In 1998, Lin & Yen compared 2 concentrations of an L acidophilus strain and 2 concentrations of an L bulgaricus strain with placebo. McDonough examined the effects of sonicated (intracellular lactase release) acidophilus milk in addition to acidophilus milk on breath hydrogen results.
Four of the 10 randomized controlled trials were performed in a crossover design (Newcomer, Lin & Savaiano, Lin & Yen, and Savaiano) while the remaining 6 varied in randomized designs.
TABLE 1 shows the validity characteristics for the 10 clinical trials published between 1981 and 1998 that met inclusion and exclusion criteria. While all were randomized controlled trials with similar patients, interventions, and controls, none of the 10 concealed the allocation of the interventions. Lin & Yen’s 1998 study failed to mention the percentage of subjects followed-up and, thus, intention-to-treat did not figure into the analysis. Three of the 10 (Dehkordi, Onwulata, McDonough) did not specify if their studies involved double-blinding.
Descriptors of each trial’s treatment arms, subjects, design, data presentation, and results are shown in TABLE W1. Of the 9 studies that measured the disease-oriented outcome of breath hydrogen, 3 were positive, 3 were negative, and 3 had both positive and negative (mixed) results. Of the 7 studies that measured the patient-oriented outcome of symptoms, 1 yielded positive results, 5 were negative, and 1 had mixed outcomes (TABLE 2).
TABLE 1
Validity characteristics of randomized controlled trials studying the effects of probiotics on lactose intolerance
| LEAD AUTHOR | PATIENTS SIMILAR | RCT | ASSIGNMENT CONCEALED | DOUBLE-BLINDING | 100% FOLLOW-UP | INTENTION TO-TREAT | INTERVENT./CONTROLS SIMILAR |
|---|---|---|---|---|---|---|---|
| Dehkordi (1995)11 | Yes | Yes | No | Not specified | Yes | N/A | Yes |
| Jiang (1996)12 | Yes | Yes | No | Yes | Yes | N/A | Yes |
| Mustapha (1997)13 | Yes | Yes | No | Yes | Yes | N/A | Yes |
| Newcomer (1983)14 | Yes | Yes | No | Yes | Yes | N/A | Yes |
| Onwulata (1989)15 | Yes | Yes | No | Not specified | Yes | N/A | Yes |
| Lin, Savaiano (1991)16 | Yes | Yes | No | Yes | Yes | N/A | Yes |
| Lin, Yen (1998)17 | Yes | Yes | No | Yes | Not mentioned | Not mentioned | Yes |
| Savaiano (1984)18 | Yes | Yes | No | Yes* | Yes | N/A | Yes |
| McDonough (1987)19 | Yes | Yes | No | Not specified | Yes | N/A | Yes |
| Kim (1983)20 | Yes | Yes | No | Yes | Yes | N/A | Yes |
| RCT, randomized controlled trial; N/A, not applicable secondary to 100% follow-up and subject analysis consistent with group assignment. | |||||||
| * Described as “blinded” but “no attempt to mask flavor or texture.” | |||||||
TABLE 2
Does the addition of probiotics to non-fermented dairy products decrease lactose intolerance at a single meal?
| LEAD AUTHOR | BREATH HYDROGEN RESULTS* | SYMPTOM RESULTS | COMMENTS |
|---|---|---|---|
| Dehkordi (1995) | Negative (1 of 1 Expt 1; 2 of 2 Expt 2) | Not measured | Non-probiotic treatment arm of whole milk with corn flakes “alleviated lactose malabsorption significantly” (P<.01).11 |
| Jiang (1996) | Positive (2 of 3) | Negative (2 of 3 flatulence, 3 of 3 abdom. pain, 3 of 3 meteorism, 3 of 3 borborygmi, 3 of 3 diarrhea) | |
| Mustapha (1997) | Positive (3 of 4) | Mixed | 1 of 4 probiotic treatment arms w/ significantly less flatulence; 1 w/ sig. less bloating; 2 w/ sig. less diarrhea. No difference in rumbling symptom. |
| Newcomer (1983) | Not measured | Negative (1 of 1) | |
| Onwulata (1989) | Negative (1 of 1) | Negative (1 of 1) | |
| Lin, Savaiano (1991) | Mixed | Negative (7 of 8) | 3 of 8 probiotic treatment arms w/ sig. difference in mean breath hydrogen. 1 of 8 probiotic treatment arms eliminated intolerance symptoms “in all subjects.” |
| Lin, Yen (1998) | Mixed | Positive (3 of 4) | 2 of 4 probiotic treatment arms w/ sig. difference in mean breath hydrogen. |
| Savaiano (1984) | Negative (1 of 1) | Negative (1 of 1) | |
| McDonough (1987) | Mixed | Not measured | 1 of 2 probiotic treatment arms w/ sig. difference in mean breath hydrogen. |
| Kim (1983) | Positive (2 of 3) | Not measured | |
| Summary (10 studies): Breath hydrogen = 3 positive studies, 3 negative, 3 mixed, 1 not measured. *Expressed as number of probiotic treatment arm results per number of probiotic treatment arms in study. Examples: negative (2 of 3) = 2 negative treatment arms of 3 probiotic treatment arms; Positive 1 of 1 = 1 positive treatment arm of 1 treatment arm. | |||
Discussion
This review of controlled clinical trials produced a negative answer to the question: “Do probiotics decrease lactose intolerance at a single meal including nonfermented dairy products?” We reviewed articles that involved the simultaneous combination of probiotics and non-fermented dairy products in objectively identified lactose-intolerant individuals.
Strengths of this review
All review studies selected patients who had both gastrointestinal symptoms and positive breath hydrogen test results. All studies used appropriate methodology of randomized design (LOE: 1b). All studies involved a control group or a crossover design in which intervention patients served as their own controls. Further strengths of this review are an adequate number of studies with strong methodology, most (7 of 10) measured the patient-oriented outcome of symptoms, and reports of no adverse effects of probiotic treatments.
Weaknesses of the review
The variations in probiotic subtype, strain, and concentration are weaknesses in this review. Probiotic subtypes and strains vary with regard to β-galactosidase activity, intestinal adherence, cell wall thickness, and other characteristics that may affect clinical efficacy. Jiang showed significant breath hydrogen results with B longum B6 grown in lactose-containing media, while the same strain grown in glucose- and lactose-containing media was not effective. He also found the former strain significantly reduced the symptom of flatulence but not pain, meteorism, borborygmi, or diarrhea.
Only 2 of the 9 L acidophilus studies reported use of similar strains of L acidophilus B (Mustapha, Lin and Yen). Six of the 9 L acidophilus studies accounted for the probiotic subtype and concentration but not its strain. Instead the L acidophilus intervention was expressed as L acidophilus milk or sweet acidophilus milk (Dehkordi, Newcomer, Onwulata, Savaiano, McDonough, Kim). A potential strain outcome association may exist with L acidophilus B. Both Mustapha and Lin and Yen showed positive outcomes with this treatment arm in breath hydrogen and symptom results (TABLE W1).
