneficial effects and safety of CHM as alternative or adjunct therapy versus conventional treatment for AIDS-related diarrhoea.
Methods: we searched eight databases: PubMed, Embase, the Cochrane Trial Registry, ClinicalTrials.gov, CNKI, VIP, WanFang Database, SinoMed, and conference proceedings for randomized controlled trials (RCTs) published up to 3 March 2019, with no language restriction. Studies were eligible if they compared oral CHM alone or as an adjuvant with conventional treatment treating HIV-infected people with diarrhoea. The outcomes included clinical cure (defined either as having two or fewer loose stools per day, or as recovering back to normal), symptoms of diarrhoea quality of life (QOL) and adverse events. We assessed the quality of trials using the Cochrane 'Risk of bias' tool and GRADEpro and did a random-effects meta-analysis to pool the data using relative risk (RR) and standard mean difference (SMD) as effect measures.
Results: we included 31 trials (34 papers) (Fig 1), published from 2005 to 2018, involving 2371 participants recruited in either hospitals or communities from 10 provinces in China. Only one trial included participants under 18, while 22 trials involved participants with chronic diarrhoea. Overall, 26 trials tested CHM alone and five tested CHM combined with conventional treatment as an adjuvant treatment using 18 different formulae. CHM alone presented a higher cure rate (RR 1.90, 95% CI 1.57 to 2.31; 20 trials) compared with conventional treatment (Fig 2). However, an asymmetric funnel plot suggested potential publication bias (Fig 3). In terms of symptoms of diarrhoea, CHM was non-inferior to conventional treatment for reducing stool frequency (SMD -0.66, 95% CI -0.89 to -0.43; 6 trials) and recovering stool consistency (SMD -1.11, 95% CI -2.02 to -0.19; 3 trials). However, there was no significant improvement in QOL measured by Karnofsky (SMD 0.43, 95% CI -0.23 to 1.09; 2 trials) and World Health Organization QOL-HIV (SMD 0.22, 95% CI -0.12 to 0.55; 2 trials). For the five trials comparing CHM as an adjunct to conventional treatment, results showed a higher cure rate in the CHM group (RR 1.36, 95% CI 1.16 to 1.59). In total, 11 trials reported the outcome of adverse events, with no reports of serious adverse events. The quality of the evidence was low due to high risk of bias, small sample size and suspected publication bias.
Conclusions: oral CHM may be safe and efficacious in AIDS-related diarrhoea, particularly in adult patients with chronic diarrhoea. However, CHM seems no better at improving patients' QOL than conventional treatment. More high-quality RCTs with adequate reporting are needed to confirm the potential benefit.
Patient or healthcare consumer involvement: none
Objectives: to assess the beneficial effects and safety of CHM as alternative or adjunct therapy versus conventional treatment for AIDS-related diarrhoea.
Methods: we searched eight databases: PubMed, Embase, the Cochrane Trial Registry, ClinicalTrials.gov, CNKI, VIP, WanFang Database, SinoMed, and conference proceedings for randomized controlled trials (RCTs) published up to 3 March 2019, with no language restriction. Studies were eligible if they compared oral CHM alone or as an adjuvant with conventional treatment treating HIV-infected people with diarrhoea. The outcomes included clinical cure (defined either as having two or fewer loose stools per day, or as recovering back to normal), symptoms of diarrhoea quality of life (QOL) and adverse events. We assessed the quality of trials using the Cochrane 'Risk of bias' tool and GRADEpro and did a random-effects meta-analysis to pool the data using relative risk (RR) and standard mean difference (SMD) as effect measures.
Results: we included 31 trials (34 papers) (Fig 1), published from 2005 to 2018, involving 2371 participants recruited in either hospitals or communities from 10 provinces in China. Only one trial included participants under 18, while 22 trials involved participants with chronic diarrhoea. Overall, 26 trials tested CHM alone and five tested CHM combined with conventional treatment as an adjuvant treatment using 18 different formulae. CHM alone presented a higher cure rate (RR 1.90, 95% CI 1.57 to 2.31; 20 trials) compared with conventional treatment (Fig 2). However, an asymmetric funnel plot suggested potential publication bias (Fig 3). In terms of symptoms of diarrhoea, CHM was non-inferior to conventional treatment for reducing stool frequency (SMD -0.66, 95% CI -0.89 to -0.43; 6 trials) and recovering stool consistency (SMD -1.11, 95% CI -2.02 to -0.19; 3 trials). However, there was no significant improvement in QOL measured by Karnofsky (SMD 0.43, 95% CI -0.23 to 1.09; 2 trials) and World Health Organization QOL-HIV (SMD 0.22, 95% CI -0.12 to 0.55; 2 trials). For the five trials comparing CHM as an adjunct to conventional treatment, results showed a higher cure rate in the CHM group (RR 1.36, 95% CI 1.16 to 1.59). In total, 11 trials reported the outcome of adverse events, with no reports of serious adverse events. The quality of the evidence was low due to high risk of bias, small sample size and suspected publication bias.
Conclusions: oral CHM may be safe and efficacious in AIDS-related diarrhoea, particularly in adult patients with chronic diarrhoea. However, CHM seems no better at improving patients' QOL than conventional treatment. More high-quality RCTs with adequate reporting are needed to confirm the potential benefit.
Patient or healthcare consumer involvement: none