Pilot clinical trial of constitutional hydrotherapy in HIV+ adults

Abstract

Background

HIV+ adults have reduced quality of life due to disease-related morbidity and adverse events related to standard medical therapy. Constitutional hydrotherapy is a traditional treatment reported to improve immune function and general well-being. Clinical research on hydrotherapy is needed.

Objective

To evaluate the short-term tolerability, safety and clinical effects of twice-weekly constitutional hydrotherapy treatments over a 6-week period in HIV+ adults.

Methods

The present study was an eight-week pilot clinical trial of fifteen HIV+ adults receiving twelve constitutional hydrotherapy treatments each over 6 weeks in an academic, Naturopathic medical clinic.

Outcome measures

Retention in the trial, adverse events, CD4+ count, viral load, and clinical chemistries, including TNF-alpha levels, erythrocyte sedimentation rate, and C-reactive protein. Other measures included anthropometrics and quality of life as measured by the RAND 36-Item Short Form Survey (SF-36). Two-sided, paired t-tests for homogeneity were applied to the difference in outcome variables between baseline and exit interviews.

Results

12 of 15 participants completed the study per protocol. Treatments were well-tolerated and without any reported “Severe” side effects. No statistically significant adverse changes were observed in hematologic or inflammatory biomarkers, or anthropometric measures. There were no significant changes in CD4+ count or viral load. Changes in clinical chemistries were non-significant, except for a reduction on sodium concentration (139.6 mmol/L ± 1.7 to 137.5 ± 1.8; p = 0.005). A non-significant decrease in mean hs-CRP was observed (7.5 mg/L, ± 14.2 to 1.7 mg/L, ± 1.4, p = 0.21) with an absolute decrease in hs-CRP in each of the three participants with elevated hs-CRP levels at baseline. A non-significant reduction in systolic blood pressure (SBP) was observed (mean change −7.7 mmHg, p = 0.22) with 58% of participants experiencing reductions in SBP. Mean percent body fat decreased significantly (22.3 ± 4.0 to 20.7 ± 5.2, p < 0.0001). In addition, a statistically significant increase in mean Energy/Fatigue score was observed (17.8 to 20.3, p = 0.03) using the RAND-36 Short Form. Trends for improved Physical Functioning and Pain scores were of borderline significance (87.9 to 94.1, p = 0.10 and 15 to 16.5, p = 0.08 respectively). All remaining domains, including General Health, were without trend for change.

Conclusions

This clinical pilot study suggests constitutional hydrotherapy can be feasibly and safely administered to HIV+ adults, including those receiving HAART, without serious short-term adverse effects. Small, but significant, increases in clinical measures, physical functioning and quality of life were observed.

Introduction

The primary treatment for HIV infection in adults is highly active anti-retroviral therapy (HAART). However, HAART has been associated with a high risk for multiple adverse events (AE), including decreases in white blood cell count, anaemia, liver toxicity, diarrhoea, nausea, vomiting, hypersensitivity reactions, hyperglycemia and iatrogenic diabetes mellitus and lipid abnormalities [1]. These adverse events can be key contributors to morbidity and negatively affect quality of life among those with HIV [2]. Many limitations exist on the use of adjunctive medications to ameliorate these untoward effects, mostly due to a large number of potential interactions with HAART medications [[1], [3]].

Research has established a positive association between systemic inflammation and HIV viral replication [4] with high inflammatory burdens inversely associated with survival in individuals with HIV/AIDS [5]. C-reactive protein (CRP), a validated biomarker of systemic inflammation, has been shown to be a predictor of survival and mortality among individuals with HIV [[5], [6]]. Inflammation appears to be self-perpetuating in the presence of HIV infection, with inflammatory cytokines, like TNF-alpha, stimulating HIV replication which further induces TNF-alpha production. Thus there is a need for “anti-inflammatory” therapies that have little to no risk of interactions with standard of care medical therapies. Such therapies should be non-invasive, and ideally, reduce the inflammatory cascade while improving physical function and quality of life in infected individuals. Hydrotherapy (i.e. The proscribed therapeutic use of water) is a relatively simple potential self-care therapy to reduce inflammation with little risk of medication interactions [7].

“Constitutional” hydrotherapy was developed in the early 1900s by Dr. O.G. Carroll, and involves the application of contrasting hot and cold water to the torso with simultaneous low-voltage transcutaneous electrical stimulation [8]. Constitutional hydrotherapy is theorised to favourably impact immune function, decrease inflammation, improve gastrointestinal function and reduce stress [9], suggesting the procedure may benefit multiple aspects of HIV infection, including side effects from HAART. Research confirming these theories is very limited, however, and theories on its effects are based mostly on clinical observations. Currently, there is no published research on the effects of constitutional hydrotherapy among the general population, or among HIV+ individuals, despite its historical and current use in clinical practice around the world. Thus, because this therapy has a traditional use in naturopathic medicine for inflammation, and a contemporary use in naturopathic practice in HIV+ patients, we sought to systematically observe the effects of constitutional hydrotherapy on inflammation and quality of life by performing an uncontrolled clinical trial.